Gadsden Properties, Inc. - Quarter Report: 2009 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10 - Q
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended March 31, 2009
OR
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from _________ to ___________
Commission
File Number 0-11365
PHOTOMEDEX,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
59-2058100
|
|
(State
or other jurisdiction
|
(I.R.S. Employer
|
|
of
incorporation or organization)
|
Identification
No.)
|
147 Keystone Drive,
Montgomeryville, Pennsylvania 18936
(Address
of principal executive offices, including zip code)
(215)
619-3600
(Registrant's
telephone number, including area code)
Indicate
by check mark whether the registrant: (i) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (ii) has been subject to such filing requirements for
the past 90 days.
Yes x No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
definitions of “large accelerated filer," “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act.)
Yes ¨ No x
The
number of shares outstanding of the issuer's Common Stock as of May 15, 2009 was
9,005,175 shares.
PHOTOMEDEX,
INC.
INDEX TO
FORM 10-Q
PAGE
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||
Part I. Financial
Information:
|
||
ITEM
1. Financial Statements:
|
||
|
a.
Consolidated Balance Sheets, March 31, 2009 (unaudited) and December 31,
2008
|
3
|
|
b.
Consolidated Statements of Operations for the three
months ended March 31, 2009 and 2008 (unaudited)
|
4
|
|
c.
Consolidated Statement of Stockholders’ Equity for the three months ended
March 31, 2009 (unaudited)
|
5
|
|
d.
Consolidated Statements of Cash Flows for the three months ended March 31,
2009 and 2008 (unaudited)
|
6
|
|
e.
Notes to Consolidated Financial Statements (unaudited)
|
7
|
ITEM
2. Management’s Discussion and Analysis of Financial Condition
and Results of Operations
|
25
|
|
ITEM
3. Quantitative and Qualitative Disclosure about Market
Risk
|
41
|
|
ITEM
4. Controls and Procedures
|
41
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Part II. Other Information:
|
||
ITEM
1. Legal Proceedings
|
41
|
|
ITEM
1A. Risk Factors
|
42
|
|
ITEM
4. Submission of Matters to a Vote of
Security Holders
|
43
|
|
ITEM
5. Other Information
|
43
|
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ITEM
6. Exhibits
|
44
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|
Signatures
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44
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Certifications
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45
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2
PART
I – Financial Information
ITEM
1. Financial Statements
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
March 31, 2009
|
December 31, 2008
|
|||||||
(Unaudited)
|
*
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 4,179,320 | $ | 3,658,607 | ||||
Restricted
cash
|
78,000 | 78,000 | ||||||
Accounts
receivable, net of allowance for doubtful accounts of $483,190 and
$486,000, respectively
|
5,678,180 | 5,421,688 | ||||||
Inventories,
net
|
9,202,545 | 6,974,194 | ||||||
Prepaid
expenses and other current assets
|
296,682 | 322,549 | ||||||
Total
current assets
|
19,434,727 | 16,455,038 | ||||||
Property
and equipment, net
|
10,592,238 | 10,388,406 | ||||||
Patents
and licensed technologies, net
|
8,438,614 | 1,142,462 | ||||||
Goodwill,
net
|
19,569,199 | 16,917,808 | ||||||
Other
intangible assets, net
|
2,470,625 | 1,095,625 | ||||||
Other
assets
|
1,244,802 | 714,930 | ||||||
Total
assets
|
$ | 61,750,205 | $ | 46,714,269 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Current
portion of notes payable
|
$ | 29,412 | $ | 28,975 | ||||
Current
portion of long-term debt
|
4,296,833 | 4,663,281 | ||||||
Accounts
payable
|
5,663,259 | 5,204,334 | ||||||
Accrued
compensation and related expenses
|
1,489,908 | 1,487,153 | ||||||
Other
accrued liabilities
|
1,373,514 | 864,433 | ||||||
Deferred
revenues
|
1,469,352 | 798,675 | ||||||
Total
current liabilities
|
14,322,278 | 13,046,851 | ||||||
Long-term
liabilities:
|
||||||||
Notes
payable
|
69,720 | 77,239 | ||||||
Long-term
debt
|
2,977,252 | 3,907,752 | ||||||
Convertible
debt
|
16,468,866 | - | ||||||
Warrants
related to convertible debt
|
1,459,089 | - | ||||||
Total
liabilities
|
35,297,205 | 17,031,842 | ||||||
Commitments
and Contingencies
|
||||||||
Stockholders’
equity:
|
||||||||
Common
stock, $.01 par value, 21,428,572 shares authorized; 9,005,175 and
9,004,601 shares issued and outstanding, respectively
|
90,051 | 90,046 | ||||||
Additional
paid-in capital
|
135,169,582 | 134,912,537 | ||||||
Accumulated
deficit
|
(108,832,343 | ) | (105,320,156 | ) | ||||
Accumulated
other comprehensive income
|
25,710 | - | ||||||
Total
stockholders’ equity
|
26,453,000 | 29,682,427 | ||||||
Total
liabilities and stockholders’ equity
|
$ | 61,750,205 | $ | 46,714,269 |
* The
December 31, 2008 balance sheet was derived from the Company’s audited financial
statements.
The
accompanying notes are an integral part of these consolidated financial
statements.
3
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
For the Three Months Ended March
31,
|
||||||||
2009
|
2008
|
|||||||
Revenues:
|
||||||||
Product
sales
|
$ | 5,197,850 | $ | 6,731,980 | ||||
Services
|
2,300,492 | 1,598,854 | ||||||
7,498,342 | 8,330,834 | |||||||
Cost
of revenues:
|
||||||||
Product
cost of revenues
|
2,459,348 | 2,864,452 | ||||||
Services
cost of revenues
|
1,338,252 | 1,253,579 | ||||||
3,797,600 | 4,118,031 | |||||||
Gross
profit
|
3,700,742 | 4,212,803 | ||||||
Operating
expenses:
|
||||||||
Selling
and marketing
|
3,900,751 | 4,112,964 | ||||||
General
and administrative
|
2,799,180 | 2,144,443 | ||||||
Engineering
and product development
|
201,697 | 438,688 | ||||||
6,901,628 | 6,696,095 | |||||||
Operating
loss from continuing operations
|
(3,200,886 | ) | (2,483,292 | ) | ||||
Other
income (loss):
|
||||||||
Interest
expense, net
|
(402,523 | ) | (227,371 | ) | ||||
Change
in fair value of warrants (see Note 1)
|
91,222 | - | ||||||
Loss
from continuing operations
|
(3,512,187 | ) | (2,710,663 | ) | ||||
Discontinued
operations:
|
||||||||
Income
from discontinued operations, net of nil in taxes
|
- | 168,802 | ||||||
Net
loss
|
$ | ( 3,512,187 | ) | $ | ( 2,541,861 | ) | ||
Basic
and diluted net loss per share:
|
||||||||
Continuing
operations
|
$ | (0.39 | ) | $ | (0.30 | ) | ||
Discontinued
operations
|
$ | (0.00 | ) | $ | 0.02 | |||
Basic
and diluted net loss per share
|
$ | (0.39 | ) | $ | (0.28 | ) | ||
Shares
used in computing basic and diluted net loss per share
|
9,005,009 | 9,004,601 |
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, 2009
(Unaudited)
Accumulated
|
||||||||||||||||||||||||
Additional
|
Other
|
|||||||||||||||||||||||
Common
Stock
|
Paid-In
|
Accumulated
|
Comprehensive
|
|||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Income
|
Total
|
|||||||||||||||||||
BALANCE,
DECEMBER 31, 2008
|
9,004,601 | $ | 90,046 | $ | 134,912,537 | $ | (105,320,156 | ) | $ | - | $ | 29,682,427 | ||||||||||||
Round
up for fractional shares due to the reverse stock split
|
574 | 5 | (5 | ) | - | - | - | |||||||||||||||||
Stock
options issued to consultants for services
|
- | - | 17,419 | - | - | 13,736 | ||||||||||||||||||
Amortization
of expense for restricted stock
|
- | - | 103,623 | - | - | 103,623 | ||||||||||||||||||
Change
in cumulative translation adjustments
|
- | - | - | - | 25,710 | 25,710 | ||||||||||||||||||
Stock-based
compensation expense related to employee options
|
- | - | 171,632 | - | - | 175,315 | ||||||||||||||||||
Registration
costs
|
- | - | (35,624 | ) | - | - | (35,624 | ) | ||||||||||||||||
Net
loss for the three months ended March 31, 2009
|
- | - | - | (3,512,187 | ) | - | (3,512,187 | ) | ||||||||||||||||
BALANCE,
MARCH 31, 2009
|
9,005,175 | $ | 90,051 | $ | 135,169,582 | $ | (108,832,343 | ) | $ | 25,710 | $ | 26,453,000 |
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,
|
||||||||
2009
|
2008
|
|||||||
Cash Flows From Operating
Activities:
|
||||||||
Net
loss
|
$ | ( 3,512,187 | ) | $ | ( 2,541,861 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating activities-continuing
operations:
|
||||||||
Depreciation
and amortization
|
995,220 | 1,027,668 | ||||||
Stock
options issued to consultants for services
|
17,419 | 46,914 | ||||||
Stock-based
compensation expense related to employee options and restricted
stock
|
275,255 | 379,629 | ||||||
Provision
for bad debts
|
26,843 | 27,571 | ||||||
Change
in estimated fair value of warrant liability (See Note 1)
|
(91,222 | ) | - | |||||
Changes
in operating assets and liabilities, net of effects from discontinued
operations:
|
||||||||
Accounts
receivable
|
559,672 | 654,562 | ||||||
Inventories
|
(554,449 | ) | 417,200 | |||||
Prepaid
expenses and other assets
|
(279,526 | ) | 237,284 | |||||
Accounts
payable
|
(226,854 | ) | 664,919 | |||||
Accrued
compensation and related expenses
|
(33,151 | ) | (316,553 | ) | ||||
Other
accrued liabilities
|
89,897 | 426,755 | ||||||
Deferred
revenues
|
94,328 | 287,290 | ||||||
Net
cash (used in) provided by operating activities – continuing
operations
|
(2,638,755 | ) | 1,311,378 | |||||
Net
cash provided by operating activities – discontinued
operations
|
- | 71,768 | ||||||
Net
cash (used in) provided by operating activities
|
(2,638,755 | ) | 1,383,146 | |||||
Cash
Flows From Investing Activities:
|
||||||||
Purchases
of property and equipment
|
(29,756 | ) | (72,069 | ) | ||||
Lasers
placed into service
|
(889,444 | ) | (1,152,900 | ) | ||||
Acquisition
costs, net of cash received
|
(12,578,022 | ) | - | |||||
Net
cash used in investing activities – continuing operations
|
(13,497,222 | ) | (1,224,969 | ) | ||||
Net
cash used in investing activities – discontinued
operations
|
- | (36,000 | ) | |||||
Net
cash used in investing activities
|
(13,497,222 | ) | (1,260,969 | ) | ||||
Cash
Flows From Financing Activities:
|
||||||||
Registration
costs
|
(35,624 | ) | - | |||||
Payments
on long-term debt other than line of credit
|
- | (32,664 | ) | |||||
Payments
on notes payable
|
(7,082 | ) | (126,324 | ) | ||||
Advances
on line of credit
|
- | 840,000 | ||||||
Repayments
on line of credit
|
(1,326,314 | ) | (1,232,937 | ) | ||||
Proceeds
from convertible debt
|
18,000,000 | - | ||||||
Net
cash provided by (used in) financing activities - continuing
operations
|
16,630,980 | (551,925 | ) | |||||
Net
cash provided by (used in) financing activities - discontinued
operations
|
- | - | ||||||
Net
cash provided by (used in) financing activities
|
16,630,980 | (551,925 | ) | |||||
Effect
of exchange rate changes on cash
|
25,710 | - | ||||||
Net
increase (decrease) in cash and cash equivalents
|
520,713 | (429,748 | ) | |||||
Cash
and cash equivalents, beginning of period
|
3,658,607 | 9,837,303 | ||||||
Cash
and cash equivalents, end of period
|
$ | 4,179,320 | $ | 9,407,555 |
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 currently operates in five
distinct business units, or segments (as described in Note 12): four in
Dermatology, - Domestic XTRAC®, International Dermatology Equipment, Skin Care
(ProCyte®) and Photo Therapeutics (PTL); and one in Surgical, - Surgical
Products (SLT®). The segments are distinguished by our management structure,
products and services offered, markets served or types of customers. A sixth
segment of business, the Surgical Services segment was sold on August 8, 2008
and was reported in the financial statements for 2008 as a discontinued
operation, including its related assets.
The
Domestic XTRAC segment generally derives revenues from procedures performed by
dermatologists in the United States. Under these circumstances, the Company’s
XTRAC laser system is placed in a dermatologist’s office without any initial
capital cost to the dermatologist, and the Company charges a fee-per-use to
treat skin disease. At times, however, the Company sells XTRAC lasers to
customers, due generally to customer circumstances and preferences. In
comparison to the Domestic XTRAC segment, the International Dermatology
Equipment segment generates revenues solely from the sale of equipment and parts
to dermatologists outside the United States through a network of distributors.
The Skin Care segment generates revenues by selling physician-dispensed skincare
products worldwide. The Photo Therapeutics segment, a business acquired on
February 27, 2009, generates revenues by selling light emitting diodes (“LEDs”)
and associated skin care products for the treatment of a range of clinical and
aesthetic dermatological conditions. It sells to professional users and,
recently, to the home-use consumer market. See Note 2, Acquisition.
The
Company designed and manufactured the XTRAC laser system to treat psoriasis,
vitiligo, atopic dermatitis and leukoderma phototherapeutically. The Company has
received clearances from the U.S. Food and Drug Administration (“FDA”) to market
the XTRAC laser system for each of these indications. The XTRAC is approved by
Underwriters’ Laboratories; it is also CE-marked, and accordingly a third party
regularly audits the Company’s quality system and manufacturing facility. The
manufacturing facility for the XTRAC is located in Carlsbad,
California.
For the
last several years the Company has sought to obtain health insurance coverage
for its XTRAC laser therapy to treat inflammatory skin disease, particularly
psoriasis. With the addition of new positive payment policies in 2008, the
Company now benefits from the fact that more than 90% of the insured United
States population has policies that provide nearly full reimbursement for the
treatment of psoriasis by means of an excimer laser (XTRAC). The Company is now
focusing its efforts on accelerating the adoption of the XTRAC laser therapy for
psoriasis and vitiligo by doctors and patients. Consequently, the Company has
increased the size of its sales force and clinical technician personnel together
with increased expenditures for marketing and advertising.
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).
Surgical
Services was a fee-based procedures business using mobile surgical laser
equipment operated by Company technicians at hospitals and surgery centers in
the United States. On August 8, 2008, the Company sold certain assets of the
business including accounts receivable, inventory and equipment, for $3,149,737.
See Note 2, Discontinued
Operations.
The
Company's board of directors approved a 1-for-7 reverse stock split of the
Company's common stock, which became effective upon receiving stockholder
consent on January 26, 2009. As a result of the reverse stock split, every seven
shares of common stock were combined and reclassified into one share of common
stock and the total number of shares outstanding was reduced from approximately
63 million shares to approximately 9 million shares for all periods
presented.
