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 September 27, 2003
[ ] 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 (I.R.S. employer
of 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.
(1) Yes [X] No [ ]; (2) Yes [X] No [ ]
The number of shares of common stock, $.01 par value, issued and outstanding as
of November 5, 2003 was 6,960,095.
Indicate by check mark whether the registrant is an accelerated filer (as
defined in Rule 12b-2 of the Exchange Act.) Yes [ ] No [X]
IRIDEX CORPORATION
TABLE OF CONTENTS
Page
----
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
Condensed Consolidated Balance Sheets as of September 27,
2003 and December 28, 2002 3
Condensed Consolidated Statements of Operations for the
three and nine months ended September 27, 2003 and September
28, 2002 4
Condensed Consolidated Statements of Cash Flows for the nine
months ended September 27, 2003 and September 28, 2002 5
Condensed Consolidated Statements of Comprehensive Income
(Loss) for the three and nine months ended September 27,
2003 and September 28, 2002 6
Notes to Condensed Consolidated Financial Statements 7
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS 13
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 29
ITEM 4. CONTROLS AND PROCEDURES 30
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS 30
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS 31
ITEM 3. DEFAULTS UPON SENIOR SECURITIES 31
ITEM 4. SUBMISSION OF MATTERS TO VOTE OF SECURITY HOLDERS 31
ITEM 5. OTHER INFORMATION 31
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K 31
SIGNATURE 33
2
PART I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
- --------------------------------------------------------
IRIDEX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
SEPTEMBER 27, DECEMBER 28,
--------------- --------------
2003 2002
--------------- --------------
(unaudited)
ASSETS
------
Current assets:
Cash and cash equivalents . . . . . . . . . . $ 7,800 $ 9,186
Available-for-sale securities . . . . . . . . 7,142 2,356
Accounts receivable, net. . . . . . . . . . . 6,225 8,037
Inventories . . . . . . . . . . . . . . . . . 9,447 10,725
Prepaids and other current assets . . . . . . 930 751
--------------- --------------
Total current assets. . . . . . . . . . . . 31,544 31,055
Property and equipment, net . . . . . . . . . 662 950
Deferred income taxes . . . . . . . . . . . . 2,267 2,267
--------------- --------------
Total assets. . . . . . . . . . . . . . . . $ 34,473 $ 34,272
=============== ==============
LIABILITIES AND STOCKHOLDERS' EQUITY
------------------------------------
Current liabilities:
Accounts payable. . . . . . . . . . . . . . . $ 876 $ 657
Accrued expenses. . . . . . . . . . . . . . . 3,431 3,417
--------------- --------------
Total liabilities . . . . . . . . . . . . . 4,307 4,074
--------------- --------------
Stockholders' equity:
Common stock. . . . . . . . . . . . . . . . . 70 70
Additional paid-in capital. . . . . . . . . . 23,723 23,631
Accumulated other comprehensive income (loss) (1) 3
Treasury stock. . . . . . . . . . . . . . . . (430) (430)
Retained earnings . . . . . . . . . . . . . . 6,804 6,924
--------------- --------------
Total stockholders' equity. . . . . . . . . 30,166 30,198
--------------- --------------
Total liabilities and stockholders' equity. $ 34,473 $ 34,272
=============== ==============
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 NINE MONTHS ENDED
SEPTEMBER 27, SEPTEMBER 28, SEPTEMBER 27, SEPTEMBER 28,
2003 2002 2003 2002
--------------- --------------- ---------------- ---------------
Sales. . . . . . . . . . . . . . . . . . . . . . . . $ 8,267 $ 6,717 $ 22,928 $ 21,113
Cost of sales. . . . . . . . . . . . . . . . . . . . 4,678 3,705 12,981 11,895
--------------- --------------- ---------------- ---------------
Gross profit . . . . . . . . . . . . . . . . . . 3,589 3,012 9,947 9,218
--------------- --------------- ---------------- ---------------
Operating expenses:
Research and development . . . . . . . . . . . . . 975 919 2,972 3,384
Sales, general and administrative. . . . . . . . . 2,402 2,098 7,430 6,897
--------------- --------------- ---------------- ---------------
Total operating expenses . . . . . . . . . . . . . . 3,377 3,017 10,402 10,281
--------------- --------------- ---------------- ---------------
Income (loss) from operations. . . . . . . . . . . . 212 (5) (455) (1,063)
Interest and other income (expense), net . . . . . 49 (31) 154 66
--------------- --------------- ---------------- ---------------
Income (loss) before benefit from income taxes . . . 261 (36) (301) (997)
Benefit from income taxes. . . . . . . . . . . . . 0 242 181 549
--------------- --------------- ---------------- ---------------
Net income (loss). . . . . . . . . . . . . . . . . . $ 261 206 $ (120) (448)
=============== =============== ================ ===============
Basic net income (loss) per common share . . . . . . $ 0.04 $ 0.03 $ (0.02) $ (0.07)
=============== =============== ================ ===============
Diluted net income (loss) per common share . . . . . $ 0.04 $ 0.03 $ (0.02) $ (0.07)
=============== =============== ================ ===============
Shares used in per common share basic
calculations . . . . . . . . . . . . . . . . . . . 6,933 6,875 6,922 6,858
=============== =============== ================ ===============
Shares used in per common share diluted
calculations . . . . . . . . . . . . . . . . . . . 7,043 6,938 6,922 6,858
=============== =============== ================ ---------------
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)
NINE MONTHS ENDED
SEPTEMBER 27, SEPTEMBER 28,
2003 2002
---------------- ----------------
Cash flows from operating activities:
Net loss. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ (120) $ (448)
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation and amortization . . . . . . . . . . . . . . . . . . . . . . . . 561 652
Provision for doubtful accounts . . . . . . . . . . . . . . . . . . . . . . . 35 (56)
Provision for inventories . . . . . . . . . . . . . . . . . . . . . . . . . . 348 18
Deferred income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . - (555)
Changes in operating assets and liabilities:
Accounts receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,777 832
