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 April 3, 2004
[ ] 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 (I.R.S. employer
incorporation or organization) 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 [ ]
Indicate by check mark whether the registrant is an accelerated filer (as
defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [X]
APPLICABLE TO CORPORATE ISSUERS:
The number of shares of common stock, $.01 par value, issued and outstanding as
of May 14, 2004 was 7,208,635.
IRIDEX CORPORATION
TABLE OF CONTENTS
Page
----
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
Condensed Consolidated Balance Sheets as of April 3,
2004 and January 3, 2004 3
Condensed Consolidated Statements of Operations for the
three months ended April 3, 2004 and March 29, 2003 4
Condensed Consolidated Statements of Cash Flows for
the three months ended April 3, 2004 and March 29, 2003 5
Condensed Consolidated Statements of Comprehensive
Loss for the three months ended April 3, 2004 and
March 29, 2003 6
Notes to Condensed Consolidated Financial Statements 7
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS 11
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 25
ITEM 4. CONTROLS AND PROCEDURES 26
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS 27
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS 27
ITEM 3. DEFAULTS UPON SENIOR SECURITIES 27
ITEM 4. SUBMISSION OF MATTERS TO VOTE OF SECURITY HOLDERS 27
ITEM 5. OTHER INFORMATION 27
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K 27
SIGNATURE 28
CERTIFICATIONS 29
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.
2
PART I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
- ----------------------------------------------------
IRIDEX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
(UNAUDITED)
APRIL 3, JANUARY 3,
------------ ------------
2004 2004
------------ ------------
ASSETS
------
Current assets:
Cash and cash equivalents . . . . . . . . . . $ 9,477 $ 10,541
Available-for-sale securities . . . . . . . . 7,438 5,751
Accounts receivable, net. . . . . . . . . . . 5,825 6,548
Inventories . . . . . . . . . . . . . . . . . 8,470 8,721
Prepaids and other current assets . . . . . . 1,374 934
Current deferred income taxes . . . . . . . . 972 972
------------ ------------
Total current assets . . . . . . . . . . . 33,556 33,467
Property and equipment, net . . . . . . . . . 796 850
Deferred income taxes . . . . . . . . . . . . 1,522 1,522
------------ ------------
Total assets . . . . . . . . . . . . . . . $ 35,874 $ 35,839
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
------------------------------------
Current liabilities:
Accounts payable. . . . . . . . . . . . . . . $ 708 $ 1,029
Accrued expenses. . . . . . . . . . . . . . . 3,005 3,380
Deferred revenue. . . . . . . . . . . . . . . 645 596
------------ ------------
Total liabilities. . . . . . . . . . . . . 4,358 5,005
------------ ------------
Stockholders' equity:
Common stock. . . . . . . . . . . . . . . . . 73 70
Additional paid-in capital. . . . . . . . . . 24,603 23,900
Accumulated other comprehensive loss. . . . . (8) (1)
Treasury stock. . . . . . . . . . . . . . . . (430) (430)
Retained earnings . . . . . . . . . . . . . . 7,278 7,295
------------ ------------
Total stockholders' equity . . . . . . . . 31,516 30,834
------------ ------------
Total liabilities and stockholders' equity $ 35,874 $ 35,839
============ ============
<FN>
The accompanying notes are an integral part of these condensed consolidated
financial statements.
3
IRIDEX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
THREE MONTHS ENDED
APRIL 3, MARCH 29,
2004 2003
---------- -----------
Sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 7,392 $ 7,226
Cost of sales . . . . . . . . . . . . . . . . . . . . . . . . . 4,177 3,988
---------- -----------
Gross profit. . . . . . . . . . . . . . . . . . . . . . . 3,215 3,238
---------- -----------
Operating expenses:
Research and development . . . . . . . . . . . . . . . . . . 1,107 950
Sales, general and administrative . . . . . . . . . . . . . . 2,193 2,464
---------- -----------
Total operating expenses. . . . . . . . . . . . . . . . . . . . 3,300 3,414
---------- -----------
Loss from operations. . . . . . . . . . . . . . . . . . . . . . (85) (176)
Interest and other income, net . . . . . . . . . . . . . . . 60 54
---------- -----------
Loss before benefit from income taxes . . . . . . . . . . . . . (25) (122)
Benefit from income taxes. . . . . . . . . . . . . . . . . . 8 40
---------- -----------
Net loss. . . . . . . . . . . . . . . . . . . . . . . . . . . . $ (17) $ (82)
========== ===========
Net loss per share - basic and diluted. . . . . . . . . . . . . $ ( 0.00) $ ( 0.01)
========== ===========
Shares used in computing net loss per share - basic and diluted 7,076 6,913
========== ===========
<FN>
The accompanying notes are an integral part of these condensed consolidated
financial statements.
