Gadsden Properties, Inc. - Quarter Report: 2005 June (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 June 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
¨
The
number of shares outstanding of the issuer's Common Stock as of August 8,
2005 was 51,190,797 shares.
1
PHOTOMEDEX,
INC. AND SUBSIDIARIES
INDEX
Part
I. Financial Information:
|
PAGE
|
||
ITEM
1.
|
Financial
Statements:
|
a.
|
Consolidated
Balance Sheets, June 30, 2005 (unaudited) and December 31,
2004
|
3
|
|
b.
|
Consolidated
Statements of Operations for the three months ended June 30,
2005 and 2004
(unaudited)
|
4
|
|
c.
|
Consolidated
Statements of Operations for the six months ended June 30,
2005 and 2004
(unaudited)
|
5
|
|
d.
|
Consolidated
Statement of Stockholders’ Equity for the six months ended June 30, 2005
(unaudited)
|
6
|
|
e.
|
Consolidated
Statements of Cash Flows for the six months ended June 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
|
26
|
|
ITEM
3.
|
Quantitative
and Qualitative Disclosure about Market Risk
|
47
|
|
ITEM
4.
|
Controls
and Procedures
|
47
|
|
Part
II. Other Information:
|
|||
ITEM
1.
|
Legal
Proceedings
|
47
|
|
ITEM
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
48
|
|
ITEM
3.
|
Defaults
Upon Senior Securities
|
48
|
|
ITEM
4.
|
Submission
of Matters to a Vote of Security Holders
|
48
|
|
ITEM
5.
|
Other
Information
|
48
|
|
ITEM
6.
|
Exhibits
|
49
|
|
Signatures
|
49
|
||
Certifications
|
83
|
2
PART
I - Financial Information
ITEM
1. Financial Statements
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
June
30, 2005
|
December
31, 2004
|
||||||
(Unaudited)
|
*
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
5,513,315
|
$
|
3,884,817
|
|||
Restricted
cash
|
206,802
|
112,200
|
|||||
Accounts
receivable, net of allowance for doubtful accounts of $676,732
and
$736,505, respectively
|
4,745,994
|
4,117,399
|
|||||
Inventories
|
8,108,142
|
4,585,631
|
|||||
Prepaid
expenses and other current assets
|
1,023,068
|
401,989
|
|||||
Total
current assets
|
19,597,321
|
13,102,036
|
|||||
Property
and equipment, net
|
6,179,352
|
4,996,688
|
|||||
Goodwill,
net
|
16,375,384
|
2,944,423
|
|||||
Patents
and licensed technologies, net
|
1,569,322
|
929,434
|
|||||
Other
intangible assets, net
|
4,932,625
|
-
|
|||||
Other
assets
|
296,400
|
989,345
|
|||||
Total
assets
|
$
|
48,950,404
|
$
|
22,961,926
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Current
portion of notes payable
|
$
|
743,455
|
$
|
69,655
|
|||
Current
portion of long-term debt
|
1,216,072
|
873,754
|
|||||
Accounts
payable
|
2,839,449
|
3,515,293
|
|||||
Accrued
compensation and related expenses
|
795,924
|
963,070
|
|||||
Other
accrued liabilities
|
1,119,249
|
924,054
|
|||||
Deferred
revenues
|
626,641
|
636,962
|
|||||
Total
current liabilities
|
7,340,790
|
6,982,788
|
|||||
Long-term
liabilities:
|
|||||||
Notes
payable
|
12,755
|
26,736
|
|||||
Long-term
debt
|
1,692,228
|
1,372,119
|
|||||
Other
liabilities
|
24,670
|
-
|
|||||
Total
liabilities
|
9,070,443
|
8,381,643
|
|||||
Commitments
and Contingencies
|
|||||||
Stockholders’
equity:
|
|||||||
Common
stock, $.01 par value, 75,000,000 shares authorized; 51,099,196
and
40,075,019 shares issued and outstanding, respectively
|
510,992
|
400,750
|
|||||
Additional
paid-in capital
|
117,493,680
|
90,427,632
|
|||||
Accumulated
deficit
|
(78,035,325
|
)
|
(76,246,562
|
)
|
|||
Deferred
compensation
|
(89,386
|
)
|
(1,537
|
)
|
|||
Total
stockholders' equity
|
39,879,961
|
14,580,283
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
48,950,404
|
$
|
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 June 30,
|
|||||||
2005
|
2004
|
||||||
Revenues:
|
|||||||
Product
sales
|
$
|
4,955,066
|
$
|
1,629,357
|
|||
Services
|
3,100,107
|
2,693,777
|
|||||
8,055,173
|
4,323,134
|
||||||
Cost
of revenues:
|
|||||||
Product
cost of revenues
|
1,990,996
|
932,621
|
|||||
Services
cost of revenues
|
2,214,320
|
1,698,748
|
|||||
|
4,205,316
|
2,631,369
|
|||||
Gross
profit
|
3,849,857
|
1,691,765
|
|||||
Operating
expenses:
|
|||||||
Selling,
general and administrative
|
4,322,706
|
2,406,453
|
|||||
Engineering
and product development
|
219,550
|
481,243
|
|||||
4,542,256
|
2,887,696
|
||||||
Loss
from operations
|
(692,399
|
)
|
(1,195,931
|
)
|
|||
Other
income
|
88,667
|
-
|
|||||
Interest
expense, net
|
(56,919
|
)
|
(11,236
|
)
|
|||
Net
loss
|
($
660,651
|
)
|
($
1,207,167
|
)
|
|||
Basic
and diluted net loss per share
|
($0.01
|
)
|
($0.03
|
)
|
|||
Shares
used in computing basic and diluted net loss per share
|
50,859,562
|
38,546,338
|
The
accompanying notes are an integral part of these consolidated financial
statements.
4
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
For
the Six Months Ended June 30,
|
|||||||
2005
|
2004
|
||||||
Revenues:
|
|||||||
Product
sales
|
7,180,765
|
$
|
3,421,757
|
||||
Services
|
5,857,740
|
4,926,607
|
|||||
13,038,505
|
8,348,364
|
||||||
Cost
of revenues:
|
|||||||
Product
cost of revenues
|
2,883,960
|
1,765,105
|
|||||
Services
cost of revenues
|
3,953,724
|
3,360,330
|
|||||
|
6,837,684
|
5,125,435
|
|||||
Gross
profit
|
6,200,821
|
3,222,929
|
|||||
Operating
expenses:
|
|||||||
Selling,
general and administrative
|
7,543,682
|
4,876,877
|
|||||
Engineering
and product development
|
406,521
|
897,193
|
|||||
7,950,203
|
5,774,070
|
||||||
Loss
from operations
|
(1,749,382
|
)
|
(2,551,141
|
)
|
|||
Other
income
|
88,667
|
-
|
|||||
Interest
expense, net
|
(128,048
|
)
|
(19,108
|
)
|
|||
Net
loss
|
($
1,788,763
|
)
|
($
2,570,249
|
)
|
|||
Basic
and diluted net loss per share
|
($0.04
|
)
|
($0.07
|
)
|
|||
Shares
used in computing basic and diluted net loss per share
|
46,322,904
|
38,159,819
|
The
accompanying notes are an integral part of these consolidated financial
statements.
5
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
FOR
THE
SIX MONTHS ENDED JUNE 30, 2005
(Unaudited)
Additional
|
|||||||||||||||||||
Common
Stock
|
Paid-In
|
Accumulated
|
Deferred
|
||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
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
|
736
|
146,324
|
-
|
-
|
147,060
|
|||||||||||||
Exercise
of stock options
|
161,673
|
1,616
|
297,319
|
-
|
-
|
298,935
|
|||||||||||||
Stock
options issued to consultants for services
|
31,859
|
31,859
|
|||||||||||||||||
Issuance
of stock
|
2,484
|
531,201
|
533,685
|
||||||||||||||||
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
|
-
|
-
|
-
|
-
|
44,232
|
44,232
|
|||||||||||||
Registration
expenses
|
-
|
-
|
(161,739
|
)
|
-
|
-
|
(161,739
|
)
|
|||||||||||
Issuance
of warrants
|
23,352
|
23,352
|
|||||||||||||||||
Net
loss for the six months ended June 30, 2005
|
-
|
-
|
-
|
(1,788,763
|
)
|
-
|
(1,788,763
|
)
|
|||||||||||
BALANCE,
JUNE 30, 2005
|
50,850,801
|
$
|
510,992
|
$
|
117,493,680
|
($78,035,325
|
)
|
($89,386
|
)
|
$
|
39,879,961
|
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 Six Months Ended
June
30,
|
|||||||
2005
|
2004
|
||||||
Cash
Flows From Operating Activities:
|
|||||||
Net
loss
|
($
1,788,763
|
)
|
($
2,570,249
|
)
|
|||
Adjustments
to reconcile net loss to net cash used
|
|||||||
in
operating activities:
|
|||||||
Depreciation
and amortization
|
1,332,754
|
878,890
|
|||||
Stock
options issued to consultants for services
|
31,859
|
48,192
|
|||||
Amortization
of deferred compensation
|
44,232
|
3,241
|
|||||
Nonmonetary
exchange of assets
|
(88,667
|
)
|
-
|
||||
Provision
for bad debts
|
276,124
|
82,157
|
|||||
Changes
in operating assets and liabilities, net of effects on acquired
assets and
liabilities:
|
|||||||
Accounts
receivable
|
232,694
|
(217,048
|
)
|
||||
Inventories
|
(587,401
|
)
|
90,397
|
||||
Prepaid
expenses and other assets
|
435,313
|
70,279
|
|||||
Accounts
payable
|
(1,281,364
|
)
|
(86,595
|
)
|
|||
Accrued
compensation and related expenses
|
(318,453
|
)
|
(89,625
|
)
|
|||
Other
accrued liabilities
|
(788,380
|
)
|
(132,660
|
)
|
|||
Deferred
revenues
|
(105,757
|
)
|
121,928
|
||||
Other
liabilities
|
(28,213
|
)
|
-
|
||||
Net
cash used in operating activities
|
(2,634,022
|
)
|
(1,801,093
|
)
|
|||
Cash
Flows From Investing Activities:
|
|||||||
Purchases
of property and equipment
|
(61,345
|
)
|
(55,527
|
)
|
|||
Lasers
placed into service
|
(1,727,800
|
)
|
(845,780
|
)
|
|||
Cash
received from acquisition, net of costs incurred
|
5,578,416
|
-
|
|||||
Net
cash provided by (used in) investing activities
|
3,789,271
|
(901,307
|
)
|
||||
Cash
Flows From Financing Activities:
|
|||||||
Proceeds
from issuance of common stock, net of direct issuance
costs
|
(161,739
|
)
|
11,199
|
||||
Proceeds
from exercise of options
|
298,935
|
62,212
|
|||||
Proceeds
from exercise of warrants
|
147,060
|
1,718,592
|
|||||
Payments
on long-term debt
|
(137,028
|
)
|
(152,907
|
)
|
|||
Payments
on notes payable
|
(318,432
|
)
|
(251,869
|
)
|
|||
Net
repayments on bank line of credit
|
-
|
(1,000,000
|
)
|
||||
Net
advancements on lease line of credit
|
739,055
|
1,369,680
|
|||||
Increase
in restricted cash and cash equivalents
|
(94,602
|
)
|
-
|
||||
Net
cash provided by financing activities
|
473,249
|
1,756,907
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
1,628,498
|
(945,493
|
)
|
||||
Cash
and cash equivalents, beginning of period
|
3,884,817
|
6,633,468
|
|||||
Cash
and cash equivalents, end of period
|
$
|
5,513,315
|
$
|
5,687,975
|
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
The
Company and Summary of Significant Accounting Policies:
The
Company:
Background
PhotoMedex,
Inc. and subsidiaries (the “Company”) is a medical device and specialty
pharmaceutical company focused on facilitating the cost-effective use of
technologies for doctors, hospitals and surgery centers to enable their patients
to achieve a higher quality of life. The Company develops, manufactures and
markets excimer-laser-based instrumentation designed to phototherapeutically
treat psoriasis, vitiligo, atopic dermatitis and leukoderma. In January 2000,
the Company received the first Food and Drug Administration (“FDA”) clearance to
market an excimer laser system, the XTRAC® system, for the treatment of
psoriasis. In March 2001, the Company received FDA clearance to treat vitiligo;
in August 2001, the Company received FDA clearance to treat atopic dermatitis;
and in May 2002, the FDA granted 510(k) clearance to market the XTRAC system
for
the treatment of leukoderma. The Company launched the XTRAC phototherapy
treatment system commercially in the United States in August 2000.
