Gadsden Properties, Inc. - Quarter Report: 2006 March (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 March 31, 2006
OR
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
|
||
SECURITIES
EXCHANGE ACT OF 1934
|
For
the transition period from _________ to ___________
Commission
File Number 0-11365
PHOTOMEDEX,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
(State
or other jurisdiction of
incorporation or organization)
|
59-2058100
(I.R.S.
Employer Identification
No.)
|
147
Keystone Drive, Montgomeryville, Pennsylvania 18936
(Address
of principal executive offices, including zip code)
(215)
619-3600
(Registrant's
telephone number, including area code)
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined
in
Rule 405 of the Securities Act.
Yes
ý
No
¨
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Exchange Act.
Yes
¨
No
ý
Indicate
by check mark whether the registrant: (i) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (ii) has been subject to such filing requirements
for
the past 90 days.
Yes
ý
No
¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of "accelerated
filer and large accelerated filer" in Rule 12b-2 of the Exchange
Act.
Large
accelerated filer ¨
|
Accelerated
filer ý
|
Non-accelerated
filer ¨
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act.)
Yes
¨
No
ý
The
number of shares outstanding of the issuer's Common Stock as of May 9, 2006
was
52,622,404 shares.
1
PHOTOMEDEX,
INC. AND SUBSIDIARIES
INDEX
Part
I. Financial Information:
|
PAGE
|
||
ITEM 1. | Financial Statements: |
a.
|
Consolidated
Balance Sheets, March 31, 2006 (unaudited) and December 31,
2005
|
3
|
|
b.
|
Consolidated
Statements of Operations for the three months ended March 31, 2006
and
2005 (unaudited)
|
4
|
|
c.
|
Consolidated
Statement of Stockholders’ Equity for the three months ended March 31,
2006 (unaudited)
|
5
|
|
e.
|
Consolidated
Statements of Cash Flows for the three months ended March 31, 2006
and
2005 (unaudited)
|
6
|
|
f.
|
Notes
to Consolidated Financial Statements (unaudited)
|
7
|
ITEM 2. |
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
26
|
|
ITEM 3. |
Quantitative
and Qualitative Disclosure about Market Risk
|
38
|
|
ITEM 4. |
Controls
and Procedures
|
39
|
|
Part
II. Other Information:
|
|||
ITEM
1. Legal Proceedings
|
39
|
||
ITEM
1A. Risk Factors
|
39
|
||
ITEM
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
40
|
||
ITEM 5. Other Information | 40 | ||
ITEM
6. Exhibits
|
40
|
||
Signatures
|
41
|
||
Certifications
|
|
2
PART
I - Financial Information
ITEM
1. Financial Statements
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
March
31, 2006
|
December
31, 2005
|
||||||
(Unaudited)
|
*
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
5,458,312
|
$
|
5,403,036
|
|||
Restricted
cash
|
207,050
|
206,931
|
|||||
Accounts
receivable, net of allowance for doubtful accounts of $754,197 and
$765,440, respectively
|
4,737,483
|
4,651,080
|
|||||
Inventories
|
7,536,171
|
8,047,444
|
|||||
Prepaid
expenses and other current assets
|
753,435
|
621,372
|
|||||
Total
current assets
|
18,692,451
|
18,929,863
|
|||||
Property
and equipment, net
|
7,407,593
|
7,044,713
|
|||||
Goodwill,
net
|
16,917,808
|
16,375,384
|
|||||
Patents
and licensed technologies, net
|
1,902,449
|
1,577,554
|
|||||
Other
intangible assets, net
|
4,235,125
|
4,467,625
|
|||||
Other
assets
|
541,010
|
280,467
|
|||||
Total
assets
|
$
|
49,696,436
|
$
|
48,675,606
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Current
portion of notes payable
|
$
|
224,655
|
$
|
228,398
|
|||
Current
portion of long-term debt
|
2,127,896
|
1,749,969
|
|||||
Accounts
payable
|
4,187,982
|
3,572,077
|
|||||
Accrued
compensation and related expenses
|
1,551,316
|
867,427
|
|||||
Other
accrued liabilities
|
709,144
|
924,968
|
|||||
Deferred
revenues
|
572,124
|
466,032
|
|||||
Total
current liabilities
|
9,373,117
|
7,808,871
|
|||||
Long-term
liabilities:
|
|||||||
Notes
payable
|
178,889
|
159,213
|
|||||
Long-term
debt
|
2,722,869
|
2,278,871
|
|||||
Other
liabilities
|
5,818
|
11,623
|
|||||
Total
liabilities
|
12,280,693
|
10,258,578
|
|||||
Commitments
and Contingencies
|
|||||||
Stockholders’
equity:
|
|||||||
Common
stock, $.01 par value, 75,000,000 shares authorized; 52,620,304 and
51,414,294 shares issued and outstanding, respectively
|
526,203
|
514,143
|
|||||
Additional
paid-in capital
|
119,422,407
|
118,140,838
|
|||||
Accumulated
deficit
|
(82,532,867
|
)
|
(80,182,606
|
)
|
|||
Deferred
compensation
|
-
|
|
(55,347
|
)
|
|||
Total
stockholders' equity
|
37,415,743
|
38,417,028
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
49,696,436
|
$
|
48,675,606
|
*
The
December 31, 2005 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
March
31,
|
|||||||
2006
|
2005
|
||||||
Revenues:
|
|||||||
Product
sales
|
$
|
5,243,912
|
$
|
2,225,699
|
|||
Services
|
2,837,250
|
2,757,633
|
|||||
8,081,162
|
4,983,332
|
||||||
Cost
of revenues:
|
|||||||
Product
cost of revenues
|
2,321,669
|
892,964
|
|||||
Services
cost of revenues
|
2,386,229
|
1,739,404
|
|||||
|
4,707,898
|
2,632,368
|
|||||
Gross
profit
|
3,373,264
|
2,350,964
|
|||||
Operating
expenses:
|
|||||||
Selling
and marketing
|
2,952,939
|
1,380,591
|
|||||
General
and administrative
|
2,407,239 | 1,840,385 | |||||
Engineering
and product development
|
242,204
|
186,971
|
|||||
5,602,382
|
3,407,947
|
||||||
Loss
from operations
|
(2,229,118
|
)
|
(1,056,983
|
)
|
|||
Interest
expense, net
|
(121,143
|
)
|
(71,129
|
)
|
|||
Net
loss
|
$
|
(2,350,261
|
)
|
$
|
(1,128,112
|
)
|
|
Basic
and diluted net loss per share
|
$
|
(0.05
|
)
|
$
|
(0.03
|
)
|
|
Shares
used in computing basic and diluted net loss per share
|
52,173,618
|
41,755,950
|
The
accompanying notes are an integral part of these consolidated financial
statements.
4
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
FOR
THE
THREE MONTHS ENDED MARCH 31, 2006
(Unaudited)
Additional
|
|||||||||||||||||||
Common
Stock
|
Paid-In
|
Accumulated
|
Deferred
|
||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Compensation
|
Total
|
||||||||||||||
BALANCE,
DECEMBER 31, 2005
|
51,414,294
|
$
|
514,143
|
$
|
118,140,838
|
$
|
(80,182,606
|
)
|
$
|
(55,347
|
)
|
$
|
38,417,028
|
||||||
Adoption of SFAS 123R | - | - | (55,347 | ) | - | 55,347 | 0 | ||||||||||||
Exercise
of stock options
|
45,000
|
450
|
67,950
|
-
|
-
|
68,400
|
|||||||||||||
Stock
options issued to consultants for services
|
-
|
-
|
76,622
|
-
|
-
|
76,622
|
|||||||||||||
Stock-based
compensation expense related to employee options
|
-
|
-
|
311,624
|
-
|
-
|
311,624
|
|||||||||||||
Stock-based
compensation expense related to severance agreement
|
-
|
-
|
195,497
|
-
|
-
|
195,497
|
|||||||||||||
Issuance
of restricted stock
|
860,000
|
8,600
|
78,544
|
-
|
-
|
87,144
|
|||||||||||||
Issuance
of stock for Stern assets acquisition
|
101,010
|
1,010
|
190,725
|
-
|
-
|
191,735
|
|||||||||||||
Issuance
of stock for AzurTec agreement
|
200,000
|
2,000
|
381,273
|
-
|
-
|
383,273
|
|||||||||||||
Amortization
of deferred compensation
|
-
|
-
|
14,718
|
-
|
-
|
14,718
|
|||||||||||||
Registration
expenses
|
-
|
-
|
(7,890
|
)
|
-
|
-
|
(7,890
|
)
|
|||||||||||
Issuance
of warrants for draws under line of credit
|
-
|
-
|
27,853
|
-
|
-
|
27,853
|
|||||||||||||
Net
loss for the three months ended March 31, 2006
|
-
|
-
|
-
|
(2,350,261
|
)
|
-
|
(2,350,261
|
)
|
|||||||||||
BALANCE,
MARCH 31, 2006
|
52,620,304
|
$
|
526,203
|
$
|
119,422,407
|
$
|
(82,532,867
|
)
|
$
|
-
|
|
$
|
37,415,743
|
The
accompanying notes are an integral part of these consolidated financial
statements.
5
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
For
the Three Months Ended
March
31,
|
|||||||
2006
|
2005
|
||||||
Cash
Flows From Operating Activities:
|
|||||||
Net
loss
|
$
|
(2,350,261
|
)
|
$
|
(1,128,112
|
)
|
|
Adjustments
to reconcile net loss to net cash used
|
|||||||
in
operating activities:
|
|||||||
Depreciation
and amortization
|
1,017,095
|
526,396
|
|||||
Stock-based
compensation expense related to employee options and restricted
stock
|
390,168
|
-
|
|||||
Stock
options issued to consultants for services
|
76,622
|
-
|
|||||
Amortization
of deferred compensation
|
14,718
|
4,199
|
|||||
Provision
for bad debts
|
58,246
|
167,412
|
|||||
Changes
in operating assets and liabilities, net of effects on acquired assets
and
liabilities:
|
|||||||
Accounts
receivable
|
(144,649
|
)
|
141,768
|
||||
Inventories
|
528,890
|
(769,136
|
)
|
||||
Prepaid
expenses and other assets
|
93,236
|
192,129
|
|||||
Accounts
payable
|
615,905
|
(210,567
|
)
|
||||
Accrued
compensation and related expenses
|
336,962
|
266,688
|
|||||
Other
accrued liabilities
|
(188,825
|
)
|
(781,200
|
)
|
|||
Cash
deposits
|
(27,000
|
)
|
9,000
|
||||
Deferred
revenues
|
106,092
|
(82,683
|
)
|
||||
Other
liabilities
|
(5,805
|
)
|
(23,860
|
)
|
|||
Net
cash provided by (used in) operating activities
|
521,394
|
(1,687,966
|
)
|
||||
Cash
Flows From Investing Activities:
|
|||||||
Purchases
of property and equipment
|
(11,366
|
)
|
(56,382
|
)
|
|||
Lasers
placed into service
|
(1,079,167
|
)
|
(722,509
|
)
|
|||
Cash
received from acquisition, net of costs incurred
|
-
|
6,014,450
|
|||||
Net
cash (used in) provided by investing activities
|
(1,090,533
|
)
|
5,235,559
|
||||
Cash
Flows From Financing Activities:
|
|||||||
Proceeds
from issuance of restricted common stock
|
8,600
|
-
|
|||||
Costs
related to issuance of common stock
|
(7,890
|
)
|
(134,462
|
)
|
|||
Proceeds
from exercise of options
|
68,400
|
53,148
|
|||||
Proceeds
from exercise of warrants
|
-
|
147,060
|
|||||
Payments
on long-term debt
|
(58,725
|
)
|
(70,131
|
)
|
|||
Payments
on notes payable
|
(205,718
|
)
|
(86,225
|
)
|
|||
Net
advancements on lease line of credit
|
819,867
|
(154,315
|
)
|
||||
(Increase)/decrease
in restricted cash and cash equivalents
|
(119
|
)
|
100,431
|
||||
Net
cash provided by (used in) financing activities
|
624,415
|
(144,494
|
)
|
||||
Net
increase in cash and cash equivalents
|
55,276
|
3,403,099
|
|||||
Cash
and cash equivalents, beginning of period
|
5,403,036
|
3,884,817
|
|||||
Cash
and cash equivalents, end of period
|
$
|
5,458,312
|
$
|
7,287,916
|
The
accompanying notes are an integral part of these consolidated financial
statements.
6
PHOTOMEDEX,
INC. AND SUBSIDIARIES
NOTES
TO
UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
Note
1
Basis
of Presentation:
The
Company:
Background
PhotoMedex,
Inc. (and its subsidiaries) (the “Company”) is a medical device and specialty
pharmaceutical company focused on facilitating the cost-effective use of
technologies for doctors, hospitals and surgery centers to enable their patients
to achieve a higher quality of life. The Company operates in five distinct
business units, or segments (as described in Note 11): three in Dermatology,
including Domestic XTRAC®, International Dermatology, and Skin Care (ProCyte®);
and two in Surgical, including Surgical Services (SIS) and Surgical Products
and
other (SLT®). The segments are distinguished by our management structure,
products and services offered, markets served or types of customers.
The
Domestic XTRAC segment derives revenues from procedures performed by
dermatologists in the United States. Our XTRAC laser system is placed in a
dermatologist’s office without any initial capital cost to the dermatologist and
then we charge a fee-per-use to treat skin disease. The International
Dermatology segment was formerly called the International XTRAC segment, but
with the addition of the VTRAC™ lamp-based system in this quarter, we have
renamed this segment. In comparison to the Domestic XTRAC segment, the
International Dermatology segment generates revenues from the sale of equipment
to dermatologists outside the United States through a network of distributors.