4
IRIDEX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
THREE MONTHS ENDED
APRIL 3, MARCH 29,
2004 2003
---------- -----------
Cash flows from operating activities:
Net loss $ (17) $ (82)
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation and amortization. . . . . . . . . . . . . . . . . . . . . . . . 137 202
Provision for inventories. . . . . . . . . . . . . . . . . . . . . . . . . . 11 (2)
Provision for doubtful accounts. . . . . . . . . . . . . . . . . . . . . . . (4) (1)
Changes in operating assets and liabilities:
Accounts receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . 727 1,652
Inventories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240 111
Prepaids and other current assets . . . . . . . . . . . . . . . . . . . . (440) (379)
Accounts payable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . (321) 339
Accrued expenses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . (375) (110)
Deferred revenue. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 94
---------- -----------
Net cash provided by operating activities. . . . . . . . . . . . . . . . . . 7 1,824
---------- -----------
Cash flows from investing activities:
Purchases of available-for-sale securities. . . . . . . . . . . . . . . . . . . (3,539) -
Proceeds from of maturity of available-for-sale securities. . . . . . . . . . . 1,845 937
Acquisition of property and equipment . . . . . . . . . . . . . . . . . . . . . (83) (80)
---------- -----------
Net cash provided by (used in) investing activities. . . . . . . . . . . . . (1,777) 857
---------- -----------
Cash flows from financing activities:
Issuance of common stock. . . . . . . . . . . . . . . . . . . . . . . . . . . . 706 21
---------- -----------
Net cash provided by financing activities. . . . . . . . . . . . . . . . . . 706 21
---------- -----------
Net increase (decrease) in cash and cash equivalents . . . . . . . . . . . . (1,064) 2,702
Cash and cash equivalents at beginning of period . . . . . . . . . . . . . . . . . 10,541 9,186
---------- -----------
Cash and cash equivalents at end of period . . . . . . . . . . . . . . . . . . . . $ 9,477 $ 11,888
========== ===========
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING ACTIVITIES:
Change in unrealized losses on available-for-sale securities $ (7) $ (1)
<FN>
The accompanying notes are an integral part of these condensed consolidated
financial statements.
5
IRIDEX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(IN THOUSANDS)
(UNAUDITED)
THREE MONTHS ENDED
APRIL 3, MARCH 29,
2004 2003
---------- -----------
Net loss . . . . . . . . . . . . . . . . . . . . . $ (17) $ (82)
Other comprehensive loss:
Change in unrealized loss on
available-for-sale securities. . . . . . . . . (7) (1)
---------- -----------
Comprehensive loss . . . . . . . . . . . . . . . . $ (24) $ (83)
========== ===========
<FN>
The accompanying notes are an integral part of these condensed consolidated
financial statements.
6
IRIDEX CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated financial statements of
IRIDEX Corporation 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, which was filed with
the Securities and Exchange Commission on April 2, 2004. The results of
operations for the three month period ended April 3, 2004 are not necessarily
indicative of the results for the year ending January 1, 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 3, 2004 which was filed with the
Securities and Exchange Commission on April 2, 2004. The Company's significant
accounting policies have not materially changed as of April 3, 2004.
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 three months ending April 3, 2004 follows (in thousands) :
Balance, January 3, 2004 $ 596
Additions to deferral 223
Revenue recognized (174)
------
Balance, April 3, 2004 $ 645
======
Warranty
The Company accrues for an estimated warranty cost upon shipment of
products in accordance with 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 income statement as a cost of sales. A reconciliation of the
changes in the Company's warranty liability for the three months ending April 3,
2004 follows (in thousands):
7
IRIDEX CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Balance, January 3, 2004 $ 801
Accruals for warranties issued during the quarter 182
Settlements made in kind during the quarter (138)
------
Balance, April 3, 2004 $ 845
======
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 loss and the related cost measured by the fair value
method is presented below.