7
Liquidity
and Going Concern
As of
March 31, 2009, the Company had an accumulated deficit of $108,832,343. 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, 2009 were $4,257,320, including restricted cash
of $78,000. The Company has historically financed its operations with cash
provided by equity financing and from lines of credit. The Company is exploring
additional financing options for its domestic XTRAC program. However, there can
be no assurance that the Company will obtain such debt financing on favorable
terms or at all. In addition, the Company completed its purchase of the
subsidiaries of Photo Therapeutics Group Ltd., and the related acquisition
financing on February 27, 2009. The acquisition financing included $3 million of
incremental working capital to the Company after payments of the acquisition
costs and expenses. Management believes that the existing cash balance, together
with its other existing financial resources and any revenues from sales,
distribution, licensing and manufacturing relationships, will be sufficient to
meet the Company’s operating and capital requirements beyond the end of the
second quarter of 2010. The revised 2009 operating plan reflects anticipated
growth from both increased fee revenues for use of the XTRAC laser system based
on increased utilization and wider insurance coverage in the United States and
anticipated growth in revenues of the Company’s skin care and LED products. In
response to prevailing economic conditions, anticipated revenue growth has been
tempered, and a flexible contingency plan has been structured to match
expenditures to lowered growth.
Summary
of Significant Accounting Policies:
Quarterly
Financial Information and Results of Operations
The
financial statements as of March 31, 2009 and for the three months ended March
31, 2009 and 2008, are unaudited and, in the opinion of management, include all
adjustments (consisting only of normal recurring adjustments) necessary to
present fairly the Company’s financial position as of March 31, 2009, and the
results of operations and cash flows for the three months ended March 31, 2009
and 2008. The results for the three months ended March 31, 2009 are not
necessarily indicative of the results to be expected for the entire year. While
management believes that the disclosures presented are adequate to make the
information not misleading, these consolidated financial statements should be
read in conjunction with the consolidated financial statements and the notes
included in the Company's Annual Report on Form 10-K for the year ended December
31, 2008. The Surgical Services business segment is presented as discontinued
operations for all 2008 periods presented.
Principles
of Consolidation
The
consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries. All significant intercompany balances and
transactions have been eliminated. The former subsidiaries of Photo Therapeutics
Group Ltd. have been included in the financial statements from February 27,
2009, the closing date of the acquisition.
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 Annual Report on
Form 10-K for the year ended December 31, 2008 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.
8
Fair
Value Measurements
The
Company measures fair value in accordance with Statement of Financial Accounting
Standards (“SFAS”) No. 157, “Fair Value Measurements”
(“SFAS No. 157”). SFAS No. 157 defines fair value, establishes a
framework and gives guidance regarding the methods used for measuring fair
value, and expands disclosures about fair value measurements. SFAS No. 157
clarifies that fair value is an exit price, representing the amount that would
be received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants. As such, fair value is a market-based
measurement that should be determined based on assumptions that market
participants would use in pricing an asset or liability. As a basis for
considering such assumptions there exists a three-tier fair-value hierarchy,
which prioritizes the inputs used in measuring fair value as
follows:
|
•
|
Level
1 - unadjusted quoted prices in active markets for identical assets or
liabilities that the Company has the ability to access as of the
measurement date.
|
•
|
Level
2 - inputs other than quoted prices included within Level 1 that are
directly observable for the asset or liability or indirectly observable
through corroboration with observable market
data.
|
•
|
Level
3 - unobservable inputs for the asset or liability only used when there is
little, if any, market activity for the asset or liability at the
measurement date.
|
This
hierarchy requires the Company to use observable market data, when available,
and to minimize the use of unobservable inputs when determining fair
value.
The
Company’s recurring fair value measurements at March 31, 2009 were as
follows:
Fair Value as
of March 31,
2009
|
Quoted Prices
in Active
Markets for
Identical Assets
(Level 1)
|
Significant
other
Observable
Inputs
(Level 2)
|
Significant
Unobservable
Inputs
(Level 3)
|
|||||||||||||
Assets:
|
||||||||||||||||
Cash
equivalents
|
$ | 2,932,424 | $ | - | $ | 2,932,424 | $ | - | ||||||||
Liabilities:
|
||||||||||||||||
Derivative
financial instruments (Note 11)
|
$ | 1,459,089 | $ | - | $ | - | $ | 1,459,089 |
Derivative
Financial Instruments
The
Company recognizes all derivatives as assets or liabilities, in accordance with
Statement of Financial Accounting Standards No. 133 “Accounting for Derivative
Instruments and Hedging Activities” (“SFAS No. 133”) and measures them at fair
value with changes in fair value reflected as current period income or loss
unless the derivatives qualify as hedges or future cash flows are accounted for
as such. As a result of the Company’s adoption of Emerging Issues Task Force
Issue No. 07-5 “Determining Whether an Instrument (or Embedded Feature) is
Indexed to an Entity’s Own Stock” (“EITF 07-5”), effective January 1, 2009,
certain warrants are now accounted for as derivatives. See Note 11, Warrants.
Revenue
Recognition
The
Company has two distribution channels for its phototherapy treatment equipment.
The Company either (i) sells the laser through a distributor or directly to a
physician or (ii) places the laser in a physician’s office (at no charge to the
physician) and charges the physician a fee for an agreed upon number of
treatments. In some cases, the Company and the customer stipulate to a quarterly
target of procedures to be performed. When the Company sells an XTRAC laser to a
distributor or directly to a foreign or domestic physician, revenue is
recognized when the following four criteria under Staff Accounting Bulletin No.
104 have been met: (i) the product has been shipped and the Company has no
significant remaining obligations; (ii) persuasive evidence of an arrangement
exists; (iii) the price to the buyer is fixed or determinable; and (iv)
collection is probable (the “SAB 104 Criteria”). At times, units are shipped,
but revenue is not recognized until all of the SAB 104 criteria have been met,
and until that time, the unit is carried on the books of the Company as
inventory.
9
The
Company ships most of its products FOB shipping point, although from time to
time certain customers, for example governmental customers, will insist upon FOB
destination. Among the factors the Company takes into account in determining the
proper time at which to recognize revenue are when title to the goods transfers
and when the risk of loss transfers. Shipments to distributors or physicians
that do not fully satisfy the collection criterion are recognized when invoiced
amounts are fully paid or fully assured.
Under the
terms of the Company’s distributor agreements, distributors do not have a
unilateral right to return any unit that they have purchased. However, the
Company does allow products to be returned by its distributors for product
defects or other claims.
When the
Company places a laser in a physician’s office, it recognizes service revenue
based on the number of patient treatments performed by the physician. Treatments
in the form of random laser-access codes that are sold to a physician, but not
yet used, are deferred and recognized as a liability until the physician
performs the treatment. Unused treatments remain an obligation of the Company
because the treatments can only be performed on Company-owned equipment. Once
the treatments are delivered to a patient, this obligation has been
satisfied.
The
Company excludes all sales of treatment codes made within the last two weeks of
the period in determining the amount of procedures performed by its
physician-customers. Management believes this approach closely approximates the
actual amount of unused treatments that existed at the end of a period. For the
three months ended March 31, 2009 and 2008, the Company deferred $1,008,979 and
$883,533, respectively, under this approach.
The
Company generates revenues from its Skin Care business primarily through two
channels. The first is through product sales for skin health, hair care and
wound care, and the second, although now to a much lesser degree, is through
sales in bulk of copper peptide compound. 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.
The
Company generates revenues from its Photo Therapeutics business primarily from
two channels. The first is through product sales of LEDs and skin care products.
The second is through royalties and milestone payments from a licensing
agreement. The Company recognizes revenues from the product sales, including
sales to distributors and other customers, when the SAB 104 Criteria have been
met. The Company recognizes the milestone payments when the milestones have been
achieved and royalty revenues as they are earned from the licensee.
The
Company generates revenues from its Surgical Products business primarily from
product sales of laser systems, related maintenance service agreements,
recurring laser delivery systems and laser accessories. Domestic sales generally
are direct to the end-user, though the Company has some sales to or through a
small number of domestic distributors; foreign sales are to distributors. The
Company recognizes revenues from surgical laser and other product sales,
including sales to distributors and other customers, when the SAB 104 Criteria
have been met.
Revenue
from maintenance service agreements is deferred and recognized on a
straight-line basis over the term of the agreements. Revenue from billable
services, including repair activity, is recognized when the service is
provided.
Impairment
of Long-Lived Assets and Intangibles
In
accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of
Long-Lived Assets,” long-lived assets, such as property and equipment, and
purchased intangibles subject to amortization, are reviewed for impairment
whenever events or changes in circumstances indicate that the carrying amount of
an asset may not be recoverable. Recoverability of assets to be held and used is
measured by a comparison of the carrying amount of an asset to the fair value of
the asset. If the carrying amount of an asset exceeds the fair value, an
impairment charge is recognized in the amount by which the carrying amount of
the asset exceeds the fair value of the asset. Assets to be disposed of would be
separately presented in the balance sheet and reported at the lower of the
carrying amount or fair value less costs to sell, and would no longer be
depreciated. The assets and liabilities of a disposed group classified as
discontinued operations would be presented separately in the appropriate asset
and liability sections of the balance sheet. As of March 31, 2009, no such
impairment exists.
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 eight
to 12 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. Significant patent costs were recorded in connection
with the acquisition of Photo Therapeutics in February 2009 and are being
amortized on a straight-line basis over ten years. Other licenses, for example,
the Stern and Mount Sinai licenses, are capitalized and amortized over the
estimated useful lives of 10 years.
Management
evaluates the recoverability of intangible assets based on estimates of
undiscounted future cash flows over the remaining useful life of the asset. If
the amount of such estimated undiscounted future cash flows is less than the net
book value of the asset, the asset is written down to fair value. As March 31,
2009, 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. With the exception of the Neutrogena intangible, which has been
written down to zero, the assets are being amortized on a straight-line basis
over 5 to 10 years. In addition, other intangible assets were recorded in
connection with the acquisition of Photo Therapeutics in February 2009. These
assets are being amortized on a straight-line basis over 10 years. See Note 2, Acquisition.
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, 2009 no such write-down was required.
Goodwill
Goodwill
was recorded in connection with the acquisition of Photo Therapeutics in
February 2009, 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, 2009, no
such write-down was required.
Accrued
Warranty Costs
The
Company offers a warranty on product sales generally for a one to two-year
period. In the case of domestic sales of XTRAC lasers, however, the Company
offers longer periods, ranging from three to four years, in order to meet
competition or meet customer demands. The Company provides for the estimated
future warranty claims on the date the product is sold. Total accrued warranty
is included in other accrued liabilities on the balance sheet. The activity in
the warranty accrual during the three months ended March 31, 2009 is summarized
as follows:
Three Months Ended
March 31, 2009
(unaudited)
|
||||
Accrual
at beginning of period
|
$ | 442,527 | ||
Additions
due to PTL acquisition
|
227,334 | |||
Additions
charged to warranty expense
|
80,738 | |||
Expiring
warranties
|
(33,865 | ) | ||
Claims
satisfied
|
(31,799 | ) | ||
Accrual
at end of period
|
$ | 684,935 |
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. Any resulting net deferred tax
assets are evaluated for recoverability and, accordingly, a valuation allowance
is provided when it is more likely than not that all of some portion of the
deferred tax asset will not be realized.
11
Net
Loss per Share
The
Company computes net loss per share in accordance with SFAS No. 128, “Earnings
per Share.” In accordance with SFAS No. 128, basic net loss per share is
calculated by dividing net loss available to common stockholders by the weighted
average of common shares outstanding for the period. Diluted net loss per share
reflects the potential dilution from the conversion or exercise into common
stock of securities such as stock options and warrants.
In these
consolidated financial statements, diluted net loss per share from continuing
operations is the same as basic net loss per share. Thus, no additional shares
for the potential dilution from the conversion or exercise of securities into
common stock are included in the denominator of this calculation, since the
result would be anti-dilutive. Common stock options and warrants of 2,345,651
and 1,515,609 as of March 31, 2009 and 2008, respectively, were excluded from
the calculation of fully diluted earnings per share from continuing operations
since their inclusion would have been anti-dilutive. Share amounts shown on the
consolidated balance sheet as of December 31, 2008 and share amounts and basic
and diluted net loss per share amounts shown on the consolidated statement of
operations for the three months ended March 31, 2008 have been adjusted to
reflect the reverse stock split of 1-for-7 effective January 26, 2009, excluding
the rounding up of fractional shares. For the three months ended March 31,
2008, there was income from discontinued operations, but basic net income per
share and diluted net income per share from discontinued operations for these
periods were both immaterial.
Comprehensive
Income (Loss)
Comprehensive
income (loss) is a more inclusive financial reporting method that includes
disclosure of certain financial information that historically has not been
recognized in the calculation of net income (loss). Comprehensive income (loss)
is defined as net income and other changes in shareholders’ investment from
transactions and events other than with shareholders. Total comprehensive income
(loss) is as follows:
Three Months Ended March 31,
(unaudited)
|
||||||||
2009
|
2008
|
|||||||
Net
loss
|
$ | (3,512,187 | ) | $ | (2,541,861 | ) | ||
Change
in cumulative translation adjustment
|
25,710 | - | ||||||
Comprehensive
loss
|
$ | (3,486,477 | ) | $ | (2,541,861 | ) |
Share-Based
Compensation
The
Company accounts for stock-based compensation in accordance with SFAS No. 123R,
“Share-based Payment”. Under the fair value recognition provision, of this
statement, share-based compensation cost is measured at the grant date based on
the fair value of the award and is recognized as expense over the applicable
vesting period of the stock award using the straight-line method.
Supplemental
Cash Flow Information
During
the three months ended March 31, 2009, the Company issued warrants to an
investor which manages an investment fund (“the Investor”) in conjunction with a
convertible debt arrangement which enabled the Company to purchase Photo
Therapeutics. These warrants were initially valued at $1,550,311, are carried as
a liability and result in a discount from the face of the convertible
debt.
During
the three months ended March 31, 2008, the Company financed certain insurance
policies through notes payable for $119,382.
For the
three months ended March 31, 2009 and 2008, the Company paid interest of
$287,038 and $297,015, respectively. Income taxes paid in the three months ended
March 31, 2009 and 2008 were immaterial.
12
Recent
Accounting Pronouncements
In May
2008, the Financial Accounting Standards Board (“FASB”) issued FASB Staff
Position (FSP) APB 14-1, “Accounting for Convertible Debt Instruments That May
Be Settled in Cash upon Conversion (Including Partial Cash Settlement)” (FSP APB
14-1). FSP APB 14-1 clarifies that convertible debt instruments that may be
settled in cash upon either mandatory or optional conversion (including partial
cash settlement) are not addressed by paragraph 12 of APB Opinion No. 14,
“Accounting for Convertible Debt and Debt issued with Stock Purchase Warrants.”
Additionally, FSP APB 14-1 specifies that issuers of such instruments should
separately account for the liability and equity components in a manner that will
reflect the entity’s nonconvertible debt borrowing rate when interest cost is
recognized in subsequent periods. FSP APB 14-1 is effective for financial
statements issued for fiscal years beginning after December 15, 2008, and
interim periods within those fiscal years. We adopted FSP APB 14-1 beginning in
the first quarter of 2009, and this standard must be applied on a retrospective
basis. The adoption of this Statement did not have a material impact on the
Company’s consolidated results of operations and financial
condition.
In June
2008, the FASB ratified EITF Issue No. 07-5, “Determining Whether an Instrument
(or Embedded Feature) Is Indexed to an Entity’s Own Stock” (“EITF 07-5”).