Inventories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 930 825
Prepaids and other current assets . . . . . . . . . . . . . . . . . . . . . (179) 171
Accounts payable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219 (381)
Accrued expenses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 278
---------------- ----------------
Net cash provided by operating activities . . . . . . . . . . . . . . . . . . 3,585 1,336
---------------- ----------------
Cash flows provided by (used in) investing activities:
Purchases of available-for-sale securities. . . . . . . . . . . . . . . . . . . (6,640) (3,075)
Proceeds from maturity of available-for-sale securities . . . . . . . . . . . . 1,850 4,489
Acquisition of property and equipment . . . . . . . . . . . . . . . . . . . . . (273) (189)
---------------- ----------------
Net cash provided by (used in) investing activities . . . . . . . . . . . . . (5,063) 1,225
---------------- ----------------
Cash flows from financing activities:
Issuance of common stock, net . . . . . . . . . . . . . . . . . . . . . . . . . 92 201
---------------- ----------------
Net cash provided by financing activities . . . . . . . . . . . . . . . . . . 92 201
---------------- ----------------
Net increase (decrease) in cash and cash equivalents. . . . . . . . . . . . (1,386) 2,762
Cash and cash equivalents at beginning of period. . . . . . . . . . . . . . . . . 9,186 4,613
---------------- ----------------
Cash and cash equivalents at end of period. . . . . . . . . . . . . . . . . . . . $ 7,800 $ 7,375
================ ================
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING ACTIVITIES:
Change in unrealized losses on available-for-sale securities
$ (4) $ -
================ ================
The accompanying notes are an integral part of these condensed consolidated
financial statements.
5
IRIDEX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(IN THOUSANDS)
(UNAUDITED)
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 27, SEPTEMBER 28, SEPTEMBER 27, SEPTEMBER 28,
2003 2002 2003 2002
-------------- -------------- --------------- ---------------
Net income (loss). . . . . . . . . . . $ 261 $ 206 $ (120) $ (448)
Other comprehensive income (loss):
Change in unrealized gain (loss) on
available-for-sale securities. . . - 5 (4) -
-------------- -------------- --------------- ---------------
Comprehensive income (loss). . . . . . $ 261 $ 211 $ (124) $ (448)
============== ============== =============== ===============
The accompanying notes are an integral part of these condensed consolidated
financial statements.
6
IRIDEX CORPORATION
NOTES TO 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 generally accepted accounting principles
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 March 28, 2003. The results of
operations for the three and nine month periods ended September 27, 2003 are not
necessarily indicative of the results for the year ending January 3, 2004 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 December 28, 2002 which was filed with
the Securities and Exchange Commission on March 28, 2003. The Company's
significant accounting policies have not materially changed as of September 27,
2003.
3. 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 statement of operations as a cost of sales. A reconciliation of
the changes in the Company's warranty liability for the nine months ending
September 27, 2003 follows (in thousands):
Balance at the beginning of the period $ 717
Accruals for warranties issued during the period 483
Settlements made in kind during the period (513)
------
Balance at the end of the period $ 687
======
4. BORROWING ARRANGEMENTS
In October 2003, we have extended an existing revolving line of credit
agreement with a bank. The line of credit which expires in October 2004 provides
for borrowing of up to $4.0 million at the bank's prime rate. The agreement
contains restrictive covenants including prohibiting payments of dividends
without the bank's prior consent. There were no borrowings against the line of
credit at September 27, 2003.
5. COMMITMENTS AND CONTINGENCIES
Lease Agreements
We lease our operating facilities under a noncancelable operating lease.
In September 2003, we entered into a lease amendment for our facilities in
Mountain View. The original lease term of this facility, which ended in
February 2004, was amended and extended until February 2009. The lease
agreement was also amended to grant us an option to renew this lease for an
additional five year period beginning 2009 until 2014 at a base monthly rental
amount to be negotiated at the time of the renewal.
Future minimum lease payments under current operating leases are summarized
as follows (in thousands):
Fiscal Year Operating Lease Payments
----------- ------------------------
2004 $ 474
2005 390
2006 402
2007 416
2008 and after 501
-------
$ 2,183
=======
7
6. ACCOUNTING FOR STOCK-BASED COMPENSATION
The Company accounts for stock-based compensation arrangements in
accordance with provisions of Accounting Principles Board Opinion No. 25,
"Accounting for Stock Issued to Employees" ("APB 25") and complies with the
disclosure provisions of Statement of Financial Accounting Standards No. 123,
"Accounting for Stock-Based Compensation" ("SFAS 123"), 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 in the table at the end of this note. To comply with pro
forma reporting requirements of SFAS 123, compensation cost is also estimated
for the fair value of Employee Stock Purchase Plan ("ESPP") issuances, which are
included in the pro forma totals below.
The Company accounts for equity instruments issued to non-employees in
accordance with the provisions of SFAS 123 and Emerging Issues Task Force Issue
("EITF") No. 96-18, "Accounting for Equity Instruments that are Issued to Other
Than Employees, or in Conjunction with Selling Goods and Services." Stock-based
compensation expense related to stock options granted to non-employees is
recognized on a straight-line basis as the stock options are earned. The
stock-based compensation expense will fluctuate as the deemed fair market value
of the common stock fluctuates. There were no equity instruments issued to
non-employees during the three and nine months ended September 27, 2003.