The Skin Care segment generates revenues by selling physician-dispensed skincare
products worldwide and by earning royalties on licenses for our patented copper
peptide compound.
The
Surgical Services segment generates revenues by providing fee-based procedures
typically using our mobile surgical laser equipment delivered and operated
by a
technician at hospitals and surgery centers in the United States. The Surgical
Products segment generates revenues by selling laser products and disposables
to
hospitals and surgery centers both domestically and internationally. The
Surgical Products segment also sells other non-laser products (e.g. the
ClearESS® II suction-irrigation system).
The
XTRAC
laser system is designed and manufactured by us 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. It was followed by FDA 510(k) clearance to treat vitiligo in March
2001, atopic dermatitis in August 2001, and leukoderma in May 2002. The first
XTRAC phototherapy treatment systems were commercially distributed in the United
States in August 2000 prior to any of its procedures being approved for medical
insurance reimbursement. In the last several years, the Company has sought
to
obtain reimbursement for psoriasis and other inflammatory skin disorders.
Obtaining reimbursement for new technologies is a major challenge for any
company and in the latter part of 2005, the Company received many approvals
for
the reimbursement for use of the XTRAC system. The manufacturing facility
for the XTRAC laser system is located in Carlsbad, California.
The
Skin
Care business resulted from the acquisition of ProCyte Corporation (“ProCyte”)
on March 18, 2005. ProCyte, located in Redmond, Washington, markets products
for
skin health, hair care and wound care. Many of these products incorporate
patented copper peptide technologies. In addition to a diversified product
line,
ProCyte has provided a national sales force and increased the Company’s
marketing department. (see Note 2).
The
Surgical businesses were acquired on December 27, 2002 as a result of the
acquisition of Surgical Laser Technologies, Inc. (“SLT”), located in
Montgomeryville, Pennsylvania. In the Surgical business, 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. The
Montgomeryville facility also serves as the Company’s corporate
headquarters.
7
Liquidity
and Going Concern
The
Company has incurred significant losses and negative cash flows from operations
since emerging from bankruptcy in May 1995. As of March 31, 2006, the Company
had an accumulated deficit of $82,532,867. The Company has historically financed
its activities from operations, the private placement of equity securities
and
borrowings under lines of credit. To date, the Company has dedicated most of
its
financial resources to research and development, marketing and general and
administrative expenses.
Cash
and
cash equivalents as of March 31, 2006 were $5,665,362, including restricted
cash
of $207,050. Management believes that the existing cash balance together with
its other existing financial resources, including its leasing credit line
facility with a remaining availability of $770,003 (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 2007. The 2006 operating plan reflects anticipated
growth from an increase in per-treatment fee revenues for use of the XTRAC
laser
system based on wider insurance coverage in the United States and continuing
cost savings from the integration of business operations acquired from ProCyte.
In addition, the 2006 operating plan calls for increased revenues and profits
from the Domestic XTRAC business and the continued growth of our 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 2006. There can be no assurance that additional financing, if needed,
will be available when required or, if available, can be obtained on terms
satisfactory to the Company.
Since
2002, the Company has made significant progress in obtaining more extensive
reimbursement approval from the Centers for Medicare and Medicaid Services
and
various private health plans for the treatment of skin disorders using the
XTRAC
system.
The
Company plans to continue to focus on securing reimbursement from more private
insurers and to concentrate sales and marketing efforts where such
reimbursement has become available. As approvals for reimbursements are
obtained, the Company will increase spending on the marketing of its psoriasis,
vitiligo, atopic dermatitis and leukoderma treatment products and, if necessary,
expansion of its manufacturing facilities. Notwithstanding the approval for
reimbursement by Centers for Medicare and Medicaid Services and recent approvals
by certain private insurers, the Company may continue to face resistance from
remaining private healthcare insurers to adopt the excimer-laser-based therapy
as an approved procedure or to provide adequate levels of reimbursement.
Management cannot provide assurance that the Company will market the product
successfully or operate profitably in the future, or that it will not require
significant additional financing in order to accomplish its business plan
objectives.
The
Company’s future success also depends in part upon increased patient acceptance
of its excimer-laser-based systems for the treatment of a variety of skin
disorders. The Company’s ability to introduce successful new products may be
adversely affected by a number of factors, such as unforeseen costs and
expenses, technological change, economic downturns, increased competition,
other
factors beyond the Company’s control or excessive costs in order to market the
product and thus win patient acceptance. The Company is continuing
implementation of its rollout strategy for the XTRAC laser system in the United
States in selected areas of the country where reimbursement is widely available.
The success of the rollout depends on increasing physician and patient demand
for the treatment.
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 the objectives of its business
plan.
Consequently, the Company’s historical operating results cannot be relied on to
be an indicator of future performance, and management cannot predict whether
the
Company will obtain or sustain positive operating cash flow or generate net
income in the future.
Summary
of Significant Accounting Policies:
Quarterly
Financial Information and Results of Operations
The
financial statements as of March 31, 2006 and for the three months ended
March 31, 2006 and 2005, are unaudited and, in the opinion of management,
include all adjustments (consisting primarily of normal recurring adjustments)
necessary to present fairly the financial position as of March 31 2006, and
the
results of operations and cash flows for the three months ended March 31, 2006
and 2005. The results for the three months ended March 31, 2006 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, 2005.
8
Principles
of Consolidation
The
consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries. All significant intercompany balances and
transactions have been eliminated.
Use
of Estimates
The
preparation of the consolidated financial statements in conformity with
accounting principles generally accepted in the United States requires
management to make estimates and assumptions that affect amounts reported in
the
financial statements and accompanying notes. Actual results could differ from
those estimates and be based on events different from those assumptions. Future
events and their effects cannot be predicted with certainty; estimating,
therefore, requires the exercise of judgment. Thus, accounting estimates change
as new events occur, as more experience is acquired, or as additional
information is obtained.
See
“Summary of Significant Accounting Policies” in the Company’s 2005 Annual Report
on Form 10-K for a discussion of the estimates and judgments necessary in the
Company’s accounting for cash and cash equivalents, accounts receivable,
inventories, property, equipment and depreciation, product development costs
and
fair value of financial instruments.
Revenue
Recognition
The
Company has two distribution channels for its phototherapy treatment equipment.
The Company either (i) sells the laser through a distributor or directly to
a
physician or (ii) places the lasers in physician’s offices (at no charge to the
physician) and charges the physician a fee for an agreed upon number of
treatments. When the Company sells an XTRAC laser to a distributor or directly
to a physician, revenue is recognized when the following four criteria under
Staff Accounting Bulletin No. 104 have been met: (i) the product has been
shipped and the Company has no significant remaining obligations; (ii)
persuasive evidence of an arrangement exists; (iii) the price to the buyer
is
fixed or determinable; (iv) and collection is probable (the “SAB 104 Criteria”).
At times, units are shipped, but revenue is not recognized until all of the
criteria are met, and until that time, the unit is carried on the books of
the
Company as inventory.
The
Company ships most of its products FOB shipping point, although from time to
time certain customers, for example governmental customers, will insist upon
FOB
destination. Among the factors the Company takes into account in determining
the
proper time at which to recognize revenue are when title to the goods transfers
and when the risk of loss transfers. Shipments to distributors that do not
fully
satisfy the collection criteria are recognized when invoiced amounts are fully
paid.
Under
the
terms of the Company’s distributor agreements, the distributors do not have the
unilateral right to return any unit that they have purchased. However, the
Company does allow products to be returned by its distributors for product
defects or other claims.
When
the
Company places a laser in a physician’s office, it recognizes service revenue
based on the number of patient treatments performed by the physician. Treatments
in the form of random laser-access codes that are sold to 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
because the treatments can only be performed on Company-owned equipment. Once
the treatments are delivered to a patient, this obligation has been satisfied.
The
Company excludes all sales of treatment codes made within the last two weeks
of
the period in determining the amount of procedures performed by its
physician-customers. Management believes this approach closely approximates
the
actual amount of unused treatments that existed at the end of a period. For
the
three months ended March 31, 2006 and 2005, the Company deferred an additional
$421,624 and $311,571, respectively, under this program.
In
the
first quarter of 2003, the Company implemented a program to support certain
physicians in addressing treatments with the XTRAC system that may be denied
reimbursement by private insurance carriers. The Company recognizes service
revenue from the sale of treatment codes to physicians participating in this
program only if and to the extent the physician has been reimbursed for the
treatments. For the three months ended March 31, 2006, the Company deferred
an additional $51,080 under this program, as all the SAB 104 Criteria for
revenue recognition had not been met. At March 31, 2006, the Company had net
deferred revenues of $101,720 under this program.
9
Under
this program, the Company may reimburse qualifying doctors for the cost of
the
Company’s fee but only if they are ultimately denied reimbursement after appeal
of their claim with the insurance company. The key components of the program
are
as follows:
·
|
The
physician practice must be in an identified location where there
is an
insufficiency of insurance companies reimbursing the
procedure;
|
·
|
The
program only covers medically necessary treatments of psoriasis as
determined by the treating
physician;
|
·
|
The
patient must have medical insurance and a claim for the treatment
must be
timely filed with the patient’s insurance company;
|
·
|
Upon
denial by the insurance company (generally within 30 days of filing
a
claim), a standard insurance form called an EOB (“Explanation of
Benefits”) must be submitted to the Company’s in-house appeals group, who
will then prosecute the appeal. The appeal process can take 6 to
9
months;
|
·
|
After
all appeals have been exhausted by the Company and the claim remains
unpaid, the physician is entitled to receive credit for the treatment
he
or she purchased from the Company (our fee only) on behalf of the
patient;
and
|
·
|
Physicians
are still obligated to make timely payments for treatments purchased,
irrespective of whether reimbursement is paid or denied. Future sale
of
treatments to a physician can be denied if timely payments are not
made,
even if a patient’s appeal is still in
process.
|
The
Company estimates a contingent liability for potential refunds under this
program by reviewing the history of denied insurance claims and appeals
processed. The Company estimates that approximately 4% of the revenues under
this program for the quarter ended March 31, 2006 are subject to being credited
or refunded to the physician. The Company estimates that 11% of the revenues
under this program for the quarter ended March 31, 2005 were subject to being
credited or refunded to the physician.
The
Company generates revenues from its skin care business primarily through
three channels. The first is through product sales for skin health, hair care
and wound care; the second is through sales of the copper peptide compound,
primarily to Neutrogena Corporation, a Johnson & Johnson company; and the
third is through royalties generated by our licenses, principally to Neutrogena.
The Company recognizes revenues on the products and copper peptide compound
when
they are shipped, net of returns and allowances. The Company ships the products
FOB shipping point. Royalty revenues are based upon sales generated by our
licensees. The Company recognizes royalty revenue at the applicable royalty
rate
applied to shipments reported by our licensee.
The
Company generates revenues from its surgical businesses primarily from two
channels. The first is through product sales of laser systems, related
maintenance service agreements, recurring laser delivery systems and laser
accessories and the second is through per-procedure surgical services. The
Company recognizes revenues from surgical laser and other product sales,
including sales to distributors, when the SAB 104 Criteria have been met.
For
per-procedure surgical services, the Company recognizes revenue upon the
completion of the procedure. Revenue from maintenance service agreements is
deferred and recognized on a straight-line basis over the term of the
agreements. Revenue from billable services, including repair activity, is
recognized when the service is provided.
Impairment
of Long-Lived Assets and Intangibles
In
accordance with SFAS No. 144, “Accounting for the Impairment of Disposal of
Long-Lived Assets”, long-lived assets, such as property and equipment, and
purchased intangibles subject to amortization, are reviewed for impairment
whenever events or changes in circumstances indicate that the carrying amount
of
an asset may not be recoverable. Recoverability of assets to be held and used
is
measured by a comparison of the carrying amount of an asset to estimated
undiscounted future cash flows expected to be generated by the asset. If the
carrying amount of an asset exceeds its estimated future cash flows, an
impairment charge is recognized by the amount by which the carrying amount
of
the asset exceeds the fair value of the asset. Assets to be disposed of would
be
separately presented in the balance sheet and reported at the lower of the
carrying amount or the fair value less costs to sell, and would no longer be
depreciated. The assets and liabilities of a disposed group would be classified
as held for sale and would be presented separately in the appropriate asset
and
liability sections of the balance sheet. As of March 31, 2006, no such
impairment existed.
10
Patent
Costs and Licensed Technologies
Costs
incurred to obtain or defend patents and licensed technologies are capitalized
and amortized over the shorter of the remaining estimated useful lives or 8
to
12 years. Developed technology was recorded in connection with the purchase
in
August 2000 of the minority interest of Acculase, a former subsidiary of the
Company, and is being amortized on a straight-line basis over seven years.
Developed technology was also recorded in connection with the acquisition of
ProCyte in March 2005 and is being amortized on a straight-line basis over
seven
years.
Management
evaluates the 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 March
31, 2006, no such write-down was required (See Impairment
of Long-Lived Assets and Intangibles).
Other
Intangible Assets
Other
intangible assets were recorded in connection with the acquisition of ProCyte
in
March 2005. The assets are being amortized on a straight-line basis over 5
to 10
years.
Management
evaluates the recoverability of such other intangible assets based on estimates
of undiscounted future cash flows over the remaining useful life of the asset.
If the amount of such estimated undiscounted future cash flows is less than
the
net book value of the asset, the asset is written down to fair value. As of
March 31, 2006, no such write-down was required.
