CUTERA INC - Quarter Report: 2009 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
quarterly period ended September 30, 2009
OR
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
transition period ________ to ________.
Commission
file number: 000-50644
Cutera, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
|
77-0492262
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
employer
identification
no.)
|
3240
Bayshore Blvd., Brisbane, California 94005
(Address
of principal executive offices)
(415)
657-5500
(Registrant’s
telephone number, including area code)
Indicate
by check mark whether the registrant (1) 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 (2) has been subject to such filing
requirements for the past 90 days. Yes x No ¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes
¨ 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 (check one):
Large accelerated filer ¨ | Accelerated filer x | Non-accelerated filer ¨ | Smaller reporting company ¨ |
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 of Registrant’s common stock issued and outstanding as of
October 23, 2009 was 13,410,668.
TABLE
OF CONTENTS
|
Page
|
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PART I
|
FINANCIAL
INFORMATION
|
|
||
Item 1.
|
Financial
Statements (unaudited)
|
|
1
|
|
Condensed
Consolidated Balance Sheets
|
|
1
|
||
Condensed
Consolidated Statements of Operations
|
|
2
|
||
Condensed
Consolidated Statements of Cash Flows
|
|
3
|
||
Notes
to Condensed Consolidated Financial Statements
|
|
4
|
||
Item 2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
15
|
|
Item 3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
|
28
|
|
Item 4.
|
Controls
and Procedures
|
|
29
|
|
PART II
|
OTHER
INFORMATION
|
|
||
Item 1.
|
Legal
Proceedings
|
|
30
|
|
Item 1A
|
Risk
Factors
|
|
30
|
|
Item 2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
43
|
|
Item 3.
|
Defaults
Upon Senior Securities
|
|
43
|
|
Item 4.
|
Submission
of Matters to a Vote of Security Holders
|
|
44
|
|
Item 5.
|
Other
Information
|
|
44
|
|
Item 6.
|
Exhibits
|
|
44
|
|
Signature
|
45
|
i
FINANCIAL
STATEMENTS
|
CUTERA,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
September
30,
|
December
31,
|
|||||||
2009
|
2008
|
|||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$
|
34,302
|
$
|
36,540
|
||||
Marketable
investments
|
62,572
|
60,653
|
||||||
Accounts
receivable, net
|
2,635
|
5,792
|
||||||
Inventories
|
7,884
|
9,927
|
||||||
Deferred
tax asset
|
244
|
4,257
|
||||||
Other
current assets and prepaid expenses
|
2,644
|
1,771
|
||||||
Total
current assets
|
110,281
|
118,940
|
||||||
Property
and equipment, net
|
939
|
1,357
|
||||||
Long-term
investments
|
7,339
|
9,627
|
||||||
Intangibles,
net
|
877
|
1,025
|
||||||
Deferred
tax asset, net of current portion
|
—
|
6,527
|
||||||
Total
assets
|
$
|
119,436
|
$
|
137,476
|
||||
Liabilities
and Stockholders' Equity
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$
|
1,212
|
$
|
1,690
|
||||
Accrued
liabilities
|
7,281
|
8,848
|
||||||
Deferred
revenue
|
6,295
|
6,758
|
||||||
Total
current liabilities
|
14,788
|
17,296
|
||||||
Deferred
rent
|
1,548
|
1,713
|
||||||
Deferred
revenue, net of current portion
|
2,331
|
4,907
|
||||||
Income
tax liability
|
882
|
1,452
|
||||||
Total
liabilities
|
19,549
|
25,368
|
||||||
Commitments
and Contingencies (Note 8)
|
||||||||
Stockholders’
equity:
|
||||||||
Common
stock
|
13
|
13
|
||||||
Additional
paid-in capital
|
84,148
|
80,318
|
||||||
Retained
earnings
|
17,247
|
31,410
|
||||||
Accumulated
other comprehensive income (loss)
|
(1,521
|
)
|
367
|
|||||
Total
stockholders’ equity
|
99,887
|
112,108
|
||||||
Total
liabilities and stockholders’ equity
|
$
|
119,436
|
$
|
137,476
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
1
CUTERA,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in
thousands, except per share data)
(unaudited)
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
September
30,
|
September
30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Net
revenue
|
$
|
12,171
|
$
|
19,110
|
$
|
38,266
|
$
|
65,482
|
||||||||
Cost
of revenue
|
4,910
|
7,823
|
15,976
|
25,313
|
||||||||||||
Gross
profit
|
7,261
|
11,287
|
22,290
|
40,169
|
||||||||||||
Operating
expenses:
|
||||||||||||||||
Sales
and marketing
|
5,112
|
8,076
|
18,186
|
28,786
|
||||||||||||
Research
and development
|
1,684
|
1,828
|
4,922
|
5,617
|
||||||||||||
General
and administrative
|
2,121
|
2,583
|
8,257
|
8,547
|
||||||||||||
Litigation
settlement
|
—
|
—
|
850
|
—
|
||||||||||||
Total
operating expenses
|
8,917
|
12,487
|
32,215
|
42,950
|
||||||||||||
Loss
from operations
|
(1,656
|
)
|
(1,200
|
)
|
(9,925
|
)
|
(2,781
|
)
|
||||||||
Interest
and other income, net
|
288
|
733
|
1,398
|
2,491
|
||||||||||||
Other-than-temporary
impairment of long-term investments
|
—
|
(2,372
|
)
|
—
|
(2,372
|
)
|
||||||||||
Loss
before income taxes
|
(1,368
|
)
|
(2,839
|
)
|
(8,527
|
)
|
(2,662
|
)
|
||||||||
Provision
(benefit) for income taxes
|
12,126
|
(86
|
)
|
9,159
|
(28
|
)
|
||||||||||
Net
loss
|
$
|
(13,494
|
)
|
$
|
(2,753
|
)
|
$
|
(17,686
|
)
|
$
|
(2,634
|
)
|
||||
Net
loss per share:
|
||||||||||||||||
Basic
and Diluted
|
$
|
(1.01
|
)
|
$
|
(0.22
|
)
|
$
|
(1.33
|
)
|
$
|
(0.21
|
)
|
||||
Weighted-average
number of shares used in per share calculations:
|
||||||||||||||||
Basic
and Diluted
|
13,382
|
12,780
|
13,274
|
12,762
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
2
CUTERA,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in
thousands)
(unaudited)
Nine
Months Ended
|
||||||||
September
30,
|
||||||||
2009
|
2008
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$
|
(17,686
|
)
|
$
|
(2,634
|
)
|
||
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities:
|
||||||||
Stock-based
compensation
|
3,396
|
3,983
|
||||||
Tax
benefit (deficit) from stock-based compensation
|
(2
|
)
|
49
|
|||||
Depreciation
and amortization
|
664
|
671
|
||||||
Provision
for excess and obsolete inventories
|
247
|
(61
|
)
|
|||||
Other-than-temporary
impairment of long term investments
|
—
|
2,372
|
||||||
Change
in allowance for doubtful accounts
|
550
|
149
|
||||||
Change
in deferred tax asset and deferred tax liability
|
10,540
|
140
|
||||||
Changes
in assets and liabilities:
|
||||||||
Accounts
receivable
|
2,607
|
4,057
|
||||||
Inventories
|
1,796
|
(1,159
|
)
|
|||||
Other
current assets and prepaid expenses
|
572
|
221
|
||||||
Accounts
payable
|
(478
|
)
|
(230
|
)
|
||||
Accrued
liabilities
|
(1,686
|
)
|
(3,557
|
)
|
||||
Deferred
rent
|
(46
|
)
|
56
|
|||||
Deferred
revenue
|
(3,039
|
)
|
1,606
|
|||||
Income
tax liability
|
(570
|
)
|
207
|
|||||
Net
cash provided by (used in) operating activities
|
(3,135
|
)
|
5,870
|
|||||
Cash
flows from investing activities:
|
||||||||
Acquisition
of property and equipment
|
(98
|
)
|
(538
|
)
|
||||
Proceeds
from sales of marketable investments
|
20,794
|
49,969
|
||||||
Proceeds
from maturities of marketable investments
|
10,560
|
18,150
|
||||||
Purchase
of marketable investments
|
(30,795
|
)
|
(58,085
|
)
|
||||
Net
cash provided by investing activities
|
461
|
9,496
|
||||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from exercise of stock options and employee stock purchase
plan
|
436
|
263
|
||||||
Net
cash provided by financing activities
|
436
|
263
|
||||||
Net
increase (decrease) in cash and cash equivalents
|
(2,238
|
)
|
15,629
|
|||||
Cash
and cash equivalents at beginning of period
|
36,540
|
11,054
|
||||||
Cash
and cash equivalents at end of period
|
$
|
34,302
|
$
|
26,683
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
3
CUTERA,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note
1. Summary of Significant Accounting Policies
Description
of Operations and Principles of Consolidation.
Cutera,
Inc. (Cutera or the Company) is a global provider of laser and other light-based
aesthetic systems for practitioners worldwide. The Company designs, develops,
manufactures, and markets the Xeo, CoolGlide, and Solera product platforms for
use by physicians and other qualified practitioners to allow its customers to
offer safe and effective aesthetic treatments to their customers.
Headquartered
in Brisbane, California, the Company has wholly-owned subsidiaries in Australia,
Canada, France, Japan, Spain, Switzerland and the United Kingdom that market,
sell and service its products outside of the United States. The Condensed
Consolidated Financial Statements include the accounts of the Company and its
subsidiaries. All inter-company transactions and balances have been
eliminated.
Unaudited
Interim Financial Information
The
financial information filed is unaudited. The Condensed Consolidated Financial
Statements included in this report reflect all adjustments (consisting only of
normal recurring adjustments) that the Company considers necessary for the fair
statement of the results of operations for the interim periods covered and of
the financial condition of the Company at the date of the interim balance sheet.
The December 31, 2008 Condensed Consolidated Balance Sheet was derived from
audited financial statements, but does not include all disclosures required by
generally accepted accounting principles in the United States of America (GAAP).
The results for interim periods are not necessarily indicative of the results
for the entire year or any other interim period. The Condensed Consolidated
Financial Statements should be read in conjunction with the Company’s financial
statements and notes thereto included in the Company’s annual report on Form
10-K for the year ended December 31, 2008 filed with the Securities and
Exchange Commission, or SEC, on March 16, 2009.
Use
of Estimates
The
preparation of interim Condensed Consolidated Financial Statements in conformity
with GAAP requires the Company’s management to make estimates and assumptions
that affect the amounts reported and disclosed in the Condensed Consolidated
Financial Statements and the accompanying notes. Actual results could differ
materially from those estimates. On an ongoing basis, the Company evaluates its
estimates, including those related to warranty obligation, sales commission,
accounts receivable and sales allowances, fair values of long-term investments,
fair values of acquired intangible assets, useful lives of intangible assets and
property and equipment, fair values of options to purchase the Company’s common
stock, deferred tax assets valuation allowance, and effective income tax rates,
among others. The Company’s management bases its estimates on historical
experience and on various other assumptions that are believed to be reasonable,
the results of which form the basis for making judgments about the carrying
values of assets and liabilities.
Summary
of Significant Accounting Policies
The
Company’s significant accounting policies are disclosed in the Company’s annual
report on Form 10-K for the year ended December 31, 2008 filed with the SEC
on March 16, 2009, and have not changed significantly as of
September 30, 2009, except for the policies adopted in the nine months
ended September 30, 2009 and discussed in the section below on “Recent
Accounting Pronouncements.”
Recent
Accounting Guidance
Updates issued and
adopted
On
September 30, 2009, the Company adopted updates issued by the Financial
Accounting Standards Board (FASB) to the authoritative hierarchy of GAAP. These
changes establish the FASB Accounting Standards CodificationTM
(ASC) as the source of authoritative accounting principles recognized by the
FASB to be applied by nongovernmental entities in the preparation of financial
statements in conformity with GAAP. Rules and interpretive releases of the
Securities and Exchange Commission (SEC) under authority of federal securities
laws are also sources of authoritative GAAP for SEC registrants. The FASB will
no longer issue new standards in the form of Statements, FASB Staff Positions,
or Emerging Issues Task Force Abstracts; instead the FASB will issue Accounting
Standards Updates. Accounting Standards Updates will not be authoritative in
their own right as they will only serve to update the Codification. These
changes and the Codification itself do not change GAAP. Other than the manner in
which new accounting guidance is referenced, the adoption of these changes had
no impact on the Condensed Consolidated Financial Statements.
4
On
June 30, 2009, the Company adopted updates issued by the FASB to accounting
for and disclosure of events that occur after the balance sheet date but before
financial statements are issued or are available to be issued, otherwise known
as “subsequent events.” Specifically, these changes set forth the period after
the balance sheet date during which management of a reporting entity should
evaluate events or transactions that may occur for potential recognition or
disclosure in the financial statements, the circumstances under which an entity
should recognize events or transactions occurring after the balance sheet date
in its financial statements, and the disclosures that an entity should make
about events or transactions that occurred after the balance sheet date. The
adoption of these changes had no impact on the Condensed Consolidated Financial
Statements
On
June 30, 2009, the Company adopted updates issued by the FASB to fair value
accounting. These changes provide additional guidance for estimating fair value
when the volume and level of activity for an asset or liability have
significantly decreased and includes guidance for identifying circumstances that
indicate a transaction is not orderly. This guidance is necessary to maintain
the overall objective of fair value measurements, which is that fair value is
the price that would be received to sell an asset or paid to transfer a
liability in an orderly transaction between market participants at the
measurement date under current market conditions. The adoption of these changes
had no impact on the Condensed Consolidated Financial Statements.
On April
1, 2009, the Company adopted updates issued by the FASB to the recognition and
presentation of other-than-temporary impairments. These changes amend existing
other-than-temporary impairment guidance for debt securities to make the
guidance more operational and to improve the presentation and disclosure of
other-than-temporary impairments on debt and equity securities. The recognition
provision applies only to fixed maturity investments that are subject to the
other-than-temporary impairments. If an entity intends to sell, or if it is more
likely than not that it will be required to sell an impaired security prior to
recovery of its cost basis, the security is other-than-temporarily impaired and
the full amount of the impairment is recognized as a loss through earnings.
Otherwise, losses on securities which are other-than-temporarily impaired are
separated into: (i) the portion of loss which represents the credit loss; or
(ii) the portion which is due to other factors.
The
credit loss portion is recognized as a loss through earnings, while the loss due
to other factors is recognized in other comprehensive income (loss), net of
taxes and related amortization. A cumulative effect adjustment is required to
accumulated earnings and a corresponding adjustment to accumulated other
comprehensive income (loss) to reclassify the non-credit portion of previously
other-than-temporarily impaired securities which were held at the beginning of
the period of adoption and for which the Company does not intend to sell and it
is more likely than not that the Company will not be required to sell such
securities before recovery of the amortized cost basis. These changes were
effective for interim and annual periods ending after June 15, 2009, with early
adoption permitted for periods ending after March 15, 2009. The Company adopted
these changes effective April 1, 2009. As a result of the implementation of this
pronouncement, the Company reclassified the cumulative effect of the non-credit
portion of previously recognized other-than-temporarily impaired adjustments of
$3.5 million by increasing accumulated earnings and decreasing accumulated other
comprehensive income (loss).
On
June 30, 2009, the Company adopted updates issued by the FASB to fair value
disclosures of financial instruments. These changes require a publicly traded
company to include disclosures about the fair value of its financial instruments
whenever it issues summarized financial information for interim reporting
periods. Such disclosures include the fair value of all financial instruments,
for which it is practicable to estimate that value, whether recognized or not
recognized in the statement of financial position; the related carrying amount
of these financial instruments; and the method(s) and significant assumptions
used to estimate the fair value. Other than the required disclosures, the
adoption of these changes had no impact on the Condensed Consolidated Financial
Statements.
On
January 1, 2009, the Company adopted updates issued by the FASB to fair
value accounting and reporting as it relates to nonfinancial assets and
nonfinancial liabilities that are not recognized or disclosed at fair value in
the financial statements on at least an annual basis. These changes define fair
value, establish a framework for measuring fair value in GAAP, and expand
disclosures about fair value measurements. This guidance applies to other GAAP
that require or permit fair value measurements and is to be applied
prospectively with limited exceptions. The adoption of these changes, as it
relates to nonfinancial assets and nonfinancial liabilities, had no impact on
the Condensed Consolidated Financial Statements. These provisions will be
applied at such time a fair value measurement of a nonfinancial asset or
nonfinancial liability is required, which may result in a fair value that is
materially different than would have been calculated prior to the adoption of
these changes.
5
On
January 1, 2009, the Company adopted updates issued by the FASB to
accounting for intangible assets. These changes amend the factors that should be
considered in developing renewal or extension assumptions used to determine the
useful life of a recognized intangible asset in order to improve the consistency
between the useful life of a recognized intangible asset outside of a business
combination and the period of expected cash flows used to measure the fair value
of an intangible asset in a business combination. The adoption of these changes
had no impact on the Condensed Consolidated Financial Statements.
On
January 1, 2009, the Company adopted updates issued by the FASB to the
calculation of earnings per share. These changes state that unvested share-based
payment awards that contain nonforfeitable rights to dividends or dividend
equivalents (whether paid or unpaid) are participating securities and shall be
included in the computation of earnings per share pursuant to the two-class
method for all periods presented. The adoption of these changes had no impact on
the Condensed Consolidated Financial Statements.
Updates issued but not yet
adopted
In
October 2009, the FASB issued updates to revenue recognition guidance. These
changes provide application guidance on whether multiple deliverables exist, how
the deliverables should be separated and how the consideration should be
allocated to one or more units of accounting. This update establishes a selling
price hierarchy for determining the selling price of a deliverable. The selling
price used for each deliverable will be based on vendor-specific objective
evidence, if available, third-party evidence if vendor-specific objective
evidence is not available, or estimated selling price if neither vendor-specific
or third-party evidence is available. The Company will be required to apply this
guidance prospectively for revenue arrangements entered into or materially
modified after January 1, 2011; however, earlier application is permitted. The
Company has not determined the impact that this update may have on its
Consolidated Financial Statements.