The following table provides a reconciliation of net income (loss) 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):
8
Three Months Ended Nine Months Ended
-------------------------------- --------------------------------
September 27, September 28, September 27, September 28,
--------------- --------------- --------------- ---------------
2003 2002 2003 2002
--------------- --------------- --------------- ---------------
Net income (loss), as reported $ 261 $ 206 $ (120) $ (448)
Add: Total stock based compensation
expense determined under fair value based
method for all awards to employees (83) (128) (304) (408)
--------------- --------------- --------------- ---------------
Pro forma net income (loss) $ 178 $ 78 $ (424) $ (856)
=============== =============== =============== ===============
Basic and diluted net income (loss) per
common share:
As reported $ 0.04 $ 0.03 $ (0.02) $ (0.07)
=============== =============== =============== ===============
Pro forma $ 0.03 $ 0.01 $ (0.06) $ (0.12)
=============== =============== =============== ===============
7. INVENTORIES (IN THOUSANDS):
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:
SEPTEMBER 27, DECEMBER 28,
2003 2002
-------------- -------------
(unaudited)
Raw materials and work in progress. $ 5,083 $ 6,511
Finished goods. . . . . . . . . . . 4,364 4,214
-------------- -------------
Total inventories . . . . . . . . . $ 9,447 $ 10,725
============== =============
8. COMPUTATIONS OF NET INCOME (LOSS) PER COMMON SHARE
Basic and diluted net income (loss) per common 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 loss per common share excludes potential common stock if their
effect is anti-dilutive. 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 is as follows
(in thousands, except share data):
9
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 27, SEPTEMBER 28, SEPTEMBER 27, SEPTEMBER 28,
2003 2002 2003 2002
--------------- -------------- --------------- ---------------
(unaudited) (unaudited)
Numerator
Net income (loss) . . . . . . . . . . . . . . . . . . $ 261 $ 206 $ (120) $ (448)
Denominator - Basic
Weighted average common stock outstanding . . . . . 6,933 6,875 6,922 6,858
=============== ============== =============== ===============
Basic income (loss) per share . . . . . . . . . . . . $ 0.04 $ 0.03 $ (0.02) $ (0.07)
=============== ============== =============== ===============
Denominator - Diluted
Weighted average common stock outstanding . . . . . 6,933 6,875 6,922 6,858
Effect of dilutive securities
Weighted average common stock options . . . . . . . 110 63 - -
--------------- -------------- --------------- ---------------
Total weighted average stock and options outstanding. 7,043 6,938 6,922 6,858
=============== ============== =============== ===============
Diluted income (loss) per share . . . . . . . . . . . $ 0.04 $ 0.03 $ (0.02) $ (0.07)
=============== ============== =============== ===============
During the three months ended September 27, 2003 and September 28, 2002
options to purchase 1,238,594 shares and 1,498,924 shares at weighted average
exercise prices of $5.89 and $5.61 per share were outstanding, but were not
included in the computations of diluted net income (loss) per common share
because the exercise price of the related options exceeded the average market
price of the common shares. For the nine month periods ended September 27, 2003
and September 28, 2002 options to purchase 2,000,040 shares and 1,751,893 shares
at weighted average prices of $5.25 and $5.15 per share were outstanding but not
included in the computations of diluted net loss per common share because their
effect was antidilutive. These options could dilute earnings per share in
future periods.
9. BUSINESS SEGMENTS (UNAUDITED)
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
September 27, 2003 and September 28, 2002 is as follows (in thousands):
10
Three Months Ended September 27, 2003 Three Months Ended September 28, 2002 Nine Months Ended September 27, 2003
------------------------------------- ------------------------------------- ---------------------------------------
Ophthalmology Dermatology Total Ophthalmology Dermatology Total Ophthalmology Dermatology Total
Medical Medical Medical Medical Medical Medical
Devices Devices Devices Devices Devices Devices
- --------- -------------- ------------ -------- -------------- ------------ -------- -------------- ------------ ---------
Sales $ 6,897 $ 1,370 $ 8,267 $ 5,416 $ 1,301 $ 6,717 $ 18,640 $ 4,288 $ 22,928
- --------- -------------- ------------ -------- -------------- ------------ -------- -------------- ------------ ---------
Direct
Cost
of Goods
Sold 2,493 835 3,328 1,713 562 2,275 6,506 2,222 8,728
- --------- -------------- ------------ -------- -------------- ------------ -------- -------------- ------------ ---------
Direct
Gross
Margin 4,404 535 4,939 3,703 739 4,442 12,134 2,066 14,200
- --------- -------------- ------------ -------- -------------- ------------ -------- -------------- ------------ ---------
Total
Unallo-
cated
Costs (4,678) (4,478) (14,501)
- --------- -------------- ------------ -------- -------------- ------------ -------- -------------- ------------ ---------
Pre-tax
income
(loss) 261 (36) (301)
- --------- -------------- ------------ -------- -------------- ------------ -------- -------------- ------------ ---------
Nine Months Ended September 28, 2002
---------------------------------------
Ophthalmology Dermatology Total
Medical Medical
Devices Devices
- --------- -------------- ------------ ---------
Sales $ 16,172 $ 4,941 $ 21,113
- --------- -------------- ------------ ---------
Direct
Cost
of Goods
Sold 5,182 2,163 7,345
- --------- -------------- ------------ ---------
Direct
Gross
Margin 10,990 2,778 13,768
- --------- -------------- ------------ ---------
Total
Unallo-
cated
Costs (14,765)
- --------- -------------- ------------ ---------
Pre-tax
income
(loss) (997)
- --------- -------------- ------------ ---------
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. RECENT ACCOUNTING PRONOUNCEMENTS
In January 2003, the Financial Accounting Standards Board ("FASB") issued
FASB Interpretation No. ("FIN") 46, Consolidation of Variable Interest Entities,
an Interpretation of ARB No. 51. FIN 46 requires certain variable interest
entities to be consolidated by the primary beneficiary of the entity if the
equity investors in the entity do not have the characteristics of a controlling
financial interest or do not have sufficient equity at risk for the entity to
finance its activities without additional subordinated financial support from
other parties. FIN 46 was effective immediately for all new variable interest
entities created or acquired after January 31, 2003. For variable interest
entities created or acquired prior to February 1, 2003, the provisions of FIN 46
must be applied for the first interim or annual period beginning after June 15,
2003. In October 2003, the FASB deferred the implementation date by which all
public companies must apply FIN 46. The FASB agreed to provide this deferral to
allow time for certain implementation issues to be addressed through the
issuance of a modification to FIN 46, and indicated that it expects to issue
this modification in final form prior to the end of 2003. We do not expect the
adoption of FIN 46 to have a material impact on our financial position or on our
results of operations.