Goodwill
Goodwill
was recorded in connection with the acquisition of ProCyte in March 2005 and
the
acquisition of Acculase in August 2000.
Management
evaluates the recoverability of such goodwill based on estimates of undiscounted
future cash flows over the remaining useful life of the asset. If the amount
of
such estimated undiscounted future cash flows is less than the net book value
of
the asset, the asset is written down to fair value. As of March 31, 2006, no
such write-down was required.
Accrued
Warranty Costs
The
Company offers a warranty on product sales generally for a one to two-year
period. The Company provides for the estimated future warranty claims on the
date the product is sold. The activity in the warranty accrual during the three
months ended March 31, 2006 is summarized as follows:
March
31, 2006
|
||||
Accrual
at beginning of period
|
$
|
204,708
|
||
Additions
charged to warranty expense
|
16,250
|
|||
Expiring
warranties
|
(57,475
|
)
|
||
Claims
paid
|
(15,284
|
) | ||
Accrual
at end of period
|
$
|
148,199
|
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.
11
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. When under the rules of SFAS No. 109 the Company may
recognize some of the deferred tax asset, the recognized portion may reduce
goodwill, increase stockholder’s equity directly and/or benefit the statement of
operations. Consistent with the rules of purchase accounting, the historical
deferred tax asset of ProCyte was written off when the Company acquired ProCyte.
If and when components of that asset are realized in the future, the acquired
goodwill of ProCyte will be reduced.
Net
Loss Per Share
The
Company computes net loss per share in accordance with SFAS No. 128, “Earnings
per Share.” In accordance with SFAS No. 128, basic net loss per share is
calculated by dividing net loss available to common stockholders by the weighted
average of common shares outstanding for the period. Diluted net loss per share
reflects the potential dilution from the conversion or exercise into common
stock of securities such as stock options and warrants.
In
these
consolidated financial statements, diluted net loss per share is the same as
basic net loss per share. No additional shares for the potential dilution from
the conversion or exercise of securities into common stock are included in
the
denominator, since the result would be anti-dilutive. Common stock options
and
warrants of 8,373,000 and 8,249,605 as of March 31, 2006 and 2005, respectively,
were excluded from the calculation of fully diluted earnings per share since
their inclusion would have been anti-dilutive.
Exchanges
of Nonmonetary Assets
Exchanges
under SFAS No. 153, “Exchanges of Nonmonetary Assets,” are measured based on the
fair value of the assets exchanged. Further, SFAS No. 153 eliminates the
previous narrow exception for nonmonetary exchanges of similar productive assets
and replaces it with a broader exception for exchanges of nonmonetary assets
that do not have “commercial substance.” Although SFAS No. 153 is generally
effective for financial statements for fiscal years beginning after June 15,
2005, the Company elected to early adopt this Statement. For the three months
ended March 31, 2006 and 2005, the Company has not recognized any income or
expense in accordance with this Statement.
Share-Based
Compensation
On
January 1, 2006, The Company adopted SFAS No. 123R, “Share-Based Payment,” which
requires all companies to measure and recognize compensation expense at fair
value for all stock-based payments to employees and directors. SFAS No. 123R
is
being applied on the modified prospective bases. Prior to the adoption of SFAS
No. 123R, the Company accounted for its stock-based compensation plans for
employees and directors under the recognition and measurement principles of
Accounting Principles Board (APB) Opinion No. 25, “Accounting for Stock Issued
to Employees”, and related interpretations, and accordingly, the Company
recognized no compensation expense related to the stock-based plans for grants
to employees or directors. Grants to consultants under the plans were recorded
under SFAS No. 123.
Under
the
modified prospective approach, SFAS No. 123R applies to new grants of options
and awards of stock as well as to grants of options that were outstanding on
January 1, 2006 and that may subsequently be repurchased, cancelled or
materially modified. Under the modified prospective approach, compensation
cost
recognized for the first quarter of fiscal 2006 includes compensation cost
for
all share-based payments granted prior to, but not yet vested on, January 1,
2006, based on fair value as of the prior grant-date and estimated in accordance
with the provisions of SFAS No. 123R. Prior periods were not restated to reflect
the impact of adopting the new standard.
SFAS
No.
123R also requires companies to calculate an initial "pool" of excess tax
benefits available at the adoption date to absorb any tax deficiencies that
may
be recognized under SFAS No. 123R. The pool includes the net excess tax benefits
that would have been recognized if the Company had adopted SFAS No. 123 for
recognition purposes on its effective date.
12
The
Company has elected to calculate the pool of excess tax benefits under the
alternative transition method described in FASB Staff Position ("FSP") No.
FAS
123(R)-3, "Transition Election Related to Accounting for Tax Effects of
Share-Based Payment Awards," which also specifies the method we must use to
calculate excess tax benefits reported on the statement of cash flows. The
Company is in a net operating loss position; therefore, no excess tax benefits
from share-based payment arrangements have been recognized for the three months
ended March 31, 2006.
The
proforma information presented in the following table illustrates the effect
on
net income and net income per share if the Company had applied the fair value
recognition provisions of FASB Statement No. 123, “Accounting for Stock-Based
Compensation,” as amended by FASB Statement No. 148, “Accounting for Stock-Based
Compensation – Transition and Disclosure,” to stock-based employee
compensation for the three months ended March 31, 2005:
Three
Months
Ended
March 31,
2005
|
||||
Net
loss:
|
||||
As
reported
|
$
|
(1,128,112
|
)
|
|
Less:
stock-based employee compensation expense included in reported net
loss
|
4,199
|
|||
Impact
of total stock-based compensation expense determined under
fair-value-based method for all grants and awards
|
(278,872
|
)
|
||
Pro-forma
|
$
|
(1,402,785
|
)
|
|
Net
loss per share:
|
||||
As
reported
|
$
|
(0.03
|
)
|
|
Pro-forma
|
$
|
(0.03
|
)
|
The
Company uses the Black-Scholes option-pricing model to estimate fair value
of
grants of stock options with the following weighted average
assumptions:
Assumptions
for Option Grants
|
Three
Months Ended March 31,
|
||
2006
|
2005
|
||
Risk-free
interest rate
|
4.58%
|
4.02%
|
|
Volatility
|
93.51%
|
98.27%
|
|
Expected
dividend yield
|
0%
|
0%
|
|
Expected
life
|
7.44
years
|
5
years
|
|
Estimated
forfeiture rate
|
11%
|
N/A
|
The
Company calculates expected volatility for a share-based grant based on
historic, daily stock price observations of our common stock during the period
immediately preceding the grant that is equal in length to the expected term
of
the grant. For estimating the expected term of share-based grants made in the
three months ended March 31, 2006, the Company has adopted the simplified method
authorized in Staff Accounting Bulletin No. 107. SFAS No. 123R also requires
that estimated forfeitures be included as a part of the estimate of expense
as
of the grant date. The Company has used historical data to estimate expected
employee behaviors related to option exercises and forfeitures. Prior to our
adoption of SFAS No. 123R, the Company reduced pro-forma share-based
compensation expense, presented in the notes to its financial statements, for
actual forfeitures as they occurred.
With
respect to both grants of options and awards of restricted stock, the risk
free
rate of interest is based on the U.S. Treasury rates appropriate for the
expected term of the grant or award.
With
respect to awards of restricted stock, the Company uses the Monte-Carlo pricing
model to estimate fair value of restricted stock awards made in the first
quarter 2006 with the following weighted average assumptions:
13
Assumptions
for Stock Awards
|
Three
Months
Ended
March
31,
2006
|
Risk-free
interest rate
|
4.32%
|
Volatility
|
70%
|
Expected
dividend yield
|
0%
|
Expected
Life
|
4.92
years
|
The
Company calculated expected volatility for restricted stock based on historic,
daily stock price observations of our common stock during the three-year period
immediately preceding the grant.
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 or deferred compensation of $132,081 was recorded and is being
amortized over the remaining vesting period, which is an average of two years.
The Company recognized $14,718 and $4,199 of such expense in the three months
ended March 31, 2006 and 2005, respectively.
There
was
$311,624 and $78,544 of compensation expense related to stock options granted
and restricted stock awarded, respectively, in the three months ended March
31,
2006. This expense is recognized in the operating results in selling, general
and administrative expenses. For stock options granted to consultants during
the
three months ended March 31, 2006, an additional selling, general, and
administrative expense in the amount of $76,622 was recognized. There was no
comparable expense for grants to consultants in the three months ended March
31,
2005.
Supplemental
Cash Flow Information
During
the three months ended March 31, 2006, the Company financed insurance policies
through notes payable for $143,775, financed certain credit facility costs
for
$41,563, financed a license agreement with a note payable of $77,876 and issued
warrants to a leasing credit facility which are valued at $27,853, and which
offset the carrying value of debt. During the three months ended March 31,
2006,
the Company issued 101,010 shares of its restricted common stock to Stern Laser
srl (“Stern”) due under another milestones under the Master Purchase Agreement;
the cost associated with this issuance is included in the license from Stern,
which is found in patents and licensed technologies. The Company also issued
200,000 shares of its restricted common stock to AzurTec, Inc. (“AzurTec”) as
part of an investment in the capital stock of AzurTec as well as for a license
agreement on AzurTec technology, both existing and to be developed in the
future.
In
connection with the purchase of ProCyte in March 2005, the Company issued
10,540,579 shares of common stock and assumed options to purchase 1,354,973
shares of its own common stock (see Note 2).
During
the three months ended March 31, 2005, the Company financed insurance policies
through note payables for $327,604, financed vehicle purchases of $30,205 under
capital leases, financed certain credit facility costs for $11,871 and issued
warrants to a leasing credit facility which are valued at $5,946, and which
offset the carrying value of the related debt.
For
the
three months ended March 31, 2006 and 2005, the Company paid interest of
$138,144 and $83,329, respectively. Income taxes paid in the three months ended
March 31, 2006 and 2005 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”. 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.
On
December 16, 2004, the FASB issued SFAS No. 123R, “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 No. 107”). SAB No. 107
expresses views of the SEC staff regarding the interaction between SFAS No.
123R
and certain SEC rules. SFAS No. 123R requires that the compensation cost
relating to share-based payment transactions be recognized in financial
statements. The cost is to be measured based on the fair value of the equity
or
liability instruments issued. The Company adopted SFAS No. 123R on January
1,
2006 using the modified prospective method. The impact of adopting this Standard
is discussed in Note 1, “Stock-Based Compensation”.
14
On
November 24, 2004, the FASB issued SFAS No. 151, “Inventory Costs,” which is an
amendment to Accounting Research Bulletin (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, such 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. The adoption of this Statement did not have a material effect on
the
consolidated financial statements.
Note
2
Acquisitions:
ProCyte
Transaction
On
March
18, 2005, the Company completed the acquisition of ProCyte Corporation, which
was organized in 1986. ProCyte develops, manufactures and markets products
for
skin health, hair care and wound care. Many of the Company’s products
incorporate its patented copper peptide technologies. ProCyte’s
focus since 1996 has been to provide unique products primarily based upon
patented technologies for selected applications in the dermatology, plastic
and
cosmetic surgery and spa markets. ProCyte also expanded the use of its novel
copper peptide technologies into the mass retail market for skin and hair care
through targeted technology licensing and supply agreements.
The
aggregate purchase price of $28,086,208 consisted of the issuance of 10,540,579
shares of the Company’s 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 $1,915,150 of transaction costs.
The merger consideration was based on a fixed exchange 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 on a stock price of $2.29 per share, which is the average
of
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
|
15
The
purchase price exceeded the fair value of the net assets acquired by
$13,973,385, which was recorded as goodwill. The increase in goodwill recognized
in the quarter ended March 31, 2006 reflects Management’s best estimate of
pre-acquisition contingencies based upon plans entered into prior to March
18,
2006.
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
months ended March 31, 2006 and 2005, assuming the acquisition had occurred
on
January 1, 2005:
Three
Months Ended March 31,
|
|||||||
2006
|
2005
|
||||||
Net
revenues
|
$
|
8,081,162
|
$
|
7,952,894
|
|||
Net
loss
|
$
|
(2,350,261
|
)
|
$
|
(1,230,164
|
)
|
|
Basic
and diluted loss per share
|
$
|
(0.05
|
)
|
$
|
(0.02
|
)
|
|
Shares
used in calculating basic and diluted loss per share
|
52,173,618
|
50,656,883
|
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, 2005, nor to be
indicative of future results of operations.
The
Company’s goals for this acquisition are summarized below:
·
|
the
addition of ProCyte's sales and marketing personnel should enhance
the
Company’s ability to market the XTRAC system;
|
·
|
ProCyte's
presence in the skin health and hair care products market should
present a
growth opportunity for PhotoMedex to market its existing products;
|
·
|
the
addition of ProCyte's cash balances as of the date of acquisition
and of
its operations should improve PhotoMedex's operating results and
strengthen its balance sheet;
|
·
|
the
combined company may reap short-term cost savings and have the opportunity
for additional longer-term cost efficiencies; and
|
·
|
the
combination of the senior management of ProCyte and PhotoMedex should
allow complementary skills to strengthen the management team.
|
Since
the
acquisition date, the Company has made progress toward the achievement of these
goals. Financial and administrative functions were transferred from Redmond
to
Montgomeryville in June 2005. Integration of and coordination between the sales
forces of the Skin Care and Domestic XTRAC business units is an ongoing process.
Mr. Clifford, who has been responsible for domestic sales and marketing of
the
dermatologic business segments, will be leaving the Company in the second
quarter of 2006, but will be available to the Company on a consulting basis.
