SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
[X] Quarterly Report Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934. For the quarterly period ended
September 30, 2001.
or
[ ] Transition Report Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934. For the Transition period from
------------------------------ to ------------------------------.
Commission File Number: 0-19671
LASERSIGHT INCORPORATED
-----------------------
(Exact name of registrant as specified in its charter)
Delaware 65-0273162
-------------------------- ----------
(State of Incorporation) (IRS Employer Identification No.)
3300 University Blvd., Suite 140, Winter Park, Florida 32792
----------------------------------------------------------------------
(Address of principal executive offices) (Zip Code)
(407) 678-9900
--------------
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes X No
----- -----
The Number of shares of the registrant's Common Stock outstanding as of
November 13, 2001 is 26,437,895.
LASERSIGHT INCORPORATED AND SUBSIDIARIES
Except for the historical information contained herein, the discussion in this
report contains forward-looking statements (within the meaning of Section 21E of
the Exchange Act) that involve risks and uncertainties. LaserSight's actual
results could differ materially from those discussed here. Factors that could
cause or contribute to such differences include, but are not limited to, those
discussed in the sections entitled "Management's Discussion and Analysis of
Financial Condition and Results of Operations - Risk Factors" in this report and
in LaserSight's Annual Report on Form 10-K for the year ended December 31, 2000.
LaserSight undertakes no obligation to update any such factors or to publicly
announce the results of any revisions to any of the forward-looking statements
contained herein to reflect any future events or developments.
INDEX
PART I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
Condensed Consolidated Balance Sheets as of September 30, 2001
and December 31, 2000
Condensed Consolidated Statements of Operations for the Three
Month Periods and Nine Month Periods Ended September 30, 2001
and 2000
Condensed Consolidated Statements of Cash Flows for the Nine
Month Periods Ended September 30, 2001 and 2000
Notes to Condensed Consolidated Financial Statements
Independent Auditors' Review Report
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations
Item 3. Management's Quantitative and Qualitative Disclosures about
Market Risk
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Item 2. Changes in Securities
Item 3. Defaults Upon Senior Securities
Item 4. Submission of Matters to a Vote of Security Holders
Item 5. Other Information
Item 6. Exhibits and Reports on Form 8-K
2
PART I - FINANCIAL INFORMATION
ITEM 1 - FINANCIAL STATEMENTS
LASERSIGHT INCORPORATED AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, December 31,
ASSETS 2001 2000
------------- ------------
Current assets: (Unaudited)
Cash and cash equivalents $ 4,570,092 8,593,858
Accounts receivable - trade, net 8,269,316 9,546,368
Notes receivable - current portion, net 3,713,450 4,065,958
Inventories 12,371,061 12,123,877
Deferred tax assets 55,522 55,522
Other current assets 805,601 272,745
------------ ------------
Total Current Assets 29,785,042 34,658,328
Notes receivable, less current portion, net 2,332,983 2,833,393
Property and equipment, net 1,788,842 2,398,292
Patents, net 4,555,143 7,204,981
Goodwill, net 3,046,476 3,232,425
Other assets, net 1,688,659 1,549,033
------------ ------------
$ 43,197,145 51,876,452
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 3,311,025 3,870,791
Accrued expenses 5,431,229 7,030,657
Accrued commissions 1,798,586 1,926,996
Deferred revenue 1,606,319 1,149,415
------------ ------------
Total Current Liabilities 12,147,159 13,977,859
Accrued expenses, less current portion 388,335 398,767
Deferred royalty revenue, less current portion 3,592,000 --
Deferred income taxes 55,522 55,522
Long-term obligations 116,930 109,730
Note payable, net of unamortized discount of $88,851
at September 30, 2001 2,911,149 --
Commitments and contingencies
Stockholders' equity:
Convertible preferred stock, authorized 10,000,000 shares;
par value $.001 per share
Series C - zero and 2,000,000 issued and outstanding
at September 30, 2001 and December 31, 2000, respectively -- 2,000
Series F - 1,276,596 and zero issued and outstanding
at September 30, 2001 and December 31, 2000, respectively 1,277 --
Common stock - par value $.001 per share; authorized
100,000,000 shares; 26,583,095 and 22,920,278 shares
issued at September 30, 2001 and December 31, 2000,
respectively 26,583 22,920
Additional paid-in capital 102,912,015 98,594,665
Stock subscription receivable (1,140,000)
Accumulated deficit (77,271,178) (59,602,364)
Less treasury stock, at cost; 145,200 common shares at
September 30, 2001 and December 31, 2000 (542,647) (542,647)
------------ ------------
23,986,050 37,334,574
------------ ------------
$ 43,197,145 51,876,452
============ ============
See accompanying notes to the condensed consolidated financial statements.
3
LASERSIGHT INCORPORATED AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------------ -------------------------
2001 2000 2001 2000
----------- ---------- ----------- -----------
Revenues:
Products $ 2,054,407 7,015,856 9,155,980 25,501,779
Royalties 72,000 827,768 320,000 2,086,449
Services 238,050 165,600 749,257 577,045
----------- ---------- ----------- -----------
2,364,457 8,009,224 10,225,237 28,165,273
Cost of revenue:
Product cost 1,382,714 3,407,500 4,858,903 10,968,931
Cost of services 104,742 99,264 329,673 303,180
----------- ---------- ----------- -----------
Gross profit 877,001 4,502,460 5,036,661 16,893,162
Research, development and regulatory
expenses 712,693 1,095,951 2,587,854 3,346,181
Other general and administrative expenses 5,433,202 5,443,899 19,346,410 16,025,028
Selling related expenses 1,045,456 2,030,860 3,705,173 5,636,986
Amortization of intangibles 177,042 645,672 573,984 1,963,834
----------- ---------- ----------- -----------
6,655,700 8,120,431 23,625,567 23,625,848
----------- ---------- ----------- -----------
Loss from operations (6,491,392) (4,713,922) (21,176,760) (10,078,867)
Other income and expenses:
Interest and dividend income 124,416 206,798 500,798 709,084
Interest expense (149,212) (10,065) (352,399) (21,219)
Gain on sale of patent -- -- 3,950,836 --
Litigation settlement -- -- (591,289) --
----------- ---------- ----------- -----------
Net loss before income taxes (6,516,188) (4,517,189) (17,668,814) (9,391,002)
Income tax expense -- -- -- --
----------- ---------- ----------- -----------
Net loss $(6,516,188) (4,517,189) (17,668,814) (9,391,002)
=========== ========== =========== ===========
Loss per common share
Basic and diluted: $ (0.25) (0.21) (0.72) (0.46)
=========== ========== =========== ===========
Weighted average number of shares
outstanding
Basic and diluted: 26,392,000 21,689,000 24,691,000 20,420,000
=========== ========== =========== ===========
See accompanying notes to the condensed consolidated financial statements.
4
LASERSIGHT INCORPORATED AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
NINE MONTHS ENDED SEPTEMBER 30, 2001 AND 2000
(Unaudited)
2001 2000
------------ ------------
Cash flow from operating activities:
Net loss $(17,668,814) (9,391,002)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 1,704,643 2,748,935
Gain on sale of patent (3,950,836) --
Common stock issued for services 60,469 --
Options issued in relation to consulting agreement 33,715 --
Changes in assets and liabilities:
Accounts and notes receivable 2,129,970 (6,958,430)
Inventories (247,184) (4,254,349)
Accounts payable (559,766) 3,356,011
Accrued expenses (1,220,466) 2,613,812
Deferred revenue 4,048,904 (193,412)
Other (99,827) (364,688)
------------ ------------
Net cash used in operating activities (15,769,192) (12,443,123)
Cash flows from investing activities:
Purchases of property and equipment, net (381,263) (1,435,715)
Proceeds from sale of patent, net 6,365,000 --
Acquisition of intangible assets -- (4,513,665)
------------ ------------
Net cash provided by (used in) investing activities 5,983,737 (5,949,380)
Cash flows from financing activities:
Proceeds from common and preferred stock financing, net 2,925,000 19,102,451
Proceeds from exercise of stock options and ESPP 59,891 84,533
Proceeds from debt financing, net 2,776,798 --
------------ ------------
Net cash provided by financing activities 5,761,689 19,186,984
------------ ------------
Increase (decrease) in cash and cash equivalents (4,023,766) 794,481
Cash and cash equivalents, beginning of period 8,593,858 11,247,801
------------ ------------
Cash and cash equivalents, end of period $ 4,570,092 12,042,282
============ ============
See accompanying notes to the condensed consolidated financial statements.
5
LASERSIGHT INCORPORATED AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Nine-Month Periods Ended September 30, 2001 and 2000
NOTE 1 BASIS OF PRESENTATION
The accompanying unaudited, condensed consolidated financial
statements of LaserSight Incorporated and subsidiaries (LaserSight) as
of September 30, 2001, and for the three- and nine-month periods ended
September 30, 2001 and 2000 have been prepared in accordance with
accounting principles generally accepted in the United States of
America on a going concern basis, which contemplates the realization
of assets and the discharge of liabilities in the normal course of
business for the foreseeable future.
The Company has incurred significant losses and negative cash flow
from operations in each of the last two years and for the nine-month
period ended September 30, 2001 and has an accumulated deficit of
$77,271,178 at September 30, 2001. The substantial portion of the
losses is attributable to delays in FDA approvals for the treatment of
various procedures on the Company's excimer laser system in the U.S.
(a key approval for the treatment of nearsightedness with or without
astigmatism was received in late September 2001) and the continued
development efforts to expand clinical approvals of the Company's
excimer laser and other products.
Management of the Company has undertaken steps as part of a plan to
improve operations with the goal of sustaining Company operations for
the next twelve months and beyond. These steps include (a) increasing
U.S. laser sales and revenues based on the recent FDA approvals
received; (b) improving pricing and terms of international sales with
custom ablation products like the recently announced Corneal
Interactive Programmed Topographic Ablation (CIPTA); (c) introducing
new refractive products that complement excimer laser systems; (d)
controlling overhead and expenses; and (e) raising, if necessary,
additional equity capital and/or debt financing.
There can be no assurance the Company can successfully accomplish
these steps. Accordingly, the Company's ability to continue as a going
concern is uncertain and dependent upon achieving improved operational
results and cash flows and, if necessary, obtaining additional
financing. These consolidated condensed financial statements do not
include any adjustments to the amounts and classification of assets
and liabilities that might be necessary should the Company be unable
to continue in business.
The condensed consolidated financial statements have been prepared in
accordance with the requirements for interim financial information and
with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X.
Accordingly, they do not include all of the information and note
disclosures required by accounting principles generally accepted in
the United States of America for complete financial statements. These
condensed consolidated financial statements should be read in
conjunction with the consolidated financial statements and notes
thereto included in LaserSight's annual report on Form 10-K for the
year ended December 31, 2000. In the opinion of management, the
condensed consolidated financial statements include all adjustments
necessary for a fair presentation of consolidated financial position
and the results of operations and cash flows for the periods
presented. There are no other components of comprehensive loss other
than the Company's consolidated net loss for the three- and nine-month
periods ended September 30, 2001 and 2000. The results of operations
for the three- and nine-month periods ended September 30, 2001 are not
necessarily indicative of the operating results for the full year. The
report of KPMG LLP, independent auditors, commenting upon their review
accompanies the condensed consolidated financial statements included
in Item 1 of Part I.
6
NOTE 2 PER SHARE INFORMATION
Basic loss per common share is computed using the weighted average
number of common shares and contingently issuable shares (to the
extent that all necessary contingencies have been satisfied). Diluted
loss per common share is computed using the weighted average number of
common shares, contingently issuable shares, and common share
equivalents outstanding during each period. Common share equivalents
include options, warrants to purchase Common Stock, and convertible
Preferred Stock and are included in the computation using the treasury
stock method if they would have a dilutive effect.
NOTE 3 INVENTORIES
Inventories, which consist primarily of excimer and erbium laser
systems and related parts and components, are stated at the lower of
cost or market. Cost is determined using the standard cost method,
which approximates costs determined on the first-in first-out basis.
The components of inventories at September 30, 2001 and December 31,
2000 are summarized as follows:
September 30, 2001 December 31, 2000
------------------ -----------------
Raw materials $ 7,313,629 6,704,447
Work-in-process 87,271 121,474
Finished goods 4,267,164 4,482,276
Test equipment - clinical trials 702,997 815,680
----------- ----------
$12,371,061 12,123,877
=========== ==========
NOTE 4 SEGMENT INFORMATION
The Company operates principally in three operating segments:
refractive products, patent services and health care services.
Refractive product operations primarily involve the development,
manufacture, and sale of ophthalmic lasers and related devices for use
in vision correction procedures. Patent services involve the revenues
and expenses generated from the ownership of certain refractive laser
procedure patents, and health care services provides health and vision
care consulting services to hospitals, managed care companies, and
physicians.
Operating profit is total revenue less operating expenses. In
determining operating profit for operating segments, the following
items have not been considered: general corporate expenses, expenses
attributable to LaserSight Centers Incorporated, a developmental stage
company in 2000 and non-operating income. Identifiable assets by
operating segment are those that are used by or applicable to each
operating segment. General corporate assets consist primarily of cash
and cash equivalents and income tax accounts.
The table below summarizes information about reported segments as of
and for the three months ended September 30:
7
Depreciation
Operating Operating and Capital
Revenues Profit (Loss) Assets Amortization Expenditures
--------- ------------- ---------- ------------ ------------
2001
Operating segments:
Refractive products $ 2,054,407 (6,186,116) 34,970,792 425,181 12,038
Patent services 72,000 72,000 -- -- --
Health care services 238,050 (93,018) 3,290,609 70,529 4,927
General corporate -- (284,258) 4,935,744 2,424 --
----------- ---------- ---------- --------- ---------
Consolidated total $ 2,364,457 (6,491,392) 43,197,145 498,134 16,965
=========== ========== ========== ========= =========
2000
Operating segments:
Refractive products $ 7,015,856 (4,832,764) 44,244,181 671,600 625,828
Patent services 827,768 697,437 2,877,099 129,330 --
Health care services 165,600 (133,465) 3,448,237 63,571 13,843
General corporate -- (375,956) 12,048,653 2,563 --
Developmental stage
company - LaserSight
Centers -- (69,174) 2,340,356 69,174 --
----------- ---------- ---------- --------- ---------
Consolidated total $ 8,009,224 (4,713,922) 64,958,526 936,238 639,671
=========== ========== ========== ========= =========
Amortization of deferred financing costs and discount on note payable of
$63,612 for the three months ended September 30, 2001, is included as
interest expense.