In April 2003, the FASB issued Statement of Financial Accounting Standards
("SFAS") No. 149, "Amendment of Statement 133 on Derivative Instruments and
Hedging Activities," SFAS No. 149
11
requires that contracts with comparable characteristics be accounted for
similarly. In particular, SFAS No. 149 clarifies under what circumstances a
contract with an initial net investment meets the characteristic of a
derivative, clarifies when a derivative contains a financing component, amends
the definition of an underlying to conform it to language used in FIN 45
Guarantor's Accounting and Disclosure Requirements for Guarantees, Including
Indirect Guarantees of Indebtedness of Others, and amends certain other existing
pronouncements. SFAS No. 149 is effective for contracts entered into or modified
after June 30, 2003, and for hedging relationships designated after June 30,
2003. In addition, provisions of SFAS No. 149 should be applied prospectively.
We do not expect the adoption of SFAS No. 149 to have a material impact on our
financial position or on our results of operations.
In May 2003, the FASB issued SFAS No. 150, "Accounting for Certain
Financial Instruments with Characteristics of both Liabilities and Equity." SFAS
No. 150 establishes standards for how an issuer classifies and measures certain
financial instruments with characteristics of both liabilities and equity. SFAS
No. 150 requires that an issuer classify a financial instrument that is within
its scope as a liability, or an asset in some circumstances. SFAS No. 150 is
effective for financial instruments entered into or modified after May 31, 2003,
and otherwise is effective at the beginning of the first interim period
beginning after June 15, 2003. SFAS No. 150 is to be implemented by reporting
the cumulative effect of a change in an accounting principle for financial
instruments created before the issuance date of SFAS No. 150 and still existing
at the beginning of the interim period of adoption. Restatement is not
permitted. We do not expect that the adoption of SFAS No. 150 to have a material
impact on our financial position or on our results of operations.
12
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; expectations for future sales growth, generally, and the potential for
production cost decreases and higher gross margins; anticipated inventory
reductions and improvements from asset management efforts; levels of future
investment in research and development efforts; favorable Center for Medicare
and Medicaid coverage decisions regarding AMD procedures that use our products;
results of clinical studies; development and introduction of new products to
market, expected increases in competition and declines in average selling
prices; 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 statement, 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 Form10-K filed with the Securities
and Exchange Commission on March 28, 2003 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 (unaudited) for the periods indicated.
THREE MONTHS ENDED NINE MONTHS ENDED
------------------------------- ------------------------------
SEPTEMBER 27, SEPTEMBER 28, SEPTEMBER 27, SEPTEMBER 28,
2003 2002 2003 2002
-------------- -------------- -------------- --------------
Sales . . . . . . . . . . . . . . . . 100.0% 100.0% 100.0% 100.0%
Cost of sales . . . . . . . . . . . . 56.6 55.2 56.6 56.3
-------------- -------------- -------------- --------------
Gross profit. . . . . . . . . . . . 43.4 44.8 43.4 43.7
-------------- -------------- -------------- --------------
Operating expenses:
Research and development. . . . . . 11.8 13.7 13.0 16.0
Sales, general and administrative . 29.0 31.2 32.4 32.7
-------------- -------------- -------------- --------------
Total operating expenses. . . . . 40.8 44.9 45.4 48.7
-------------- -------------- -------------- --------------
Income (loss) from operations . . . . 2.6 (0.1) (2.0) (5.0)
Interest and other income, net. . . 0.6 (0.4) 0.7 0.3
-------------- -------------- -------------- --------------
Loss before benefit from income taxes 3.2 (0.5) (1.3) (4.7)
Benefit from income taxes . . . . . . 0.0 3.6 0.8 2.6
-------------- -------------- -------------- --------------
Net income (loss) . . . . . . . . . . 3.2% 3.1% (0.5)% (2.1)%
============== ============== ============== ==============
13
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
---------------------------------------------- ----------------------------------------------
September 27, 2003 September 28, 2002 September 27, 2003 September 28, 2002
---------------------- ---------------------- ---------------------- ----------------------
Amount Percentage Amount Percentage Amount Percentage Amount Percentage
of total of total of total of total
sales sales sales sales
-------- ------------ -------- ------------ -------- ------------ -------- ------------
Domestic $ 5,222 63.2% $ 4,471 66.6% $ 14,442 63.0% $ 13,214 62.6%
International 3,045 36.8% 2,246 33.4% 8,486 37.0% 7,899 37.4%
Total $ 8,267 100.0% $ 6,717 100.0% $ 22,928 100.0% $ 21,113 100.0%
Ophthalmology:
Domestic $ 4,061 49.1% $ 3,175 47.3% $ 11,111 48.5% $ 9,212 43.6%
International 2,836 34.3% 2,241 33.3% 7,529 32.8% 6,960 33.0%
Total $ 6,897 83.4% $ 5,416 80.6% $ 18,640 81.3% $ 16,172 76.6%
Dermatology:
Domestic $ 1,161 14.1% $ 1,296 19.3% $ 3,331 14.5% $ 4,002 19.0%
International 209 2.5% 5 0.1% 957 4.2% 939 4.4%
Total $ 1,370 16.6% $ 1,301 19.4% $ 4,288 18.7% $ 4,941 23.4%
Combined Ophthalmology and Dermatology
Sales
Sales for the three months ended September 27, 2003 increased by 23.1% to
$8.3 million from $6.7 million for the corresponding three month period ended
September 28, 2002. Ophthalmology sales increased by $1.5 million while
dermatology sales increased by $0.1 million for the three months ended September
27, 2003. Sales for the nine months ended September 27, 2003 increased 8.6% to
$22.9 million from $21.1 million for the nine months ended September 28, 2002.