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”). In March 2006, the Company issued an additional 101,010 shares of its
restricted common stock to Stern based on a milestone set forth in the Master
Agreement. As of March 31, 2006, the Company has issued an aggregate 589,854
shares of its restricted common stock to Stern in connection with the Master
Agreement. The Company also agreed to pay Stern up to an additional $250,000
based on the achievement of two remaining milestones. The Company retains the
right to pay these conditional sums in cash or in shares of its common stock,
in
its sole discretion. To provide for the issuance of shares, the Company has
reserved for issuance, and placed into escrow, 110,136 shares of its
unregistered stock. The per-share price of any shares issued in the future
will
be 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. Stern also
has
served as the distributor of the Company’s XTRAC laser system in South Africa
and Italy since 2000. The primary asset acquired from Stern in the transaction
is a license for Stern’s lamp-based technology, which was carried on the
Company’s books at $1,107,979, net as of March 31, 2006. Amortization of this
intangible is on a straight-line basis over 10 years and began in January 2005.
In the quarter ended March 2006, Stern purchased $28,000 of products from the
Company.
16
AzurTec
Transaction
On
March
30, 2006, the Company closed the transaction set forth in an Investment
Agreement with AzurTec, Inc. (“AzurTec”). The Company issued 200,000 shares of
its restricted common stock in exchange for 6,855,141 shares of AzurTec common
stock and 181,512 shares of AzurTec Class A preferred stock, which represents
a
14% interest on a fully diluted basis. In accordance with APB No. 18, and
related interpretations, the Company will account for its investment in AzurTec
on the cost basis.
The
Company also received a license from AzurTec with respect to its existing
and
future technology for the MetaSpex Laboratory System. The license gives the
Company rights to manufacture and market the ex vivo versions of the MetaSpex
product in exchange for certain royalty obligations. The license also confers
on
the Company certain rights on a potential in situ version of the MetaSpex
product. AzurTec remains responsible for the development and clinical trial
costs of the MetaSpex products, for which AzurTec is committed to raise
additional equity capital. AzurTec has contracted with the Company to resume
development work of the ex vivo versions of the MetaSpex product. The Company
will resume, and be paid for, such work once AzurTec has raised additional
equity capital and has its outstanding arrearage to the Company for prior
development work.
The
Company assigned $268,291 as the fair value of the investment in AzurTec. It
also assigned $114,982 as the fair value of the license it acquired from
AzurTec. Amortization of this intangible is on a straight-line basis over 10
years, which began April 2006.
Note
3
Inventories:
Set
forth
below is a detailed listing of inventories:
March 31, 2006
|
December 31, 2005
|
||||||
Raw
materials and work in progress
|
$
|
4,509,987
|
$
|
4,998,847
|
|||
Finished
goods
|
3,026,184
|
3,048,597
|
|||||
Total
inventories
|
$
|
7,536,171
|
$
|
8,047,444
|
Work-in-process
is immaterial, given the Company’s typically short manufacturing cycle, and
therefore is disclosed in conjunction with raw materials. Finished goods
includes $0 and $69,963 as of March 31, 2006 and December 31, 2005,
respectively, for laser systems shipped to distributors, but not recognized
as
revenue until all 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 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 the distributors that do
not
fully satisfy the collection criteria are recognized when invoiced amounts
are
fully paid. As of March 31, 2006 and December 31, 2005, the Company carried
specific reserves against its inventories of $952,733 and $931,719,
respectively.
17
Note
4
Property
and Equipment:
Set
forth
below is a detailed listing of property and equipment:
March
31, 2006
|
December
31, 2005
|
||||||
Lasers
in service
|
$
|
13,661,846
|
$
|
12,657,701
|
|||
Computer
hardware and software
|
334,490
|
334,490
|
|||||
Furniture
and fixtures
|
341,573
|
338,089
|
|||||
Machinery
and equipment
|
737,948
|
755,565
|
|||||
Autos
and trucks
|
382,690
|
382,690
|
|||||
Leasehold
improvements
|
246,158
|
238,276
|
|||||
15,704,705
|
14,706,811
|
||||||
Accumulated
depreciation and amortization
|
(8,297,112
|
)
|
(7,662,098
|
)
|
|||
Property
and equipment, net
|
$
|
7,407,593
|
$
|
7,044,713
|
Depreciation
expense was $710,036 and $436,994 for the three months ended March 31, 2006
and 2005, respectively. At March 31, 2006 and December 31, 2005, net
property and equipment included $496,292 and $530,191, respectively, of assets
recorded under capitalized lease arrangements, of which $243,984 and $302,710
was included in long-term debt at March 31, 2006 and December 31, 2005,
respectively (see Note 9).
Note
5
Patents
and Licensed Technologies:
Set
forth
below is a detailed listing of patents and licensed technologies:
March
31, 2006
|
December
31, 2005
|
||||||
Patents,
owned and licensed, at gross costs of $453,801 and $438,940, net
of
accumulated amortization of $203,895 and $194,660,
respectively
|
$
|
249,906
|
$
|
244,280
|
|||
Other
licensed or developed technologies, at gross costs of $2,432,258
and
$2,047,665, net of accumulated amortization of $779,715 and $714,391,
respectively
|
1,652,543
|
1,333,274
|
|||||
$
|
1,902,449
|
$
|
1,577,554
|
Related
amortization expense was $74,559 and $56,028 for the three months ended
March 31, 2006 and 2005, respectively. Included in other licensed and
developed technologies is $200,000 in developed technologies acquired from
ProCyte and $114,982 for the license with AzurTec (see Note 2). On March 31,
2006, the Company closed the transaction set forth in a License Agreement with
Mount Sinai School of Medicine of New York University (“Mount Sinai”). The
Company will reimburse to Mount Sinai, over the first 18 months of the license
term and at no interest for $77,876 of extant patent prosecution costs incurred
to date. The Company is also obligated, beginning April 1, 2006, to pay Mount
Sinai a royalty on a combined base of domestic sales of XTRAC treatment codes
used for psoriasis as well as for vitiligo. In the first four years of the
license, however, Mount Sinai may elect to be paid royalties on an alternate
base, comprised simply of treatments for vitiligo, but at a higher royalty
rate
than the rate applicable to the combined base. This technology is for the laser
treatment of vitiligo and is included in other licensed or developed
technologies.
18
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:
March
31, 2006
|
December
31, 2005
|
||||||
Neutrogena
Agreement, at gross cost of $2,400,000 net of accumulated amortization
of
$498,000 and $378,000, respectively.
|
$
|
1,902,000
|
$
|
2,022,000
|
|||
Customer
Relationships, at gross cost of $1,700,000 net of accumulated amortization
of $352,746 and $267,747, respectively.
|
1,347,254
|
1,432,253
|
|||||
Tradename,
at gross cost of $1,100,000 net of accumulated amortization of $114,129
and $86,628, respectively.
|
985,871
|
1,013,372
|
|||||
$
|
4,235,125
|
$
|
4,467,625
|
Related
amortization expense was $232,500 and $33,375 for the three months ended
March 31, 2006 and 2005, respectively. Amortization for 2005 was from March
18 to 31, 2005 due to the closing date of the merger with ProCyte. Under the
Neutrogena Agreement, the Company licenses to Neutrogena rights to its copper
peptide technology for which the Company receives royalties. Customer
Relationships embody the value to the Company of relationships that ProCyte
had
formed with its customers. Tradename includes the name of “ProCyte” and various
other trademarks associated with ProCyte’s products.
Note
7
Other
Accrued Liabilities:
Set
forth
below is a detailed listing of other accrued liabilities:
March
31, 2006
|
December
31, 2005
|
||||||
Accrued
professional and consulting fees
|
$
|
351,384
|
$
|
437,396
|
|||
Accrued
warranty
|
148,199
|
204,708
|
|||||
Accrued
sales taxes
|
176,202
|
184,764
|
|||||
Other
accrued expenses
|
33,359
|
98,100
|
|||||
Total
other accrued liabilities
|
$
|
709,144
|
$
|
924,968
|
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:
March
31, 2006
|
December
31, 2005
|
||||||
Note
Payable – secured creditor, interest at 6%, payable in monthly
principal and interest installments of $2,880 through June 2012
|
$
|
177,508
|
$
|
183,425
|
|||
Note
Payable – unsecured creditor, non-interest bearing, payable in 18 equal
monthly installments of $4,326 through October 2007
|
77,876
|
-
|
|||||
Note
payable – secured creditor, interest at 16.47%, payable in monthly
principal and interest installments of $2,618 through December
2006.
|
19,888
|
26,736
|
|||||
Note
Payable – unsecured creditor, interest at 7.42%, payable in monthly
principal and interest installments of $61,493 through March
2006
|
-
|
177,450
|
|||||
Note
Payable – unsecured creditor, interest at 8.97%, payable in monthly
principal and interest installments of $16,578 through November
2006
|
128,272
|
-
|
|||||
403,544
|
387,611
|
||||||
Less:
current maturities
|
(224,655
|
)
|
(228,398
|
)
|
|||
Notes
payable, net of current maturities
|
$
|
178,889
|
$
|
159,213
|
20
Note
9
Long-term
Debt:
Set
forth
below is a detailed listing of the Company’s long-term debt:
March
31, 2006
|
December
31, 2005
|
||||||
Borrowings
on credit facility:
|
|||||||
Draw
1 – effective interest at 17.79%, payable in monthly principal and
interest installments of $48,156.46 through June 2007.
|
$
|
669,543
|
$
|
792,362
|
|||
Draw
2 – effective interest at 17.14%, payable in monthly principal and
interest installments of $9,957.08 through September 2007.
|
164,605
|
189,543
|
|||||
Draw
3 – effective interest at 17.61%, payable in monthly principal and
interest installments of $4,796.60 through December 2007.
|
90,944
|
102,541
|
|||||
Draw
4 – effective interest at 12.62%, payable in monthly principal and
interest installments of $34,859.11 through June 2008.
|
840,022
|
922,350
|
|||||
Draw
5 – effective interest at 12.94%, payable in monthly principal and
interest installments of $28,756.93 through September
2008.
|
758,072
|
823,810
|
|||||
Draw
6 – effective interest at 13.36%, payable in monthly principal and
interest installments of $28,923.11 through December 2008.
|
823,960
|
895,524
|
|||||
Draw
7 – effective interest at 13.74%, payable in monthly principal and
interest installments of $40,887.14 through March 2009.
|
1,259,635
|
-
|
|||||
Total
borrowings on credit facility
|
$
|
4,606,781
|
$
|
3,726,130
|
|||
Capital
lease obligations (see Note 4)
|
243,984
|
302,710
|
|||||
Less:
current portion
|
(2,127,896
|
)
|
(1,749,969
|
)
|
|||
Total
long-term debt
|
$
|
2,722,869
|
$
|
2,278,871
|
Leasing
Credit Facility
The
Company entered into a leasing credit facility with GE Capital Corporation
(“GE”) on June 25, 2004. The credit facility has a commitment term of three
years, expiring on June 25, 2007. For each year of the term, called a “tranche,”
various parameters are set or re-set. 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 security for
the
borrowings. The Company depreciates the lasers over their remaining useful
lives, as established when originally placed into service. Each draw against
the
credit facility has a self-amortizing repayment period of three years and is
secured by specified lasers, which the Company has sold to GE and leased back
for continued deployment in the field.
Under
the
first tranche, GE made available $2,500,000 under the line. A draw under that
tranche is set at an interest rate based on 522 basis points above the
three-year Treasury note rate. Each such draw is discounted by 7.75%; the first
monthly payment is applied directly to principal. With each draw, the Company
agreed to issue warrants to purchase shares of the Company’s common stock equal
to 5% of the draw. The number of warrants is determined by dividing 5% of the
draw by the average closing price of the Company’s common stock for the ten days
preceding the date of the draw. The warrants have a five-year term from the
date
of each issuance and bear an exercise price set at 10% over the average closing
price of the Company’s common stock for the ten days preceding the date of the
draw.
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.
21
The
Company has accounted for these warrants as equity instruments in accordance
with EITF 00-19, "Accounting for Derivative Financial Instruments Indexed to,
and Potentially Settled in, a Company's Own Stock" since there is no option
for
cash or net-cash settlement when the warrants are exercised. Future exercises
and forfeitures will reduce the amount of warrants. Exercises will increase
the
amount of common stock outstanding and additional paid in capital.
The
Company obtained 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 trading days preceding the date of the draw. The warrants have a
five-year term from the date of each issuance and bear an exercise price set
at
10% over the average closing price of the Company’s common stock for the ten
trading days preceding the date of the draw.
On
March
29, 2006, the Company made a draw against the second tranche, as follows:
Draw
7
|
||
Amount
of draw
|
$1,287,487
|
|
Stated
interest rate
|
9.45%
|
|
Effective
interest rate
|
13.74%
|
|
Number
of warrants issued
|
20,545
|
|
Exercise
price of warrants per share
|
$2.06
|
|
Fair
value of warrants
|
$27,853
|
The
fair
value of the warrants granted under the draws is estimated using the
Black-Scholes option-pricing model with the following weighted average
assumptions applicable to the warrants granted:
Warrants
granted
under
Draw 7
|
||
Risk-free
interest rate
|
4.79%
|
|
Volatility
|
87.16%
|
|
Expected
dividend yield
|
0%
|
|
Expected
warrant life
|
5
years
|
For
reporting purposes, the carrying value of the liability is reduced at the time
of each draw by the value ascribed to the warrants. This reduction will be
amortized at the effective interest rate to interest expense over the term
of
the draw.