Beginning
with 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 has had negative cash flows from
operations since emerging from bankruptcy in May 1995. As of June 30, 2005,
the
Company had an accumulated deficit of $78,035,325. However, the Company was
successful in reducing its net loss for the three months ended June 30,
2005 by $546,516, a 45% improvement, compared to the three months ended
June 30, 2004. The Company also reduced its net loss for the six months
ended June 30, 2005 by $781,583, a 30% improvement, compared to the six months
ended June 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.
To
increase patient acceptance of targeted UVB therapy for skin disorders using
the
XTRAC, the Company needed to obtain current procedural terminology (“CPT”) codes
from the American Medical Association, which established such codes in the
latter part of 2002. By early 2003, the Centers for Medicare and Medicaid
Services (“CMS”) had approved rates of reimbursement for these new CPT codes.
The Company also needed private health insurance carriers to adopt medical
policies to reimburse patients for the treatment. The Company therefore began
to
focus its efforts on securing approval by various private health plans to
reimburse for treatments of psoriasis using the XTRAC. Simultaneously the
Company re-launched the marketing of its XTRAC system in the United States.
The
Company plans to continue to focus on securing reimbursement from more private
insurers and to devote sales and marketing efforts in the areas where such
reimbursement has become available. As favorable momentum is achieved and
maintained, the Company will spend substantial amounts on the marketing of
its
psoriasis, vitiligo, atopic dermatitis and leukoderma treatment products
and
expansion of its manufacturing efforts. Notwithstanding the approval by CMS
for
Medicare and Medicaid reimbursement 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 resistance from plans that adopt favorable policies but set
the
reimbursement rates so low that physicians are discouraged from performing
such
procedures 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.
The
Company’s future revenues and 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 excimer-laser-based system for the treatment of
psoriasis, vitiligo, atopic dermatitis and leukoderma is currently generating
revenues in both the United States and abroad. The Company’s ability to
introduce successful new products based on its business focus and the expected
benefits to be obtained from these products may be adversely affected by
a
number of factors, such as unforeseen costs and expenses, technological change,
economic downturns, competitive factors or other events beyond the Company’s
control. Consequently, the Company’s historical operating results cannot be
relied upon as indicators 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.
8
Cash
and
cash equivalents were $5,720,117, including restricted cash of $206,802,
as of
June 30, 2005. Management believes that the existing cash balance
together
with its existing financial resources, including the leasing credit line
facility (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 second 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 costs 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.
Summary
of Significant Accounting Policies:
Quarterly
Financial Information and Results of Operations
The
financial statements as of June 30, 2005 and for the six months ended
June 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 June 30,
2005, and
the results of operations and cash flows for the six months ended June 30,
2005 and 2004. The results for the six months ended June 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 perceived with certainty; estimating,
therefore, requires the exercise of judgment. Thus, accounting estimates
change
as new events occur, as more experience is acquired, or as additional
information is obtained. See Revenue
Recognition
for
discussion of updates and changes in estimates for XTRAC domestic revenues
in
accordance with Staff Accounting Bulletin Nos. 101 and 104 and Statement
of
Financial Accounting Standards (“SFAS”) No. 48.
Cash
and Cash Equivalents
The
Company invests its excess cash in highly liquid, short-term investments.
The
Company considers short-term investments that are purchased with an original
maturity of three months or less to be cash equivalents. Cash and cash
equivalents consisted of cash and money market accounts at June 30,
2005
and December 31, 2004.
Cash
that is pledged to secure obligations is disclosed separately as restricted
cash. The Company maintains its cash and cash equivalents in accounts in
several
banks, the balances of which at times may exceed federally insured
limits.
Accounts
Receivable
The
majority of the Company’s accounts receivables are due from distributors
(domestic and international), hospitals, universities and physicians and
other
entities in the medical field. Credit is extended based on evaluation of
a
customer’s financial condition and, generally, collateral is not required.
Accounts receivable are most often due within 30 to 90 days and are stated
at
amounts due from customers net of an allowance for doubtful accounts. Accounts
outstanding longer than the contractual payment terms are considered past
due.
The Company determines its allowance by considering a number of factors,
including the length of time trade accounts receivable are past due, the
customer’s previous loss history, the customer’s current ability to pay its
obligation to the Company, and the condition of the general economy and the
industry as a whole. The Company writes off accounts receivable when they
become
uncollectible, and payments subsequently received on such receivables are
credited to the bad debt expense. The Company does not accrue interest on
accounts receivable that are past due.
9
Inventories
Inventories
are stated at the lower of cost (first-in, first-out basis) or market. Costs
are
determined to be purchased cost for raw materials and the production cost
(materials, labor and indirect manufacturing cost) for work-in-process and
finished goods. Throughout the laser manufacturing process, the related
production costs are recorded within the cost of inventory. Work-in-process
is
immaterial, given the typically short manufacturing cycle, and therefore
is
disclosed in conjunction with raw materials. The Company performs full physical
inventory counts for XTRAC and cycle counts on the other inventory to maintain
controls and obtain accurate data.
The
Company's skin disorder treatment equipment will either (i) be sold to
distributors or physicians directly or (ii) be placed in a physician's office
and remain the property of the Company. The cost to build a laser, whether
for
sale or for placement, is accumulated in inventory. When a laser is placed
in a
physician’s office, the cost is transferred from inventory to “lasers in
service” within property and equipment. At times, units are shipped to
distributors, but revenue is not recognized until all of the criteria of
Staff
Accounting Bulletin No. 104 have been met, and until that time, the cost
of the
unit is carried on the books of the Company as finished goods inventory.
Revenue
is not recognized from these distributors until payment is either assured
or
paid in full.
Reserves
for slow moving and obsolete inventories are provided based on historical
experience and product demand. Management evaluates the adequacy of these
reserves periodically based on forecasted sales and market trend.
Property,
Equipment and Depreciation
Property
and equipment are recorded at cost. Excimer lasers-in-service are depreciated
on
a straight-line basis over the estimated useful life of three years. Surgical
lasers-in-service are depreciated on a straight-line basis over an estimated
useful life of seven years if the equipment is new, and five years or less
if it
is used. The straight-line depreciation basis for lasers-in-service is
reflective of the pattern of use. For other property and equipment, depreciation
is calculated on a straight-line basis over the estimated useful lives of
the
assets, primarily three to seven years for computer hardware and software,
furniture and fixtures, automobiles, and machinery and equipment. Leasehold
improvements are amortized over the lesser of the useful lives or lease terms.
Expenditures for major renewals and betterments to property and equipment
are
capitalized, while expenditures for maintenance and repairs are charged to
operations as incurred. Upon retirement or disposition, the applicable property
amounts are deducted from the accounts and any gain or loss is recorded in
the
consolidated statements of operations.
Laser
units and laser accessories located at medical facilities for sales evaluation
and demonstration purposes or those units and accessories used for development
and medical training are included in property and equipment under the caption
“machinery and equipment.” These units and accessories are being depreciated
over a period of up to five years. Laser units utilized in the provision
of
surgical services or in the treatment of skin disorders are included, as
discussed above, in property and equipment under the caption “lasers in
service.”
Management
evaluates the realizability of property and equipment based on estimates
of
undiscounted future cash flows over the remaining useful life of the asset.
If
the amount of such estimated undiscounted future cash flows is less than
the net
book value of the asset, the asset is written down to its net realizable
value.
As of June 30, 2005, no such write-down was required (see Impairment
of Long-Lived Assets
below).
Patent
Costs and Licensed Technologies
Costs
incurred to obtain or defend patents and licensed technologies are capitalized
and amortized over the shorter of the remaining estimated useful lives or
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 recorded in connection with the acquisition of ProCyte
in March 2005 and is being amortized on a straight-line basis over seven
years.
10
Management
evaluates the realizability of intangible assets based on estimates of
undiscounted future cash flows over the remaining useful life of the asset.
If
the amount of such estimated undiscounted future cash flows is less than
the net
book value of the asset, the asset is written down to fair value. As of
June 30, 2005, no such write-down was required (see Impairment
of Long-Lived Assets
below).
Other
Intangible Assets
Other
intangible assets were recorded in connection with the acquisition of ProCyte
in
March 2005. The assets are being amortized on a straight-line basis over
5 to 10
years.
Management
evaluates the realizability 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
June 30, 2005, no such write-down was required (see Impairment
of Long-Lived Assets
below).
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
six
months ended June 30, 2005 is summarized as follows:
June
30, 2005
|
||||
Accrual
at beginning of period
|
$
|
196,890
|
||
Additions
charged to warranty expense
|
42,000
|
|||
Claims
paid and expiring warranties
|
(26,288
|
)
|
||
Accrual
at end of period
|
$
|
212,602
|
Revenue
Recognition
The
Company has two distribution channels for its phototherapy treatment equipment.
The Company will 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 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: the product has been shipped
and the Company has no significant remaining obligations; persuasive evidence
of
an arrangement exists; the price to the buyer is fixed or determinable; and
collection is probable (the “SAB 104 Criteria”). At times, units are shipped but
revenue is not recognized until all of the criteria have been met, and until
that time, the unit is carried on the books of the Company as inventory.
The
Company ships most of its products FOB shipping point, although from time
to
time certain customers, for example governmental customers, will insist on
FOB
destination. Among the factors the Company takes into account in determining
the
proper time at which to recognize revenue are when title to the goods transfers
and when the risk of loss transfers. Shipments to 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.
Until
the
fourth quarter of 2004, unused treatments had 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 purchased quantity 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: 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 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.
11
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 that the actual amount of unused treatments
that existed at that date is more closely approximated by its present approach
than by 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 proforma amounts for prior periods.
The
Company has continued this approach or method for estimating the amount of
unused treatments at June 30, 2005. Due to this updated approach in estimates,
XTRAC domestic revenues were increased by $60,000 for the three months ended
June 30, 2005 and decreased by $62,000 for the six months ended June 30,
2005,
as compared to the prior method of estimation.
In
the
first quarter of 2003, the Company implemented a program to support certain
physicians by 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. The Company must estimate the extent to which a physician
participating in the program has been reimbursed. For the three and six months
ended June 30, 2005, the Company’s XTRAC domestic revenues were reduced by
an additional $51,865 and $32,715, respectively, under this program as all
the
criteria for revenue recognition were not met.
Under
this program, qualifying doctors can be reimbursed for the cost of the Company’s
fee 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 qualify to be in the program (i.e. it 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, if the claim remains
unpaid, then the physician is entitled to receive refund or credit
for the
treatment he or she purchased from the Company (the Company’s 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.
|
12
Historically,
the Company estimated this contingent liability for potential refund 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 91,000 treatments in the last two years and detailed record
keeping of denied insurance claims and appeals processed, the Company can
reliably estimate 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 estimation procedure 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 have recorded this change in accordance with the
relevant provisions of SFAS No. 48 and APB No. 20. These requirements 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 $154,000 and $56,000 for the three and six months ended June
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 $214,000 for the three months ended June 30, 2005 and to decrease
revenues by approximately $6,000 for the six months ended June 30, 2005.
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; 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.
Product
Development Costs
Costs
of
research, new product development and product redesign are charged to expense
as
incurred.
Income
Taxes
The
Company accounts for income taxes in accordance with SFAS No. 109, “Accounting
for Income Taxes.” Under SFAS No. 109, the liability method is used for income
taxes. Under this method, deferred tax assets and liabilities are determined
based on differences between the financial reporting and tax basis of assets
and
liabilities and are measured using enacted tax rates and laws that are expected
to be in effect when the differences reverse.
The
Company’s deferred tax asset has been fully reserved under a valuation
allowance, reflecting the uncertainties as to realizability evidenced by
the
Company’s historical results and restrictions on the usage of the net operating
loss carryforwards. Consistent with the rules of purchase accounting, the
historical deferred tax asset of ProCyte was 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.
13
Net
Loss Per Share
The
Company computes net loss per share in accordance with SFAS No. 128, “Earnings
per Share.” In accordance with SFAS No. 128, basic net loss per share is
calculated by dividing net loss available to common stockholders by the weighted
average number of common shares outstanding for the period. Diluted net loss
per
share reflects the potential dilution from the conversion or exercise 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 8,509,883 and 9,316,850 as of June 30, 2005 and 2004,
respectively, were excluded from the calculation of fully diluted earnings
per
share since their inclusion would have been anti-dilutive.