The table below summarizes information about reported segments as of
and for the nine months ended September 30:
Depreciation
Operating Operating and Capital
Revenues Profit (Loss) Assets Amortization Expenditures
--------- ------------- ---------- ------------ ------------
2001
Operating segments:
Refractive products $ 9,155,980 (20,055,632) 34,970,792 1,347,078 320,720
Patent services 320,000 320,000 -- -- --
Health care services 749,257 (239,083) 3,290,609 209,777 60,543
General corporate -- (1,202,045) 4,935,744 7,842 --
----------- ----------- ---------- --------- ---------
Consolidated total $10,225,237 (21,176,760) 43,197,145 1,564,697 381,263
=========== =========== ========== ========= =========
2000
Operating segments:
Refractive products $25,501,779 (9,754,619) 44,244,181 1,938,767 1,418,129
Patent services 2,086,449 1,697,458 2,877,099 387,990 --
Health care services 577,045 (326,712) 3,448,237 206,929 17,586
General corporate -- (1,487,458) 12,048,653 7,727 --
Developmental stage
company - LaserSight
Centers -- (207,536) 2,340,356 207,522 --
----------- ----------- ---------- --------- ---------
Consolidated total $28,165,273 (10,078,867) 64,958,526 2,748,935 1,435,715
=========== =========== ========== ========= =========
Amortization of deferred financing costs and discount on note payable of
$139,946 for the nine months ended September 30, 2001, is included as
interest expense.
8
NOTE 5 SALE OF INTELLECTUAL PROPERTY
Sale of Patent
--------------
On March 1, 2001, the Company completed the sale of U.S. Patent No.
4,784,135 (Blum Patent) for a cash payment of $6.5 million offset by
expenses of $135,000. The Company retained a non-exclusive royalty
free license and the rights associated with a third party's license
under the Blum Patent. Net of costs associated with the sale, the
Company recognized a gain on the sale of the patent of approximately
$4.0 million.
NOTE 6 LICENSE AGREEMENTS
Keratome
--------
Effective January 3, 2001, the Company entered into an amended and
restated license and royalty agreement related to the Company's
keratome products. This agreement replaced an agreement originally
entered into in September 1997 and amended in January 2000. Under the
terms of the amended and restated license, 730,552 shares of Common
Stock were issued, valued at approximately $1.1 million, in partial
payment for royalties during the term of the license. The term of the
original agreement was extended for three years until July 31, 2005.
In addition, minimum royalty payments totaling approximately $6.2
million will be due in quarterly installments through the term of the
amendment. As of September 30, 2001, remaining minimum royalty
payments totaled $5.2 million. The royalty rate was reduced from 50%
to 10% of gross profits in the amended and restated license.
Scanning Patent
---------------
On September 7, 2001, the Company entered into a non-exclusive license
agreement to its U.S. Patent No. 5,520,679 ('679 Scanning Patent) in
exchange for $3.0 million in cash. The licensor has the option until
mid-December 2001 to license additional intellectual property owned by
the Company for an additional payment of $2.0 million. If the licensor
fails to exercise this option, they will be entitled to receive 10
percent of net royalties, if any, received from future licensees
pertaining to the '679 Scanning Patent, up to a maximum of $3.0
million. In the event the licensor fails to exercise their option, the
Company has the option to terminate the license agreement and all
rights to future net royalties in exchange for $3.0 million in cash.
NOTE 7 LOAN AGREEMENT
On March 12, 2001, the Company entered into a loan agreement with
Heller Healthcare Finance, Inc. (Heller) for a $3.0 million term loan
at an annual interest rate of prime plus 2.5% (11% at inception date)
and a revolving loan in an amount of up to 85% of eligible receivables
related to U.S. sales, but not more than $10.0 million, at an annual
interest rate of prime plus 1.25% (9.75% at inception date). Eligible
accounts receivable will primarily be based on future U.S. sales.
There have been no borrowings under the revolving loan to date. The
term loan and the revolving loan mature on March 12, 2003. In
connection with the loans, the Company paid an origination fee of
$130,000 and issued warrants to purchase 243,750 shares of Common
Stock. At the termination of the loan, an additional fee of $148,125
will be payable to Heller. The warrants are exercisable at any time
from March 12, 2001 through March 12, 2004 at an exercise price per
share of $3.15. Borrowings under the loan agreement are secured by
substantially all of the Company's assets. The loan agreement requires
the Company to meet certain covenants, including the maintenance of a
minimum level of net worth.
9
NOTE 8 STOCKHOLDERS' EQUITY
Private Placement
-----------------
On July 6, 2001, the Company closed a transaction for the sale of
1,276,596 shares of Series F convertible participating preferred stock
to a total of two investors in exchange for the Company receiving $3.0
million in cash. The Series F preferred stock is convertible into
Common Stock on a share for share basis. In addition, the investors
received a total of 838,905 shares of Common Stock under price
protection provisions of the Company's September 2000 private
placement.
10
Independent Auditors' Review Report
The Board of Directors
LaserSight Incorporated:
We have reviewed the condensed consolidated balance sheet of LaserSight
Incorporated and subsidiaries as of September 30, 2001, and the related
condensed consolidated statement of operations for the three-month and
nine-month periods ended September 30, 2001 and 2000 and the condensed
consolidated statement of cash flows for the nine-month periods ended September
30, 2001 and 2000. These condensed consolidated financial statements are the
responsibility of the Company's management.
We conducted our review in accordance with standards established by the American
Institute of Certified Public Accountants. A review of interim financial
information consists principally of applying analytical procedures to financial
data and making inquiries of persons responsible for financial and accounting
matters. It is substantially less in scope than an audit conducted in accordance
with auditing standards generally accepted in the United States of America, the
objective of which is the expression of an opinion regarding the financial
statements taken as a whole. Accordingly, we do not express such an opinion.
Based on our review, we are not aware of any material modifications that should
be made to the condensed consolidated financial statements referred to above for
them to be in conformity with accounting principles generally accepted in the
United States of America.
We have previously audited, in accordance with auditing standards generally
accepted in the United States of America, the consolidated balance sheet of
LaserSight Incorporated and subsidiaries as of December 31, 2000, and the
related consolidated statements of operations, comprehensive loss, stockholders'
equity, and cash flows for the year then ended (not presented herein); and in
our report dated February 9, 2001, except as to note 16, which is as of March
12, 2001, we expressed an unqualified opinion on those consolidated financial
statements. In our opinion, the information set forth in the accompanying
condensed consolidated balance sheet as of December 31, 2000, is fairly stated,
in all material respects, in relation to the consolidated balance sheet from
which it has been derived.
/s/ KPMG LLP
St. Louis, Missouri
November 1, 2001
11
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
LaserSight is principally engaged in the manufacture and supply of narrow
beam scanning excimer laser systems, keratomes, keratome blades and other
related products used to perform procedures that correct common refractive
vision disorders such as nearsightedness, farsightedness and astigmatism. Since
1994, we have marketed our laser systems commercially in over 30 countries
worldwide and currently have an installed base of over 350 laser systems,
including approximately 180 of our LaserScan LSX(TM) laser systems. In March
2000, we began commercial shipments of our LaserScan LSX laser system to
customers in the U.S.
NEW ACCOUNTING PRONOUNCEMENTS
In July 2001, the FASB issued Statement No. 141, "Business Combinations",
and Statement No. 142, "Goodwill and Other Intangible Assets". Statement 141
requires that the purchase method of accounting be used for all business
combinations initiated after June 30, 2001 as well as all purchase method
business combinations completed after June 30, 2001. Statement 142 will require
that goodwill with indefinite useful lives no longer be amortized, but instead
tested for impairment at least annually in accordance with the provisions of
Statement 142.
The Company is required to adopt the provisions of Statement 141
immediately and Statement 142 effective January 1, 2002. Furthermore, any
goodwill and intangible assets determined to have an indefinite useful life
acquired in a purchase business combination completed after June 30, 2001, but
before Statement 142 is adopted in full, will not be amortized, but will
continue to be evaluated for impairment in accordance with the appropriate
pre-Statement 142 accounting literature. Goodwill and intangible assets acquired
in business combinations completed before July 1, 2001 will continue to be
amortized and tested for impairment in accordance with the appropriate
pre-Statement 142 accounting literature prior to the full adoption of Statement
142.
Management does not expect Statement No. 141 to have a material effect on
the consolidated financial statements. Management does expect Statement No. 142
to result in the elimination of amortization of goodwill from previous
acquisitions in the amount of approximately $240,000 in 2002. In connection with
Statement 142's transitional goodwill impairment evaluation, the Statement will
require the Company to perform an assessment of whether there is an indication
that goodwill is impaired as of the date of adoption. Any transitional
impairment loss will be recognized as the cumulative effect of a change in
accounting principle in the Company's Statement of Operations. Management will
test for impairment of goodwill from previous acquisitions at least annually.
In October 2001, the FASB issued Statement No. 144 "Accounting for the
Impairment or Disposal of Long-Lived Assets", which supersedes Statement No. 121
"Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to
be Disposed Of". Statement No. 144 also supercedes the accounting and reporting
provisions of APB Opinion No. 30 "Reporting the Results of Operations-Reporting
the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual
and Infrequently Occurring Events and Transactions." Statement No. 144 is
intended to establish one accounting model for long-lived assets to be disposed
of by sale and to address significant implementation issues. The Company will
adopt Statement No. 144 on January 1, 2002. Management does not expect Statement
No. 144 to have a material effect on the consolidated financial statements.
RESULTS OF OPERATIONS
The following table sets forth for the periods indicated information
derived from our statements of operations for those periods expressed as a
percentage of net sales, and the percentage change in such items from the
comparable prior year period. Any trends illustrated in the following table are
not necessarily indicative of future results.
12
Percent Increase (Decrease)
As a Percentage of Net Revenues Over Prior Periods
------------------------------- -------------------------
Three Months Nine Months Three Months Nine Months
Ended Ended Ended Ended
September 30, September 30, September 30, September 30,
2001 2000 2001 2000 2001 vs. 2000 2001 vs. 2000
---- ---- ---- ---- ------------- -------------
Statement of Operations Data:
Net Revenues:
Refractive products............ 86.9% 87.6% 89.6 90.5% (70.7%) (64.1%)
Patent service................. 3.0 10.3 3.1 7.4 (91.3) (84.7)
Healthcare services............ 10.1 2.1 7.3 2.1 43.8 29.8
----- ----- ----- -----
Net Revenues............... 100.0 100.0 100.0 100.0 (70.5) (63.7)
Cost of Revenue................... 62.9 43.8 50.7 40.0 (57.6) (54.0)
----- ----- ----- -----
Gross Profit (1).................. 37.1 56.2 49.3 60.0 (80.5) (70.2)
Research, development and
regulatory expenses (2)........ 30.1 13.7 25.3 11.9 (35.0) (22.7)
Other general and administrative
expenses....................... 229.8 67.9 189.2 56.9 (0.2) 20.7
Selling-related expenses (3)...... 44.2 25.4 36.2 20.0 (48.5) (34.3)
Amortization of intangibles....... 7.5 8.1 5.6 7.0 (72.6) (70.8)
----- ----- ----- -----
Loss from operations.............. (274.5) (58.9) (207.0) (35.8) 37.7 110.1
---------------
(1) As a percentage of net revenues, the gross profit for refractive products
only for the three months ended September 30, 2001 and 2000, and the nine
months ended September 30, 2001 and 2000, was 33%, 51%, 47% and 57%,
respectively.
(2) As a percentage of refractive product net sales, research, development and
regulatory expenses for each of the three months ended September 30, 2001
and 2000, and the nine months ended September 30, 2001 and 2000, were 35%,
16%, 28% and 13%, respectively.
(3) As a percentage of refractive product net sales, selling-related expenses
for the three months ended September 30, 2001 and 2000, and the nine months
ended September 30, 2001 and 2000, were 51%, 29%, 40% and 22%,
respectively.
THREE MONTHS ENDED SEPTEMBER 30, 2001, COMPARED TO THREE MONTHS ENDED SEPTEMBER
30, 2000
Revenues. Net revenues for the three months ended September 30, 2001
decreased by $5.6 million, or 70%, to $2.4 million from $8.0 million for the
comparable period in 2000.
During the three months ended September 30, 2001, refractive products
revenues decreased $5.0 million, or 71%, to $2.0 million from $7.0 million for
the comparable period in 2000. This revenue decrease was primarily the result of
decreased sales of the LaserScan LSX excimer laser system. During the three
months ended September 30, 2001, excimer laser system sales accounted for
approximately $1.6 million in revenues compared to $6.3 million in revenues over
the same period in 2000. During the three months ended September 30, 2001, 6
laser systems were sold compared to 19 laser systems sold during the comparable
period in 2000. The reduction in laser sales is primarily attributable to the
delayed FDA approval, received in a letter dated September 28, 2001, of our
laser in the U.S. for the treatment of nearsightedness with astigmatism and the
general economic slowdown in many regions of the world.
Net revenues from patent services for the three months ended September 30,
2001 decreased approximately $0.7 million, or 91%, to $0.1 million from $0.8
million for the comparable period in 2000. This revenue decrease was due to the
March 2001 sale of most rights associated with the patent responsible for
generating patent service revenue.
Net revenues from health care services for the three months ended September
30, 2001 increased approximately $72,000 from the comparable period in 2000.
13
Cost of Revenues; Gross Profit. For the three months ended September 30,
2001 and 2000, gross profit margins were 37% and 56%, respectively. The gross
margin decrease during the three months ended September 30, 2001 was primarily
attributable to decreased sales of the LaserScan LSX excimer laser system. The
decreased sales resulted in lower raw material costs relating to the LaserScan
LSX excimer laser system of $1.3 million from the comparable period in 2000.