In August
2009, the FASB issued updates to fair value accounting for liabilities. These
changes clarify existing guidance that in circumstances in which a quoted price
in an active market for the identical liability is not available, an entity is
required to measure fair value using either a valuation technique that uses a
quoted price of either a similar liability or a quoted price of an identical or
similar liability when traded as an asset, or another valuation technique that
is consistent with the principles of fair value measurements, such as an income
approach (e.g., present value technique). This guidance also states that both a
quoted price in an active market for the identical liability and a quoted price
for the identical liability when traded as an asset in an active market when no
adjustments to the quoted price of the asset are required are Level 1 fair value
measurements. These changes will become effective for the Company’s Consolidated
Financial Statements for the year ended December 31, 2009. The Company has not
determined the impact that this update may have on its Consolidated Financial
Statements.
Note
2. Balance Sheet Details
Cash
and Cash Equivalents, Marketable Investments and Long-Term
Investments:
The
Company considers all highly liquid investments, with an original maturity of
three months or less at the time of purchase, to be cash equivalents.
Investments in debt securities are accounted for as “available-for-sale”
securities, carried at fair value with unrealized gains and losses reported in
other comprehensive income (loss), held for use in current operations and
classified in current assets as “Marketable investments” and in long term assets
as “Long-term investments.”
The
following is a summary of cash and cash equivalents, marketable investments and
long-term investments (in thousands):
September
30, 2009
|
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Market
Value
|
|||||||||
Cash
and cash equivalents
|
$
|
34,302
|
$
|
—
|
$
|
—
|
$
|
34,302
|
|||||
Marketable
investments:
|
|||||||||||||
Municipal
securities
|
62,127
|
301
|
(11)
|
62,417
|
|||||||||
Auction
rate securities
|
126
|
29
|
—
|
155
|
|||||||||
Total
marketable investments
|
62,253
|
330
|
(11)
|
62,572
|
|||||||||
Long-term
investments in auction rate securities
|
8,920
|
—
|
(1,581)
|
7,339
|
|||||||||
$
|
105,475
|
$
|
330
|
$
|
(1,592)
|
$
|
104,213
|
6
December 31,
2008
|
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Market
Value
|
|||||||||
Cash
and cash equivalents
|
$
|
36,540
|
$
|
—
|
$
|
—
|
$
|
36,540
|
|||||
Marketable
investments:
|
|||||||||||||
Municipal
securities
|
59,837
|
566
|
—
|
60,403
|
|||||||||
Auction
rate securities
|
219
|
31
|
—
|
250
|
|||||||||
Total
marketable investments
|
60,056
|
597
|
—
|
60,653
|
|||||||||
Long-term
investments in auction rate securities
|
9,627
|
—
|
—
|
9,627
|
|||||||||
$
|
106,223
|
$
|
597
|
$
|
—
|
$
|
106,820
|
Fair
Value of Financial Instruments:
Fair
value is defined as the price that would be received to sell an asset or paid to
transfer a liability in an orderly transaction between market participants at
the measurement date. The fair value hierarchy distinguishes between
(1) market participant assumptions developed based on market data obtained
from independent sources (observable inputs) and (2) an entity’s own
assumptions about market participant assumptions developed based on the best
information available in the circumstances (unobservable inputs). The fair value
hierarchy consists of three broad levels, which gives the highest priority to
unadjusted quoted prices in active markets for identical assets or liabilities
(Level 1) and the lowest priority to unobservable inputs (Level 3). The three
levels of the fair value hierarchy are described below:
·
|
Level
1: Quoted prices (unadjusted) in active markets that are accessible at the
measurement date for assets or
liabilities.
|
·
|
Level
2: Directly or indirectly observable inputs as of the reporting date
through correlation with market data, including quoted prices for similar
assets and liabilities in active markets and quoted prices in markets that
are not active. Level 2 also includes assets and liabilities that are
valued using models or other pricing methodologies that do not require
significant judgment since the input assumptions used in the models, such
as interest rates and volatility factors, are corroborated by readily
observable data from actively quoted markets for substantially the full
term of the financial instrument.
|
·
|
Level
3: Unobservable inputs that are supported by little or no market activity
and reflect the use of significant management judgment. These values are
generally determined using pricing models for which the assumptions
utilize management’s estimates of market participant
assumptions.
|
In
determining fair value, the Company utilizes valuation techniques that maximize
the use of observable inputs and minimize the use of unobservable inputs to the
extent possible as well as considers counterparty credit risk in its assessment
of fair value.
As of
September 30, 2009, financial assets measured and recognized at fair value
on a recurring basis and classified under the appropriate level of the fair
value hierarchy as described above was as follows (in thousands):
Level
1
|
Level
2
|
Level
3
|
Total
|
|||||||||||||
Cash
equivalents
|
$
|
31,868
|
$
|
—
|
$
|
—
|
$
|
31,868
|
||||||||
Marketable
investments:
|
||||||||||||||||
Available-for-sale
securities
|
—
|
62,572
|
—
|
62,572
|
||||||||||||
Long-term
investments:
|
||||||||||||||||
Available-for-sale
ARS
|
—
|
—
|
7,339
|
7,339
|
||||||||||||
Total
assets at fair value
|
$
|
31,868
|
$
|
62,572
|
$
|
7,339
|
$
|
101,779
|
7
The
Company’s Level 1 financial assets are money market funds and highly liquid debt
instruments of federal and municipal governments and their agencies with stated
maturities of three months or less from the date of purchase, whose fair values
are based on quoted market prices. The Company’s Level 2 financial assets are
highly liquid debt instruments of federal and municipal governments and their
agencies with stated maturities of greater than three months, whose fair values
are obtained from readily-available pricing sources for the identical underlying
security that may, or may not, be actively traded.
At
September 30, 2009, observable market information was not available to determine
the fair value of the Company’s ARS investments. Therefore, the fair value is
based on broker-provided valuation models that relied on Level 3 inputs
including those that are based on expected cash flow streams and collateral
values, assessments of counterparty credit quality, default risk underlying the
security, market discount rates and overall capital market liquidity. The
valuation of the Company’s ARS investment portfolio is subject to uncertainties
that are difficult to predict. Factors that may impact the valuations in the
future include changes to credit ratings of the securities, as well as to the
underlying assets supporting those securities, rates of default of the
underlying assets, underlying collateral value, discount rates, counterparty
risk and ongoing strength and quality of market credit and liquidity. These
financial instruments are classified within Level 3 of the fair value
hierarchy.
The table
presented below summarizes the change in carrying value associated with Level 3
financial assets for the nine months ended September 30, 2009 (in
thousands):
Three Months
Ended
September 30,
2009
|
Nine Months
Ended
September 30,
2009
|
|||||||
Beginning
Balance
|
$ | 7,640 | $ | 9,627 | ||||
Transfers
out of Level 3
|
(296 | ) | (2,326 | ) | ||||
Unrealized
gain (loss) included in other comprehensive income
|
(5 | ) | 38 | |||||
Ending
Balance
|
$ | 7,339 | $ | 7,339 |
Other
Current Assets and Prepaid Expenses:
Other
current assets and prepaid expenses consist of the following (in
thousands):
September
30,
2009
|
December 31,
2008
|
|||||||
Tax
receivable
|
$
|
1,437
|
$
|
235
|
||||
Deposits
|
542
|
824
|
||||||
Prepaid
expense
|
665
|
712
|
||||||
$
|
2,644
|
$
|
1,771
|
Inventories:
Inventories
consist of the following (in thousands):
September
30,
2009
|
December 31,
2008
|
|||||||
Raw
materials
|
$ | 4,643 | $ | 5,071 | ||||
Finished
goods
|
3,241 | 4,856 | ||||||
$ | 7,884 | $ | 9,927 |
8
Intangible
Assets:
Intangible
assets were principally comprised of a patent sublicense acquired from Palomar
Medical Technologies in 2006, a technology patent sublicense acquired in 2002
and other intangible assets acquired in 2007. The components of intangible
assets at September 30, 2009 and December 31, 2008 were as follows (in
thousands):
September
30, 2009
|
|||||||||
Gross Carrying
Amount
|
Accumulated
Amortization
Amount
|
Net Carrying
Amount
|
|||||||
Patent
sublicense
|
$ | 1,218 | $ | 483 | $ | 735 | |||
Technology
patent sublicense
|
538 | 396 | 142 | ||||||
Other
intangibles
|
20 | 20 | — | ||||||
Total
|
$ | 1,776 | $ | 899 | $ | 877 |
December 31,
2008
|
|||||||||
Gross Carrying
Amount
|
Accumulated
Amortization
Amount
|
Net Carrying
Amount
|
|||||||
Patent
sublicense
|
$ | 1,218 | $ | 379 | $ | 839 | |||
Technology
sublicense
|
538 | 356 | 182 | ||||||
Other
intangibles
|
20 | 16 | 4 | ||||||
Total
|
$ | 1,776 | $ | 751 | $ | 1,025 |
For the
nine months ended September 30, 2009 and 2008, amortization expense for
intangible assets was $148,000 and $151,000, respectively.
Based on
intangible assets recorded at September 30, 2009, and assuming no subsequent
additions to, or impairment of the underlying assets, the remaining estimated
annual amortization expense is expected to be as follows (in
thousands):
Fiscal
Year Ending December 31,
|
||||
2009
remainder
|
$
|
47
|
||
2010
|
192
|
|||
2011
|
192
|
|||
2012
|
158
|
|||
2013
|
138
|
|||
Thereafter
|
150
|
|||
Total
|
$
|
877
|
9
Note
3. Stock-based Compensation Expense
Total
pre-tax stock-based compensation expense by department recognized during the
three and nine months ended September 30, 2009 and 2008 was as follows (in
thousands):
Three Months Ended
September 30,
|
Nine Months
Ended
September 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Cost
of sales
|
$
|
161
|
$
|
222
|
$
|
568
|
$
|
648
|
||||||||
Sales
and marketing
|
250
|
440
|
817
|
1,290
|
||||||||||||
Research
and development
|
116
|
170
|
364
|
443
|
||||||||||||
General
and administrative
|
368
|
494
|
1,647
|
1,602
|
||||||||||||
Total
stock-based compensation expense
|
$
|
895
|
$
|
1,326
|
$
|
3,396
|
$
|
3,983
|
Option
Exchange Program
In July
2009, the Company completed its Option Exchange Program for its employees to
exchange certain options outstanding for new options to purchase shares of the
Company’s common stock. As a result, options to purchase 864,373 shares of the
Company’s common stock were cancelled and new options to purchase up to 447,841
shares of the Company’s common stock were issued in exchange. The new options
have an exercise price per share of $8.49, the closing price of the Company’s
common stock as reported on the Nasdaq Global Market on the date that the offer
expired and Option Exchange Program was completed, are unvested as of the grant
date, and subject to an additional six (6) months of vesting over and above the
vesting schedule of the surrendered options.
Given the
Option Exchange Program was designed to be approximately a “value-for-value”
exchange, the Company will not incur any significant additional non-cash
compensation charges as the fair value of the replacement options was
approximately equal to or less than the fair value of the surrendered options.
The Company determined the fair value of stock options using the Black Scholes
valuation model.
Note
4. Net Loss Per Share
Basic net
loss per share is calculated by dividing net loss by the weighted-average number
of common shares outstanding during the year. Diluted net income per share is
calculated by using the weighted-average number of common shares outstanding
during the period increased to include the number of additional shares of common
stock that would have been outstanding if the dilutive potential shares of
common stock had been issued. The dilutive effect of outstanding options,
Employee Stock Purchase Plan, or ESPP, shares and restricted stock units is
reflected in diluted net income per share by application of the treasury stock
method, which includes consideration of stock-based compensation. Diluted net
loss per common share is the same as basic net loss per common share, as the
effect of the potential common stock equivalents is anti-dilutive, and as such,
is excluded from the calculations of the diluted net loss per
share.
The
following table sets forth the computation of basic and diluted net loss
available to common stockholders and the weighted average number of shares used
in computing basic and diluted net loss per share (in thousands):
Three Months Ended
September 30,
|
Nine Months
Ended
September 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Numerator:
|
||||||||||||||||
Net
loss available to common stockholders – Basic and Diluted
|
$
|
(13,494
|
)
|
$
|
(2,753
|
)
|
$
|
(17,686
|
)
|
$
|
(2,634
|
)
|
||||
Denominator:
|
||||||||||||||||
Weighted-average
number of common shares outstanding used in computing basic and diluted
net loss per share
|
13,382
|
12,780
|
13,274
|
12,762
|
10
Anti-dilutive
securities
The
following number of shares outstanding, prior to the application of the treasury
stock method, were excluded from the computation of diluted net loss per common
share for the periods presented because including them would have had an
anti-dilutive effect (in thousands):
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Options
to purchase common stock
|
2,846
|
3,160
|
2,769
|
2,812
|
||||||||||||
Restricted
stock units
|
—
|
13
|
7
|
21
|
||||||||||||
Employee
stock purchase plan shares
|
29
|
31
|
63
|
63
|
||||||||||||
Total
|
2,875
|
3,204
|
2,839
|
2,896
|
Note
5. Service Contract Revenue
Service
contract revenue is recognized on a straight-line basis over the period of the
applicable service contract. The following table provides the changes in the
deferred revenue for the nine months ended September 30, 2009 and 2008 (in
thousands):
|
September
30,
|
|||||||
|
2009
|
2008
|
||||||
Beginning
Balance
|
|
$
|
11,665
|
$
|
10,564
|
|||
Add:
Payments received
|
|
4,643
|
7,987
|
|||||
Less:
Revenue recognized
|
|
(7,682
|
)
|
(6,381
|
)
|
|||
Ending
Balance
|
|
$
|
8,626
|
$
|
12,170
|
Costs
incurred under service contracts during the nine months ended September 30, 2009
and 2008, amounted to $3.5 million and $3.4 million, respectively, and are
recognized as incurred.
Note
6. Comprehensive Loss
Comprehensive
loss comprises net loss and other comprehensive income (loss) (OCI). OCI
includes certain changes in stockholders’ equity that are excluded from net
loss. Specifically, the Company includes in OCI net unrealized loss on
securities available for sale. The activity in comprehensive loss for the
periods presented was as follows (in thousands):
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
2009
|
2008
|
2009
|
2008
|
||||||||||||
Net
loss
|
$ |
(13,494
|
)
|
$
|
(2,753
|
)
|
$
|
(17,686
|
)
|
$
|
(2,634
|
)
|
|||
Net
change in unrealized gain (loss) on available-for
sale-securities
|
(105 | ) | 1,733 | 1,635 | (256 | ) | |||||||||
Change in income tax effect on unrealized gain (loss) on available-for sale-securities | (66 | ) | - | 1 | - | ||||||||||
Comprehensive
loss
|
$ | (13,665 | ) | $ | (1,020 | ) | $ | (16,050 | ) | $ | (2,890 | ) |
11
Note
7. Income Taxes
The
Company recognized an income tax provision of $12.1 million and $9.2 million for
the three months and nine months ended September 30, 2009, respectively, despite
losses before taxes. The year-to-date provision is primarily due to the
recording of a valuation allowance of $10.2 million on the Company’s U.S.
deferred tax assets as of September 30, 2009. The valuation allowance was
recorded at the end of the third quarter of 2009 to reduce certain U.S. federal
and state net deferred tax assets to their anticipated realizable value. The
valuation allowance was offset by $969,000 of certain tax benefits resulting
from losses generated during fiscal 2009 that can be carried-back to prior
periods. Also, included in the third quarter 2009 provision is the reversal of
$3.1 million tax benefit primarily related to net operating losses previously
recognized in the first and second quarters of 2009.
ASC 740
requires the consideration of a valuation allowance to reflect the likelihood of
realization of deferred tax assets. Significant management judgment is required
in determining any valuation allowance recorded against deferred tax assets. In
evaluating the ability to recover deferred tax assets, the Company considered
available positive and negative evidence, giving greater weight to its recent
cumulative losses and its ability to carry-back losses against prior taxable
income and lesser weight to its projected financial results due to the
challenges of forecasting future periods. The Company also considered,
commensurate with its objective verifiability, the forecast of future taxable
income including the reversal of temporary differences. The Company performed
this evaluation as of the year ended December 31, 2008 and the quarters ended
March 31, 2009 and June 30, 2009. At that time the Company continued to have
sufficient positive evidence, including recent cumulative profits, a reduction
in operating expenses, the ability to carry-back losses against prior taxable
income and an expectation of improving operating results, showing a valuation
allowance was not required. At the end of the quarter ended September 30, 2009,
changes in previously anticipated expectations and continued operating losses
necessitated a valuation allowance against the tax benefits recognized in this
quarter and prior quarters since they are no longer “more-likely-than-not”
realizable. Under current tax laws, this valuation allowance will not limit the
Company’s ability to utilize U.S. federal and state deferred tax assets provided
it can generate sufficient future taxable income in the U.S.
As of the
end of the third quarter of 2009, the Company recorded a net decrease of
approximately $538,000 in gross unrecognized tax benefits due to a change
in management’s assessment of its uncertain tax positions. As of September 30,
2009, the gross unrecognized tax benefit for uncertain tax positions was
$882,000.
The
Company anticipates it will continue to record a valuation allowance against the
losses of certain jurisdictions, primarily federal and state, until such time as
we are able to determine it is “more-likely-than-not” the deferred tax asset
will be realized. Such position is dependent on whether there will be sufficient
future taxable income to realize such deferred tax assets. The
Company expects its future tax provisions (benefits), during the time such
valuation allowances are recorded, will consist primarily of the tax expense of
our non-US jurisdictions that are profitable. The Company’s effective tax rate
may vary from period to period based on changes in estimated taxable income or
loss by jurisdiction, changes to the valuation allowance, changes to federal,
state or foreign tax laws, future expansion into areas with varying country,
state, and local income tax rates, deductibility of certain costs and expenses
by jurisdiction.
Undistributed
earnings of the Company’s foreign subsidiaries of approximately $2.5 million and
$2.0 million at September 30, 2009 and 2008, respectively, are considered to be
indefinitely reinvested and, accordingly, no provision for U.S. federal and
state income taxes has been provided thereon. Upon distribution of those
earnings in the form of dividends or otherwise, the Company would be subject to
both U.S. income taxes (subject to an adjustment for foreign tax credits) and
withholding taxes payable to various foreign countries.