The following table provides a reconciliation of net loss to pro forma net
loss as if the fair value method had been applied to all employee awards (in
thousands, except per share data):
Three Months Ended Three Months Ended
April 3, 2004 March 29, 2003
Net loss, as reported $ (17) $ (82)
Add: Total stock based compensation expense
determined under fair value based method for all
awards to employees (144) (114)
-------------------- --------------------
Pro forma net loss $ (161) $ (196)
==================== ====================
Basic and diluted net loss per share:
As reported $ (0.00) $ (0.01)
==================== ====================
Pro forma $ (0.02) $ (0.03)
==================== ====================
The determination of fair value of all options granted by the Company
includes assumptions on expected volatility, risk free interest rate, expected
term and expected dividends.
8
IRIDEX CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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):
APRIL 3, JANUARY 3,
2004 2004
------------ -----------
Raw materials and work in progress . . . . . . . $ 4,572 $ 4,426
Finished goods . . . . . . . . . . . . . . . . . 3,898 4,295
------------ -----------
Total inventories. . . . . . . . . . . . . . . . $ 8,470 $ 8,721
============ ===========
4. COMPUTATIONS OF NET LOSS PER COMMON SHARE
Basic and diluted net loss per share are computed by dividing net loss for
the period by the weighted average number of shares of common stock outstanding
during the period. The calculation of diluted net loss per share excludes
potential common stock if their effect is antidilutive. Potential common stock
consists of incremental common shares issuable upon the exercise of stock
options. Basic and diluted net loss per share are equivalent for all periods
presented due to the Company's net loss position.
During the three months ended April 3, 2004 and March 29, 2003, options to
purchase 1,853,016 and 1,713,563 shares of common stock at weighted average
exercise prices of $5.44 and $5.26 per share were outstanding, but were not
included in the computations of diluted net loss per common share because it
would have an antidilutive effect. These options could dilute earnings per
share in future periods.
5. 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 months ended April 3, 2004
and March 29, 2003 is as follows (in thousands):
9
IRIDEX CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Three Months Ended April 3, 2004 Three Months Ended March 29, 2003
Ophthalmology Dermatology Ophthalmology Dermatology
Medical Medical Medical Medical
Devices Devices Total Devices Devices Total
Sales $ 6,243 $ 1,149 $ 7,392 $ 5,724 $ 1,502 $ 7,226
Direct Cost
of Goods
Sold 2,241 648 2,889 1,966 706 2,672
-------------- ------------ -------- -------------- ------------ --------
Direct Gross
Margin 4,002 501 4,503 3,758 796 4,554
Total
Unallocated
Costs (4,528) (4,676)
-------- --------
Pre-tax loss $ (25) $ (122)
======== ========
Indirect costs of manufacturing, research and development, and selling,
general and administrative costs are not allocated to the segments.
The Company's assets and liabilities are not evaluated on a segment basis.
Accordingly, no disclosure on segment assets and liabilities is provided.
10
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 2, 2004 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
APRIL 3, MARCH 29,
2004 2003
--------- ----------
Sales . . . . . . . . . . . . . . . . . . 100.0% 100.0%
Cost of sales . . . . . . . . . . . . . . 56.5 55.2
--------- ----------
Gross profit . . . . . . . . . . . . . 43.5 44.8
--------- ----------
Operating expenses:
Research and development . . . . . . . 15.0 13.1
Sales, general and administrative. . . 29.6 34.1
--------- ----------
Total operating expenses. . . . . . 44.6 47.2
--------- ----------
Loss from operations. . . . . . . . . . . (1.1) (2.4)
Interest and other income, net. . . . . . 0.8 0.7
--------- ----------
Loss before benefit from income taxes . . (0.3) (1.7)
Benefit from income taxes . . . . . . . . 0.1 0.6
--------- ----------
Net loss. . . . . . . . . . . . . . . . . (0.2)% (1.1)%
========= ==========
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.
11
Three Months Ended
April 3, 2004 March 29, 2003
Amount Percentage Amount Percentage
of total sales of total sales
Domestic $ 4,156 56.2% $ 4,541 62.8%
International 3,236 43.8% 2,685 37.2%
------- --------------- ------- ---------------
Total $ 7,392 100.0% $ 7,226 100.0%
------- --------------- ------- ---------------
Ophthalmology:
Domestic $ 3,366 45.5% $ 3,423 47.4%
International 2,877 38.9% 2,301 31.8%
------- --------------- ------- ---------------
Total $ 6,243 84.4% $ 5,724 79.2%
------- --------------- ------- ---------------
Dermatology:
Domestic $ 790 10.7% $ 1,118 15.5%
International 359 4.9% 384 5.3%
------- --------------- ------- ---------------
Total $ 1,149 15.6% $ 1,502 20.8%
------- --------------- ------- ---------------
Ophthalmology Sales
Ophthalmology sales increased 9.1% to $6.2 million for the three months
ended April 3, 2004 from $5.7 million for the three months ended March 29, 2003.