Research, Development and Regulatory Expenses. Research, development and
regulatory expenses for the three months ended September 30, 2001, decreased
$0.4 million, or 35%, to $0.7 million from $1.1 million for the comparable
period in 2000. We continued to develop our keratome systems and excimer laser
systems and continued to pursue protocols in our effort to attain and expand our
FDA approvals for our refractive products. As a result of the continued
development of our AstraMax diagnostic workstation, we expect research and
development expenses during the remainder of 2001 to continue at approximately
the same levels as the average of the first three quarters of 2001. Regulatory
expenses are expected to remain constant as a result of our continued pursuit of
various FDA approvals, including pre-market approval supplements, and the
possible development of additional pre-market approval supplements and future
protocols for submission to the FDA.
Other General and Administrative Expenses. Other general and administrative
expenses for the three months ended September 30, 2001 was $5.4 million,
approximately the same as the comparable period in 2000. Third quarter 2001
expenses included restructuring costs of approximately $0.4 million related to
personnel reductions and relocation of European operations. The expense level
during the third quarter of 2001 decreased approximately $1.8 million from the
second quarter of 2001 due to legal expense reductions of approximately $1.3
million resulting from patent litigation that was settled in May 2001, lower
sales, marketing and customer service related expenses of approximately $0.7
million and a reduction in personnel related costs of approximately $0.1
million, partially offset by an increase in bad debt expense of $0.3 million.
Selling-Related Expenses. Selling-related expenses consist of those items
directly related to sales activities, including commissions on sales, royalty or
license fees, warranty expenses, and costs of shipping and installation.
Commissions and royalties, in particular, can vary significantly from sale to
sale or period to period depending on the location and terms of each sale.
Selling-related expenses for the three months ended September 30, 2001 decreased
$1.0 million, or 49%, to $1.0 million from $2.0 million during the comparable
period in 2000. This decrease was primarily attributable to a $0.4 million
decrease in sales commissions resulting from lower sales and a decrease of $0.4
million of warranty expense primarily related to decreased laser system sales.
Selling-related expenses increased as a percentage of revenue during the three
months ended September 30, 2001 over the comparable period in 2000. This
increase primarily resulted from additional license fee expense for our keratome
products of $0.4 million due to minimum royalties under our January 2001 amended
and restated license agreement, regardless of keratome sales, and a higher
proportion in 2001 of international laser sales, which include a royalty based
on selling price, to total sales.
Amortization of Intangibles. During the three months ended September 30,
2001, amortization of intangible assets decreased $0.4 million, or 73%, to $0.2
million from $0.6 million for the comparable period in 2000. This decrease was
due to the impairment loss incurred on certain intangible assets at December 31,
2000 of approximately $4.1 million, reducing future amortization expenses, and
the sale of the Blum Patent in March 2001 that had an unamortized book value at
the date of sale of approximately $2.4 million. Our intangible assets include
acquired technologies, patents, license agreements and goodwill.
Loss From Operations. The operating loss for the three months ended
September 30, 2001 was $6.5 million compared to the operating loss of $4.7
million for the same period in 2000. This increase in the loss from operations
was primarily due to the decrease in sales of our LaserScan LSX excimer laser
system.
Other Income and Expenses. Interest and dividend income for the three
months ended September 30, 2001 was $0.1 million, a decrease of $0.1 million
over the comparable period in 2000. Interest and dividend income was earned from
the investment of cash and cash equivalents and the collection of long-term
14
receivables related to laser system sales. Interest expense of approximately
$0.1 million for the three months ended September 30, 2001 was primarily
attributable to the loan and credit facility we established in March 2001.
Income Taxes. For the three months ended September 30, 2001 and 2000,
LaserSight had no income tax expense.
Net Loss. Net loss for the three months ended September 30, 2001, was $6.5
million compared to a net loss of $4.5 million for the comparable period in
2000. The increased net loss for the three months ended September 30, 2001 can
be attributed to the decrease in sales of our LaserScan LSX excimer laser
system.
Loss Per Share. The loss per basic and diluted share was $0.25 for the
three months ended September 30, 2001 and $0.21 for the comparable period in
2000. During the three months ended September 30, 2001, the weighted average
shares of common stock outstanding increased primarily due to the conversion of
preferred stock during 2001, the September 2000 private placement of common
stock, the issuance of common stock related to our July 2001 financing and the
issuance of shares in connection with the amended and restated license and
royalty agreement related to our keratome products.
NINE MONTHS ENDED SEPTEMBER 30, 2001, COMPARED TO NINE MONTHS ENDED SEPTEMBER
30, 2000
Revenues. Net revenues for the nine months ended September 30, 2001
decreased by $18.0 million, or 64%, to $10.2 million from $28.2 million for the
comparable period in 2000.
During the nine months ended September 30, 2001, refractive products
revenues decreased $16.3 million, or 64%, to $9.2 million from $25.5 million for
the comparable period in 2000. This revenue decrease was primarily the result of
decreased sales of the LaserScan LSX excimer laser system. During the nine
months ended September 30, 2001, excimer laser system sales accounted for
approximately $8.0 million in revenues compared to $22.3 million in revenues
over the same period in 2000. During the nine months ended September 30, 2001,
29 laser systems were sold compared to 68 laser systems sold during the
comparable period in 2000. The reduction in laser sales is primarily
attributable to the delayed FDA approval of our laser in the U.S. for the
treatment of astigmatism and the general economic slowdown in many regions of
the world.
Net revenues from patent services for the nine months ended September 30,
2001 decreased approximately $1.8 million, or 85%, to $0.3 million from $2.1
million for the comparable period in 2000, due to the March 2001 sale of most
rights associated with the patent responsible for generating patent service
revenue.
Net revenues from health care services for the nine months ended September
30, 2001 increased approximately $172,000 from the comparable period in 2000.
Cost of Revenues; Gross Profit. For the nine months ended September 30,
2001 and 2000, gross profit margins were 49% and 60%, respectively. The gross
margin decrease during the nine months ended September 30, 2001 was primarily
attributable to decreased sales of the LaserScan LSX excimer laser system. The
decreased sales resulted in lower raw material costs relating to the LaserScan
LSX excimer laser system of $4.3 million and there was a decrease in our
inventory obsolescence reserve of $0.5 million from the comparable period in
2000.
Research, Development and Regulatory Expenses. Research, development and
regulatory expenses for the nine months ended September 30, 2001 decreased $0.7
million, or 23%, to $2.6 million from $3.3 million for the comparable period in
2000. We continued to develop our keratome systems and excimer laser systems and
continued to pursue protocols in our effort to attain and expand our FDA
approvals for our refractive products. As a result of the continued development
of our AstraMax diagnostic workstation, we expect research and development
expenses during the remainder of 2001 to continue at approximately the same
levels incurred during the average of the first three quarters of 2001.
15
Regulatory expenses are expected to remain constant as a result of our continued
pursuit of various FDA approvals, including pre-market approval supplements, and
the possible development of additional pre-market approval supplements and
future protocols for submission to the FDA.
Other General and Administrative Expenses. Other general and administrative
expenses for the nine months ended September 30, 2001 increased $3.3 million, or
21%, to $19.3 million from $16.0 million for the comparable period in 2000. This
increase was due to an increase in expenses incurred at our refractive products
operations of approximately $3.6 million related to enhancements to the customer
support and training, sales and marketing and software development departments
of $1.4 million, higher depreciation costs of $0.2 million and $1.9 million of
legal fees related to patent issues and litigation. The patent litigation, which
accounted for a significant portion of those legal fees, was settled in May
2001, and we have experienced a significant decrease in our legal expenses since
that time.
Selling-Related Expenses. Selling-related expenses consist of those items
directly related to sales activities, including commissions on sales, royalty or
license fees, warranty expenses, and costs of shipping and installation.
Commissions and royalties, in particular, can vary significantly from sale to
sale or period to period depending on the location and terms of each sale.
Selling-related expenses for the nine months ended September 30, 2001 decreased
$1.9 million, or 34%, to $3.7 million from $5.6 million during the comparable
period in 2000. This decrease was primarily attributable to a $1.0 million
decrease in sales commissions resulting from lower sales and a decrease of $1.1
million of warranty expense primarily related to decreased laser system sales.
Selling-related expenses increased as a percentage of revenue during the three
months ended September 30, 2001 over the comparable period in 2000. This
increase primarily resulted from additional license fee expense for our keratome
products of $1.2 million due to minimum royalties under our January 2001 amended
and restated license agreement, regardless of keratome sales, and a higher
proportion in 2001 of international laser sales, which include a royalty based
on selling price, to total sales.
Amortization of Intangibles. During the nine months ended September 30,
2001, costs relating to the amortization of intangible assets decreased $1.4
million, or 71%, to $0.6 million from $2.0 million for the comparable period in
2000. This decrease was due to the impairment loss incurred on certain
intangible assets at December 31, 2000 of approximately $4.1 million, reducing
future amortization expenses, and the sale of the Blum Patent in March 2001 that
had an unamortized book value at the date of sale of approximately $2.4 million.
Our intangible assets include acquired technologies, patents, license agreements
and goodwill.
Loss From Operations. The operating loss for the nine months ended
September 30, 2001 was $21.2 million compared to the operating loss of $10.1
million for the same period in 2000. This increase in the loss from operations
was primarily due to the decrease in sales of our LaserScan LSX excimer laser
system and an increase in other general and administrative expenses related to
our refractive products operations.
Other Income and Expenses. Interest and dividend income for the nine months
ended September 30, 2001 was $0.5 million, a decrease of $0.2 million over the
comparable period in 2000. Interest and dividend income was earned from the
investment of cash and cash equivalents and the collection of long-term
receivables related to laser system sales. Interest expense of approximately
$0.4 million for the nine months ended September 30, 2001 was primarily
attributable to the loan and credit facility we established in March 2001. Other
income included a net gain, after expenses associated with the sale, of $4.0
million from the sale of the Blum Patent in March 2001. The patent was sold for
$6.4 million net of related expenses and, prior to the sale, had a book value at
the date of sale of approximately $2.4 million. Other expenses for the nine
months ended September 30, 2001 included approximately $0.6 million in payments
related to the settlement of patent litigation.
Income Taxes. For the nine months ended September 30, 2001 and 2000,
LaserSight had no income tax expense.
Net Loss. Net loss for the nine months ended September 30, 2001, was $17.7
million compared to a net loss of $9.4 million for the comparable period in
2000. The increased net loss for the nine months ended September 30, 2001 can be
16
attributed to the decrease in sales of our LaserScan LSX excimer laser system
and an increase in other general and administrative expenses related to our
refractive products operations, partially offset by the gain generated by the
sale of the Blum Patent.
Loss Per Share. The loss per basic and diluted share was $0.72 for the nine
months ended September 30, 2001 and $0.46 for the comparable period in 2000.
During the nine months ended September 30, 2001, the weighted average shares of
common stock outstanding increased primarily due to the conversion of preferred
stock during 2000 and 2001, the September 2000 private placement of common
stock, the issuance of common stock related to our July 2001 financing and the
issuance of shares related to the amended and restated license and royalty
agreement related to our keratome products.
LIQUIDITY AND CAPITAL RESOURCES
Our principal sources of funds have historically been from sales of
preferred stock and common stock, sales of subsidiaries and patent rights and,
to a lesser extent, our operating cash flows. We issued equity securities
totaling approximately $14.8 million in 1997, $15.8 million in 1998, $8.9
million in 1999, $19.1 million in 2000 and $3.0 million through November 13,
2001, and received proceeds from the exercise of stock options, warrants and our
Employee Stock Purchase Plan of approximately $98,000 in 1997, $0.5 million in
1998, $10.4 million in 1999, $85,000 in 2000 and $60,000 to date in 2001. In
addition, we sold subsidiaries and various patent rights, resulting in proceeds
to us of approximately $10.5 million in 1997, $12.7 million in 1998 and $6.5
million to date in 2001. Additionally, we received $3.0 million in September
2001 for a paid up license to our '679 Scanning Patent. We have principally used
these capital resources to fund operating losses, working capital requirements,
capital expenditures, acquisitions and retirement of debt. At September 30,
2001, we had an accumulated deficit of $77.3 million.
On March 1, 2001, we completed the sale of U.S. Patent No. 4,784,135 (Blum
Patent) for a cash payment of $6.4 million, net of related expenses. We retained
a non-exclusive royalty free license under the patent, which relates to the use
of ultraviolet light for the removal of organic tissue. Our net book value of
the patent at the date of the sale was approximately $2.4 million.
On March 12, 2001, we established a $3.0 million term loan and $10.0
million revolving credit facility with Heller. We borrowed $3.0 million under
the term loan at a rate per annum equal to two and one-half percent (2.5%) above
the prime rate. Interest is payable monthly and the loan must be repaid on March
12, 2003. Under the credit facility, we have the option to borrow amounts at a
rate per annum equal to one and one-quarter percent (1.25%) above the prime rate
for short-term working capital needs or such other purposes as may be approved
by Heller. Borrowings are limited to 85% of eligible accounts receivable related
to U.S. sales. Eligible accounts receivable will primarily be based on future
U.S. sales, which are expected to increase with the recent FDA approval of our
laser for the treatment of nearsightedness with astigmatism. Borrowings under
the loans are secured by substantially all of the Company's assets. The term
loan and credit facility require us to meet certain covenants, including the
maintenance of a minimum net worth. The terms of the loans extend to March 12,
2003. In addition to the costs and fees associated with the transaction, we
issued to Heller a warrant to purchase 243,750 shares of common stock at an
exercise price of $3.15 per share. The warrant expires on March 12, 2004. At
November 13, 2001, we had no borrowings under the revolving credit facility.
Our working capital decreased $3.1 million from $20.7 million at December
31, 2000 to $17.6 million as of September 30, 2001. This decrease in working
capital resulted primarily from the net loss of $17.7 million offset by cash
generated from the sale of a patent, the licensing of a patent, the July 2001
private placement and the proceeds of the term loan, for net proceeds of $15.7
million.
Operating activities used net cash of $15.8 million during the nine months
ended, September 30, 2001, compared to $12.4 million of net cash used during the
same period in 2000, and $15.7 million during the year ended December 31, 2000.
We expect to incur a loss and a deficit in cash flow from operations for the
fourth quarter of 2001. There can be no assurance that we can regain or sustain
17
profitability or positive operating cash flow in any subsequent fiscal period.