Note
8. Commitments and Contingencies
Warranty
Obligations
The
Company provides standard one-year or two-year warranty coverage on its systems.
Warranty coverage provided is for labor and parts necessary to repair the
systems during the warranty period. The Company accounts for the estimated
warranty cost of the standard warranty coverage as a charge to cost of revenue
when revenue is recognized. The estimated warranty cost is based on historical
product performance. Utilizing actual service records, the Company calculates
the average service hours and parts expense per system and applies the actual
labor and overhead rates to determine the estimated warranty charge. The Company
updates these estimated charges on a quarter basis.
12
The
following table provides the changes in the product warranty accrual for the
nine months ended September 30, 2009 and 2008 (in thousands):
|
September
30,
|
|||||||
|
2009
|
2008
|
||||||
Balance
at December 31, 2008 and 2007
|
|
$
|
1,916
|
$
|
2,725
|
|||
Add:
Accruals for warranties issued during the period
|
|
1,402
|
3,735
|
|||||
Less:
Settlements made during the period
|
|
(2,229
|
)
|
(4,263
|
)
|
|||
Balance
at September 30, 2009 and 2008
|
|
$
|
1,089
|
$
|
2,197
|
Facility
Leases
The
Company leases its Brisbane, California, office and manufacturing facility under
a non-cancelable operating lease which expires in 2013. In addition, the Company
has leased office facilities in certain international countries, including:
Japan, Switzerland, France, and Spain. As of September 30, 2009, the Company was
committed to minimum lease payments for facilities and other leased assets under
long-term non-cancelable operating leases as follows (in
thousands):
Fiscal
Year Ending December 31,
|
||||
2009
(remainder)
|
$
|
413
|
||
2010
|
1,443
|
|||
2011
|
1,326
|
|||
2012
|
1,431
|
|||
2013
|
1,545
|
|||
Future
minimum rental payments
|
$
|
6,158
|
Purchase
Commitments
The
Company maintains certain open inventory purchase commitments with its suppliers
to ensure a smooth and continuous supply for key components. The Company’s
liability in these purchase commitments is generally restricted to a forecasted
time-horizon as agreed between the parties. These forecasted time-horizons can
vary among different suppliers. The Company’s open inventory purchase
commitments were not material at September 30, 2009.
Litigation
Two
securities class action lawsuits were filed against the Company and two of the
Company’s executive officers in April 2007 and May 2007, respectively, in the
U.S. District Court for the Northern District of California following declines
in the Company’s stock price. The plaintiffs claim to represent purchasers of
the Company’s common stock from January 31, 2007 through May 7, 2007.
The complaints generally allege that materially false statements and omissions
were made regarding the Company’s financial prospects, and seek unspecified
monetary damages. On November 1, 2007, the Court ordered the two cases
consolidated. On December 17, 2007, the plaintiffs filed a consolidated,
amended complaint, and on January 31, 2008, the Company filed a motion to
dismiss that complaint. On September 30, 2008, in response to the Company’s
motion, the Court issued an order dismissing the plaintiffs’ amended complaint
without prejudice. On October 28, 2008, the plaintiffs filed a Notice Of
Intention Not to File A Second Amended Consolidated Complaint. On
November 25, 2008, the Court closed the case on its own initiative. On
November 26, 2008, the plaintiffs filed a Notice of Appeal to the U.S.
Court of Appeals for the Ninth Circuit, on April 16, 2009 the plaintiffs
filed their opening brief with that Court, on June 17, 2009 the Company filed
its response to Plaintiff’s brief, and on July 1, 2009 the plaintiffs filed
their response to the Company’s brief. No hearing date with regard to the appeal
has been scheduled. The Company intends to continue to defend this case
vigorously, regardless of the stage of litigation. Although the Company retains
director and officer liability insurance, there is no assurance that such
insurance will cover the claims that are made or will insure the Company fully
for all losses on covered claims. Since the Company does not believe that a
significant adverse result in this litigation is probable and since the amount
of potential damages in the event of an adverse result is not reasonably
estimable, no expense has been recorded with respect to the contingent liability
associated with this matter.
13
A
Telephone Consumer Protection Act, or TCPA, class action lawsuit was filed
against the Company in January 2008 in the Illinois Circuit Court, Cook County,
by Bridgeport Pain Control Center, Ltd., seeking monetary damages, injunctive
relief, costs and other relief. The complaint alleges that the Company violated
the TCPA by sending unsolicited advertisements by facsimile to the plaintiff and
other recipients nationwide during the four-year period preceding the lawsuit
without the prior express invitation or permission of the recipients. Two state
law claims, limited to Illinois recipients, allege a class period of three and
five years, respectively. Under the TCPA, recipients of unsolicited facsimile
advertisements may be entitled to damages of $500 per violation for inadvertent
violations and $1,500 per violation for knowing or willful violations. On
February 22, 2008, the Company removed the case to federal court in the
Northern District of Illinois. On August 25, 2009, following negotiations
between the parties, the parties entered into a settlement agreement that would
resolve the case on a class-wide basis. The Court gave its preliminary approval
to the proposed settlement on August 27, 2009, and a final hearing on the
settlement is scheduled for April 6, 2010. Under the terms of the settlement,
the Company will cause to be paid a total of $950,000 in exchange for a full
release of facsimile-related claims. The Company included in its Condensed
Consolidated Statement of Operations for the nine months ended September 30,
2009, $850,000 for the estimated cost of the settlement, net of administrative
expenses and amounts that are expected to be recoverable from its insurance
carrier. If the proposed settlement does not receive final approval, the Company
intends to defend this case vigorously.
An
employment litigation lawsuit was filed against the Company in July 2009 in the
United States District Court for the Northern District of California by a former
sales representative at the Company. The complaint alleges that the employee was
wrongfully terminated, that the Company violated Florida's Private Sector
Whistleblower Act by retaliating against him and that the Company breached a
contract that it had with him. The complaint seeks unspecified damages,
reimbursement of costs, expenses and legal fees, and requests a jury trial. The
Company denies the allegations in the complaint and intends to defend this case
vigorously. Although the Company has insurance coverage for this matter, there
is no assurance that such insurance will cover the claims that are made or will
insure the Company fully for all losses on covered claims. Since the Company
does not believe that a significant adverse result in this litigation is
probable, and since the amount of potential damages in the event of an adverse
result is not reasonably estimable, no expense has been recorded in the
Company’s Condensed Consolidated Financial Statements with respect to the
contingent liability associated with this matter.
Other
Legal Matters
In
addition to the foregoing lawsuits, the Company is named from time to time as a
party to product liability, employment and other lawsuits in the normal course
of its business. As of September 30, 2009, the Company is not a party to any
other material pending litigation.
Indemnifications
In the
normal course of business, the Company enters into agreements that contain a
variety of representations, warranties, and indemnification obligations. For
example, the Company has entered into indemnification agreements with each of
its directors and executive officers. The Company’s executive officers are named
as defendants in securities class action litigation – see “Litigation” above.
The Company’s exposure under its various indemnification obligations, including
those under the indemnification agreements with its directors and executive
officers, is unknown since the outcome of that securities litigation is
unpredictable, the amount that could be payable thereunder is not reasonably
estimable, and future claims that are covered by the Company’s indemnification
obligations may be made against the Company’s officers or directors. To date,
the Company has not accrued or paid any amounts for any such indemnification
obligations. However, the Company may record charges in the future as a result
of these potential indemnification obligations, including those related to the
securities class action litigation.
Note
9. Subsequent Events
Management
evaluated all activity of the Company through November 2, 2009 (the issue date
of these Condensed Consolidated Financial Statements) and concluded that no
subsequent events have occurred that would require recognition in the Condensed
Consolidated Financial Statements or disclosure in Notes to Condensed
Consolidated Financial Statements.
14
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
Caution
Regarding Forward-Looking Statements
The
following discussion should be read in conjunction with the attached financial
statements and notes thereto, and with our audited financial statements and
notes thereto for the fiscal year ended December 31, 2008 as contained in
our annual report on Form 10-K filed with the SEC on March 16, 2009. This
quarterly report, including the following sections, contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of
1995. Throughout this report, and particularly in this Item 2, the
forward-looking statements are based upon our current expectations, estimates
and projections and reflect our beliefs and assumptions based upon information
available to us at the date of this report. In some cases, you can identify
these statements by words such as “may,” “might,” “will,” “should,” “expects,”
“plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or
“continue,” and other similar terms. These forward-looking statements are not
guarantees of future performance and are subject to risks, uncertainties, and
assumptions that are difficult to predict. Our actual results, performance or
achievements could differ materially from those expressed or implied by the
forward-looking statements. These forward-looking statements include, but are
not limited to, statements relating to our future financial performance, the
ability to grow our business, increase our revenue, manage expenses, generate
additional cash, achieve and maintain profitability, develop and commercialize
existing and new products and applications, and improve the performance of our
worldwide sales and distribution network, and the outlook regarding long term
prospects. These forward-looking statements involve risks and uncertainties. The
cautionary statements set forth below and those contained in Part II,
Item 1A – “Risk Factors” commencing on page 30, identify important
factors that could cause actual results to differ materially from those
predicted in any such forward-looking statements. We caution you to not place
undue reliance on these forward-looking statements, which reflect management’s
analysis and expectations only as of the date of this report. We undertake no
obligation to update forward-looking statements to reflect events or
circumstances occurring after the date of this Form 10-Q.
Introduction
The
Management’s Discussion and Analysis, or MD&A, is organized as
follows:
·
|
Executive Summary. This
section provides a general description and history of our business, a
brief discussion of our product lines and the opportunities, trends,
challenges and risks we focus on in the operation of our
business.
|
·
|
Critical Accounting Policies
and Estimates. This section describes the key accounting policies
that are affected by critical accounting
estimates.
|
·
|
Recent Accounting
Guidance. This section describes the issuance and effect of new
accounting pronouncements that are and may be applicable to
us.
|
·
|
Results of Operations.
This section provides our analysis and outlook for the significant line
items on our Consolidated Statements of
Operations.
|
·
|
Liquidity and Capital
Resources. This section provides an analysis of our liquidity and
cash flows, as well as a discussion of our commitments that existed as of
September 30, 2009.
|
Executive
Summary
Company
Description. We are a global medical device company engaged in the
design, development, manufacture, marketing and servicing of laser and other
light-based aesthetics systems for practitioners worldwide. We offer products on
three platforms—Xeo, CoolGlide, and Solera— for use by physicians and other
qualified practitioners to allow our customers to offer safe and effective
aesthetic treatments to their customers.
15
Our
corporate headquarters and U.S. operations are located in Brisbane, California,
from where we conduct our manufacturing, warehousing, research and development,
regulatory, sales and marketing, service, and administrative activities. In the
United States, we market, sell and service our products primarily through direct
sales and service employees and through a distribution relationship with PSS
World Medical Shared Services, Inc., a wholly owned subsidiary of PSS World
Medical, or PSS, which has over 700 sales representatives serving physician
offices throughout the United States. In addition, we also sell certain items,
like Titan hand piece refills and marketing brochures, through the
internet.
International
sales are generally made through direct sales employees and through a worldwide
distributor network in over 30 countries. Outside the United States, we have a
direct sales presence in Australia, Canada, France, Japan, Spain, Switzerland
and the United Kingdom.
Products.
Our revenue is derived from the sale of Products, Upgrades, Service and Titan
hand piece refills. Product revenue represents the sale of a system, which
consists of one or more hand pieces and a console that incorporates a universal
graphic user interface, a laser and/or other light-based module, control system
software and high voltage electronics. However, depending on the application,
the laser or other light-based module is sometimes contained in the hand piece,
such as with our Pearl and Pearl Fractional applications, instead of in the
console. We offer our customers the ability to select the system that best fits
their practice at the time of purchase and then to cost-effectively add
applications to their system as their practice grows. This enables customers to
upgrade their systems whenever they want and provides us with a source of
recurring revenue, which we classify as Upgrade revenue. Service revenue relates
to amortization of pre-paid service contract revenue and receipts for services
on out-of-warranty products. Titan hand piece refill revenue is associated with
our Titan hand piece which requires replacement of the optical source after a
set number of pulses has been used.
Significant
Business Trends. We believe that our ability to grow revenue has been,
and will continue to be, primarily dependent on the following:
·
|
Investments
made in our global sales and marketing
infrastructure.
|
·
|
Use
of clinical results to support new aesthetic products and
applications.
|
·
|
Enhanced
luminary development and reference selling efforts (to develop a location
where our products can be displayed and used to assist in selling
efforts).
|
·
|
Customer
demand for our products and consumer demand for the applications they
offer.
|
·
|
Marketing
to physicians in the core dermatology and plastic surgeon specialties, as
well as outside those specialties.
|
·
|
Generating
Service, Upgrade and Titan hand piece refill revenue from our growing
installed base of customers.
|
Our U.S.
revenue decreased 49% for the three months and 54% for the nine months ended
September 30, 2009, compared to the same periods in 2008, and our international
revenue decreased 24% for the three months and 28% for the nine months ended
September 30, 2009, compared to the same periods in 2008. International revenue
as a percent of total revenue was 60% for the three months and 59% for the nine
months ended September 30, 2009, compared with 50% for the three months and 48%
for the nine months ended September 30, 2008. We believe that the decline in
U.S. and international revenue was primarily attributable to the global
recession that has caused our prospective customers to be reluctant to spend
significant amounts of money on capital equipment during these unstable economic
times. Historically a significant portion of our U.S. revenue was sourced from
the non-core market of practitioners such as primary care physicians,
gynecologists and physicians offering aesthetic treatments in spa environments.
We believe our U.S. revenue declined greater than our international revenue,
because the recession impacted the U.S. market ─ and particularly the non-core
market ─ more severely than our international market. Further, we also believe
that those prospective customers who do not have established medical offices,
are finding it more difficult to obtain credit financing, which also contributed
to the reduced U.S. revenue.
16
Our
service revenue increased 10% for the three months and 19% for the nine months
ended September 30, 2009, compared to the same periods in 2008. Service contract
amortization is the primary component of our total service revenue. Due to an
increasing installed base of customers, our revenue from contract amortization
has consistently increased. However, our deferred service revenue balance
decreased by $3.0 million, or 26%, to $8.6 million as of September 30, 2009,
compared to December 31, 2008. We believe, this decline was primarily
attributable to: (i) fewer customers purchasing extended service contracts in
response to improved product liability and the tougher economy, (ii) a
decrease in unit sales volume in the U.S. that historically included an element
of deferred revenue for service contracts beyond our standard warranty terms;
(iii) a shift by customers towards purchasing more quarterly, rather than
annual or multi-year, service contracts and (iv) a reduction of our service
contract pricing, but including prorate charges for hand piece usage, which
resulted in a reduction of our deferred service revenue balance as of
September 30, 2009. With the reconfiguring of our service contracts to include
prorate charges for hand piece usage during the service coverage period, we
expect that in the long term, there will be an increase in revenue derived from
hand piece sales which would offset the service contract amortization decline
resulting from lower priced contracts being sold.
Our gross
margin increased slightly to 60% for the three months ended September 30, 2009,
compared to 59% for the same period in 2008, and decreased to 58% for the nine
months ended September 30, 2009, compared to 61% for the same period in 2008.
This decrease in gross margin for the nine months ended September 30, 2009, was
due primarily to: (i) lower overall revenue, due to lower volume, which resulted
in reduced leverage of our manufacturing and service department expenses; (ii)
higher Service and Titan refill revenue as a percentage of our total revenue,
which has a lower gross margin than our total revenue; and (iii) higher
international distributor revenue as a percentage of total revenue, which has a
lower gross margin than our direct business; partially offset by (iv) reduced
manufacturing expenses resulting primarily from headcount reductions and
improved product reliability.
Our sales
and marketing expenses, as a percentage of net revenue, remained flat at 42% for
the three months ended September 30, 2009, compared to the same period in 2008,
and increased to 47% for the nine months ended September 30, 2009, compared to
44% for the same period of 2008. This increase in expenses as a percentage of
net revenue for the nine months ended September 30, 2009, was due primarily to
lower revenue in the nine months ended September 30, 2009, compared to the same
period in 2008. In absolute dollars, sales and marketing expenses decreased by
$3.0 million to $5.1 million for the three months and decreased by $10.6 million
to $18.2 million for the nine months ended September 30, 2009, compared to same
periods in 2008. These decreases in absolute dollars were due primarily to
reduced personnel expenses in the United States, attributable to lower
headcount, and reduced sales commission expenses resulting from lower
revenue.
Our
research and development (R&D) expenses, as a percentage of net revenue,
increased to 14% for the three months ended September 30, 2009, compared to 10%
for the same period in 2008, and increased to 13% for the nine months ended
September 30, 2009, compared to 9% for the same period in 2008. These increases
in expenses as a percentage of net revenue were due primarily to lower revenue
in the three and nine months ended September 30, 2009, compared to the same
period in 2008. In absolute dollars, R&D expenses decreased by $144,000 to
$1.7 million for the three months and decreased by $695,000 to $4.9 million for
the nine months ended September 30, 2009, compared to the same periods in 2008.
These decreases in absolute dollars were due primarily to lower material
spending resulting from one of our products under development in our R&D
pipeline nearing commercialization. During the initial phases of the development
of a product, material expenditure is significantly higher due to the design and
development of a prototype, however, in the later stages of the product
development efforts are mostly labor intensive.
General
and administrative (G&A) expenses, as a percentage of net revenue, increased
to 17% for the three months ended September 30, 2009, compared to 13% for the
same period in 2008, and increased to 22% for the nine months ended September
30, 2009, compared to 13% for the same period in 2008. These increases in
expenses as a percentage of net revenue was due primarily to lower revenue in
the three and nine months ended September 30, 2009, compared to the same period
in 2008. In absolute dollars, G&A expenses decreased by $462,000 to $2.1
million for the three months and decreased by $290,000 to $8.3 million for the
nine months ended September 30, 2009, compared to the same periods in 2008. The
decrease in G&A expenses for the three months ended September 30, 2009, was
due primarily to a decrease in personnel expenses and legal, audit, tax, and
consulting fees. The decrease in G&A expenses for the nine months ended
September 30, 2009, was due primarily to a decrease in legal, audit, tax, and
consulting fees, and other legal expense.
