IRIDEX CORP - Quarter Report: 2005 October (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 10-Q
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
For
the
quarterly period ended October 1, 2005
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
For
the
Transition period
from
to
Commission
File Number: 0-27598
IRIDEX
CORPORATION
(Exact
name of registrant as specified in its charter)
Delaware
|
77-0210467
|
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
employer identification
No.)
|
1212
Terra Bella Avenue
Mountain
View, California 94043-1824
(Address
of principal executive offices, including zip code)
(650)
940-4700
(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 o
Indicate
by check mark whether the registrant is an accelerated filer (as defined in
Rule
12b-2 of the Exchange Act). Yes o No x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No
x
APPLICABLE
TO CORPORATE ISSUERS:
The
number of shares of common stock, $.01 par value, issued and outstanding as
of
November 11, 2005 was 7,497,361.
IRIDEX
Corporation
Table
of Contents
Page
|
||
PART
I.
|
FINANCIAL
INFORMATION
|
|
Item
1.
|
Condensed
Consolidated Financial Statements
(unaudited)
|
|
3
|
||
4
|
||
|
||
5
|
||
|
||
6
|
||
|
||
7
|
||
|
||
Item
2.
|
14
|
|
|
||
Item
3.
|
30
|
|
|
||
Item
4.
|
31
|
|
|
||
PART
II.
|
OTHER
INFORMATION
|
|
|
||
Item
1.
|
32
|
|
|
||
Item
2.
|
32
|
|
|
||
Item
3.
|
32
|
|
|
||
Item
4.
|
32
|
|
|
||
Item
5.
|
32
|
|
|
||
Item
6.
|
32
|
|
|
||
33
|
||
|
||
CERTIFICATIONS
|
35
|
|
|
||
Exhibit
31.1
|
Certification
of Chief Executive Officer pursuant to Securities Exchange Act
Rules
13a-14(a) and 15d-14(a)
|
|
Exhibit
31.2
|
Certification
of Chief Financial Officer pursuant to Securities Exchange Act
Rules
13a-14(a) and 15d-14(a)
|
|
Exhibit
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
|
Part
I.
|
FINANCIAL
INFORMATION
|
Item
1. Condensed Consolidated Financial Statements
IRIDEX
Corporation
Condensed
Consolidated Balance Sheets
(in
thousands)
(unaudited)
October
1,
2005
|
January
1,
2005
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
11,055
|
$
|
10,381
|
|||
Available-for-sale
securities
|
9,017
|
3,323
|
|||||
Accounts
receivable, net
|
6,857
|
7,404
|
|||||
Inventories
|
9,327
|
8,922
|
|||||
Prepaids
and other current assets
|
763
|
814
|
|||||
Current
deferred income taxes
|
1,808
|
1,808
|
|||||
Total
current assets
|
38,827
|
32,652
|
|||||
Long
term portion available-for-sale securities
|
-
|
4,324
|
|||||
Property
and equipment, net
|
845
|
852
|
|||||
Deferred
income taxes
|
1,265
|
1,265
|
|||||
Total
assets
|
$
|
40,937
|
$
|
39,093
|
|||
|
|||||||
Liabilities
and Stockholders’ Equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,188
|
$
|
1,233
|
|||
Accrued
expenses
|
4,693
|
5,167
|
|||||
Deferred
revenue
|
1,242
|
910
|
|||||
Total
liabilities
|
7,123
|
7,310
|
|||||
Contingencies (Note 4) | |||||||
Stockholders’
equity:
|
|||||||
Common
stock
|
76
|
74
|
|||||
Additional
paid-in capital
|
26,030
|
25,281
|
|||||
Accumulated
other comprehensive loss
|
(44
|
)
|
(35
|
)
|
|||
Treasury
stock
|
(430
|
)
|
(430
|
)
|
|||
Retained
earnings
|
8,182
|
6,893
|
|||||
Total
stockholders’ equity
|
33,814
|
31,783
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
40,937
|
$
|
39,093
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
IRIDEX
Corporation
Condensed
Consolidated Statements of
Operations
(in
thousands, except per share data)
(unaudited)
Three
Months Ended
|
Nine
Months Ended
|
||||||||||||
October
1,
2005
|
October
2,
2004
|
October
1,
2005
|
October
2,
2004
|
||||||||||
Sales
|
$
|
9,081
|
$
|
8,178
|
$
|
26,613
|
$
|
23,679
|
|||||
Cost
of sales
|
4,202
|
4,708
|
13,511
|
13,187
|
|||||||||
Gross
profit
|
4,879
|
3,470
|
13,102
|
10,492
|
|||||||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
1,172
|
1,025
|
3,133
|
3,409
|
|||||||||
Sales,
general and administrative
|
2,990
|
3,855
|
8,852
|
8,452
|
|||||||||
Total
operating expenses
|
4,162
|
4,880
|
11,985
|
11,861
|
|||||||||
Income
(loss) from operations
|
717
|
(1,410
|
)
|
1,117
|
(1,369
|
)
|
|||||||
Interest
and other income, net
|
157
|
83
|
413
|
212
|
|||||||||
Income
before income taxes
|
874
|
(1,327
|
)
|
1,530
|
(1,157
|
)
|
|||||||
(Provision
for) benefit from income taxes
|
5
|
607
|
(241
|
)
|
553
|
||||||||
Net
income (loss)
|
$
|
879
|
$
|
(720
|
)
|
$
|
1,289
|
$
|
(604
|
)
|
|||
Net
income (loss) per share - basic
|
$
|
0.12
|
$
|
(
0.10
|
)
|
$
|
0.17
|
$
|
(
0.08
|
)
|
|||
Net
income (loss) per share - diluted
|
$
|
0.11
|
$
|
(
0.10
|
)
|
$
|
0.16
|
$
|
(
0.08
|
)
|
|||
Shares
used in computing net income (loss) per share - basic
|
7,441
|
7,244
|
7,373
|
7,171
|
|||||||||
Shares
used in computing net income (loss) per share - diluted
|
8,102
|
7,244
|
7,885
|
7,171
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
IRIDEX
Corporation
Condensed
Consolidated Statements of Cash
Flows
(in
thousands)
(unaudited)
Nine
Months Ended
|
|||||||
October
1,
|
October
2,
|
||||||
2005
|
2004
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
income (loss)
|
$
|
1,289
|
$
|
(604
|
)
|
||
Adjustments
to reconcile net income (loss) to net cash provided by operating
activities:
|
|||||||
Depreciation
and amortization
|
320
|
296
|
|||||
Warrants
issued for services
|
87
|
--
|
|||||
Provision
for doubtful accounts
|
38
|
287
|
|||||
Provision
for inventories
|
167
|
429
|
|||||
Deferred
income taxes.
|
--
|
(607
|
)
|
||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable
|
509
|
(255
|
)
|
||||
Inventories
|
(572
|
)
|
(113
|
)
|
|||
Prepaids
and other current assets
|
51
|
196
|
|||||
Accounts
payable
|
(45
|
)
|
(79
|
)
|
|||
Accrued
expenses
|
(469
|
)
|
1,233
|
||||
Deferred
revenue
|
332
|
193
|
|||||
Net
cash provided by operating activities
|
1,707
|
976
|
|||||
|
|||||||
Cash
flows from investing activities:
|
|||||||
Purchases
of available-for-sale securities
|
(5,592
|
)
|
(8,960
|
)
|
|||
Proceeds
from maturity of available-for-sale securities
|
4,222
|
5,181
|
|||||
Acquisition
of property and equipment
|
(327
|
)
|
(218
|
)
|
|||
Net
cash used in investing activities
|
(
1,697
|
)
|
(3,997
|
)
|
|||
|
|||||||
Cash
flows from financing activities:
|
|||||||
Issuance
of common stock
|
664
|
1,092
|
|||||
Net
cash provided by financing activities
|
664
|
1,092
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
674
|
(1,929
|
)
|
||||
|
|||||||
Cash
and cash equivalents at beginning of period
|
10,381
|
10,541
|
|||||
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
11,055
|
$
|
8,612
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
IRIDEX
Corporation
Condensed
Consolidated Statements of Comprehensive Income
(loss)
(in
thousands)
(unaudited)
Three
Months Ended
|
Nine
Months Ended
|
||||||||||||
October
1,
|
October
2,
|
October
1,
|
October
2,
|
||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Net
income (loss)
|
$
|
879
|
$
|
(720
|
)
|
$
|
1,289
|
$
|
(604
|
)
|
|||
Other
comprehensive income (loss):
|
|||||||||||||
Change
in unrealized loss on available-for-sale securities
|
4
|
9
|
(9
|
)
|
(19
|
)
|
|||||||
Comprehensive
income (loss)
|
$
|
883
|
$
|
(711
|
)
|
$
|
1,280
|
$
|
(623
|
)
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
IRIDEX
Corporation
Notes
to Unaudited Condensed Consolidated Financial Statements
1.
|
Basis
of Presentation
|
The
accompanying unaudited condensed consolidated financial statements of IRIDEX
Corporation (“the Company”) have been prepared in accordance with generally
accepted accounting principles in the United States of America for interim
financial information and pursuant to the instructions to Form 10-Q and Article
10-01 of Regulation S-X. Accordingly, they do not include all of the information
and footnotes required by accounting principles generally accepted in the United
States of America for complete financial statements. In the opinion of
management, all adjustments, consisting of normal recurring adjustments,
considered necessary for a fair presentation have been included.
The
condensed consolidated financial statements should be read in conjunction with
the audited financial statements and notes thereto, together with management’s
discussion and analysis of financial condition and results of operations,
contained in our Annual Report on Form 10-K for the fiscal year ended January
1,
2005, which was filed with the Securities and Exchange Commission on April
1,
2005. The results of operations for the three month period ended October 1,
2005
are not necessarily indicative of the results for the year ending December
31,
2005 or any future interim period.
2.
|
Summary
of Significant Accounting
Policies
|
The
Company’s significant accounting policies are disclosed in our Annual Report on
Form 10-K for the year ended January 1, 2005 which was filed with the Securities
and Exchange Commission on April 1,
2005.
The Company’s significant accounting policies have not materially changed as of
October 1, 2005.
Deferred
Revenue
Deferred
revenue related to warranty contracts is recognized on a straight line basis
over the period of the applicable contract. Cost is recognized as incurred.