Net cash provided by investing activities of $6.0 million during the nine months
ended September 30, 2001, can be attributed primarily to the sale of the Blum
patent. As of September 30, 2001, we had no significant commitments for capital
expenditures. Net cash provided from financing activities during the nine months
ended September 30, 2001 of $5.8 million can be attributed to entering into the
term loan agreement and the $3.0 million private placement in July 2001,
described below.
On July 6, 2001, we completed a $3.0 million placement of series F
convertible participating preferred stock. We are exploring opportunities for
additional equity financing through a private placement of our common stock. If
our recent FDA approval for the treatment of nearsightedness with or without
astigmatism doesn't result in an increase in U.S. sales of our LaserScan LSX
excimer laser system or we experience unanticipated delays in the commercial
release of our AstraMax diagnostic workstation, we will be required to seek
additional debt or equity financing during the next 12 months. There can be no
assurance that the assumptions underlying our business plan will be met or that
additional financing will not be needed or that financing, if needed, would be
available. Our belief regarding future working capital requirements is based on
various factors and assumptions including: the successful reduction of a
significant amount of expenses currently being implemented, the uncertain timing
of additional supplemental FDA approvals for our LaserScan LSX excimer laser
system, which could continue to negatively impact our sales during 2001 and
2002, potential growth in laser sales after receipt of further FDA approvals,
increases in accounts receivable and inventory purchases when sales increase,
the potential for borrowing under our revolving credit facility, the uncertain
impact of the market introduction of our UltraShaper(TM) durable keratomes,
commercial acceptance of our UltraEdge(TM) keratome blades and UniShaper(TM)
single-use keratomes, which we believe is partially dependent upon the
successful introduction of the UltraShaper, the timely collection of
receivables, and the absence of unanticipated product development and marketing
costs. See "Risk Factors--Industry and Competitive Risks--We cannot assure you
that our keratome products will achieve market acceptance" and "--We cannot
assure you that our LaserScan LSX laser system will achieve market acceptance in
the U.S., and our business model for selling our laser system in the U.S. is new
and unproven." These factors and assumptions are subject to certain
contingencies and uncertainties, some of which are beyond our control.
Similarly, our long-term liquidity will be dependent on the successful entrance
into the U.S. market of our laser systems, the successful entrance into U.S. and
international markets of our diagnostic workstation and keratome products, and
our ability to collect our receivables on a timely basis. We may seek additional
debt or equity financing in the future to implement our business plan or any
changes thereto in response to future developments or unanticipated
contingencies. Other than the $10.0 million credit facility completed in March
2001 with Heller, we currently do not have any commitments for additional
financing. See "Risk Factors--Financial and Liquidity Risks--We could require
additional financing, which might not be available if we need it."
RISK FACTORS
The business, results of operations and financial condition of LaserSight
and the market price of our common stock may be adversely affected by a variety
of factors, including the ones noted below:
INDUSTRY AND COMPETITIVE RISKS
WE CANNOT ASSURE YOU THAT OUR LASERSCAN LSX LASER SYSTEM WILL ACHIEVE
MARKET ACCEPTANCE IN THE U.S., AND OUR BUSINESS MODEL FOR SELLING OUR LASER
SYSTEM IN THE U.S. IS NEW AND UNPROVEN.
We received the FDA approval necessary for the commercial marketing and
sale of our LaserScan LSX excimer laser system in the U.S. in late 1999 and
commercial shipments to customers in the U.S. began in March 2000.
The anticipated level of per procedure fees payable to us by refractive
surgeons resulting from our recent receipt of FDA approval for treatment of
nearsightedness with or without astigmatism may not be accepted by the
marketplace or may exceed those charged by our competitors. While we believe
18
that gaining access to our scanning microspot laser technology justifies the
required per procedure fee levels, we cannot assure you that this business model
will be accepted by a large number of refractive surgeons. If our competitors
reduce or do not charge per procedure fees to users of their systems, we could
be forced to reduce or eliminate the fees charged under this business model,
which could significantly reduce our revenues. For example, Nidek Co., Ltd., one
of our competitors, has publicly stated that it will not charge per procedure
fees to users of its laser systems in the U.S. and internationally. See also
"--Company and Business Risks--Required per procedure fees payable to Visx under
our license agreement may exceed per procedure fees collected by us."
Successful implementation of this business model is crucial to our success
in selling our LaserScan LSX laser system in the U.S. and may require the
expenditure of significant financial and other resources to create awareness of
the LaserScan LSX laser system and create demand by refractive surgeons. If our
laser system fails to achieve market acceptance in the U.S., we may not be able
to execute our business plan, which would have a material adverse effect on our
business, financial condition and results of operations.
WE CANNOT ASSURE YOU THAT OUR KERATOME PRODUCTS WILL ACHIEVE MARKET
ACCEPTANCE.
Keratomes are surgical devices used to create a corneal flap immediately
prior to LASIK laser vision correction procedures. We began to roll out our
MicroShape(TM) family of keratome products with the commercial launch of our
UltraEdge keratome blades in July 1999 and of our UniShaper single-use keratomes
and control consoles in December 1999. In November 2001, we commercially
released our UltraShaper durable keratomes after a thorough process of
engineering refinement and validity testing. Our UniShaper single-use keratome
was the first disposable keratome product to be commercially marketed, and we
cannot assure you that refractive surgeons, including in particular refractive
surgeons who perform a large volume of LASIK procedures, will accept our
UniShaper product as either a replacement for or a supplement to the durable
keratomes traditionally used to create corneal flaps. In our recent experience,
many surgeons are reluctant to use a disposable keratome product as their
primary keratome. Also, market acceptance of the UniShaper may be hindered by
surgeons needing to alter their surgical technique in order to achieve the
desired clinical results. Our UltraShaper durable keratome incorporates the
features found in the Automated Corneal Shaper (ACS) keratome previously
marketed by Bausch & Lomb, Inc. with new enhancements and features. However,
Bausch & Lomb has not aggressively marketed or serviced the ACS since 1997 when
we licensed the rights to commercially market keratomes based on the same
technology, and has successfully transitioned a large number of refractive
surgeons from the ACS to its Hansatome durable keratome product. We believe that
many refractive surgeons learned to perform the LASIK procedure using the ACS
and prefer the surgical technique required by the ACS, which is also used to
operate our UltraShaper durable keratome, to the surgical technique required to
operate the Hansatome keratome product. However, we cannot assure you that we
will be successful in commercially introducing or achieving broad market
acceptance of our UltraShaper durable keratome or our other keratome products.
We have previously indicated that the successful implementation of our
keratome product sales strategy is in part dependent upon our marketing and
distribution alliance with Becton Dickinson. Due to the delay in the commercial
launch of our UltraShaper durable keratome we initiated discussions with Becton
Dickinson in order to modify our manufacturing and marketing agreements. While
these discussions were ongoing we received notices from Becton Dickinson
claiming that they have the right to end our marketing arrangement in nine
months and that they are not bound by the terms of our manufacturing agreement.
Following our receipt of these notices, Becton Dickinson indicated a willingness
to discuss modified terms for a marketing and manufacturing relationship, but to
date there's been no meaningful discussions. While we do not agree that Becton
Dickinson has the right to unilaterally end our current agreements, we intend to
discuss mutually beneficial modified agreements. If we cannot successfully
market and sell our keratome products or if we are unable to successfully modify
or replace our marketing and distribution alliance with Becton Dickinson, we may
not be able to execute our business plan, which would have a material adverse
effect on our business, financial condition and results of operations. See also
"--Company and Business Risks--Required minimum payments under our keratome
license agreement may exceed our gross profits from sales of our keratome
products."
19
The vision correction industry currently consists of a few established
providers with significant market shares and we may encounter difficulties
competing in this highly competitive environment.
The vision correction industry is subject to intense, increasing
competition, and we do not know if we will be able to compete successfully
against our current and future competitors. Many of our competitors have
established products, distribution capabilities and customer service networks in
the U.S. marketplace, are substantially larger and have greater brand
recognition and greater financial and other resources than we do. Visx, the
historical industry leader for excimer laser system sales in the U.S., sold
laser systems that performed a significant majority of the laser vision
correction procedures performed in the U.S. in 1999 and 2000. Similarly, Bausch
& Lomb sold a significant majority of the keratomes used by refractive surgeons
in the U.S. in 1999 and 2000. In 2000, Alcon acquired Summit Autonomous Inc. The
merger resulted in a combined entity with enhanced market presence, technology
base and distribution capabilities and provided Alcon with a narrow beam laser
technology platform that will compete more directly with our precision beam
scanning microspot LaserScan LSX excimer laser system. In addition, as a result
of the acquisition, the combined entity will be able to sell narrow beam laser
systems under a royalty-free license to certain Visx patents without incurring
the expense and uncertainty associated with intellectual property litigation
with Visx. We anticipate that Alcon will leverage the sale of its laser systems
with its other ophthalmic products.
MANY OF OUR COMPETITORS RECEIVED EARLIER REGULATORY APPROVALS THAN US AND
MAY HAVE A COMPETITIVE ADVANTAGE OVER US DUE TO THE SUBSEQUENT EXPANSION OF
THEIR REGULATORY APPROVALS AND THEIR SUBSTANTIAL EXPERIENCE IN THE U.S. MARKET.
We received the FDA approval necessary for the commercial sale of our
LaserScan LSX excimer laser system in the U.S. in November 1999 and commercial
shipments to customers in the U.S. began in March 2000. Our direct competitors
include large corporations such as Visx and Alcon, each of whom received FDA
approval of excimer laser systems more than three years prior to our approval
and has substantial experience manufacturing, marketing and servicing laser
systems in the U.S. In addition to Visx and Alcon, Nidek and Bausch & Lomb have
also received FDA approval for their laser systems.
In the U.S., a manufacturer of excimer laser vision correction systems
gains a competitive advantage by having its systems approved by the FDA for a
wider range of treatments. Initial FDA approvals of excimer laser vision
correction systems historically have been limited to the treatment of low to
moderate nearsightedness, with additional approvals for other and broader
treatments granted only as a result of subsequent FDA applications and clinical
trials. Our LaserScan LSX is currently approved for the LASIK treatment of
nearsightedness with and without astigmatism for a range of treatment of
refractive errors up to -6.0 diopters manifest refraction spherical equivalent
(MRSE) with or without a refractive astigmatism up to 4.5 diopters and the PRK
treatment of low to moderate nearsightedness (up to -6.0 diopters) without
astigmatism. Additionally, we have received FDA approval to operate our laser
systems at a 200 Hz pulse repetition rate, twice the originally approved rate.
We have submitted PMA supplements to the FDA to permit our laser systems sold to
customers in the U.S. to utilize LASIK to treat hyperopia, hyperopic astigmatism
and mixed astigmatism. FDA approval of these applications is anticipated in
2002, though we cannot ensure if or when the approval will be received. Our
ability to sell our laser systems in the U.S. may be severely impaired if the
FDA does not give timely approval to these supplements.
Currently, excimer laser vision correction systems manufactured by Visx,
Alcon, Bausch & Lomb and Nidek have been approved for higher levels of
nearsightedness than the LaserScan LSX. Alcon's Apex Plus and Ladarvision
Excimer Laser Workstations, Visx's Star S2 Excimer Laser System and Nidek's
EC-5000 Excimer Laser System have received FDA approval for the LASIK treatment
of nearsightedness with or without astigmatism. The approvals for most of the
systems are for the correction of nearsightedness in the range of 0 diopters to
-14.0 diopters and nearsightedness with astigmatism generally in the range of
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-0.5 diopters to -5.0 diopters. Bausch & Lomb's Technolas 217 excimer laser has
also received FDA approval for the treatment of nearsightedness up to -7.0
diopters with up to -3.0 diopters of astigmatism. The Visx and Alcon excimer
laser systems are also approved for the treatment of moderate farsightedness. In
September 2000, the FDA approved Alcon's Ladarvision system for the correction
using LASIK of farsightedness of up to +6.0 diopters and an astigmatism range of
up to 6.0 diopters. In October 2000, the FDA approved Visx's Star S2 and S3
systems for the correction using PRK of farsightedness of up to +5.0 diopters
and an astigmatism range of up to 4.0 diopters. Competitors' earlier receipt of
LASIK-specific FDA regulatory approvals could give them a significant
competitive advantage that could impede our ability to successfully sell our
LaserScan LSX system in the U.S. Our failure to successfully market our product
could have a material adverse effect on our business, financial condition and
results of operations.
All of our principal competitors in the keratome business, including
current market leader Bausch & Lomb, received FDA clearance prior to the
commercialization of our keratome products and have substantial experience
marketing their keratome products. The established market presence in the U.S.
of previously approved laser systems and keratome products, as well as the entry
of new competitors into the market upon receipt of new or expanded regulatory
approvals, could impede our ability to successfully introduce our LaserScan LSX
system in the U.S. and our keratome products worldwide and may have a material
adverse effect on our business, financial condition and results of operations.
WE DEPEND UPON OUR ABILITY TO ESTABLISH AND MAINTAIN STRATEGIC
RELATIONSHIPS.
We believe that our ability to establish and maintain strategic
relationships will have a significant impact on our ability to meet our business
objectives. These strategic relationships are critical to our future success
because we believe that these relationships will help us to:
o extend the reach of our products to a larger number of refractive surgeons;
o develop and deploy new products;
o further enhance the LaserSight brand; and
o generate additional revenue.
Entering into strategic relationships is complicated because some of our
current and future strategic partners may decide to compete with us in some or
all of our markets. In addition, we may not be able to establish relationships
with key participants in our industry if they have relationships with our
competitors, or if we have relationships with their competitors. Moreover, some
potential strategic partners have resisted, and may continue to resist, working
with us until our products and services have achieved widespread market
acceptance. Once we have established strategic relationships, we will depend on
our partners' ability to generate increased acceptance and use of our products
and services. To date, we have established only a limited number of strategic
relationships, and many of these relationships are in the early stages of
development. There can be no assurance as to the terms, timing or consummation
of any future strategic relationships. If we lose any of these strategic
relationships or fail to establish additional relationships, or if our strategic
relationships fail to benefit us as expected, we may not be able to execute our
business plan, and our business will suffer.
BECAUSE THE SALE OF OUR PRODUCTS IS DEPENDENT ON THE CONTINUED MARKET
ACCEPTANCE OF LASER-BASED REFRACTIVE EYE SURGERY USING THE LASIK PROCEDURE, THE
LACK OF BROAD MARKET ACCEPTANCE WOULD HURT OUR BUSINESS.