For the three month periods ended April 3, 2004 and March 29, 2003, domestic
ophthalmology sales remained relatively constant at $3.4 million. An increase of
$0.5 million in unit sales of delivery devices and service was offset by a $0.5
million decrease in unit sales of visible laser consoles. International
ophthalmology sales increased 25.0% to $2.9 million for the three months ended
April 3, 2004 from $2.3 million for the three months ended March 29, 2003. The
increase in international ophthalmology sales during this period was due to a
$0.3 million increase in unit sales of visible laser consoles, a $0.2 million
increase in unit sales of infrared laser consoles and a $0.1 million increase in
unit sales of delivery devices.
Dermatology Sales
Dermatology sales decreased 23.5% to $1.1 million for the three months
ended April 3, 2004 from $1.5 million for the three months ended March 29, 2003.
For the three month period ended April 3, 2004 domestic dermatology sales
decreased 29.3% to $0.8 million from $1.1 million for the comparable prior year
three month period. Domestic dermatology sales decreased during this period due
primarily to a $0.3 million decrease in unit sales of the DioLite laser which
resulted, in part, from increased competition and some turnover in our direct
sales personnel. International dermatology product sales remained relatively
constant at $0.4 million for the three month periods ended April 3, 2004 and
March 29, 2003. Our dermatology product sales, both domestically and
internationally, continue to be affected by economic conditions. Additionally
dermatology procedures are typically elective procedures that are deferred
12
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 decreased by $23,000 to $3.21 million for
the three month period ended April 3, 2004 compared to $3.24 million for the
three months ended March 29, 2003. Gross profit as a percentage of sales for the
three months ended April 3, 2004 decreased to 43.5% from 44.8% for the
comparable prior year three month period. The total 1.3% decrease in gross
profit as a percentage of sales during this period included a decrease of 1.2%
relating to increased inventory reserves, a decrease of 0.9% for increased
manufacturing overhead costs primarily related to the overhead charge associated
with a reduction in overall inventory offset by an increase of 0.7% for the
combined impact of product mix and average selling prices and an increase of
0.1% for lower product costs including warranty charges. 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 16.5% to $1.1 million for the three months ended April 3, 2004 from $1.0
million for the three months ended March 29, 2003. Research and development
expenses increased as a percentage of sales to 15.0% for the three months ended
April 3, 2004 from 13.1% 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 April 3, 2004 was due
primarily to $0.1 million in increased research and development project
spending.
Sales, General and Administrative. Our sales, general and administrative
expenses decreased by 11.0% to $2.2 million for the three months ended April 3,
2004 from $2.5 million for the three months ended March 29, 2003. As a
percentage of sales, sales, general and administrative expenses decreased to
29.6% for the three months ended April 3, 2004 from 34.1% 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 April 3, 2004 was due primarily to $0.2 million in decreased
spending by our direct sales force due to open positions and $0.1 million in
decreased spending on marketing programs.
Interest and Other Income, net. For the three months ended April 3, 2004 we
had net other income of $60,000 as compared with net other income of $ 54,000
for the three months ended March 29, 2003. The change in net other income for
this period was due primarily to an increase in interest income associated with
increased cash, cash equivalents and available for sale securities.
Income Taxes. The effective income tax rate for the three month periods
ending April 3, 2004 and March 29, 2003 was 32%. The tax rate for these periods
was 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.
LIQUIDITY AND CAPITAL RESOURCES
At April 3, 2004, our primary sources of liquidity included cash and cash
equivalents and available-for-sale securities in the aggregate amount of $16.9
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
2004. As of
13
April 3, 2004, no borrowings were outstanding under this credit facility. We
expect to renew the line of credit in October 2004, assuming that the terms
continue to be acceptable.
During the three months ended April 3, 2004, operating activities provided
$7,000 of cash. The primary sources of cash from operating activities included a
decrease in net accounts receivable of $0.7 million, a decrease in net inventory
of $0.3 million and depreciation of $0.1 million offset by uses of cash which
included a $0.3 million decrease in accounts payable, a $0.4 million decrease in
accrued expenses and an increase in prepaid expenses and other current assets of
$0.4 million. The decrease in accounts receivable resulted primarily from
continued focus on collection efforts. The decrease in inventory and in accounts
payable related primarily to decreased inventory purchases due to implementation
of an inventory reduction program, whereby inventory purchases were reduced. The
decrease in accrued expenses related mainly to the timing of salary payments.