As
of
March 31, 2006, the Company had available $770,003 from the second tranche
of
the line of credit from which to draw on in the future.
The
Company has accepted a letter of intent from GE to open a third line of leasing
credit for $5,000,000. Final approval from GE is expected in the second quarter
of 2006. If the third tranche is extended to the Company, the remaining
availability for the second tranche will be retired.
Capital
Leases
The
obligations under capital leases are at fixed interest rates and are
collateralized by the related property and equipment (see Note 4).
22
Note
10
Employee
Stock Benefit Plans
The
Company has stock-based compensation plans available to grant, among other
things, incentive and non-incentive stock options to employees, directors and
third-party service-providers as well as restricted stock to key employees.
Under the 2005 Equity Compensation Plan (the “Plan”), a maximum of 3,160,000
shares of the Company’s common stock was reserved for issuance. Following the
approval of the Plan on December 28, 2005, the Company will not grant any new
awards under any previously existing stock-based compensation plans, except
the
Outside Director Plan. At March 31, 2006, 1,214,000 shares were available for
future grants under the Plan and 403,750 under the Outside Director Plan. No
grants of options have been made as of March 31, 2006 under the 2005 Investment
Plan.
Stock
option activity under the Company’s share-based compensation plans for the three
months ended March 31, 2006 was as follows:
Number
of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
||||||||
Outstanding,
January 1, 2006
|
5,077,646
|
$
|
2.12
|
4.03
|
||||||
Granted
|
1,269,000
|
2.15
|
||||||||
Exercised
|
(45,000
|
)
|
3.03
|
|||||||
Cancelled
|
(49,500
|
)
|
4.05
|
|||||||
Outstanding,
March 31, 2006
|
6,252,146
|
$
|
2.11
|
5.04
|
||||||
Options
excercisable at March 31, 2006
|
3,560,994
|
$
|
1.73
|
At
March
31, 2006, there was $5,827,144 of total unrecognized compensation cost related
to non-vested stock option awards that is expected to be recognized over a
weighted-average period of 3.09 years.
Note
11
Business
Segment and Geographic Data:
Segments
are distinguished by the Company’s management structure, products and services
offered, markets served and types of customers. The Domestic XTRAC business
derives revenues from procedures performed by dermatologists in the United
States. The International Dermatology Equipment segment, in comparison,
generates revenues from the sale of equipment, both XTRAC and VTRAC, to
dermatologists outside the United States through a network of distributors.
The
Skin Care (ProCyte) segment generates revenues by selling skincare products
and
by earning royalties on licenses for the Company’s patented copper peptide
compound. The Surgical Services segment generates revenues by providing
fee-based procedures typically using the Company’s mobile surgical laser
equipment delivered and operated by a technician at hospitals and surgery
centers in the United States. The Surgical Products segment generates revenues
by selling laser products and disposables to hospitals and surgery centers
on
both a domestic and international basis. For the three months ended
March 31, 2006 and 2005, the Company did not have material revenues from
any individual customer.
Unallocated
operating expenses include costs incurred for administrative and accounting
staff, general liability and other insurance, professional fees and other
similar corporate expenses. Unallocated assets include cash, prepaid expenses
and deposits. Goodwill that was carried at $2,944,423 at March 31, 2006 and
December 31, 2005 has been allocated to the domestic XTRAC and international
dermatology equipment segments based upon its fair value as of the date of
the
Acculase acquisition in the amounts of $2,061,096 and $883,327, respectively.
Goodwill of $13,973,385 at March 31, 2006 from the ProCyte acquisition has
been
entirely allocated to the Skin Care segment.
23
The
following tables reflect results of operations from our business segments for
the periods indicated below:
Three
Months Ended March 31, 2006
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
1,059,630
|
$
|
531,065
|
$
|
3,460,561
|
$
|
1,616,034
|
$
|
1,413,872
|
$
|
8,081,162
|
|||||||
Costs
of revenues
|
946,612
|
330,290
|
1,052,444
|
1,414,578
|
963,974
|
4,707,898
|
|||||||||||||
Gross
profit
|
113,018
|
200,775
|
2,408,117
|
201,456
|
449,898
|
3,373,264
|
|||||||||||||
Gross
profit %
|
10.7%
|
37.8%
|
69.6%
|
12.5%
|
31.8%
|
41.7%
|
|||||||||||||
Allocated
Operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
1,131,951
|
17,431
|
1,428,174
|
252,076
|
140,807
|
2,970,439
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
105,735
|
-
|
136,469
|
242,204
|
|||||||||||||
Unallocated
Operating expenses
|
-
|
-
|
-
|
-
|
-
|
2,389,739
|
|||||||||||||
1,131,951
|
17,431
|
1,533,909
|
252,076
|
277,276
|
5,602,382
|
||||||||||||||
Income
(loss) from operations
|
(1,018,933
|
)
|
183,344
|
874,208
|
(50,620
|
)
|
172,622
|
(2,229,118
|
)
|
||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(121,143
|
)
|
||||||||||||
Net
income (loss)
|
$
|
(1,018,933
|
)
|
$
|
183,344
|
$
|
874,208
|
$
|
(50,620
|
)
|
$
|
172,622
|
$
|
(2,350,261
|
)
|
Three
Months Ended March 31, 2005
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
634,018
|
$
|
288,202
|
$
|
623,301
|
$
|
2,070,650
|
$
|
1,367,161
|
$
|
4,983,332
|
|||||||
Costs
of revenues
|
403,181
|
159,596
|
225,957
|
1,315,460
|
528,174
|
2,632,368
|
|||||||||||||
Gross
profit
|
230,837
|
128,606
|
397,344
|
755,190
|
838,987
|
2,350,964
|
|||||||||||||
Gross
profit %
|
36.4%
|
|
44.6%
|
|
63.7%
|
|
36.5%
|
|
61.3%
|
|
47.2%
|
|
|||||||
Allocated
Operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
530,988
|
61,033
|
356,802
|
291,116
|
158,152
|
1,398,091
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
13,797
|
-
|
173,174
|
186,971
|
|||||||||||||
Unallocated
Operating expenses
|
-
|
-
|
-
|
-
|
-
|
1,822,885
|
|||||||||||||
530,988
|
61,033
|
370,599
|
291,116
|
331,326
|
3,407,947
|
||||||||||||||
Income
(loss) from operations
|
(300,151
|
)
|
67,573
|
26,745
|
464,074
|
507,661
|
(1,056,983
|
)
|
|||||||||||
Interest
expense, net
|
-
|
-
|
4,079
|
|
-
|
-
|
(71,129
|
)
|
|||||||||||
Net
income (loss)
|
$
|
(300,151
|
)
|
$
|
67,573
|
$
|
30,824
|
$
|
464,074
|
$
|
507,661
|
$
|
(1,128,112
|
)
|
24
March
31, 2006
|
December
31, 2005
|
||||||
Assets:
|
|||||||
Total
assets for reportable segments
|
$
|
43,182,951
|
$
|
42,341,988
|
|||
Other
unallocated assets
|
6,513,485
|
6,333,618
|
|||||
Consolidated
total
|
$
|
49,696,436
|
$
|
48,675,606
|
For
the
three months ended March 31, 2006 and 2005, there were no material net
revenues attributed to any individual foreign country. Net revenues by
geographic area were, as follows:
For
the Three Months Ended
March
31,
|
|||||||
2006
|
2005
|
||||||
Domestic
|
$
|
6,659,378
|
$
|
4,465,666
|
|||
Foreign
|
1,421,784
|
517,666
|
|||||
$
|
8,081,162
|
$
|
4,983,332
|
Note
12
Significant
Alliances/Agreements:
On
March
31, 2005, the Company entered into a Sales and Marketing Agreement with
GlobalMed (Asia) Technologies Co., Inc. (“GlobalMed”). Under this agreement,
GlobalMed acts as master distributor in the Pacific Rim for the Company’s XTRAC
excimer laser and for the Company’s LaserPro® diode surgical laser system. The
Company’s diode laser will be marketed for, among other things, use in a
gynecological procedure pioneered by David Matlock, MD. The
Company has engaged Dr. Matlock as a consultant to explore further business
opportunities for the Company. In connection with this engagement, Dr. Matlock
received options to purchase up to 25,000 shares of the common stock of the
Company, granted with an exercise price based on the market value of the
Company’s common stock on the date of the grant.
On
July
27, 2005, the Company entered into a Marketing Agreement with KDS Marketing,
Inc. (“KDS”). Using money invested by each party, KDS will research market
opportunities for the Company’s diode laser and related delivery systems, and
KDS will then market the diode laser, primarily through a website on which
physicians may access for information about and purchase the lasers. KDS began
marketing the laser in the first quarter 2006.
On
March
30, 2006, the Company entered a strategic relationship with AzurTec, Inc. to
resume development, and to undertake the manufacture and distribution, of
AzurTec's MetaSpex Laboratory System, a light-based system designed to detect
certain cancers of the skin. PhotoMedex also acquired, on a fully diluted basis,
a 14 percent stake in AzurTec in exchange for 200,000 shares of the Company’s
restricted common stock. The Company will assist
in
the development of FDA-compliant prototypes for AzurTec’s product. Continuing
development of this project requires additional investment by AzurTec, which
AzurTec has undertaken to raise. The Company will resume development once the
additional investment has been raised, and AzurTec has settled its prior
indebtedness to the Company.
On
March
31, 2006, the Mount Sinai School of Medicine of New York University granted
the
Company an exclusive license, effective April 1, 2006, to use Mount Sinai's
patented methodology for utilization of ultraviolet laser light for the
treatment of vitiligo. The licensed patent is US Patent No. 6,979,327, Treatment
of Vitiligo. It was issued December 27, 2005, and the inventor is James M.
Spencer, MD, a member of the Company’s Scientific Advisory Board.
On
April
14, 2006, the Company entered into a Clinical Trial Agreement protocol with
the
University of California at San Francisco. The agreement covers a protocol
for a
phase 4, randomized, double-blinded study to evaluate the safety and efficacy
of
the XTRAC laser system in the treatment of moderate to severe psoriasis. John
Koo, MD, a member of our Scientific Advisory Board, will guide the study using
our high-powered Ultra™ excimer laser.
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,
2005.
The
following discussion and analysis should be read in conjunction with the
consolidated financial statements and related notes included elsewhere in this
Report.
Introduction,
Outlook and Overview of Business Operations
We
view
our business as comprised of the following five business segments:
·
|
Domestic
XTRAC,
|
·
|
International
Dermatology Equipment,
|
·
|
Skin
Care (ProCyte),
|
·
|
Surgical
Services, and
|
·
|
Surgical
Products.
|
Domestic
XTRAC
The
Domestic XTRAC segment is a U.S. business with revenues derived from procedures
performed by dermatologists. We are engaged in the development, manufacturing
and marketing of our proprietary XTRAC® excimer laser and delivery systems and
techniques used in the treatment of inflammatory skin disorders, including
psoriasis, vitiligo, atopic dermatitis and leukoderma. In January 2000, we
received approval of our 510(k) submission from the Food and Drug
Administration, or FDA, establishing that our XTRAC laser system is
substantially equivalent to currently marketed devices for the treatment of
psoriasis.
As
part
of our commercialization strategy in the United States, we provide the XTRAC
laser 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 laser system and will
increase market penetration.
For
the
past six years, we have sought to clear the path of obstacles and barriers
to a
smooth and orderly roll-out of the XTRAC laser system in dermatology. In 2000,
the laser system, which was originally designed for cardiology applications,
was
found to have significant therapeutic advantages for psoriasis patients who
were
treated with the UVB light emitted from the excimer based laser system. For
the
first two years, we invested in establishing the clinical efficacy of the
product and mechanical reliability of the equipment. In the last three years,
we
have pursued widespread reimbursement commencing with obtaining newly created
CPT reimbursement codes that became effective in 2003. This was followed by
the
lengthy process of persuading private medical insurers to adopt a positive
reimbursement policy for the procedure. Substantive progress on reimbursement
was achieved in the second half of 2005. We increased our dermatology sales
force and marketing department as part of the acquisition of ProCyte in March
2005. We
now
have ten sales representatives in the domestic XTRAC segment and 18 sales
representatives in the Skin care segment. The representatives of each segment
provide follow-up sales support for each other and share sales leads with each
other with a view to enhancing opportunities to cross selling. The marketing
department has been instrumental in expanding the advertising campaign for
the
XTRAC laser system. In November 2005, we commenced an advertising
campaign in selected regions that we believed have reimbursement potential
in
order to make consumers aware of the technology and therapeutic benefits of
targeted UVB laser treatment for psoriasis.
26
International
Dermatology Equipment
In
the
international market, we derive revenues by selling the dermatology laser
systems to distributors and directly to physicians. In this market, we have
benefited from both our clinical studies and from the improved reliability
and
functionality of the XTRAC laser system. Compared
to the domestic segment, the sales of laser systems in the international segment
is influenced to a greater degree by competition from similar laser technologies
as well as non-laser lamp alternatives. Over time, this competition has reduced
the prices we charge to international distributors for our XTRAC products.
In
2005, as a result of the acquisition of worldwide rights to certain proprietary
light-based technology from Stern Laser, we also explored new product offerings
in the treatment of dermatological conditions. We intend to expand the
international marketing of this product, called the VTRAC™, in 2006. The VTRAC
is designed to be a best-in-class lamp-based UVB targeted therapy, positioned
at
a price point lower than the XTRAC laser system so that it will effectively
compete with other non-laser based therapies for psoriasis and
vitiligo.