We believe that whether we achieve profitability and growth will depend, in
part, upon the continued acceptance of laser vision correction using the LASIK
procedure in the U.S. and other countries. We cannot be certain that laser
vision correction will continue to be accepted by either the refractive surgeons
or the public at large as an alternative to existing methods of treating
refractive vision disorders. The acceptance of laser vision correction and,
specifically, the LASIK procedure may be adversely affected by:
21
o possible concerns relating to safety and efficacy, including the
predictability, stability and quality of results;
o the public's general resistance to surgery;
o the effectiveness and lower cost of alternative methods of correcting
refractive vision disorders;
o the lack of long-term follow-up data;
o the possibility of unknown side effects;
o the lack of third-party reimbursement for the procedures;
o the cost of the procedure; and
o unfavorable publicity involving patient outcomes from the use of laser
vision correction.
Unfavorable side effects and potential complications that may result from
the use of laser vision correction systems manufactured by any manufacturer may
broadly affect market acceptance of laser-based vision correction surgery.
Potential patients may not distinguish between our precision beam scanning spot
technology and the laser technology incorporated by our competitors in their
laser systems, and customers may not differentiate laser systems and procedures
that have not received FDA approval from FDA-approved systems and procedures.
Any adverse consequences resulting from procedures performed with a competitor's
systems or an unapproved laser system could adversely affect consumer acceptance
of laser vision correction in general. In addition, because laser vision
correction is an elective procedure that is not typically covered by insurance
and that involves more significant immediate expense than eyeglasses or contact
lenses, adverse changes in the U.S. or international economy may cause consumers
to reassess their spending choices and to select lower-cost alternatives for
their vision correction needs. Any such shift in spending patterns could reduce
the volume of LASIK procedures performed that would, in turn, reduce our
revenues from per procedure fees and sales of single-use products such as our
UniShaper keratome and our UltraEdge keratome blades.
The failure of laser vision correction to achieve continued market
acceptance could have a material adverse effect on our business prospects. Even
if laser vision correction achieves and sustains market acceptance, sales of our
keratome products could be adversely impacted if a laser procedure that does not
require the creation of a corneal flap were to emerge as the procedure of
choice.
NEW PRODUCTS OR TECHNOLOGIES COULD ERODE DEMAND FOR OUR PRODUCTS OR MAKE
THEM OBSOLETE, AND OUR BUSINESS COULD BE HARMED IF WE CANNOT KEEP PACE WITH
ADVANCES IN TECHNOLOGY.
In addition to competing with eyeglasses and contact lenses, excimer laser
vision correction competes or may compete with newer technologies such as
intraocular lenses, corneal rings and surgical techniques using different or
more advanced types of lasers. Two products that may become competitive within
the near term are implantable contact lenses, which are pending FDA approval,
and corneal rings, which have been approved by the FDA. Both of these products
require procedures with lens implants, and their ultimate market acceptance is
unknown at this time. To the extent that any of these or other new technologies
are perceived to be clinically superior or economically more attractive than
currently marketed excimer laser vision correction procedures or techniques,
they could erode demand for our excimer laser and keratome products, cause a
reduction in selling prices of such products or render such products obsolete.
In addition, if one or more competing technologies achieves broader market
acceptance or renders laser vision correction procedures obsolete, it would have
a material adverse effect on our business, financial condition and results of
operations.
As is typical in the case of new and rapidly evolving industries, the
demand and market for recently introduced products and technologies is
uncertain, and we cannot be certain that our LaserScan LSX laser system,
UltraShaper durable keratome, UltraEdge keratome blades, UniShaper single-use
keratome or future new products and enhancements will be accepted in the
marketplace. In addition, announcements or the anticipation of announcements of
new products, whether for sale in the near future or at some later date, may
cause customers to defer purchasing our existing products.
22
If we cannot adapt to changing technologies, our products may become
obsolete, and our business could suffer. Our success will depend, in part, on
our ability to continue to enhance our existing products, develop new technology
that addresses the increasingly sophisticated needs of our customers, license
leading technologies and respond to technological advances and emerging industry
standards and practices on a timely and cost-effective basis. The development of
our proprietary technology entails significant technical and business risks. We
may not be successful in using new technologies effectively or adapting our
proprietary technology to evolving customer requirements or emerging industry
standards.
COMPANY AND BUSINESS RISKS
WE WILL BE REQUIRED TO SIGNIFICANTLY EXPAND OUR U.S. MANUFACTURING
OPERATIONS TO MEET OUR BUSINESS PLAN AND MUST COMPLY WITH STRINGENT REGULATION
OF OUR MANUFACTURING OPERATIONS.
We manufacture our LaserScan LSX laser systems for sale in the U.S. at our
manufacturing facility in Winter Park, Florida, and continue to manufacture our
laser systems for sale in international markets at our manufacturing facility in
Costa Rica. Our U.S. personnel have limited experience manufacturing laser
systems. We cannot, therefore, assure you that we will not encounter
difficulties in increasing our production capacity for our laser systems at our
Florida facility, including problems involving production delays, quality
control or assurance, component supply and lack of qualified personnel. Any
products manufactured or distributed by us pursuant to FDA clearances or
approvals are subject to extensive regulation by the FDA, including
record-keeping requirements and reporting of adverse experience with the use of
the product. Our manufacturing facilities are subject to periodic inspection by
the FDA, certain state agencies and international regulatory agencies. We
require that our key suppliers comply with recognized standards as well as our
own quality standards, and we regularly test the components and sub-assemblies
supplied to us. Any failure by us or our suppliers to comply with applicable
regulatory requirements, including the FDA's quality systems/good manufacturing
practice (QSR/GMP) regulations, could cause production and distribution of our
products to be delayed or prohibited, either of which could have a material
adverse effect on our business, financial condition and results of operations.
REQUIRED PER PROCEDURE FEES PAYABLE TO VISX UNDER OUR LICENSE AGREEMENT MAY
EXCEED PER PROCEDURE FEES COLLECTED BY US.
In addition to the risk that our refractive lasers will not be accepted in
the marketplace, we are required to pay Visx a royalty for each procedure
performed in the U.S. using our refractive lasers. The required per procedure
fees we are required to pay to Visx may exceed the per procedure fees we are
able to charge and/or collect from refractive surgeons.
REQUIRED MINIMUM PAYMENTS UNDER OUR KERATOME LICENSE AGREEMENT MAY EXCEED
OUR GROSS PROFITS FROM SALES OF OUR KERATOME PRODUCTS.
We are required to make certain minimum payments to the licensor under our
keratome license agreement that was amended and restated on January 4, 2001.
This amendment replaced a January 18, 2000 amendment in its entirety. Under the
terms of the amendment we issued 730,552 shares of common stock to the
licensors, valued at approximately $1.1 million, in partial payment for
royalties during the term of the license. The term of the license was extended
three years until July 31, 2005. In addition, remaining minimum royalty payments
totaling approximately $4.8 million as of November 13, 2001 will be due in
quarterly installments through the term of the amendment. As a result of our
obligations under this license arrangement, the minimum royalty payments we are
required to make to the licensors may exceed our gross profits from sales of our
UniShaper and UltraShaper keratome products. The amendment eliminated a
restriction on us manufacturing, marketing and selling other keratomes, but the
sale of other keratomes will be included in the gross profit to be shared with
the licensors. The licensor's share of the gross profit, as defined in the
amendment, decreased from 50% to 10%.
23
OUR FAILURE TO TIMELY OBTAIN OR EXPAND REGULATORY APPROVALS FOR OUR
PRODUCTS AND TO COMPLY WITH REGULATORY REQUIREMENTS COULD ADVERSELY AFFECT OUR
BUSINESS.
Our excimer laser systems and keratome products are subject to strict
governmental regulations that materially affect our ability to manufacture and
market these products and directly impact our overall business prospects. FDA
regulations impose design and performance standards, labeling and reporting
requirements, and submission conditions in advance of marketing for all medical
laser products in the U.S. New product introductions, expanded treatment types
and levels for approved products, and significant design or manufacturing
modifications require a premarket clearance or approval by the FDA prior to
commercialization in the U.S. The FDA approval process, which is lengthy and
uncertain, requires supporting clinical studies and substantial commitments of
financial and management resources. Failure to obtain or maintain regulatory
approvals and clearances in the U.S. and other countries, or significant delays
in obtaining these approvals and clearances, could prevent us from marketing our
products for either approved or expanded indications or treatments, which could
substantially decrease our future revenues. Additionally, product and procedure
labeling and all forms of promotional activities are subject to examination by
the FDA, and current FDA enforcement policy prohibits the marketing by
manufacturers of approved medical devices for unapproved uses. Noncompliance
with these requirements may result in warning letters, fines, injunctions,
recall or seizure of products, suspension of manufacturing, denial or withdrawal
of PMAs, and criminal prosecution. Laser products marketed in foreign countries
are often subject to local laws governing health product development processes,
which may impose additional costs for overseas product development. Future
legislative or administrative requirements, in the U.S. or elsewhere, may
adversely affect our ability to obtain or retain regulatory approval for our
products. The failure to obtain approvals for new or additional uses on a timely
basis could have a material adverse effect on our business, financial condition
and results of operations.
OUR BUSINESS DEPENDS ON OUR INTELLECTUAL PROPERTY RIGHTS, AND IF WE ARE
UNABLE TO PROTECT THEM, OUR COMPETITIVE POSITION MAY BE ADVERSELY AFFECTED.
Our business plan is predicated on our proprietary systems and technology,
including our precision beam scanning microspot technology laser systems. We
protect our proprietary rights through a combination of patent, trademark, trade
secret and copyright law, confidentiality agreements and technical measures. We
generally enter into non-disclosure agreements with our employees and
consultants and limit access to our trade secrets and technology. We cannot
assure you that the steps we have taken will prevent misappropriation of our
intellectual property. Misappropriation of our intellectual property would have
a material adverse effect on our competitive position. In addition, we may have
to engage in litigation or other legal proceedings in the future to enforce or
protect our intellectual property rights or to defend against claims of
invalidity. These legal proceedings may consume considerable resources,
including management time and attention, which would be diverted from the
operation of our business, and the outcome of any such legal proceeding is
inherently uncertain.
We are aware that certain competitors are developing products that may
potentially infringe patents owned or licensed exclusively by us. In order to
protect our rights in these patents, we may find it necessary to assert and
pursue infringement claims against such third parties. We could incur
substantial costs and diversion of management resources litigating such
infringement claims and we cannot assure you that we will be successful in
resolving such claims or that the resolution of any such dispute will be on
terms that are favorable to us. See "--Patent infringement allegations may
impair our ability to manufacture and market our products."
PATENT INFRINGEMENT ALLEGATIONS MAY IMPAIR OUR ABILITY TO MANUFACTURE AND
MARKET OUR PRODUCTS.
There are a number of U.S. and foreign patents covering methods and
apparatus for performing corneal surgery that we do not own or have the right to
use. If we were found to infringe a patent in a particular market, we and our
customers may be enjoined from manufacturing, marketing, selling and using the
24
infringing product in the market and may be liable for damages for any past
infringement of such rights. In order to continue using such rights, we would be
required to obtain a license, which may require us to make royalty, per
procedure or other fee payments. We cannot be certain if we or our customers
will be successful in securing licenses, or that if we obtain licenses, such
licenses will be available on acceptable terms. Alternatively, we might be
required to redesign the infringing aspects of these products. Any redesign
efforts that we undertake could be expensive and might require regulatory
review. Furthermore, the redesign efforts could delay the reintroduction of
these products into certain markets, or may be so significant as to be
impractical. If redesign efforts were impractical, we could be prevented from
manufacturing and selling the infringing products, which would have a material
adverse effect on our business, financial condition and results of operations.
Litigation involving patents is common in our industry. While we do not
believe our laser systems or keratome products infringe any valid and
enforceable patents that we do not own or have a license to, we cannot assure
you that one or more of our other competitors or other persons will not assert
that our products infringe their intellectual property, or that we will not in
the future be deemed to infringe one or more patents owned by them or some other
party. We could incur substantial costs and diversion of management resources
defending any infringement claims. Furthermore, a party making a claim against
us could secure a judgment awarding substantial damages, as well as injunctive
or other equitable relief that could effectively block our ability to market one
or more of our products. In addition, we cannot assure you that licenses for any
intellectual property of third parties that might be required for our products
will be available on commercially reasonable terms, or at all.
WE ARE SUBJECT TO CERTAIN RISKS ASSOCIATED WITH OUR INTERNATIONAL SALES.
Our international sales accounted for 73% and 45% of our total revenues
during the nine months ended September 30, 2001 and year ended December 31,
2000, respectively. In the future, we expect that sales to international
accounts will represent a lower percentage of our total sales as a result of our
recent additional regulatory approval for our LaserScan LSX laser system in the
U.S. and the commercial launch of our UltraShaper durable keratome in November
2001. See "--Industry and Competitive Risks--We cannot assure you that our
keratome products will achieve market acceptance."
International sales of our products may be limited or disrupted by:
o the imposition of government controls;
o export license requirements;
o economic or political instability;
o trade restrictions;
o difficulties in obtaining or maintaining export licenses;
o changes in tariffs; and
o difficulties in staffing and managing international operations.
Our sales have historically been and are expected to continue to be
denominated in U.S. dollars. The European Economic Union's conversion to a
common currency, the euro, is not expected to have a material impact on our
business. However, due to our significant export sales, we are subject to
exchange rate fluctuations in the U.S. dollar, which could increase the
effective price in local currencies of our products. This could result in
reduced sales, longer payment cycles and greater difficulty in collecting
receivables relating to our international sales.
OUR SUPPLY OF CERTAIN CRITICAL COMPONENTS AND SYSTEMS MAY BE INTERRUPTED
BECAUSE OF OUR RELIANCE ON A LIMITED NUMBER OF SUPPLIERS.