We are a
defendant in a Telephone Consumer Protection Act class action lawsuit. See Part
II, Item 1 – Legal Proceedings below. We have included $850,000 in our Condensed
Consolidated Statement of Operations for the nine months ended September 30,
2009 for the estimated cost of the tentative settlement, net of administrative
expenses and amounts that may be recoverable from our insurance
carrier.
17
In
response to the current economic environment, we reduced our company-wide
workforce by approximately 12% in April 2009 and implemented other
cost-reduction measures in the first half of 2009. The headcount reductions
impacted all departments and functions and resulted in restructuring charges of
approximately $646,000 in our second quarter ended June 30, 2009. As of June 30,
2009, there were no service requirements outstanding from the employees who were
affected. As a result of these cost-reduction measures our third quarter 2009
quarterly operating expenses declined, compared to our first and second quarter
2009 operating expenses.
We
recognized an income tax provision of $12.1 million and $9.2 million for the
three months and nine months ended September 30, 2009, respectively, despite
losses before taxes. The year-to-date provision is primarily due to the
recording of a valuation allowance of $10.2 million on our U.S. deferred tax
assets as of September 30, 2009. The valuation allowance was recorded at the end
of the third quarter of 2009 to reduce certain U.S. federal and state net
deferred tax assets to their anticipated realizable value. The valuation
allowance was offset by $969,000 of certain tax benefits resulting from losses
generated during fiscal 2009 that can be carried-back to prior periods. Also,
included in the third quarter 2009 provision is the reversal of $3.1 million tax
benefit primarily related to net operating losses previously recognized in the
first and second quarters of 2009. See “Provision (Benefit) for Income Taxes”
below for further discussion.
Factors
that May Impact Future Performance.
Our
industry is impacted by numerous competitive, regulatory and other significant
factors. Our industry is highly competitive and our future performance depends
on our ability to compete successfully. Additionally, our future performance is
dependent upon our ability to continue to develop new products and innovative
technologies, obtain regulatory clearances for our products, protect the
proprietary technology of our products and our manufacturing processes,
manufacture our products cost effectively, and successfully market and
distribute our products in a profitable manner. If we fail to execute on the
aforementioned initiatives, our business would be adversely affected. A detailed
discussion of these and other factors that could impact our future performance
are provided in Part II, Item 1A “Risk Factors” below.
Critical
Accounting Policies and Estimates.
The
preparation of our Condensed Consolidated Financial Statements and related
disclosures in conformity with generally accepted accounting principles in the
United States, or GAAP, requires us to make estimates, judgments and assumptions
that affect the reported amounts of assets, liabilities, revenue and expenses.
These estimates, judgments and assumptions are based on historical experience
and on various other factors that we believe are reasonable under the
circumstances. We periodically review our estimates and make adjustments when
facts and circumstances dictate. To the extent that there are material
differences between these estimates and actual results, our financial condition
or results of operations will be affected.
Critical
accounting policy and estimates, as defined by the SEC, are those that are most
important to the portrayal of our financial condition and results of operations
and require our management’s most difficult and subjective judgments and
estimates of matters that are inherently uncertain. The accounting policies that
we consider to be critical, subjective, and requiring judgment in their
application are summarized in “Item 7—Management’s Discussion and Analysis of
Financial Condition and Results of Operations” in our Annual Report on Form 10-K
for the year ended December 31, 2008 filed with SEC on March 16, 2009.
There have been no significant changes to those accounting policies and
estimates disclosed in our Form 10-K, except for the following policies that
were adopted in 2009 and discussed below.
Fair Value Measurement of
our Long Term Auction Rate Securities Investments
We hold a
variety of interest bearing auction rate securities (ARS) that represent
investments in pools of student loan assets. At the time of acquisition, these
ARS investments were intended to provide liquidity through an auction process
that resets the applicable interest rate at predetermined calendar intervals,
allowing investors to either roll over their holdings or gain immediate
liquidity by selling such interests at par. Since February 2008, uncertainties
in the credit markets affected our ARS investments and auctions for some of ARS
have continued to fail to settle on their respective settlement dates while some
have been redeemed in full at their respective par values. The current portfolio
of investments shown as “Long term investments” in our Condensed Consolidated
Financial Statements represents those investments that are not currently liquid
and we will not be able to access these funds until a future auction of these
investments is successful, a buyer is found outside of the auction process or
the issuer refinances their debt. Maturity dates for these ARS investments range
from to 2028 to 2043.
18
At
September 30, 2009, total financial assets measured and recognized at fair value
were $101.8 million and of these assets, $7.3 million, or 7%, were ARS that were
measured and recognized using significant unobservable inputs (Level 3). During
the nine months ended September 30, 2009, as a result of the redemption of $4.1
million at their full par value, we transferred $2.2 million of Level 3 assets
into cash and cash equivalents (Level 1) and $155,000 of Level 3 assets into
marketable investments (Level 2). This redemption resulted in a gain of $1.9
million being recorded to accumulated comprehensive income (loss) for the nine
months ended September 30, 2009.
As of
September 30, 2009, we had $8.9 million par value ($7.3 million fair value) of
long-term ARS investments and $155,000 par value of ARS recorded in marketable
investments. The aggregate loss in value is included as an unrealized loss in
accumulated other comprehensive income (loss). Given observable market
information was not available to determine the fair values of our ARS portfolio,
we valued these investments based on a discounted cash flow model. While our ARS
valuation model was based on both Level 2 (credit quality and interest rates)
and Level 3 inputs, we determined that the Level 3 inputs were the most
significant to the overall fair value measurement, particularly the estimates of
risk adjusted discount rates. The expected future cash flows of the ARS were
discounted using a risk adjusted discount rate that compensated for the
illiquidity. Projected future cash flows over the economic life of the ARS were
modeled based on the contractual penalty rates for the security added to a tax
adjusted LIBOR interest rate curve. The discount rates that were applied to the
cash flows were based on a premium over the projected yield curve and included
an adjustment for credit, illiquidity, and other risk factors. See Note 2
“Balance Sheet Details- Fair Value of Financial Instruments” in Notes to
Condensed Consolidated Financial Statement in Part I, Item 1 of this Form 10-Q
for more information.
The
valuation of our investment portfolio is subject to uncertainties that are
difficult to predict. Factors that may impact the valuation include duration of
time that the ARS remain illiquid, changes to credit ratings of the securities,
rates of default of the underlying assets, changes in the underlying collateral
value, market discount rates for similar illiquid investments, and ongoing
strength and quality of credit markets. If the auctions for our ARS investments
continue to fail, and there is a further decline in their valuation, then we
would have to: (i) record additional reductions to the fair value of our ARS
investments; (ii) record unrealized losses in our accumulated comprehensive
income (loss) for the losses in value that are associated with market risk; and
(iii) record an other-than-temporary-impairment charge in our Consolidated
Statement of Operations for the loss in value associated with the worsening of
the credit worthiness (credit losses) of the issuer, which would reduce future
earnings and harm our business.
We had no
non-financial assets or liabilities measured at fair value as of September 30,
2009.
Recognition and Presentation
of Other-Than-Temporary-Impairments
We review
our impairments on a quarterly basis in order to determine the classification of
the impairment as “temporary” or “other-than-temporary.” Beginning April 1,
2009, impairment recognition applies only to fixed maturity investments that are
subject to the other-than-temporary impairments. If an entity intends to sell or
if it is more likely than not that it will be required to sell an impaired
security prior to recovery of its cost basis, the security is
other-than-temporarily impaired and the full amount of the impairment is
required to be recognized as a loss through earnings. Otherwise, losses on
securities which are other-than-temporarily impaired are separated into: (i) the
portion of loss which represents the credit loss; or (ii) the portion which is
due to other factors.
The
credit loss portion is recognized as a loss through earnings while the loss due
to other factors is recognized in other comprehensive income (loss), net of
taxes and related amortization.
With
respect to the ARS that we held as of April 1, 2009, we determined that the
cumulative effect adjustment required to reclassify the non-credit portion of
previously recognized other-than-temporarily impaired adjustments was $3.5
million. Therefore, we increased our accumulated earnings and decreased our
accumulated other comprehensive income (loss) by the $3.5 million cumulative
effect adjustment. With respect to the $9.1 million of par value ARS investments
held as of September 30, 2009, the unrealized losses included in accumulated
comprehensive income (loss) was $1.6 million.
Recently
Adopted and Recently Issued Accounting Guidance
For a
full description of recent accounting pronouncements, including the respective
expected dates of adoption and effects on results of operations and financial
condition see Note 1 “Summary of Significant Accounting Policies – Recent
Accounting Guidance” in Notes to Condensed Consolidated Financial Statements in
Part I, Item 1 of this Form 10-Q”.
19
Results of Operations
The
following table sets forth selected consolidated financial data for the periods
indicated, expressed as a percentage of net total revenue.
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Operating
Ratio:
|
||||||||||||||||
Net
revenue
|
100%
|
100%
|
100%
|
100%
|
||||||||||||
Cost
of revenue
|
40%
|
41%
|
42%
|
39%
|
||||||||||||
Gross
profit
|
60%
|
59%
|
58%
|
61%
|
||||||||||||
Operating
expenses:
|
||||||||||||||||
Sales
and marketing
|
42%
|
42%
|
47%
|
44%
|
||||||||||||
Research
and development
|
14%
|
10%
|
13%
|
9%
|
||||||||||||
General
and administrative
|
17%
|
13%
|
22%
|
13%
|
||||||||||||
Litigation
settlement
|
—%
|
—%
|
2%
|
—%
|
||||||||||||
Total
operating expenses
|
73%
|
65%
|
84%
|
66%
|
||||||||||||
Loss
from operations
|
(13%
|
)
|
(6%
|
)
|
(26%
|
)
|
(5%
|
)
|
||||||||
Interest
and other income, net
|
2%
|
3%
|
4%
|
4%
|
||||||||||||
Other-than-temporary
impairment on long term investments
|
—%
|
(12%
|
)
|
—%
|
(3%
|
)
|
||||||||||
Loss
before income taxes
|
(11%
|
)
|
(15%
|
)
|
(22%
|
)
|
(4%
|
)
|
||||||||
Provision
(benefit) for income taxes
|
100%
|
(1%
|
)
|
24%
|
0%
|
|||||||||||
Net
loss
|
(111%
|
)
|
(14%
|
)
|
(46%
|
)
|
(4%
|
)
|
Net
Revenue
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||||||
(Dollars
in thousands)
|
|
2009
|
% Change
|
2008
|
2009
|
% Change
|
2008
|
|||||||||||||
Revenue
mix by geography:
|
|
|||||||||||||||||||
United
States
|
|
$
|
4,825
|
(49%
|
)
|
$
|
9,498
|
$
|
15,721
|
(54%
|
)
|
$
|
34,266
|
|||||||
International
|
|
7,346
|
(24%
|
)
|
9,612
|
22,545
|
(28%
|
)
|
31,216
|
|||||||||||
Consolidated
total revenue
|
|
$
|
12,171
|
(36%
|
)
|
$
|
19,110
|
$
|
38,266
|
(42%
|
)
|
$
|
65,482
|
|||||||
|
||||||||||||||||||||
United
States as a percentage of total revenue
|
|
40%
|
50%
|
41%
|
52%
|
|||||||||||||||
International
as a percentage of total revenue
|
|
60%
|
50%
|
59%
|
48%
|
|||||||||||||||
Revenue
mix by product category:
|
|
|||||||||||||||||||
Products
|
|
$
|
6,322
|
(51%
|
)
|
$
|
12,920
|
$
|
20,024
|
(57%
|
)
|
$
|
46,610
|
|||||||
Upgrades
|
|
1,352
|
(31%
|
)
|
1,948
|
4,307
|
(32%
|
)
|
6,333
|
|||||||||||
Service
|
|
3,210
|
10%
|
2,920
|
9,860
|
19%
|
8,311
|
|||||||||||||
Titan
hand piece refills
|
|
1,287
|
(3%
|
)
|
1,322
|
4,075
|
(4%
|
)
|
4,228
|
|||||||||||
Consolidated
total revenue
|
|
$
|
12,171
|
(36%
|
)
|
$
|
19,110
|
$
|
38,266
|
(42%
|
)
|
$
|
65,482
|
20
Our U.S.
revenue decreased 49% for the three months and 54% for the nine months ended
September 30, 2009, compared to the same periods in 2008, and our international
revenue decreased 24% for the three months and 28% for the nine months ended
September 30, 2009, compared to the same periods in 2008. International revenue
as a percent of total revenue was 60% for the three months and 59% for the nine
months ended September 30, 2009, compared with 50% for the three months and 48%
for the nine months ended September 30, 2008. We believe that the decline in
U.S. and international revenue was primarily attributable to the global
recession that has caused our prospective customers to be reluctant to spend
significant amounts of money on capital equipment during these unstable economic
times. Historically a significant portion of our U.S. revenue was sourced from
the non-core market of practitioners such as primary care physicians,
gynecologists and physicians offering aesthetic treatments in spa environments.
We believe our U.S. revenue declined greater than our international revenue,
because the recession impacted the U.S. market ─ and particularly the non-core
market ─ more severely than our international market. Further, we also believe
that those prospective customers who do not have established medical offices,
are finding it more difficult to obtain credit financing, which also contributed
to the reduced U.S. revenue.
Our
product revenue decreased 51% for the three months and 57% for the nine months
ended September 30, 2009, compared to the same periods in 2008. We believe the
decrease in Product and Upgrade revenue in 2009 was primarily driven by the
global recession that has caused our prospective customers to be reluctant on
spending significant amounts of money on capital equipment during these unstable
economic times. We also believe that those prospects who do not have established
medical offices are finding it more difficult to obtain credit
financing.
Our
service revenue increased 10% for the three months and 19% for the nine months
ended September 30, 2009, compared to the same periods in 2008. Service contract
amortization is the primary component of our total service revenue. Due to an
increasing installed base of customers, our revenue from contract amortization
has consistently increased. However, our deferred service revenue balance
decreased by $3.0 million, or 26%, to $8.6 million as of September 30, 2009,
compared to December 31, 2008. We believe, this decline was primarily
attributable to: (i) fewer customers purchasing extended service contracts in
response to improved product liability and the tougher economy, (ii) a
decrease in unit sales volume in the U.S. that historically included an element
of deferred revenue for service contracts beyond our standard warranty terms;
(iii) a shift by customers towards purchasing more quarterly, rather than
annual or multi-year, service contracts and (iv) a reduction of our service
contract pricing, but including prorate charges for hand piece usage, which
resulted in a reduction of our deferred service revenue balance as of
September 30, 2009. With the reconfiguring of our service contracts to include
prorate charges for hand piece usage during the service coverage period, we
expect that in the long term, there will be an increase in revenue derived from
hand piece sales which would offset the service contract amortization decline
resulting from lower priced contracts being sold.
Our Titan
hand piece refill revenue decreased 3% for the three months and 4% for the nine
months ended September 30, 2009, compared to the same periods in 2008. We
believe that these slight decreases were due primarily to a decline in consumer
spending on Titan procedures in response to the global recession.
Gross
Profit
|
Three Months Ended
September 30,
|
Nine
Months Ended September 30,
|
||||||||||||||||||
(Dollars
in thousands)
|
|
2009
|
% Change
|
2008
|
2009
|
% Change
|
2008
|
|||||||||||||
Gross
profit
|
|
$
|
7,261
|
(36%
|
)
|
$
|
11,287
|
$
|
22,290
|
(45%
|
)
|
$
|
40,169
|
|||||||
As
a percentage of total revenue
|
|
60%
|
59%
|
58%
|
61%
|
21
Our cost
of revenue consists primarily of material, labor, stock-based compensation,
royalty expense, warranty and manufacturing overhead expenses. Gross margin as a
percentage of net revenue was 60% for the three months ended September 30, 2009
compared to 59% for the same period in 2008, and 58% for the nine months ended
September 30, 2009, compared to 61% for the same period in 2008. We believe this
decrease in gross margin in 2009, was primarily attributable to:
(i)
|
Lower
overall revenue, due to lower volume, which resulted in reduced leverage
of our manufacturing and service department
expenses;
|
(ii)
|
Higher
Service and Titan refill revenue, as a percentage of our total revenue,
which has a lower gross margin than our total revenue;
and
|
(iii)
|
Higher
international distributor revenue, as a percentage of total revenue, which
has a lower gross margin than our direct business; partially offset
by
|
(iv)
|
Reduced
manufacturing expenses resulting primarily from headcount reductions and
improved product reliability.
|
Sales
and Marketing
|
Three Months Ended
September 30,
|
Nine
Months Ended September 30,
|
||||||||||||||||||
(Dollars
in thousands)
|
|
2009
|
% Change
|
2008
|
2009
|
% Change
|
2008
|
|||||||||||||
Sales
and marketing
|
|
$
|
5,112
|
(37%
|
)
|
$
|
8,076
|
$
|
18,186
|
(37%
|
)
|
$
|
28,786
|
|||||||
As
a percentage of total revenue
|
|
42%
|
42%
|
47%
|
44%
|
Sales and
marketing expenses consist primarily of labor, stock-based compensation,
expenses associated with customer-attended workshops and trade shows, and
advertising. Sales and marketing expenses decreased by $3.0 million in the three
months and $10.6 million for the nine months ended September 30, 2009, compared
to the same periods in 2008. This decrease was mainly attributable to the
following:
(i)
|
A
decrease in personnel expenses of $1.5 million for the three months and
$5.7 million for the nine months ended September 30, 2009, compared to the
same periods in 2008, due primarily to lower headcount and reduced sales
commission expenses resulting from lower
revenue;
|
(ii)
|
A
decrease in marketing expenses associated with workshop, advertising and
other promotional activities of $258,000 for the three months and $1.9
million for the nine months ended September 30, 2009, compared to the same
periods in 2008; and
|
(iii)
|
A
decrease in travel and related expense of $449,000 for the three months
and $1.6 million for the nine months ended September 30, 2009, compared to
the same periods in 2008, due primarily to lower
headcount.
|
Sales and
marketing expenses, as a percentage of net revenue, remained flat at 42% for the
three months ended September 30, 2009, compared to the same period in 2008, and
increased to 47% for the nine months ended September 30, 2009, compared to 44%
for the same period of 2008. This increase in expenses as a percentage of net
revenue for the nine months ended September 30, 2009, was due primarily to lower
revenue in the nine months ended September 30, 2009, compared to the same period
in 2008.