For the nine month period the overall increase in sales of 8.6% was driven
primarily by an increase in sales of our ophthalmology products of $2.5 million
offset by a $0.7 million decrease in sales of our dermatology products.
Domestic sales increased 16.8% to $5.2 million for the three month period
ended September 27, 2003 from $4.5 million for the three month period ended
14
September 28, 2002. For the nine months ended September 27, 2003 domestic sales
increased 9.3% to $14.4 million from $13.2 million. The overall increase for the
nine month period was driven mainly by $1.9 million in increased sales of our
ophthalmology products offset by a $0.7 million decrease in sales of our
dermatology products.
International sales increased 35.6% to $3.0 million for the three months
ended September 27, 2003 from $2.2 million for the comparable prior year
three-month period as a result of $0.6 million in increased sales of our
ophthalmology products and $0.2 million in increased sales of our dermatology
products. For the nine months ended September 27, 2003 international sales
increased 7.4% to $8.5 million from $7.9 million for the nine months ended
September 28, 2002. The increase in international sales during this period was
driven mainly by $0.6 million in increased sales of our ophthalmology products.
We continue to face challenges marketing and selling our products in the
current difficult economic environment, both domestically and internationally,
and expect to face these challenges for the foreseeable future. See "-Factors
That May Affect Future Results - Our Business has been Adversely Impacted by the
Worldwide Economic Slowdown and Related Uncertainties."
Ophthalmology Sales
Ophthalmology sales increased 27.3% to $6.9 million for the three months
ended September 27, 2003 from $5.4 million for the three months ended September
28, 2002. For the nine months ended September 27, 2003 ophthalmology sales
increased 15.3% to $18.6 million from $16.2 million for the comparable prior
year nine-month period. Domestic ophthalmology sales increased 27.9% to $4.1
million for the three months ended September 27, 2003 from $3.2 million for the
comparable prior year three-month period. The increase in domestic sales during
this period occurred mainly as a result of $0.3 million in increased unit sales
of visible laser systems, including the Millennium Endolase module, which is
incorporated as a component of Bausch and Lomb's Millennium Microsurgical
System, $0.2 million in increased unit sales of infrared laser systems, $0.4
million in increased unit sales of delivery devices and increased service
revenue. For the nine months ended September 27, 2003 domestic ophthalmology
sales increased 20.6% to $11.1 million from $9.2 million for the comparable
prior year nine month period. Domestic ophthalmology sales increased during this
period mainly as a result of $1.1 million in increased unit sales of visible
laser systems, including the Millennium Endolase module, $0.8 million in
increased unit sales of delivery devices and increased service revenue.
International ophthalmology sales increased 26.6% to $2.8 million for the three
months ended September 27, 2003 from $2.2 million for the comparable prior year
three-month period. The increase in international ophthalmology sales for this
period was due mainly to $0.5 million in increased unit sales of our visible
laser systems, $0.3 million in increased unit sales of delivery devices offset
by $0.2 million in decreased unit sales of our infrared laser systems. For the
nine month period ended September 27, 2003 international ophthalmology sales
increased 8.2% to $7.5 million from $7.0 million for the nine months ended
September 28, 2002. The increase in international ophthalmology for the nine
month period was due primarily to $0.6 million in increased unit sales of
visible laser systems, $0.3 million in increased unit sales of delivery devices,
offset by $0.4 million in decreased unit sales of infrared laser systems.
Dermatology Sales
Dermatology sales increased 5.3% to $1.4 million for the three months ended
September 27, 2003 from $1.3 million for the three months ended September 28,
2002. Domestic dermatology sales decreased 10.4% to $1.2 million for the three
month period ended September 27, 2003 from $1.3 million for the three month
period ended September 28, 2002. The decrease in domestic dermatology sales was
due primarily to a $0.2 million decrease in unit sales and average selling
prices of dermatology products. International dermatology sales increased to
$0.2 million for the three month period ended September 27, 2003 from $5,000 for
the three months ended September 28, 2002 due to increased unit sales of
dermatology products. For the nine months ended
15
September 27, 2003 dermatology sales decreased 13.2% to $4.3 million from $4.9
million for the comparable prior year nine-month period. Domestic dermatology
sales decreased 16.8% to $3.3 million for the nine months ended September 27,
2003 from $4.0 million for the comparable prior year nine-month period. The
decrease in domestic dermatology sales for this period was due mainly to a $0.4
million decrease in average selling prices and a $0.3 million decrease in unit
sales of products. International dermatology sales for the nine months ended
September 27, 2003 remained at approximately the same level when compared to the
corresponding nine month period ended September 28, 2002.
Gross Profit. Gross margin decreased to 43.4% for the three months ended
September 27, 2003 from 44.8% for the comparable three month period in 2002. The
decrease in gross margin for this period was due to an unfavorable impact of
1.1% associated with lower average selling prices, an unfavorable impact of 0.6%
related to products costs and overhead and an unfavorable impact of 0.3% related
to warranty charges offset by a favorable impact of 0.6% related to product mix.