We currently purchase certain components used in the production, operation
and maintenance of our laser systems and keratome products from a limited number
of suppliers, and certain key components are provided by a single vendor. For
example, all of our keratome blades are currently manufactured exclusively by
25
Becton Dickinson and the majority of our UltraShaper components are manufactured
exclusively by Owens Industries pursuant to our agreement with them. We do not
have long-term contracts with providers of some key laser system components,
including TUI Lasertechnik und Laserintegration GmbH, which currently is a
single source supplier for the laser heads used in our LaserScan LSX excimer
laser system. Currently, SensoMotoric Instruments GmbH, Teltow, Germany, is a
single source supplier for the eye tracker boards used in the LaserScan LSX. Any
interruption in the supply of critical laser or keratome components could have a
material adverse effect on our business, financial condition and results of
operations. If any of our key suppliers ceases providing us with products of
acceptable quality and quantity at a competitive price and in a timely fashion,
we would have to locate and contract with a substitute supplier and, in some
cases, such substitute supplier would need to be qualified by the FDA. If
substitute suppliers cannot be located and qualified in a timely manner or could
not provide required products on commercially reasonable terms, it would have a
material adverse effect on our business, financial condition and results of
operations.
UNLAWFUL TAMPERING OF OUR SYSTEM CONFIGURATIONS COULD RESULT IN REDUCED
REVENUES AND ADDITIONAL EXPENSES.
We include a procedure counting mechanism on LaserScan LSX lasers
manufactured for sale and use in the U.S. Users of our LaserScan LSX excimer
laser system could tamper with the software or hardware configuration of the
system so as to alter or eliminate the procedure counting mechanism that
facilitates the collection of per procedure fees. Unauthorized tampering with
our procedure counting mechanism by users could result in us being required to
pay per procedure fees to Visx that we were not able to collect from users. If
we are unable to prevent such tampering, our license agreement with Visx could
be terminated after all applicable notice and cure periods have expired.
THE LOSS OF KEY PERSONNEL COULD ADVERSELY AFFECT OUR BUSINESS.
Our ability to maintain our competitive position depends in part upon the
continued contributions of our executive officers and other key employees,
especially Michael R. Farris, our president and chief executive officer. A loss
of one or more such officers or key employees could have a material adverse
effect on our business. We do not carry "key person" life insurance on any
officer or key employee.
As we commercially launch our laser system and keratome products in the
U.S., we will need to continue to implement and expand our operational, sales
and marketing, financial and management resources and controls. While to date we
have not experienced problems recruiting or retaining the personnel necessary to
expand our business, we cannot assure you that we will not have such problems in
the future. Our recent layoff may have a negative impact on our ability to
attract and retain personnel. If we fail to attract and retain qualified
individuals for necessary positions, and if we are unable to effectively manage
growth in our domestic or international operations, it could have a material
adverse effect on our business, financial condition and results of operations.
INADEQUACY OR UNAVAILABILITY OF INSURANCE MAY EXPOSE US TO SUBSTANTIAL
PRODUCT LIABILITY CLAIMS.
Our business exposes us to potential product liability risks and possible
adverse publicity that are inherent in the development, testing, manufacture,
marketing and sale of medical devices for human use. These risks increase with
respect to our products that receive regulatory approval for commercialization.
We have agreed in the past, and we will likely agree in the future, to indemnify
certain medical institutions and personnel who conduct and participate in our
clinical studies. While we maintain product liability insurance, we cannot be
certain that any such liability will be covered by our insurance or that damages
will not exceed the limits of our coverage. Even if a claim is covered by
insurance, the costs of defending a product liability, malpractice, negligence
or other action, and the assessment of damages in excess of insurance coverage
in the event of a successful product liability claim, could have a material
adverse effect on our business, financial condition and results of operations.
Further, product liability insurance may not continue to be available, either at
existing or increased levels of coverage, on commercially reasonable terms.
26
FINANCIAL AND LIQUIDITY RISKS
WE HAVE EXPERIENCED SIGNIFICANT LOSSES AND OPERATING CASH FLOW DEFICITS AND
WE EXPECT THAT OPERATING CASH FLOW DEFICITS WILL CONTINUE THROUGH AT LEAST THE
REMAINDER OF 2001.
We experienced significant net losses and deficits in cash flow from
operations for the years ended December 31, 2000 and 1999 and the nine months
ended September 30, 2001, as set forth in the following table. We cannot be
certain that we will be able to achieve or sustain profitability or positive
operating cash flow in the future.
Year Ended December 31, Nine Months Ended
1999 2000 September 30, 2001
---- ---- ------------------
Net loss $14.4 million $21.4 million $17.7 million
Deficit in cash flow
from operations $11.7 million $15.7 million $15.8 million
As of September 30, 2001, we had an accumulated deficit of $77.3 million.
IF OUR UNCOLLECTIBLE RECEIVABLES EXCEED OUR RESERVES WE WILL INCUR
ADDITIONAL UNANTICIPATED EXPENSES, AND WE MAY EXPERIENCE DIFFICULTY COLLECTING
RESTRUCTURED RECEIVABLES WITH EXTENDED PAYMENT TERMS.
Although we monitor the status of our receivables and maintain a reserve
for estimated losses, we cannot be certain that our reserves for estimated
losses, which were approximately $5.6 million at September 30, 2001, will be
sufficient to cover the amount of our actual write-offs over time. At September
30, 2001, our net trade accounts and notes receivable totaled approximately
$14.3 million, and accrued commissions, the payment of which generally depends
on the collection of such net trade accounts and notes receivable, totaled
approximately $2.2 million. Actual write-offs that exceed amounts reserved could
have a material adverse effect on our consolidated financial condition and
results of operations. The amount of any loss that we may have to recognize in
connection with our inability to collect receivables is principally dependent on
our customers' ongoing financial condition, their ability to generate revenues
from our laser systems, and our ability to obtain and enforce legal judgments
against delinquent customers.
Our ability to evaluate the financial condition and revenue-generating
ability of our prospective customers located outside of the U.S., and our
ability to obtain and enforce legal judgments against customers located outside
of the U.S., is generally more limited than for our customers located in the
U.S. Our agreements with our international customers typically provide that the
contracts are governed by Florida law. We have not determined whether or to what
extent courts or administrative agencies located in foreign countries would
enforce our right to collect such receivables or to recover laser systems from
customers in the event of a customer's payment default. When a customer is not
paying according to established terms, we attempt to communicate and understand
the underlying causes and work with the customer to resolve any issues we can
control or influence. In most cases, we have been able to resolve the customer's
issues and continue to collect our receivable, either on the original schedule
or under restructured terms. If such issues are not resolved, we evaluate our
legal and other alternatives based on existing facts and circumstances. In most
such cases, we have concluded that the account should be written off as
uncollectible.
At September 30, 2001, we had extended the original payment terms of laser
customer accounts totaling approximately $2.1 million by periods ranging from 5
to 60 months. Such restructured receivables represent approximately 10.4% of our
gross receivables as of that date. Our liquidity and operating cash flow would
be adversely affected if additional extensions become necessary in the future.
In addition, it would be more difficult to collect laser system receivables if
the payment schedule extends beyond the expected or actual economic life of the
system, which we estimate to be approximately five to seven years. To date, we
do not believe any payment schedule extends beyond the economic life of the
applicable laser system.
27
WE COULD REQUIRE ADDITIONAL FINANCING, WHICH MIGHT NOT BE AVAILABLE IF WE
NEED IT.
During the nine months ended September 30, 2001 and year ended December 31,
2000, we experienced deficits in cash flow from operations of $15.8 million and
$15.7 million, respectively. In July 2001, we completed a $3.0 million private
placement of series F convertible participating preferred stock. We are
exploring opportunities for additional equity financing through a private
placement of our common stock. If our recent FDA approval for the treatment of
myopic astigmatism doesn't result in an increase in U.S. sales of our LaserScan
LSX excimer laser system or we experience unanticipated delays in the commercial
release of our AstraMax diagnostic workstation, we will be required to seek
additional debt or equity financing during the next 12 months. There can be no
assurance that the assumptions underlying our business plan will be met or that
additional financing will not be needed or that financing, if needed, would be
available. Our belief regarding future working capital requirements is based on
various factors and assumptions including: the successful reduction of a
significant amount of expenses currently being implemented, the uncertain timing
of additional supplemental FDA approvals for our LaserScan LSX excimer laser
system, which could continue to negatively impact our sales during 2001 and
2002, potential growth in laser sales after receipt of further FDA approvals,
increases in accounts receivable and inventory purchases when sales increase,
the potential for borrowing under our revolving credit facility, the uncertain
impact of the market introduction of our UltraShaper durable keratomes,
commercial acceptance of our UltraEdge keratome blades and UniShaper single-use
keratomes, which we believe is partially dependent upon the successful
introduction of the UltraShaper, the anticipated timely collection of
receivables, and the absence of unanticipated product development and marketing
costs. See "--Industry and Competitive Risks--We cannot assure you that our
keratome products will achieve market acceptance" and "--We cannot assure you
that our LaserScan LSX laser system will achieve market acceptance in the U.S.,
and our business model for selling our laser system in the U.S. is new and
unproven." These factors and assumptions are subject to certain contingencies
and uncertainties, some of which are beyond our control. If we do not collect a
material portion of current receivables in a timely manner, or experience less
market demand for our products than we anticipate, our liquidity could be
materially and adversely affected.
On March 12, 2001, we established a $3.0 million term loan and $10.0
million revolving credit facility with Heller. We borrowed $3.0 million under
the term loan at a rate per annum equal to two and one-half percent (2.5%) above
the prime rate. Interest is payable monthly and the loan must be repaid on March
12, 2003. Under the credit facility, we have the option to borrow amounts at a
rate per annum equal to one and one-quarter percent (1.25%) above the prime rate
for short-term working capital needs or such other purposes as may be approved
by Heller. Borrowings are limited to 85% of eligible accounts receivable related
to U.S. sales. Eligible accounts receivable will primarily be based on future
U.S. sales, which are expected to increase with the recent FDA approval of our
laser for the treatment of nearsightedness with astigmatism. Borrowings under
the loans are secured by substantially all of the Company's assets. The term
loan and credit facility require us to meet certain covenants, including the
maintenance of a minimum net worth. The terms of the loans extend to March 12,
2003. In addition to the costs and fees associated with the transaction, we
issued to Heller a warrant to purchase 243,750 shares of common stock at an
exercise price of $3.15 per share. The warrant expires on March 12, 2004. At
November 13, 2001, we had no borrowings under the revolving credit facility.
We may seek additional equity financing in the future to implement our
business plan or any changes thereto in response to future developments or
unanticipated contingencies. Other than the $10.0 million revolving credit
facility with Heller, we currently do not have any commitments for additional
financing. We cannot be certain that additional financing will be available in
the future to the extent required or that, if available, it will be on
commercially acceptable terms. If we raise additional funds by issuing equity or
convertible debt securities, the terms of the new securities could have rights,
preferences and privileges senior to those of our common stock. If we raise
additional funds through debt financing, the terms of the debt could require a
substantial portion of our cash flow from operations to be dedicated to the
payment of principal and interest and may render us more vulnerable to
competitive pressures and economic downturns. If we are not able to obtain
financing necessary to meet our working capital needs, it could have a material
adverse effect on our financial condition and results of operations.
28
COMMON STOCK RISKS
VARIATIONS IN OUR SALES AND OPERATING RESULTS MAY CAUSE OUR STOCK PRICE TO
FLUCTUATE.
Our operating results have fluctuated in the past, and may continue to
fluctuate in the future, as a result of a variety of factors, many of which are
outside of our control. For example, historically a significant portion of our
laser system orders for a particular quarter have been received and shipped near
the end of the quarter. As a result, our operating results for any quarter often
depend on the timing of the receipt of orders and the subsequent shipment of our
laser systems. Other factors that may cause our operating results to fluctuate
include:
o timing of regulatory approvals and the introduction or delays in shipment
of new products;
o reductions, cancellations or fulfillment of major orders;
o the addition or loss of significant customers;
o the relative mix of our business;
o changes in pricing by us or our competitors;
o costs related to expansion of our business; and
o increased competition.
As a result of these fluctuations, we believe that period-to-period
comparisons of our operating results cannot be relied upon as indicators of
future performance. In some quarters our operating results may fall below the
expectations of securities analysts and investors due to any of the factors
described above or other uncertainties.
THE MARKET PRICE OF OUR COMMON STOCK MAY CONTINUE TO EXPERIENCE EXTREME
FLUCTUATIONS DUE TO MARKET CONDITIONS THAT ARE UNRELATED TO OUR OPERATING
PERFORMANCE.
The stock market, and in particular the securities of technology companies
like us, could experience extreme price and volume fluctuations unrelated to our
operating performance. Our stock price has historically been volatile. Factors
such as announcements of technological innovations or new products by us or our
competitors, changes in domestic or foreign governmental regulations or
regulatory approval processes, developments or disputes relating to patent or
proprietary rights, public concern as to the safety and efficacy of refractive
vision correction procedures, and changes in reports and recommendations of
securities analysts, have and may continue to have a significant impact on the
market price of our common stock.
THE SIGNIFICANT NUMBER OF SHARES ELIGIBLE FOR FUTURE SALE AND DILUTIVE
STOCK ISSUANCES MAY ADVERSELY AFFECT OUR STOCK PRICE.
Sales, or the possibility of sales, of substantial amounts of our common
stock in the public market could adversely affect the market price of our common
stock. Substantially all of our 26,437,895 shares of common stock outstanding at
November 13, 2001 were freely tradable without restriction or further
registration under the Securities Act of 1933, except to the extent such shares
are held by "affiliates" as that term is defined in Rule 144 under the
Securities Act or subject only to the satisfaction of a prospectus delivery
requirement.
Shares of common stock that we may issue in the future in connection with
acquisitions or financings or pursuant to outstanding warrants or agreements
could also adversely affect the market price of our common stock and cause
significant dilution in our earnings per share and net book value per share. We
may be required to issue more than 8,100,000 additional shares of common stock
upon the conversion of outstanding preferred stock, the exercise of outstanding
warrants and stock options, and the satisfaction of certain contingent
contractual obligations.
29
The anti-dilution provisions of certain of our existing securities and
obligations require us to issue additional shares if we issue shares of common
stock below specified price levels. If a future share issuance triggers these
adjustments, the beneficiaries of such provisions effectively receive some
protection from declines in the market price of our common stock, while our
other stockholders incur additional dilution of their ownership interest. We may
include similar anti-dilution provisions in securities issued in connection with
future financings.