Fair
Value of Financial Instruments
The
estimated fair values for financial instruments under SFAS No. 107, “Disclosures
about Fair Value of Financial Instruments,” are determined at discrete points in
time based on relevant market information. These estimates involve uncertainties
and cannot be determined with precision. The fair value of cash is based
on its
demand value, which is equal to its carrying value. The fair value of notes
payable is based on borrowing rates that are available to the Company for
loans
with similar terms, collateral and maturity. The estimated fair value of
notes
payable approximate the carrying values. Additionally, the carrying value
of all
other monetary assets and liabilities is equal to their fair value due to
the
short-term nature of these instruments.
Impairment
of Long-Lived Assets
In
accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of
Long-Lived Assets,” long-lived assets, such as property and equipment, and
purchased intangibles subject to amortization, are reviewed for impairment
whenever events or changes in circumstances indicate that the carrying amount
of
an asset may not be recoverable. Recoverability of assets to be held and
used is
measured by a comparison of the carrying amount of an asset to estimated
undiscounted future cash flows expected to be generated by the asset. If
the
carrying amount of an asset exceeds its estimated future cash flows, an
impairment charge is recognized by the amount by which the carrying amount
of
the asset exceeds the fair value of the asset. Assets to be disposed of would
be
separately presented in the balance sheet and reported at the lower of the
carrying amount or fair value less costs to sell, and would no longer be
depreciated. The assets and liabilities of a disposed group classified as
held
for sale would be presented separately in the appropriate asset and liability
sections of the balance sheet. As of June 30, 2005, no such impairment
existed.
Exchanges
of Nonmonetary Assets
Exchanges
under SFAS No. 153, “Exchanges of Nonmonetary Assets,” should be measured based
on the fair value of the assets exchanged. Further, SFAS No. 153 eliminates
the
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.” SFAS No. 153 is generally effective for
financial statements for fiscal years beginning after June 15, 2005. The
Company
has elected to adopt this Statement for the current fiscal year. For the
three
and six months ended June 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.
14
Options
that were assumed from ProCyte and that were unvested as of March 18, 2005
were
re-measured as of March 18, 2005 under intrinsic-value-based accounting.
Unearned compensation of $132,081 was recorded and will be amortized over
the
remaining vesting period, which is an average of two years.
Had
stock
compensation cost for the Company’s common stock options been determined based
upon the fair value of the options at the date of grant, as prescribed under
SFAS No. 123, the Company’s net loss and net loss per share would have been
increased to the following pro-forma amounts:
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Net
loss:
|
|||||||||||||
As
reported
|
($660,651
|
)
|
($1,207,167
|
)
|
($1,788,763
|
)
|
($2,570,249
|
)
|
|||||
Less:
stock-based employee compensation expense included in reported
net
loss
|
40,033
|
1,621
|
44,232
|
3,241
|
|||||||||
Impact
of total stock-based compensation expense determined under
fair-value-based method for all grants and awards
|
(496,366
|
)
|
(427,720
|
)
|
(781,468
|
)
|
(872,523
|
)
|
|||||
Pro-forma
|
($1,116,984
|
)
|
($1,633,266
|
)
|
($2,525,999
|
)
|
($3,439,531
|
)
|
|||||
Net
loss per share:
|
|||||||||||||
As
reported
|
($0.01
|
)
|
($0.03
|
)
|
($0.04
|
)
|
($0.07
|
)
|
|||||
Pro-forma
|
($0.02
|
)
|
($0.04
|
)
|
($0.05
|
)
|
($0.09
|
)
|
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 six-month periods:
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
||||||
2005
|
2004
|
2005
|
2004
|
||||
Risk-free
interest rate
|
4.45%
|
3.07%
|
4.17%
|
3.07%
|
|||
Volatility
|
117.09%
|
99.9%
|
103.88%
|
99.9%
|
|||
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 six months ended June 30, 2005, the Company financed insurance
policies
through notes payable for $978,252. During the six months ended June 30,
2004, the Company financed insurance policies through notes payable for
$530,997. During the six months ended June 30, 2005, the Company issued 248,395
shares of common stock to Stern upon attainment of certain milestones, which
is
included in patents and licensed technologies.
For
the
six months ended June 30, 2005 and 2004, the Company paid interest of $162,107
and $41,746, respectively. Income taxes paid in the six months ended June
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.
15
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 an 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
ProCyte
is a Washington corporation 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 bring unique products primarily based upon patented
technologies such as GHK and AHK copper peptide technologies, to selected
markets. ProCyte currently sells its products directly to 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 specifically targeted technology licensing and
supply
agreements.
ProCyte’s
products address the growing demand for skin health and hair care products,
including products designed to address the effects aging has on the skin
and
hair and to enhance appearance. ProCyte’s products are formulated, branded for
and targeted at specific markets. ProCyte’s initial products in this area
addressed the dermatology, plastic and cosmetic surgery markets for use
following various procedures. Anti-aging skin care products were added to
expand
into a comprehensive approach for incorporation into a patient’s skin care
regimen. Certain of these products incorporate ProCyte’s patented technologies,
while others complement the product line such as ProCyte’s advanced sunscreen
products that reduce the effects of sun damage and aging on the
skin.
16
The
aggregate purchase price was $27,543,784 and was paid through 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 the incurrence of $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, resulting in goodwill in the same amount.
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
six months ended June 30, 2005 and 2004, assuming the acquisition had occurred
on January 1, 2004.
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Net
revenues
|
$
|
8,055,173
|
$
|
8,007,812
|
$
|
16,008,067
|
$
|
15,252,802
|
|||||
Net
loss
|
(660,651
|
)
|
(1,446,587
|
)
|
(1,890,815
|
)
|
(2,949,889
|
)
|
|||||
Basic
and diluted loss per share
|
(0.01
|
)
|
(0.03
|
)
|
(0.04
|
)
|
(0.06
|
)
|
|||||
Shares
used in calculating basic and diluted loss per share
|
50,859,562
|
49,086,917
|
50,748,782
|
48,700,398
|
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.
17
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 June 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 $874,254 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.
June 30, 2005
|
December 31, 2004
|
||||||
Raw
materials and work in progress
|
$
|
4,057,222
|
$
|
2,968,728
|
|||
Finished
goods
|
4,050,920
|
1,616,903
|
|||||
Total
inventories
|
$
|
8,108,142
|
$
|
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 $31,774
and
$84,000 as of June 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.
Note
4
Property
and Equipment:
Set
forth
below is a detailed listing of property and equipment.
June
30, 2005
|
December
31, 2004
|
||||||
Lasers
in service
|
$
|
11,136,888
|
$
|
9,333,591
|
|||
Computer
hardware and software
|
393,266
|
256,340
|
|||||
Furniture
and fixtures
|
309,884
|
239,520
|
|||||
Machinery
and equipment
|
625,003
|
522,643
|
|||||
Autos
and trucks
|
382,690
|
400,570
|
|||||
Leasehold
improvements
|
110,441
|
110,441
|
|||||
12,958,172
|
10,863,105
|
||||||
Accumulated
depreciation and amortization
|
(6,778,820
|
)
|
(5,866,417
|
)
|
|||
Property
and equipment, net
|
$
|
6,179,352
|
$
|
4,996,688
|
Depreciation
expense was $946,267 and $795,554 for the six months ended June 30,
2005
and 2004, respectively. At June 30, 2005 and December 31, 2004, net
property and equipment included $617,883 and $666,326, respectively, of assets
recorded under capitalized lease arrangements, of which $428,218 and $565,245
was included in long-term debt at June 30, 2005 and December 31, 2004,
respectively (see Note 9).
18
Note
5
Patents
and Licensed Technologies:
Set
forth
below is a detailed listing of patents and licensed technologies.
June
30, 2005
|
December
31, 2004
|
||||||
Patents,
owned and licensed, at gross costs of $428,338 and $403,023, net
of
accumulated amortization of $176,157 and $155,522
respectively
|
$
|
252,181
|
$
|
247,501
|
|||
Other
licensed or developed technologies, at gross costs of $1,911,254
and
$1,177,568, net of accumulated amortization of $594,113 and $495,635
respectively
|
1,317,141
|
681,933
|
|||||
$
|
1,569,322
|
$
|
929,434
|
Related
amortization expense was $119,112 and $83,336 for the six months ended
June 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.
June
30, 2005
|
||||
Neutrogena
Agreement, at gross costs of $2,400,000 net of accumulated amortization
of
$138,000.
|
$
|
2,262,000
|
||
Customer
Relationships, at gross costs of $1,700,000 net of accumulated
amortization of $97,750.
|
1,602,250
|
|||
Tradename,
at gross costs of $1,100,000 net of accumulated amortization of
$31,625.
|
1,068,375
|
|||
$
|
4,932,625
|
Related
amortization expense was $267,375 for the six months ended June 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.
Note
7
Other
Accrued Liabilities:
Set
forth
below is a detailed listing of other accrued liabilities.
June
30, 2005
|
December
31, 2004
|
||||||
Accrued
warranty
|
$
|
212,603
|
$
|
196,890
|
|||
Accrued
liability from matured notes
|
244,988
|
245,849
|
|||||
Accrued
professional and consulting fees
|
355,247
|
412,019
|
|||||
Accrued
sales taxes
|
146,619
|
61,142
|
|||||
Other
accrued expenses
|
159,792
|
8,154
|
|||||
Total
other accrued liabilities
|
$
|
1,119,249
|
$
|
924,054
|
During
2002, SLT resumed direct control of $223,000 of funds previously set aside
for
the payment of SLT’s subordinated notes, which matured and ceased to bear
interest on July 30, 1999, and $31,000 of funds set aside to pay related
accrued
interest. As of June 30, 2005 and December 31, 2004, the matured principal
and related interest was $244,988. After July 30, 2005, the outstanding notes,
and the related funds, are no longer redeemable.
19
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.
June
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.
|
$
|
39,618
|
$
|
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
|
107,668
|
-
|
|||||
Note
payable - unsecured creditor, interest at 7.42%, payable in monthly
principal and interest installments of $15,600 through November
2005
|
76,575
|
-
|
|||||
Note
Payable - unsecured creditor, interest at 7.42%, payable in monthly
principal and interest installments of $61,493 through March
2006
|
532,349
|
-
|
|||||
756,210
|
96,391
|
||||||
Less:
current maturities
|
(743,455
|
)
|
(69,655
|
)
|
|||
Notes
payable, net of current maturities
|
$
|
12,755
|
$
|
26,736
|
Note
9
Long-term
Debt:
Set
forth
below is a detailed listing of the Company’s long-term debt.
June
30, 2005
|
December
31, 2004
|
||||||
Borrowings
on credit facility
|
$
|
2,480,082
|
$
|
1,680,627
|
|||
Capital
lease obligations (see Note 4)
|
428,218
|
565,246
|
|||||
Less:
current portion
|
(1,216,072
|
)
|
(873,754
|
)
|
|||
Total
long-term debt
|
$
|
1,692,228
|
$
|
1,372,119
|
The
Company obtained a leasing credit facility from 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 continues to depreciate 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.
20
As
of
June 30, 2005, the Company had made three draws against the first tranche
of the
line.
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 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.
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
June 30, 2005, the Company had made its first draw against the second tranche
of
the line (which is Draw 4 under the line), as follows:
Draw
4
|
|
Date
of draw
|
6/28/05
|
Amount
of draw
|
$1,113,326
|
Stated
interest rate
|
8.42%
|
Effective
interest rate
|
12.63%
|
Number
of warrants issued
|
14,714
|
Exercise
price of warrants per share
|
$2.50
|
Fair
value of warrants
|
$23,352
|
The
fair
value of the warrants granted under Draw 4 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
|
|
Risk-free
interest rate
|
4.17%
|
Volatility
|
94.6%
|
Expected
dividend yield
|
0%
|
Expected
option life
|
5
years
|
21
The
carrying value of the liability under Draw 4 is, for reporting purposes,
reduced
at the time of the 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 Draw 4.
Concurrent
with the SLT acquisition, the Company assumed a $3,000,000 credit facility
from
a bank. The credit facility had a commitment term of four years, which expired
May 31, 2004, permitted deferment of principal payments until the end of
the
commitment term, and was secured by SLT’s business assets, including
collateralization (until May 13, 2003) of $2,000,000 of SLT’s cash and cash
equivalents and short-term investments. The bank agreed to allow the Company
to
apply the cash collateral to a paydown of the facility in 2003. The credit
facility had an interest rate of the 30-day LIBOR plus 2.25%.
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
six months ended June 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
six months ended June 30, 2004, 976,263 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
$1,720,842 in cash proceeds from the exercises. Of these proceeds, $803,450
was
from the exercise of warrants that were exercisable at $1.77 per share and
were
set to expire on March 31, 2004.