The increase in prepaid expenses and other current assets related mainly to
increased trade show spending and to the accumulation of costs on behalf of
Miravant related to their March 31, 2004 FDA submission.
Investing activities used $1.8 million in cash and cash equivalents during
the three months ended April 3, 2004, primarily due to net purchases of
available for sale securities of $1.7 million and purchases of fixed assets of
$0.1 million.
Net cash provided by financing activities during the three months ended
April 3, 2004 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 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. We
plan to utilize all of the reacquired shares for reissuance in connection with
employee stock programs. No shares were repurchased during the three months
ended April 3, 2004. To date, we have purchased 103,000 shares of our common
stock under this program.
CRITICAL ACCOUNTING POLICIES
The Company's significant accounting policies are disclosed in our Annual
Report on Form 10-K for the year ended January 3, 2004 which was filed with the
Securities and Exchange Commission on April 2, 2004.
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
market. We also market visible and infrared light semiconductor-based
photocoagulator medical laser systems to the 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:
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- Product performance, features, ease of use, scalability and
durability;
- Recommendations and opinions by ophthalmologists, dermatologists,
other clinicians, plastic surgeons and their associated opinion
leaders;
- 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
Lumenis Ltd., Carl Zeiss, Inc., Alcon, Quantel and Nidek, Inc. All of these
companies currently offer a competitive semiconductor-based laser system in
ophthalmology. Our principal competitors in dermatology are Laserscope, Candela
Corporation, Palomar Technologies, Lumenis Ltd. and Cutera, Inc. 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 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
15
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. These variables
include 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.
Our Business Has Been Adversely Impacted By the Worldwide Economic Slowdown
and Related Uncertainties. The overall weak economic conditions worldwide have
resulted in reduced demand for some of our products, particularly demand for our
dermatology products. Political and social turmoil in various parts of the
world or terrorist acts may adversely impact global economic conditions. These
political, social and economic conditions and related economic uncertainties
make it difficult for us, our customers and our distributors to forecast orders
and sales of our products and, accordingly, plan future business activities.
This level of uncertainty strongly challenges our ability to operate profitably
or grow our business. If economic or market conditions do not improve, this may
have a material adverse impact on our financial position, results of operation
and cash flows.
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 Face Risks of Manufacturing. 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.
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 source. In addition,
16
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:
- Unavailability of, 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, requiring 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.
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 April 3, 2004, our
international sales were $3.2 million or 43.8% 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 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;
17
- 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 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 April 3, 2004 our ophthalmology sales were $6.2 million
or 84.4% 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 50 micron slit lamp adapter and our expanded EndoProbe product line, and
support clinical trials in the field of ophthalmology, including the TTT4CNV
clinical trial for the treatment of wet AMD.
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 (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 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 OcuLight SLx laser system 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
18
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.
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 are currently supporting several ongoing clinical
trials, including, for example, the TTT4CNV clinical trial. The TTT4CNV clinical
trial is a multi-center, prospective, double-masked, placebo-controlled,
randomized trial conducted at 22 centers in the United States. This clinical
trial is a post marketing study 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 AMD compared to a
randomized control, which should reflect the natural history of the disease. We
believe that a favorable outcome from the TTT4CNV clinical trial will increase
laser sales although this process may take a number of years. In March 2003, we
announced that the Executive Committee for the TTT4CNV clinical trial accepted
the recommendations of the independent Data and Safety Monitoring Committee that
an adequate number of patients were enrolled to detect a clinically relevant
difference between outcomes in TTT-treated eyes and patients not being treated.
We believe that results of the TTT4CNV study for wet AMD will likely be released
during the fourth quarter of 2004. In June 2003, we announced the publication of
two additional clinical studies, which also support the effectiveness of TTT for
the treatment of wet age-related macular degeneration. 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. We cannot assure
you that results from the TTT4CNV clinical trial will prove to be successful. If
the future results of the TTT4CNV clinical trial or any other clinical trial
regarding our products fails to demonstrate improved outcomes of treatments
using our products, our ability to generate revenues from new products or new
applications using our products would be adversely affected and our business
would be harmed.
Our Operating Result 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
our 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;
19
- 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.