Research
and Development
|
Three Months Ended
September 30,
|
Nine
Months Ended September 30,
|
||||||||||||||||||
(Dollars
in thousands)
|
|
2009
|
% Change
|
2008
|
2009
|
% Change
|
2008
|
|||||||||||||
Research
and development
|
|
$
|
1,684
|
(8%
|
)
|
$
|
1,828
|
$
|
4,922
|
(12%
|
)
|
$
|
5,617
|
|||||||
As
a percentage of total revenue
|
|
14%
|
10%
|
13%
|
9%
|
22
R&D
expenses consist primarily of labor,
stock-based compensation, clinical, regulatory and material costs. R&D
expenses decreased by $144,000 in the three months and $695,000 for the nine
months ended September 30, 2009, compared to the same periods in 2008. These
decreases were due primarily to lower material spending resulting from one of
our products under development in our R&D pipeline nearing
commercialization. During the initial phases of the development of a product,
material expenditure is significantly higher due to the design and development
of a prototype, however, in the later stages of the product development efforts
are mostly labor intensive.
R&D
expenses, as a percentage of net revenue, increased to 14% for the three months
ended September 30, 2009, compared to 10% for the same period in 2008, and
increased to 13% for the nine months ended September 30, 2009, compared to 9%
for the same period in 2008. These increases in expenses as a percentage of net
revenue was due primarily to lower revenue in the three and nine months ended
September 30, 2009, compared to the same period in 2008.
General
and Administrative (G&A)
|
Three Months Ended
September 30,
|
Nine
Months Ended September 30,
|
||||||||||||||||||
(Dollars
in thousands)
|
|
2009
|
% Change
|
2008
|
2009
|
% Change
|
2008
|
|||||||||||||
General
and Administrative
|
|
$
|
2,121
|
(18%
|
)
|
$
|
2,583
|
$
|
8,257
|
(3%
|
)
|
$
|
8,547
|
|||||||
As
a percentage of total revenue
|
|
17%
|
13%
|
22%
|
13%
|
General
and administrative expenses consist primarily of labor, stock-based
compensation, legal fees, accounting, audit and tax consulting fees, and other
general and administrative expenses.
G&A
expenses decreased by $462,000 in the three months ended September 30, 2009,
compared to the same period in 2008, due primarily to:
(i)
|
A
decrease in personnel expenses of $174,000, primarily attributable to
lower headcount in the United
States;
|
(ii)
|
A
decrease in legal, audit and tax consulting fees of $121,000, due to
reduced fees from the consulting firms, partially offset by higher
consulting fees related to our 2009 Option Exchange
Program;
|
(iii)
|
A
decrease in bad debt expense by $91,000, a decrease in travel and related
expenses of $38,000, and a decrease in facility and equipment expenses of
$38,000.
|
G&A
expenses decreased by $290,000 for the nine months ended September 30, 2009,
compared to the same periods in 2008, due primarily to:
(i)
|
A
decrease in legal, audit and tax consulting fees of $354,000, due to
reduced fees from the consulting firms, partially offset by higher
consulting fees related to our 2009 Option Exchange Program;
and
|
(ii)
|
A
decrease in product litigation settlement expense of $78,000, a decrease
in facility and equipment expenses of $73,000, and a decrease in travel
and related expenses of $66,000, partly offset
by;
|
(iii)
|
An
increase in bad debt expense of $363,000, resulting primarily from one
leasing company that defaulted on its payment in the second quarter of
2009 due to it having significant financial
problems.
|
23
G&A
expenses, as a percentage of net revenue, increased to 17% for the three months
ended September 30, 2009, compared to 13% for the same period in 2008, and
increased to 22% for the nine months ended September 30, 2009, compared to 13%
for the same period in 2008. These increases in expenses as a percentage of net
revenue was due primarily to lower revenue in the three and nine months ended
September 30, 2009, compared to the same period in 2008.
Litigation
Settlement
We are a
defendant in a Telephone Consumer Protection Act class action lawsuit. See
“Litigation” in Note 8 of Notes to Condensed Consolidated Financial Statements
in Part I, Item 1 of this quarterly report of Form 10-Q. We have included
$850,000 in our Condensed Consolidated Statement of Operations for the nine
months ended September 30, 2009 for the estimated cost of the tentative
settlement, net of administrative expenses and amounts that may be recoverable
from our insurance carrier.
Interest
and Other Income, Net
Interest
and other income, net consist of the following:
|
Three Months Ended
September 30,
|
Nine
Months Ended September 30,
|
||||||||||||||||||||||
(Dollars
in thousands)
|
|
2009
|
%
Change
|
2008
|
2009
|
%
Change
|
2008
|
|||||||||||||||||
Interest
income
|
$
|
288
|
(61%
|
) |
$
|
741
|
$
|
1,148
|
(54% | ) |
$
|
2,485
|
||||||||||||
Other
income (expense), net
|
—
|
N/A |
(8
|
)
|
250
|
N/A |
6
|
|||||||||||||||||
Total
Interest and other income, net
|
|
$
|
288
|
(61%
|
)
|
$
|
733
|
$
|
1,398
|
(44%
|
)
|
$
|
2,491
|
Interest
and other income, net decreased by $445,000 for the three months and $1.1
million for the nine months ended September 30, 2009, compared to the same
period in 2008. These decreases were the result of:
(i)
|
A
decrease in interest income of $453,000 for the three months and $1.3
million for the nine months ended September 30, 2009, compared to the same
periods in 2008, due primarily to reduced tax-exempt interest yields as a
result of the Federal Reserve cutting interest rates; which was partially
offset by
|
(ii)
|
An
increase in net foreign exchange gains of $223,000 for the nine months
ended September 30, 2009, compared to the same period in 2008, due
primarily to translation gains resulting form the devaluation of the US
dollar relative to the currencies of our foreign
subsidiaries.
|
Other-Than-Temporary
Impairment of Long Term Investments
As of
September 30, 2008, due to the lack of liquidity experienced in the global
credit and capital markets, and specifically in the ARS market, our ARS
portfolio experienced failed auctions since February 2008 and continued declines
in their fair market values. As a result, we concluded that the previously
unrealized loss on our ARS investments was other-than-temporary and therefore
recognized approximately $2.4 million as an impairment of long term investments,
with a corresponding decrease in ‘Accumulated Other Comprehensive Income
(Loss),’ during the third quarter ended September 30, 2008.
Provision
(Benefit) for Income Taxes
|
Three Months Ended
September 30,
|
Nine
Months Ended September 30,
|
||||||||||||||||||||||
(Dollars
in thousands)
|
|
2009
|
Change
|
2008
|
2009
|
Change
|
2008
|
|||||||||||||||||
Loss
before income taxes
|
|
$
|
(1,368
|
)
|
$
|
1,471
|
$
|
(2,839
|
)
|
$
|
(8,527
|
)
|
$
|
(5,865
|
)
|
$
|
(2,662
|
)
|
||||||
Provision
(benefit) for income taxes
|
|
12,126
|
12,212
|
(86
|
)
|
9,159
|
9,187
|
(28
|
)
|
|||||||||||||||
Effective
tax rate
|
N/A
|
3%
|
N/A
|
1%
|
24
We
recognized an income tax provision of $12.1 million and $9.2 million for the
three months and nine months ended September 30, 2009, respectively, despite
losses before taxes. The year-to-date provision is primarily due to the
recording of a valuation allowance of $10.2 million on our U.S. deferred tax
assets as of September 30, 2009. The valuation allowance was recorded at the end
of the third quarter of 2009 to reduce certain U.S. federal and state net
deferred tax assets to their anticipated realizable value. The valuation
allowance was offset by $969,000 of certain tax benefits resulting from losses
generated during fiscal 2009 that can be carried-back to prior periods. Also,
included in the third quarter 2009 provision is the reversal of $3.1 million tax
benefit primarily related to net operating losses previously recognized in the
first and second quarters of 2009.
ASC 740
requires the consideration of a valuation allowance to reflect the likelihood of
realization of deferred tax assets. Significant management judgment is required
in determining any valuation allowance recorded against deferred tax assets. In
evaluating the ability to recover deferrfsed tax assets, we considered available
positive and negative evidence, giving greater weight to our recent cumulative
losses and our ability to carry-back losses against prior taxable income and
lesser weight to its projected financial results due to the challenges of
forecasting future periods. We also considered, commensurate with its objective
verifiability, the forecast of future taxable income including the reversal of
temporary differences. We performed this evaluation as of the year ended
December 31, 2008 and the quarters ended March 31, 2009 and June 30, 2009. At
that time we continued to have sufficient positive evidence, including recent
cumulative profits, a reduction in operating expenses, the ability to carry-back
losses against prior taxable income and an expectation of improving operating
results, showing a valuation allowance was not required. At the end of the
quarter ended September 30, 2009, changes in previously anticipated expectations
and continued operating losses necessitated a valuation allowance against the
tax benefits recognized in this quarter and prior quarters since they are no
longer “more-likely-than-not” realizable. Under current tax laws, this valuation
allowance will not limit our ability to utilize federal and state deferred tax
assets provided we can generate sufficient future taxable income in the
U.S.
We
anticipate we will continue to record a valuation allowance against the losses
of certain jurisdictions, primarily federal and state, until such time as we are
able to determine it is “more-likely-than-not” the deferred tax asset will be
realized. Such position is dependent on whether there will be sufficient future
taxable income to realize such deferred tax assets. We expect our
future tax provisions (benefits), during the time such valuation allowances are
recorded, will consist primarily of the tax expense of our non-US jurisdictions
that are profitable. Our effective tax rate may vary from period to period based
on changes in estimated taxable income or loss by jurisdiction, changes to the
valuation allowance, changes to federal, state or foreign tax laws, future
expansion into areas with varying country, state, and local income tax rates,
deductibility of certain costs and expenses by jurisdiction.
Liquidity
and Capital Resources
Liquidity
is the measurement of our ability to meet potential cash requirements, fund the
planned expansion of our operations and acquire businesses. Our sources of cash
include operations and stock option exercises. We actively manage our cash usage
and investment of liquid cash to ensure the maintenance of sufficient funds to
meet our daily needs. The majority of our cash and investments are held in U.S.
banks and our foreign subsidiaries maintain a limited amount of cash in their
local banks to cover their short-term operating expenses.
Cash,
Cash Equivalents and Marketable Investments Summary
The
following table summarizes our cash and cash equivalents, marketable investments
and long-term investments (in thousands):
September
30, 2009
|
December 31, 2008
|
Change
|
||||||||||
Cash
and cash equivalents
|
$
|
34,302
|
$
|
36,540
|
$
|
(2,238
|
)
|
|||||
Marketable
investments
|
62,572
|
60,653
|
1,919
|
|||||||||
Long-term
investments
|
7,339
|
9,627
|
(2,288
|
)
|
||||||||
Total
|
$
|
104,213
|
$
|
106,820
|
$
|
(2,607
|
)
|
25
Cash
Flows
|
Nine Months Ended September
30,
|
|||||||
(Dollars
in thousands)
|
|
2009
|
2008
|
|||||
Net
cash flow provided by (used in):
|
|
|||||||
Operating
activities
|
|
$
|
(3,135
|
)
|
$
|
5,870
|
||
Investing
activities
|
|
461
|
9,496
|
|||||
Financing
activities
|
|
436
|
263
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
|
$
|
(2,238
|
)
|
$
|
15,629
|
Cash
Flows from Operating Activities
Net cash
used in operating activities was $3.1 million in the nine months ended September
30, 2009, which was due primarily to:
·
|
$2.3
million used by the net loss of $17.7 million after adjusting for non-cash
related items of $15.4 million- consisting primarily of valuation
allowance on our deferred tax asset of $12.3 million as of December 31,
2008, stock-based compensation expense of $3.4 million, net increase in
the allowance for doubtful accounts of $550,000 due primarily to one
leasing company that has defaulted on its payment and an increase in the
provision for excess and obsolete inventories of $247,000 resulting from
the reduced future demand for our
products;
|
·
|
$3.0
million used as a result of a decrease in deferred revenue due primarily
to a decrease in unit sales volume of Products and Upgrades that included
purchases of extended service contracts, a reduction in our service
contract pricing beginning in 2009, a shift by customers towards
purchasing shorter term contracts, and fewer customers purchasing extended
service contracts in response to improved product reliability and to a
tougher economy; and
|
·
|
$1.7
million used to pay down the higher 2008 year-end accrued liabilities
relating primarily to: (i) lower accrued personnel expenses of
$679,000 due primarily to reduced accruals for commissions and employee
benefit expenses; (ii) reduction of accrued warranty expenses of
$827,000 due primarily to fewer units remaining under warranty;
(iii) reduction of the income taxes payable balance by $285,000; and
(iv) net reduction of $245,000 of accrued royalties due to the
reduced revenue in the third quarter of 2009. This was partially offset by
higher accrued legal settlement expense of $850,000 relating to our TCPA
litigation matter (see “Litigation” in Note 8 of Notes to the Condensed
Consolidated Financial Statements in Part I, Item 1 of this quarterly
report of Form 10-Q); partially offset
by
|
·
|
$2.6
million of cash generated by the decrease in gross accounts receivable
balance from December 31, 2008 to September 30, 2009 that resulted from
the collection of the higher 2008 year-end accounts receivable balances;
and
|
·
|
$1.8
million generated by the decrease in gross inventory balance from December
31, 2009 to September 30, 2009, that resulted from slowing our inventory
build to better match the reduced sales of our
products.
|
Net cash
provided by operating activities was $5.9 million in the nine months ended
September 30, 2008, which was due primarily to:
·
|
$4.7
million generated from net loss of $2.6 million after adjusting for
non-cash related items primarily consisting of $4.0 million of stock-based
compensation, other-than-temporary impairment of long term investments of
$2.4 million, and depreciation and amortization of
$671,000;
|
·
|
$4.1
million of cash generated from the collection of the higher accounts
receivable balance as of December 31,
2007;
|
·
|
$1.6
million of cash generated due to an increase in deferred revenue resulting
primarily from higher service contract revenue; partially offset
by
|
·
|
$3.6
million used to pay down the higher year-end accrued liabilities relating
primarily to personnel expenses of $410,000, net reduction of $1.1 million
of the income tax payable due to the payment of the 2007 year-end income
tax liability, net reduction of $1.0 million of royalty accrual, and
$528,000 relating to the reduction in accrued warranty costs due primarily
to fewer units remaining under warranty;
and
|
26
·
|
$1.2
million cash used as a result of the increase in inventories due to the
lower than expected revenue in the first nine months of 2008 and to ramp
up production for our Pearl Fractional product that started shipping in
September 2008.
|
Cash
Flows from Investing Activities
Net cash
provided by investing activities was $461,000 in the nine months ended September
30, 2009, which was due primarily to:
·
|
$31.4
million in net proceeds from the sale and maturity of marketable
investments and long-term investments; partially offset
by
|
·
|
$30.8
million of cash used to purchase marketable
investments.
|
Net cash
provided by investing activities was $9.5 million in the nine months ended
September 30, 2008, which was due primarily to:
·
|
$68.1
million in net proceeds from the sale and maturity of marketable
investments and long-term investments; partially offset
by
|
·
|
$58.1
million of cash used to purchase marketable investments;
and
|
·
|
$538,000
cash used to purchase property and equipment primarily for the research
and development function.
|
Cash
Flows from Financing Activities
Net cash
provided by financing activities was $436,000 in the nine months ended September
30, 2009 and $263,000 for the nine months ended September 30, 2008, which
represented cash generated by the issuance of stock through our stock option and
employee stock purchase plan.
Adequacy
of cash resources to meet future needs
We had
cash, cash equivalents, marketable investments and long-term investments of
$104.2 million as of September 30, 2009. Of this amount, we had $7.5 million
invested in student loan auction rate securities that were rated Aaa to A3 by a
major credit rating agency and are guaranteed by The Federal Family Education
Loan Program (FFELP). These securities were classified under the caption of
“Long-term investments” in the Condensed Consolidated Balance Sheet as auctions
for these securities have been failing since February 2008 due to the current
overall credit concerns in capital markets. Upon an auction failure, the
interest rates do not reset at a market rate but instead reset based on a
formula contained in the security prospectus, which rate is generally higher
than the current market rate. The failure of the auctions impacts our ability to
readily liquidate our ARS into cash until a future auction of these investments
is successful or the auction rate security is refinanced by the issuer into
another type of debt instrument. Based on our ability to access our cash, cash
equivalents and other short term marketable investments and our expected
operating cash flows, we do not anticipate the current lack of liquidity on
these investments will affect our ability to operate our business as usual over
the next twelve months.
Off-Balance
Sheet Arrangements
We do not
participate in transactions that generate relationships with unconsolidated
entities or financial partnerships, such as entities often referred to as
structured finance, variable interest or special purpose entities, which would
have been established for the purpose of facilitating off-balance sheet
arrangements or other contractually narrow or limited purposes. As of September
30, 2009, we were not involved in any unconsolidated transactions.
Contractual
Obligations
We
believe that there were no significant changes during the three and nine months
ended September 30, 2009 in our payments due under contractual obligations, as
disclosed in our Annual Report on Form 10-K for the year ended December 31,
2008.
Commitments
and Contingencies
We are
party to various legal proceedings. For a discussion of these contingencies and
a schedule of our minimum commitments, see Note 8, “Commitments and
Contingencies,” in Notes to Condensed Consolidated Financial Statements in Part
I, Item 1 of this quarterly report on Form 10-Q.