Equity-linked instruments (or embedded features) that otherwise meet the
definition of a derivative as outlined in SFAS No. 133, “Accounting for
Derivative Instruments and Hedging Activities,” are not accounted for as
derivatives if certain criteria are met, one of which is that the instrument (or
embedded feature) must be indexed to the entity’s stock. EITF 07-5 provides
guidance on determining if equity-linked instruments (or embedded features) such
as warrants to purchase our stock are considered indexed to our stock. EITF 07-5
is effective for the financial statements issued for fiscal years and interim
periods within those fiscal years, beginning after December 15, 2008 and will be
applied to outstanding instruments as of the beginning of the fiscal year in
which it is adopted. Upon adoption, a cumulative effect adjustment will be
recorded, if necessary, based on amounts that would have been recognized if this
guidance had been applied from the issuance date of the affected instruments.
The adoption of this Statement had a material impact on the on the Company’s
consolidated results of operations and financial condition. See Note 11, Warrants.
In April
2008, the FASB issued FASB Staff Position No. FSP 142-3, “Determining the Useful
Life of Intangible Assets” FSP 142-3 amends the factors to be considered in
determining the useful life of intangible assets. Its intent is to improve the
consistency between the useful life of an intangible asset and the period of
expected cash flows used to measure its fair value. FSP 142-3 is effective for
fiscal years beginning after December 15, 2008. The adoption of FSP 142-3 did
not have an impact on the Company’s financial statements.
In April
2009, the FASB issued FSP FAS No. 107-1 and Accounting Principles Board Opinion
28-1, “Interim Disclosures about Fair Value of Financial Instruments: (“APB
28-1”). This FSP amends SFAS No. 107, “Fair Value of Financial Instruments” to
require disclosures about fair value of financial instruments for interim
reporting periods in addition to the required disclosures in annual financial
statements. This FSP also amends APB Opinion 28, “Interim Financial Reporting”,
to require those disclosures in summarized financial information at interim
reporting periods. FSP FAS 107-1 and APB 28-1 are effective for interim
reporting periods ending after June 15, 2009.
In
October 2008, the FASB issued FSP No. 157-3, “Determining the Fair Value of a
Financial Asset When the Market for That Asset Is Not Active” (“FSP 157-3”). FSP
157-3 clarifies the application of SFAS No. 157 in a market that is not active
and provides an example to illustrate key considerations in determining the fair
value of a financial asset when the market for that financial asset is not
active. FSP 157-3 was effective for the Company on September 30, 2008 for all
financial assets and liabilities recognized or disclosed at fair value in our
consolidated financial statements on a recurring basis (at least
annually).
In May
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles.” The Statement is intended to improve financial reporting
by identifying a consistent hierarchy for selecting accounting principles to be
used in preparing financial statements that are presented in conformity with
GAAP. Prior to the issuance of SFAS No. 162, GAAP hierarchy was defined in the
American Institute of Certified Public Accountants (“AICPA”) Statement on
Auditing Standards (SAS) No. 69, “The Meaning of Present Fairly in Conformity
With Generally Accepted Accounting Principles.” Unlike SAS No. 69, SFAS No. 162
is directed to the entity rather than the auditor. SFAS No. 162 is effective 60
days following the SEC’s approval of the Public Company Accounting Oversight
Board Auditing amendments to AU Section 411, The Meaning of Present Fairly in
Conformity with Generally Accepted Accounting Principles. SFAS No. 162 is not
expected to have any material impact on the Company’s results of operations,
financial condition or liquidity.
13
Effective
January 1, 2008, the Company adopted SFAS No. 157, ”Fair Value Measurements“. In
February 2008, the FASB issued FASB Staff Position No. FAS 157-2, "Effective
Date of FASB Statement No. 157", which provides a one year deferral of the
effective date of SFAS No. 157 for non-financial assets and non-financial
liabilities, except those that are recognized or disclosed in the financial
statements at fair value at least annually. Therefore, the Company has adopted
the provisions of SFAS No. 157 only with respect to its financial assets and
liabilities. SFAS No. 157 defines fair value, establishes a framework for
measuring fair value under generally accepted accounting principles and enhances
disclosures about fair value measurements. Fair value is defined under SFAS No.
157 as the exchange price that would be received for an asset or paid to
transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market
participants on the measurement date. Valuation techniques used to measure fair
value under SFAS No. 157 must maximize the use of observable inputs and minimize
the use of unobservable inputs. The standard describes a fair value hierarchy
based on three levels of inputs, of which the first two are considered
observable and the last unobservable, that may be used to measure fair value.
The adoption of this Statement did not have a material impact on the Company's
consolidated results of operations and financial condition.
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), “Business
Combinations”, or SFAS No. 141R. SFAS No. 141R replaces SFAS No. 141. This
Statement establishes principles and requirements for how an acquirer recognizes
and measures in its financial statements the identifiable assets acquired, the
liabilities assumed, any non-controlling interest in the acquiree and the
goodwill acquired. For example, expenses incurred in an acquisition are to be
expensed and not capitalized. This Statement also establishes disclosure
requirements which will enable users to evaluate the nature and financial
effects of the business combination. This Statement is effective for business
combinations for which the acquisition date is on or after the beginning of the
first annual reporting period beginning on or after December 15, 2008. The
acquisition of the subsidiaries of Photo Therapeutics Group Ltd. was completed
after December 31, 2008 and therefore SFAS No. 141R applies to the acquisition.
Acquisition costs amounting to $1,532,798 and incurred through December 31, 2008
were expensed as of December 31, 2008; acquisition costs amounting to $432,353
and incurred in 2009 were expensed as of February 27, 2009.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests in
Consolidated Financial Statements—an Amendment of Accounting Research Bulletin
No. 51.” SFAS No. 160 establishes accounting and reporting standards for
ownership interests in subsidiaries held by parties other than the parent, the
amount of consolidated net income attributable to the parent and to the
noncontrolling interest, changes in a parent’s ownership interest and the
valuation of retained noncontrolling equity investments when a subsidiary is
deconsolidated. This Statement also establishes reporting requirements that
provide sufficient disclosures that clearly identify and distinguish between the
interests of the parent and the interests of the noncontrolling owners. This
Statement is effective for fiscal years, and interim periods within those fiscal
years, beginning on or after December 15, 2008. The Company’s adoption of this
statement did not have a material impact on the Company's consolidated financial
statements.
Note
2
Acquisition:
Photo
Therapeutics Transaction:
On
February 27, 2009, the Company completed the acquisition of the subsidiaries of
Photo Therapeutics Group Ltd. The subsidiaries are Photo Therapeutics Ltd.
(based in the United Kingdom) and Photo Therapeutics, Inc. (based in California)
and are collectively referred to herein as “Photo Therapeutics” or
“PTL”. Photo Therapeutics is a developer and provider of non-laser light
aesthetic devices for the treatment of a range of clinical and non-clinical
dermatological conditions.
14
The
Company paid an aggregate purchase price of $13 million for the Photo
Therapeutics acquisition. The fair value of the assets acquired and liabilities
assumed were based on management estimates and values derived from an outside
independent appraisal. 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
|
$ | 421,978 | ||
Accounts
receivable
|
843,007 | |||
Inventories
|
1,633,150 | |||
Prepaid
expenses and other current assets
|
187,232 | |||
Property
and equipment
|
80,462 | |||
Patents
and licensed technologies
|
7,400,000 | |||
Other
intangible assets
|
1,500,000 | |||
Total
assets acquired at fair value
|
12,065,829 | |||
Accounts
payable
|
(685,779 | ) | ||
Accrued
compensation and related expenses
|
(35,906 | ) | ||
Other
accrued liabilities
|
(419,186 | ) | ||
Deferred
revenues
|
(576,349 | ) | ||
Total
liabilities assumed
|
(1,717,220 | ) | ||
Net
assets acquired
|
$ | 10,348,609 |
The
purchase price exceeded the fair value of the net assets acquired by $2,651,391,
which was recorded as goodwill. Acquisition costs amounting to $1,532,798 and
incurred through December 31, 2008 were expensed as of December 31, 2008;
acquisition costs amounting to $432,353 and incurred in 2009 were expensed as of
February 27, 2009.
The
accompanying consolidated financial statements do not include any revenues or
expenses related to the PTL business on or prior to February 27, 2009, the
closing date of the acquisition. The Company’s unaudited pro-forma results for
the three months ended March 31, 2009 and 2008 are summarized in the following
table, assuming the acquisition had occurred on January 1, 2008:
Three Months Ended March 31,
(unaudited)
|
||||||||
2009
|
2008
|
|||||||
Net
revenues
|
$ | 8,325,751 | $ | 10,431,374 | ||||
Net
loss
|
$ | (4,225,350 | ) | $ | (3,157,934 | ) | ||
Basic
and diluted loss per share
|
$ | (0.47 | ) | $ | (0.35 | ) | ||
Shares
used in calculating basic and diluted loss per share
|
9,005,009 | 9,004,601 |
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, 2008, nor to be
indicative of future results of operations.
Discontinued
Operations:
Surgical
Services is a fee-based procedures business using mobile surgical laser
equipment operated by Company technicians at hospitals and surgery centers in
the United States. The Company decided to sell this division primarily because
the growth rates and operating margins of the division have decreased as the
business had changed to rely more heavily upon procedures performed using
equipment from third-party suppliers, thereby limiting the profit potential of
these services. After preliminary investigations and discussions, the Board of
Directors of the Company decided on June 13, 2008 to enter into, with the aid of
its investment banker, substantive, confidential discussions with potential
third-party buyers and began to develop plans for implementing a disposal of the
assets and operations of the business. The Company accordingly classified this
former segment as held for sale in accordance with SFAS No. 144. On August 1,
2008, the Company entered into a definitive agreement to sell specific assets of
the business including accounts receivable, inventory and equipment, for
$3,500,000, subject to certain closing adjustments. Such closing adjustments
resulted in net proceeds to the Company of $3,149,737. The transaction closed on
August 8, 2008. No income tax benefit was recognized by the Company from the
loss on the sale of discontinued operations.
15
Prior
year financial statements for 2008 have been restated in conformity with
generally accepted accounting principles to present the operations of Surgical
Services as a discontinued operation.
Revenues
from Surgical Services for the three months ended March 31, 2008 were
$1,899,739. Income from Surgical Services for the three months ended March 31,
2008 was $168,802.
Note
3
Inventories:
Set forth
below is a detailed listing of inventories:
March 31, 2009
|
December 31, 2008
|
|||||||
(unaudited)
|
||||||||
Raw
materials and work in progress
|
$ | 6,418,349 | $ | 5,157,455 | ||||
Finished
goods
|
2,784,196 | 1,816,739 | ||||||
Total
inventories
|
$ | 9,202,545 | $ | 6,974,194 |
Work-in-process
is immaterial, given the Company’s typically short manufacturing cycle, and
therefore is disclosed in conjunction with raw materials. As of March 31, 2009
and December 31, 2008, the Company carried specific reserves for excess and
obsolete stocks against its inventories of $2,236,065 and $1,836,441,
respectively.
Note
4
Property
and Equipment:
Set forth
below is a detailed listing of property and equipment:
March 31, 2009
|
December
31, 2008
|
|||||||
(unaudited)
|
||||||||
Lasers
in service
|
$ | 17,901,030 | $ | 17,288,400 | ||||
Computer
hardware and software
|
367,432 | 341,407 | ||||||
Furniture
and fixtures
|
637,709 | 562,418 | ||||||
Machinery
and equipment
|
804,461 | 830,778 | ||||||
Leasehold
improvements
|
259,595 | 259,595 | ||||||
19,970,227 | 19,282,598 | |||||||
Accumulated
depreciation and amortization
|
(9,377,989 | ) | (8,894,192 | ) | ||||
Property
and equipment, net
|
$ | 10,592,238 | $ | 10,388,406 |
Depreciation
and related amortization expense was $755,077 and $743,138 for the three months
ended March 31, 2009 and 2008, respectively.
16
Note
5
Patents
and Licensed Technologies:
Set forth
below is a detailed listing of patents and licensed technologies:
March 31, 2009
|
December 31, 2008
|
|||||||
(unaudited)
|
||||||||
Patents,
owned and licensed, at gross costs of $7,994,919 and $583,623, net of
accumulated amortization of $433,246 and $359,195,
respectively.
|
$ | 7,561,673 | $ | 224,428 | ||||
Other
licensed or developed technologies, at gross costs of $2,328,059, net of
accumulated amortization of $1,451,118 and $1,410,025,
respectively.
|
876,941 | 918,034 | ||||||
$ | 8,438,614 | $ | 1,142,462 |
Related
amortization expense was $115,113 and $52,857 for the three months ended March
31, 2009 and 2008, respectively. Included in Patents is $7,400,000 in patents,
patents pending and related know-how acquired in the Photo Therapeutics
transaction. Included in other licensed or developed technologies is $200,000 in
developed technologies acquired from ProCyte and $88,659 for the license from
the Mount Sinai School of Medicine of New York University. The Company is also
obligated to pay Mount Sinai a royalty on a combined base of domestic sales of
XTRAC treatment codes used for psoriasis as well as for vitiligo. In the first
four years of the license, however, Mount Sinai may elect to be paid royalties
on an alternate base, comprised simply of treatments for vitiligo, but at a
higher royalty rate than the rate applicable to the combined base. This
technology is for the laser treatment of vitiligo and is included in other
licensed or developed technologies.
Note
6
Other
Intangible Assets:
Set forth
below is a detailed listing of other intangible assets, which were acquired from
Photo Therapeutics and ProCyte and were recorded at their appraised fair market
values at the date of their respective acquisitions:
March 31, 2009
|
December 31, 2008
|
|||||||
(unaudited)
|
||||||||
Customer
Relationships, at gross cost of $2,200,000 and $1,700,000, net of
accumulated amortization of $1,376,901 and $1,287,735,
respectively.
|
823,099 | 412,265 | ||||||
Tradename,
at gross cost of $2,100,000 and $1,100,000, net of accumulated
amortization of $452,474 and $416,640, respectively.
|
1,647,526 | 683,360 | ||||||
$ | 2,470,625 | $ | 1,095,625 |
Related
amortization expense was $125,000 and $232,500 for the three months ended March
31, 2009 and 2008, respectively. Customer Relationships embody the value to the
Company of relationships that ProCyte and Photo Therapeutics had formed with
their customers, as well as the value of a non-compete covenant agreed to by
Photo Therapeutics Group Ltd. Tradename includes the name of “ProCyte” and
various other trademarks associated with ProCyte’s products. It also includes
the various trademarks associated with Photo Therapeutics
products.
17
Note
7
Other
Accrued Liabilities:
Set forth
below is a detailed listing of other accrued liabilities:
March 31, 2009
|
December 31, 2008
|
|||||||
(unaudited)
|
||||||||
Accrued
professional and consulting fees
|
$ | 244,834 | $ | 186,162 | ||||
Accrued
warranty
|
684,935 | 442,527 | ||||||
Accrued
sales taxes
|
222,054 | 196,121 | ||||||
Accrued
interest expense
|
120,000 | - | ||||||
Accrued
other expense
|
101,691 | 39,623 | ||||||
Total
other accrued liabilities
|
$ | 1,373,514 | $ | 864,433 |
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, 2009
|
December 31, 2008
|
|||||||
(unaudited)
|
||||||||
Note
Payable – secured creditor, interest at 6%, payable in monthly principal
and interest installments of $2,880 through June 2012
|
$ | 99,132 | $ | 106,214 | ||||
99,132 | 106,214 | |||||||
Less:
current maturities
|
(29,412 | ) | (28,975 | ) | ||||
Notes
payable, net of current maturities
|
$ | 69,720 | $ | 77,239 |
Note
9
Long-term
Debt:
In the
following table is a summary of the Company’s long-term debt.