A
reconciliation of changes in the Company’s deferred revenue balances for the
nine months ended October 1, 2005 and October 2, 2004 follows (in
thousands):
Nine
Months Ended
|
|||||||
October
1, 2005
|
October
2, 2004
|
||||||
Balance,
beginning of period
|
$
|
910
|
$
|
596
|
|||
Additions
to deferral
|
1,135
|
787
|
|||||
Revenue
recognized
|
(803
|
)
|
(594
|
)
|
|||
Balance,
end of period
|
$
|
1,242
|
$
|
789
|
Warranty
The
Company accrues for an estimated warranty cost upon shipment of products in
accordance with Statement of Financial Accounting Standards (“SFAS”) No. 5,
“Accounting for Contingencies.” Actual warranty costs incurred have not
materially differed from those accrued. The Company’s warranty policy is
effective for shipped products which are considered defective or fail to meet
the product specifications. Warranty costs are reflected in the statement of
operations as a cost of sales. A reconciliation of the changes in the Company’s
warranty liability for the nine months ended October 1, 2005 and October 2,
2004
follows (in thousands):
Nine
Months Ended
|
|||||||
October
1, 2005
|
October
2, 2004
|
||||||
Balance,
beginning of period
|
$
|
933
|
$
|
801
|
|||
Accruals
for warranties issued during the period
|
955
|
441
|
|||||
Settlements
made in kind during the period
|
(789
|
)
|
(393
|
)
|
|||
Balance,
end of period
|
$
|
1,099
|
$
|
849
|
Accounting
for Stock-Based Compensation
The
Company accounts for stock-based compensation arrangements in accordance with
provisions of Accounting Principles Board Opinion (“APB”) No. 25, “Accounting
for Stock Issued to Employees” and complies with the disclosure provisions of
SFAS No. 123, “Accounting for Stock-Based Compensation,” as amended by SFAS No.
148, “Accounting for Stock-Based Compensation - Transition and Disclosure - an
Amendment of FASB Statement No. 123.”
Under
APB
25, compensation expense for grants to employees is based on the difference,
if
any, on the date of the grant, between the fair value of the Company’s stock and
the option’s exercise price. SFAS 123 defines a “fair value” based method of
accounting for an employee stock option or similar equity investment. The pro
forma disclosure of the difference between compensation expense included in
net
income and the related cost measured by the fair value method is presented
below.
The
following table provides a reconciliation of net income to pro forma net income
(loss) as if the fair value method had been applied to all employee awards
(in
thousands, except per share data):
Three
Months Ended
|
Nine
Months Ended
|
||||||||||||
October
1, 2005
|
October
2, 2004
|
October
1, 2005
|
October
2, 2004
|
||||||||||
Net
income (loss), as reported
|
$
|
879
|
$
|
(720
|
)
|
$
|
1,289
|
$
|
(604
|
)
|
|||
Add:
Total stock based compensation expense, net of tax, determined under
fair
value based method for all awards to employees
|
(205
|
)
|
(152
|
)
|
(537
|
)
|
(418
|
)
|
|||||
Pro
forma net income (loss)
|
$
|
674
|
$
|
(872
|
)
|
$
|
752
|
$
|
(1,022
|
)
|
|||
Basic
net income (loss) per share:
|
|||||||||||||
As
reported
|
$
|
0.12
|
($
0.10
|
)
|
$
|
0.17
|
($
0.08
|
)
|
|||||
Pro
forma
|
$
|
0.09
|
($
0.12
|
)
|
$
|
0.10
|
($
0.14
|
)
|
|||||
Diluted
net income (loss) per share:
|
|||||||||||||
As
reported
|
$
|
0.11
|
($
0.10
|
)
|
$
|
0.16
|
($
0.08
|
)
|
|||||
Pro
forma
|
$
|
0.08
|
($
0.12
|
)
|
$
|
0.10
|
($
0.14
|
)
|
The
determination of fair value of all options granted by the Company is computed
based on the following assumptions:
|
Employee
Stock Option Plan
|
Employee
Stock Option Plan
|
Employee
Stock Purchase Plan
|
Employee
Stock Purchase Plan
|
||||
|
Three
Months Ended
|
Nine
Months Ended
|
Three
Months Ended
|
Nine
Months Ended
|
||||
|
October
1, 2005
|
October
2, 2004
|
October
1, 2005
|
October
2, 2004
|
October
1, 2005
|
October
2, 2004
|
October
1, 2005
|
October
2, 2004
|
Average
risk free interest rate
|
4.04%
|
4.25%
|
4.13%
|
5.10%
|
3.68%
|
1.95%
|
3.25%
|
1.36%
|
Expected
life (in years)
|
3
|
2
|
3
|
2
|
0.5
|
0.5
|
0.5
|
0.5
|
Dividend
yield
|
--
|
--
|
--
|
--
|
--
|
--
|
--
|
--
|
Average
volatility
|
84.0%
|
87.0%
|
84.0%
|
87.0%
|
83.0%
|
87.0%
|
84.0%
|
87.0%
|
3.
|
Inventories
|
Inventories
are stated at the lower of cost or market. Cost is based on actual sales
computed on a first in, first out basis. The components of inventories consist
of the following (in thousands):
October
1,
2005
|
January
1,
2005
|
||||||
Raw
materials and work in progress
|
$
|
5,609
|
$
|
5,460
|
|||
Finished
goods
|
3,718
|
3,462
|
|||||
Total
inventories
|
$
|
9,327
|
$
|
8,922
|
4.
|
Contingencies
|
From
time
to time, the Company may be engaged in certain administrative proceedings,
incidental to its normal business activities. Management believes that
liabilities resulting from such proceedings, or claims which are pending or
known to be threatened, are adequately covered by liability insurance and will
not have a material adverse effect on the Company’s financial position or
results of operations.
5.
|
Computations
of Net Income (Loss) Per Common Share
|
Basic
and
diluted net income (loss) per share are computed by dividing net income (loss)
for the period by the weighted average number of shares of common stock
outstanding during the period. The calculation of diluted net income per share
includes the dilutive effect of potentially dilutive common stock provided
the
inclusion of such potential common stock is not antidilutive. Potential common
stock consists of incremental common shares issuable upon the exercise of stock
options.
A
reconciliation of the numerator and denominator of net income (loss) per common
share and diluted net income (loss) per common share is as follows (in
thousands, except per share amounts):
Three
Months Ended
|
Nine
Months Ended
|
|||
October
1, 2005
|
October
2, 2004
|
October
1, 2005
|
October
2, 2004
|
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
|
Numerator—Net
income (loss) per common share and diluted net income per common
share
|
||||
Net
income (loss)
|
$
879
|
($
720)
|
$
1,289
|
($
604)
|
Denominator—Net
income per common share
Weighted
average
common stock outstanding
|
7,441
|
7,244
|
7,373
|
7,171
|
Basic
net income (loss) per common share
|
$
0.12
|
($
0.10)
|
$
0.17
|
($
0.08)
|
Denominator—
Diluted net income (loss) per common share
|
||||
Weighted
average
common stock outstanding
|
7,441
|
7,244
|
7,373
|
7,171
|
Effect
of dilutive securities
Weighted
average
common stock options
|
661
|
-
|
512
|
-
|
Total
weighted average stock and options outstanding
|
8,102
|
7,244
|
7,885
|
7,171
|
Diluted
net income (loss) per common share
|
$
0.11
|
($
0.10)
|
$
0.16
|
($
0.08)
|
During
the three months ended October 1, 2005 options to purchase 306,196 shares of
common stock at a weighted average exercise price of $9.17 per share were not
included in the computations of diluted net income per common share because
the
exercise price of the related options exceeded the average market price of
the
common shares. During the nine months ended October 1, 2005 options to purchase
488,832 shares at a weighted average exercise price of $8.32 were outstanding,
but were not included in the computations of diluted net income per share
because the exercise price of the related options exceeded the average market
price of the common shares. During the three and nine months ended October
2,
2004, options to purchase 1,861,275 shares at a weighted average exercise price
of $ 5.40 were outstanding, but were not included in the computations of diluted
net loss per share because their effect was antidilutive. These options could
dilute earnings per share in future periods.
6.
|
Business
Segments
|
We
operate in two reportable segments: the ophthalmology medical device segment
and
the dermatology medical device segment. In both segments, we develop,
manufacture and market medical devices. Our revenues arise from the sale of
consoles, delivery devices, disposables and service and support
activities.
Information
on reportable segments for the three and nine months ended October 1, 2005
and
October 2,
2004
is as follows (in thousands):
Three
Months Ended October 1, 2005
|
Three
Months Ended October 2, 2004
|
||||||||||||||||||
Ophthalmology
Medical Devices
|
Dermatology
Medical Devices
|
Total
|
Ophthalmology
Medical Devices
|
Dermatology
Medical Devices
|
Total
|
||||||||||||||
Sales
|
$
|
7,883
|
$
|
1,198
|
$
|
9,081
|
$
|
7,193
|
$
|
985
|
$
|
8,178
|
|||||||
Direct
Cost of Goods Sold
|
2,461
|
465
|
2,926
|
2,641
|
717
|
3,358
|
|||||||||||||
Direct
Gross Margin
|
5,422
|
733
|
6,155
|
4,552
|
268
|
4,820
|
|||||||||||||
Total
Unallocated Costs
|
(5,281
|
)
|
(6,147
|
)
|
|||||||||||||||
Pre-tax
income (loss)
|
$ |
874
|
$
|
(1,327
|
)
|
Nine
Months Ended October 1, 2005
|
Nine
Months Ended October 2, 2004
|
||||||||||||||||||
Ophthalmology
Medical Devices
|
Dermatology
Medical Devices
|
Total
|
Ophthalmology
Medical Devices
|
Dermatology
Medical Devices
|
Total
|
||||||||||||||
Sales
|
$
|
21,764
|
$
|
4,849
|
$
|
26,613
|
$
|
20,122
|
$
|
3,557
|
$
|
23,679
|
|||||||
Direct
Cost of Goods Sold
|
7,219
|
2,393
|
9,612
|
7,096
|
2,141
|
9,237
|
|||||||||||||
Direct
Gross Margin
|
14,545
|
2,456
|
17,001
|
13,026
|
1,416
|
14,422
|
|||||||||||||
Total
Unallocated Costs
|
(15,471
|
)
|
(15,599
|
)
|
|||||||||||||||
Pre-tax
income (loss)
|
$
|
1,530
|
$
|
(1,157
|
)
|
Indirect
costs of manufacturing, research and development, and selling, general and
administrative costs are not allocated to the segments.