Note
11
Business
Segment and Geographic Data:
Segments
are distinguished primarily by the organization of the Company’s management
structure. Industry considerations and the business model used to generate
revenues also influence distinctions. The Domestic XTRAC segment is a
procedure-based business model used to date only in the United States with
revenues derived from procedures performed by dermatologists. The International
XTRAC segment presently generates revenues from the sale of equipment to
dermatologists through a network of distributors outside the United States.
The
Surgical Services segment generates revenues by providing fee-based procedures
generally 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 royalties on licenses for the patented copper
peptide compound. For the three and six months ended June 30, 2005
and
2004, the Company did not have material net 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 June 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
June 30, 2005 from the ProCyte acquisition has been allocated to the Skin
Care
(ProCyte) segment.
22
Three
Months Ended June 30, 2005
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
XTRAC
|
SURGICAL
SERVICES |
SURGICAL
PRODUCTS AND
OTHER
|
SKIN
CARE
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
889,171
|
$
|
314,183
|
$
|
2,003,380
|
$
|
1,326,225
|
$
|
3,522,214
|
$
|
8,055,173
|
|||||||
Costs
of revenues
|
689,990
|
234,155
|
1,502,219
|
736,490
|
1,042,462
|
4,205,316
|
|||||||||||||
Gross
profit
|
199,181
|
80,028
|
501,161
|
589,735
|
2,479,752
|
3,849,857
|
|||||||||||||
Gross
profit %
|
22.4%
|
|
25.5%
|
|
25.0%
|
|
44.5%
|
|
70.4%
|
|
47.8%
|
|
|||||||
Allocated
Operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
674,934
|
92,594
|
330,183
|
145,243
|
1,594,667
|
2,837,621
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
-
|
174,023
|
45,527
|
219,550
|
|||||||||||||
|
|||||||||||||||||||
Unallocated
Operating expenses
|
-
|
-
|
-
|
-
|
-
|
1,485,085
|
|||||||||||||
|
674,934
|
92,594
|
330,183
|
319,266
|
1,640,194
|
4,542,256
|
|||||||||||||
Income
(loss) from operations
|
(475,753
|
)
|
(12,566
|
)
|
170,978
|
270,469
|
839,558
|
(692,399
|
)
|
||||||||||
|
|||||||||||||||||||
Other
income
|
88,667
|
||||||||||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(56,919
|
)
|
||||||||||||
|
|||||||||||||||||||
Net
income (loss)
|
($475,753
|
)
|
($12,566
|
)
|
$
|
170,978
|
$
|
270,469
|
$
|
839,558
|
($660,651
|
)
|
|||||||
Three
Months Ended June 30, 2004
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
XTRAC
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
SKIN
CARE
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
719,263
|
$
|
454,770
|
$
|
1,933,936
|
$
|
1,215,165
|
-
|
$
|
4,323,134
|
||||||||
Costs
of revenues
|
540,841
|
322,380
|
1,121,165
|
646,983
|
-
|
2,631,369
|
|||||||||||||
Gross
profit
|
178,422
|
132,390
|
812,771
|
568,182
|
-
|
1,691,765
|
|||||||||||||
Gross
profit %
|
24.8%
|
|
29.1%
|
|
42.0%
|
|
46.8%
|
|
-%
|
|
39.1%
|
|
|||||||
Allocated
Operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
460,135
|
122,945
|
341,076
|
178,460
|
-
|
1,102,616
|
|||||||||||||
Engineering
and product development
|
180,426
|
112,949
|
-
|
187,868
|
-
|
481,243
|
|||||||||||||
Unallocated
Operating expenses
|
-
|
-
|
-
|
-
|
-
|
1,303,837
|
|||||||||||||
640,561
|
235,894
|
341,076
|
366,328
|
-
|
2,887,696
|
||||||||||||||
Income
(loss) from operations
|
(462,139
|
)
|
(103,504
|
)
|
471,695
|
201,854
|
-
|
(1,195,931
|
)
|
||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(11,236
|
)
|
||||||||||||
Net
income (loss)
|
($462,139
|
)
|
($103,504
|
)
|
$
|
471,695
|
$
|
201,854
|
-
|
($1,207,167
|
)
|
23
Six
Months Ended June 30, 2005
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
XTRAC
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
SKIN
CARE
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
1,523,189
|
$
|
602,385
|
$
|
4,074,030
|
$
|
2,693,386
|
$
|
4,145,515
|
$
|
13,038,505
|
|||||||
Costs
of revenues
|
1,093,171
|
393,750
|
2,817,679
|
1,264,665
|
1,268,419
|
6,837,684
|
|||||||||||||
Gross
profit
|
430,018
|
208,635
|
1,256,351
|
1,428,721
|
2,877,096
|
6,200,821
|
|||||||||||||
Gross
profit %
|
28.2%
|
|
34.6%
|
|
30.8%
|
|
53.0%
|
|
69.4%
|
|
47.6%
|
|
|||||||
Allocated
Operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
1,205,922
|
153,627
|
621,299
|
303,396
|
1,951,469
|
4,235,713
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
-
|
347,197
|
59,324
|
406,521
|
|||||||||||||
|
|||||||||||||||||||
Unallocated
Operating expenses
|
-
|
-
|
-
|
-
|
-
|
3,307,969
|
|||||||||||||
1,205,922
|
153,627
|
621,299
|
650,593
|
2,010,793
|
7,950,203
|
||||||||||||||
Income
(loss) from operations
|
(775,904
|
)
|
55,008
|
635,052
|
778,128
|
866,303
|
(1,749,382
|
)
|
|||||||||||
Other
income
|
88,667
|
||||||||||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(128,048
|
)
|
||||||||||||
Net
income (loss)
|
($775,904
|
)
|
$
|
55,008
|
$
|
635,052
|
$
|
778,128
|
$
|
866,303
|
($1,788,763
|
)
|
Six
Months Ended June 30, 2004
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
XTRAC
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
SKIN
CARE
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
1,269,864
|
$
|
1,035,514
|
$
|
3,573,540
|
$
|
2,469,446
|
-
|
$
|
8,348,364
|
||||||||
Costs
of revenues
|
1,027,127
|
692,760
|
2,260,075
|
1,145,473
|
-
|
5,125,435
|
|||||||||||||
Gross
profit
|
242,737
|
342,754
|
1,313,465
|
1,323,973
|
-
|
3,222,929
|
|||||||||||||
Gross
profit %
|
19.1%
|
|
33.1%
|
|
36.8%
|
|
53.6%
|
|
-%
|
|
38.6%
|
|
|||||||
Allocated
Operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
960,875
|
251,046
|
667,067
|
302,914
|
-
|
2,181,902
|
|||||||||||||
Engineering
and product development
|
343,220
|
214,860
|
-
|
339,113
|
-
|
897,193
|
|||||||||||||
Unallocated
Operating expenses
|
-
|
-
|
-
|
-
|
-
|
2,694,975
|
|||||||||||||
1,304,095
|
465,906
|
667,067
|
642,027
|
-
|
5,774,070
|
||||||||||||||
Income
(loss) from operations
|
(1,061,358
|
)
|
(123,152
|
)
|
646,398
|
681,946
|
-
|
(2,551,141
|
)
|
||||||||||
Interest
expense (income), net
|
-
|
-
|
-
|
-
|
-
|
(19,108
|
)
|
||||||||||||
Net
income (loss)
|
($1,061,358
|
)
|
$
|
(123,152
|
)
|
$
|
646,398
|
$
|
681,946
|
-
|
($2,570,249
|
)
|
|||||||
June
30, 2005
|
December
31, 2004
|
||||||
Assets:
|
|||||||
Total
assets for reportable segments
|
$
|
42,166,914
|
$
|
18,547,510
|
|||
Other
unallocated assets
|
6,783,491
|
4,414,416
|
|||||
Consolidated
total
|
$
|
48,950,405
|
$
|
22,961,926
|
24
For
the
three and six months ended June 30, 2005 and 2004, there were no material
net revenues attributed to an individual foreign country. Net revenues by
geographic area were as follows:
For
the Three Months Ended
June 30, |
For
the Six Months Ended
June
30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Domestic
|
$
|
7,217,589
|
$
|
3,687,091
|
$
|
11,683,255
|
$
|
6,956,838
|
|||||
Foreign
|
837,584
|
636,043
|
1,355,250
|
1,391,526
|
|||||||||
$
|
8,055,173
|
$
|
4,323,134
|
$
|
13,038,505
|
$
|
8,348,364
|
Note
12
Significant
Alliances/Agreements:
On
March
31, 2005, the Company entered into a Sales and Marketing Agreement with
GlobalMed (Asia) Technologies Co., Inc. Under this Agreement, GlobalMed will
act
as master distributor in the Pacific Rim for the Company’s XTRAC excimer laser,
including the Ultra™ excimer laser, as well as 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
25,000
options in the common stock of the Company, issued at fair market
value.
On
July
27, 2005, the Company entered a Marketing Agreement with KDS Marketing, Inc.
Using money invested by each party, KDS will research market opportunities
for
the Company’s diode laser and related delivery systems; based on such research,
KDS will market the diode laser, subject to guidelines established by the
Company. The hub of the marketing program will be a website which physicians
may
access for information about the laser and which they may use to purchase
the
laser. KDS’s return on its investment will be based primarily on commissions
earned on diode lasers that are sold under the program.
25
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
presently view our business as comprised of five business segments:
· |
Domestic
XTRAC,
|
· |
International
XTRAC,
|
· |
Surgical
Services,
|
· |
Surgical
Products, and
|
· |
Skin
Care (ProCyte).
|
These
segments are distinguished primarily by the organization of our management
structure. Industry considerations and the business model used to generate
revenues also influence distinctions.
· |
The
Domestic XTRAC segment is a procedure-based business model used
only in
the United States with revenues derived from procedures performed
by
dermatologists.
|
· |
The
International XTRAC segment presently generates revenues from the
sale of
equipment to dermatologists through a network of distributors outside
the
United States.
|
· |
The
Surgical Services segment generates revenues by providing fee-based
procedures generally using our mobile surgical laser equipment
delivered
and operated by a technician at hospitals and surgery centers in
the
United States.
|
· |
The
Surgical Products segment generates revenues by selling (but not
as
fee-per-procedure) 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, by selling bulk copper peptide compound, and by royalties
on our
licenses to both the domestic and international
markets.
|
26
Domestic
XTRAC
We
are
engaged in the development, manufacturing and marketing of our proprietary
XTRAC® excimer laser and delivery systems and techniques directed toward the
treatment of inflammatory skin disorders. In
connection with our current business plan, the initial medical applications
for
our excimer laser technology are intended for the treatment of 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,
relating to the use of our XTRAC system for the treatment of psoriasis. The
510(k) establishes that our XTRAC system has been determined to be substantially
equivalent to currently marketed devices for purposes of treating
psoriasis.
As
part
of our commercialization strategy in the United States, we are providing
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. This strategy has and will continue to require us to
identify and target appropriate dermatologists and to balance the planned
roll-out of our XTRAC lasers during 2005 against uncertainties in acceptance
by
physicians, patients and health plans and the constraints on the number of
XTRAC
systems we are able to provide. Our marketing force has limited experience
in
dealing with such challenges. We also expect that we will face increasing
competition as more private insurance plans adopt favorable policies for
reimbursement for treatment of psoriasis.
Starting
in March 2003, we had introduced a more reliable version of the XTRAC and,
based
on the establishment of CPT codes by the AMA and reimbursement rates from
the
CMS, we began efforts to secure such favorable policies from private insurance
plans. To persuade such plans to adopt favorable policies, we also commissioned
a clinical and economic study of the use of the XTRAC laser as a second-step
therapy for psoriasis. In December 2003, we deployed the findings of the
study
through a Data Compendium and mailed a copy of the Data Compendium to a number
of medical insurance plans in our ongoing marketing efforts to secure favorable
reimbursement policies.
Our
primary focus in 2004 was to secure from private health plans favorable
reimbursement policies for treatment of psoriasis using the XTRAC® excimer
laser. We
therefore expanded
our deployment of the study. From feedback we have received from the medical
insurers to the Data Compendium, we anticipate that the study, coupled with
our
other marketing efforts, will continue to gain a place on the agenda of private
plans as they consider their coverage and reimbursement policies. As of the
date
of this report, we have received approval from seven significant plans, 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 from the FDA concurrence under a 510(k) to market
the
new XTRAC Ultra™, a smaller-size dermatology laser with increased functionality
for inflammatory skin disorders. We introduced this product at the American
Academy of Dermatology trade show in February 2005 in New Orleans. The increased
functionality of the laser will allow shorter treatment times. While the
Ultra
comes within our core excimer intellectual property, the increased functionality
of the laser is based on proprietary improvements, which extend its utility
and
broaden its clinical applications.