March 31, 2009
|
December 31, 2008
|
|||||||
(unaudited)
|
||||||||
Total
borrowings on credit facility
|
$ | 7,274,085 | $ | 8,571,033 | ||||
Less:
current portion
|
(4,296,833 | ) | (4,663,281 | ) | ||||
Total
long-term debt
|
$ | 2,977,252 | $ | 3,907,752 |
Term
Note Credit Facility
In
December 2007, the Company entered into a term-note facility with CIT Healthcare
LLC and Life Sciences Capital LLC, as equal participants (collectively, “CIT”),
for which CIT Healthcare acts as the agent. The facility had a maximum principal
amount of $12 million and for a term of one year. The stated interest rate for
any draw under the credit facility was set as 675 basis points above the
three-year Treasury rate. CIT levied no points on a draw. Each draw was secured
by specific XTRAC laser systems consigned under usage agreements with
physician-customers.
The first
draw had two discrete components: carryover debt attributable to the former
borrowings, as increased by extinguishment costs (including redemption of the
certain warrants) which CIT financed; and debt newly incurred to CIT on XTRAC
units not previously pledged. The carryover components maintained the monthly
debt service payments with increases to principal and changes in the stated
interest rates causing minor changes in the number of months set to pay off the
discrete draws. The second component was self-amortizing over three
years.
The
beginning principal of each component was $6,337,325 and $3,990,000,
respectively. The effective interest rate for the first draw was 12.50%. The
pay-off of each component is between 27 to 36 months. On March 31, 2008, the
Company made an additional draw under the credit facility for $840,000. This
additional draw is amortized over 36 months at an effective interest rate of
8.55%. On June 30, 2008, the Company made another draw under the credit facility
for $832,675 based on the limitations on gross borrowings under the facility.
This draw is amortized over 36 months at an effective interest rate of
9.86%.
18
On
September 30, 2008, CIT amended the credit facility to increase the amount the
Company could draw on the credit facility by $1,927,534. The interest rate for
draws against this amount was set at 850 basis points above the LIBOR rate two
days prior to the draw. Each draw was to be secured by certain XTRAC laser
systems consigned under usage agreements with physician-customers and the stream
of payments generated from such lasers. Each draw has a repayment period of
three years. On September 30, 2008, the Company made another draw under the
credit facility for the maximum amount allowable under the credit facility. This
draw is amortized over 36 months at an effective interest rate of 12.90%. CIT
also raised certain defaults of the Company, which the Company took steps to
cure and which CIT waived as of February 27, 2009.
The
Company has used its entire availability under the CIT credit facility. The
Company is considering multiple written proposals for additional debt financing,
but there can be no assurance whether any such proposals will materialize on
terms favorable to the Company or at all.
In
connection with the CIT credit facility, the Company issued warrants to purchase
235,525 shares of the Company’s common stock to each of CIT
Healthcare and Life Sciences Capital in December 2007 (33,646 shares as adjusted
to reflect the reverse stock split of 1-for-7 effective January 26, 2009). In
connection with the amendment to the CIT facility, the Company issued warrants
to purchase an additional 192,753 shares to CIT Healthcare in September 2008
(27,536 shares as adjusted to reflect the reverse stock split of 1-for-7
effective January 26, 2009). The warrants are treated as a discount to the debt
and are accreted
under the effective interest method over the repayment term of 36 months. The
Company has accounted for these warrants as equity instruments in accordance
with EITF 00-19, “Accounting for Derivative Financial Instruments Indexed to,
and Potentially Settled in, a Company’s Own Stock” since there is no option for
cash or net-cash settlement when the warrants are exercised and there is no
down-round price protection provision. The Company computed the value of the
warrants using the Black-Scholes method. Set forth below are the key assumptions
used to value the warrants, as adjusted to reflect the reserve stock split of
1-for-7 effective January 26, 2009:
December
2007
|
September
2008
|
|||||||
Number
of warrants
|
67,292 | 27,536 | ||||||
Exercise
price
|
$ | 7.84 | $ | 3.08 | ||||
Fair
value of warrants
|
$ | 221,716 | $ | 44,366 | ||||
Volatility
|
59.44 | % | 60.92 | % | ||||
Risk-free
interest rate
|
3.45 | % | 2.98 | % | ||||
Expected
dividend yield
|
0 | % | 0 | % | ||||
Expected
warrant life
|
5
years
|
5
years
|
The
following table summarizes the future minimum payments that the Company expects
to make for the draws made under the credit facility:
Year
Ended December 31,
|
||||
2009
for nine months
|
$ | 3,839,836 | ||
2010
|
3,444,782 | |||
2011
|
811,059 | |||
Total
minimum payments
|
8,095,677 | |||
Less:
interest
|
(730,515 | ) | ||
Less:
unamortized warrant discount
|
(91,077 | ) | ||
Present
value of total minimum obligations
|
$ | 7,274,085 |
19
Note
10
Convertible
Debt:
In the
following table is a summary of the Company’s convertible debt.
March 31, 2009
|
||||
(unaudited)
|
||||
Total
borrowings on credit facility
|
$ | 16,468,866 | ||
Less:
current portion
|
- | |||
Total
long-term debt
|
$ | 16,468,866 |
The
February 27, 2009 acquisition of Photo Therapeutics was funded simultaneously
through a convertible debt investment of $18 million from an investor which
manages an investment fund (the “Investor”). The convertible note
transaction financed the $13 million purchase price of the acquisition, and a
further $5 million in working capital at the closing of the acquisition. Under
the terms of the investment, the Investor shall make up to an additional $7
million convertible debt investment in the Company in the event additional,
earn-out consideration is payable under the terms of the Photo Therapeutics
acquisition. After the payment of approximately $2 million of transaction
expenses associated with the acquisition and the debt investment, the Company
had approximately $3 million remaining for use as working capital.
At the
closing of the convertible debt financing, and in exchange for the Investor’s
payment to the Company of the $18 million purchase price, the Company: (i)
issued the Investor (A) a convertible note in the principal amount of $18
million, and (B) a warrant to purchase 1,046,204 shares of the Company’s common
stock; and (ii) paid a transaction fee of $210,000 in cash. The conversion price
of the convertible note and the exercise price of the warrant are each
$5.16.
The note
is due in 60 months with interest payments bi-annually at 8%, due on September 1
and March 1 of each year. The interest can be paid by the issuance of additional
convertible notes. The effective interest rate is 11.62%, which takes into
account paid interest as well as accreted interest under an effective interest
method from the warrants and loan origination costs. The warrants that were
issued give rise to a discount to the debt. This discount, as well as loan
origination costs and the transaction fee paid to the Investor, are accreted as
interest expense under the effective interest method over the repayment term of
60 months.
The
Company has accounted for the Investor’s warrants as a liability under EITF
07-5, due to the “down-round” price protection provision. See Note 1, Fair Value
Measurements. The Company computed the value of the warrants using the
Black-Scholes method. The key assumptions used to value the warrants at February
27, 2009 are as follows:
Number
of warrants
|
1,046,204 | |||
Exercise
price
|
$ | 5.16 | ||
Fair
value of warrants
|
$ | 1,550,311 | ||
Volatility
|
87.89 | % | ||
Risk-free
interest rate
|
2.69 | % | ||
Expected
dividend yield
|
0 | % | ||
Expected
warrant life
|
8
years
|
As
security for the Company’s obligations to the Investor under the convertible
notes, the Company granted the Investor a first priority security interest in:
(i) all of the stock of (A) ProCyte Corporation, the Company’s wholly-owned
subsidiary, and (B) Photo Therapeutics, Inc., which became a wholly-owned
subsidiary of the Company upon the PTL Closing; (ii) 65% of the stock of Photo
Therapeutics Limited, which also became a wholly-owned subsidiary of the Company
upon the acquisition; and (iii) certain other assets of the Company related to
the skin care business.
20
Note
11
Warrants
The
Company adopted EITF 07-5 effective January 1, 2009. The adoption of EITF 07-5
affects the requirements of accounting for warrants and many convertible
instruments that have provisions that protect holders from a decline in the
stock price (or “down-round” provisions). For example, warrants with such
provisions will no longer be recorded in equity but as liabilities. Down-round
provisions reduce the exercise or conversion price of a warrant or convertible
instrument if a company either issues equity shares for a price that is lower
than the exercise or conversion price of those instruments or issues new
warrants or convertible instruments that have a lower exercise or conversion
price. The Company evaluated whether warrants to acquire the Company’s common
stock contain provisions that protect holders from declines in the stock price
or otherwise could result in modification of the exercise price and/or shares to
be issued under the respective warrant agreements based on a variable that is
not an input to the fair value of a “fixed-for-fixed” option.
The
warrant issued to the Investor, in conjunction with the convertible note (Note
10) contains a down-round provision. The Company concluded that such a
triggering event was not based on an input to the fair value of
“fixed-for-fixed” option and therefore is not considered indexed to the
Company’s own stock. The warrant contains a net settlement provision and because
it is not indexed to the Company’s own stock, is accounted for as a derivative
in accordance with SFAS No. 133.
In
accordance with EITF 07-5, the Company recognizes these warrants as a liability
at the fair value on each reporting date. The Company measured the fair value of
these warrants as of March 31, 2009, and recorded other income of $91,222
resulting from the reduction of the liability associated with fair value of the
warrants as of March 31, 2009. The Company determined the fair values of these
securities using the Black-Scholes valuation model with the following
assumptions:
Number
of warrants
|
1,046,204 | |||
Exercise
price
|
$ | 5.16 | ||
Fair
value of warrants
|
$ | 1,459,089 | ||
Volatility
|
88.67 | % | ||
Risk-free
interest rate
|
2.28 | % | ||
Expected
dividend yield
|
0 | % | ||
Expected
warrant life
|
7.92
years
|
The
Company’s recurring fair value measurements at March 31, 2009 related only to
the warrants issued to the Investor, and had a fair value of $1,459,089. The
inputs used in measuring the fair value of these warrants are of Level 3,
significant unobservable inputs.
The
warrants issued in the private placement of November 2006 and to CIT in
connection with the term-note credit facility do not contain down-round
provisions.
Recurring
Level 3 Activity and Reconciliation
The table
below provides a reconciliation of the beginning and ending balances for the
liability measured at fair value using significant unobservable inputs (Level
3). The table reflects gains and losses for the quarter for all financial
liabilities categorized as Level 3 as of March 31, 2009.
Fair
Value Measurements Using Significant Unobservable Inputs (Level 3):
Warrant
liability:
|
||||
Balance
as of January 1, 2009
|
$ | - | ||
Initial
measurement of warrants
|
1,550,311 | |||
Decrease
in fair value of warrants
|
(91,222 | ) | ||
Balance
as of March 31, 2009
|
$ | 1,459,089 |
21
Note
12
Employee
Stock Benefit Plans
The
Company has three active, stock-based compensation plans available to grant,
among other things, incentive and non-qualified stock options to employees,
directors and third-party service-providers as well as restricted stock to key
employees. At our Annual Meeting in January 26, 2009, our stockholders approved
an increase of 285,715 shares in the number of shares reserved for the 2005
Equity Compensation Plan. Under the 2005 Equity Compensation Plan, a maximum of
1,165,714 shares of the Company’s common stock have been reserved for issuance.
At March 31, 2009, 567,292 shares were available for future grants under this
plan. Under the Outside Director Plan and under the 2005 Investment Plan, 68,037
shares and 55,428 shares, respectively, were available for issuance as of March
31, 2009. The other stock options plans are frozen and no further grants will be
made from them. The foregoing figures reflect the 1-for-7 reverse
split.
Stock
option activity under all of the Company’s share-based compensation plans for
the three months ended March 31, 2009 was as follows:
Number of
Options
|
Weighted
Average
Exercise
Price
|
|||||||
Outstanding,
January 1, 2009
|
870,865 | $ | 12.49 | |||||
Granted
|
47,507 | 1.95 | ||||||
Cancelled
|
(97,182 | ) | 13.67 | |||||
Outstanding,
March 31 2009
|
821,190 | $ | 11.74 | |||||
Options
excercisable at March 31, 2009
|
556,893 | $ | 13.53 |
At March
31, 2009, there was $888,017 of total unrecognized compensation cost related to
non-vested option grants and stock awards that is expected to be recognized over
a weighted-average period of 1.93 years. The intrinsic value of options
outstanding and exercisable at March 31, 2009 was not significant.
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,
(unaudited)
|
|||||||
2009
|
2008
|
|||||||
Risk-free
interest rate
|
2.42 | % | 3.725 | % | ||||
Volatility
|
86.74 | % | 84.16 | % | ||||
Expected
dividend yield
|
0 | % | 0 | % | ||||
Expected
life
|
8.1
years
|
8.1
years
|
||||||
Estimated
forfeiture rate
|
12 | % | 12 | % |
The
Company calculates expected volatility for a share-based grant based on historic
daily stock price observations of its common stock during the period immediately
preceding the grant that is equal in length to the expected term of the grant.
For estimating the expected term of share-based grants made in the three months
ended March 31, 2009 and 2008, the Company has adopted the simplified method
authorized in Staff Accounting Bulletin No. 107. SFAS No. 123R also requires
that estimated forfeitures be included as a part of the estimate of expense as
of the grant date. The Company has used historical data to estimate expected
employee behaviors related to option exercises and forfeitures.
With
respect to both grants of options and awards of restricted stock, the risk-free
rate of interest is based on the U.S. Treasury rates appropriate for the
expected term of the grant or award.
With
respect to awards of restricted stock, the Company uses the Monte-Carlo pricing
model to estimate fair value of restricted stock awards. The Company calculates
expected volatility for restricted stock based on a mirror approach, where the
daily stock price of our common stock during the seven-year period immediately
after the grant would be the mirror of the historic daily stock price of our
common stock during the seven-year period immediately preceding the grant. There
were no restricted stock awards for the three months ended March 31, 2009 and
2008.
22
Compensation
expense for the three months ended March 31, 2009 included $171,632 from stock
options grants and $103,623 from restricted stock awards. Compensation expense
for the three months ended March 31, 2008 included $276,006 from stock options
grants and $103,623 from restricted stock awards.
Compensation
expense is presented as part of the operating results in selling, general and
administrative expenses. For stock options granted to consultants, an additional
selling, general, and administrative expense in the amount of $17,419 was
recognized during the three months ended March 31, 2009. For stock options
granted to consultants an additional selling, general, and administrative
expense in the amount of $46,914 was recognized during the three months ended
March 31, 2008.
Note
12
Business
Segment and Geographic Data:
Segments
are distinguished by the Company’s management structure, products and services
offered, markets served and types of customers. The Domestic XTRAC business
derives its primary revenues from procedures performed by dermatologists in the
United States. The International Dermatology Equipment segment, in comparison,
generates revenues from the sale of equipment to dermatologists outside the
United States through a network of distributors. The Skin Care (ProCyte) segment
generates primary revenues by selling skincare products. The Photo Therapeutics
(PTL) segment generates revenues by selling LED and associated skincare products
for the treatment of a range of clinical and aesthetic dermatological conditions
and by earning milestone payments and royalties, from a licensing agreement. The
Surgical Products segment generates revenues by selling laser products and
disposables to hospitals and surgery centers on both a domestic and an
international basis. For the three months ended March 31, 2009 and 2008,
the Company did not have material revenues from any individual
customer.
Unallocated
operating expenses include costs that are not specific to a particular segment
but are general to the group; included are expenses incurred for administrative
and accounting staff, general liability and other insurance, professional fees
and other similar corporate expenses. Unallocated assets include cash, prepaid
expenses and deposits. Goodwill from the buy-out of Acculase that was carried at
$2,944,423 at March 31, 2009 and 2008 has been allocated to the domestic and
international XTRAC segments based upon its fair value as of the date of the
buy-out in the amounts of $2,061,096 and $883,327, respectively. Goodwill of
$13,973,385 at March 31, 2009 and 2008 from the ProCyte acquisition has been
entirely allocated to the Skin Care segment. Goodwill of $2,651,391 at March 31,
2009 from the Photo Therapeutics acquisition has been entirely allocated to the
PTL segment.