7. |
Warrant
to Purchase Common Stock
|
On
July
5, 2005, in consideration for services performed under a recruiting contract,
the Company issued a warrant to purchase 25,000 shares of the Company's common
stock at an exercise price of $6.07 per share. The warrant is exercisable at
any
time and expires in July 5, 2008. The fair value of the warrants of
$87,000 was recorded as an expense for the nine month period ended October
1, 2005. The fair value of the warrant was calculated using the Black-Scholes
pricing model with the following assumptions: divided yield 0 percent,
contractual life of 3 years, risk free rates of 4.04 percent and
volatility of 83 percent. At October 1, 2005, all the warrant remains
outstanding.
The
Company’s assets and liabilities are not evaluated on a segment basis.
Accordingly, no disclosure on segment assets and liabilities is
provided.
8.
|
Subsequent
Events
|
In
October 2005, the Company announced that it filed suit against Synergetics
USA,
Inc. for infringement of the IRIDEX Patent No. 5,085,492 entitled “Optical Fiber
with Electrical Encoding” covering its laser probe technology. The suit seeks
monetary damages as well as a permanent injunction against continued
infringement by Synergetics for the sale of its Quick Disconnect laser probes
and its Quick Disconnect Laser Probe Adapter.
9.
|
Recent
Accounting Pronouncements
|
In
November 2004, the Financial Accounting Standards Board, or FASB issued SFAS
No.
151, Inventory Costs, an amendment of Accounting Research Bulletin, or ARB,
No.
43, Chapter 4. SFAS No. 151 clarifies the accounting for abnormal amounts of
idle facility expense, freight, handling costs and wasted material. SFAS No.
151
is effective for inventory costs incurred during fiscal years beginning after
June 15, 2005. We do not believe the adoption of SFAS No. 151 will have a
material effect on our financial position, results of operations or cash
flows.
In
December 2004, the FASB issued SFAS No. 123R, Share-Based Payment, which will
replace SFAS No. 123 and supersede APB 25. SFAS No. 123R addresses the
accounting for share-based payment transactions in which a company receives
employee services in exchange for either equity instruments of the company
or
liabilities that are based on the fair value of the company's equity instruments
or that may be settled by the issuance of such equity instruments. Under SFAS
No. 123R, companies will no longer be able to account for share-based
compensation transactions using the intrinsic method in accordance with APB
25,
but will be required to account for such transactions using a fair-value method
and recognize the expense in the consolidated statement of earnings. SFAS No.
123R is effective at the beginning of fiscal 2006. We have not yet determined
which fair-value method and transitional provision we will follow and have
not
yet determined the impact on our financial statements of SFAS No.
123R.
In
March
2005, the SEC issued Staff Accounting Bulletin No. 107, “Share-Based
Payment” (“SAB
107”).
SAB 107
provides guidance on the initial implementation of SFAS 123R. In particular,
the
statement includes guidance related to share-based payment awards for
non-employees, valuation methods and selecting underlying assumptions such
as
expected volatility and expected term. SAB 107 also gives guidance on the
classification of compensation expense associated with such awards and
accounting for the income tax effects of those awards upon the adoption of
SFAS
123R. We are currently assessing the guidance provided in SAB 107 in connection
with the implementation of SFAS 123R.
In
April
2005, the SEC announced the adoption of a new rule that amends the effective
date of SFAS 123R. The effective date of the new standard under these new rules
for our financial statements is January 1, 2006. Adoption of this statement
is
expected to have a significant impact on our financial statements as we will
be
required to expense the fair value of our stock option grants and stock
purchases under our employee stock purchase plan (“ESPP”) rather than disclose
the impact on our net loss within our footnotes, as is our current practice.
The
full impact of SFAS 123R on our financial statements and related disclosures
is
still being evaluated by management but is expected to be material to our
results of operations. Our actual share-based compensation expense in 2006
will
be dependent on a number of factors, including the amount of awards granted
and
the fair value of those awards at the time of grant.
Item
2.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF
FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
This
Quarterly Report on Form 10-Q contains trend analysis and other forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933,
as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended,
such as statements relating to levels of future sales and operating results,
actual order rate and market acceptance of our products; expectations for future
sales growth, generally, including expectations of additional sales from our
new
products and new applications of our existing products; the potential for
production cost decreases and higher gross margins; our ability to develop
and
introduce new products through strategic alliances; favorable Center for
Medicare and Medicaid coverage decisions regarding AMD procedures that use
our
products; results of clinical studies and risks associated with bringing new
products to market; general economic conditions; and levels of international
sales. In some cases, forward-looking statements can be identified by
terminology, such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“believes,” “estimates,” “predicts,” “intends,” “potential,” “continue,” or the
negative of such terms or other comparable terminology. These statements involve
known and unknown risks, uncertainties and other factors which may cause our
actual results, performance or achievements to differ materially from those
expressed or implied by such forward-looking statements, including as a result
of the factors set forth under “Factors That May Affect Future Operating
Results” and other risks detailed in our Annual Report on Form 10-K filed with
the Securities and Exchange Commission on April 1, 2005 and detailed from time
to time in our reports filed with the Securities and Exchange Commission. The
reader is cautioned not to place undue reliance on these forward-looking
statements, which reflect management’s analysis only as of the date of this Form
10-Q. We undertake no obligation to update such forward-looking statements
to
reflect events or circumstances occurring after the date of this
report.
Results
of Operations
The
following table sets forth certain operating data as a percentage of sales
for
the periods indicated.
Three
Months Ended
|
Nine
Months Ended
|
||||||||||||
October
1,
|
October
2,
|
October
1,
|
October
2,
|
||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Sales
|
100.0
|
%
|
100.0
|
%
|
100.0
|
%
|
100.0
|
%
|
|||||
Cost
of sales
|
46.3
|
%
|
57.6
|
%
|
50.8
|
%
|
55.7
|
%
|
|||||
Gross
profit
|
53.7
|
%
|
42.4
|
%
|
49.2
|
%
|
44.3
|
%
|
|||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
12.9
|
%
|
12.5
|
%
|
11.8
|
%
|
14.4
|
%
|
|||||
Sales,
general and administrative
|
32.9
|
%
|
47.2
|
%
|
33.2
|
%
|
35.7
|
%
|
|||||
Total
operating expenses
|
45.8
|
%
|
59.7
|
%
|
45.0
|
%
|
50.1
|
%
|
|||||
|
|||||||||||||
Income
(loss) from operations
|
7.9
|
%
|
(17.2
|
)%
|
4.2
|
%
|
(5.8
|
)%
|
|||||
Interest
and other income, net
|
1.7
|
%
|
1.0
|
%
|
1.5
|
%
|
0.9
|
%
|
|||||
Income
(loss) before income taxes
|
9.6
|
%
|
(16.2
|
)%
|
5.7
|
%
|
(4.9
|
)%
|
|||||
(Provision
for) benefit from income taxes
|
0.0
|
%
|
7.4
|
%
|
(0.9
|
%)
|
2.3
|
%
|
|||||
Net
income (loss)
|
9.6
|
%
|
(8.8
|
)%
|
4.8
|
%
|
(2.6
|
)%
|
The
following table sets forth for the periods indicated the amount of sales for
our
operating segments and sales as a percentage of total sales.
Three
Months Ended
|
Nine
Months Ended
|
||||||||||||||||||||||||
October
1, 2005
|
October
2, 2004
|
October
1, 2005
|
October
2, 2004
|
||||||||||||||||||||||
Amount
|
Percentage
of total sales
|
Amount
|
Percentage
of total sales
|
Amount
|
Percentage
of total sales
|
Amount
|
Percentage
of total sales
|
||||||||||||||||||
Domestic
|
$
|
5,787
|
63.7
|
%
|
$
|
5,161
|
63.1
|
%
|
$
|
16,438
|
61.8
|
%
|
$
|
14,162
|
59.8
|
%
|
|||||||||
International
|
3,294
|
36.3
|
%
|
3,017
|
36.9
|
%
|
10,175
|
38.2
|
%
|
9,517
|
40.2
|
%
|
|||||||||||||
Total
|
9,081
|
100.0
|
%
|
8,178
|
100.0
|
%
|
26,613
|
100.0
|
%
|
23,679
|
100.0
|
%
|
|||||||||||||
Ophthalmology:
|
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Domestic
|
4,733
|
52.1
|
%
|
4,541
|
55.5
|
%
|
12,481
|
46.9
|
%
|
11,964
|
50.5
|
%
|
|||||||||||||
International
|
3,150
|
34.7
|
%
|
2,652
|
32.4
|
%
|
9,283
|
34.9
|
%
|
8,157
|
34.5
|
%
|
|||||||||||||
Total
|
7,883
|
86.8
|
%
|
7,193
|
87.9
|
%
|
21,764
|
81.8
|
%
|
20,121
|
85.0
|
%
|
|||||||||||||
Dermatology:
|
|||||||||||||||||||||||||
Domestic
|
1,054
|
11.6
|
%
|
620
|
7.6
|
%
|
3,957
|
14.9
|
%
|
2,198
|
9.3
|
%
|
|||||||||||||
International
|
144
|
1.6
|
%
|
365
|
4.5
|
%
|
892
|
3.3
|
%
|
1,360
|
5.7
|
%
|
|||||||||||||
Total
|
$
|
1,198
|
13.2
|
%
|
$
|
985
|
12.1
|
%
|
$
|
4,849
|
18.2
|
%
|
$
|
3,558
|
15.0
|
%
|
Ophthalmology
Sales
Ophthalmology
sales increased 9.6% to $7.9 million for the three months ended October 1,
2005
from $7.2 million for the three months ended October 2, 2004. For the nine
months ended October 1, 2005, ophthalmology sales increased 8.2% to $21.8
million from $20.1 million for the nine months ended October 2, 2004. For the
three month period ended October 1, 2005, domestic ophthalmology sales increased
4.2% to $4.7 million from $4.5 million for the three months ended October 2,
2004 due to approximately $0.1 million in increased unit sales of laser
consoles and a $0.1 million increase in unit sales of delivery devices. Domestic
ophthalmology sales increased 4.3% for the nine months ended October 1, 2005
to
$12.5 million from $12.0 million for the nine months ended October 2, 2004
due
to a $0.7 million increase in unit sales of laser consoles (primarily to our
OEM
ophthalmology customers) and service revenue offset by a $0.2 million decrease
in unit sales of delivery devices. International ophthalmology sales increased
18.8% to $3.2 million for the three months ended October 1, 2005 from $2.7
million for the three months ended October 2, 2004. The increase in
international ophthalmology sales during this period was due to a $0.4 million
increase in unit sales of laser consoles and a $0.1 million increase in unit
sales of delivery devices. For the nine months ended October 1, 2005,
international ophthalmology sales increased 13.8% to $9.3 million from $8.2
million for the nine months ended October 2, 2004 due to a $0.8 million increase
in unit sales of laser consoles and service and a $0.3 million increase in
unit
sales of delivery devices.