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 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 April 3, 2004 our direct sales force consisted of 11 employees
with 3 open positions and we maintained relationships with 66 independent
distributors internationally selling 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 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. We have entered into
collaborative relationships with academic medical centers and physicians in
connection with the research and development and clinical testing of our
20
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
collaborate 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 SnET2, the
photodynamic drug developed, did not meet the primary efficacy endpoint in the
study population. As we could not be assured that SnET2 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 initiated discussions with the FDA regarding patients treated per protocol
in a subset of the Phase III clinical trials and in late March 2004 announced
that it has submitted an NDA/PMA (New Drug Application/Premarket Approval) to
the FDA seeking marketing approval of SnET2-PDT as a new treatment for patients
with wet AMD. SnET2-PDT has been granted Fast Track product status by the FDA.
As a result, within 60 days of the NDA/PMA submission, the FDA will make a
determination to accept or refuse to file the NDA/PMA and, if accepted, will
designate its review status. Approval by the FDA of the SnET2-PDT product may be
obtained, in the best case, by October 2003. Successful commercialization of
this product will depend on Miravant's ability to successfully market and sell
this therapy.
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 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
fourteen United States patents and two foreign patents on the technologies
related to our products and processes. We have approximately four pending
patent applications in the United States and eight 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 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,
21
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.
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 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.
22
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 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.
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
maintain product liability insurance with coverage limits of $11.0 million per
occurrence and an annual aggregate maximum of $12.0 million, our coverage from
our insurance policies may not be adequate. 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 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
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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.
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 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. We prepare our financial statements in conformity
with accounting principles generally accepted in the United States of America.
These principles are subject to interpretation by the Securities and Exchange
Commission (the "SEC") and various bodies formed to interpret and create
appropriate accounting policies. A change in these policies can have a
significant effect on our reported results and may even retroactively affect
previously reported transactions. In particular, changes to FASB guidelines
relating to accounting for stock-based compensation will likely increase our
compensation expense, could make our net income less predictable in any given
reporting period and could change the way we compensate our employees or cause
other changes in the way we conduct our business. On March 31, 2004, the
Financial Accounting Standards Board (FASB) issued an Exposure Draft,
Share-Based Payment: an amendment of FASB statements No. 123 and 95, which would
require a company to recognize, as an expense, the fair value of stock options
and other stock-based compensation to employees beginning in 2005 and subsequent
reporting periods. If we elect or are required to record an expense for our
stock-based compensation plans using the fair value method as described in the
Exposure Draft, we could have significant and ongoing accounting charges, which
could significantly reduce our net income.
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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 April 3, 2004.
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 terms of 12-24 months and the interest rates
are primarily fixed.
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.
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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.
26
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
The Company is not subject to any material legal proceedings as of the date
of this report.
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
In accordance with Section 10A(i)(2) of the Securities Exchange Act of 1934, as
added by Section 202 of the Sarbanes-Oxley Act of 2002, the Registrant is
responsible for disclosing the non-audit services approved by the Company's
Audit Committee to be performed by PricewaterhouseCoopers LLP, the Company's
independent auditor. Non-audit services are defined in the law as services other
than those provided in connection with an audit or a review of the financial
statements of the Company. The additional engagements of PricewaterhouseCoopers
LLP for the matters listed below are each considered by the Company to be
audit-related services that are closely related to the financial audit process.
During the quarterly period covered by this filing, the Audit Committee approved
the additional engagements of PricewaterhouseCoopers LLP for certain tax matter
consultations and for the review of the Company's filings under the Securities
Act of 1933, as amended.
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.
(b) Reports on Form 8-K
On May 4, 2004 the registrant furnished a Current Report on Form 8-K
reporting under Item 12 of Form 8-K that on May 4, 2004, the Company issued a
press release regarding the Company's financial results for the fiscal quarter
ended April 3, 2004.
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 Scanner,
ColdTip Handpiece, Varispot Handpiece 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.
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IRIDEX Corporation
(Registrant)
Date: May 18, 2004 By: /s/ Larry Tannenbaum
--------------------
Larry Tannenbaum
Chief Financial Officer and Vice President,
Administration (Principal Financial, Principal
Accounting Officer and Authorized Signatory)
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Exhibit Index
31.1 Certification of Chief Executive Officer pursuant to Securities Exchange
Act Rules 13a-14(a) and 15d-14(a)
31.2 Certification of Chief Financial Officer pursuant to Securities Exchange
Act Rules 13a-14(a) and 15d-14(a)
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.
29