23
The
following tables reflect results of operations from our business segments for
the periods indicated below:
Three Months Ended March 31, 2009
(unaudited)
|
||||||||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN CARE
|
PTL *
|
SURGICAL
PRODUCTS
AND OTHER
|
TOTAL
|
|||||||||||||||||||
Revenues
|
$ | 2,675,309 | $ | 999,084 | $ | 2,202,459 | $ | 746,048 | $ | 875,442 | $ | 7,498,342 | ||||||||||||
Costs
of revenues
|
1,534,831 | 684,863 | 769,932 | 179,082 | 628,892 | 3,797,600 | ||||||||||||||||||
Gross
profit
|
1,140,478 | 314,221 | 1,432,527 | 566,966 | 246,550 | 3,700,742 | ||||||||||||||||||
Gross
profit %
|
42.6 | % | 31.5 | % | 65.0 | % | 76.0 | % | 28.2 | % | 49.4 | % | ||||||||||||
Allocated
operating expenses:
|
||||||||||||||||||||||||
Selling,
general and administrative
|
2,058,447 | 69,162 | 1,501,966 | 307,550 | 66,322 | 4,003,447 | ||||||||||||||||||
Engineering
and product development
|
- | - | 79,516 | 22,171 | 100,010 | 201,697 | ||||||||||||||||||
Unallocated
operating expenses
|
- | - | - | - | - | 2,696,484 | ||||||||||||||||||
2,058,447 | 69,162 | 1,581,482 | 329,721 | 166,332 | 6,901,628 | |||||||||||||||||||
Income
(loss) from operations
|
(917,969 | ) | 245,059 | (148,955 | ) | 237,245 | 80,218 | (3,200,886 | ) | |||||||||||||||
Interest
expense, net
|
- | - | - | - | - | (402,523 | ) | |||||||||||||||||
Change
in fair value of warrant
|
- | - | - | - | - | 91,222 | ||||||||||||||||||
(Loss)
income from continuing operations
|
(917,969 | ) | 245,059 | (148,955 | ) | 237,245 | 80,218 | (3,512,187 | ) | |||||||||||||||
Discontinued
operations:
|
||||||||||||||||||||||||
Income
from discontinued operations
|
- | - | - | - | - | - | ||||||||||||||||||
Net
(loss) income
|
$ | (917,969 | ) | $ | 245,059 | $ | (148,955 | ) | $ | 237,245 | $ | 80,218 | $ | (3,512,187 | ) |
* From
February 27, 2009 (the date of acquisition) through March 31, 2009.
Three Months Ended March 31, 2008
(unaudited)
|
||||||||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN CARE
|
PTL
|
SURGICAL
PRODUCTS
AND OTHER
|
TOTAL
|
|||||||||||||||||||
Revenues
|
$ | 2,110,707 | $ | 1,168,205 | $ | 3,274,692 | $ | - | $ | 1,777,230 | $ | 8,330,834 | ||||||||||||
Costs
of revenues
|
1,430,778 | 570,649 | 960,452 | - | 1,156,152 | 4,118,031 | ||||||||||||||||||
Gross
profit
|
679,929 | 597,556 | 2,314,240 | - | 621,078 | 4,212,803 | ||||||||||||||||||
Gross
profit %
|
32.2 | % | 51.2 | % | 70.7 | % | N/A | 34.9 | % | 50.6 | % | |||||||||||||
Allocated
operating expenses:
|
||||||||||||||||||||||||
Selling,
general and administrative
|
1,991,499 | 73,488 | 1,924,707 | - | 142,271 | 4,131,965 | ||||||||||||||||||
Engineering
and product development
|
168,214 | 20,790 | 141,188 | - | 108,496 | 438,688 | ||||||||||||||||||
Unallocated
operating expenses
|
- | - | - | - | - | 2,125,442 | ||||||||||||||||||
2,159,713 | 94,278 | 2,065,895 | - | 250,767 | 6,696,095 | |||||||||||||||||||
Income
(loss) from operations
|
(1,479,784 | ) | 503,278 | 248,345 | - | 370,311 | (2,483,292 | ) | ||||||||||||||||
Interest
expense, net
|
- | - | - | - | - | (227,371 | ) | |||||||||||||||||
(Loss)
income from continuing operations
|
(1,479,784 | ) | 503,278 | 248,345 | - | 370,311 | (2,710,663 | ) | ||||||||||||||||
Discontinued
operations:
|
||||||||||||||||||||||||
Income
from discontinued operations
|
- | - | - | - | - | 168,802 | ||||||||||||||||||
Net
(loss) income
|
$ | (1,479,784 | ) | $ | 503,278 | $ | 248,345 | $ | - | $ | 370,311 | $ | (2,541,861 | ) |
24
March 31, 2009
|
December 31, 2008
|
|||||||
(unaudited)
|
||||||||
Assets:
|
||||||||
Total
assets for reportable segments
|
$ | 56,542,865 | $ | 42,075,242 | ||||
Other
unallocated assets
|
5,207,340 | 4,639,027 | ||||||
Consolidated
total
|
$ | 61,750,205 | $ | 46,714,269 |
For the
three months ended March 31, 2009 and 2008 there were no material net revenues
attributed to any individual foreign country. Net revenues by geographic area
were, as follows:
Three Months Ended
March 31, (unaudited)
|
||||||||
2009
|
2008
|
|||||||
Domestic
|
$ | 5,313,822 | $ | 6,220,557 | ||||
Foreign
|
2,184,520 | 2,110,277 | ||||||
$ | 7,498,342 | $ | 8,330,834 |
The
Company discusses segmental details in its Management Discussion & Analysis
found elsewhere in its Form 10-Q for the period ending March 31,
2009.
Note
13
Significant
Alliances/Agreements:
The
Company continues in alliance with GlobalMed (Asia) Technologies Co., Inc. as
well as with the Mount Sinai School of Medicine as described in our Annual
Report on Form 10-K for the year ended December 31, 2008.
With
respect to the Clinical Trial Agreement protocol with the University of
California at San Francisco, Dr. Koo presented the favorable findings of the
study at the Hawaii Dermatology Seminar in March 2008. Dr. Koo concluded that
the XTRAC Excimer Laser may be appropriate for the majority of moderate to
severe psoriasis sufferers. It also allows dermatologists to treat those
patients with a high level of safety, as opposed to the use of many systemic
products. Other phototherapy treatments such as broadband or narrow band
ultraviolet-B (“UVB”) can also be used; however, undesirable aspects of these
treatments include exposure of healthy skin to UVB light, and the inconvenience
of extended treatment periods, which are often necessary for moderate to severe
patients. We expensed $189,000 in 2008 in payment for this study. At the annual
meeting of the American Academy of Dermatology in March 2009, Dr. Koo delivered
a follow-up presentation of his earlier favorable findings. At the meeting, the
Company introduced its XTRAC Velocity excimer laser.
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,
2008.
25
The
following discussion and analysis should be read in conjunction with the
consolidated financial statements and related notes included elsewhere in this
Report.
Introduction,
Outlook and Overview of Business Operations
We view
our current business as comprised of the following five business
segments:
|
·
|
Domestic
XTRAC,
|
|
·
|
International
Dermatology Equipment,
|
|
·
|
Skin
Care (ProCyte),
|
|
·
|
Photo
Therapeutics (PTL), and
|
|
·
|
Surgical
Products.
|
Domestic
XTRAC
Our
Domestic XTRAC segment is a U.S. business with revenues primarily derived from
procedures performed by dermatologists. We are engaged in the development,
manufacturing and marketing of our proprietary XTRAC® excimer laser and delivery
systems and techniques used in the treatment of inflammatory skin
disorders, including psoriasis,
vitiligo, atopic dermatitis and leukoderma.
As part
of our commercialization strategy in the United States, we generally offer the
XTRAC laser system to targeted dermatologists at no initial capital cost. Under
this contractual arrangement, we maintain ownership of the laser and earn
revenue each time a physician treats a patient with the equipment. We believe
this arrangement will increase market penetration. At times, however, we sell
the laser directly to the customer for certain reasons, including the costs of
logistical support and customer preference as well as a means of addressing
under-performing accounts while still preserving a vendor-customer relationship.
We believe that we are able to reach a sector of the laser market
that is better suited to a sale model than a per-procedure model at reasonable
margins.
For the
last several years we have sought to obtain health insurance coverage for XTRAC
laser therapy to treat inflammatory skin disease, particularly psoriasis. With
the addition of new positive payment policies from Blue Cross Blue Shield plans
from certain states in 2008, we now benefit from the fact that, by our
estimates, more than 90% of the insured United States population has policies
that provide nearly full reimbursement for the treatment of psoriasis by means
of an excimer laser. We currently focus our efforts on accelerating the adoption
of the XTRAC laser therapy for psoriasis and vitiligo by doctors and patients.
Consequently, we have increased the size of our sales force and clinical
technician personnel together with increased expenditures for marketing and
advertising.
We have
tried various direct-to-consumer marketing programs that have positively
influenced utilization, but the increase in utilization is expected to be
attained in periods subsequent to the period in which we incurred the expense.
We have also increased the number of sales representatives and established a
group of clinical support specialists to optimize utilization levels and better
secure the willingness and interest of patients to seek follow-up treatment
after the effect of the initial treatment sessions starts to wear off. We have
recently promoted a regional sales director in the Domestic XTRAC segment to
head our XTRAC marketing operations, with the aim of helping our less successful
customers emulate the business and clinical methods of our more successful
customers.
International
Dermatology Equipment
In the
international market, we derive revenues by selling our dermatology laser and
lamp systems and replacement parts to distributors and directly to physicians.
In this market, we have benefited from both our clinical studies and from the
improved reliability and functionality of the XTRAC laser system. Compared
to the domestic segment, the sales of laser and lamp systems in the
international segment are influenced to a greater degree by competition from
similar laser technologies as well as non-laser lamp alternatives. Over time,
this competition has reduced the prices we are able to charge to international
distributors for our XTRAC products. To compete with other non-laser UVB
products, we offer a lower-priced, lamp-based system called the VTRAC. We have
expanded the international marketing of the VTRAC since its introduction in
2006. The VTRAC is used to treat psoriasis and vitiligo.
26
Skin
Care (ProCyte)
Our Skin
Care segment generates revenues primarily from the sale of skin health, hair
care and wound care products. In prior periods, the sale of copper peptide
compound in bulk to Neutrogena and royalties from Neutrogena on licenses for our
patented copper peptide compound were a significant factor in our revenues. More
recently, however, Neutrogena’s sales of peptide-based products have
declined.
Our focus
has been to provide unique products, primarily based upon patented technologies
for selected applications in the dermatology, plastic and cosmetic surgery and
medical spa markets. We have also expanded the use of our copper peptide
technologies into the mass retail market for skin and hair care through targeted
technology licensing and supply agreements.
Our skin
care 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. Our skin care products are formulated, branded and
targeted at specific markets. Our 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. In 2009, we have introduced Neova® Skin Care
Systems, which are kits of Neova products that target specific conditions with
complete treatment programs. The programs are Intense Age Defense, Extremely
Clear, and Essential Eye Recovery. These kits make it simpler for physicians to
dispense the products and to ensure patient compliance and
satisfaction.
Photo
Therapeutics (PTL)
Our PTL
segment is a developer and provider of non-laser light aesthetic devices for the
treatment of a range of clinical and non-clinical dermatological conditions. Our
PTL segment has a portfolio of independent, experimental research that supports
the efficacy and safety of its Omnilux™ technology system. Based on a patented
technology platform comprised of a unique light-emitting diode
(“LED”) array, this technology delivers narrow-band, spectrally pure
light of specific intensity, wavelength and dose to achieve clinically proven
results via a process called photo bio-modulation. Since this technology
generates no heat, a patient feels no pain or discomfort which results in
improved regime compliance and likelihood of repeat procedures; this is in
direct contrast to the current laser light-based technologies serving the
aesthetics market today.
Our PTL
LED products compete in the professional aesthetics device market for LED
aesthetic medical procedures. In addition, we have recently developed a line of
consumer devices to address the home-use market opportunity. The FDA has issued
over the counter (“OTC”) clearances for our two hand-held consumer
devices.
To date,
we have incorporated our PTL technology offering into a range of products
targeting both the professional based sector and the larger home-use market.
Therefore, our PTL segment’s current portfolio of products is divided into three
types: professional products comprising the Omnilux™ systems for the medical
market; the Lumiere™ systems to address the non-medical professional market; and
home-use products to address the consumer market.
The
consolidated financial statements include the results of Photo Therapeutics from
February 27, 2009, the date of acquisition, through March 31, 2009.
Surgical
Products
Our
Surgical Products segment generates revenues by selling laser products and
disposables to hospitals and surgery centers both within and outside of the
United States. Also included in this segment are various non-laser surgical
products (e.g. the ClearEss® II suction-irrigation system). We believe that
sales of surgical laser systems and the related disposable base will tend to
erode as hospitals continue to seek outsourcing solutions instead of purchasing
lasers and related disposables for their operating rooms. We are working to
offset such erosion by increasing sales from the Diode surgical laser, including
original equipment manufacturer (“OEM”) arrangements.
27
In
September 2007, we entered into a three-year OEM agreement with AngioDynamics
under which we manufacture for AngioDynamics, on a non-exclusive basis, a
private-label, 980-nanometer diode laser system. The OEM agreement provides that
we shall supply this laser on an exclusive basis to AngioDynamics, should
AngioDynamics meet certain purchase requirements. Through June 30, 2008,
shipments to AngioDynamics exceeded the minimum purchase requirement for
delivery of lasers over the first contract year and therefore triggered
exclusivity for worldwide sale in the peripheral vascular treatment field.
Given, however, that AngioDynamics purchased the assets of a competitive diode
laser company, we anticipate that it will elect to source its diodes through the
assets so purchased instead of through us. We have not shipped any lasers to
AngioDynamics since July 1, 2008.
Sales
and Marketing
As of
March 31, 2009, our sales and marketing organization consists of 75 full-time
positions. Of the 75 sales personnel, they are directed to sales as follows: 72
in Domestic XTRAC, Skin Care and PTL and three in International Dermatology
Equipment and Surgical Products.
Sale
of Surgical Services Business
Our
Surgical Services segment was a fee-based procedures business using mobile
surgical laser equipment operated by our technicians at hospitals and surgery
centers in the United States. We decided to sell this division primarily because
the growth rates and operating margins of the division have decreased as the
business changed to rely more heavily upon procedures performed using equipment
from third-party suppliers, thereby limiting the profit potential of these
services. After preliminary investigations and discussions, our Board of
Directors decided on June 13, 2008, with the aid of our financial advisors, to
enter into substantive, confidential discussions with potential third-party
buyers and began to develop plans for implementing a disposal of the assets and
operations of the business. On August 8, 2008, we sold certain assets of the
business, including accounts receivable, inventory and equipment, for
$3,149,737.
Reverse
Stock Split
On
January 26, 2009, we completed the reverse split of our common stock in the
ratio of 1-for-7, whereby, once effective, every seven shares of our common
stock was exchanged for one share of our common stock. Our common stock began
trading at the market opening on January 27, 2009 on a split-adjusted basis. The
reverse split is intended to enable us to increase our marketability to
institutional investors and to maintain our listing on the Nasdaq Global Market,
among other benefits. As a result of the reverse stock split, as of March 31,
2009 we had 9,005,175 shares of common stock outstanding, taking into account
the rounding up of fractional shares.