Dermatology
Sales
Primarily
based on strong domestic sales of our dual-wave length VariLite laser,
introduced in late 2004, dermatology sales increased 21.6% to $1.2 million
for
the three months ended October 1, 2005 from $1.0 million for the three months
ended October 2, 2004. For the nine months ended October 1, 2005 dermatology
sales increased 36.3% to $4.8 million from $3.6 million for the nine months
ended October 2, 2004. Domestic dermatology sales increased 70.0% to $1.1
million for the three month period ended October 1, 2005 from $0.6 million
for
the comparable prior year three month period due primarily to a $0.4 million
increase in unit sales of laser consoles. For the nine months ended October
1,
2005 domestic dermatology sales increased 80.0% to $4.0 million from $2.2
million due to a $1.8 million increase in unit sales of laser consoles and
domestic dermatology service revenue. International dermatology sales for both
the three and nine month periods ended October 1, 2005 decreased primarily
as a
result of the level of sales in 2004 associated with our hair removal laser
on
which we offered decreased average selling prices based on our decision to
discontinue the product. Specifically, international dermatology sales decreased
60.5% to $0.1 million for the three months ended October 1, 2005 from $0.4
million for the three months ended October 2, 2004 primarily due to a $0.2
million decrease in unit sales of our hair removal laser consoles and a $0.1
million decrease in service revenue. For the nine months ended October 1, 2005,
international dermatology sales decreased 34.4% to $0.9 million from $1.4
million due to a $0.9 million decrease in unit sales of our discontinued hair
removal laser offset by an increase of $0.4 million in unit sales of other
laser
consoles. Dermatology procedures are typically elective procedures that are
deferred by patients in difficult economic times. See “-Factors that May Affect
Future Results - Our Business Has Been Adversely Impacted by the Worldwide
Economic Slowdown and Related Uncertainties.”
Gross
Profit.
Our
gross profit increased by $1.4 million to $4.9 million for the three month
periods ended October 1, 2005 compared to $3.5 million for the three months
ended October 2, 2004. Gross profit as a percentage of sales for the three
months ended October 1, 2005 increased to 53.7% from 42.4% for the comparable
prior year three month period. The
improvement in our gross margin was fueled in particular by atypically high
gross margins on certain non-recurring domestic OEM ophthalmology
products. The total 11.2% increase in gross profit as a percentage
of sales during this period included an increase of 8.0% relating to lower
product costs including product mix (such
as
the mix impact of the OEM ophthalmology products), inventory
reserves and warranty charges as well as an increase of 3.7% due to lower
manufacturing overhead spending offset by a 0.5% decrease due to reduced average
selling prices. For the nine months ended October 1, 2005, gross profit
increased by $2.6 million to $13.1million from $10.5 million for the nine months
ended October 2, 2004. Gross profit as a percentage of sales for the nine months
ended October 1, 2005 increased to 49.2% from 44.3%. The total 4.9% increase
in
gross profit as a percentage of sales related to an increase of 2.9% associated
with decreased manufacturing spending as a percent of sales, an increase of
2.8%
due to lower product costs including product mix and the change in inventory
reserves and warranty charges offset by an increase of 0.8% for lower average
selling prices. While we believe in the next few years that we can achieve
the type of operating efficiencies necessary to consistently reach the level
of
gross margin reported as of October 1, 2005, we expect margins for the next
year or so to be below the atypically high level achieved for the third quarter
of fiscal year 2005. Although increasing competition has continued to
result in a downward trend in average selling prices for some products, we
intend to continue our efforts to reduce the cost of components and
manufacturing and thereby mitigate the impact of price reductions on our gross
profit. In addition, as we evaluate gross margins on each of our product lines,
we may choose to place greater focus on product lines with better margins.
See
“-Factors That May Affect Future Results - If We Cannot Increase Our Sales
Volumes, Reduce Our Costs or Introduce Higher Margin Products to Offset
Anticipated Reductions in the Average Unit Selling Price of our Products, Our
Operating Results May Suffer.” We expect our gross profit margins to continue to
fluctuate due to changes in the relative proportions of domestic and
international sales, mix of sales of existing products, pricing, product costs
and a variety of other factors. See “-Factors That May Affect Future Results -
Our Operating Results May Fluctuate from Quarter to Quarter and Year to
Year.”
Research
and Development.
Our
research and development expenses increased by 14.3% to $1.2 million for the
three months ended October 1, 2005 from $1.0 million for the three months ended
October 2, 2004. Research and development expenses increased as a percentage
of
sales to 12.9% for the three months ended October 1, 2005 from 12.5% for the
comparable prior year three-month period. The increase in research and
development expense in absolute dollars and as a percentage of sales for the
three month period ended October 1, 2005 was due primarily to increased spending
on engineering projects and associated consulting costs of $0.2 million. For
the
nine months ended October 1, 2005 research and development expenses decreased
8.1% to $3.1 million from $3.4 million for the nine months ended October 2,
2004. As a percentage of sales, research and development expense decreased
to
11.8% for the nine months ended October 1, 2005 from 14.4% for the nine months
ended October 2, 2004. The decrease in research and development expense in
absolute dollars and as a percentage of sales for the nine month period ended
October 1, 2005 was due primarily to $0.3 million in decreased spending on
engineering projects associated with the release of the VariLite and IQ810
products in 2004.
Sales,
General and Administrative.
Our
sales, general and administrative expenses decreased by 22.4% to $3.0 million
for the three months ended October 1, 2005 from $3.9 million for the three
months ended October 2, 2004. As a percentage of sales, sales, general and
administrative expenses decreased to 32.9% for the three months ended October
1,
2005 from 47.2% for the comparable prior year three-month period. The decrease
in sales, general and administrative expense in absolute dollars and as a
percentage of sales for the three month period ended October 1, 2005 as compared
to the three month period ended October 2, 2004 was due primarily to a one
time
charge of $1.2 million for sales tax as well as a $0.3 million increase in
the
allowance for doubtful accounts in the third quarter of fiscal 2004 offset
by
$0.6 million in increased selling, general and administrative spending in the
third quarter of fiscal 2005. The $0.6 million increase in selling, general
and
administrative expense related mainly to $0.3 million in increased selling
expenses associated primarily with increased headcount and expenses associated
with increased revenue, the accrual of bonus for 2005 as well as $0.1 million
in
increased general and administrative costs. For the nine months ended October
1,
2005 sales, general and administrative expense increased 4.7% to $8.9 million
from $8.5 million for the nine months ended October 2, 2004. As a percentage
of
sales, sales, general and administrative expense decreased to 33.2% for the
nine
months ended October 1, 2005 from 35.7% for the nine months ended October 2,
2004. The increase in sales, general and administrative expense in absolute
dollars was due to net increases in spending for sales of $0.3 million and
marketing of $0.3 million offset by a net decrease in general and administrative
spending of $0.2 million. The increase in selling expense included $0.6 million
in increased spending primarily for increased headcount and expenses associated
with increased revenue offset by a $0.3 million increase in the third quarter
of
fiscal 2004 to the allowance for doubtful accounts. The $0.3 million increase
in
marketing expense was associated with increased spending on marketing programs.
The net decrease in general and administrative expense of $0.2 million included
a decrease of $1.2 million representing a one-time charge for sales tax offset
by increased general and administrative spending of $1.0 million due to
increased recruiting and headcount costs mainly for our new CEO, increased
consulting fees associated with preparation for Sarbanes-Oxley 404 compliance,
increased legal and other administrative spending. The decrease in sales,
general and administrative expense as a percentage of sales for the nine months
ended October 1, 2005 was based mainly on the increase in selling, general
and
administrative expense relative to the level of increased revenue during that
period.
Interest
and Other Income, net.
For the
three months ended October 1, 2005 we had net other income of $157,000 as
compared with net other income of $ 83,000 for the three months ended October
2,
2004. For the nine months ended October 1, 2005, net other income was $413,000
as compared with $212,000 for the nine months ended October 2, 2004. The change
in net other income for both the three and nine month periods was due primarily
to increased interest rates and to increased cash, cash equivalents and
available for sale securities.
Income
Taxes.
The
effective income tax rates for both the three and nine month periods ending
October 1, 2005 and October 2, 2004 were lower than the Federal and State
combined statutory rate of 40% because of certain tax benefits associated with
tax credits for research and development activities and due to the adjustment
of
certain tax reserves following the expiration of Federal and State statutes
of
limitations.
Liquidity
and Capital Resources
At
October 1, 2005, our primary sources of liquidity included cash and cash
equivalents and available-for-sale securities in the aggregate amount of $20.1
million. In addition, we have available $4 million under our unsecured line
of
credit which bears interest at the bank’s prime rate and expires in October
2006. As of October 1, 2005, no borrowings were outstanding under this credit
facility. We expect to renew the line of credit in October 2006, assuming that
the terms continue to be acceptable.
During
the nine months ended October 1, 2005, operating activities provided $1.7
million of cash. The primary sources of cash from operating activities included
net income of $1.3 million, a decrease in net accounts receivable of $0.5
million, an increase in deferred revenue of $0.3 million, depreciation of $0.3
million, the valuation of warrants for $0.1 million and a decrease in prepaid
expenses of $0.1 million offset by uses of cash which included a $0.5 million
decrease in accrued expenses and an increase in net inventory of $0.4 million.
The decrease in accounts receivable resulted primarily from continued focus
on
collection efforts. The increase in deferred revenue related primarily to
increased extended service contracts and to advanced payment on revenue. The
decrease in accrued expenses was due mainly to payment of state sales taxes.
The
increase in net inventory was associated with new product
introductions.
Investing
activities used $1.7 million in cash and cash equivalents during the nine months
ended October 1, 2005, primarily due to net purchases of available for sale
securities of $1.4 million and by purchases of fixed assets of $0.3 million.
Net
cash
provided by financing activities during the nine months ended October 1, 2005
was $0.7 million which consisted of the issuance of common stock under employee
option plans and the employee stock purchase plan.
We
believe that, based on current estimates, our cash, cash equivalents and
available-for-sale securities together with cash generated from operations
and
our credit facility will be sufficient to meet our anticipated cash requirements
for at least the next 12 months. Our liquidity could be negatively affected
by a
decline in demand for our products, the need to invest in new product
development or reductions in spending by our customers as a result of the
continuing economic downturn or other factors. There can be no assurance that
additional debt or equity financing will be available when required or, if
available, can be secured on terms satisfactory to us. See “-Factors That May
Affect Future Results - We May Need Additional Capital, which May Not Be
Available, and Our Ability to Grow May Be Limited as a Result.”