For the nine months ended September 27, 2003, gross profit as a percentage of
net sales decreased slightly to 43.4% as compared to 43.7% for the comparable
nine month period. For the nine month period ended September 27, 2003, the
decrease in gross profit as a percentage of net sales was primarily due to an
unfavorable impact of 0.8% related to product mix, an unfavorable impact of 0.7%
related to lower average selling prices, an unfavorable impact of 0.2% related
to product costs and overhead offset by favorable impacts of 1.4% for decreased
warranty costs. Although increasing competition has continued to result in
reduced average selling prices for some of our products, we intend to continue
our efforts to reduce inventory and the overall cost of manufacturing and
thereby mitigate the impact of price reductions on our gross profit. 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." Overall, 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. For the three months ended September 27, 2003,
our research and development expenses of $1.0 million increased by $0.1 million
or 6.1% from $0.9 million for the three months ended September 28, 2002.
However, research and development expenses decreased as a percentage of net
sales to 11.8% for the three months ended September 27, 2003 from 13.7% for the
comparable prior year three-month period. The increase in research and
development expense in absolute dollars for the three month period ended
September 27, 2003 was due primarily to $0.1 million in increased spending on
new projects. The decrease in research and development as a percentage of net
sales was due to the fact that the increase in sales for the three month period
ended September 27, 2003 exceeded the increase in research and development
expense. For the nine month period ended September 27, 2003 research and
development expense was $3.0 million, a decrease of 12.2% or $0.4 million from
the comparable nine month period in the prior year. The decrease in research and
development expense was due to $0.2 million in reduced payroll costs as a result
of the reduction in force in June 2002, which resulted in lower research and
development expenses for the remaining three months of the nine month period
ended September 28, 2002 and for the entire nine month period ended September
27, 2003, $0.1 million in reduced clinical spending and $0.1 million in reduced
project spending. As a percentage of net sales research and development expense
decreased to 13.0% from 16.0% for the comparable prior year nine month period.
The decrease in research and development expense as a percentage of sales for
the nine month period ended September 27, 2003 was due primarily to the increase
in revenue.
Sales, General and Administrative. Our sales, general and administrative
expenses increased by 14.5% to $2.4 million for the three months ended September
16
27, 2003 from $2.1 million for the three months ended September 28, 2002. As a
percentage of net sales, sales, general and administrative expenses decreased to
29.0% for the three months ended September 27, 2003 from 31.2% for the
comparable prior year three-month period. The increase in sales, general and
administrative expense in absolute dollars for the three month period ending
September 27, 2003 was due primarily to $0.2 million in increased non-commission
related selling activities and a $0.1 million net increase in administrative
spending, which consisted primarily of insurance. The decrease in sales, general
and administrative expense as a percentage of net sales was driven mainly by the
increase in revenue relative to the increase in sales, general and
administrative expense. For the nine months ended September 27, 2003, sales,
general and administrative expenses increased by 7.7% to $7.4 million from $6.9
million for the comparable period in 2002. Sales, general and administrative
expenses as a percentage of net sales decreased slightly to 32.4% for the nine
months ended September 27, 2003 from 32.7% for the comparable period in 2002.
The increase in absolute dollars for the nine month period ended September 27,
2003 was due primarily to $0.4 million in increased non-commission related
selling activities and $0.2 million in increased administrative spending
associated mainly with consulting and insurance costs. The decrease in sales,
general and administrative expenses as a percentage of net sales for the nine
month period was due mainly to the increase in revenue relative to the increase
in sales, general and administrative expense.
Interest and Other Income, net. For the three months ended September 27,
2003, we realized net interest and other income of $49,000 as compared with
$31,000 in net interest expense for the comparable quarter in 2002. For the nine
months ended September 27, 2003, net interest and other income was $154,000 as
compared with $66,000 for the comparable nine month period ended September 28,
2002.
Income Taxes. The effective income tax rates for the three and nine month
periods ended September 27, 2003 were lower for periods where we had pre-tax
income and higher for periods where we had pre-tax losses than the Federal and
State combined statutory rate of 40% primarily because of certain tax benefits
associated with tax credits for research and development activities. Based on
our year to date tax liability, no tax expense was recorded in the third quarter
of 2003.
LIQUIDITY AND CAPITAL RESOURCES
At September 27, 2003, our primary sources of liquidity included cash and
cash equivalents and available-for-sale securities in the aggregate amount of
$14.9 million. In addition, we have available $4.0 million under our unsecured
line of credit which bears interest at the bank's prime rate and expires in
October 2004. As of September 27, 2003, 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 nine months ended September 27, 2003, we used $1.4 million in
cash and cash equivalents. During this period, operating activities provided
$3.6 million of cash. Sources of cash from operating activities included a
decrease in net accounts receivable of $1.8 million, a decrease in net
inventories of $1.3 million, depreciation of $0.6 million, an increase in
combined accounts payable and accrued expenses of $0.2 million, offset in part,
by uses of cash including a net loss of $0.1 million, and an increase in prepaid
expenses of $0.2 million. The decrease in accounts receivable and inventories
resulted from focused asset management efforts to increase our cash position.
We will continue to place a high priority on our asset management efforts to
further increase our cash position.
17
Investing activities used $5.1 million in cash and cash equivalents during
the nine months ended September 27, 2003, primarily due to net purchases of
available for sale securities of $4.8 million and $0.3 million for the
acquisition of property and equipment.
Net cash provided by financing activities during the nine months ended
September 27, 2003 was $92,000 which resulted from the issuance of common stock.
Our operating facilities are located in 37,000 square feet of space in
Mountain View, California. In September 2003, we entered into a lease amendment
for our facilities in Mountain View. The original lease term of this facility,
which ended in February 2004, was amended and extended until February 2009. The
lease agreement was also amended to grant us an option to renew this lease for
an additional five year period beginning 2009 until 2014 at a base monthly
rental amount to be negotiated at the time of the renewal. A summary of our
future minimum commitments under this lease is presented in Note 4 -
"Commitments and Contingencies" in the Notes to Condensed Consolidated Financial
Statements.