Critical
Accounting Policies and Estimates
There
have been no changes to our critical accounting policies and estimates in the
three months ended March 31, 2009, except as noted below. Critical accounting
policies and the significant estimates made in accordance with them are
regularly discussed with our Audit Committee. Those policies are discussed under
“Critical Accounting Policies” in our “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” included in Item 7 of our Annual
Report on Form 10-K for the year ended December 31, 2008.
We
adopted Emerging Issues Task Force Issue No. 07-5, Determining Whether an Instrument
(or Embedded Feature) is Indexed to an Entity’s Own Stock (“EITF 07-5”)
effective January 1, 2009. The adoption of EITF 07-5’s requirements can affect
the accounting for warrants and many convertible instruments with provisions
that protect holders from a decline in the stock price (or “down-round”
provisions). For example, warrants with such provisions will no longer be
recorded as equity. Down-round provisions reduce the exercise price of a warrant
or convertible instrument if a company either issues equity shares for a price
that is lower than the exercise price of those instruments or issues new
warrants or convertible instruments that have a lower exercise price. Management
evaluated whether warrants to acquire our common stock contain provisions that
protect holders from declines in the stock price or otherwise could result in
modification of the exercise price and/or shares to be issued under the
respective warrant agreements based on a variable that is not an input to the
fair value of a “fixed-for-fixed” option. Management determined that the
warrants issued to the Investor, in conjunction with the convertible note
contain such provisions, thereby concluding they were not indexed to our stock.
In accordance with EITF 07-5, we recognize these warrants as a liability at the
fair value on each reporting date. We measured the fair value of these warrants
as of March 31, 2009, and recorded a $91,222 reduction in the liability
associated with these warrants as of March 31, 2009. We determined the fair
values of these securities using a Black-Scholes valuation model.
28
We
adopted SFAS No. 141 (revised 2007), “Business Combinations” (“SFAS No. 141R”).
SFAS No. 141R replaces SFAS No. 141 effective January 1, 2009. SFAS No. 141R
establishes principles and requirements for how an acquirer recognizes and
measures in its financial statements the identifiable assets acquired, the
liabilities assumed, any non-controlling interest in an acquisition and the
goodwill acquired. For example, expenses incurred in an acquisition are to be
expensed and not capitalized. This Statement also establishes disclosure
requirements which will enable users to evaluate the nature and financial
effects of the business combination. This Statement is effective for business
combinations for which the acquisition date is on or after the beginning of the
first annual reporting period beginning on or after December 15,
2008.
The
acquisition of the subsidiaries of Photo Therapeutics Group Ltd. was completed
after December 31, 2008 and therefore SFAS No. 141R applies to the acquisition.
Acquisition costs amounting to $1,532,798 and incurred through December 31, 2008
were expensed as of December 31, 2008; acquisition costs amounting to $432,353
and incurred in 2009 were expensed as of February 27, 2009.
Results
of Operations
Revenues
The
following table presents revenues from our five business segments for the
periods indicated below:
Three Months Ended
March 31, (unaudited)
|
||||||||
2009
|
2008
|
|||||||
XTRAC
Domestic Services
|
$ | 2,675,309 | $ | 2,110,707 | ||||
International
Dermatology Equipment Products
|
999,084 | 1,168,205 | ||||||
Skin
Care (ProCyte) Products
|
2,202,459 | 3,274,692 | ||||||
Photo
Therapeutics (PTL) Products
|
746,048 | - | ||||||
Total
Dermatology Revenues
|
6,622,900 | 6,553,604 | ||||||
Surgical
Products
|
875,442 | 1,777,230 | ||||||
Total
Surgical Revenues
|
875,442 | 1,777,230 | ||||||
Total
Revenues
|
$ | 7,498,342 | $ | 8,330,834 |
Revenues
from our Surgical Services segment, in the amount of $1,899,739 through March
31, 2008, have been accounted for in 2008 as a discontinued
operation.
Domestic XTRAC
Segment
Recognized treatment revenue for the
three months ended March 31, 2009 and 2008 for domestic XTRAC procedures was
$2,037,004 and $1,565,907, respectively, reflecting billed procedures of 35,744
and 28,819, respectively. In addition, 1,805 and 1,519 procedures were performed
in the three months ended March 31, 2009 and 2008, 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, 2009
compared to the comparable period in 2008 was largely related to our continuing
progress in securing favorable reimbursement policies from private insurance
plans and to our increased marketing programs. Increases in procedures are
dependent upon building market acceptance through marketing programs with our
physician partners and their patients that the XTRAC procedures will be of
clinical benefit and generally reimbursed.
29
We have a program to support certain
physicians who may be denied reimbursement by private insurance carriers for
XTRAC treatments. In accordance with the requirements of Staff Accounting
Bulletin No. 104, we recognize service revenue under this program from the sale
of XTRAC procedures or equivalent treatments to physicians participating in this
program only to the extent the physicians have been reimbursed for the
treatments. For the three months ended March 31, 2009, we recognized net
revenues of $26,384 (400 procedures) under this program compared to deferred net
revenues of $727 (11 procedures) for the three months ended March 31, 2008. The
change in deferred revenue under this program is presented in the table
below.
We exclude 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, 2009 and
2008, we deferred net revenues of $347,417 (5,266 procedures) and $320,197
(4,891 procedures), respectively, under this approach.
For the three months ended March 31,
2009 and 2008, domestic XTRAC laser sales were $638,305 and $544,800,
respectively. There were 14 and 10 lasers sold during these periods,
respectively. Laser sales are made for various reasons, including costs of
logistical support and customer preferences. We believe that we are able to
reach a sector of the laser market that is better suited to a sale model than a
per-procedure model at reasonable margins.
The
following table sets forth the above analysis for our Domestic XTRAC segment for
the periods reflected below:
Three Months Ended
March 31, (unaudited)
|
||||||||
2009
|
2008
|
|||||||
Total
revenue
|
$ | 2,675,309 | $ | 2,110,707 | ||||
Less:
laser sales revenue
|
(638,305 | ) | (544,800 | ) | ||||
Recognized
treatment revenue
|
2,037,004 | 1,565,907 | ||||||
Change
in deferred program revenue
|
(26,384 | ) | 727 | |||||
Change
in deferred unused treatments
|
347,417 | 320,197 | ||||||
Net
billed revenue
|
$ | 2,358,037 | $ | 1,886,831 | ||||
Procedure
volume total
|
37,549 | 30,338 | ||||||
Less:
Non-billed procedures
|
1,805 | 1,519 | ||||||
Net
billed procedures
|
35,744 | 28,819 | ||||||
Avg.
price of treatments billed
|
$ | 65.97 | $ | 65.47 | ||||
Change
in procedures with deferred program revenue, net
|
(400 | ) | 11 | |||||
Change
in procedures with deferred unused treatments, net
|
5,266 | 4,891 |
The
average price for an XTRAC treatment may be reduced in some instances based on
the volume of treatments performed. The average price for a treatment also
varies based upon the mix of mild and moderate psoriasis patients treated by our
physician partners. We charge a higher price per treatment for moderate
psoriasis patients due to the increased body surface area required to be
treated, although there are fewer patients with moderate psoriasis than there
are with mild psoriasis.
30
International Dermatology
Equipment Segment
International
sales of our XTRAC and VTRAC laser systems and related parts were $999,084 for
the three months ended March 31, 2009 compared to $1,168,205 for the three
months ended March 31, 2008. We sold 15 and 23 systems in the three-month
periods ended March 31, 2009 and 2008, respectively. The average price of
dermatology equipment sold internationally varies due to the quantities of
refurbished domestic XTRAC systems and VTRACs sold. Both of these products have
lower average selling prices than new XTRAC laser systems. However, by adding
these to our product offerings along with expanding into new geographic
territories where the products are sold, we have been able to increase overall
international dermatology equipment revenues.
|
·
|
We
sell refurbished domestic XTRAC laser systems into the international
market. The selling price for used equipment is substantially less than
new equipment, some of which may be substantially depreciated in
connection with its use in the domestic market. We sold no such used
lasers in the three months ended March 31, 2009. We sold two such lasers
in the three months ended March 31, 2008, at an average price of $37,500;
and
|
|
·
|
In
addition to the XTRAC laser system (both new and used), we sell the VTRAC,
a lamp-based, alternative UVB light source that has a wholesale sales
price that is below our competitors’ international dermatology equipment
and below our XTRAC laser. In the three months ended March 31, 2009, we
sold no VTRAC systems. In the three months ended March 31, 2008, we sold
seven VTRAC systems.
|
The
following table illustrates the key changes in our International Dermatology
Equipment segment for the periods reflected below:
Three Months Ended
March 31, (unaudited)
|
||||||||
2009
|
2008
|
|||||||
Revenues
|
$ | 999,084 | $ | 1,168,205 | ||||
Less:
part sales
|
(229,184 | ) | (229,205 | ) | ||||
Laser/lamp
revenues
|
769,900 | 939,000 | ||||||
Laser/lamp
systems sold
|
15 | 23 | ||||||
Average
revenue per laser/lamp
|
$ | 51,327 | $ | 40,826 |
Skin Care (ProCyte)
Segment
For the
three months ended March 31, 2009, our skin care (“ProCyte”) segment revenues
were $2,202,459 compared to $3,274,692 in the three months ended March 31, 2008.
These revenues are generated from the sale of various skin, hair care and wound
products and from the sale of copper peptide compound.
|
·
|
The
product sales decreased for the three months ended March 31, 2009 due to
macro-economic conditions and to transitioning from our discontinued MD
Lash Factor eyelash conditioning product to our internally developed Neova
Advanced Essential Lash™ eyelash conditioner, which was launched February
1, 2009. This segment is more susceptible to such economic conditions than
our other segments because cosmetic products are more likely to be
discretionary and not medically necessary. Product sales for the three
months ended March 31, 2009 were approximately $2.1 million, down from
approximately $3.2 million for the three months ended March 31,
2008.
|
|
·
|
Included
in product sales for the three months ended March 31, 2008, were $451,577
of revenues from MD Lash Factor as part of an exclusive license to
distribute in the United States. In the three months ended March 31, 2009,
there were no revenues from this product as we have discontinued marketing
MD Lash Factor as of January 31, 2009 under the terms of an agreement with
Allergan, Inc. in settlement of certain patent litigation, and we have
replaced it with our own peptide-based conditioner. From the launch date
on February 1 through March 31, 2009, we sold $130,192 of Neova Advanced
Essential Lash.
|
31
|
·
|
Bulk
compound sales decreased by $47,920 for the three months ended March 31,
2009 compared to the three months ended March 31, 2008. Minimum
contractual royalties from Neutrogena expired in November 2007, and as a
result such royalties were immaterial over the two
periods.
|
The
following table illustrates the key changes in our Skin Care (ProCyte) segment
for the periods reflected below:
Three Months Ended
March 31, (unaudited)
|
||||||||
2009
|
2008
|
|||||||
Product
sales
|
$ | 2,121,576 | $ | 3,242,692 | ||||
Bulk
compound sales
|
79,920 | 32,000 | ||||||
Royalties
|
963 | - | ||||||
Total
ProCyte revenues
|
$ | 2,202,459 | $ | 3,274,692 |
Photo Therapeutics (PTL)
Segment
For the
period from February 27, 2009 through March 31, 2009, our PTL segment’s revenues
were $746,048. Since PTL was acquired on February 27, 2009, there are no
corresponding revenues for the three months ended March 31, 2008. PTL revenues
are generated from the sale of LED devices and milestone payments on a licensing
agreement targeting the mass consumer acne market.
The
following table illustrates the key changes in our PTL segment for the periods
reflected below:
Three Months
Ended March 31,
2009 (unaudited)
|
||||
Product
revenues
|
$ | 532,943 | ||
Licensing
revenues
|
213,105 | |||
Total
PTL revenues
|
$ | 746,048 |
We are
actively seeking distribution channels to reach the home-use consumer market
with our New-U™ hand-held LED device. Licensing revenues are from a license of
the Clear-U, which the licensee intends to use as a platform to attempt to
address the mass consumer acne market. We expect it to be several years over
several development milestones before the platform product may be
released.
Surgical Products
Segment
Surgical
Products revenues include revenues derived from the sale of surgical laser
systems together with sales of related laser fibers and laser disposables. Laser
fibers and laser disposables are more profitable than laser systems, but the
sales of laser systems generate subsequent recurring sales of fibers and
disposables.
For the
three months ended March 31, 2009, surgical products revenues were $875,442
compared to $1,777,230 in the three months ended March 31, 2008. The decrease in
the three-month periods was mainly related to our OEM contract with
AngioDynamics, which had initial shipments in December 2007. In the second half
of 2008, AngioDynamics purchased the assets of Diomed, a competitive diode laser
company. If AngioDynamics sources its diodes through the business which it has
purchased, our future sales of diode lasers to them may be severely limited.
Sales to AngioDynamics were $0 for the three months ended March 31, 2009,
compared to sales of $700,000 for the three months ended March 31, 2008. We
therefore do not expect the OEM business with AngioDynamics will recover in the
foreseeable future, if at all.
32
The
change in average price per laser between the periods, as set forth in the table
below, was largely due to the mix of lasers sold and partly due to the trade
level at which the lasers were sold (i.e. wholesale versus retail). Our diode
laser has replaced our Nd:YAG laser, which had a higher sales price. Included in
laser sales during the three months ended March 31, 2009 and 2008 were sales of
1 and 62 diode lasers, respectively. The diode lasers have lower sales prices
than our other types of lasers, and thus the decrease in the number of diodes
sold increased the average price per laser. We are phasing out our holmium and
CO2 laser systems.
Fiber and
other disposables sales increased 3% between the comparable three-month periods
ended March 31, 2009 and 2008. We expect that our disposables base may erode
over time as hospitals continue to seek outsourcing solutions instead of
purchasing lasers and related disposables for their operating
rooms.
The
following table illustrates the key changes in the Surgical Products segment for
the periods reflected below:
Three Months Ended
March 31, (unaudited)
|
||||||||
2009
|
2008
|
|||||||
Revenues
|
$ | 875,442 | $ | 1,777,230 | ||||
Laser
systems sold
|
2 | 64 | ||||||
Laser
system revenues
|
$ | 63,646 | $ | 972,745 | ||||
Average
revenue per laser
|
$ | 31,823 | $ | 15,199 |
Cost
of Revenues
Our costs
of revenues are comprised of product cost of revenues and service cost of
revenues. Within product cost of revenues are the costs of products sold in our
International Dermatology Equipment segment, our Skin Care segment (with
royalties included in the services side of the segment), our PTL segment and our
Surgical Products segment (with laser maintenance fees included in the services
side of this segment). Product costs also include XTRAC domestic laser sales.
Within services cost of revenues are the costs associated with our Domestic
XTRAC segment, excluding laser sales, as well as costs associated with royalties
and maintenance revenue.
Product
cost of revenues for the three months ended March 31, 2009 was $2,459,348,
compared to $2,864,452 in the comparable period in 2008. The $405,104 decrease
is due to the decreases in product cost of sales for surgical products of
$533,077 related to the decrease in laser sales, and in skincare products of
$190,520 resulting from the switch to our internally produced Neova product.
These decreases were offset, in part, by an increase in domestic XTRAC laser
sales in the amount of $25,197 and international dermatology equipment sales in
the amount of $114,214. In addition, there was an increase due to the inclusion
of $179,082 in product costs for our PTL business.