In
December 1998, we instituted a stock repurchase program whereby up to 150,000
shares of our common stock may be repurchased in the open market. To date,
we
have purchased 103,000 shares of our common stock under this program. We have
utilized all of the reacquired shares for reissuance in connection with employee
stock programs. No shares were repurchased during the three months ended October
1, 2005. There are no plans to repurchase additional shares as the stock
repurchase program has been discontinued in 2005.
Critical
Accounting Policies
The
Company’s significant accounting policies are disclosed in our Annual Report on
Form 10-K for the year ended January 1, 2005 which was filed with the Securities
and Exchange Commission on April 1, 2005.
Recent
Accounting Pronouncements
In
November 2004, the Financial Accounting Standards Board, or FASB issued SFAS
No.
151, Inventory Costs, an amendment of Accounting Research Bulletin, or ARB,
No.
43, Chapter 4. SFAS No. 151 clarifies the accounting for abnormal amounts of
idle facility expense, freight, handling costs and wasted material. SFAS No.
151
is effective for inventory costs incurred during fiscal years beginning after
June 15, 2005. We do not believe the adoption of SFAS No. 151 will have a
material effect on our financial position, results of operations or cash
flows.
In
December 2004, the FASB issued SFAS No. 123R, Share-Based Payment, which will
replace SFAS No. 123 and supersede APB 25. SFAS No. 123R addresses the
accounting for share-based payment transactions in which a company receives
employee services in exchange for either equity instruments of the company
or
liabilities that are based on the fair value of the company’s equity instruments
or that may be settled by the issuance of such equity instruments. Under SFAS
No. 123R, companies will no longer be able to account for share-based
compensation transactions using the intrinsic method in accordance with APB
25,
but will be required to account for such transactions using a fair-value method
and recognize the expense in the consolidated statement of earnings. SFAS No.
123R is effective at the beginning of fiscal 2006. We have not yet determined
which fair-value method and transitional provision we will follow and have
not
yet determined the impact on our financial statements of SFAS No.
123R.
In
March
2005, the SEC issued Staff Accounting Bulletin No. 107, “Share-Based
Payment” (“SAB
107”).
SAB 107
provides guidance on the initial implementation of SFAS 123R. In particular,
the
statement includes guidance related to share-based payment awards for
non-employees, valuation methods and selecting underlying assumptions such
as
expected volatility and expected term. SAB 107 also gives guidance on the
classification of compensation expense associated with such awards and
accounting for the income tax effects of those awards upon the adoption of
SFAS
123R. We are currently assessing the guidance provided in SAB 107 in connection
with the implementation of SFAS 123R.
In
April
2005, the SEC announced the adoption of a new rule that amends the effective
date of SFAS 123R. The effective date of the new standard under these new rules
for our financial statements is January 1, 2006. Adoption of this statement
is
expected to have a significant impact on our financial statements as we will
be
required to expense the fair value of our stock option grants and stock
purchases under our employee stock purchase plan (“ESPP”) rather than disclose
the impact on our net loss within our footnotes, as is our current practice.
The
full impact of SFAS 123R on our financial statements and related disclosures
is
still being evaluated by management but is expected to be material to our
results of operations. Our actual share-based compensation expense in 2006
will
be dependent on a number of factors, including the amount of awards granted
and
the fair value of those awards at the time of grant.
Factors
That May Affect Future Results
We
Rely on Continued Market Acceptance of Our Existing Products and Any Decline
in
Sales of Our Existing Products Would Adversely Affect Our Business and Results
of Operations.
We
currently market visible and infrared light semiconductor-based photocoagulator
medical laser systems to the ophthalmic and dermatology market. We believe
that
continued and increased sales, if any, of these medical laser systems is
dependent upon a number of factors including the following:
§
|
Product
performance, features, ease of use, scalability and
durability;
|
§
|
Recommendations
by and opinions of ophthalmologists, dermatologists, other clinicians,
plastic surgeons and their associated opinion leaders, including
study
outcomes;
|
§
|
Price
of our products and prices of competing products and
technologies;
|
§
|
Availability
of competing products, technologies and alternative
treatments;
|
§
|
Willingness
of ophthalmologists and dermatologists to convert to semiconductor-based
or infrared laser systems from alternative technologies;
and
|
§
|
Level
of reimbursement for treatments administered with our
products.
|
In
addition, we derive a meaningful portion of our revenues from the sale of
delivery devices. Our ability to increase revenues from the sale of delivery
devices will depend primarily upon the features, ease of use and prices of
our
products, including the relationship to prices of competing delivery devices.
The level of service revenues will depend on our quality of care, responsiveness
and the willingness of our customers to request our services rather than
purchase competing products or services. Any significant decline in market
acceptance of our products or our revenues derived from the sales of laser
consoles, delivery devices or services would have a material adverse effect
on
our business, results of operations and financial condition.
We
Face Strong Competition in Our Markets and Expect the Level of Competition
to
Grow in the Foreseeable Future. Competition
in the market for devices used for ophthalmic and dermatology treatment
procedures is intense and is expected to increase. Our competitive position
depends on a number of factors including product performance, characteristics
and functionality, ease of use, scalability, durability and cost. Our principal
competitors in ophthalmology are Carl Zeiss, Inc., Alcon, Nidek, Inc., Lumenis
Ltd. and Synergetics. All of these companies currently offer a competitive
semiconductor-based laser system to be used in the ophthalmology
market. Also within ophthalmology pharmaceutical alternative treatments for
AMD
such as Visudyne (Novartis), Macugen (Eyetech) and Genentech (Lucentis) compete
rigorously with traditional laser procedures. Our principal competitors in
dermatology are Laserscope, Palomar Technologies, Candela Corporation, Lumenis
Ltd and Syneron. Some competitors have substantially greater financial,
engineering, product development, manufacturing, marketing and technical
resources than we do. Some companies also have greater name recognition than
we
do and long-standing customer relationships. In addition to other companies
that
manufacture photocoagulators, we compete with pharmaceuticals, other
technologies and other surgical techniques. Some medical companies, academic
and
research institutions, or others, may develop new technologies or therapies
that
are more effective in treating conditions targeted by us or are less expensive
than our current or future products. Any such developments could have a material
adverse effect on our business, financial condition and results of
operations.
Our
Future Success Depends on Our Ability to Develop and Successfully Introduce
New
Products and New Applications.
Our
future success is dependent upon, among other factors, our ability to develop,
obtain regulatory approval or clearance of, manufacture and market new products.
In the first nine months of 2005, we released six endo ocular
probes, three stepped EndoProbe, and one straight EndoProbe. In October
2004, we introduced two new laser products, the IQ810 in ophthalmology and
the
VariLite in dermatology. In May 2004, we introduced a new type of illuminating
EndoProbe. In June 2003 we began shipment of two new products; a 50 micron
slit
lamp adaptor and a 25 gauge single-use EndoProbe. In October 2002, we announced
the introduction of a number of new products, specifically the OcuLight Symphony
multi-wavelength laser delivery system, an expanded EndoProbe product line
and a
5 mm Large Spot Slit Lamp Adapter. We also announced the Millennium Endolase
module in 2002, which we manufacture to be included in Bausch & Lomb’s
Millennium Microsurgical System. Successful commercialization of these and
other
new products and new applications will require that we effectively transfer
production processes from research and development to manufacturing and
effectively coordinate with our suppliers. In addition, we must successfully
sell and achieve market acceptance of new products and applications and enhanced
versions of existing products. The extent of, and rate at which, market
acceptance and penetration are achieved by future products is a function of
many
variables, which include, among other things, price, safety, efficacy,
reliability, marketing and sales efforts, the development of new applications
for these products, the availability of third-party reimbursement of procedures
using our new products, the existence of competing products and general economic
conditions affecting purchasing patterns. Our ability to market and sell new
products may also be subject to government regulation, including approval or
clearance by the United States Food and Drug Administration, or FDA, and foreign
government agencies. Any failure in our ability to successfully develop and
introduce new products or enhanced versions of existing products and achieve
market acceptance of new products and new applications could have a material
adverse effect on our operating results and would cause our net revenues to
decline.
If
We
Cannot Increase Our Sales Volumes, Reduce Our Costs or Introduce Higher Margin
Products to Offset Anticipated Reductions in the Average Unit Price of Our
Products, Our Operating Results May Suffer. We
have
experienced declines in the average unit price of our products and expect to
continue to suffer from declines in the future. The average unit price of our
products may decrease in the future in response to changes in product mix,
competitive pricing pressures, new product introductions by our competitors
or
other factors. If we are unable to offset the anticipated decrease in our
average selling prices by increasing our sales volumes or through new product
introductions, our net revenues will decline. In addition, to maintain our
gross
margins, we must continue to reduce the manufacturing cost of our products.
If
we cannot maintain our gross margins, our business could be seriously harmed,
particularly if the average selling price of our products decreases
significantly without a corresponding increase in sales.
We
Depend on Sales of Our Ophthalmology Products for a Significant Portion of
Our
Operating Results.
We
derive, and expect to continue to derive, a large portion of our revenue and
profits from sales of our ophthalmology products. For the three months ended
October 1, 2005 our ophthalmology sales were $7.9 million or 86.8% of total
sales. For the nine months ended October 1, 2005, our ophthalmology sales were
$21.8 million or 81.8% of total sales. We anticipate that sales of our
ophthalmology products will continue to account for a significant portion of
our
revenues in the foreseeable future as we continue to introduce new ophthalmology
products, such as the new stepped and endo ocular probes introduced in the
second quarter of 2005.
We
Depend on International Sales for a Significant Portion of Our Operating
Results.
We
derive, and expect to continue to derive, a large portion of our revenue from
international sales. For the three months ended October 1, 2005, our
international sales were $3.3 million or 36.3% of total sales. For the nine
months ended October 1, 2005, our international sales were $10.2 million or
38.2% of total sales. We anticipate that international sales will continue
to
account for a significant portion of our revenues in the foreseeable future.
None of our international revenues and costs has been denominated in foreign
currencies. As a result, an increase in the value of the U.S. dollar relative
to
foreign currencies makes our products more expensive and thus less competitive
in foreign markets. The factors stated above could have a material adverse
effect on our business, financial condition or results of operations. Our
international operations and sales are subject to a number of other risks
including:
§
|
Longer
accounts receivable collection
periods;
|
§
|
Impact
of recessions in economies outside of the United
States;
|
§
|
Foreign
certification requirements, including continued ability to use the
“CE”
mark in Europe;
|
§
|
Reduced
or limited protections of intellectual property rights in jurisdictions
outside the United States;
|
§
|
Potentially
adverse tax consequences; and
|
§
|
Multiple
protectionist, adverse and changing foreign governmental laws and
regulations.
|
Any
one
or more of these factors stated above could have a material adverse effect
on
our business, financial condition or results of operations. For additional
discussion about our foreign currency risks, see Item 3, “Quantitative and
Qualitative Disclosures about Market Risk.”