27
Indemnifications
In the
normal course of business, we enter into agreements that contain a variety of
representations, warranties, and indemnification obligations. For example, we
have entered into indemnification agreements with each of our directors and
executive officers. Our executive officers are named as defendants in securities
class action litigation – See “Litigation” in Note 8 of Notes to the Condensed
Consolidated Financial Statements in Part I, Item 1 of this quarterly report of
Form 10-Q. Our exposure under the various indemnification obligations, including
those under the indemnification agreements with our directors and officers, is
unknown since the outcome of the securities litigation is unpredictable and the
amount that could be payable thereunder is not reasonably estimable, and since
other indemnification obligations involve future claims that may be made against
us. We have not accrued or paid any amounts for any such indemnification
obligations. However, we may record charges in the future as a result of these
potential indemnification obligations, including those related to the securities
class action litigation.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
Interest
Rate Sensitivity
Our
exposure to interest rate risk relates primarily to our investment portfolio.
Fixed rate securities may have their fair market value adversely impacted due to
fluctuations in interest rates, while floating rate securities may produce less
income than expected if interest rates fall. Due in part to these factors, our
future investment income may fall short of expectation due to changes in
interest rates or we may suffer losses in principal if forced to sell securities
which have declined in market value due to changes in interest rates. The
primary objective of our investment activities is to preserve principal while at
the same time maximizing yields without significantly increasing risk. To
achieve this objective, we invest in debt instruments of the U.S. Government and
its agencies and municipal bonds, and, by policy, restrict our exposure to any
single type of investment or issuer by imposing concentration limits. To
minimize the exposure due to adverse shifts in interest rates, we maintain
investments at a weighted average maturity (interest reset date for ARS) of
generally less than eighteen months. Assuming a hypothetical increase in
interest rates of one percentage point, the fair value of our total investment
portfolio would have potentially declined by approximately $389,000 as of
September 30, 2009.
We hold
interest bearing ARS that represent investments in pools of student loans issued
by the Federal Family Education Loan Program. At the time of acquisition, these
ARS investments were intended to provide liquidity via an auction process that
resets the applicable interest rate at predetermined calendar intervals,
allowing investors to either roll over their holdings or gain immediate
liquidity by selling such interests at par. Since February 2008, uncertainties
in the credit markets affected our holdings in ARS investments and auctions for
all of our investments in these securities failed until December 31, 2008. In
the first nine months of 2009, approximately $4.3 million of our original $13.4
million par value portfolio has been redeemed in full and as of September 30,
2009 we had $8.9 million par value (fair value of $7.3 million) of long-term
ARS, whose auctions continue to fail. These investments are not currently liquid
and we will not be able to access these funds until a future auction of these
investments is successful, a buyer is found outside of the auction process or
the ARS is refinanced by the issuer into another type of debt instrument.
Maturity dates for these ARS investments range from 2028 to 2043. We currently
classify all of these investments as long-term investments in our Condensed
Consolidated Balance Sheet because of our continuing inability to determine when
these investments will settle. We have also modified our current investment
strategy and increased our investments in more liquid money market investments,
United States Treasury securities, municipal bonds, and eliminated investments
in corporate debt. The valuation of our ARS investment portfolio is subject to
uncertainties that are difficult to predict. Factors that may impact its
valuation include, duration of time that the ARS remain illiquid, changes to
credit ratings of the securities, rates of default of the underlying assets,
changes in the underlying collateral value, market discount rates for similar
illiquid investments, ongoing strength and quality of credit markets. If the
auctions for our ARS investments continue to fail, and there is a further
decline in the valuation, then we would have to: (i) record additional
reductions to the fair value of our ARS investments; (ii) record unrealized
losses in our accumulated comprehensive income (loss) for the losses in value
that are associated with market risk; and (iii) record an
other-than-temporary-impairment charge in our Consolidated Statement of
Operations for the loss in value associated with the worsening of the credit
worthiness (credit losses) of the issuer, which would reduce future earnings and
harm our business.
28
Foreign
Currency Exchange Risk
We have
international subsidiaries and operations and are, therefore, subject to foreign
currency rate exposure. Although the majority of our revenue and purchases are
denominated in U.S. dollars, we have revenue to certain international customers
and expenses denominated in the Japanese Yen, Euro, Pounds Sterling, Australian
Dollars, Swiss Francs and Canadian Dollars. The net gains and losses from the
revaluation of foreign denominated assets and liabilities was a gain of
approximately $32,000 for the three months and a gain of approximately $142,000
for the nine months ended September 30, 2009, which is included in our
Condensed Consolidated Statements of Operations. Movements in currency exchange
rates could cause variability in our revenues, expenses or interest and other
income (expense). Though to date our exposure to exchange rate volatility has
not been significant, we cannot assure that there will not be a material impact
in the future. Future fluctuations in the value of the U.S. dollar may affect
the price competitiveness of our products. We do not believe, however, that we
currently have significant direct foreign currency exchange rate risk and have
not hedged exposures denominated in foreign currencies.
We do not
utilize derivative financial instruments, derivative commodity instruments or
other market risk sensitive instruments.
CONTROLS
AND PROCEDURES
|
Evaluation
of Disclosure Controls and Procedures
Attached
as exhibits to this Quarterly Report are certifications of the Company’s Chief
Executive Officer (CEO) and Chief Financial Officer (CFO), which are required in
accordance with Rule 13a-14 of the Securities Exchange Act of 1934, as amended
(Exchange Act). This Controls and Procedures section includes the information
concerning the controls evaluation referred to in the certifications, and it
should be read in conjunction with the certifications for a more complete
understanding of the topics presented.
We
conducted an evaluation of the effectiveness of the design and operation of its
disclosure controls and procedures (as defined in the Rules 13a-15(e) and
15d-15(e) under the Exchange Act) as of the end of the period covered by this
Report required by Exchange Act Rules 13a-15(b) or 15d-15(b). The controls
evaluation was conducted under the supervision and with the participation of our
management, including the CEO and CFO. Based on this evaluation, the CEO and our
CFO have concluded that as of the end of the period covered by this report the
Company’s disclosure controls and procedures were effective at a reasonable
assurance level.
Definition
of Disclosure Controls
Disclosure
Controls are controls and procedures designed to reasonably assure that
information required to be disclosed in our reports filed under the Exchange
Act, such as this Report, is recorded, processed, summarized and reported within
the time periods specified in the SEC’s rules and forms. Disclosure Controls are
also designed to reasonably assure that such information is accumulated and
communicated our management, including the CEO and CFO, as appropriate to allow
timely decisions regarding required disclosure. Our Disclosure Controls include
components of its internal control over financial reporting, which consists of
control processes designed to provide reasonable assurance regarding the
reliability of its financial reporting and the preparation of financial
statements in accordance with generally accepted accounting principles in the
U.S. To the extent that components of our internal control over financial
reporting are included within its Disclosure Controls, they are included in the
scope of our annual controls evaluation.
Limitations
on the Effectiveness of Controls
The
Company’s management, including the CEO and CFO, does not expect that the
Company’s disclosure controls or internal control over financial reporting will
prevent all error and all fraud. A control system, no matter how well designed
and operated, can provide only reasonable, not absolute, assurance that the
control system’s objectives will be met. Further, the design of a control system
must reflect the fact that there are resource constraints, and the benefits of
controls must be considered relative to their costs. Because of the inherent
limitations in all control systems, no evaluation of controls can provide
absolute assurance that all control issues and instances of fraud, if any,
within the Company have been detected. These inherent limitations include the
realities that judgments in decision making can be faulty and that breakdowns
can occur because of simple error or mistake. Controls can also be circumvented
by the individual acts of some persons, by collusion of two or more people, or
by management override of the controls. The design of any system of controls is
based in part on certain assumptions about the likelihood of future events, and
there can be no assurance that any design will succeed in achieving its stated
goals under all potential future conditions. Over time, controls may become
inadequate because of changes in conditions or deterioration in the degree of
compliance with policies or procedures. Because of the inherent limitations in a
cost-effective control system, misstatements due to error or fraud may occur and
not be detected.
29
Changes
in Internal Control over Financial Reporting
There
were no changes in the Company’s internal control over financial reporting that
occurred during the most recent fiscal quarter that have materially affected, or
are reasonably likely to materially affect, the Company’s internal control over
financial reporting.
PART
II. OTHER INFORMATION
LEGAL
PROCEEDINGS
|
The
information under the heading “Litigation” set forth in Note 8 of Notes to
Condensed Consolidated Financial Statements in Part I, Item 1 of this
quarterly report on Form 10-Q is incorporated herein by
reference.
RISK
FACTORS
|
We
are in a difficult economic period, and the uncertainty in the economy may
further reduce customer demand for our products, cause potential customers to
delay their purchase decisions and make it more difficult for some potential
customers to obtain credit financing, all of which would adversely affect our
business and may increase the volatility of our stock price.
Our
revenue decreased by 36% and 42% in the three and nine months ended September
30, 2009, respectively, compared to the same periods in 2008. The general
economic difficulties being experienced by our customers, reduced end consumer
demand for procedures, the lack of availability of consumer credit for some of
our customers, and the general reluctance of many of our current and prospective
customers to spend significant amounts of money on capital equipment during
these unstable economic times, are adversely affecting the market in which we
operate. In times of economic uncertainty individuals often reduce the amount of
money that they spend on discretionary items, including aesthetic procedures.
This economic uncertainty may cause potential customers to further delay their
capital equipment purchase decisions, and may make it more difficult for some
potential customers to obtain credit financing necessary to purchase our
products or make timely payments to us, each of which can have a material
adverse effect on our revenue, profitability and business and may increase the
volatility of our stock price.
We
rely heavily on our sales professionals to market and sell our products
worldwide. If we are unable to effectively train, retain and manage these
employees, our ability to manage our business will be harmed, which would impair
our future revenue and profitability.
Our
success largely depends on our ability to manage and improve the productivity
levels of our sales professionals worldwide. If we experience significant levels
of attrition, or reductions in productivity among our sales professionals or our
sales managers, our revenue and profitability may be adversely affected and this
could materially harm our business.
Measures
we implement in an effort to retain, train and manage our sales professionals
and improve their productivity may not be successful. Our direct sales
professionals have a material portion of their compensation based on
commissions. Unless revenue improves, their total compensation may remain low,
which could result in higher turnover. In response to reduced commission
earnings resulting from the decrease in revenue, some of our sales professionals
left the industry entirely or left our company to work for competitors. We are
selectively hiring new sales professionals in key territories to fill vacant
positions. The replacement of seasoned sales professionals with new sales
professionals or the absence of a sales professional in a certain territory may
adversely affect our revenue. Following the resignation of our Vice President of
Sales in June 2009, we promoted our General Manager for our Japan operations to
the Vice President of North American Sales position in July 2009. If the North
American sales team does not align with our new Vice President of North American
Sales, we could experience more turnover in the future.
The
initiatives that we are implementing in an effort to improve revenue and
profitability could be unsuccessful, which could harm our business.
For the
three and nine months ended September 30, 2009, our total revenue decreased 36%
and 42%, U.S. revenue decreased by 49% and 54% and international revenue
decreased by 24% and 28%, respectively, compared to the same periods in 2008. In
an effort to improve our revenue and profitability, we have implemented several
strategic initiatives focusing on our worldwide sales and marketing
infrastructure, product introductions and expense management. For example, we
had company-wide reductions in force in January 2009 and April 2009 resulting in
a total net reduction of approximately 22% of our workforce from
December 31, 2008, and we reduced or eliminated certain employee benefit
programs. Further, following the resignation of our Vice President of Sales in
June 2009, we promoted our General Manager for our Japan operations to the Vice
President of North American Sales position. These initiatives are intended to
improve our revenue and profitability; however, they may instead contribute to
employee turnover, instability to our operations, or further reduction in our
revenue and harm to our business.
30
A
lack of customer demand for our products in any of our markets would harm our
revenue.
Most of
our products are marketed to established dermatology and plastic surgeon medical
offices, as well as the non-core businesses, such as family practitioners,
primary care physicians, gynecologists, and non-medical models. Our most recent
product introductions, Pearl and Pearl Fractional are targeted at dermatologists
and plastic surgeons. Continuing to achieve and maintain penetration into each
of our markets is a material assumption of our business strategy.
Demand
for our products in any of our markets could be weakened by several factors,
including:
·
|
Current
lack of credit financing for some of our potential
customers;
|
·
|
Poor
financial performance of market segments that try introducing aesthetic
procedures to their businesses;
|
·
|
The
inability to differentiate our products from those of our
competitors;
|
·
|
Reduced
patient demand for elective aesthetic
procedures;
|
·
|
Failure
to build and maintain relationships with opinion leaders within the
various market segments;
|
·
|
An
increase in malpractice lawsuits;
and
|
·
|
Our
ability to develop and market our products to the core market specialties
of dermatologists and plastic
surgeons.
|
At recent
industry conferences, we announced plans to release a new body contouring
product called True Sculpt. We can provide no assurance that such a product
launch will be successfully or be widely adopted by our customers. If we do not
achieve anticipated demand for our products our revenue may be adversely
impacted.
We
offer credit terms to some qualified customers and also to leasing companies to
finance the purchase of our products. In the event that any of these customers
default on the amounts payable to us, our earnings may be adversely
affected.
While we
qualify customers to whom we offer credit terms (generally net 30 to 60 days),
we cannot provide any assurance that the financial position of these customers
will not change adversely before we receive payment. For example, in the second
quarter ended June 30, 2009, one leasing company that owed us approximately
$472,000 defaulted on its payment due to significant financial difficulties they
experienced. As a result, our general and administrative expenses, and therefore
net loss, for the three months ended June 30, 2009, and the nine months ended
September 30, 2009, was negatively impacted by an increase in the allowance for
doubtful accounts. In the event that there is a default by any other customers
to whom we have provided credit terms, this could further negatively affect our
earnings and results of operations.
We
may have exposure to additional tax liabilities which could negatively impact
our income tax provision (benefit), net income (loss) and cash
flow.
We are
subject to income taxes and other taxes in both the U.S. and the foreign
jurisdictions in which we currently operate or have historically operated. The
determination of our worldwide provision for income taxes and current and
deferred tax assets and liabilities requires judgment and estimation. In the
ordinary course of our business, there are many transactions and calculations
where the ultimate tax determination is uncertain. We are subject to regular
review and audit by both domestic and foreign tax authorities and to the
prospective and retrospective effects of changing tax regulations and
legislation. Although we believe our tax estimates are reasonable, the ultimate
tax outcome may materially differ from the tax amounts recorded in our Condensed
Consolidated Financial Statements and may materially affect our income tax
provision (benefit), net income (loss), and cash flows in the period in which
such determination is made.
31
Deferred
tax assets are recognized for the expected future tax consequences of temporary
differences between the financial reporting and tax bases of assets and
liabilities, and for operating losses and tax credit carryforwards. A valuation
allowance reduces deferred tax assets to estimated realizable value, which
assumes that it is more likely than not that we will be able to generate
sufficient future taxable income in certain tax jurisdictions to realize the net
carrying value. We review our deferred tax assets and valuation allowance on a
quarterly basis. As part of our review, we consider positive and negative
evidence, including cumulative results in recent years. As a result of our
review for the quarter ended September 30, 2009, we provided for a valuation
allowance of $10.2 million on the deferred tax assets as of December 31, 2008
and reversed $3.1 million tax benefit primarily related to net operating losses
previously recognized in the first and second quarters of 2009. This resulted in
a material income tax charge.
We
anticipate we will continue to record a valuation allowance against the losses
of certain jurisdictions, primarily federal and state, until such time as we are
able to determine it is “more-likely-than-not” the deferred tax asset will be
realized. Such position is dependent on whether there will be sufficient future
taxable income to realize such deferred tax assets. We expect our
future tax provisions (benefits), during the time such valuation allowances are
recorded, will consist primarily of the tax expense of our non-US jurisdictions
that are profitable.
Healthcare
reform legislation and changes occurring at U.S. Food and Drug Administration,
or FDA, could adversely affect our revenue and financial condition.
In recent
years, there have been numerous initiatives on the federal and state levels for
comprehensive reforms affecting the payment for, the availability of and
reimbursement for healthcare services in the United States. These initiatives
have ranged from proposals to fundamentally change federal and state healthcare
reimbursement programs, including providing comprehensive healthcare coverage to
the public under governmental funded programs, to minor modifications to
existing programs. Recently, the current administration and members of Congress
have proposed significant reforms to the U.S. healthcare system. Both the U.S.
Senate and House of Representatives have conducted hearings about U.S.
healthcare reform. Our products are not reimbursed by insurance companies or
federal or state governments and some of this proposed legislation will
therefore not affect us. This proposed legislation, however, includes a tax on
manufacturers of medical devices and diagnostic products which would be
applicable to us and, if passed, would decrease our net income.
In
addition, there are several changes occurring at FDA that may lengthen the
regulatory approval process for medical devices and require additional clinical
data to support regulatory clearance for the sale and marketing of products such
as ours. These changes in the FDA regulatory approval process may delay or
prevent the approval of new products and could result in lost market
opportunity. Changes in FDA regulations may require additional safety
monitoring, labeling changes, restrictions on product distribution or use, or
other measures after the introduction of our products to market, which could
increase our costs of doing business, adversely affect the future permitted uses
of approved products, or otherwise adversely affect the market for our
products.
The
ultimate content or timing of any future healthcare reform legislation, and its
impact on us, is impossible to predict. If significant reforms are made to the
healthcare system in the United States, or in other jurisdictions, those reforms
may have an adverse effect on our financial condition and results of
operations.
To
successfully market and sell our products internationally, we must address many
issues that are unique to our international business.
Our
international revenue was $7.3 million and $22.5 million for the three and nine
months ended September 30, 2009, respectively, which represented 60% and 59% of
our total revenue for the three and nine months ended September 30, 2009,
respectively. International revenue is a material component of our business
strategy. We depend on third-party distributors and a direct sales force to sell
our products internationally, and if they underperform we may be unable to
increase or maintain our level of international revenue. To grow our business,
we will need to improve productivity in current sales territories and expand
into new territories. However, direct sales productivity may not improve and
distributors may not accept our business or commit the necessary resources to
market and sell our products to the level of our expectations. As a result, we
may not be able to increase or maintain international revenue
growth.