Service
cost of revenues was $1,338,252 in the three months ended March 31, 2009
compared to $1,253,579 in the comparable period in 2008 representing an increase
of $84,673. The increase is directly related to the increase in Domestic XTRAC
segment costs of $78,856.
Certain
allocable XTRAC manufacturing overhead costs are charged against the XTRAC
service revenues. Our manufacturing facility in Carlsbad, California is used
exclusively for the production of the XTRAC lasers. The unabsorbed costs are
allocated to the domestic XTRAC and the international dermatology equipment
segments based on actual production of lasers for each segment. Included in
these allocated manufacturing costs are unabsorbed labor and direct plant
costs.
33
The following table illustrates the key
changes in cost of revenues for the periods reflected below:
Three Months Ended
March 31, (unaudited)
|
||||||||
2009
|
2008
|
|||||||
Product:
|
||||||||
XTRAC
Domestic
|
$ | 227,090 | $ | 201,893 | ||||
International
Dermatology Equipment
|
684,863 | 570,649 | ||||||
Skin
Care
|
769,932 | 960,452 | ||||||
PTL
|
179,082 | - | ||||||
Surgical
products
|
598,381 | 1,131,458 | ||||||
Total
Product costs
|
$ | 2,459,348 | $ | 2,864,452 | ||||
Services:
|
||||||||
XTRAC
Domestic
|
$ | 1,307,741 | $ | 1,228,885 | ||||
Surgical
products
|
30,511 | 24,694 | ||||||
Total
Services costs
|
$ | 1,338,252 | $ | 1,253,579 | ||||
Total
Costs of Revenues
|
$ | 3,797,600 | $ | 4,118,031 |
Gross
Profit Analysis
Gross
profit decreased to $3,700,742 during the three months ended March 31, 2009 from
$4,212,803 during the same period in 2008. As a percent of revenues, gross
margin decreased to 49.4% for the three months ended March 31, 2009 from 50.6%
for the same period in 2008.
The
following table analyzes changes in our gross profit for the periods reflected
below:
Company Profit Analysis
|
Three Months Ended
March 31, (unaudited)
|
|||||||
2009
|
2008
|
|||||||
Revenues
|
$ | 7,498,342 | $ | 8,330,834 | ||||
Percent
decrease
|
(10.0 | )% | ||||||
Cost
of revenues
|
3,797,600 | 4,118,031 | ||||||
Percent
decrease
|
(7.8 | )% | ||||||
Gross
profit
|
$ | 3,700,742 | $ | 4,212,803 | ||||
Gross
margin percentage
|
49.4 | % | 50.6 | % |
The
primary reasons for the changes in gross profit and the gross margin percentage
for the three months ended March 31, 2009, compared to the same period in 2008
were as follows:
|
·
|
Our
Skin Care segment is more susceptible to the macro economic conditions
than our other segments because cosmetic products are more likely to be
discretionary and not medically necessary. Product sales for the first
quarter of 2009 were approximately $2.1 million down from approximately
$3.2 million for the first quarter of
2008.
|
|
·
|
In
our Surgical Products segment there were 62 fewer laser systems sold in
the three months ended March 31, 2009 than in the comparable period of
2008. This included 60 sales due to our OEM arrangement, but in the second
half of 2008, AngioDynamics purchased the assets of Diomed, a competitive
diode laser company. Since that time, our sales to AngioDynamics have been
$0, including for the three months ended March 31, 2009. Additionally, the
higher manufacturing levels in 2008 caused better absorption of fixed
overheads thereby lowering average unit costs and resulting in a higher
gross margin in 2008 compared to
2009.
|
34
|
·
|
Offsetting
the above items that had a negative impact on gross profit, is the gross
profit realized from our PTL segment. We acquired PTL on February 27,
2009, so only the activity after that date is recorded in our financial
statements. There was no activity recorded in our financial statements in
2008.
|
|
·
|
We
sold a greater number of XTRAC treatment procedures in 2009 than in 2008.
Procedure volume increased 24% from 28,819 to 35,744 billed procedures in
the three months ended March 31, 2009 compared to the same period in 2008.
Since each incremental treatment procedure carries negligible variable
cost, this significantly enhanced profit margins. The increase in
procedure volume was a direct result of improving insurance reimbursement
and increased marketing efforts.
|
|
·
|
We
sold approximately $93,505 worth of additional domestic XTRAC lasers in
the three months ended March 31, 2009 at higher margins compared to the
same period in 2008. Certain of these lasers were previously being
depreciated, since they were previously placements. The margin on these
capital equipment sales was 64% in 2009 compared to 63% in
2008.
|
The
following table analyzes the gross profit for our Domestic XTRAC segment for the
periods presented below:
XTRAC Domestic Segment
|
Three Months Ended
March 31, (unaudited)
|
|||||||
2009
|
2008
|
|||||||
Revenues
|
$ | 2,675,309 | $ | 2,110,707 | ||||
Percent
increase
|
26.7 | % | ||||||
Cost
of revenues
|
1,534,831 | 1,430,778 | ||||||
Percent
increase
|
7.3 | % | ||||||
Gross
profit
|
$ | 1,140,478 | $ | 679,929 | ||||
Gross
margin percentage
|
42.6 | % | 32.2 | % |
Gross
profit increased for this segment for the three months ended March 31, 2009 from
the comparable period in 2008 by $460,549. In addition to the overall higher
revenues between the periods, other key factors for the increases were as
follows:
|
·
|
Key
drivers in increasing the fee-per-procedure revenue from this segment are
insurance reimbursement and increased direct-to-consumer advertising in
targeted territories. Improved insurance reimbursement, together with
greater consumer awareness of the XTRAC therapy, increased treatment
revenue accordingly. Our clinical support specialists focus their efforts
on increasing physicians’ utilization of the XTRAC laser system.
Consequently, procedure volume increased 24% from 28,819 to 35,744 billed
procedures in the three months ended March 31, 2009 compared to the same
period in 2008. Price per procedure did not change significantly between
the periods. Each incremental treatment procedure carries negligible
variable cost.
|
|
·
|
We
sold approximately $93,505 worth of additional domestic XTRAC lasers in
the three months ended March 31, 2009 at higher margins compared to the
same period in 2008. Certain of these lasers were previously being
depreciated, since they were previous placements. The margin on these
capital equipment sales was 64% in the three months ended March 31, 2009
compared to 63% in the comparable period in
2008.
|
|
·
|
The
cost of revenues increased by $104,053 for the three months ended March
31, 2009. This increase is due to an increase in cost of revenues related
to laser sales of $25,197 over the comparable period in 2008.
Additionally, there was an increase in the service expenses due to the
increase in lasers placed in the field, of approximately $101,700.
Offsetting the increase were decreases in certain allocable XTRAC
manufacturing overhead costs that are charged against the XTRAC service
revenues. The depreciation costs will continue to increase in subsequent
periods as the business grows.
|
35
The
following table analyzes the gross profit for our International Dermatology
Equipment segment for the periods presented below:
International Dermatology
Equipment Segment
|
Three Months Ended
March 31, (unaudited)
|
|||||||
2009
|
2008
|
|||||||
Revenues
|
$ | 999,084 | $ | 1,168,205 | ||||
Percent
decrease
|
(14.5 | %) | ||||||
Cost
of revenues
|
684,863 | 570,649 | ||||||
Percent
decrease
|
(20.0 | %) | ||||||
Gross
profit
|
$ | 314,221 | $ | 597,556 | ||||
Gross
margin percentage
|
31.5 | % | 51.2 | % |
Gross
profit for the three months ended March 31, 2009 decreased by $283,335 from the
comparable period in 2008. The key factors for the decrease were as
follows:
|
·
|
We
sold 15 XTRAC laser systems and no VTRAC lamp-based excimer systems during
the three months ended March 31, 2009 and 17 XTRAC laser systems and seven
VTRAC systems in the comparable period in 2008. Consequently, gross profit
decreased as a result of a decrease in the volume of units sold. The gross
margin percentage for the VTRAC is higher than for the
XTRAC.
|
|
·
|
International
part sales, which have a higher margin percentage than system sales,
remained consistent for the three months ended March 31, 2009 as compared
to the same period in 2008.
|
|
·
|
In
addition, there were increases in certain allocable XTRAC manufacturing
overhead costs that are charged against our international dermatology
equipment revenues.
|
The
following table analyzes the gross profit for our SkinCare (ProCyte) segment for
the periods presented below:
Skin Care (ProCyte) Segment
|
Three Months Ended
March 31, (unaudited)
|
|||||||
2009
|
2008
|
|||||||
Product
revenues
|
$ | 2,121,576 | $ | 3,242,692 | ||||
Bulk
compound revenues
|
79,920 | 32,000 | ||||||
Royalties
|
963 | - | ||||||
Total
revenues
|
2,202,459 | 3,274,692 | ||||||
Percent
decrease
|
(32.7 | )% | ||||||
Product
cost of revenues
|
724,364 | 937,668 | ||||||
Bulk
compound cost of revenues
|
45,568 | 22,784 | ||||||
Total
cost of revenues
|
769,932 | 960,452 | ||||||
Percent
decrease
|
(19.8 | )% | ||||||
Gross
profit
|
$ | 1,432,527 | $ | 2,314,240 | ||||
Gross
margin percentage
|
65.0 | % | 70.7 | % |
Gross
profit decreased for the three months ended March 31, 2009 from the comparable
periods by $881,713. The key factors for the changes in this business segment
were as follows:
36
·
|
The
decrease in revenues for the three months ended March 31, 2009 is due to
the macro economic conditions. This segment is more susceptible to such
economic conditions than our other segments because cosmetic products are
more likely to be discretionary and not medically necessary. Product sales
for the first quarter of 2009 were approximately $2.1 million down from
approximately $3.2 million for the first quarter of
2008.
|
|
·
|
Copper
peptide bulk compound is sold at a substantially lower gross margin than
our other skin care products.
|
The
following table analyzes the gross profit for our PTL segment for the periods
presented below:
PTL Segment
|
Three Months
Ended March 31,
2009 (unaudited)
|
|||
Revenues
|
$ | 746,048 | ||
Percent
increase
|
100 | % | ||
Cost
of revenues
|
179,082 | |||
Percent
increase
|
100 | % | ||
Gross
profit
|
$ | 566,966 | ||
Gross
margin percentage
|
76.0 | % |
The key
factors in this business segment were as follows:
|
·
|
Revenues
included a milestone payment of $213,000 under a certain licensing
arrangement for the Clear U™ hand-held device. The licensee intends to use
the device and its technology as a platform to attempt to address the mass
consumer acne market. There are no costs associated with this revenue
stream.
|
|
·
|
The
business was acquired on February 27, 2009, and consequently the above
reflects only one month of
activity.
|
The
following table analyzes the gross profit for our Surgical Products segment for
the periods presented below:
Surgical Products Segment
|
Three Months Ended
March 31, (unaudited)
|
|||||||
2009
|
2008
|
|||||||
Revenues
|
$ | 875,442 | $ | 1,777,230 | ||||
Percent
decrease
|
(50.7 | )% | ||||||
Cost
of revenues
|
628,892 | 1,156,152 | ||||||
Percent
decrease
|
(45.6 | )% | ||||||
Gross
profit
|
$ | 246,550 | $ | 621,078 | ||||
Gross
margin percentage
|
28.2 | % | 34.9 | % |
Gross
profit for our Surgical Products segment in the three months ended March 31,
2009 compared to the same period in 2008 decreased by $374,528. The key factors
impacting gross profit were as follows:
|
·
|
This
segment includes product sales of surgical laser systems and laser
disposables. Disposables are more profitable than laser systems, but the
sale of laser systems generates the subsequent recurring sale of laser
disposables.
|
37
|
·
|
Revenues
for the three months ended March 31, 2009 decreased by $901,788 from the
three months ended March 31, 2008 while cost of revenues decreased by
$527,260 between the same periods. There were 62 fewer laser systems sold
in the three months ended March 31, 2009 than in the comparable period of
2008. However, the lasers sold in the 2009 period were at higher prices
than those sold in the comparable period in 2008. The increase in average
price per laser was largely due to the mix of lasers sold and volume
discounts. Included in the laser sales for the three months ended March
31, 2009 and 2008 were sales of diode lasers of $24,000, representing 1
system, and $888,000, representing 62 systems respectively, which have
substantially lower list sales prices than our other types of surgical
lasers.
|
|
·
|
The
sales of diode systems, in the three months ended March 31, 2008, included
60 sales due to our OEM arrangement, but in the second half of 2008
AngioDynamics purchased the assets of Diomed, a competitive diode laser
company. Since that time, our sales to AngioDynamics have been $0,
including for the three months ended March 31, 2009. Additionally, the
higher manufacturing levels in 2008 caused better absorption of fixed
overhead costs, thereby lowering average unit costs resulting in a higher
gross margin in 2008 compared to
2009.
|
|
·
|
Additionally,
there was an increase in sales of disposables between the periods, which
have a higher gross margin as a percent of revenues than lasers. Fiber and
other disposables sales increased 3% between the comparable three-month
periods ended March 31, 2009 and
2008.
|
Selling,
General and Administrative Expenses
For the three months ended March 31,
2009, selling, general and administrative expenses increased to $6,699,930 from
$6,471,240 for the three months ended March 31, 2008 for the following
reasons:
|
·
|
Selling,
general and administrative expenses related to our PTL segment accounted
for $307,550 of the increase.
|
|
·
|
We
expensed $432,000 of additional costs under SFAS No. 141R incurred in
connection with the acquisition of Photo
Therapeutics.
|
|
·
|
Offsetting
the above increases was a decrease of $381,000 in salaries, benefits and
travel expenses associated with a decrease in the sales force and
decreased revenues which generated lower commission expenses, particularly
in our Skin Care segment. Additionally, there was a decrease in
amortization expense of $107,500 related to the impairment of certain
intangibles as of the year end December 31,
2008.
|
Given the
state of, and the uncertainty in, the macro economic climate, we are in process
of rationalizing our facilities and personnel costs. For example, we are
consolidating the skincare warehouse operations in Redmond to our headquarters
in Montgomeryville.
Engineering
and Product Development
Engineering
and product development expenses for the three months ended March 31, 2009
decreased to $201,697 from $438,688 for the three months ended March 31, 2008.
Engineering and product development expenses related to our PTL segment
accounted for $22,171 of the decrease. The decrease for the three months ended
March 31, 2009 was primarily due to meeting our financial sponsorship
obligations in March 2008 for the severe psoriasis study by John Koo, MD, of the
University of California at San Francisco, of $189,000. The balance of the
decrease was due to a decrease in product studies in our Skin Care
segment.
38
Interest
Expense, Net
Net
interest expense for the three months ended March 31, 2009 increased to
$402,523, as compared to $227,371 for the three months ended March 31, 2008. The
change in net interest expense was the result of the interest expense on the
convertible debt which was issued on February 27, 2009. The following table
illustrates the change in interest expense, net:
Three Months Ended March 31,
(unaudited)
|
||||||||||||
2009
|
2008
|
Change
|
||||||||||
Interest
expense
|
$ | 407,038 | $ | 297,015 | $ | 110,023 | ||||||
Interest
income
|
(4,515 | ) | (69,644 | ) | 65,129 | |||||||
Net
interest expense
|
$ | 402,523 | $ | 227,371 | $ | 175,152 |
Change
in fair value of warrants
Beginning
on January 1, 2009 and in accordance with EITF 07-5, we began recognizing
certain warrants as liabilities at their respective fair values on each
reporting date. We measured the fair value of these warrants as of March 31,
2009, and recognized $91,222 other income in recording the liability associated
with these warrants at their fair value as of March 31, 2009.