In
2005,
we intend to continue our efforts on securing a wider base of private insurance
coverage for psoriasis patients in the United States. In addition, we intend
to
expand our selling efforts for the XTRAC in combination with the increased
dermatology sales force obtained in connection with the ProCyte merger. We
have
integrated and cross-trained the sales force and reorganized it to be able
to
increase the XTRAC installed base and the procedures performed in that base.
International
XTRAC
Our
revenues from International XTRAC sales provided needed working capital in
2004
and have continued to do so in 2005. Unlike the domestic market, we derive
revenues from the XTRAC in the international market by selling the dermatology
laser system to distributors, or in certain countries, directly to physicians.
We have benefited in the international market from our clinical studies and
the
physician researchers involved in such studies. We have also benefited from
the
improved reliability and functionality of the XTRAC. Due
to
the revenue model used overseas, the international XTRAC operations are more
widely influenced by competition from similar laser technologies from other
manufacturers and non-laser lamp alternatives for treating inflammatory skin
disorders. Over time, competition has also served to reduce the prices we
charge
international distributors for our XTRAC products.
27
XTRAC
laser sales vary from quarter to quarter. While the number of lasers sold
was
equal for the three months ended June 30, 2005 as in the same period for
2004,
the average price per laser system and parts was less in the 2005 period
($52,364) than in the 2004 period ($75,795). While the average price per
laser
system and parts was relatively equal for the six months ended June 30, 2005
($54,762) as in the same period for 2004 ($64,720), the number of lasers
sold
was less in the 2005 period than in the 2004 period. In addition, of the
16
lasers recognized in the six months ended June 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 financial resources required, we
were
reluctant in 2004 to implement an international XTRAC fee-per-use revenue
model,
similar to the domestic revenue model, but as reimbursement in the domestic
market has become more widespread, we have recently begun to implement a
pilot
version of this model overseas.
In
2005,
we also are exploring new product offerings to our international customers
as a
result of our recent acquisition of worldwide rights to certain proprietary
light-based technology from Stern Laser. The technology may play a role in
expanding our product offerings in the treatment of dermatological
conditions.
The
technology based on these newly acquired rights could be introduced by the
second half of 2005, depending on favorable technical progress and marketing
analyses, but it is more likely that it will be not be introduced until
2006.
Surgical
Services
We
experienced revenue growth in Surgical Services in 2004 and are experiencing
continued growth in 2005, showing revenue increases of $69,444 and $500,490
in
the three and six months ended June 30, 2005 over the comparable periods
in
2004, respectively. Our plan in 2004 was to grow in a controlled fashion
such
that capital expenditures necessary for that growth would come from these
operations. Although we intend to increase our investment in this business
segment for 2005, we will continue to be very deliberate and controlled with
capital expenditures to grow this business. In this manner, we intend to
conserve our cash resources for the XTRAC business segments.
We
have
growing, but still limited marketing experience in expanding our surgical
services business. The preponderance of this business is in the southeastern
part of the United States. New procedures and geographies, together with
new
customers and different business habits and networks, will likely pose different
challenges than the ones we have encountered in the past. There can be no
assurance that our experience will be sufficient to overcome such challenges.
Surgical
Products
Although
the surgical product revenues increased by $111,060 and $223,940 in the three
and six months ended June 30, 2005, respectively, when compared to the same
periods in 2004, we expect that sales of surgical laser systems will vary
from
quarter to quarter, and we also expect that the surgical laser systems and
the
related disposable base may 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 an offset to this erosion
through expanding our surgical services segment. With the introduction of
the
CO2 and diode surgical lasers in the second quarter of 2004, we hope to offset
any decline in laser sales and have a further offset to the erosion of
disposables revenues.
In
the
second quarter 2004, we received from the FDA concurrence under a 510(k)
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. Each system will also complement the Surgical
Products business in assisting us in finding end-user buyers domestically
and
overseas. We are also actively exploring opportunities for supplying the
lasers
on an OEM basis or under manufacturing-marketing collaborations.
28
Furthermore,
in July 2004, we entered into a development agreement with AzurTec, Inc.
AzurTec
is a development-stage company based outside Philadelphia. AzurTec’s product in
development is a device that seeks to rapidly and accurately detect the presence
of cancerous cells in excised tissue. AzurTec’s target customers are generally
the dermatologist and particularly the MOHS surgeon. We intend to assist
in the
development of FDA-compliant prototypes for AzurTec’s product. We have collected
payments under the agreement aggregating $240,000 through June 30, 2005.
In the
three and six months ended June 30, 2005, we recognized $0 and $124,000,
respectively, in other revenue under this agreement, but we have suspended
recognition of $89,751 in revenues due to the uncertainty of collection.
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. We acquired
three
revenue streams: one from the sale of skin health, hair care and wound care
products; the second from the sale of copper peptide compound in bulk; and
the
third from royalties on license for the patented copper peptide
compound.
The
operating results of ProCyte for the six months ended June 30, 2005 include
activity from ProCyte from March 19, 2005 through June 30, 2005. Under purchase
accounting rules, however, the operating results of ProCyte for prior periods
are not included in our Statement of Operations for such prior periods. Proforma
operating results are disclosed as part of Note 2, Acquisitions
to the
financial statements.
We
accounted for our acquisition of ProCyte as a purchase under generally accepted
accounting principles. We allocated the purchase price based on the fair
value
of ProCyte's acquired assets and assumed liabilities. We consolidated the
operating results of ProCyte with our own operating results, beginning as
of the
date the parties completed the merger. The allocation of the purchase price
was
as follows: $8,712,823 of acquired assets, net of assumed liabilities,
$5,400,000 of other acquired intangibles and $13,430,961 of goodwill. As
of June
30, 2005, goodwill increased by $436,034 for acquisition expenses incurred
in
connection with severances for departing employees, appraisal costs on the
assets acquired, investment banking expenses, relocation of a ProCyte executive,
final legal expenses, and cancellation of certain insurance policies.
ProCyte
has been in operation since 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 has been to bring unique products, primarily based upon patented
technologies such as GHK and AHK copper peptide technologies, to selected
markets. ProCyte currently sells its products directly to 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 specifically targeted technology licensing and supply
agreements.
ProCyte’s
products address the growing demand for skin health and hair care products,
including products designed to address the effects aging has on the skin
and
hair and to enhance appearance. ProCyte’s products are formulated, branded for
and targeted at specific markets. ProCyte’s initial products in this area
addressed the dermatology, plastic and cosmetic surgery markets for use
following various procedures. Anti-aging skin care products were added to
expand
into a comprehensive approach for incorporation into a patient’s skin care
regimen. Certain of these products incorporate ProCyte’s patented technologies,
while others, such as our advanced sunscreen products that reduce the effects
of
sun damage and aging on the skin, complement the product line.
Our
goals
from 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;
|
29
· |
the
addition of ProCyte's sales and marketing personnel will enhance
our
ability to market the XTRAC excimer
laser;
|
· |
the
addition of ProCyte's operations and existing cash balances will
enhance
PhotoMedex's operating results and balance
sheet;
|
· |
the
combination of the senior management of ProCyte and PhotoMedex
will allow
complimentary 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, thus providing additional
cash flow for operations.
|
We
have
begun to realize each of these goals. After the acquisition, we had also
targeted significant growth in revenues from ProCyte’s skin care products, but
have yet to realize this expected growth while the sales forces are in the
process of being integrated. As we gain a deeper understanding of the dynamics
of the Skin Care segment, we expect that we will modify the amount of emphasis
and expenditure that are presently devoted to some of the components of this
segment.
ProCyte
has 48 employees, consisting of 20 in sales, 13 in marketing, eight in
warehouse/research and development and seven in finance and administration.
We
are integrating the sales personnel from the Skin Care and the Domestic XTRAC
segments under John F. Clifford, who will be our Executive Vice President
for
Dermatology. We are in the process of transferring ProCyte’s finance functions
to Montgomeryville, Pennsylvania.
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
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.
30
Under
the
terms of the distributor agreements, our distributors do not have the right
to
return any unit that they have purchased. However, we allow products to be
returned by our distributors in redress of product defects or other claims.
When
we
place a laser in a physician’s office, we recognize service revenue based on the
number of patient treatments used by the physician. Treatments in the form
of
random laser-access codes that are sold to physicians, but not yet used,
are
deferred and recognized as a liability until the physician performs the
treatment. Unused treatments remain our obligation inasmuch as the treatments
can only be performed on equipment made by us. Once the treatments are delivered
to a patient, this obligation has been satisfied.
The
calculation of unused treatments 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 June 30, 2005. Due to this updated approach in estimates, XTRAC domestic
revenues were increased by $60,000 for the three months ended June 30, 2005
and
decreased by $62,000 for the six months ended June 30, 2005, 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
six months ended June 30, 2005, we deferred additional revenues of $51,865
and
$32,715, respectively, under this program. At June 30, 2005, we had net deferred
revenues of $146,506 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 qualify to be in the program (i.e. it 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;
|
31
· |
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, if the claim remains unpaid,
then
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.
|
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
$154,000 and $56,000 for the three and six months ended June 30, 2005,
respectively, 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 $214,000 for the three months ended June 30, 2005 and to decrease
revenues by approximately $6,000 for the six months ended June 30,
2005.
In
April
2005, we entered 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. Our share
of
the cost of the improvements is $195,000, for which 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, whereas for our former space rent and operating
expenses amounted to $11,900.
Surgical
Products and Service Operations
Through
our surgical businesses, we generate revenues primarily from two
channels:
· |
Product
sales of laser systems, related maintenance service agreements,
recurring
laser delivery systems and laser accessories.
|
· |
Per-procedure
surgical services.
|
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.
32
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 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.
|
· |
The
third is through 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.
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
June 30, 2005 and December 31, 2004, we had net property and equipment of
$6,179,352 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 realizability of the net carrying value of the lasers is
predicated on increasing revenues from the physicians’ use of the lasers. We
believe that such usage will increase in the future based on the approved
CPT
codes, recent approvals of private health plans of our XTRAC procedure and
expected increases in performed, reimbursed procedures. XTRAC lasers-in-service
are depreciated on a straight-line basis over the estimated useful life of
three
years. Surgical lasers-in-service are depreciated on a straight-line basis
over
an estimated useful life of seven years if new, five years or less if used
equipment. The straight-line depreciation basis for lasers-in-service is
reflective of the pattern of use. For other property and equipment, including
property and equipment acquired from ProCyte, depreciation is calculated
on a
straight-line basis over the estimated useful lives of the assets, primarily
three to seven years for computer hardware and software, furniture and fixtures,
automobiles, and machinery and equipment. Leasehold improvements are amortized
over the lesser of the useful lives or lease terms. Useful lives are determined
based upon an estimate of either physical or economic obsolescence.
33
Intangibles.
Our
balance sheet includes goodwill and other intangible assets that affect the
amount of future period amortization expense and possible impairment expense
that we will incur. Management’s judgment regarding the existence of impairment
indicators is based on various factors, including market conditions and
operational performance of our business. As of June 30, 2005 and December
31,
2004, we had $22,877,332 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 forecast process. Also, on a quarterly basis, we evaluate
whether events have occurred that would negatively impact the realizable
value
of our intangibles or goodwill.
There
has
been no change 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 account. 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 would adversely affect our operating
results.
Results
of Operations
Revenues
We
generated revenues of $8,055,173 during the three months ended June 30, 2005,
of
which $3,329,606 was from the surgical laser products and services operations
and $3,522,214 was from the ProCyte operations. The balance of revenues was
from
phototherapy products and services, including $314,183 from XTRAC international
sales of excimer systems and parts and $889,171 from domestic XTRAC procedures.
We generated revenues of $4,323,134 during the three months ended June 30,
2004,
of which $3,149,101 was from the surgical product and services operations.
The
balance of revenues was from phototherapy products and services, including
$454,770 from XTRAC international sales of excimer systems and parts and
$719,263 from domestic XTRAC procedures.