32
We
believe that an increasing amount of our future revenue will come from
international sales as we expand our overseas operations and develop
opportunities in additional international territories. International sales are
subject to a number of risks, including:
·
|
Difficulties
in staffing and managing our foreign
operations;
|
·
|
Export
restrictions, trade regulations and foreign tax
laws;
|
·
|
Fluctuating
foreign currency exchange rates;
|
·
|
Foreign
certification and regulatory
requirements;
|
·
|
Lengthy
payment cycles and difficulty in collecting accounts
receivable;
|
·
|
Customs
clearance and shipping delays;
|
·
|
Political
and economic instability;
|
·
|
Lack
of awareness of our brand in international
markets;
|
·
|
Preference
for locally-produced products; and
|
·
|
Reduced
protection for intellectual property rights in some
countries.
|
If one or
more of these risks were realized, it could require us to dedicate significant
resources to remedy the situation; and if we were unsuccessful at finding a
solution, we may not be able to sell our products in a particular market and, as
a result, our revenue may decline.
We
compete against companies that have longer operating histories, newer and
different products, and greater resources, each of which may result in a
competitive disadvantage to us and harm our business.
Our
industry is subject to intense competition. Our products compete against similar
products offered by public companies, such as Candela, Cynosure, Elen (in
Italy), Iridex, Palomar, Solta, and Syneron and as well as private companies
such as Aesthera, Alma, Lumenis, Sciton and several other companies. We are
likely to compete with new companies in the future. Competition with these
companies could result in reduced selling prices, reduced profit margins and
loss of market share, any of which would harm our business, financial condition
and results of operations. We also face competition from medical products, such
as Botox, an injectable compound used to reduce wrinkles, and collagen
injections. Other alternatives to the use of our products include sclerotherapy,
a procedure involving the injection of a solution into the vein to collapse it,
electrolysis, a procedure involving the application of electric current to
eliminate hair follicles, and chemical peels. We may also face competition from
manufacturers of pharmaceutical and other products that have not yet been
developed. Our ability to compete effectively depends upon our ability to
distinguish our company and our products from our competitors and their
products, and includes such factors as:
·
|
Success
and timing of new product development and
introductions;
|
·
|
Product
performance;
|
·
|
Product
pricing;
|
·
|
Quality
of customer support;
|
33
·
|
Development
of successful distribution channels, both domestically and
internationally; and
|
·
|
Intellectual
property protection.
|
To
compete effectively, we have to demonstrate that our products are attractive
alternatives to other devices and treatments by differentiating our products on
the basis of such factors as performance, brand name, service and price, and
this is difficult to do in a crowded aesthetic market. Some of our competitors
have newer or different products and more established customer relationships
than we do, which could inhibit our market penetration efforts. For example, we
have encountered, and expect to continue to encounter, situations where, due to
pre-existing relationships, potential customers decided to purchase additional
products from our competitors. Potential customers also may need to recoup the
cost of products that they have already purchased from our competitors and may
decide not to purchase our products, or to delay such purchases. If we are
unable to achieve continued market penetration, we will be unable to compete
effectively and our business will be harmed.
In
addition, some of our current and potential competitors have greater financial,
research and development, business development, manufacturing, and sales and
marketing resources than we have. Our competitors could utilize their greater
financial resources to acquire other companies to gain enhanced name recognition
and market share, as well as new technologies or products that could effectively
compete with our existing product lines. Recently there has been some
consolidation in the aesthetic industry leading to companies combining their
resources. For example, Thermage acquired Reliant in December 2008 and renamed
the combined company, Solta. In addition, in September 2009, Syneron agreed to
acquire Candela. Our competitors could also form strategic alliances with other
companies to develop products and solutions that effectively compete with our
products. For example, Syneron has entered into agreements with Proctor and
Gamble for the proposed development of home-use aesthetic devices. Business
combinations and alliances by our competitors could increase competition, which
could harm our business.
The
aesthetic equipment market is characterized by rapid innovation. To compete
effectively, we must develop and acquire new products, market them successfully,
and identify new markets for our technology.
We have
created products to apply our technology to hair removal, treatment of veins and
skin rejuvenation, including the treating of diffuse redness, skin laxity, fine
lines, wrinkles, skin texture, pore size and pigmented lesions. Currently, these
applications represent the majority of offered laser and other energy-based
aesthetic procedures. To grow in the future, we must develop and acquire new and
innovative aesthetic applications, identify new markets for our existing
technologies, and develop and acquire new technologies for various platforms. To
successfully expand our product offerings, we must, among other
things:
·
|
Develop
and acquire new products that either add to or significantly improve our
current products;
|
·
|
Convince
our customers and prospects that our new products or upgrades would be an
attractive revenue-generating addition to their
practices;
|
·
|
Sell
our products to a broad customer
base;
|
·
|
Identify
new markets and alternative applications for our
technology;
|
·
|
Protect
our existing and future products with defensible intellectual property;
and
|
·
|
Satisfy
and maintain all regulatory requirements for
commercialization.
|
Every
year since 2000, except for year-to-date 2009, we have introduced at least one
new product. Historically, these introductions have generally been a significant
component of our financial performance. Our business strategy is based, in part,
on our expectation that we will continue to make regular product introductions
that we can sell to new customers as systems and to existing customers as
upgrades to their existing systems. However, even with a significant investment
in research and development, we may be unable to continue to develop, acquire or
effectively launch and market new products and technologies regularly, or at
all, which could adversely affect our business.
34
In
addition, our former Executive Vice President of Research &
Development, who is also one of our founders, resigned from his employment with
us effective March 2009 to pursue personal interests. Although we have appointed
a new Vice President of Research & Development and our founder continues to
provide consulting services to us, our founder’s full-time employment,
experience and leadership was critical to our historical product development
initiatives. As a result, we may not be able to continue our trend of regular
new product introductions. Also, we may need additional research and development
resources to make new product introductions, which may be more costly and time
consuming to our organization.
Some of
our competitors release new products more often and more successfully than we
do. We believe that, to increase revenue from sales of new products and related
upgrades, we need to continue to develop our clinical support, further expand
and nurture relationships with industry thought leaders and increase market
awareness of the benefits of our new products. If we fail to successfully
commercialize any of our new products, our business could be
harmed.
While we
attempt to protect our products through patents and other intellectual property,
there are few barriers to entry that would prevent new entrants or existing
competitors from developing products that compete directly with ours. For
example, while our CoolGlide product was the first long-pulse Nd:YAG, or long
wavelength, laser system cleared by the FDA for permanent hair reduction on all
skin types, competitors have subsequently introduced systems that utilize Nd:YAG
lasers, and received FDA clearances to market these products as treating all
skin types. We expect that any competitive advantage we may enjoy from other
current and future innovations, such as combining multiple hand pieces in a
single system to perform a variety of applications, may diminish over time, as
companies successfully respond to our, or create their own, innovations.
Consequently, we believe that we will have to continuously innovate and improve
our products and technology to compete successfully. If we are unable to
innovate successfully, our products could become obsolete and our revenue could
decline as our customers and prospects purchase our competitors’
products.
If
there is not sufficient consumer demand for the procedures performed with our
products, practitioner demand for our products could be inhibited, resulting in
unfavorable operating results and reduced growth potential.
Continued
expansion of the global market for laser and other energy-based aesthetic
procedures is a material assumption of our business strategy. Most procedures
performed using our products are elective procedures not reimbursable through
government or private health insurance, with the costs borne by the patient. The
decision to utilize our products may therefore be influenced by a number of
factors, including:
·
|
Consumer
disposable income and access to consumer credit, which as a result of the
unstable economy, may have been significantly
impacted;
|
·
|
The
cost of procedures performed using our
products;
|
·
|
The
cost, safety and effectiveness of alternative treatments, including
treatments which are not based upon laser or other energy-based
technologies and treatments which use pharmaceutical
products;
|
·
|
The
success of our sales and marketing efforts;
and
|
·
|
The
education of our customers and patients on the benefits and uses of our
products, compared to competitors’ products and
technologies.
|
If, as a
result of these factors, there is not sufficient demand for the procedures
performed with our products, practitioner demand for our products could be
reduced, which could have a material adverse effect on our business, financial
condition, revenue and result of operations.
If
PSS World Medical fails to perform to our expectations, we may fail to achieve
anticipated operating results.
We have a
distribution agreement with PSS World Medical. PSS sales professionals work in
coordination with our sales force to locate new customers for our products
throughout the United States. Revenue from PSS declined significantly in the
nine months ended September 30, 2009, compared with the same period in 2008. PSS
revenue represented approximately 14% of our worldwide revenue in 2008 and 2007
and 7% of total revenue in the nine months ended September 30, 2009. In
addition, our revenue from PSS as a percentage of U.S. revenue was 16% in the
nine months ended September 30, 2009, compared to 29% in 2008 and 23% in 2007.
Although we continue to work closely with, and focus our attention on, our PSS
relationship, there is no assurance that this will translate into increased
revenue for us. Further, if PSS does not perform adequately under the
arrangement, or terminates our relationship, it may have a material adverse
effect on our business, financial condition and results of
operations.
35
We
depend on skilled and experienced personnel to operate our business effectively.
If we are unable to recruit, hire and retain these employees, our ability to
manage and expand our business will be harmed, which would impair our future
revenue and profitability.
Our
success largely depends on the skills, experience and efforts of our officers
and other key employees. Except for Change of Control and Severance Agreements
for our executive officers, we do not have employment contracts with any of our
officers or other key employees. Any of our officers and other key employees may
terminate their employment at any time. We do not have a succession plan in
place for each of our officers and key employees. In addition, we do not
maintain “key person” life insurance policies covering any of our employees. The
loss of any of our senior management team members could weaken our management
expertise and harm our business.
Our
ability to retain our skilled labor force and our success in attracting and
hiring new skilled employees are critical factors in determining whether we will
be successful in the future. We may not be able to meet our future hiring needs
or retain existing personnel. We may face particularly significant challenges
and risks in hiring, training, managing and retaining engineering and sales and
marketing employees. Failure to attract and retain personnel, particularly
technical and sales and marketing personnel, would materially harm our ability
to compete effectively and grow our business.
We
may incur substantial expenses if our practices are shown to have violated the
Telephone Consumer Protection Act, and defending ourselves against the related
litigation could distract management and harm our business.
A
Telephone Consumer Protection Act, or TCPA, class action lawsuit was filed
against us in January 2008 in the Illinois Circuit Court, Cook County, by
Bridgeport Pain Control Center, Ltd., seeking monetary damages, injunctive
relief, costs and other relief. The complaint alleges that we violated the TCPA
by sending unsolicited advertisements by facsimile to the plaintiff and other
recipients nationwide during the four-year period preceding the lawsuit without
the prior express invitation or permission of the recipients. Two state law
claims, limited to Illinois recipients, allege a class period of three and five
years, respectively. Under the TCPA, recipients of unsolicited facsimile
advertisements may be entitled to damages of $500 per violation for inadvertent
violations and $1,500 per violation for knowing or willful violations. On
February 22, 2008, we removed the case to federal court in the Northern
District of Illinois. On August 25, 2009, following negotiations between the
parties, the parties entered into a settlement agreement that would resolve the
case on a class-wide basis. The Court gave its preliminary approval to the
proposed settlement on August 27, 2009, and a final hearing on the settlement is
scheduled for April 6, 2010. Under the terms of the settlement, we will cause to
be paid a total of $950,000 in exchange for a full release of facsimile-related
claims. We included in our Condensed Consolidated Statement of Operations for
the nine months ended September 30, 2009, $850,000 for the estimated cost of the
settlement, net of administrative expenses and amounts that are expected to be
recoverable from our insurance carrier. If the proposed settlement does not
receive final approval, we intend to defend this case vigorously.
Two
securities class action lawsuits were filed against us in April and May 2007,
respectively, based upon the decreases in our stock price following the
announcement of our preliminary first quarter 2007 revenue and earnings, and the
announcement of our revised 2007 guidance. Defending ourselves against this
litigation could distract management and harm our business.
Two class
action lawsuits were filed against us following declines in our stock price in
the spring of 2007. On November 1, 2007, the court ordered the two cases
consolidated. These consolidated cases have been on appeal since November 2008
after our motion to dismiss the plaintiffs’ complaint was granted. See
“Litigation” set forth in Note 8 of Notes to Condensed Consolidated
Financial Statements in Part I, Item 1 of this quarterly report on
Form 10-Q for further details.
Although
we retain director and officer liability insurance, there can be no guarantee
that such insurance will cover the claims that are made or will insure us fully
for all losses on covered claims. This litigation may distract our management
and consume resources that would otherwise have been directed toward operating
our business. Each of these factors could harm our business.
36
We
are exposed to fluctuations in the market values of our portfolio of
investments, specifically auction rate securities (ARS), and due to interest
rates changes. Due to failed auctions for some of our ARS since February 2008,
we are unable to readily liquidate them into cash, and in 2008, we took
impairment charges. If the auctions for our ARS investments continue to fail,
and there is a further decline in their valuation, then we would have to: (i)
record additional reductions to the fair value of our ARS investments; (ii)
record unrealized losses in our accumulated comprehensive income (loss) for the
losses in value that are associated with market risk; and (iii) record an
other-than-temporary-impairment charge in our Consolidated Statement of
Operations for the loss in value associated with the worsening of the credit
worthiness (credit losses) of the issuer, which would reduce future earnings,
harm our business and cause our stock price to decline.
We invest
our excess cash primarily in money market funds and in highly liquid debt
instruments of the U.S. government and its agencies, U.S. municipalities
(including ARS). As of September 30, 2009, our balance in marketable securities
was $101.8 million. The longer the duration of a security, the more susceptible
it is to changes in market interest rates and bond yields. As yields increase,
those securities with a lower yield-at-cost show a mark-to-market unrealized
loss. For example, assuming a hypothetical increase in interest rates of one
percentage point, the fair value of our total investment portfolio as of
September 30, 2009 would have potentially decreased by approximately $389,000,
resulting in an unrealized loss that would subsequently adversely impact our
earnings. As a result, changes in the market interest rates will affect our
future net income (loss).
Included
under the caption of “Long-term investments” in the Condensed Consolidated
Balance Sheet as of September 30, 2009, are $7.3 million of ARS. These ARS are
designed to provide liquidity through an auction process that resets the
applicable interest rate at predetermined calendar intervals, generally every 35
days. Though approximately $4.3 million (par value) of our original holdings of
$13.4 million (par value) of ARS, have been redeemed at full par value since
December 31, 2008, auctions for the remaining ARS in our portfolio at September
30, 2009 have continued to fail since February 2008 due to the lack of liquidity
and overall credit concerns in capital markets. Upon an auction failure, the
interest rates do not reset at a market rate but instead reset based on a
formula contained in the security, which rate is generally higher than the
current market rate. The failure of the auctions impacts our ability to readily
liquidate our ARS into cash until a future auction of these investments is
successful, a buyer is found outside of the auction process or the ARS is
refinanced by the issuer into another type of debt instrument.
If the
auctions for our ARS investments continue to fail, and there is a further
decline in the valuation, then we would have to: (i) record additional
reductions to the fair value of our ARS investments; (ii) record unrealized
losses in our accumulated comprehensive income (loss) for the losses in value
that are associated with market risk; and (iii) record an
other-than-temporary-impairment charge in our Consolidated Statement of
Operations for the loss in value associated with the worsening of the credit
worthiness (credit losses) of the issuer, which would reduce future earnings,
harm our business and cause our stock price to decline.
The
price of our common stock may fluctuate substantially. We have a limited number
of shares of common stock outstanding, a large portion of which is held by a
small number of investors, which could result in the increase in volatility of
our stock price.
As of
June 30, 2009, approximately 58% of our outstanding shares of common stock were
held by 10 institutional investors. As a result of our relatively small public
float, our common stock may be less liquid than the stock of companies with
broader public ownership. Among other things, trading of a relatively small
volume of our common stock may have a greater impact on the trading price for
our shares than would be the case if our public float were larger.
The
public market price of our common stock has in the past fluctuated substantially
and, due to the current concentration of stockholders, it may continue to do so
in the future. The market price for our common stock could also be affected by a
number of other factors, including:
·
|
The
general market conditions unrelated to our operating
performance;
|
·
|
Sales
of large blocks of our common stock, including sales by our executive
officers, directors and our large institutional
investors;
|
37
·
|
Quarterly
variations in our, or our competitors’ results of
operations;
|
·
|
Changes
in analysts’ estimates, investors’ perceptions, recommendations by
securities analysts or our failure to achieve analysts’
estimates;
|
·
|
The
announcement of new products or service enhancements by us or our
competitors;
|
·
|
The
announcement of the departure of a key employee or executive
officer;
|
·
|
Regulatory
developments or delays concerning our, or our competitors’ products;
and
|
·
|
The
initiation of litigation by us or against
us.
|
Actual or
perceived instability in our stock price could reduce demand from potential
buyers of our stock, thereby causing our stock price to either remain depressed
or to decline further.
We
may be involved in future costly intellectual property litigation, which could
impact our future business and financial performance.
Our
competitors or other patent holders may assert that our present or future
products and the methods we employ are covered by their patents. In addition, we
do not know whether our competitors own or will obtain patents that they may
claim prevent, limit or interfere with our ability to make, use, sell or import
our products. Although we may seek to resolve any potential future claims or
actions, we may not be able to do so on reasonable terms, or at all. If,
following a successful third-party action for infringement, we cannot obtain a
license or redesign our products, we may have to stop manufacturing and selling
the applicable products and our business would suffer as a result. In addition,
a court could require us to pay substantial damages, and prohibit us from using
technologies essential to our products, any of which would have a material
adverse effect on our business, results of operations and financial
condition.
We may
become involved in litigation not only as a result of alleged infringement of a
third party’s intellectual property rights but also to protect our own
intellectual property. For example, we have been, and may hereafter become,
involved in litigation to protect the trademark rights associated with our
company name or the names of our products. Infringement and other intellectual
property claims, with or without merit, can be expensive and time-consuming to
litigate, and could divert management’s attention from our core
business.
Intellectual
property rights may not provide adequate protection for some or all of our
products, which may permit third parties to compete against us more
effectively.