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. However, we may require or desire additional funds to
support our operating expenses and capital requirements or for other purposes,
such as acquisitions, competitive reasons or for new product development, and
may seek to raise such additional funds through public or private equity
financing or from other sources. 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."
CRITICAL ACCOUNTING POLICIES
The Company's significant accounting policies are disclosed in our Annual
Report on Form 10-K for the year ended December 28, 2002 which was filed with
the Securities and Exchange Commission on March 28, 2003.
RECENT ACCOUNTING PRONOUNCEMENTS
In November 2002, the Emerging Issues Task Force, or EITF, reached a
consensus on Issue No. 00-21, Revenue Arrangements with Multiple Deliverables.
EITF Issue No. 00-21 provides guidance on how to account for arrangements that
involve the delivery or performance of multiple products, services and/or rights
to use assets. The provisions of EITF Issue No. 00-21 will apply to revenue
arrangements entered into in fiscal periods beginning after June 15, 2003. We do
not expect the adoption of EITF Issue No. 00-21 to have a material impact on our
financial position or on our results of operations.
In January 2003, the FASB issued FASB Interpretation No. 46, or FIN 46,
Consolidation of Variable Interest Entities, an Interpretation of ARB No. 51.
FIN 46 requires certain variable interest entities to be consolidated by the
primary beneficiary of the entity if the equity investors in the entity do not
have the characteristics of a controlling financial interest or do not have
sufficient equity at risk for the entity to finance its activities without
additional subordinated financial support from other parties. FIN 46 was
effective immediately for all new variable interest entities created or acquired
after January 31, 2003. For variable interest entities created or acquired prior
to February 1, 2003, the provisions of FIN 46 must be applied for the first
interim or annual period beginning after June 15, 2003. In October 2003, the
18
FASB deferred the implementation date by which all public companies must apply
FIN 46. We must apply FIN 46 no later than the first reporting period ending
after December 15, 2003. The FASB agreed to provide this deferral to allow time
for certain implementation issues to be addressed through the issuance of a
modification to FIN 46, and indicated that it expects to issue this modification
in final form prior to the end of 2003. We do not expect the adoption of FIN 46
to have a material impact on our financial position or on our results of
operations.
In April 2003, the FASB issued Statement No. 149 Amendment of Statement 133
on Derivative Instruments and Hedging Activities, or SFAS No. 149. SFAS No. 149
requires that contracts with comparable characteristics be accounted for
similarly. In particular, SFAS No. 149 clarifies under what circumstances a
contract with an initial net investment meets the characteristic of a
derivative, clarifies when a derivative contains a financing component, amends
the definition of an underlying to conform it to language used in FIN 45
Guarantor's Accounting and Disclosure Requirements for Guarantees, Including
Indirect Guarantees of Indebtedness of Others, and amends certain other existing
pronouncements. SFAS No. 149 is effective for contracts entered into or modified
after June 30, 2003, and for hedging relationships designated after June 30,
2003. In addition, provisions of SFAS No. 149 should be applied prospectively.
We do not expect the adoption of SFAS No. 149 to have a material impact on our
financial position or on our results of operations.
In May 2003, the FASB issued Statement No. 150 Accounting for Certain
Financial Instruments with Characteristics of both Liabilities and Equity, or
SFAS No. 150. SFAS No. 150 establishes standards for how an issuer classifies
and measures certain financial instruments with characteristics of both
liabilities and equity. SFAS No. 150 requires that an issuer classify a
financial instrument that is within its scope as a liability, or an asset in
some circumstances. SFAS No. 150 is effective for financial instruments entered
into or modified after May 31, 2003, and otherwise is effective at the beginning
of the first interim period beginning after June 15, 2003. SFAS No. 150 is to be
implemented by reporting the cumulative effect of a change in an accounting
principle for financial instruments created before the issuance date of SFAS No.
150 and still existing at the beginning of the interim period of adoption.
Restatement is not permitted. We do not expect that the adoption of SFAS No. 150
to have a material impact on our financial position or on our results of
operations.
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:
- Product performance, features, ease of use, scalability and
durability;
- Recommendations and opinions by ophthalmologists, dermatologists,
clinicians, plastic surgeons and their associated opinion
leaders;
- Price of our products and prices of competing products and
technologies;
19
- 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 and from service revenues. Our ophthalmology and dermatology
medical laser consoles are not designed to exclusively utilize our delivery
devices and can be used with the delivery devices of our competitors. Our
ability to increase revenues from the sale of delivery devices will depend
primarily upon the feature, ease of use and prices of our products, including
relative to the 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 a competing
product 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 treatments 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., Nidek, Inc., Carl Zeiss, Inc., Alcon Inc. and Quantel. All of
these companies currently offer a competitive semiconductor-based laser system
in ophthalmology. Our principal competitors in dermatology are Lumenis Ltd.,
Laserscope, Candela Corporation and Altus Medical Inc and Palomar Technologies.
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
of, manufacture and market new products. 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. 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
20
products may also be subject to government regulation, including approval 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. Continued political and social turmoil in Iraq or other
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 the economic or market conditions continue
to further deteriorate, 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 us or our competitors or other
factors. If we are unable to offset the anticipated decrease in our average
selling prices by increasing our sales volumes, our net revenues will decline.