34
We
generated revenues of $13,038,505 during the six months ended June 30, 2005,
of
which $6,767,416 was from the surgical laser products and services operations
and $4,145,515 was from the ProCyte operations. The balance of revenues was
from
phototherapy products and services, including $602,385 from XTRAC international
sales of excimer systems and parts and $1,523,189 from domestic XTRAC
procedures. We generated revenues of $8,348,364 during the six months ended
June
30, 2004, of which $6,042,986 was from the surgical product and services
operations. The balance of revenues was from phototherapy products and services,
including $1,035,514 from XTRAC international sales of excimer systems and
parts
and $1,269,864 from domestic XTRAC procedures.
The
following table illustrates revenues from our five business segments for
the
periods listed below:
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
XTRAC
Domestic Services
|
$
|
889,171
|
$
|
719,263
|
$
|
1,523,189
|
$
|
1,269,864
|
|||||
XTRAC
International Products
|
314,183
|
454,770
|
602,385
|
1,035,514
|
|||||||||
Total
XTRAC Revenues
|
1,203,354
|
1,174033
|
2,125,574
|
2,305,378
|
|||||||||
Surgical
Services
|
2,003,380
|
1,933,936
|
4,074,030
|
3,573,540
|
|||||||||
Surgical
Products
|
1,326,225
|
1,215,165
|
2,693,386
|
2,469,446
|
|||||||||
Total
Surgical Products
|
3,329,605
|
3,149,101
|
6,767,416
|
6,042,986
|
|||||||||
Skin
Care (ProCyte) Revenues
|
3,522,214
|
-
|
4,145,515
|
-
|
|||||||||
Total
Revenues
|
$
|
8,055,173
|
$
|
4,323,134
|
$
|
13,038,505
|
$
|
8,348,364
|
Domestic
XTRAC Segment
Recognized
revenue for the three months ended June 30, 2005 and 2004 for domestic XTRAC
procedures was $889,171 and $719,263, respectively. Total XTRAC procedures
for
the same periods were approximately 15,500 and 12,700, respectively, of which
1,692 and 810 procedures, respectively, were performed by customers without
billing from us. These procedures were performed in connection with customer
evaluations of the XTRAC laser, as well as for clinical research. Recognized
revenue for the six months ended June 30, 2005 and 2004 for domestic XTRAC
procedures was $1,523,189 and $1,269,864, respectively. Total XTRAC procedures
for the same periods were approximately 27,900 and 23,400, respectively,
of
which 2,806 and 1,900 procedures, respectively, were performed by customers
without billing from us. These procedures were performed in connection with
customer evaluations of the XTRAC laser, as well as for clinical research.
The
increase in procedures in the periods ended June 30, 2005 was 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
in
addressing treatments with the XTRAC system that may be denied reimbursement
by
private insurance carriers. Applying the requirements of Staff Accounting
Bulletin No. 104 to the program, we recognize service revenue during the
program
from the sale of XTRAC procedures, or equivalent 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 six months ended June 30,
2005,
we deferred net revenues of $51,865 (795 procedures) and $32,715 (497
procedures), respectively, under this program. For the three and six months
ended June 30, 2004, we deferred net revenues of $106,490, (1,541 procedures)
and $249,761 (3,593 procedures), respectively, under this program.
35
In
the
first three and six months of 2005, recognized revenues for the domestic
XTRAC
segment increased by approximately $154,000 and $56,000, respectively, due
to a
change in accounting estimate for potential credits or refunds under the
reimbursement program. In addition, in the first three and six months of
2005,
recognized revenues for the domestic XTRAC segment increased by approximately
$60,000 and decreased by approximately $62,000, respectively, due to a change
in
accounting estimate for unused physician treatments that existed at June
30,
2005. The net effect of these two changes in accounting estimates, as detailed
in the discussion of our revenue recognition policy, was to increase revenue
for
this segment for the three months ended June 30, 2005 by approximately $214,000
and to decrease revenue for this segment for the six months ended June 30,
2005
by approximately $6,000.
The
following table illustrates the above analysis for the Domestic XTRAC segment
for the periods reflected below:
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Recognized
revenue
|
$
|
889,171
|
$
|
719,263
|
$
|
1,523,189
|
$
|
1,269,864
|
|||||
Change
in deferred program revenue
|
51,865
|
106,490
|
32,715
|
249,761
|
|||||||||
Change
in deferred unused treatments
|
(39,700
|
)
|
(4,800
|
)
|
95,800
|
(23,350
|
)
|
||||||
Net
billed revenue
|
$
|
901,336
|
$
|
820,953
|
$
|
1,651,704
|
$
|
1,496,275
|
|||||
Procedure
volume total
|
15,503
|
12,688
|
27,921
|
23,425
|
|||||||||
Less:
Non-billed procedures
|
1,692
|
810
|
2,806
|
1,900
|
|||||||||
Net
billed procedures
|
13,811
|
11,878
|
25,115
|
21,525
|
|||||||||
Avg.
price of treatments billed
|
$
|
65.26
|
$
|
69.12
|
$
|
65.77
|
$
|
69.51
|
|||||
Change
in procedures with deferred program revenue, net
|
795
|
1,541
|
497
|
3,593
|
|||||||||
Change
in procedures with deferred/(recognized) unused treatments,
net
|
(608
|
)
|
(69
|
)
|
1,457
|
(336
|
)
|
The
average price for a treatment can vary from quarter to quarter 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. As a percentage of
the
psoriasis patient population, there are fewer patients with moderate psoriasis
than there are with mild psoriasis. Due to the amount of treatment time
required, it has not been generally practical to use our therapy to treat
severe
psoriasis patients. However, this may change going forward, as our new product,
the XTRAC Ultra, has shorter treatment times.
International
XTRAC Segment
International
XTRAC sales of our excimer laser system and related parts were $314,183 for
the
three months ended June 30, 2005 compared to $454,770 for the three months
ended
June 30, 2004. We sold six laser systems in each of the three months ended
June
30, 2005 and 2004. International XTRAC sales of our excimer laser system
and
related parts were $602,385 for the six months ended June 30, 2005 compared
to
$1,035,514 for the six months ended June 30, 2004. We sold 11 laser systems
in
the six months ended June 30, 2005 compared to 16 laser systems in the six
months ended June 30, 2004. The international XTRAC operations are more widely
influenced by competition from similar laser technology from other manufacturers
and from non-laser lamp alternatives for treating inflammatory skin disorders.
Over time, competition has also served to reduce the prices we charge
international distributors for our excimer products. In addition, of the
16
lasers recognized in the six months ended June 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.
36
The
following table illustrates the key changes in the International XTRAC segment
for the periods reflected below:
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
314,183
|
$
|
454,770
|
$
|
602,385
|
$
|
1,035,514
|
|||||
Laser
systems sold
|
6
|
6
|
11
|
16
|
|||||||||
Average
revenue per laser
|
$
|
52,364
|
$
|
75,795
|
$
|
54,762
|
$
|
64,720
|
Surgical
Services Segment
In
the
three months ended June 30, 2005 and 2004, surgical services revenues were
$2,003,380 and $1,933,936, respectively. In the six months ended June 30,
2005
and 2004, surgical services revenues were $4,074,030 and $3,573,540,
respectively. Revenues in surgical services grew for the three and six months
ended June 30, 2005 from 2004 by 3.6% and 14%, respectively, primarily due
to
growth in urological procedures performed with laser systems purchased from
a
third-party manufacturer. Such procedures included a charge for the use of
the
laser and the technician to operate it, as well as a charge for the third
party’s proprietary fiber delivery system.
The
following table illustrates the key changes in the Surgical Services segment
for
the periods reflected below:
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
2,003,380
|
$
|
1,933,936
|
$
|
4,074,030
|
$
|
3,573,540
|
|||||
Percent
increase
|
3.6%
|
|
14.0%
|
|
|||||||||
Cost
of revenues
|
1,502,219
|
1,121,165
|
2,817,679
|
2,260,075
|
|||||||||
Gross
profit
|
$
|
501,161
|
$
|
812,771
|
$
|
1,256,351
|
$
|
1,313,465
|
|||||
Percent
of revenue
|
25.0%
|
|
42.0%
|
|
30.8%
|
|
36.8%
|
|
Products
Segment
For
the
three months ended June 30, 2005 and 2004, surgical products revenues were
$1,326,225 and $1,215,165, respectively. 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 disposables and fibers
are
more profitable than laser systems. However, sales of laser systems create
recurring sales of laser fibers and laser disposables. We had 12 sales of
surgical laser systems aggregating approximately $395,800 for the three months
ended June 30, 2005 compared to six surgical laser system sales aggregating
approximately $290,000 for the three months ended June 30, 2004.
For
the
six months ended June 30, 2005 and 2004, surgical products revenues were
$2,693,386 and $2,469,446, respectively. Surgical products revenues include
revenues derived from the sales of surgical laser systems together with sales
of
related laser fibers and laser disposables. We had 17 sales of surgical laser
systems aggregating approximately $650,000 for the six months ended June
30,
2005 compared to nine surgical laser system sales aggregating approximately
$460,000 for the six months ended June 30, 2004.
The
decrease in average price per laser was due to the mix of lasers sold. Included
in the laser sales for the three and six months ended June 30, 2005 were
sales
of eight and nine diode lasers, respectively, which have lower sales prices
than
the other types of lasers. There was only one sale of these lasers for the
three
and six months ended June 30, 2004, since they were introduced in June 2004.
Disposable and fiber sales were relatively level between the comparable
three-month periods. The change in the laser sale product mix contributed
to a
slightly higher margin in the three and six months ended June 30, 2005 compared
to the same period in the prior year.
37
Sales
of
surgical laser systems vary quarter by quarter. There is significant competition
for the types of surgical laser systems we offer for sale. Additionally,
we have
expected that the disposables base might 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
an
offset to this erosion through expansion of our surgical services. Similarly,
some of the decrease in laser system sales is related to the trend of hospitals
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 lasers
and have a further offset to the erosion of disposables revenues.
The
following table illustrates the key changes in the Surgical Products segment
for
the periods reflected below:
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
1,326,225
|
$
|
1,215,165
|
$
|
2,693,386
|
$
|
2,469,446
|
|||||
Percent
increase
|
9.1%
|
|
9.1%
|
|
|||||||||
Laser
systems sold
|
12
|
6
|
17
|
9
|
|||||||||
Laser
system revenues
|
$
|
395,800
|
$
|
289,644
|
$
|
649,695
|
$
|
460,302
|
|||||
Average
revenue per laser
|
$
|
32,983
|
$
|
48,274
|
$
|
38,217
|
$
|
51,145
|
Skin
Care (ProCyte) Segment
For
the
three and six months ended June 30, 2005, ProCyte revenues were $3,522,214
and
$4,145,515. Since ProCyte was acquired on March 18, 2005, there are no
corresponding revenues for the three and six months ended June 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 June 30,
|
Six
Months Ended June 30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Product
sales
|
$
|
3,007,076
|
$
|
-
|
$
|
3,459,940
|
$
|
-
|
|||||
Bulk
compound sales
|
347,550
|
-
|
503,550
|
-
|
|||||||||
Royalties
|
167,588
|
182,025
|
|||||||||||
Total
ProCyte revenues
|
$
|
3,522,214
|
$
|
-
|
4,145,515
|
$
|
-
|
Cost
of Revenues
Product
cost of revenues for the three months ended June 30, 2005 were $1,990,996
compared to $932,621 for the three months ended June 30, 2004. Included in
the
costs for the three months ended June 30, 2005 was $1,042,462 from the recently
acquired skincare business. There were no corresponding costs in the three
months ended June 30, 2004.
Also
included in these costs were $714,379 and $610,241, related to surgical product
revenues, for the three months ended June 30, 2005 and 2004, respectively.
The
remaining product cost of revenues during these periods of $234,155 and
$322,380, respectively, related primarily to the production costs of the
XTRAC
laser equipment sold outside of the United States.
Product
cost of revenues for the six months ended June 30, 2005 were $2,883,960 compared
to $1,765,105 for the six months ended June 30, 2004. Included in these costs
were $1,221,791 and $1,072,345, related to surgical product revenues, for
the
six months ended June 30, 2005 and 2004, respectively. Also included in the
costs for the six months ended June 30, 2005 was $1,268,419 from the recently
acquired skincare business. There were no corresponding costs in the three
months ended June 30, 2004. The remaining product cost of revenues during
these
periods of $393,750 and $692,760, respectively, related primarily to the
production costs of the XTRAC laser equipment sold outside of the United
States.
38
The
increase in the product cost of sales for the three and six months ended
June
30, 2005, excluding Skin Care product costs, were due to an increase in surgical
product laser system sales, which have higher costs associated with them
than
other products. This increase was offset, in part, by a decrease in the
unabsorbed manufacturing costs due to the manufacturing efficiencies of our
newly designed excimer technology. The increase for the six months ended
June
30, 2005 was also offset, in part, by a decrease in product cost of sales
for
the international XTRAC revenues for the six months ended June 30, 2005.