We
Rely on Our Direct Sales Force and Network of International Distributors to
Sell
Our Products and any Failure to Maintain Our Direct Sales Force and Distributor
Relationships Could Harm Our Business. Our
ability to sell our products and generate revenue depends upon our direct sales
force within the United States and relationships with independent distributors
outside the United States. As of October 1, 2005 our direct sales force
consisted of 14 employees with 4 additional open positions and we maintained
relationships with 73 independent distributors internationally who sell our
products into 107 countries. We generally grant our distributors exclusive
territories for the sale of our products in specified countries. The amount
and
timing of resources dedicated by our distributors to the sales of our products
is not within our control. Our international sales are entirely dependent on
the
efforts of these third parties. If any distributor breaches or fails to generate
sales of our products, we may be forced to replace the distributor and our
ability to sell our products into that exclusive sales territory would be
adversely affected.
We
do not
have any long-term employment contracts with the members of our direct sales
force. We may be unable to replace our direct sales force personnel with
individuals of equivalent technical expertise and qualifications, which may
limit our revenues and our ability to maintain market share. The loss of the
services of these key personnel would harm our business. Similarly, our
distributorship agreements are generally terminable at will by either party
and
distributors may terminate their relationships with us, which would affect
our
international sales and results of operations.
We
are Dependent on the Successful Outcome of Clinical Trials of Our Products
and
New Applications Using Our Products. Our
success will depend in part on the successful outcome of clinical trials of
our
products and new applications using our products. Clinical trials are long,
expensive and uncertain processes. We have supported several clinical trials,
including, for example, the TTT4CNV clinical trial. The TTT4CNV clinical trial
is a physician initiated multi-center, prospective, double-masked,
placebo-controlled, randomized trial conducted at 22 centers in the United
States. This is a clinical trial performed within the FDA cleared indications
of
the OcuLight SLx and is being conducted to determine whether TTT laser treatment
using our OcuLight SLx infrared laser system and Large Spot Slit Lamp Adapter
can reduce the risk of vision loss for patients with wet age-related macular
degeneration (“wet AMD”) compared to a randomized control, which should reflect
the natural history of the disease. In June 2003, we announced the publication
of two additional clinical studies, which also support the effectiveness of
TTT
for the treatment of wet AMD. Both studies were prospective, non-randomized,
non-masked case series that were performed using our OcuLight SLx laser and
Large Spot Size Slit Lamp Adapter. In October 2004, we announced that the
preliminary visual outcome data in the intent-to-treat evaluation showed that
TTT, as applied in the TTT4CNV trial, showed favorable trends but overall did
not demonstrate a significant beneficial effect relative to sham treatments
and
announced that further subgroup analysis would be conducted. Since that time,
results of subgroup analysis has demonstrated a statistically significant
benefit in a subgroup of patients with baseline visual acuity of 20/100 or
worse. Within the TTT4CNV Clinical trial, about 41% of the patients enrolled
had
baseline vision of 20/100 or worse. Specifically, at 12 months following
treatment 23% of TTT treated eyes improved vision by one or more lines and
14%
of TTT treated eyes improved vision by three or more lines compared with none
of
the eyes in the placebo treated control group. Furthermore, at 18 months, there
was a 2 line benefit in preserving vision in this subgroup when compared to
placebo treated eyes. Specifically, TTT treated eyes on average lost 2 lines
of
visual acuity while placebo treated eyes lost 4 lines. Any impact on laser
sales
related to these trial results may take a number of years. If the future results
of any clinical trial regarding our products fails to demonstrate improved
outcomes of treatment using our products, our ability to generate revenues
from
new products or new applications using our products would be adversely
affected.
We
Face Manufacturing Risks.
The
manufacture of our infrared and visible light photocoagulators and the related
delivery devices is a highly complex and precise process. We assemble critical
subassemblies and all of our final products at our facility in Mountain View,
California. We may experience manufacturing difficulties, quality control issues
or assembly constraints, particularly with regard to new products that we may
introduce. We may not be able to manufacture sufficient quantities of our
products, which may require that we qualify other manufacturers for our
products. Furthermore, we may experience delays, disruptions, capacity
constraints or quality control problems in our manufacturing operations and,
as
a result, product shipments to our customers could be delayed, which would
negatively impact our net revenues.
If
We
Fail to Accurately Forecast Demand For Our Product and Component Requirements
For the Manufacture of Our Product, We Could Incur Additional Costs or
Experience Manufacturing Delays and May Experience Lost Sales or Significant
Inventory Carrying Costs. We
use
quarterly and annual forecasts based primarily on our anticipated product orders
to plan our manufacturing efforts and determine our requirements for components
and materials. It is very important that we accurately predict both the demand
for our product and the lead times required to obtain the necessary components
and materials. Lead times for components vary significantly and depend on
numerous factors, including the specific supplier, the size of the order,
contract terms and current market demand for such components. If we overestimate
the demand for our product, we may have excess inventory, which would increase
our costs. Over the past several quarters, we have placed a high priority on
our
asset management efforts to, among other things, reduce overall inventory levels
and increase our cash position. If we underestimate demand for our product
and,
consequently, our component and materials requirements, we may have inadequate
inventory, which could interrupt our manufacturing, delay delivery of our
product to our customers and result in the loss of customer sales. Any of these
occurrences would negatively impact our business and operating
results.
We
Depend on Sole Source or Limited Source Suppliers. We
rely
on third parties to manufacture substantially all of the components used in
our
products, including optics, laser diodes and crystals. We have some long term
or
volume purchase agreements with our suppliers and currently purchase components
on a purchase order basis. Some of our suppliers and manufacturers are sole
or
limited sources. In addition, some of these suppliers are relatively small
private companies that may discontinue their operations at any time. There
are
risks associated with the use of independent manufacturers, including the
following:
§
|
Shortages
or limitations on the ability to obtain supplies of components in
the
quantities that we require;
|
§
|
Delays
in delivery or failure of suppliers to deliver critical components
on the
dates we require;
|
§
|
Failure
of suppliers to manufacture components to our specifications, and
potentially reduced quality; and
|
§
|
Inability
to obtain components at acceptable
prices.
|
Our
business and operating results may suffer from the lack of alternative sources
of supply for critical sole
and
limited source components.
The
process of qualifying suppliers is complex, requires extensive testing with
our
products, and may be lengthy, particularly as new products are introduced.
New
suppliers would have to be educated in our production processes. In addition,
the use of alternate components may require design alterations to our products
and additional product testing under FDA and relevant foreign regulatory agency
guidelines, which may delay sales and increase product costs. Any failures
by
our vendors to adequately supply limited and sole source components may impair
our ability to offer our existing products, delay the submission of new products
for regulatory approval and market introduction, materially harm our business
and financial condition and cause our stock price to decline. Establishing
our
own capabilities to manufacture these components would be expensive and could
significantly decrease our profit margins. We do not currently intend to
manufacture any of these components. Our business, results of operations and
financial condition would be adversely affected if we are unable to continue
to
obtain components in the quantity and quality desired and at the prices we
have
budgeted.
Our
Operating Results May Fluctuate from Quarter to Quarter and Year to
Year.
Our
sales and operating results may vary significantly from quarter to quarter
and
from year to year in the future. Our operating results are affected by a number
of factors, many of which are beyond our control. Factors contributing to these
fluctuations include the following:
·
|
General
economic uncertainties and political
concerns;
|
·
|
The
timing of the introduction and market acceptance of new products,
product
enhancements and new applications;
|
·
|
Changes
in demand for our existing line of dermatology and ophthalmic
products;
|
·
|
The
cost and availability of components and subassemblies, including
the
ability of our sole or limited source suppliers to deliver components
at
the times and prices that we have
planned;
|
·
|
Our
ability to maintain sales volumes at a level sufficient to cover
fixed
manufacturing and operating costs;
|
·
|
Fluctuations
in our product mix between dermatology and ophthalmic products and
foreign
and domestic sales;
|
·
|
The
effect of regulatory approvals and changes in domestic and foreign
regulatory requirements;
|
·
|
Introduction
of new products, product enhancements and new applications by our
competitors, entry of new competitors into our markets, pricing pressures
and other competitive factors;
|
·
|
Our
long and highly variable sales
cycle;
|
·
|
Changes
in the prices at which we can sell our
products;
|
·
|
Changes
in customers’ or potential customers’ budgets as a result of, among other
things, reimbursement policies of government programs and private
insurers
for treatments that use our products;
and
|
·
|
Increased
product development costs.
|
·
|
Legal
costs associated with litigation, in particular the law suit filed
against
Synergetics USA, Inc. for infringement of IRIDEX Patent No.
5,085,492.
|
In
addition to these factors, our quarterly results have been, and are expected
to
continue to be, affected by seasonal factors.
Our
expense levels are based, in part, on expected future sales. If sales levels
in
a particular quarter do not meet expectations, we may be unable to adjust
operating expenses quickly enough to compensate for the shortfall of sales,
and
our results of operations may be adversely affected. In addition, we have
historically made a significant portion of each quarter’s product shipments near
the end of the quarter. If that pattern continues, any delays in shipment of
products could have a material adverse effect on results of operations for
such
quarter. Due to these and other factors, we believe that quarter to quarter
and
year to year comparisons of our past operating results may not be meaningful.
You should not rely on our results for any quarter or year as an indication
of
our future performance. Our operating results in future quarters and years
may
be below expectations, which would likely cause the price of our common stock
to
fall.
We
Depend on Collaborative Relationships to Develop, Introduce and Market New
Products, Product Enhancements and New Applications.
We
depend on both clinical and commercial collaborative relationships to develop,
introduce and market new products, product enhancements and new applications.