Due
to
the significant financial investment requirements, we
were
previously reluctant to implement an international XTRAC and/or VTRAC
fee-per-use revenue model, similar to the domestic revenue model. However,
as
reimbursement in the domestic market has become more widespread, we have
recently started to offer a version of this model overseas.
Skin
Care (ProCyte)
On
March
18, 2005, we completed the acquisition of ProCyte Corporation. ProCyte generates
revenues from the sale of skin health, hair care and wound care products; the
sale of copper peptide compound in bulk; and royalties on licenses for the
patented copper peptide compound.
The
operating results of ProCyte for the three months ended March 31, 2005 are
included from March 19, 2005 through March 31, 2005. Under purchase accounting
rules, the operating results of ProCyte for prior periods are not included
in
our Statement of Operations. A description of transaction and proforma operating
results are disclosed as part of Note 2, “Acquisitions”,
to the
financial statements.
ProCyte’s
focus has been to provide unique products, primarily based upon patented
technologies for selected applications in the dermatology, plastic and cosmetic
surgery and spa markets. ProCyte has also expanded the use of its novel copper
peptide technologies into the mass retail market for skin and hair care through
targeted technology licensing and supply agreements.
ProCyte’s
products are aimed at the growing demand for skin health and hair care products,
including products to enhance appearance and address the effects of aging on
skin and hair. ProCyte’s products are formulated, branded and targeted at
specific markets. ProCyte’s initial products addressed the dermatology, plastic
and cosmetic surgery markets for use after various procedures. Anti-aging skin
care products were added to offer a comprehensive approach for a patient’s skin
care regimen.
Since
the
acquisition date, we have made progress toward the achievement of these goals.
Financial and administrative functions were transferred from Redmond to
Montgomeryville in June 2005. Integration of and coordination between the sales
forces of the Skin Care and Domestic XTRAC business units is
ongoing.
Surgical
Services
The
Surgical Services segment generates revenues by providing fee-based procedures
typically using our mobile surgical laser equipment delivered and operated
by a
technician at hospitals and surgery centers in the United States. Although
we
intend to increase our investment in this business segment in 2006, we will
continue to pursue a very cautious growth strategy in order to conserve our
cash
resources for the XTRAC business segments.
27
We
have
limited marketing experience in expanding our surgical services business. The
majority of this business is in the southeastern part of the United States.
New
procedures and geographical expansion, together with new customers and different
business habits and networks, will likely pose different challenges compared
to
those that we have encountered in the past. There can be no assurance that
we
will be able to overcome such challenges.
Surgical
Products
The
Surgical Products segment generates revenues by selling laser products and
disposables to hospitals and surgery centers both inside and outside of the
United States. Also included are various non-laser surgical products (e.g.
the
ClearEss ® II suction-irrigation system). Although surgical product revenues
increased in 2006 compared to 2005, we expect that sales of surgical laser
systems and the related disposable base may begin to erode as hospitals continue
to seek outsourcing solutions instead of purchasing lasers and related
disposables for their operating rooms. We are working at offsetting this erosion
by expanding our surgical services segment and by increasing sales from the
diode surgical laser introduced in 2004.
Critical
Accounting Policies
The
discussion and analysis of our financial condition and results of operations
in
this Report are based upon our Consolidated Financial Statements, which have
been prepared in accordance with accounting principles generally accepted in
the
United States. The preparation of financial statements requires management
to
make estimates and judgments that affect the reported amounts of assets and
liabilities, revenues and expenses and related disclosures at the date of the
financial statements. On an on-going basis, we evaluate our estimates,
including, but not limited to, those related to revenue recognition, accounts
receivable, inventories, impairment of property and equipment and of
intangibles, deferred taxes and accruals for warranty claims. We use
authoritative pronouncements, historical experience and other assumptions as
the
basis for making estimates. Actual results could differ from those estimates.
Management believes that the following critical accounting policies affect
our
more significant judgments and estimates in the preparation of our Consolidated
Financial Statements. These critical accounting policies and the significant
estimates made in accordance with them have been discussed with our Audit
Committee. There have been no changes to our critical accounting policies in
the
three months ended March 31, 2006. See "Critical Accounting Policies" in our
"Management’s Discussion and Analysis of Financial Condition and Results of
Operations" in Item 7 of our Annual Report on Form 10-K for the year ended
December 31, 2005 for further information.
28
Results
of Operations
Revenues
The
following table presents revenues from our five business segments for the
periods listed below:
Three
Months Ended
March
31,
|
|||||||
2006
|
2005*
|
||||||
XTRAC
Domestic Services
|
$
|
1,059,630
|
$
|
634,018
|
|||
International
Dermatology Equipment Products
|
531,065
|
288,202
|
|||||
Skin
Care (ProCyte) Products
|
3,460,561
|
623,301
|
|||||
Total
Dermatology Revenues
|
5,051,256
|
1,545,521
|
|||||
Surgical
Services
|
1,616,034
|
2,070,650
|
|||||
Surgical
Products
|
1,413,872
|
1,367,161
|
|||||
Total
Surgical Revenues
|
3,029,906
|
3,437,811
|
|||||
Total
Revenues
|
$
|
8,081,162
|
$
|
4,983,332
|
* |
Since
ProCyte was acquired on March 18, 2005, there are only 14 days
of revenues
for the three months ended March 31,
2005.
|
Domestic
XTRAC Segment
Recognized
revenue for the three months ended March 31, 2006 and 2005 for domestic XTRAC
procedures was $1,059,630 and $634,018, respectively, reflecting billed
procedures of 18,760 and 11,304, respectively. In addition, 1,173 and 1,114
procedures were performed in the three months ended March 31, 2006 and 2005,
respectively, without billing from us, in connection with clinical research
and
customer evaluations of the XTRAC laser. The increase in procedures in the
period ended March 31, 2006 compared to the comparable period in 2005 was
largely related to our continuing progress in securing favorable reimbursement
policies from private insurance plans. Increases in these levels are dependent
upon more widespread adoption of CPT codes with comparable rates by private
healthcare insurers and on building market acceptance through marketing programs
with our physician partners and their patients that the XTRAC procedures will
be
of clinical benefit and be generally reimbursed.
In
the
first quarter of 2003, we implemented a program to support certain physicians
who may be denied reimbursement by private insurance carriers for XTRAC
treatments. In accordance with the requirements of Staff Accounting Bulletin
No.
104, we recognize service revenue during this program from the sale of XTRAC
procedures or equivalent treatments to physicians participating in this program
only to the extent the physician has been reimbursed for the treatments. For
the
three months ended March 31, 2006, we deferred net revenues of $51,080 under
this program compared to $19,150 of net recognized revenue for the three months
ended March 31, 2005. The change in deferred revenue under this program is
presented in the table below.
29
The
following table sets forth the above analysis for the Domestic XTRAC segment
for
the periods reflected below:
Three
Months Ended March 31,
|
|||||||
2006
|
2005
|
||||||
Recognized
revenue
|
$
|
1,059,630
|
$
|
634,018
|
|||
Change
in deferred program revenue
|
51,080
|
(19,150
|
)
|
||||
Change
in deferred unused treatments
|
110,053
|
135,500
|
|||||
Net
billed revenue
|
$
|
1,220,763
|
$
|
750,368
|
|||
Procedure
volume total
|
19,933
|
12,418
|
|||||
Less:
Non-billed procedures
|
1,173
|
1,114
|
|||||
Net
billed procedures
|
18,760
|
11,304
|
|||||
Avg.
price of treatments billed
|
$
|
65.07
|
$
|
66.38
|
|||
Change
in procedures with deferred/(recognized) program revenue,
net
|
785
|
(288
|
)
|
||||
Change
in procedures with deferred unused treatments, net
|
1,691
|
2,041
|
The
average price for a treatment varies based upon the mix of mild and moderate
psoriasis patients treated by our physician partners. We charge a higher price
per treatment for moderate psoriasis patients due to the increased body surface
area required to be treated, although there are fewer patients with moderate
psoriasis than there are with mild psoriasis. Due to the length of treatment
time required, it has not been generally practical to use our therapy to treat
severe psoriasis patients, but this may change as our new product, the XTRAC
Ultra, has shorter treatment times.
International
Dermatology Equipment Segment
International
sales of our dermatology equipment and related parts were $531,065 for the
three
months ended March 31, 2006 compared to $288,202 for the three months ended
March 31, 2005. We sold 12 and 5 laser systems in the three months ended March
31, 2006 and 2005, respectively. Compared to the domestic business, the
international dermatology equipment operations are more influenced by
competition from similar laser technology from other manufacturers and from
non-laser lamps. Such competition has reduced the prices we charge to
international distributors. Furthermore, average selling prices for
international dermatology equipment are influenced by the following two
factors:
·
|
We
have begun selling refurbished domestic XTRACs laser systems into
the
international market. Such used equipment is sold for substantially
less
than new equipment. We sold three of these used lasers at an average
price
of $28,000 for the three months ended March 31, 2006;
and
|
·
|
We
have begun selling the new VTRAC, a lamp based alternative UVB light
source that has a wholesale sales price internationally that is
substantially below other international dermatology equipment. In
the
three months ended March 31, 2006, we have sold two VTRAC
systems.
|
The
following table illustrates the key changes in the International Dermatology
Equipment segment for the periods reflected below:
Three
Months Ended March 31,
|
|||||||
2006
|
2005
|
||||||
Revenues
|
$
|
531,065
|
$
|
288,202
|
|||
Laser
systems sold
|
12
|
5
|
|||||
Average
revenue per laser
|
$
|
44,255
|
$
|
57,640
|
30
Skin
Care (ProCyte) Segment
For
the
three months ended March 31, 2006, ProCyte revenues were $3,460,561 compared
to
$623,301 in the three months ended March 31, 2005. Since ProCyte was acquired
on
March 18, 2005, there are only 14 days of revenues for the three months ended
March 31, 2005. 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. For the full quarter March 31, 2005,
unaudited Skin Care revenues were approximately $3.59 million.
The
following table illustrates the key changes in the Skin Care (ProCyte) segment
for the periods reflected below:
Three
Months Ended March 31,
|
|||||||
2006
|
2005
|
||||||
Product
sales
|
$
|
3,077,561
|
$
|
452,864
|
|||
Bulk
compound sales
|
256,000
|
156,000
|
|||||
Royalties
|
127,000
|
14,437
|
|||||
Total
ProCyte revenues
|
$
|
3,460,561
|
$
|
623,301
|
Surgical
Services Segment
In
the
three months ended March 31, 2006 and 2005, surgical services revenues were
$1,616,034 and $2,070,650, respectively, representing a 22% decrease from the
comparable period in 2005. This decrease was primarily due to the six
territories that we closed since January 1, 2005 and business interruption
in
New Orleans and Alabama from the hurricanes. Two of our territories were
closed on the western side of Florida due to the termination of a customer
contract. We closed the other four territories for insufficient profitability.
During the first quarter of 2006, we have begun work with a regional hospital
system in central Florida, which we expect will generate annual revenue
exceeding the annual revenue lost in the western part of the state.
The
following table illustrates the key changes in the Surgical Services segment
for
the periods reflected below:
Three
Months Ended March 31,
|
|||||||
2006
|
2005
|
||||||
Revenues
|
$
|
1,616,034
|
$
|
2,070,650
|
Surgical
Products Segment
Surgical
Products revenues include revenues derived from the sale of surgical laser
systems together with sales of related laser fibers and laser disposables.
Sales
of laser systems create recurring sales of laser fibers and laser disposables
that are more profitable than laser systems.
For
the
three months ended March 31, 2006, surgical products revenues were $1,413,872
compared to $1,367,161 in the three months ended March 31, 2005. The increase
was due to $214,000 in additional laser system revenues reflecting the increase
in the number of systems sold (18 vs. 5), partially offset by a decline in
the
average price per laser sold. This increase was offset, in part, by $120,885
of
revenues from the AzurTec project in the three months ended March 31, 2005
for
which there were no corresponding revenues in the three months ended March
31,
2006.
The
decrease in average price per laser was largely due to the mix of lasers sold.
Included in laser sales for the three months ended March 31, 2006 were sales
of
thirteen diode lasers, which have lower sales prices than our other types of
lasers. There was only one sale of a diode laser during the three months ended
March 31, 2005.
31
Disposables
and fiber sales decreased 7% between the comparable three-month periods ended
March 31, 2006 and 2005. We expect that our disposables base may continue to
erode over time as hospitals continue to seek outsourcing solutions instead
of
purchasing lasers and related disposables for their operating rooms. We have
continued to seek to offset this erosion through expansion of our surgical
services. Similarly, we believe there will be continuing pressure on laser
system sales as hospitals continue to outsource their laser-assisted procedures
to third parties, such as our surgical services business. We hope to offset
the
decline in laser and disposables revenues by sales on CO2 and diode surgical
lasers.
The
following table illustrates the key changes in the Surgical Products segment
for
the periods reflected below:
Three
Months Ended March 31,
|
|||||||
2006
|
2005
|
||||||
Revenues
|
$
|
1,413,872
|
$
|
1,367,161
|
|||
Laser
systems sold
|
18
|
5
|
|||||
Laser
system revenues
|
$
|
467,600
|
$
|
253,885
|
|||
Average
revenue per laser
|
$
|
25,978
|
$
|
50,779
|
Cost
of Revenues
Our
cost
of revenues are comprised of product cost of revenues and service cost of
revenues. Within product cost of revenues are the costs of products sold in
the
International Dermatology Equipment segment, the Skin Care segment (with
royalties being transferred over from the products side to the services side
of
the segment), and the Surgical Products segment (with laser maintenance being
transferred over from the products side to the services side of this segment).