Services
cost of revenues was $2,214,320 and $1,698,748 in the three months ended
June
30, 2005 and 2004, respectively. Included in these costs for the same periods
were $1,524,330 and $1,157,907, respectively, related to surgical services
revenues. The remaining services cost of revenues of $689,990 and $540,841
during the periods ended June 30, 2005 and 2004, respectively, were primarily
attributable to manufacturing, depreciation and field service costs on the
lasers in service for XTRAC domestic revenues.
Services
cost of revenues was $3,953,724 and $3,360,330 in the six months ended June
30,
2005 and 2004, respectively. Included in these costs for the same periods
were
$2,860,553 and $2,333,203, respectively, related to surgical services revenues.
The remaining services cost of revenues of $1,093,171 and $1,027,127 during
the
periods ended June 30, 2005 and 2004, respectively, were primarily attributable
to manufacturing, depreciation and field service costs on the lasers in service
for XTRAC domestic revenues.
The
increase in the service cost of sales related primarily to the surgical services
cost of sales. The growth in revenues related primarily to the 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. The increase was also due to
the
depreciation on additional lasers placed in served and to the incremental
increases in salaries, benefits and travel expense for the increased field
technicians.
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 $3,849,857 during the three months ended June 30, 2005
from
$1,691,765 during the same period in 2004, or an increase of $2,158,092.
Revenues increased during the three months ended June 30, 2005 to $8,055,173
from $4,323,134 during the same period in 2004, or an increase of $3,732,039.
The cost to produce those revenues increased during the three months ended
June
30, 2005 to $4,205,316 from $2,631,369 during the same period in 2004, or
an
increase of $1,573,947. Overall gross margin increased for the three months
ended June 30, 2005 to 47.8% from 39.1% for the same period in 2004. The
greatest single factor contributing to the increase in revenues, increase
in
cost of revenues, and increase in margin for the three months ended June
30,
2005 was the addition of the ProCyte business acquired on March 18,
2005.
Gross
margin increased to $6,200,821 during the six months ended June 30, 2005
from
$3,222,929 during the same period in 2004, or an increase of $2,977,892.
Revenues increased during the six months ended June 30, 2005 to $13,038,505
from
$8,348,364 during the same period in 2004, or an increase of $4,690,141.
The
cost to produce those revenues increased during the six months ended June
30,
2005 to $6,837,684 from $5,125,435 during the same period in 2004, or an
increase of $1,712,249. Overall gross margin increased for the six months
ended
June 30, 2005 to 47.6% from 38.6% for the same period in 2004. The greatest
single factor contributing to the increase in revenues, increase in cost
of
revenues, and increase in margin for the six months ended June 30, 2005 was
the
addition of the ProCyte business acquired on March 18, 2005.
39
The
following table analyzes changes in our gross margin for the periods reflected
below:
Company
Margin Analysis
|
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
|||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
8,055,173
|
$
|
4,323,134
|
$
|
13,038,505
|
$
|
8,348,364
|
|||||
Percent
increase
|
86.3%
|
|
56.2%
|
|
|||||||||
Cost
of revenues
|
4,205,316
|
2,631,369
|
6,837,684
|
5,125,435
|
|||||||||
Percent
increase
|
59.8%
|
|
33.4%
|
|
|||||||||
Gross
profit
|
$
|
3,849,857
|
$
|
1,691,765
|
$
|
6,200,821
|
$
|
3,222,929
|
|||||
Percent
of revenue
|
47.8%
|
|
39.1%
|
|
47.6%
|
|
38.6%
|
|
The
primary reasons for improvement in gross margin for the three and six months
ended June 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 comparative
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
continued to increase the volume of sales to existing customers
and add
new customers to our existing base.
|
· |
We
benefited from the manufacturing efficiencies due to the newly
designed
XTRAC Ultra laser, which resulted in less unabsorbed manufacturing
costs.
|
The
following table analyzes our gross margin for our Domestic XTRAC segment
for the
periods reflected below:
XTRAC
Domestic Segment
|
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
|||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
889,171
|
$
|
719,263
|
$
|
1,523,189
|
$
|
1,269,864
|
|||||
Percent
increase
|
23.6%
|
|
19.9%
|
|
|||||||||
Cost
of revenues
|
689,990
|
540,841
|
1,093,171
|
1,027,127
|
|||||||||
Percent
increase
|
27.6%
|
|
6.4%
|
|
|||||||||
Gross
profit
|
$
|
199,181
|
$
|
178,422
|
$
|
430,018
|
$
|
242,737
|
|||||
Percent
of revenue
|
22.4%
|
|
24.8%
|
|
28.2%
|
|
19.1%
|
|
We
increased the gross margin for this segment for the three and six months
ended
June 30, 2005 over the comparable periods in 2004 by $20,759 and $187,281,
primarily due to increases in revenues in the 2005 periods from the comparable
2004 periods. The key factors were as follows:
· |
A
key driver in increased revenue in this segment is insurance
reimbursement. In 2004, we focused on private health insurance
plans
adopting the XTRAC laser therapy for psoriasis as an approved medical
procedure. 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 16% from 11,878 to 13,811 billed procedures in
the three
months ended June 30, 2005 compared to the same period in 2004.
Procedure
volume increased 17% from 21,525 to 25,115 billed procedures in
the six
months ended June 30, 2005 compared to the same period in
2004.
|
40
· |
Price
per procedure was not a meaningful component of the revenue change
between
the periods.
|
· |
In
the first quarter of 2003, we implemented a limited program to
support
certain physicians in addressing treatments with the XTRAC system
that may
be denied reimbursement by private insurance carriers. We recognize
service revenue under the program for the sale of treatment codes
to
physicians participating in this program only if and to the extent
the
physician has been reimbursed for the treatments. For the three
months
ended June 30, 2005, we deferred net revenues of $51,865, under
the
program compared to $106,490 for the three months ended June 30,
2004. For
the six months ended June 30, 2005, we deferred net revenues of
$32,715,
under the program compared to $249,761 for the three months ended
June 30,
2004.
|
· |
The
cost of revenues increased by $149,149 and $66,044 for the three
and six
months ended June 30, 2005. An incremental procedure at a physician’s
office does not increase our operating costs associated with that
laser.
Even though there was a reduction in unabsorbed manufacturing costs,
the
domestic segment was allocated a higher percentage of those costs
(76% in
2005 vs. 62% in 2004) due to increased production for the domestic
segment.
|
The
following table analyzes our gross margin for our International XTRAC segment
for the periods reflected below:
XTRAC
International Segment
|
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
|||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
314,183
|
$
|
454,770
|
$
|
602,385
|
$
|
1,035,514
|
|||||
Percent
decrease
|
(30.9%)
|
|
(41.8%)
|
|
|||||||||
Cost
of revenues
|
234,155
|
322,380
|
393,750
|
692,760
|
|||||||||
Percent
decrease
|
(27.4%)
|
|
(43.2%)
|
|
|||||||||
Gross
profit
|
$
|
80,028
|
$
|
132,390
|
$
|
208,635
|
$
|
342,754
|
|||||
Percent
of revenue
|
25.5%
|
|
29.1%
|
|
34.6%
|
|
33.1%
|
|
The
gross
profit for the three and six months ended June 30, 2005 decreased by $52,362
and
$134,119, respectively, from the comparable period in 2004. The key factors
in
this business segment were as follows:
· |
We
sold six XTRAC laser systems during the three months ended June
30, 2005
and six lasers in the comparable period in 2004. We sold 11 XTRAC
laser
systems during the six months ended June 30, 2005 and 16 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 more widely influenced by competition
from similar laser technology from other manufacturers and from
non-laser
lamp alternatives for treating inflammatory skin disorders. Over
time,
competition has also served to reduce the prices we charge international
distributors for our excimer products. After adjusting the revenue
for the
three months ended June 30, 2005 for parts sales of approximately
$54,000,
the average price for lasers sold during this period was approximately
$43,400. After adjusting the revenue for the three months ended
June 30,
2004 for part sales of approximately $67,000, the average price
for lasers
sold during this period was approximately $64,600. After adjusting
the
revenue for the six months ended June 30, 2005 for parts sales
of
approximately $90,000, the average price for lasers sold during
this
period was approximately $46,500. After adjusting the revenue for
the six
months ended June 30, 2004 for part sales of approximately $77,000,
the
average price for lasers sold during this period was approximately
$59,900.
|
41
· |
Although
the individual standard cost per unit was relatively level between
the
comparable periods, increased production levels served to reduce
the
average cost per laser produced. The difference between standard
manufacturing costs and total cost of goods sold represents unabsorbed
overhead costs charged to cost of goods sold in the period of the
sale.
|
The
following table analyzes our gross margin for our Surgical Services segment
for
the periods reflected below:
Surgical
Services Segment
|
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
|||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
2,003,380
|
$
|
1,933,936
|
$
|
4,074,030
|
$
|
3,573,540
|
|||||
Percent
increase
|
3.6%
|
|
14.0%
|
|
|||||||||
Cost
of revenues
|
1,502,219
|
1,121,165
|
2,817,679
|
2,260,075
|
|||||||||
Percent
increase
|
34.0%
|
|
24.7%
|
|
|||||||||
Gross
profit
|
$
|
501,161
|
$
|
812,771
|
$
|
1,256,351
|
$
|
1,313,465
|
|||||
Percent
of revenue
|
25.0%
|
|
42.0%
|
|
30.8%
|
|
36.8%
|
|
Gross
margin in the Surgical Services segment for the three and six months ended
June
30, 2005 decreased by $311,610 and $57,114, respectively, from the comparable
period in 2004. The key factors impacting gross margin for the Surgical Services
business were as follows:
· |
A
significant part of the revenue was in urological procedures performed
with laser systems we purchased from a third party manufacturer.
Such
procedures included a charge for the use of the laser and the technician
to operate it, as well as a charge for the third party’s proprietary fiber
delivery system. This procedure has a lower gross margin than other
types
of procedures. As the volume increases, the overall gross margin
percent
decreases.
|
· |
We
have closed three geographic areas of business due to unacceptable
operating profit from these territories. Although by closing these
territories we will save costs and improve profitability over time,
the
costs saved for the three months ended June 30, 2005 have not kept
pace
with the revenues lost by closing these territories during the
three
months ended June 30, 2005.
|
The
following table analyzes our gross margin for our Surgical Products segment
for
the periods reflected below:
Surgical
Products Segment
|
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
|||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
1,326,225
|
$
|
1,215,165
|
$
|
2,693,386
|
$
|
2,469,446
|
|||||
Percent
increase
|
9.1%
|
|
9.1%
|
|
|||||||||
Cost
of revenues
|
736,490
|
646,983
|
1,264,665
|
1,145,473
|
|||||||||
Percent
increase
|
13.8%
|
|
10.4%
|
|
|||||||||
Gross
profit
|
$
|
589,735
|
$
|
568,182
|
$
|
1,428,721
|
$
|
1,323,973
|
|||||
Percent
of revenue
|
44.5%
|
|
46.8%
|
|
53.0%
|
|
53.6%
|
|
Gross
margin for the Surgical Products segment in the three and six months ended
June
30, 2005 compared to the same periods in 2004 increased by $21,553 and $104,748,
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.
However,
the sale of laser systems generates the subsequent recurring sale
of laser
disposables.
|
42
· |
Revenues
for the three months ended June 30, 2005 increased by $111,060
from the
three months ended June 30, 2004. Cost of revenues increased by
$89,507
between the same periods. There were seven more laser system sales
in the
three months ended June 30, 2005 than in the comparable period
of 2004.