ANTI-TAKEOVER PROVISIONS UNDER DELAWARE LAW AND IN OUR CERTIFICATE OF
INCORPORATION, BY-LAWS AND STOCKHOLDER RIGHTS PLAN MAY MAKE AN ACQUISITION OF
LASERSIGHT MORE DIFFICULT AND COULD PREVENT YOU FROM RECEIVING A PREMIUM OVER
THE MARKET PRICE OF OUR STOCK.
Certain provisions of our certificate of incorporation, by-laws,
stockholder rights plan and Delaware law could delay or frustrate the removal of
incumbent directors, discourage potential acquisition proposals and delay, defer
or prevent a change in control of us, even if such events could be beneficial,
in the short term, to the economic interests of our stockholders. For example,
our certificate of incorporation allows us to issue preferred stock with rights
senior to those of the common stock without stockholder action, and our by-laws
require advance notice of director nominations or other proposals by
stockholders. We also are subject to provisions of Delaware corporation law that
prohibit a publicly-held Delaware corporation from engaging in a broad range of
business combinations with a person who, together with affiliates and
associates, owns 15% or more of the corporation's common stock (an interested
stockholder) for three years after the person became an interested stockholder,
unless the business combination is approved in a prescribed manner. We also have
adopted a stockholder rights agreement, or "poison pill," and declared a
dividend distribution of one preferred share purchase right for each share of
common stock. The rights would cause substantial dilution to a person or group
that attempts to acquire 15% or more of our common stock on terms not approved
by our board of directors.
ACQUISITION RISKS
PAST AND POSSIBLE FUTURE ACQUISITIONS THAT ARE NOT SUCCESSFULLY INTEGRATED
WITH OUR EXISTING OPERATIONS MAY ADVERSELY AFFECT OUR BUSINESS.
We have made several significant acquisitions since 1994, and we may in the
future selectively pursue strategic acquisitions of, investments in or enter
into joint ventures or other strategic alliances with companies whose business
or technology complement our business. We may not be able to identify suitable
candidates to acquire or enter into joint ventures or other arrangements with
entities, and we may not be able to obtain financing on satisfactory terms for
such activities. In addition, we could have difficulty assimilating the
personnel, technology and operations of any acquired companies, which could
prevent us from realizing expected synergies, and may incur unanticipated
liabilities and contingencies. This could disrupt our ongoing business and
distract our management and other resources.
AMORTIZATION AND CHARGES RELATING TO OUR SIGNIFICANT INTANGIBLE ASSETS
COULD ADVERSELY AFFECT OUR STOCK PRICE AND REPORTED NET INCOME OR LOSS.
Of our total assets at September 30, 2001, approximately $8.5 million, or
20%, were goodwill or other intangible assets. Any reduction in net income or
increase in net loss resulting from the amortization of goodwill and other
intangible assets resulting from future acquisitions by us may have an adverse
impact upon the market price of our common stock. In addition, in the event of a
sale of LaserSight or our assets, we cannot be certain that the value of such
intangible assets would be recovered.
In accordance with FASB Statement No. 121, we review intangible assets for
impairment whenever events or changes in circumstances, including a history of
operating or cash flow losses, indicate that the carrying amount of an asset may
not be recoverable. If we determine that an intangible asset is impaired, a
non-cash impairment charge would be recognized. We continue to assess the
current results and future prospects of TFG, our subsidiary that provides health
care and vision care consulting services, in view of the substantial reduction
in the subsidiary's operating results in 1997. Though TFG's operating results
30
improved in 1998 when compared to 1997, operating losses similar to those
incurred during the first half of 1998 continued during 1999. Since 1999, TFG's
operations have reflected financial improvement. If TFG is unsuccessful in
continuing to improve its financial performance, some or all of the carrying
amount of goodwill recorded, $3.0 million at September 30, 2001, may be subject
to an impairment adjustment. See "Management's Discussion and Analysis of
Financial Condition and Results of Operations--New Accounting Pronouncements."
OTHER RISKS
The risks described above are not the only risks facing LaserSight. There
may be additional risks and uncertainties not presently known to us or that we
have deemed immaterial which could also negatively impact our business
operations. If any of the foregoing risks actually occur, it could have a
material adverse effect on our business, financial condition and results of
operations. In that event, the trading price of our common stock could decline,
and you may lose all or part of your investment.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We believe that our exposure to market risk for changes in interest and
currency rates is not significant. Our investments are limited to highly liquid
instruments generally with maturities of three months or less. At September 30,
2001, we had approximately $4.1 million of short-term investments classified as
cash and equivalents. All of our transactions with international customers and
suppliers are denominated in U.S. dollars.
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Certain legal proceedings against LaserSight are described in Item 3
(Legal Proceedings) of LaserSight's Form 10-K for the year ended
December 31, 2000.
FORMER MRF, INC. SHAREHOLDER. On May 14, 2001, a motion for summary
judgment was granted in favor of Michael R. Farris in connection with
a lawsuit that was filed on November 12, 1999 in the U.S. District
Court for the Eastern District of Missouri on behalf of a former
shareholder of MRF, Inc. (the "Subsidiary"), a wholly-owned subsidiary
of LaserSight. The lawsuit names Mr. Farris, LaserSight's chief
executive officer, as the sole defendant and alleges fraud and breach
of fiduciary duty by Mr. Farris in connection with the redemption by
the Subsidiary of the former shareholder's capital stock in the
Subsidiary. At the time of the redemption, which redemption occurred
prior to LaserSight's acquisition of the Subsidiary, Mr. Farris was
the president and chief executive officer of the Subsidiary.
LaserSight's Board of Directors authorized LaserSight to retain and,
to the fullest extent permitted by the Delaware General Corporation
Law, pay the fees of counsel to defend Mr. Farris, the Subsidiary and
LaserSight in the litigation so long as a court has not determined
that Mr. Farris failed to act in good faith and in a manner Mr. Farris
reasonably believed to be in the best interest of the Subsidiary at
the time of the redemption. The plaintiff appealed the U.S. District
Court's order granting summary judgment in favor of Mr. Farris to the
United States Court of Appeals for the 8th Circuit. All briefing has
been completed, and the parties are waiting for the Court of Appeals
to set a date for oral argument.
DISTRIBUTORS. In October 2001, three entities that previously served
as distributors for LaserSight's excimer laser system in the United
States, Balance, Inc. d/b/a Bal-Tech Medical, Sun Medical, Inc. and
Surgical Lasers, Inc., filed a lawsuit in the Circuit Court of the
Ninth Judicial Circuit, Orange County, Florida. The lawsuit names
LaserSight Technologies, Inc. ("LST"), Mr. Farris and James Spivey,
LST's Vice President of Sales, as defendants. The lawsuit alleges
31
various claims related to LST's termination of the distribution
arrangements with the plaintiffs including breach of contract, breach
of the covenant of good faith and fair dealing, tortious interference
with business relationships, fraudulent misrepresentation, conversion
and unjust enrichment. Plaintiffs request actual damages in excess of
$5,000,000, punitive damages, prejudgment interest, attorneys' fees
and costs and other equitable relief. Management believes that LST has
satisfied its obligations under the distribution agreements, and that
the allegations against LST, Mr. Farris and Mr. Spivey are without
merit and intend to vigorously defend this lawsuit. Management
believes that the outcome of this litigation will not have a material
adverse impact of LaserSight's business, financial condition or
results from operations. However, the outcome of litigation is
inherently uncertain, and an unfavorable outcome in this litigation
could have a material adverse effect on LaserSight's business,
financial condition and results from operations.
ITEM 2. CHANGES IN SECURITIES
a) Not applicable.
b) Not applicable.
c) During the third quarter ended September 30, 2001, the Company
sold the following unregistered securities:
In July 2001, LaserSight closed a transaction for the sale
of 1,276,596 shares of Series F convertible participating
preferred stock, convertible into common stock on a share
for share basis, to a total of two investors in exchange
for the Company receiving $3.0 million in cash. In
addition, the investors received a total of 838,905 shares
of common stock under price protection provisions of the
Company's September 2000 private placement. Reference is
made to the Securities Purchase Agreement filed as
exhibits to LaserSight's Form 8-K filed with the SEC on
July 18, 2001, for more detailed information regarding
these private placements.
The issuance and sale of all such shares was exempt from
the registration and prospectus delivery requirements of
the Securities Act of 1933 by virtue of Section 4(2)
thereof due to, among other things, (i) the limited number
of persons to whom the shares were issued, (ii) the
distribution of disclosure documents to all investors,
(iii) the fact that each such person represented and
warranted to LaserSight, among other things, that such
person was acquiring the shares for investment only and
not with a view to the resale or distribution thereof, and
(iv) the fact that certificates representing the shares
were issued with a legend to the effect that such shares
had not been registered under the Securities Act or any
state securities laws and could not be sold or transferred
in the absence of such registration or an exemption
therefrom.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On July 12, 2001, at the Company's annual meeting of shareholders, the
following members were elected to the Board of Directors:
32
Votes For Votes Against
Michael R. Farris 22,239,790 180,778
Terry Fuller, Ph.D. 22,239,890 180,678
D. Michael Litscher 22,239,790 180,778
Guy W. Numann 22,239,890 180,678
Francis E. O'Donnell, Jr., M.D. 22,239,890 180,678
David T. Pieroni 22,239,890 180,678
Amendment to the Company's 1996 Equity Incentive Plan adjusting the
aggregate number of shares available for issuance was ratified as
follows:
Votes For 10,946,014
Votes Against 772,783
Abstain 82,911
A proposal to appoint KPMG LLP as auditors was ratified as follows:
Votes for 22,247,836
Votes Against 88,775
Abstain 83,957
ITEM 5. OTHER INFORMATION
Not applicable.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
a) Exhibits
INDEX TO EXHIBITS
Exhibit
Number Description
------ ---------------------------------------------------------------------
2.1 See Exhibits 10.1, 10.2, 10.6, 10.7, 10.15, 10.20, 10.23, 10.24,
10.27, 10.28, 10.48 and 10.55.
3.1 Certificate of Incorporation, as amended (incorporated by reference to
Exhibit 1 of Form 8-A/A (Amendment No. 6) filed by the Company on
August 10, 2001*).
3.2 Bylaws, as amended (filed as Exhibit 3.2 to the Company's Form 8-K
filed on December 20, 1999*).
3.3 Rights Agreement, dated as of July 2, 1998, between LaserSight
Incorporated and American Stock Transfer & Trust Company, as Rights
Agent, which includes (I) as Exhibit A thereto the form of Certificate
of Designation of the Series E Junior Participating Preferred Stock,
(ii) as Exhibit B thereto the form of Right Certificate (separate
certificates for the Rights will not be issued until after the
Distribution Date) and (iii) as Exhibit C thereto the Summary of
Stockholder Rights Agreement (incorporated by reference to Exhibit
99.1 to the Form 8-K filed by the Company on July 8, 1998*).
3.4 First Amendment to Rights Agreement, dated as of March 22, 1999,
between LaserSight Incorporated and American Stock Transfer & Trust
Company, as Rights Agent (incorporated by reference to Exhibit 2 to
Form 8-A/A filed by the Company on March 29, 1999*).
33
3.5 Second Amendment to Rights Agreement, dated as of January 28, 2000,
between LaserSight Incorporated and American Stock Transfer & Trust
Company, as Rights Agent (incorporated by reference to Exhibit 99.6 to
Form 8-K filed by the Company on February 8, 2000*).
3.6 Third Amendment to Rights Agreement, dated as of June 29, 2001,
between LaserSight Incorporated and American Stock Transfer & Trust
Company, as Rights Agent (incorporated by reference to Exhibit 99.5 to
Form 8-K filed by the Company on July 18, 2001*).
4.1 See Exhibits 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 10.17, 10.21, 10.26, 10.31,
10.32, 10.33, 10.40, 10.42, 10.43, 10.44, 10.45, 10.46, 10.47, 10.51,
10.52, 10.53, 10.54, 10.56, 10.57, 10.59, 10.60, 10.63, 10.64 and
10.65.
10.1 Agreement for Purchase and Sale of Stock by and among LaserSight
Centers Incorporated, its stockholders and LaserSight Incorporated
dated January 15, 1993 (filed as Exhibit 2 to the Company's Form 8-K/A
filed on January 25, 1993*).
10.2 Amendment to Agreement for Purchase and Sale of Stock by and among
LaserSight Centers Incorporated, its stockholders, and LaserSight
Incorporated dated April 5, 1993 (filed as Exhibit 2 to the Company's
Form 8-K/A filed on April 19, 1993*).
10.3 Royalty Agreement by and between LaserSight Centers Incorporated and
LaserSight Partners dated January 15, 1993 (filed as Exhibit 10.5 to
the Company's Form 10-K for the year ended December 31, 1995*).
10.4 Exchange Agreement dated January 25, 1993 between LaserSight Centers
Incorporated and Laser Partners (filed as Exhibit 10.6 to the
Company's Form 10-K for the year ended December 31, 1995*).
10.5 Stipulation and Agreement of Compromise, Settlement and Release dated
April 18, 1995 among James Gossin, Francis E. O'Donnell, Jr., J.T.
Lin, Wen S. Dai, Emanuela Dobrin-Charlton, C.H. Huang, W. Douglas
Hajjar, and LaserSight Incorporated (filed as Exhibit 10.7 to the
Company's Form 10-K for the year ended December 31, 1995*).
10.6 Agreement for Purchase and Sale of Stock dated December 31, 1993,
among LaserSight Incorporated, MRF, Inc., and Michael R. Farris (filed
as Exhibit 2 to the Company's Form 8-K filed on December 31, 1993*).
10.7 First Amendment to Agreement for Purchase and Sale of Stock by and
among MRF, Inc., Michael R. Farris and LaserSight Incorporated dated
December 28, 1995 (filed as Exhibit 10.9 to the Company's Form 10-K
for the year ended December 31, 1995*).
10.8 LaserSight Incorporated 1995 Stock Option Plan (filed as Exhibit 10.5
to the Company's Form 10-Q for the quarter ended September 30, 1995*).
10.9 Modified Promissory Note between LaserSight Incorporated, EuroPacific
Securities Services, GmbH and Co. KG and Wolf Wiese (filed as Exhibit
10.6 to the Company's Form 10-Q for the quarter ended September 30,
1995*).