In addition, to maintain our gross margins, we must continue to reduce the
manufacturing cost of our products. Further, should average unit prices of our
current products decline, we must develop and introduce new products and product
enhancements with higher margins. 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. We do not currently
intend to utilize any external 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, 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:
21
- 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 and
interoperability 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 September 27, 2003,
our international sales were $3.0 million or 36.8% 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;
- reduced or limited protections of intellectual property rights in
jurisdictions outside the United States;
- potentially adverse tax consequences; and
22
- 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 September 27, 2003, sales of our ophthalmology products
were $6.9 million or 83.4% of total sales and contributed $4.4 million to total
direct gross margins of $4.9 million for the three month period. 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 previously announced OcuLight
Symphony multi-wavelength laser delivery system, expanded EndoProbe product line
and 5 mm Large Spot Slit Lamp Adapter, 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. For example, 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, only three carriers-Noridian Mutual
Insurance, which is the CMS Part B Carrier for Alaska, Arizona, Colorado,
Hawaii, Iowa, Nevada, North Dakota, Oregon, South Dakota, Washington and
Wyoming; Cigna, which is the carrier for North Carolina, Tennessee and Idaho;
and National Heritage Insurance, which is the carrier for California-have made
coverage decisions approving the use of the Transpupillary Thermotherapy, or TTT
protocol for the treatment of wet AMD. No other carriers have approved
reimbursement of such AMD procedures using the OcuLight SLx, and domestic sales
of the OcuLight SLx laser system 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
23
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.
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, 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. In order to successfully
commercialize the use of our OcuLight SLx for TTT procedures, we must be able
to, among other things, demonstrate with substantial evidence from
well-controlled clinical trials where TTT procedures using the Oculight SLx
product are both safe and effective. 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. 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 validate the safety and effectiveness 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;
- Fluctuations in our product mix between dermatology and ophthalmic
products and foreign and domestic sales;
24
- 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;
- Decreases 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 September 27, 2003 our direct sales force consisted of 15
employees and we maintained relationships with 50 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.
25
We Depend on 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. We plan to collaborate with third parties to develop and
commercialize existing and new products. In October 2002, we announced our
collaboration 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. 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
thirteen United States patents and one foreign patent on the technologies
related to our products and processes. We have approximately eleven pending
patent applications in the United States and nine 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,
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
26
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 approval process implemented by the FDA under federal law. A device
manufacturer must obtain market clearance through either the 510(k) premarket
notification process or the lengthier premarket approval application 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 FDA good manufacturing
practice regulations, which include quality control and quality assurance
requirements, as well as maintenance of records and documentation. 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
27
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" registered, 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 IRIS Medical and
IRIDERM products are CE registered, continued registration is based on
successful review of the process by our European Registrar during their annual
audit. Any loss of registration 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 in the future. 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 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
28
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.
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 September 27, 2003.
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 fiscal year 2004 and the interest rates are
primarily fixed.
29
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.
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
EVALUATION OF DISCLOSURE CONTROLS AND PROCEDURES
Our management have evaluated, with the participation of our President and
Chief Executive Officer, who is our principal executive officer, and our Chief
Financial Officer and Vice President, Administration, who is our principal
financial officer, the effectiveness of our "disclosure controls and procedures"
(as defined in Rules 13a-15(e) and 15(d)-15(e) of the Securities and Exchange
Act of 1934, as amended) as of the end of the period covered by this Quarterly
Report on Form 10-Q. Based on that evaluation, our President and Chief Executive
Officer and our Chief Financial Officer and Vice President Administration
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 and Exchange Act of 1934, as amended, is recorded,
processed, summarized and reported within the time periods specified in the
Securities Exchange Commission rules and forms.
CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING
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
None.
30
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 engagement 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
10.1 Lease Agreement dated December 6, 1996, by and between Zappetini
---- --------------------------------------------------------------------
Investment Co. and the Registrant, as amended by that certain Lease
--------------------------------------------------------------------
Amendment and Extension, dated September 15, 2003.
-------------------------------------------------------
31 Certifications of Chief Executive Officer and Chief Financial
-- --------------------------------------------------------------------
Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under
--------------------------------------------------------------------
the Securities Exchange Act of 1934, as adopted pursuant to Section
--------------------------------------------------------------------
302 of the Sarbanes-Oxley Act of 2002.
-----------------------------------------
32 Certifications 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
The Company filed a report on Form 8-K on October 21, 2003 relating to a
press release regarding the Company's financial results for the fiscal quarter
ended September 27, 2003.
31
TRADEMARK ACKNOWLEDGMENTS
- --------------------------
IRIDEX, the IRIDEX logo, IRIS Medical, Oculight, EndoProbe and Apex are our
- --------------------------------------------------------------------------------
registered trademarks, IRIDERM and Britelight product names are our trademarks.
- --------------------------------------------------------------------------------
All other trademarks or trade names appearing in this Form 10-Q are the property
- --------------------------------------------------------------------------------
of their respective owners.
- -----------------------------
32
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 12, 2003 By: /s/ Larry Tannenbaum
-----------------------
Larry Tannenbaum
Chief Financial Officer,
Senior Vice President of Finance and
Administration and Secretary
(Principal Financial and Principal
Accounting Officer)
EXHIBIT INDEX
--------------
EXHIBIT
- -------
NUMBER DESCRIPTION
- ------ -----------
10.1 Lease Agreement dated December 6, 1996, by and between Zappetini
- ---- -------------------------------------------------------------------------
Investment Co. and the Registrant, as amended by that certain Lease
--------------------------------------------------------------------------
Amendment and Extension, dated September 15, 2003.
-------------------------------------------------------
31 Certifications of Chief Executive Officer and Chief Financial Officer
- -- --------------------------------------------------------------------------
pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities
--------------------------------------------------------------------------
Exchange Act of 1934, as adopted pursuant to Section 302 of the
--------------------------------------------------------------------------
Sarbanes-Oxley Act of 2002.
----------------------------
32 Certifications 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.
----------------------------------
33