Revenues for the six months ended June 30, 2005 increased by $223,940
from
the six months ended June 30, 2004. Cost of revenues increased
by $119,192
between the same periods. There were nine more laser system sales
in the
six months ended June 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 disposables between the
periods.
|
· |
Disposables,
which have a higher gross margin than lasers, represented a lower
percentage of revenue in the three and six months June 30, 2005
compared
to the same periods in 2004.
|
The
following table analyzes our gross margin for our SkinCare (ProCyte) segment
for
the periods reflected below:
Skin
Care (ProCyte) Segment
|
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
|||||||||||
2005
|
2004
|
||||||||||||
Product
revenues
|
$
|
3,007,076
|
$
|
-
|
$
|
3,459,940
|
$
|
-
|
|||||
Bulk
compound revenues
|
347,550
|
-
|
503,550
|
-
|
|||||||||
Royalties
|
167,558
|
-
|
182,025
|
-
|
|||||||||
Total
revenues
|
3,522,214
|
-
|
4,145,515
|
-
|
|||||||||
Product
cost of revenues
|
804,759
|
-
|
901,440
|
-
|
|||||||||
Bulk
compound cost of revenues
|
237,703
|
-
|
366,979
|
-
|
|
||||||||
Total
cost of revenues
|
1,042,462
|
-
|
1,268,419
|
-
|
|||||||||
Gross
profit
|
$
|
2,479,752
|
$
|
-
|
$
|
2,877,096
|
$
|
-
|
|||||
Percent
of revenue
|
70.4
|
%
|
69.4
|
%
|
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. customers, which tend to be
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 June 30, 2005, selling, general and administrative expenses
were $4,322,706 compared to $2,406,453 for the three months ended June 30,
2004,
or an increase of 79.6%. $1,594,667 of these costs were ProCyte-related selling,
general and administrative expenses. The remaining increase was related to
an
increase in domestic sales force of approximately $140,000 in salaries, benefits
and travel expenses; an increase in legal and accounting expenses of $150,000;
and an increase in corporate insurance of $76,000. Offsetting some of the
increases for the three months ended June 30, 2005, were the settlement of
past
audit fee claims for $130,000 less than the accrued amounts together with
the
settlement of past royalty claims for $32,000 less than the accrued
amount.
For
the
six months ended June 30, 2005, selling, general and administrative expenses
were $7,543,682 compared to $4,876,877 for the six months ended June 30,
2004,
or an increase of 54.7%. $1,951,469 of these costs were ProCyte-related selling,
general and administrative expenses. The remaining increase was related to
an
increase in domestic sales force of approximately $196,000 in salaries, benefits
and travel expenses; an increase in legal and accounting expenses of $390,000
and an increase in corporate insurance of $89,000. Offsetting some of the
increases for the six months ended June 30, 2005, were the settlement of
past
audit fee claims for $130,000 less than the accrued amounts together with
the
settlement of past royalty claims for $32,000 less than the accrued
amount.
43
Engineering
and Product Development
Engineering
and product development expenses for the three months ended June 30, 2005
decreased to $219,550 from $481,243 for the three months ended June 30, 2004.
Engineering and product development expenses for the six months ended June
30,
2005 decreased to $406,521 from $897,193 for the six months ended June 30,
2004.
The decreases are mainly due to the fact that in 2004, our California
engineering resources dedicated much of their time to product development
for
the Ultra, the new smaller and faster excimer laser. For the three and six
months ended June 30, 2005, the development of the Ultra was completed, thus
allowing these California resources to devote more time to
manufacturing.
Other
Income
Other
income for the three and six months ended June 30, 2005 was $88,667. This
was
due to 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. There was no other income in the comparable periods in 2004.
Interest
Expense, Net
Net
interest expense for the three months ended June 30, 2005 increased to $56,919,
as compared to $11,236 for the three months ended June 30, 2004. Net interest
expense for the six months ended June 30, 2005 increased to $128,048, as
compared to $19,108 for the six months ended June 30, 2004. The increase
in net
interest expense was direct result of the draws on the lease line of credit
during the second, third and fourth quarters of 2004.
Net
Loss
The
aforementioned factors resulted in a net loss of $660,651 during the three
months ended June 30, 2005, as compared to a net loss of $1,207,167 during
the
three months ended June 30, 2004, a decrease of 45.3%. The aforementioned
factors resulted in a net loss of $1,788,763 during the six months ended
June
30, 2005, as compared to a net loss of $2,570,249 during the six months ended
June 30, 2004, a decrease of 30.4%. These decreases were 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 through the use of working capital provided
from 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 six months ended June 30, 2005
and
we expect the combined companies to cause revenues to increase throughout
2005
as compared to 2004. We expect to save costs 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. The established revenues from ProCyte will help to absorb the
costs
of the infrastructure of the combined company.
At
June
30, 2005, the ratio of current assets to current liabilities was 2.67 to
1.00
compared to 1.88 to 1.00 at December 31, 2004. As of June 30, 2005, we had
$12,256,531 of working capital compared to $6,119,248 as of December 31,
2004.
Cash and cash equivalents were $5,720,117 as March 31, 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 June
30, 2005 compared to $112,200 at December 31, 2004.
44
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 second 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 costs savings
from the integration of ProCyte and PhotoMedex. 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. Similarly, if our growth outstrips
the business plan, 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.
We
obtained a leasing credit facility from GE Capital Corporation (“GE”) on June
25, 2004. 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 self-amortizing
repayment period of three years and is secured by specified lasers, which
we
have 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, we agreed
to
issue warrants to purchase shares of our 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 our 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
June 30, 2005, we have made three draws against the first tranche of the
line.
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 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.
45
We
obtained from GE a second tranche under the leasing credit facility for
$5,000,000 on June 28, 2005. We account 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, we have agreed
to
issue warrants to purchase shares of our 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 our 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 June 30, 2005, we have made our first
draw
against the second tranche of the line (which is Draw 4 under the line),
as
follows:
Draw
4
|
||||
Date
of draw
|
6/28/05
|
|||
Amount
of draw
|
$
|
1,113,326
|
||
Stated
interest rate
|
8.42%
|
|
||
Effective
interest rate
|
12.63%
|
|
||
Number
of warrants issued
|
14,714
|
|||
Exercise
price of warrants per share
|
$
|
2.50
|
||
Fair
value of warrants
|
$
|
23,352
|
||
Concurrent
with the SLT acquisition, we assumed a $3,000,000 credit facility from a
bank.
The credit facility had a commitment term of four years, which expired May
31,
2004, permitted deferment of principal payments until the end of the commitment
term, and was secured by SLT’s business assets, including collateralization
(until May 13, 2003) of $2,000,000 of SLT’s cash and cash equivalents and
short-term investments. The bank agreed to allow us to apply the cash collateral
to a paydown of the facility in 2003. The credit facility had an interest
rate
of the 30-day LIBOR plus 2.25%.
Operating
cash flow for the six months ended June 30, 2005 compared to the six months
ended June 30, 2004 decreased mostly due to the payment of various previously
recorded costs associated with the acquisition and increases in inventory
for
the new products. Net cash used in operating activities was $2,634,022 for
six
months ended June 30, 2005, compared to $1,801,093 for the same period in
2004.
Net
cash
provided by investing activities was $3,789,271 for the six months ended
June
30, 2005 compared to cash used of $901,307 for the six months ended June
30,
2004. During the six months ended June 30, 2005, we received cash of $5,578,416,
net of acquisition costs, in the ProCyte acquisition. During the six months
ended June 30, 2005 and 2004, we utilized $1,727,800 and $845,780, respectively,
for production of our lasers in service.
Net
cash
provided by financing activities was $473,249 for the six months ended June
30,
2005 compared to $1,756,907 for the six months ended June 30, 2004. In the
six
months ended June 30, 2005 we made payments of $455,460 on certain notes
payable
and capital lease obligations and $161,737 in registration costs. These payments
were offset, in part, by the advances under the lease line of credit, net
of
payments, of $739,055 and by receipts of $445,995 from the exercise of common
stock options. In the six months ended June 30, 2004, we received $1,780,804
from the exercise of common stock options and warrants and a net increase
of
$369,680 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 $404,776
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 vary 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.
46
Commitments
and Contingencies
During
the three and six months ended June 30, 2005, there were no 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.
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 limitations, 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 June 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 June 30, 2005.
Changes
in Internal Controls
There
has
been no significant change in our internal controls over financial reporting
that occurred during the second 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 has processed ProCyte transactions through existing ProCyte internal
control structures through the second quarter of this year, and will process
such transactions through existing PhotoMedex internal control structures
beginning with 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.
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 demurred to our amended complaint. The court heard
the matter on July 29, 2005. The Court rejected the demurrer with respect
to our
counts under breach of good faith and fair dealing, money had and received,
unjust enrichment and breach of constructive trust and sustained the demurrer
with respect to our counts under breach of contract, beach of fiduciary duty
and
conversion. The defendants must now answer.
In
the
matter brought against us by City National Bank of Florida, our former landlord
in Orlando, Florida, our motion for summary judgment will be heard on August
23,
2005, and if the motion is not granted, the trial will commence promptly
thereafter.
47
In
the
matter brought by us against RA Medical Systems, Inc. and Dean Stewart Irwin
in
the Superior Court for San Diego County, California, the California Supreme
Court declined to hear our appeal from the award of attorneys’ fees to the
defendants. On July 1, 2005, we satisfied the judgment of April 27, 2004,
awarding costs and attorney’s fees, plus interest accrued to the date of
satisfaction. Defendants have petitioned the Superior Court for further fees
and
costs incurred in collecting the judgment and defending against our appeal.
In
the
matter brought for malicious prosecution by RA Medical Systems and Dean Irwin
against PhotoMedex, Inc., et al., our appeal brief is to be filed with the
appellate court on August 10, 2005.
On
May
13, 2005, Vida Brown brought suit in the Circuit Court, 20th
Judicial
Circuit for Charlotte County, Florida, for injuries sustained during a surgical
laser procedure on her lower back. Ms. Brown has sued, among others, the
surgeon, the anesthesiologist, the supplier of the laser delivery system
(viz.
Clarus Medical LLC) and the supplier of the holmium laser system and technician
(viz. our former subsidiary, Surgical Innovations & Services, Inc.). The
laser delivery system supplied by Clarus proved defective in the course of
the
procedure, notwithstanding which the surgeon continued to perform the procedure.
The holmium laser provided by SIS did not perform deficiently. Ms. Brown
has
alleged that we failed to provide a properly trained operator for the holmium
laser and that our operator failed to warn the surgeon of the danger of
continuing to use a defective laser delivery system. Our insurance carrier
is
providing a defense for us in this matter.
ITEM
2. Unregistered Sales of Equity Securities and Use of
Proceeds
Recent
Issuances of Unregistered Securities
In
June
2005, we issued 248,395 restricted shares of our common stock to Stern Laser
srl
in connection with the achievement of certain milestones under our Master
Agreement with Stern Laser. The securities were issued pursuant to exemption
from registration under Section 4(2) of the Securities Act.
ITEM
3. Defaults Upon Senior Securities
Not
applicable.
ITEM
4. Submission of Matter to a Vote of Security Holders
None.
ITEM
5. Other Information
On
March
31, 2005, we entered into a Sales and Marketing Agreement with GlobalMed
(Asia)
Technologies Co., Inc. Under this Agreement, GlobalMed will act as master
distributor in the Pacific Rim for our XTRAC excimer laser, including the
Ultra™
excimer laser, as well as for our LaserPro® diode surgical laser system. The
diode laser will be marketed for, among other things, use in a gynecological
procedure pioneered by David Matlock, MD. We will
engage Sanders Ergas, who is a principal of GlobalMed, and Dr. Matlock as
our
consultants to explore further business opportunities. In connection with
this
engagement, each consultant will receive 25,000 options in our common stock,
issued at fair value.
On
July
27, 2005, we entered a Marketing Agreement with KDS Marketing, Inc. Using
money
invested by each party, KDS will research market opportunities for our LaserPro®
diode laser and related delivery systems; based on such research, KDS will
market the diode laser, subject to guidelines which we establish. The hub
of the
marketing program will be a website which physicians may access for information
about the laser and which they may use to purchase the laser. KDS’s return on
its investment will be based primarily on commissions earned on diode lasers
that are sold under the program.
We
have
adopted a Code of Ethics on Interactions with Health Care Professionals,
to take
effect on July 1, 2005. We also have adopted a related Comprehensive Compliance
Program. The Code and Program can be viewed on our website at
www.photomedex.com, under Corporate Governance.
48
ITEM
6. Exhibits
10.42
|
Standard
Industrial/Commercial Multi-Tenant Lease - Net, dated March 17,
2005, by
and between PhotoMedex, Inc. and Wells Fargo Bank, N.A. as Trustee
for the
Hutton Trust.
|
|
10.43
|
Code
of Ethics on Interactions with Health Care Professionals, adopted
June 30,
2005, and related Comprehensive Compliance Program.
|
|
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
|
——————
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: August 9, 2005 | By: | /s/ Jeffrey F. O’Donnell |
Jeffrey F. O’Donnell |
||
President and Chief Executive Officer |
Date: August 9, 2005 | By: | /s/ Dennis M. McGrath |
Dennis M. McGrath |
||
Chief
Financial Officer
|
49