We
have entered into collaborative relationships with academic medical centers
and
physicians in connection with the research and development and clinical testing
of our products. Commercially, we currently collaborate with Bausch & Lomb
to design and manufacture a solid-state green wavelength (532 nm) laser
photocoagulator module, called the Millennium Endolase module. The Millennium
Endolase module is designed to be a component of Bausch & Lomb’s ophthalmic
surgical suite product offering and is not expected to be sold as a stand-alone
product. Sales of the Millennium Endolase module are dependent upon the actual
order rate from and shipment rate to Bausch & Lomb, which depends on the
efforts of our partner and is beyond our control. We cannot assure you that
our
relationship with Bausch & Lomb will result in further sales of our
Millennium Endolase module. We also collaborated with Miravant Medical
Technologies, a maker of photodynamic drugs, on a device that emits a laser
beam
to activate a photodynamic drug developed by Miravant for the treatment of
wet
AMD. In January 2002, Miravant announced that the top line results of their
Phase III clinical trial indicated that PHOTREX, the photodynamic
drug developed, did not meet the primary efficacy endpoint in the study
population. As we could not be assured that PHOTREX would be timely or
successfully pursued through clinical trials by Miravant, we charged to expense
in the fourth quarter of 2001, $0.3 million of inventory related to the OcuLight
664, the laser used by Miravant in the Phase III clinical trials. Miravant
has
since received an approvable letter from the FDA for PHOTREX with conditions
for
final marketing approval which includes a request for an additional confirmatory
clinical trial. Miravant has recently started those clinical trials requested
by
the FDA. Our OcuLight 664 activation laser has been exclusively used in this
application and is included in the FDA trials. We are the exclusive provider
of
the OcuLight 664 activation laser used in this application. Successful
commercialization of this product will depend, among other things, on the
results of the confirmatory clinical trial, acceptance of this product and
Miravant’s ability to successfully market and sell this therapy. The failure of
any current or future clinical or commercial collaboration relationships could
have a material adverse effect on our ability to introduce new products or
applications and therefore could have a material adverse effect on our business,
results of operations and financial condition.
We
Face Risks Associated with our Collaborative Relationships.
Our
collaborators may not pursue further development and commercialization of
products resulting from collaborations with us or may not devote sufficient
resources to the marketing and sale of such products. Our reliance on others
for
clinical development, manufacturing and distribution of our products may result
in unforeseen problems. Further, our collaborative partners may develop or
pursue alternative technologies either on their own or in collaboration with
others. If a collaborator elects to terminate its agreement with us, our ability
to develop, introduce, market and sell the product may be significantly impaired
and we may be forced to discontinue altogether the product resulting from the
collaboration. We may not be able to negotiate alternative collaboration
agreements on acceptable terms, if at all. The failure of any current or future
collaboration efforts could have a material adverse effect on our ability to
introduce new products or applications and therefore could have a material
adverse effect on our business, results of operations and financial
condition.
We
Are Subject To Government Regulation Which May Cause Us to Delay or Withdraw
the
Introduction of New Products or New Applications for Our
Products.
The
medical devices that we market and manufacture are subject to extensive
regulation by the FDA and by foreign and state governments. Under the Federal
Food, Drug and Cosmetic Act and the related regulations, the FDA regulates
the
design, development, clinical testing, manufacture, labeling, sale, distribution
and promotion of medical devices. Before a new device can be introduced into
the
market, the product must undergo rigorous testing and an extensive regulatory
review process implemented by the FDA under federal law. Unless otherwise
exempt, a device manufacturer must obtain market clearance through either the
510(k) premarket notification process or the lengthier premarket approval
application (PMA) process. Depending upon the type, complexity and novelty
of
the device and the nature of the disease or disorder to be treated, the FDA
process can take several years, require extensive clinical testing and result
in
significant expenditures. Even if regulatory approval is obtained, later
discovery of previously unknown safety issues may result in restrictions on
the
product, including withdrawal of the product from the market. Other countries
also have extensive regulations regarding clinical trials and testing prior
to
new product introductions. Our failure to obtain government approvals or any
delays in receipt of such approvals would have a material adverse effect on
our
business, results of operations and financial condition.
The
FDA
imposes additional regulations on manufacturers of approved medical devices.
We
are required to comply with the applicable Quality System regulations (QSRs)
and
our manufacturing facilities are subject to ongoing periodic inspections by
the
FDA and corresponding state agencies, including unannounced inspections, and
must be licensed as part of the product approval process before being utilized
for commercial manufacturing. Noncompliance with the applicable requirements
can
result in, among other things, fines, injunctions, civil penalties, recall
or
seizure of products, total or partial suspension of production, withdrawal
of
marketing approvals, and criminal prosecution. The FDA also has the authority
to
request repair, replacement or refund of the cost of any device we manufacture
or distribute. Any of these actions by the FDA would materially and adversely
affect our ability to continue operating our business and the results of our
operations.
In
addition, we are also subject to varying product standards, packaging
requirements, labeling requirements, tariff regulations, duties and tax
requirements. As a result of our sales in Europe, we are required to have all
products “CE” marked, an international symbol affixed to all products
demonstrating compliance with the European Medical Device Directive and all
applicable standards. While currently all of our released products are CE
marked, continued certification is based on the successful review of our quality
system by our European Registrar during their annual audit. Any loss of
certification would have a material adverse effect on our business, results
of
operations and financial condition.
Our
Products Could Be Subject to Recalls Even After Receiving FDA Approval or
Clearance. A Recall Would Harm our Reputation and Adversely Affect our Operating
Results. The
FDA
and similar governmental authorities in other countries in which we market
and
sell our products have the authority to require the recall of our products
in
the event of material deficiencies or defects in design or manufacture. A
government mandated recall, or a voluntary recall by us, could occur as a result
of component failures, manufacturing errors or design defects, including defects
in labeling. A recall could divert management’s attention, cause us to incur
significant expenses, harm our reputation with customers and negatively affect
our future sales.
If
we
modify one of our FDA approved or cleared devices, we may need to seek new
approvals or clearances which, if not granted, would prevent us from selling
our
modified products.
Any
modifications to an FDA-approved or 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 PMA
approval. We may not be able to obtain additional 510(k) clearances or PMA
approvals for new products or for modifications to, or additional intended
uses
or indications for, our existing products in a timely fashion, or at all. Delays
in obtaining future clearances 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
and
the labeling of our devices in the past and may make additional modifications
in
the future that we believe do not or will not require additional clearances
or
approvals. If the FDA disagrees and requires new clearances or approvals for
the
modifications, we may be required to recall and stop marketing the modified
devices, which could harm our operating results and require us to redesign
or
relabel our products.
We
Rely on Patents and Proprietary Rights to Protect our Intellectual Property
and
Business.
Our
success and ability to compete is dependent in part upon our proprietary
information. We rely on a combination of patents, trade secrets, copyright
and
trademark laws, nondisclosure and other contractual agreements and technical
measures to protect our intellectual property rights. We file patent
applications to protect technology, inventions and improvements that are
significant to the development of our business. We have been issued fifteen
United States patents and five foreign patents on the technologies related
to
our products and processes. We have approximately six pending patent
applications in the United States and five foreign pending patent applications
that have been filed. Our patent applications may not be approved. Any patents
granted now or in the future may offer only limited protection against potential
infringement and development by our competitors of competing products. Moreover,
our competitors, many of which have substantial resources and have made
substantial investments in competing technologies, may seek to apply for and
obtain patents that will prevent, limit or interfere with our ability to make,
use or sell our products either in the United States or in international
markets. In October 2005, the Company announced that it filed suit against
Synergetics USA, Inc. for infringement of the IRIDEX Patent No. 5,085,492
entitled “Optical Fiber with Electrical Encoding” covering its laser probe
technology. The suit seeks monetary damages as well as a permanent injunction
against continued infringement by Snergetics for the sale of its Quick
Disconnect laser probes and its Quick Disconnect Laser Probe
Adapter.
In
addition to patents, we rely on trade secrets and proprietary know-how which
we
seek to protect, in part, through proprietary information agreements with
employees, consultants and other parties. Our proprietary information agreements
with our employees and consultants contain industry standard provisions
requiring such individuals to assign to us without additional consideration
any
inventions conceived or reduced to practice by them while employed or retained
by us, subject to customary exceptions. Proprietary information agreements
with
employees, consultants and others may be breached, and we may not have adequate
remedies for any breach. Also, our trade secrets may become known to or
independently developed by competitors.
The
laser
and medical device industry is characterized by frequent litigation regarding
patent and other intellectual property rights. Companies in the medical device
industry have employed intellectual property litigation to gain a competitive
advantage. Numerous patents are held by others, including academic institutions
and our competitors. Until recently patent applications were maintained in
secrecy in the United States until the patents issued. Patent applications
filed
in the United States after November 2000 generally will be published eighteen
months after the filing date. However, since patent applications continue to
be
maintained in secrecy for at least some period of time, both within the United
States and with regards to international patent applications, we cannot assure
you that our technology does not infringe any patents or patent applications
held by third parties. We have, from time to time, been notified of, or have
otherwise been made aware of, claims that we may be infringing upon patents
or
other proprietary intellectual property owned by others. If it appears necessary
or desirable, we may seek licenses under such patents or proprietary
intellectual property. Although patent holders commonly offer such licenses,
licenses under such patents or intellectual property may not be offered or
the
terms of any offered licenses may not be reasonable.
Any
claims, with or without merit, and regardless of whether we are successful
on
the merits, would be time-consuming, result in costly litigation and diversion
of technical and management personnel, cause shipment delays or require us
to
develop noninfringing technology or to enter into royalty or licensing
agreements. An adverse determination in a judicial or administrative proceeding
and failure to obtain necessary licenses or develop alternate technologies
could
prevent us from manufacturing and selling our products, which would have a
material adverse effect on our business, results of operations and financial
condition.
Our
Operating Results May be Adversely Affected by Changes in Third Party Coverage
and Reimbursement Policies and any Uncertainty Regarding Healthcare Reform
Measures.
Our
ophthalmology products are typically purchased by doctors, clinics, hospitals
and other users, which bill various third-party payers, such as governmental
programs and private insurance plans, for the health care services provided
to
their patients. Third-party payers are increasingly scrutinizing and challenging
the coverage of new products and the level of reimbursement for covered
products. Doctors, clinics, hospitals and other users of our products may not
obtain adequate reimbursement for use of our products from third-party payers.
While we believe that the laser procedures using our products have generally
been reimbursed, payers may deny coverage and reimbursement for our products
if
they determine that the device was not reasonable and necessary for the purpose
used, was investigational or was not cost-effective. In addition, third party
payers may not initiate coverage of new procedures using our products for a
significant period. In September 2000, the Center for Medicare and Medicaid
Services, or CMS, advised that claims for reimbursement for certain age related
macular degeneration, or AMD, procedures which use our OcuLight SLx laser
system, could be submitted for reimbursement, with coverage and payment to
be
determined by the local medical carriers at their discretion. To date five
carriers representing 17 states have written reimbursement coverage policies
on
Transpupillary Thermotherapy, or TTT. The states reimbursing for TTT are Alaska,
Arizona, California, Colorado, Hawaii, Iowa, Idaho, Mississippi, North Carolina,
North Dakota, Nevada, Oregon, Pennsylvania, South Dakota, Tennessee, Washington
and Wyoming. Domestic sales of the infrared laser systems may continue to be
limited until more local medical carriers reimburse for performing such AMD
procedures or until CMS advises that claims for these procedures may be
submitted directly to CMS at the national level.