Within services cost of revenues are the costs associated with the Domestic
XTRAC segment and the Surgical Services segment, as well as costs associated
with such royalties and maintenance.
Product
cost of revenues for the three months ended March 31, 2006 were $2,321,669
compared to $892,964 for the three months ended March 31, 2005. The $1,428,705
increase reflected an increase of $826,487 of costs for the ProCyte business
acquired on March 18, 2005 (entire period vs. 14 days), an increase of $431,524
for surgical products due to lower production levels that resulted in increased
unabsorbed overhead costs, and $170,694 associated with the increase in sales
of
dermatology laser equipment sold outside the United States.
Services
cost of revenues was $2,386,229 in the three months ended March 31, 2006
compared to $1,739,404 in the comparable period in 2005. Contributing to the
$646,825 increase was a $103,394 increase in the surgical services business
associated with increased laser repair costs and increased technician costs.
In
addition, cost of revenues in the Domestic XTRAC business segment increased
$543,431 due to increased depreciation on the lasers of $244,000 and abnormal
gas consumption, which has been corrected by software modifications.
Certain
allocable XTRAC manufacturing overhead costs are charged against the XTRAC
service revenues. The manufacturing facility in Carlsbad, California is used
exclusively for the production of the XTRAC lasers. The unabsorbed costs are
allocated to the domestic XTRAC and the international dermatology laser system
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 $3,373,264 during the three months ended March 31, 2006
from
$2,350,964 during the same period in 2005. As a percent of revenues, gross
margin decreased to 41.7% for the three months ended March 31, 2006 from 47.2%
for the same period in 2005.
32
The
following table analyzes changes in our gross margin for the periods reflected
below:
Company
Margin Analysis
|
Three
Months Ended
March
31,
|
||||||
2006
|
2005
|
||||||
Revenues
|
$
|
8,081,162
|
$
|
4,983,332
|
|||
Percent
increase
|
62.2%
|
||||||
Cost
of revenues
|
4,707,898
|
2,632,368
|
|||||
Percent
increase
|
78.8%
|
||||||
Gross
profit
|
$
|
3,373,264
|
$
|
2,350,964
|
|||
Gross
profit percentage
|
41.7%
|
47.2%
|
The
primary reasons for changes in gross margin for the three months ended March
31,
2006, compared to the same period in 2005 were as follows:
·
|
Our
skin care business has the highest gross profit percentage of any
of our
business segments. However, we acquired ProCyte on March 18, 2005,
so only
the activity after that date is recorded in our financial statements.
|
·
|
We
sold a greater number of treatment procedures for the XTRAC laser.
The
increase in procedure volume was a direct result of improving insurance
reimbursement.
|
·
|
We
sold a greater number of surgical laser systems due to the increased
marketing of the diode laser. These units were primarily sold to
our
master distributor at approximately 36% gross
margin.
|
·
|
Offsetting
the above was an increase in depreciation of $244,000 included in
the
XTRAC domestic cost of sales as a result of increasing the overall
placements of new lasers since the period ended March 31,
2005.
|
·
|
In
the surgical products segment, unabsorbed labor and overhead plant
costs,
due to lower production levels, accounted for $387,000 of the increase
in
increased cost of goods sold for the three months ended March 31,
2006.
|
·
|
Surgical
Services revenues decreased due to lost contracts, while costs related
to
laser repairs increased during the period. Some revenues were lost
due to
hurricanes. While we believe a portion of the loss will be covered
by
insurance, we will not record any expected recovery until we have
greater
assurance of such recovery.
|
The
following table analyzes our gross margin for our Domestic XTRAC segment for
the
periods presented below:
XTRAC
Domestic Segment
|
Three
Months Ended
March
31,
|
||||||
2006
|
2005
|
||||||
Revenues
|
$
|
1,059,630
|
$
|
634,018
|
|||
Percent
increase
|
67.1%
|
||||||
Cost
of revenues
|
946,612
|
403,181
|
|||||
Percent
increase
|
134.8%
|
||||||
Gross
profit
|
$
|
113,018
|
$
|
230,837
|
|||
Gross
profit percentage
|
10.7%
|
36.4%
|
Gross
margin decreased for this segment for the three months ended March 31, 2006
from
the comparable period in 2005 by $117,819. The key factors for the decrease
were
as follows:
33
·
|
The
cost of revenues increased by $543,431 for the three months ended
March
31, 2006. This increase is due to an increase in depreciation on
the
lasers in service of $244,000 over the comparable prior year period
and
abnormal gas consumption, which has been corrected by software
modification. The depreciation costs will continue to increase
in
subsequent periods as the business grows. In addition, there was
an
increase in certain allocable XTRAC manufacturing overhead costs
that are
charged against the XTRAC service
revenues.
|
·
|
Price
per procedure did not change significantly between the
periods.
|
·
|
A
key driver in increased revenue in this segment is insurance
reimbursement. In 2004, we focused on encouraging private health
insurance
plans to adopt the XTRAC laser therapy as an approved medical procedure
for the treatment of psoriasis. Since January 2004, several major
health
insurance plans instituted medical policies to pay claims for the
XTRAC
therapy, including Regence, Wellpoint, Aetna, Anthem, Cigna, United
Healthcare and Independence Blue Cross of
Pennsylvania.
|
·
|
Procedure
volume increased 66% from 11,304 to 18,760 billed procedures in the
three
months ended March 31, 2006 compared to the same period in 2005.
|
The
following table analyzes our gross margin for our International Dermatology
Equipment segment for the periods presented below:
International
Dermatology Equipment Segment
|
Three
Months Ended
March
31,
|
||||||
2006
|
2005
|
||||||
Revenues
|
$
|
531,065
|
$
|
288,202
|
|||
Percent
increase
|
84.3%
|
||||||
Cost
of revenues
|
330,290
|
159,596
|
|||||
Percent
increase
|
107.0%
|
||||||
Gross
profit
|
$
|
200,775
|
$
|
128,606
|
|||
Gross
profit percentage
|
37.8%
|
44.6%
|
Gross
margin for the three months ended March 31, 2006 increased by $72,169 from
the
comparable period in 2005. The key factors for the increase were as
follows:
·
|
We
sold ten XTRAC laser systems and two VTRAC lamp-based excimer systems
during the three months ended March 31, 2006 and five XTRAC laser
systems
in the comparable period in 2005.
|
·
|
The
International dermatology equipment operations are influenced by
competition from similar laser technology from other manufacturers
and
from non-laser lamp alternatives for treating inflammatory skin disorders,
which has served to reduce the prices we charge international distributors
for our excimer products. Partially
offsetting the increase in the number of laser systems sold was a
decrease
in the average price of the laser systems sold. After adjusting the
revenue for parts sales of approximately $87,000, the average price
for
lasers sold during this period was approximately $37,000 in the three
months ended March 31, 2006, down from $49,300 in the comparable
period in
2005. Contributing to the overall average selling price decrease
in the
three months ended March 31, 2006 was the sale of certain used lasers
which were previously deployed in the US operations and sold at a
discount
to the list price for new equipment. We sold 4 of these used lasers
at an
average price of $28,000. Each of these lasers had a net book value
of
less than the cost of a new XTRAC laser
system.
|
34
The
following table analyzes our gross margin for our SkinCare (ProCyte) segment
for
the periods presented below:
Skin
Care (ProCyte) Segment
|
Three
Months Ended
March
31,
|
||||||
|
2006
|
2005
|
|||||
Product
revenues
|
$
|
3,077,561
|
$
|
452,864
|
|||
Bulk
compound revenues
|
256,000
|
156,000
|
|||||
Royalties
|
127,000
|
14,437
|
|||||
Total
revenues
|
3,460,561
|
623,301
|
|||||
Product
cost of revenues
|
893,564
|
96,681
|
|||||
Bulk
compound cost of revenues
|
158,880
|
129,276
|
|||||
Total
cost of revenues
|
1,052,444
|
225,957
|
|||||
Gross
profit
|
$
|
2,408,117
|
$
|
397,344
|
|||
Gross
profit percentage
|
69.6%
|
63.7%
|
Gross
margin for the three months ended March 31, 2006 increased by $2,010,773 for
the
comparable period in 2005. The key factors in this business segment were as
follows:
·
|
Copper
Peptide bulk compound is sold at a substantially lower gross margin
than
skin care products, while revenues generated from licensees have
no
significant costs associated with this revenue
stream.
|
·
|
Product
revenues come primarily from U.S.
dermatologists.
|
·
|
Lesser
product revenues come from sales directed to consumers at spas
and from
marketing directly to the consumer (e.g.
infomercials).
|
The
following table analyzes our gross margin for our Surgical Services segment
for
the periods presented below:
Surgical
Services Segment
|
Three
Months Ended
March
31,
|
||||||
2006
|
2005
|
||||||
Revenues
|
$
|
1,616,034
|
$
|
2,070,650
|
|||
Percent
decrease
|
(22.0%)
|
|
|||||
Cost
of revenues
|
1,414,578
|
1,315,460
|
|||||
Percent
increase
|
7.5%
|
||||||
Gross
profit
|
$
|
201,456
|
$
|
755,190
|
|||
Gross
profit percentage
|
12.5%
|
36.5%
|
Gross
margin in the Surgical Services segment for the three months ended March 31,
2006 decreased by $553,734 from the comparable period in 2005. The key factors
impacting gross margin for the Surgical Services business were as
follows:
·
|
The
cost of revenues increased due to laser repair costs of $47,000 for
laser
material and parts over the comparable prior year period. Also due
to an
increase in product cost percentage on revenue due to a change in
the mix
of procedures performed.
|
·
|
We
have closed seven geographic areas of business due to unacceptable
operating profit and one territory due to competition. Although closing
these unprofitable territories will save costs and improve profitability
over time, the overall costs saved for the three months ended March
31,
2006 have not kept pace with the revenues lost. Nevertheless, in
the case
of the territory lost to competition, we have opened a new, contiguous
territory in which we have secured a long-term contract from which we
anticipate significant procedure volume. For that reason, we have
relocated our personnel and material from the lost territory to the
new
one.
|
35
·
|
We
have suffered business interruption due to hurricanes in the New
Orleans
and Alabama territories.
|
The
following table analyzes our gross margin for our Surgical Products segment
for
the periods presented below:
Surgical
Products Segment
|
Three
Months Ended
March
31,
|
||||||
2006
|
2005
|
||||||
Revenues
|
$
|
1,413,872
|
$
|
1,367,161
|
|||
Percent
increase
|
3.4%
|
||||||
Cost
of revenues
|
963,974
|
528,174
|
|||||
Percent
increase
|
82.5%
|
||||||
Gross
profit
|
$
|
449,898
|
$
|
838,987
|
|||
Gross
profit percentage
|
31.8%
|
61.4%
|
Gross
margin for the Surgical Products segment in the three months ended March 31,
2006 compared to the same period in 2005 decreased by $389,089. The key factors
in this business segment were as follows:
·
|
This
segment includes product sales of surgical laser systems and laser
disposables. Disposables are more profitable than laser systems,
but the
sale of laser systems generates the subsequent recurring sale of
laser
disposables.
|
·
|
Revenues
for the three months ended March 31, 2006 increased by $46,711 from
the
three months ended March 31, 2005 while cost of revenues increased
by
$435,799 between the same periods. There were 13 more laser system
sold in
the three months ended March 31, 2006 than in the comparable period
of
2005. However, the lasers sold in the 2005 period were at higher
prices
than in the comparable period in 2006. The decrease in average price
per
laser was largely due to the mix of lasers sold. Included in the
laser
sales for the three months ended March 31, 2006 and 2005 were sales
of
$230,500 and $35,000 of diode lasers, respectively, which have
substantially lower list sales prices than the other types of surgical
lasers.
|
·
|
Unabsorbed
labor and overhead plant costs, due to lower production levels, accounted
for $387,000 of the increase in cost of goods sold for the three
months
ended March 31, 2006.
|
·
|
This
revenue increase was partly offset by a decrease in AzurTec project
revenues and a decrease in sales of disposables between the periods.
The
AzurTec revenues recognized in 2005 had substantially no direct costs
associated with these revenues. Disposables, which have a higher
gross
margin as a percent of revenues than lasers, represented a lower
percentage of revenue in the three months ended March 31, 2006 compared
to
the same period in 2005.
|
Selling,
General and Administrative Expenses
For
the
three months ended March 31, 2006, selling, general and administrative expenses
increased $2,139,202 to $5,360,178 from the three months ended March 31, 2005.
Selling, general and administrative expenses related to the ProCyte business
accounted for $1,154,000 of the increase with the remaining increase related
to
$185,000 in salaries, benefits and travel expenses associated with an increase
in the sales force, particularly in the domestic XTRAC segment; an increase
in
direct-to-consumer advertising of $305,000, an increase in corporate insurance
of $96,000, $390,000 for stock-based compensation expense following adoption
of
SFAS No. 123R (see Note 1, “Stock-Based Compensation”) and $76,622 for stock
options issued to consultants. Offsetting some of the increases for the three
months ended March 31, 2006, was a reduction of bad debt expense of $87,000
compared to the prior year period.
36
Engineering
and Product Development
Engineering
and product development expenses for the three months ended March 31, 2006
increased to $242,204 from $186,971 for the three months ended March 31, 2005.
The increase is mainly due to the engineering and product development expenses
related to the ProCyte business being included during the entire period, which
caused a $91,938 net increase. During the 2005 and 2006 periods, the engineers
at the Carlsbad plant were primarily focused on manufacturing efforts, and
therefore, their costs have been reflected in cost of goods sold.