We rely
on patent, copyright, trade secret and trademark laws and confidentiality
agreements to protect our technology and products. At September 30, 2009, we had
twelve issued U.S. patents. Some of our components, such as our laser module,
electronic control system and high-voltage electronics, are not, and in the
future may not be, protected by patents. Additionally, our patent applications
may not issue as patents or, if issued, may not issue in a form that will be
advantageous to us. Any patents we obtain may be challenged, invalidated or
legally circumvented by third parties. Consequently, competitors could market
products and use manufacturing processes that are substantially similar to, or
superior to, ours. We may not be able to prevent the unauthorized disclosure or
use of our technical knowledge or other trade secrets by consultants, vendors,
former employees or current employees, despite the existence generally of
confidentiality agreements and other contractual restrictions. Monitoring
unauthorized uses and disclosures of our intellectual property is difficult, and
we do not know whether the steps we have taken to protect our intellectual
property will be effective. Moreover, the laws of many foreign countries will
not protect our intellectual property rights to the same extent as the laws of
the United States.
The
absence of complete intellectual property protection exposes us to a greater
risk of direct competition. Competitors could purchase one of our products and
attempt to replicate some or all of the competitive advantages we derive from
our development efforts, design around our protected technology, or develop
their own competitive technologies that fall outside of our intellectual
property rights. If our intellectual property is not adequately protected
against competitors’ products and methods, our competitive position and our
business could be adversely affected.
38
If
we fail to obtain or maintain necessary FDA clearances for our products and
indications, if clearances for future products and indications are delayed or
not issued, if there are federal or state level regulatory changes or if we are
found to have violated applicable FDA marketing rules, our commercial operations
would be harmed.
Our
products are medical devices that are subject to extensive regulation in the
United States by the FDA for manufacturing, labeling, sale, promotion,
distribution and shipping. Before a new medical device, or a new use of or
labeling claim for an existing product, can be marketed in the United States, it
must first receive either 510(k) clearance or pre-marketing approval from the
FDA, unless an exemption applies. Either process can be expensive and lengthy.
In the event that we do not obtain FDA clearances or approvals for our products,
our ability to market and sell them in the United States and revenue derived
there from may be adversely affected.
Medical
devices may be marketed in the United States only for the indications for which
they are approved or cleared by the FDA. For example, we have FDA clearance to
market our Titan product in the United States only for deep heating for the
temporary relief of muscle aches and pains and to market our Pearl Fractional
product in the United States only for skin resurfacing, and are therefore
prevented from promoting or advertising Titan in the United States and Pearl
Fractional in the United States for any other
indications. If we fail to comply with these regulations, it could result in
enforcement action by the FDA which could lead to such consequences as warning
letters, adverse publicity, criminal enforcement action and/or third-party civil
litigation, each of which could adversely affect us.
We have
obtained 510(k) clearance for the indications for which we market our products.
However, our clearances can be revoked if safety or effectiveness problems
develop. We also are subject to Medical Device Reporting regulations, which
require us to report to the FDA if our products cause or contribute to a death
or serious injury, or malfunction in a way that would likely cause or contribute
to a death or serious injury. Our products are also subject to state
regulations, which are, in many instances frequently changing. Changes in state
regulations may impede sales. For example, federal regulations allow our
products to be sold to, or on the order of, “licensed practitioners,” as
determined on a state-by-state basis. As a result, in some states,
non-physicians may legally purchase our products. However, a state could change
its regulations at any time, thereby disallowing sales to particular types of
end users. We cannot predict the impact or effect of future legislation or
regulations at the federal or state levels.
The
FDA and state authorities have broad enforcement powers. If we fail to comply
with applicable regulatory requirements, it could result in enforcement action
by the FDA or state agencies, which may include any of the following
sanctions:
·
|
Warning
letters, fines, injunctions, consent decrees and civil
penalties;
|
·
|
Repair,
replacement, recall or seizure of our
products;
|
·
|
Operating
restrictions or partial suspension or total shutdown of
production;
|
·
|
Refusing
our requests for 510(k) clearance or pre-market approval of new products,
new intended uses, or modifications to existing
products;
|
·
|
Withdrawing
510(k) clearance or pre-market approvals that have already been granted;
and
|
·
|
Criminal
prosecution.
|
If any of
these events were to occur, it could harm our business.
39
If
we fail to comply with the FDA’s Quality System Regulation and laser performance
standards, our manufacturing operations could be halted, and our business would
suffer.
We are
currently required to demonstrate and maintain compliance with the FDA’s Quality
System Regulation, or QSR. The QSR is a complex regulatory scheme that covers
the methods and documentation of the design, testing, control, manufacturing,
labeling, quality assurance, packaging, storage and shipping of our products.
Because our products involve the use of lasers, our products also are covered by
a performance standard for lasers set forth in FDA regulations. The laser
performance standard imposes specific record-keeping, reporting, product testing
and product labeling requirements. These requirements include affixing warning
labels to laser products, as well as incorporating certain safety features in
the design of laser products. The FDA enforces the QSR and laser performance
standards through periodic unannounced inspections. Our failure to take
satisfactory corrective action in response to an adverse QSR inspection or our
failure to comply with applicable laser performance standards could result in
enforcement actions, including a public warning letter, a shutdown of our
manufacturing operations, a recall of our products, civil or criminal penalties,
or other sanctions, such as those described in the preceding paragraph, which
would cause our sales and business to suffer.
If
we modify one of our FDA-approved devices, we may need to seek re-approval,
which, if not granted, would prevent us from selling our modified products or
cause us to redesign our products.
Any
modifications to an FDA-cleared device that would significantly affect its
safety or effectiveness or that would constitute a major change in its intended
use would require a new 510(k) clearance or possibly a pre-market approval. We
may not be able to obtain additional 510(k) clearance or pre-market approvals
for new products or for modifications to, or additional indications for, our
existing products in a timely fashion, or at all. Delays in obtaining future
clearance would adversely affect our ability to introduce new or enhanced
products in a timely manner, which in turn would harm our revenue and future
profitability.
We have
made modifications to our devices in the past and may make additional
modifications in the future that we believe do not or will not require
additional clearance or approvals. If the FDA disagrees, and requires new
clearances or approvals for the modifications, we may be required to recall and
to stop marketing the modified devices, which could harm our operating results
and require us to redesign our products.
We
may be unable to obtain or maintain international regulatory qualifications or
approvals for our current or future products and indications, which could harm
our business.
Sales of
our products outside the United States are subject to foreign regulatory
requirements that vary widely from country to country. In addition, exports of
medical devices from the United States are regulated by the FDA. Complying with
international regulatory requirements can be an expensive and time-consuming
process and approval is not certain. The time required to obtain clearance or
approvals, if required by other countries, may be longer than that required for
FDA clearance or approvals, and requirements for such clearances or approvals
may significantly differ from FDA requirements. We may be unable to obtain or
maintain regulatory qualifications, clearances or approvals in other countries.
We may also incur significant costs in attempting to obtain and in maintaining
foreign regulatory approvals or qualifications. If we experience delays in
receiving necessary qualifications, clearances or approvals to market our
products outside the United States, or if we fail to receive those
qualifications, clearances or approvals, we may be unable to market our products
or enhancements in international markets effectively, or at all, which could
have a material adverse effect on our business and growth strategy.
Any
acquisitions that we make could disrupt our business and harm our financial
condition.
We expect
to evaluate potential strategic acquisitions of complementary businesses,
products or technologies. We may also consider joint ventures and other
collaborative projects. We may not be able to identify appropriate acquisition
candidates or strategic partners, or successfully negotiate, finance or
integrate any businesses, products or technologies that we acquire. Furthermore,
the integration of any acquisition and management of any collaborative project
may divert management’s time and resources from our core business and disrupt
our operations and we may incur significant legal, accounting and banking fees
in connection with such a transaction. In addition, if we purchase a company
that is not profitable, our cash balances may be reduced or depleted. We do not
have any experience as a team with acquiring companies or products. If we decide
to expand our product offerings beyond laser and other energy-based products, we
may spend time and money on projects that do not increase our revenue. Any cash
acquisition we pursue would diminish our available cash balances to us for other
uses, and any stock acquisition could be dilutive to our
stockholders.
While we
from time to time evaluate potential collaborative projects and acquisitions of
businesses, products and technologies, and anticipate continuing to make these
evaluations, we have no present understandings, commitments or agreements with
respect to any material acquisitions or collaborative projects.
40
The
expense and potential unavailability of insurance coverage for our customers
could adversely affect our ability to sell our products, and therefore our
financial condition.
Some of
our customers and prospective customers have had difficulty in procuring or
maintaining liability insurance to cover their operation and use of our
products. Medical malpractice carriers are withdrawing coverage in certain
states or substantially increasing premiums. If this trend continues or worsens,
our customers may discontinue using our products and potential customers may opt
against purchasing laser and other energy based products due to the cost or
inability to procure insurance coverage. The unavailability of insurance
coverage for our customers and prospects could adversely affect our ability to
sell our products, and that could harm our financial condition.
Because
we do not require training for users of our products, and sell our products at
times to non-physicians, there exists an increased potential for misuse of our
products, which could harm our reputation and our business.
Federal
regulations allow us to sell our products to or on the order of “licensed
practitioners.” The definition of “licensed practitioners” varies from state to
state. As a result, our products may be purchased or operated by physicians with
varying levels of training, and in many states, by non-physicians, including
nurse practitioners, chiropractors and technicians. Outside the United States,
many jurisdictions do not require specific qualifications or training for
purchasers or operators of our products. We do not supervise the procedures
performed with our products, nor do we require that direct medical supervision
occur. We and our distributors generally offer but do not require product
training to the purchasers or operators of our products. In addition, we
sometimes sell our systems to companies that rent our systems to third parties
and that provide a technician to perform the procedures. The lack of training
and the purchase and use of our products by non-physicians may result in product
misuse and adverse treatment outcomes, which could harm our reputation and our
business, and, in the event these result in product liability litigation,
distract management and subject us to liability, including legal
expenses.
Product
liability suits could be brought against us due to a defective design, material
or workmanship or misuse of our products and could result in expensive and
time-consuming litigation, payment of substantial damages and an increase in our
insurance rates.
If our
products are defectively designed, manufactured or labeled, contain defective
components or are misused, we may become subject to substantial and costly
litigation by our customers or their patients. Misusing our products or failing
to adhere to operating guidelines could cause significant eye and skin damage,
and underlying tissue damage. In addition, if our operating guidelines are found
to be inadequate, we may be subject to liability. We have been involved, and may
in the future be involved, in litigation related to the use of our products.
Product liability claims could divert management’s attention from our core
business, be expensive to defend and result in sizable damage awards against us.
We may not have sufficient insurance coverage for all future claims. We may not
be able to obtain insurance in amounts or scope sufficient to provide us with
adequate coverage against all potential liabilities. Any product liability
claims brought against us, with or without merit, could increase our product
liability insurance rates or prevent us from securing continuing coverage, could
harm our reputation in the industry and could reduce product sales. In addition,
we have been experiencing steep increases in our product liability insurance
premiums. If our premiums continue to rise, we may no longer be able to afford
adequate insurance coverage.
If we are
unable to maintain adequate insurance coverage, or we have product liability
claims in excess of our insurance coverage, claims would be paid out of cash
reserves, thereby harming our financial condition, operating results and
profitability.
Our
manufacturing operations are dependent upon third-party suppliers, making us
vulnerable to supply shortages and price fluctuations, which could harm our
business.
Many of
the components and materials that comprise our products are currently
manufactured by a limited number of suppliers. A supply interruption or an
increase in demand beyond our current suppliers’ capabilities could harm our
ability to manufacture our products until a new source of supply is identified
and qualified. Our reliance on these suppliers subjects us to a number of risks
that could harm our business, including:
·
|
Interruption
of supply resulting from modifications to or discontinuation of a
supplier’s operations;
|
41
·
|
Delays
in product shipments resulting from uncorrected defects, reliability
issues or a supplier’s variation in a
component;
|
·
|
A
lack of long term supply arrangements for key components with our
suppliers;
|
·
|
Inability
to obtain adequate supply in a timely manner, or on reasonable
terms;
|
·
|
Difficulty
locating and qualifying alternative suppliers for our components in a
timely manner;
|
·
|
Production
delays related to the evaluation and testing of products from alternative
suppliers and corresponding regulatory qualifications;
and
|
·
|
Delay
in supplier deliveries.
|
Any
interruption in the supply of components or materials, or our inability to
obtain substitute components or materials from alternate sources at acceptable
prices in a timely manner, could impair our ability to meet the demand of our
customers, which would have an adverse effect on our business.
Any
defects in the design, material or workmanship of our products may not be
discovered prior to shipment to customers, which could result in warranty
obligations that may reduce our future revenue and increase our
cost.
The
design of our products is complex. To manufacture them successfully, we must
procure quality components and employ individuals with a significant degree of
technical expertise. If our designs are defective, if suppliers fail to deliver
components to specification, or if our employees fail to properly assemble, test
and package our products, the reliability and performance of our products will
be compromised.
If our
products contain defects that cannot be repaired easily and inexpensively, we
may experience:
·
|
Loss
of customer orders and delay in order
fulfillment;
|
·
|
Damage
to our brand reputation;
|
·
|
Increased
cost of our warranty program due to product repair or
replacement;
|
·
|
Inability
to attract new customers;
|
·
|
Diversion
of resources from our manufacturing and research and development
departments into our service department;
and
|
·
|
Legal
action.
|
The
occurrence of any one or more of the foregoing could materially harm our
business.
We
forecast sales to determine requirements for components and materials used in
our products and if our forecasts are incorrect, we may experience either delays
in shipments or increased inventory costs.
We keep
limited materials and components on hand. To manage our manufacturing operations
with our suppliers, we forecast anticipated product orders and material
requirements to predict our inventory needs up to twelve months in advance and
enter into purchase orders on the basis of these requirements. Our experience of
materials usage may not provide us with enough data to accurately predict future
demand. If our sales demand decreases significantly, or if we overestimate our
component and material requirements, we will have excess inventories and incur
costs associated with the termination of existing purchase order obligations,
which would increase our expenses. If our business expands, or if we
underestimate our component and material requirements, we may have inadequate
inventories, which could interrupt, delay or prevent delivery of our products to
our customers. Any of these occurrences would negatively affect our financial
performance and the level of satisfaction our customers have with our
business.
42
Our
gross and operating margins may vary over time.
Our gross
and operating margins may be adversely affected by a number of factors,
including decreases in our shipment volume, reductions in, or obsolescence of,
our inventory, shifts in our product mix and increased expenses associated with
repairing defective products covered by our warranty program. In addition, the
competitive market environment in which we operate may adversely affect pricing
for our products. Because we own most of our manufacturing capacity, a
significant portion of our operating costs are fixed. If we experience a
decrease in shipment volume, or have to reduce our pricing to remain
competitive, or experience a greater than expected failure rate for any of our
products, our gross and operating margins will be adversely
impacted.
We
are subject to fluctuations in the exchange rate of the U.S. dollar and foreign
currencies.
As a
result of recent fluctuations in currency markets and the strong dollar relative
to many other major currencies, our products priced in U.S. dollars may be more
expensive relative to products of our foreign competitors, which could result in
lower sales. We do not actively hedge our exposure to currency rate
fluctuations. While we transact business primarily in U.S. Dollars, and a
significant proportion of our revenue is denominated in U.S. Dollars, a portion
of our costs and revenue is denominated in other currencies, such as the Euro,
Japanese Yen, Australian Dollar, Canadian Dollar and British Pound Sterling. As
a result, changes in the exchange rates of these currencies to the
U.S. Dollar will affect our net income (loss).
Anti-takeover
provisions in our Amended and Restated Certificate of Incorporation and Bylaws,
and Delaware law, contain provisions that could discourage a
takeover.
Our
Amended and Restated Certificate of Incorporation and Bylaws, and Delaware law,
contain provisions that might enable our management to resist a takeover, and
might make it more difficult for an investor to acquire a substantial block of
our common stock. These provisions include:
·
|
A
classified board of directors;
|
·
|
Advance
notice requirements to stockholders for matters to be brought at
stockholder meetings;
|
·
|
A
supermajority stockholder vote requirement for amending certain provisions
of our Amended and Restated Certificate of Incorporation and
bylaws;
|
·
|
Limitations
on stockholder actions by written consent;
and
|
·
|
The
right to issue preferred stock without stockholder approval, which could
be used to dilute the stock ownership of a potential hostile
acquirer.
|
These
provisions, as well as Change of Control and Severance Agreements entered into
with each of our executive officers, might discourage, delay or prevent a change
in control of our company or a change in our management. The existence of these
provisions could adversely affect the voting power of holders of common stock
and limit the price that investors might be willing to pay in the future for
shares of our common stock.
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
|
We did
not sell any equity securities during the period covered by this
report.
DEFAULTS
UPON SENIOR SECURITIES
|
None.
43
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY
HOLDERS
|
None.
OTHER
INFORMATION
|
ITEM 6.
|
EXHIBITS
|
Exhibit No.
|
Description
|
|
3.2(1)
|
Amended
and Restated Certificate of Incorporation of the Registrant
(Delaware).
|
|
3.4(1)
|
Bylaws
of the Registrant.
|
|
4.1(2)
|
Specimen
Common Stock certificate of the Registrant.
|
|
10.14(3)
|
Cutera,
Inc. 2004 Equity Incentive Plan, as amended by its Board of Directors on
April 25, 2008
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
|
32.1
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to 18
U.S.C Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
________________
(1)
|
Incorporated
by reference from our Registration Statement on Form S-1 (Registration
No. 333-111928) which was declared effective on March 30,
2004.
|
||
(2)
|
Incorporated
by reference from our Annual Report on Form 10-K filed with the SEC on
March 25, 2005.
|
||
(3)
|
Incorporated
by reference from our Definitive Proxy Statement on Form 14A filed with
the SEC on April 28, 2008.
|
44
SIGNATURE
Pursuant
to the requirements of Section 13 or 15(d) of The Securities Exchange Act
of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized, in the city of Brisbane, State of
California, on the 2nd day of November, 2009.
CUTERA,
INC.
|
/S/
RONALD J. SANTILLI
|
Ronald
J. Santilli
|
Executive Vice President and Chief Financial Officer
|
(Principal
Financial and Accounting Officer)
|
45