Changes
in government legislation or regulation or in private third-party payers’
policies toward reimbursement for procedures employing our products may prohibit
adequate reimbursement. There have been a number of legislative and regulatory
proposals to change the healthcare system, reduce the costs of healthcare and
change medical reimbursement policies. Doctors, clinics, hospitals and other
users of our products may decline to purchase our products to the extent there
is uncertainty regarding reimbursement of medical procedures using our products
and any healthcare reform measures. Further proposed legislation, regulation
and
policy changes affecting third party reimbursement are likely. We are unable
to
predict what legislation or regulation, if any, relating to the health care
industry or third-party coverage and reimbursement may be enacted in the future,
or what effect such legislation or regulation may have on us. However, denial
of
coverage and reimbursement of our products would have a material adverse effect
on our business, results of operations and financial condition.
If
Product Liability Claims are Successfully Asserted Against Us, We may Incur
Substantial Liabilities That May Adversely Affect Our Business or Results of
Operations.
We may
be subject to product liability claims from time to time. Our products are
highly complex and some are used to treat extremely delicate eye tissue and
skin
conditions on and near a patient’s face. Although we currently maintain and
intend to continue the Company’s product liability insurance, adequate insurance
may not be available on acceptable terms, if at all, and may not provide
adequate coverage against potential liabilities. Product liability insurance
is
expensive. We might not be able to obtain product liability insurance in the
future on acceptable terms or in sufficient amounts to protect us, if at all.
A
successful claim brought against us in excess of our insurance coverage could
have a material adverse effect on our business, results of operations and
financial condition.
If
We
Fail to Manage Growth Effectively, Our Business Could Be Disrupted Which Could
Harm Our Operating Results. We
have
experienced, and may continue to experience growth in our business. We have
made
and expect to continue to make significant investments to enable our future
growth through, among other things, new product development and clinical trials
for new applications and products. We must also be prepared to expand our work
force and to train, motivate and manage additional employees as the need for
additional personnel arises. Our personnel, systems, procedures and controls
may
not be adequate to support our future operations. Any failure to effectively
manage future growth could have a material adverse effect on our business,
results of operations and financial condition.
If
Our Facilities Were To Experience Catastrophic Loss, Our Operations Would Be
Seriously Harmed. Our
facilities could be subject to catastrophic loss such as fire, flood or
earthquake. All of our research and development activities, manufacturing,
our
corporate headquarters and other critical business operations are located near
major earthquake faults in Mountain View, California. Any such loss at any
of
our facilities could disrupt our operations, delay production, shipments and
revenue and result in large expense to repair and replace our
facilities.
We
May Need Additional Capital, which May Not Be Available, and Our Ability to
Grow
May be Limited as a Result. We
believe that our existing cash balances, available-for-sale securities, credit
facilities and cash flow expected to be generated from future operations will
be
sufficient to meet our capital requirements at least through the next 12 months.
However, we may be required, or could elect, to seek additional funding prior
to
that time. The development and marketing of new products and associated support
personnel requires a significant commitment of resources. If cash from available
sources is insufficient, we may need additional capital, which may not be
available on favorable terms, if at all. If we cannot raise funds on acceptable
terms, we may not be able to develop or enhance our products, take advantage
of
future opportunities, fund potential acquisitions or respond to competitive
pressures or unanticipated requirements. Any inability to raise additional
capital when we require it would seriously harm our business.
Our
Stock Price Has Been and May Continue to be Volatile and an Investment in Our
Common Stock Could Suffer a Decline in Value.
The
trading price of our common stock has been subject to wide fluctuations in
response to a variety of factors, some of which are beyond our control,
including quarterly variations in our operating results, announcements by us
or
our competitors of new products or of significant clinical achievements, changes
in market valuations of other similar companies in our industry and general
market conditions. We receive only limited attention by securities analysts
and
may experience an imbalance between supply and demand for our common stock
resulting from low trading volumes. In addition, the stock market has
experienced extreme volatility in the last few years that has often been
unrelated to the performance of particular companies. These broad market
fluctuations could have a significant impact on the market price of our common
stock regardless of our performance.
Changes
in Accounting Rules for Stock-Based Compensation Will Adversely Affect Our
Operating Results, Our Stock Price and Our Competitiveness in the Employee
Marketplace.
We have
a history of using employee stock options and other stock-based compensation
to
hire, motivate and retain our workforce. In December 2004, the Financial
Accounting Standards Board issued Statement of Financial Accounting Standards
No. 123R, “Share-Based Payment,” which will require us, commencing for the
fiscal year ending December 31, 2005, to measure compensation costs for all
stock-based compensation (including stock options and our employee stock
purchase plan) at fair value and to recognize these costs as expenses in our
statement of operations. The recognition of these expenses in our statements
of
operations will result in lower earnings per share, which could negatively
impact our future stock price. In addition, if we reduced or altered our use
of
stock-based compensation to minimize the recognition of these expenses, our
ability to recruit, motivate and retain employees may be impaired, which could
put us at a competitive disadvantage in the employee marketplace.
Compliance
with Internal Controls Evaluations and Attestation Requirements.
Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, we will be required,
beginning in fiscal 2007, to perform an evaluation of our internal controls
over
financial reporting and have our auditor publicly attest to such evaluation.
We
have prepared an internal plan of action for compliance, which includes a
timeline and scheduled activities, although as of the date of this filing we
have not yet prepared the evaluation. Compliance with these requirements is
expected to be expensive and time-consuming. If we fail to timely complete
this
evaluation, or if our registered independent public accounting firm cannot
timely attest to our evaluation, we could be subject to regulatory scrutiny
and
a loss of public confidence in our internal controls. In addition, any failure
to implement required new or improved controls, or difficulties encountered
in
their implementation, could harm our operating results or cause us to fail
to
meet our reporting obligations.
Item
3.
|
Quantitative
and Qualitative Disclosure about Market
Risk
|
Quantitative
Disclosures
We
are
exposed to market risks inherent in our operations, primarily related to
interest rate risk and currency risk. These risks arise from transactions and
operations entered into in the normal course of business. We do not use
derivatives to alter the interest characteristics of our marketable securities
or our debt instruments. We have no holdings of derivative or commodity
instruments.
Interest
Rate Risk.
We are
subject to interest rate risks on cash and cash equivalents, available-for-sale
marketable securities and any future financing requirements. Interest rate
risks
related to marketable securities are managed by managing maturities in our
marketable securities portfolio. We have no long-term debt as of October 1,
2005.
The
fair
value of our investment portfolio or related income would not be significantly
impacted by changes in interest rates since the marketable securities maturities
do not exceed a term of 12 - 14 months.
Qualitative
Disclosures
Interest
Rate Risk.
Our
primary interest rate risk exposures relate to:
§
|
The
available-for-sale securities will fall in value if market interest
rates
increase.
|
§
|
The
impact of interest rate movements on our ability to obtain adequate
financing to fund future
operations.
|
We
have
the ability to hold at least a portion of the fixed income investments until
maturity and therefore would not expect the operating results or cash flows
to
be affected to any significant degree by a sudden change in market interest
rates on its short- and long-term marketable securities portfolio.
Management
evaluates our financial position on an ongoing basis.
Currency
Rate Risk.
As
all of
our sales transactions are denominated in U.S. currency, we do not hedge any
balance sheet exposures against future movements in foreign exchange rates.
The
exposure related to currency rate movements would not have a material impact
on
future net income or cash flows.
Item
4.
|
Controls
and Procedures
|
(a)
|
Evaluation
of Disclosure Controls and
Procedures
|
Our
management, with the participation of our Chief Executive Officer and our Chief
Financial Officer, evaluated the effectiveness of our disclosure controls and
procedures (as defined in Rule 13a-15(e) of the Securities Exchange Act of
1934,
as of the end of the period covered by this Quarterly Report on Form 10-Q.
Based
on that evaluation, our Chief Executive Officer and our Chief Financial Officer
concluded that our disclosure controls and procedures are effective to ensure
that information we are required to disclose in reports that we file or submit
under the Securities Exchange Act of 1934 is recorded, processed, summarized
and
reported within the time periods specified in the Securities and Exchange
Commission rules and forms.
(b)
|
Changes
in Internal Controls
|
There
was
no change in our internal control over financial reporting that occurred during
the period covered by this Quarterly Report on Form 10-Q that has materially
affected, or is reasonably likely to materially affect, our internal control
over financial reporting.
PART
II.
|
OTHER
INFORMATION
|
Item
1.
|
Legal
Proceedings
|
In
October 2005, the Company announced that it filed suit against Synergetics
USA,
Inc. for infringement of the IRIDEX Patent No. 5,085,492 entitled “Optical Fiber
with Electrical Encoding” covering its laser probe technology. The suit seeks
monetary damages as well as a permanent injunction against continued
infringement by Snergetics for the sale of its Quick Disconnect laser probes
and
its Quick Disconnect Laser Probe Adapter.
Item
2.
|
Changes
in Securities and Use of
Proceeds
|
None.
Item
3.
|
Defaults
Upon Senior Securities
|
None.
Item
4.
|
Submission
of Matters to Vote of Security
Holders
|
None.
Item
5.
|
Other
Information
|
None.
Item
6.
|
Exhibits
and Reports on Form 8-K
|
(a)
|
Exhibits
|
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.
|
Trademark
Acknowledgments
IRIDEX,
the IRIDEX logo, IRIS Medical, OcuLight, SmartKey, EndoProbe and Apex are our
registered trademarks. IRIDERM, G-Probe, DioPexy, DioVet, TruFocus, TrueCW,
UltraView, DioLite 532, Long Pulse, MicroPulse, ScanLite, ColdTip (Handpiece),
VariSpot (Handpiece), TruView and EasyFit product names are our trademarks.
All
other trademarks or trade names appearing in the Form 10-Q are the property
of
their respective owners.
SIGNATURE
Pursuant
to the requirements 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.
IRIDEX
Corporation
(Registrant)
Date:
November 15, 2005
|
By: |
/s/
Larry Tannenbaum
|
||
Larry Tannenbaum | ||||
Chief Financial Officer and Vice President, Administration | ||||
(Principal Financial, Principal Accounting Officer and Authorized Signatory) |
Exhibit
Index
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
|
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.
|
34