Interest
Expense, Net
Net
interest expense for the three months ended March 31, 2006 increased to
$121,144, as compared to $71,129 for the three months ended March 31, 2005.
The
increase in net interest expense was the result of the draws on the lease line
of credit during the second, third and fourth quarters of 2005.
Net
Loss
The
aforementioned factors resulted in a net loss of $2,350,261 during the three
months ended March 31, 2006, as compared to a net loss of $1,128,112 during
the
three months ended March 31, 2005, an increase of 108%. This increase was
primarily the result of the increase in cost of sales and resulting decrease
in
gross margin, stock option expense of $466,790 due stock-based compensation
expense following the adoption of SFAS No. 123R and an increase of $490,699
of
depreciation and amortization over the comparable prior year period. The
following table illustrates the impact of these major expenses between the
periods:
For
the three months ended March 31,
|
||||||||||
2006
|
|
|
2005
|
|
|
Change
|
||||
Net
Loss
|
$
|
2,350,261
|
$
|
1,128,112
|
$
|
1,222,149
|
||||
Major
Expenses:
|
||||||||||
Depreciation
and amortization
|
1,017,095
|
526,396
|
490,699
|
|||||||
Stock-based
compensation
|
466,790
|
-
|
466,790
|
|||||||
$
|
1,483,885
|
$
|
526,396
|
$
|
957,489
|
Income
taxes were immaterial, given our current period losses and operating loss
carryforwards.
Liquidity
and Capital Resources
We
have
historically financed our operations with cash provided by equity financing
and
from lines of credit and, on recent occasions, from positive results from
operations.
On
March
18, 2005, we acquired ProCyte. The skincare products and royalties provided
by
ProCyte increased revenues for the three months ended March 31, 2006. We expect
to realize cost savings from the consolidation of the administrative and
marketing infrastructure of the combined company. Additionally, once the
consolidated infrastructure is in place, we expect our revenues to grow without
proportionately increasing the rate of growth in our fixed costs.
At
March
31, 2006, our current ratio was 1.99 compared to 2.42 at December 31,
2005. As of March 31, 2006, we had $9,319,334 of working capital compared to
$11,120,992 as of December 31, 2005. Cash and cash equivalents were $5,665,362
as March 31, 2006, as compared to $5,609,967 as of December 31, 2005. We had
$207,050 of cash that was classified as restricted as of March 31, 2006 compared
to $206,931 as of December 31, 2005.
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 2007. The 2006 operating plan reflects costs
savings from the integration of ProCyte as well as increases in per-treatment
fee revenues for use of the XTRAC system based on wider insurance coverage
in
the United States. In addition, the 2006 operating plan calls for increased
revenues and profits from our newly acquired Skin Care business. We cannot
give
assurances that we will be able to execute our business plan, which may require
us to obtain additional equity or debt financing to meet our working capital
requirements or capital expenditure needs. Also, if our growth exceeds the
business plan projections, we may require additional equity or debt financing.
There can be no assurance that additional financing, if needed, will be
available when required or, if available, will be on terms satisfactory to
us.
37
On
June
25, 2004, we entered into a leasing credit facility from GE Capital Corporation
(“GE”). The credit facility has a commitment term of three years, expiring on
June 25, 2007. We account for each draw as funded indebtedness taking the form
of a capital lease, with equitable ownership in the lasers remaining with us.
GE
retains title as a form of security over the lasers. Each draw against the
credit facility has a repayment period of three years and is secured by specific
lasers, which we have sold to GE and leased back for deployment in the field.
A
summary of the activity under the GE leasing credit facility is presented in
Note 9, “Long-term Debt.”
Net
cash
provided by operating activities was $521,394 for three months ended March
31,
2006, compared to net cash used of $1,687,966 for the same period in 2005.
The
change was primarily due to a decrease in inventory and increases in accounts
payable.
Net
cash
used in investing activities was $1,090,533 for the three months ended March
31,
2006 compared to cash provided by of $5,235,559 for the three months ended
March
31, 2005. During the three months ended March 31, 2005, we received cash of
$6,014,450, net of acquisition costs, in the ProCyte acquisition and used
$722,509 for production of our lasers-in-service compared to $1,079,167 for
the
same period in 2006.
Net
cash
provided by financing activities was $624,415 for the three months ended March
31, 2006 compared to net cash used of $144,494 for the three months ended March
31, 2005. In the three months ended March 31, 2006 we made payments of $264,443
on certain notes payable and capital lease obligations and $7,890 in
registration costs. These payments were offset, in part, by the advances under
the lease line of credit, net of payments, of $819,867 and by receipts of
$68,400 from the exercise of common stock options. In the three months ended
March 30, 2005, we received $200,208 from the exercise of common stock options
and warrants and $100,431 of restricted cash that was released from restriction.
These cash receipts were offset by $156,356 for the payment of certain notes
payable and capital lease obligations, $154,315 of net payments on the lease
line of credit and $134,462 of registration costs.
Our
ability to expand our business operations is currently dependent in significant
part on financing from external sources. There can be no assurance that changes
in our manufacturing and marketing, engineering and product development plans
or
other changes affecting our operating expenses and business strategy will not
require financing from external sources before we will be able to develop
profitable operations. There can be no assurance that additional capital will
be
available on terms favorable to us, if at all. To the extent that additional
capital is raised through the sale of additional equity or convertible debt
securities, the issuance of such securities could result in additional dilution
to our stockholders. Moreover, our cash requirements may differ materially
from
those now planned because of results of marketing, product testing, changes
in
the focus and direction of our marketing programs, competitive and technological
advances, the level of working capital required to sustain our planned growth,
litigation, operating results, including the extent and duration of operating
losses, and other factors. In the event that we experience the need for
additional capital, and are not able to generate capital from financing sources
or from future operations, management may be required to modify, suspend or
discontinue our business plan.
Commitments
and Contingencies
During
the three months ended March 31, 2006, there were no items that significantly
impacted our commitments and contingencies as discussed in the notes to our
2005
annual financial statements included in our Annual Report on Form 10-K. However,
a contingency pre-dating the acquisition of ProCyte Corporation materialized
and
was resolved in the three months ended March 31, 2006. 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.
38
ITEM
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief
Financial Officer, evaluated the effectiveness of our disclosure controls and
procedures as of the end of the period covered by this report. Based on that
evaluation, the Chief Executive Officer and Chief Financial Officer concluded
that our disclosure controls and procedures as of the end of the period covered
by this report are functioning effectively to provide reasonable that the
information required to be disclosed by us in reports filed under the Securities
Exchange Act f 1934 is (i) recorded, processed, summarized and reported within
the time periods specified in the Securities and Exchange Commission’s rules and
forms and (ii) accumulated and communicated to our management, including the
Chief Executive Officer and Chief Financial Officer, as appropriate to allow
timely decisions regarding disclosure. A control system cannot provide absolute
assurance, however, the objectives of the control system are met and no
evaluation of controls can provide absolute assurance that all control issues
and instances of fraud, if any, within a company have been
detected.
Change
in Internal Control Over Financial Reporting
No
change
in our internal control over financial reporting occurred during the quarter
ended March 31, 2006 that has materially affected, or is reasonably likely
to
materially affect, our internal control over financial reporting.
PART
II - Other Information
ITEM
1. Legal Proceedings
Reference
is made to Item 3, Legal
Proceedings,
in our
Annual Report on Form 10-K for the year ended December 31, 2005 for descriptions
of our legal proceedings.
In
the
matter brought by us against RA Medical Systems, Inc. and Dean Stewart Irwin
in
the United States District Court for the Southern District of California, the
court has denied the defendants’ motion for summary judgment, which was based on
a theory of res judicata. In view of this denial, the Court has authorized
for
discovery in the case to resume. Our motion for partial summary judgment, is
based on a theory that defendants have competed unfairly against us in that
RA
Medical did not have, until January 2006, a license from the State of California
to manufacture or market their medical devices. Our motion will stand submitted
for decision on May 30, 2006, after briefing is completed.
In
the
matter brought by RA Medical Systems, Inc. and Dean Stewart Irwin against us,
Jenkens & Gilchrist, LLP (our outside counsel) and Michael R. Matthias, Esq.
(litigation partner at our outside counsel), the appellate court denied our
motion to have the action dismissed under California Code of Civil Procedure
section 425.16. We are appealing this decision.
We
are
involved in certain other legal actions and claims arising in the ordinary
course of business. We believe, based on discussions with legal counsel, that
such litigation and claims will be resolved without a material effect on our
consolidated financial position, results of operations or liquidity.
ITEM
1A. Risk Factors
We
noted
in Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended
December 31, 2005, that “we depend on our executive officers and key personnel
to implement our business strategy and could be harmed by the loss of their
services.” By way of update to this risk factor, we note that Mr. Clifford, our
Executive Vice President, Dermatology, will be leaving the Company in the
second
quarter 2006. As Mr. Clifford’s responsibilities included domestic sales and
marketing of our dermatology segments, his departure could adversely affect
our
ability to manage our dermatology businesses and to develop and introduce
new
products. We intend to mitigate any adverse effects by entering into a
consulting arrangement with Mr. Clifford and by redistributing Mr. Clifford’s
responsibilities, to the extent possible, over existing resources. There
can be
no assurance, however, that such efforts in mitigation will be
successful.
39
ITEM
2. Unregistered Sales of Equity Securities and Use of
Proceeds
Recent
Issuances of Unregistered Securities
On
January 15, 2006, we issued 860,000 shares of restricted common stock to two
of
our executives. The issuance was approved by our stockholders on December 28,
2005. These shares were subsequently registered as part of the registration
under Form S-8 in March 2006 of our 2005 Equity Compensation Plan.
On
March
17, 2006, we issued 101,010 shares
of
our restricted common stock to Stern Laser srl. The issuance was related to
a
milestone in the Master Agreement. These shares were subsequently registered
under Form S-3 in March 2006.
On
March
29, 2006, we issued to GE Capital Corporation a warrant to purchase 20,545
shares of our common stock. The warrant was issued in connection with the fourth
draw under the second tranche of the leasing line of credit. These shares were
subsequently registered under Form S-3 in March 2006.
On
March
30, 2006, we issued 200,000 shares of our restricted common stock in connection
with the Investment Agreement with AzurTec, Inc.
ITEM
5. Other Information
We
entered into a Separation Agreement dated April 30, 2006 (the “Separation
Agreement”) with John F. Clifford, our Executive Vice President of Dermatology.
The agreement became effective on May 8, 2006, upon the expiration of the
seven-day revocation period provided by applicable law. Pursuant
to the terms of the Separation Agreement, Mr. Clifford's Employment Agreement
with us, dated March 18, 2005, was terminated.
Pursuant
to the Separation Agreement, Mr. Clifford will resign as our Executive
Vice
President of Dermatology on a date convenient to both parties, but no later
than
June 30, 2006. Mr. Clifford will continue to receive his current base salary
through his resignation date. For a two-year period following his resignation
date, Mr. Clifford will act as a consultant to us in the dermatology market.
In
his first year as our consultant, Mr. Clifford will receive a consulting
fee
equal to $300,000. In the second year, Clifford will receive three payments
of
$17,500 each on the first day of the first, second and third months of
such
year.
We
will
pay for Mr. Clifford’s coverage under our health plan until the later of
September 30, 2007 or the date upon which Mr. Clifford secures comparable,
full-time employment with another employer. Mr. Clifford’s participation in all
our other benefit plans, including our 401(k) plan and auto allowance benefit,
will terminate as of the date of his resignation.
Mr.
Clifford’s outstanding stock options will continue to vest on their regular
schedule up to his resignation date. On Mr. Clifford’s resignation date,
one-half of his unvested options shall fully vest and the remaining unvested
options shall be cancelled. Such vested options will remain exercisable by
him
during his consulting period and for a period of 90 days thereafter. Any
options
that are not exercised by Mr. Clifford during such period shall be cancelled
at
that time.
As
a
condition to receiving the benefits under the Separation Agreement, Mr. Clifford
has, among other things, released us from any and all past, present and future
alleged claims, agreed to keep all information relating to our business
confidential and agreed not to compete with us for a period of one year (two
years with respect to certain activities) following the date of his resignation.
ITEM
6. Exhibits
10.56
|
Investment
Agreement, dated March 30, 2006, between AzurTec, Inc. and PhotoMedex,
Inc. (1)
|
10.57
|
License
Agreement, dated March 30, 2006, between AzurTec, Inc. and PhotoMedex,
Inc. (2)
|
10.58
|
License
Agreement, delivered March 31, 2006 and effective April 1, 2006,
between
Mount Sinai School of Medicine and PhotoMedex, Inc. (3)
|
10.59
|
Separation
Agreement, dated April 30, 2006, between PhotoMedex, Inc. and John
F.
Clifford
|
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
|
(1)
|
Incorporated by reference to Exhibit 10.1 to Form 8-K, filed on April 6, 2006 |
(2)
|
Incorporated
by reference to Exhibit 10.2 to Form 8-K, filed on April 6,
2006.
|
(3)
|
Incorporated
by reference to Exhibit 10.1 to Form 8-K, filed on April 10, 2006.
|
40
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1934, the registrant has duly
caused this Report to be signed on its behalf by the undersigned, thereunto
duly
authorized.
PHOTOMEDEX, INC. | ||
|
|
|
Date: May 10, 2006 | By: | /s/ Jeffrey F. O’Donnell |
Jeffrey F. O’Donnell |
||
President and Chief Executive Officer |
Date: May 10, 2006 | By: | /s/ Dennis M. McGrath |
Dennis M. McGrath |
||
Chief Financial Officer |
41