Net
Loss
The
aforementioned factors resulted in a net loss of $3,512,187 during the three
months ended March 31, 2009, as compared to a net loss of $2,541,862 during the
three months ended March 31, 2008, an increase of 38.2%.
The
following table illustrates the impact of major expenses, namely depreciation,
amortization and stock option expense between the periods:
For the three months ended March 31,
(unaudited)
|
||||||||||||
2009
|
2008
|
Change
|
||||||||||
Net
loss
|
$ | 3,512,187 | $ | 2,541,861 | $ | 970,326 | ||||||
Components
included in net loss:
|
||||||||||||
Acquisition
expenses
|
$ | (432,352 | ) | $ | - | $ | (432,352 | ) | ||||
Depreciation
and amortization
|
(995,220 | ) | (1,214,612 | ) | 219,392 | |||||||
Stock-based
compensation
|
(292,674 | ) | (426,543 | ) | 133,869 | |||||||
Interest
expense, net
|
(402,523 | ) | (227,371 | ) | (175,152 | ) | ||||||
Change
in fair value of warrants
|
91,222 | - | 91,222 | |||||||||
$ | (2,031,547 | ) | $ | (1,868,526 | ) | $ | (163,021 | ) |
Liquidity
and Capital Resources
We have
historically financed our operations with cash provided by equity financing and
from lines of credit.
At March 31, 2009, our current ratio
was 1.36 compared to 1.26 at December 31, 2008. As of March 31, 2009 we had
$5,112,448 of working capital compared to $3,408,187 as of December 31, 2008.
Cash and cash equivalents were $4,257,320 as of March 31, 2009, as compared to
$3,736,607 as of December 31, 2008. We had $78,000 of cash that was classified
as restricted as of March 31, 2009 and December 31, 2008.
We
believe that our existing cash balance (including the working capital received
in the financing of the PTL acquisition), together with our other existing
potential financial resources and any revenues from sales and distribution, will
be sufficient to meet our operating and capital requirements beyond the second
quarter of 2010. The 2009 operating plan reflects increases in per-treatment fee
revenues for use of the XTRAC system based on increased utilization of the XTRAC
by physicians and on wider insurance coverage in the United States. In addition,
our 2009 operating plan calls for increased revenues and profits from our Skin
Care business and a contribution from the newly acquired business of Photo
Therapeutics. In
response to prevailing economic conditions, anticipated revenue growth has been
tempered, and a flexible contingency plan has been structured to match
expenditures to lowered growth.
39
On
December 31, 2007, we entered into a term-note credit facility from CIT
Healthcare and Life Sciences Capital (collectively “CIT”). The credit facility
had a commitment term of one year, which expired on December 31, 2008. We
accounted for each draw as funded indebtedness, with ownership in the lasers
remaining with us. CIT holds a security interest in the lasers and in their
revenue streams. Each draw against the credit facility has a repayment period of
three years, except for legacy components refinanced from previous borrowings.
On September 30, 2008, the facility was amended to permit us to make a fourth
draw of $1.9 million in the third quarter of 2008; Life Sciences Capital did not
participate in the fourth draw. We have used our entire availability under the
CIT credit facility and are considering multiple written proposals for
additional debt financing. However, no assurance can be given that any such
proposal will materialize on terms favorable to us, if at all. A summary of the
terms and activity under the CIT credit facility is presented in Note 9, Long-term
Debt, of the Financial Statements included in this Report.
On
February 27, 2009, the Investor funded $5 million of working capital as part of
the first tranche of the convertible debt financing in connection with our
acquisition of Photo Therapeutics. A summary of the terms and activity under the
convertible debt is presented in Note 10, Convertible
Debt, of the Financial Statements included in this Report.
Net cash and cash equivalents used in
operating activities – continuing operations was $2,638,755 for the three months
ended March 31, 2009 compared to cash provided by $1,311,378 for the three
months ended March 31, 2008. The decrease was mostly due to the decreases in
accounts payable and other accrued liabilities and by increases in
inventories.
Net cash
and cash equivalents used in investing activities – continuing operations was
$13,497,222 for the three months ended March 31, 2009 compared to $1,224,969 for
the three months ended March 31, 2008. This was primarily due to acquisition
costs, net of cash received, of $12,578,022 in connection with the PTL
acquisition. The balance of the increase was mainly for the placement of lasers
into service.
When we
retire a laser from service, we transfer the laser into inventory and then write
off the net book value of the laser, which is typically negligible. Over the
last few years the retirements of lasers from service have been minor or
immaterial and, therefore, they are reported with placements on a net
basis.
Net cash
and cash equivalents provided by financing activities was $16,630,980 for the
three months ended March 31, 2009 compared to cash used of $551,925 for the
three months ended March 31, 2008. In the three months ended March 31, 2009 we
received $18 million in proceeds in the convertible debt financing which was
partially offset by repayment of $1,326,314 on the line of credit and $7,082 for
certain notes payable.
Commitments
and Contingencies
Except
for items discussed in Legal
Proceedings below, during the three months ended March 31, 2009, there
were no other items that significantly impacted our commitments and
contingencies as discussed in the notes to our 2008 annual financial statements
included in our Annual Report on Form 10-K.
Off-Balance
Sheet Arrangements
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.
40
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. However, the warrants
issued to the Investor are accounted for as derivatives pursuant to EITF 07-5,
which requires such accounting due to a “down-round” provision within the
warrants. See Note 1,
Fair Value
Measurements, in the financial statements.
Our PTL
business segment is exposed to currency fluctuations. The majority of our sales
invoicing is done in either Euros or US dollars, while product costs and the
overhead of our UK offices is denominated in Pounds Sterling. We believe our US
operations, with US dollar operating costs, serve to reduce the exposure to
fluctuations in the value of the Pounds Sterling or the Euro.
ITEM
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief
Financial Officer, evaluated the effectiveness of our disclosure controls and
procedures as of the end of the period covered by this Report. Based on that
evaluation, the Chief Executive Officer and Chief Financial Officer concluded
that our disclosure controls and procedures as of the end of the period covered
by this Report are effective such that information required to be disclosed by
us in reports filed under the Securities Exchange Act of 1934 is (i) recorded,
processed, summarized and reported within the time periods specified in the
Securities and Exchange Commission’s rules and forms and (ii) accumulated and
communicated to our management, including the Chief Executive Officer and Chief
Financial Officer, as appropriate to allow timely decisions regarding
disclosure.
Change in
Internal Control Over Financial Reporting
No change
in our internal control over financial reporting occurred during the three
months ended March 31, 2009 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, 2008 for descriptions of our legal proceedings.
In the
matter brought by us on January 4, 2004 against Ra Medical Systems, Inc. and
Dean Irwin in the United States District Court for the Southern District of
California, we have appealed to the Ninth Circuit Court of Appeals from the
district court judge’s grant of summary judgment to the defendants. Oral
argument has been set for June 4, 2009.
In the
matter which Ra Medical and Mr. Irwin brought against us on June 6, 2006 for
unfair competition and which we removed to the United States District Court for
the Southern District of California, the district court judge certified our
interlocutory appeal to the Ninth Circuit of Appeals from the judge’s dismissal
for, among other things, of our counterclaim of misappropriation. Oral argument
has been set for June 4, 2009.
On
October 29, 2008, Ra Medical and Dean Irwin brought a second malicious
prosecution action against us, and our outside counsel, in the California
Superior Court for San Diego County. The plaintiffs allege that the action we
brought in January 2004 against Ra Medical and Mr. Irwin was initiated and
maintained with malice. On January 22, 2009, we filed a demurrer to the
complaint on the grounds that it was brought while the underlying federal court
action was still on appeal before the Ninth Circuit Court of Appeals, and
therefore before the plaintiffs had secured a final and favorable judgment in
the underlying federal action, a necessary pre-condition to bringing the action.
Our demurrer was sustained by the Superior Court, but the action was not
dismissed but was stayed with leave to amend the complaint.
41
On
December 1, 2008, we filed a complaint for declaratory judgment in the United
States District Court for the Southern District of California based on the
accusations made by Ra Medical in a press release on October 30, 2008
notwithstanding that the district judge in the underlying federal action had
specifically ruled that we had not acted in the litigation vexatiously or in bad
faith. We have asked the court to rule on whether the accusations made in the
press release are true or false. The defendants moved to dismiss our complaint
based on lack of jurisdiction in the Federal court. The Federal court declined
defendants’ motion on April 29, 2009. The parties are to submit their briefs on
whether the Court should exercise its discretion in rendering a declaratory
judgment on May 29, 2009.
We
notified St. Paul Fire and Marine Insurance Company (“St. Paul”), our
general liability and umbrella liability insurer, of the suit that Ra Medical
and Mr. Irwin stated in their press release that they had brought for malicious
prosecution. St. Paul brought an action on January 29, 2009 in the California
Superior Court for San Diego County for a declaratory judgment that it has no
duty to defend us or indemnify us, asserting that it had been released from such
duties in the settlement of the first malicious prosecution action brought by Ra
Medical and also asserting that the policy should be governed by California law,
not Pennsylvania law. We removed that action to the U.S. District Court for the
Southern District of California. Notwithstanding, on March 20, 2009, St. Paul
has informed us that it will pay for the cost of defense subject to a full
reservation of rights. The Federal court has scheduled a conference among the
parties for May 21, 2009.
The
insurance policy under which we seek coverage from St. Paul is the same policy
under which St. Paul defended and indemnified us in the first malicious
prosecution action brought by Ra Medical against us. In connection with the
first malicious prosecution action, we filed a declaratory judgment action in
the U.S. District Court for the Eastern District of Pennsylvania against St.
Paul seeking a ruling that it was obligated to pay all reasonable defense costs
incurred in the defense of that action and any judgment or settlement we might
incur. We obtained a summary judgment in that action holding that, under
governing Pennsylvania law, the policy covered malicious prosecution claims and
St. Paul was required to provide full coverage (indemnity and reasonable counsel
fees) for the action brought by Ra Medical. On March 3, 2009, we filed an action
in the U.S. District Court for the Eastern District of Pennsylvania seeking a
declaratory a judgment, consistent with the earlier ruling of this
court, that the law of Pennsylvania governs the policy and that the policy
provides coverage for the latest malicious prosecution action. Our complaint was
served on St. Paul on March 4, 2009. The case has been assigned to the same
judge who granted our motion for summary judgment in the earlier declaratory
judgment action. We have filed a motion for partial summary judgment seeking a
ruling that, consistent with the earlier decision of the court, Pennsylvania law
governs construction of the policy in regard to coverage for the latest
malicious prosecution action. St. Paul has moved to dismiss our
complaint or, in the alternative, to have our action stayed pending a decision
in the Southern District of California or to have our action transferred to the
Southern District of California. Both motions have been fully briefed and are
pending with the judge .
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
these other litigation and claims will likely be resolved without a material
effect on our consolidated financial position, results of operations or
liquidity.
ITEM
1A. Risk Factors
There
have been no material changes in our risk factors from those disclosed in our
Annual Report on Form 10-K for the year ended December 31,
2008.
42
ITEM 4.
Submission of Matters to
a Vote of Security Holders
In our
definitive proxy filed December 18, 2008, we placed six non-procedural matters
on the agenda for decision by our stockholders and they were approved by our
stockholders at our 2009 annual meeting on January 26, 2009. The matters
were:
|
·
|
The
election to our Board of Directors each of Richard J. DePiano, Jeffrey F.
O’Donnell, Alan R. Novak, Anthony J. Dimun, David W. Anderson, Wayne M.
Withrow and Stephen P. Connelly. The vote tally is set forth
below:
|
Votes For
|
Votes Against
|
Votes Abstaining
|
|||
Richard
J. DePiano
|
49,386,491
|
0
|
6,782,122
|
||
Jeffrey
F. O’Donnell
|
47,587,186
|
0
|
8,581,427
|
||
Alan
R. Novak
|
49,432,545
|
0
|
6,736,068
|
||
Anthony
J. Dimun
|
49,443,634
|
0
|
6,724,979
|
||
David
W. Anderson
|
50,601,570
|
0
|
5,567,043
|
||
Wayne
M. Withrow
|
49,386,270
|
0
|
6,782,343
|
||
Stephen
P. Connelly
|
49,532,835
|
0
|
6,635,778
|
|
·
|
The
ratification of the appointment of Amper, Politziner & Mattia, LLP as
our independent registered public accounting firm for the fiscal year
ending December 31, 2008, with 55,367,056 votes for, 545,706 votes against
and 255,850 votes abstaining.
|
|
·
|
An
amendment to our 2005 Equity Compensation Plan to increase the number of
shares of the Company’s common stock, reserved for issuance thereunder
from 6,160,000 to 8,160,000 shares and add provisions relating to the
grant of performance-based stock awards that are designed to qualify as
“qualified performance-based compensation” under Internal Revenue Code
Section 162(m), with 28,465,404 votes for, 9,228,251 votes against ,
128,161 votes abstaining and 18,349,797 broker
non-votes.
|
|
·
|
Issuance
of shares of our common stock pursuant to the terms and conditions of the
Securities Purchase Agreement, dated as of August 4, 2008, by and between
us and Perseus Partners VII, L.P., upon conversion of the convertible note
and exercise of the warrants, with 36,616,728 votes for, 1,130,569
votes against, 71,519 votes abstaining and 18,349,797 broker
non-votes.
|
|
·
|
An
amendment to our Restated Certificate of Incorporation, as amended, to
effect a reverse stock split of the Company’s outstanding common stock at
an exchange ratio of 1-for-7 and to authorize the Company’s Board of
Directors to implement the reverse stock split at any time prior to the
2010 annual meeting of stockholders by filing an amendment to the our
Restated Certificate of Incorporation, as amended, with 36,596,853 votes
for, 1,149,745 votes against, 72,218 votes abstaining and 18,349,797
broker non-votes.
|
|
·
|
An
amendment to our Restated Certificate of Incorporation, as amended, to
increase the number of authorized shares of common stock from 100,000,000
shares to 150,000,000, with 53,785,851 votes for, 2,284,175 votes against
and 98,585 votes abstaining.
|
Following
our 2009 annual meeting, on January 26, 2009, we filed an amendment to our
Certificate of Incorporation to effect the reverse stock split and the increase
in the number of authorized shares of common stock.
ITEM
5. Other Information
None.
43
ITEM
6. Exhibits
3.3
|
Amendment to Restated Certificate of Incorporation, filed on January 26, 2009. (2) |
4.2
|
Amendment
No. 1 to Securities Purchase Agreement, dated February 27, 2009.
(1)
|
4.3
|
First Tranche Convertible Promissory Note, dated February 27, 2009. (1) |
4.4
|
Pledge and Security Agreement, dated February 27, 2009. (1) |
4.5
|
First Tranche Warrant, dated February 27, 2009. (1) |
4.6
|
Registration Rights Agreement, dated February 27, 2009 (2) |
10.39
|
Amendment No. 1 to Omnibus Amendment, dated February 27 2009 (1) |
10.40
|
Indemnification Agreement between PhotoMedex, Inc. and John M. Glazer (1) |
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) | Filed as part of our Current Report on Form 8-K on March 5, 2009. |
(2) | Filed as part of our Annual Report on Form 10-K for the year ended December 31, 2008. |
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
15, 2009
|
By:
|
/s/ Jeffrey F.
O’Donnell
|
Jeffrey
F. O’Donnell
|
||
President
and Chief Executive Officer
|
||
Date: May
15, 2009
|
By:
|
/s/ Dennis M.
McGrath
|
Dennis
M. McGrath
|
||
Chief
Financial Officer
|
44