34
10.10 Patent License Agreement dated December 21, 1995 by and between
Francis E. O'Donnell, Jr. and LaserSight Centers, Inc. (filed as
Exhibit 10.21 to the Company's Form 10-K for the year ended December
31, 1995*).
10.11 LaserSight Incorporated Amended and Restated 1996 Equity Incentive
Plan (filed as Exhibit 10.11 to the Company's Form 10-Q filed on
November 14, 2000*).
10.12 LaserSight Incorporated Amended and Restated Non-Employee Directors
Stock Option Plan (filed as Exhibit 10.12 to the Company's Form 10-Q
filed on November 14, 2000*).
10.13 Agreement dated January 1, 1997, between International Business
Machines Corporation and LaserSight Incorporated (filed as Exhibit
10.37 to the Company's Form 10-K for the year ended December 31,
1996*).
10.14 Addendum dated March 7, 1997 to Agreement between International
Business Machines Corporation and LaserSight Incorporated (filed as
Exhibit 10.38 to the Company's Form 10-K for the year ended December
31, 1996*).
10.15 Second Amendment to Agreement for Purchase and Sale of Stock by and
among LaserSight Centers Incorporated, its stockholders and LaserSight
Incorporated dated March 14, 1997 (filed as Exhibit 99.1 to the
Company's Form 8-K filed on March 27, 1997*).
10.16 Amendment to Royalty Agreement by and between LaserSight Centers
Incorporated, Laser Partners and LaserSight Incorporated dated March
14, 1997 (filed as Exhibit 99.2 to the Company" Form 8-K filed on
March 27, 1997*).
10.17 Warrant to purchase 500,000 shares of common stock dated March 31,
1997 by and between LaserSight Incorporated and Foothill Capital
Corporation (filed as Exhibit 10.44 to the Company's Form 10-Q filed
on August 14, 1997*).
10.18 License Agreement dated May 20, 1997 by and between Visx Incorporated
and LaserSight Incorporated (filed as Exhibit 10.45 to the Company's
Form 10-Q filed on August 14, 1997*).
10.19 Patent Purchase Agreement dated July 15, 1997 by and between
LaserSight Incorporated and Frederic B. Kremer, M.D. (filed as Exhibit
2.(I) to the Company's Form 8-K filed on August 13, 1997*).
10.20 Agreement and Plan of Merger dated July 15, 1997 by and among
LaserSight Incorporated, Photomed Acquisition, Inc., Photomed, Inc.,
Frederic B. Kremer, M.D., Linda Kremer, Robert Sataloff, Trustee for
Alan Stewart Kremer and Robert Sataloff, Trustee for Mark Adam Kremer
(filed as Exhibit 2.(ii) to the Company's Form 8-K filed on August 13,
1997*).
10.21 Warrant to purchase 750,000 shares of common stock dated August 29,
1997 by and between LaserSight Incorporated and purchasers of Series B
Convertible Participating Preferred Stock of LaserSight Incorporated
(filed as Exhibit 10.39 to the Company's Form 10-Q filed on November
14, 1997*).
10.22 Independent Contractor Agreement by and between Byron Santos, M.D. and
LaserSight Technologies, Inc. (filed as Exhibit 10.42 to the Company's
Form 10-Q filed on November 14, 1997*).
35
10.23 Stock Purchase Agreement, dated December 30, 1997, by and among
LaserSight Incorporated, LSI Acquisition, Inc., MEC Health Care, Inc.
and Vision Twenty-One, Inc. (filed as Exhibit 2.(I) to the Company's
Form 8-K filed on January 14, 1998*).
10.24 Stock Distribution Agreement, dated December 30, 1997, by and among
LaserSight Incorporated, LSI Acquisition, Inc., MEC Health Care, Inc.
and Vision Twenty-One, Inc. (filed as Exhibit 2.(ii) to the Company's
Form 8-K filed on January 14, 1998*).
10.25 Agreement dated April 1, 1992 between International Business Machines
Corporation and LaserSight Incorporated (filed as Exhibit 10.1 on Form
10-K for the year ended December 31, 1995*).
10.26 Securities Purchase Agreement, dated June 5, 1998, by and between
LaserSight Incorporated and TLC The Laser Center, Inc. (filed as
Exhibit 99.1 to the Company's Form 8-K filed on June 25, 1998*).
10.27 Letter Agreement dated September 11, 1998, amending the Agreement and
Plan of Merger dated July 15, 1997, by and among LaserSight
Incorporated, Photomed Acquisition, Inc., Photomed, Inc., Frederic B.
Kremer, M.D., Linda Kremer, Robert Sataloff, Trustee for Alan Stewart
Kremer and Robert Sataloff, Trustee for Mark Adam Kremer (filed as
Exhibit 10.31 to the Company's Form 10-Q filed on November 16, 1998*).
10.28 Exclusive License Agreement dated August 20, 1998, by and between
LaserSight Technologies, Inc. and TLC The Laser Center Patents Inc.
(filed as Exhibit 10.32 to the Company's Form 10-Q filed on November
16, 1998*).
10.29 Manufacturing Agreement, dated September 10, 1997, by and between
LaserSight Technologies, Inc. and Frantz Medical Development Ltd.
(filed as Exhibit 10.3 to the Company's Form S-3, Pre-Effective
Amendment No. 1 filed on February 1, 1999*).
10.30 Employment Agreement by and between LaserSight Incorporated and
Michael R. Farris dated October 30, 1998 (filed as Exhibit 10.37 to
the Company's Form 10-K filed on March 31, 1999*).
10.31 Securities Purchase Agreement by and between LaserSight Incorporated
and purchasers of common stock dated March 22, 1999 (filed as Exhibit
10.38 to the Company's Form 10-K filed on March 31, 1999*).
10.32 Warrant to purchase 225,000 shares of common stock dated March 22,
1999 by and between LaserSight Incorporated and purchasers of common
stock of LaserSight Incorporated (filed as Exhibit 10.39 to the
Company's Form 10-K filed on March 31, 1999*).
10.33 Warrant to purchase 67,500 shares of common stock dated February 22,
1999 by and between LaserSight Incorporated and Guy Numann (filed as
Exhibit 10.40 to the Company's Form 10-Q filed on May 17, 1999*).
10.34 Manufacturing and Marketing Agreement, and Addendum thereto, dated May
14, 1999, by and between LaserSight Technologies, Inc. and Becton,
Dickinson and Company (filed as Exhibit 10.40 to the Company's Form
10-Q filed on August 11, 1999*)**.
10.35 First Amendment to Manufacturing and Marketing Agreement, dated
October 23, 1999, by and between LaserSight Technologies, Inc. and
Becton, Dickinson and Company (filed as Exhibit 10.1 to the Company's
8-K, filed on October 27, 1999*)**.
36
10.36 Distribution Agreement, dated October 23, 1999, by and between
LaserSight Technologies, Inc. and Becton, Dickinson and Company (filed
as Exhibit 10.2 to the Company's 8-K, filed on October 27, 1999*)**.
10.37 Employment Agreement, by and between LaserSight Technologies, Inc. and
J. Richard Crowley, dated as of July 3, 1997 (filed as Exhibit 10.43
to the Company's Form 10-Q filed on November 15, 1999*).
10.38 Employment Agreement, by and between LaserSight Incorporated and
Michael P. Dayton, dated November 10, 1998 (filed as Exhibit 10.44 to
the Company's Form 10-Q filed on November 15, 1999*).
10.39 Relocation Agreement, by and between LaserSight Incorporated and
Gregory L. Wilson, dated October 13, 1999 (filed as Exhibit 10.45 to
the Company's Form 10-Q filed on November 15, 1999*).
10.40 Technology Development and License Agreement, dated October 23, 1999,
by and between LaserSight Technologies, Inc. and Quadrivium, L.L.C.
(filed as Exhibit 10.46 to the Company's Form 10-Q filed on November
15, 1999*).
10.41 Employment Agreement, by and between LaserSight Technologies, Inc. and
Jack T. Holladay, dated October 27, 1999 (filed as Exhibit 10.47 to
the Company's Form 10-Q filed on November 15, 1999*).
10.42 Securities Purchase Agreement by and between LaserSight Incorporated
and TLC Laser Eye Centers Inc. dated January 31, 2000 (filed as
Exhibit 99.2 to the Company's Form 8-K filed on February 8, 2000*).
10.43 Registration Rights Agreement dated January 31, 2000 by and between
LaserSight Incorporated and TLC Laser Eye Centers Inc. (filed as
Exhibit 99.3 to the Company's Form 8-K filed on February 8, 2000*).
10.44 Securities Purchase Agreement by and between LaserSight Incorporated,
BayStar Capital, L.P. and BayStar International, Ltd. dated January
31, 2000 (filed as Exhibit 99.4 to the Company's Form 8-K filed on
February 8, 2000*).
10.45 Registration Rights Agreement dated January 31, 2000 by and between
LaserSight Incorporated, BayStar Capital, L.P. and BayStar
International, Ltd. (filed as Exhibit 99.5 to the Company's Form 8-K
filed on February 8, 2000*).
10.46 Securities Purchase Agreement by and between LaserSight Incorporated,
Engmann Options, Inc. and MDNH Partners, L.P. dated February 18, 2000.
The Company undertakes to provide to the Commission upon its request
the schedules omitted from this exhibit (filed as Exhibit 10.54 to the
Company's Form 10-K filed on March 30, 2000*).
10.47 Registration Rights Agreement dated February 18, 2000 by and between
LaserSight Incorporated, Engmann Options, Inc. and MDNH Partners, L.P.
(filed as Exhibit 10.55 to the Company's Form 10-K filed on March 30,
2000*).
10.48 Technology Purchase Agreement dated as of March 8, 2000 by and between
LaserSight Technologies, Inc., Premier Laser Systems, Inc. and
Eyesys-Premier, Inc. The Company undertakes to provide to the
Commission upon its request the schedules omitted from this exhibit
(filed as Exhibit 10.56 to the Company's Form 10-K filed on March 30,
2000*).
37
10.49 Employment Agreement, by and between LaserSight Technologies, Inc and
Donald M. Litscher dated February 23, 2000 (filed as Exhibit 10.57 to
the Company's Form 10-Q filed on May 12, 2000*).
10.50 Amended and Restated Employment Agreement, by and between LaserSight
Technologies, Inc. and L. Stephen Dalton dated effective as of August
1, 2001 (filed as Exhibit 10.50 to the Company's Form 10-Q filed on
August 14, 2001*).
10.51 Securities Purchase Agreement dated September 8, 2000 among LaserSight
Incorporated, BayStar Capital, L.P. and BayStar International, Ltd.
The Company undertakes to provide to the Commission upon its request
the schedules omitted from this exhibit (filed as Exhibit 99.2 to the
Company's Form 8-K filed on September 22, 2000*).
10.52 Warrant agreement dated September 8, 2000 among LaserSight
Incorporated and BayStar Capital, L.P. (filed as Exhibit 99.3 to the
Company's Form 8-K filed on September 22, 2000*).
10.53 Warrant agreement dated September 8, 2000 among LaserSight
Incorporated and BayStar International, Ltd. (filed as Exhibit 99.4 to
the Company's Form 8-K filed on September 22, 2000*).
10.54 Registration Rights Agreement dated September 8, 2000 among LaserSight
Incorporated, BayStar Capital, L.P. and BayStar International, Ltd.
(filed as Exhibit 99.5 to the Company's Form 8-K filed on September
22, 2000*).
10.55 Assignment Agreement dated as of February 27, 2001 among LaserSight
Patents, Inc. and Alcon Laboratories, Inc. (filed as Exhibit 99.1 to
the Company's Form 8-K filed on March 16, 2001*)**.
10.56 Amended and Restated License and Royalty Agreement dated as of January
3, 2001 by and between LaserSight Technologies, Inc., Luis A. Ruiz,
M.D. and Sergio Lenchig (filed as Exhibit 10.56 to the Company's Form
10-K filed on March 30, 2001*).
10.57 Registration Rights Agreement dated January 3, 2001 among LaserSight
Incorporated, Luis A. Ruiz, M.D. and Sergio Lenchig (filed as Exhibit
10.57 to the Company's Form 10-K filed on March 30, 2001*).
10.58 Loan and Security Agreement dated March 12, 2001 among LaserSight
Incorporated and subsidiaries and Heller Healthcare Finance, Inc.
(filed as Exhibit 10.58 to the Company's Form 10-K filed on March 30,
2001*).
10.59 Warrant agreement dated March 12, 2001 among LaserSight Incorporated
and Heller Healthcare Finance, Inc. (filed as Exhibit 10.59 to the
Company's Form 10-K filed on March 30, 2001*).
10.60 Registration Rights Agreement dated March 12, 2001 among LaserSight
Incorporated and Heller Healthcare Finance, Inc. (filed as Exhibit
10.60 to the Company's Form 10-K filed on March 30, 2001*).
10.61 Employment Agreement, by and between LaserSight Technologies, Inc and
Christine A. Oliver effective as of October 30, 2000 (filed as Exhibit
10.61 to the Company's Form 10-Q filed on August 14, 2001*).
38
10.62 Settlement and License Agreement dated as of May 25, 2001 between
LaserSight Incorporated and Visx, Incorporated (filed as Exhibit 10.62
to the Company's Form 10-Q filed on August 14, 2001*).***
10.63 Securities Purchase Agreement dated July 6, 2001 among LaserSight
Incorporated, BayStar Capital, L.P. and BayStar International, Ltd.
(file as Exhibit 99.2 to the Company's Form 8-K filed on July 18,
2001*).
10.64 Series F Registration Rights Agreement dated July 6, 2001 among
LaserSight Incorporated, BayStar Capital, L.P. and BayStar
International, Ltd. (filed as Exhibit 99.3 to the Company's Form 8-K
filed on July 18, 2001*).
10.65 Series G Registration Rights Agreement dated July 6, 2001 among
LaserSight Incorporated, BayStar Capital, L.P. and BayStar
International, Ltd. (filed as Exhibit 99.6 to the Company's Form 8-K
filed on July 18, 2001*).
10.66 Non-Exclusive License Agreement dated September 7, 2001 among
LaserSight Incorporated, LaserSight Technologies, Inc. and Bausch &
Lomb Incorporated.
11 Statement of Computation of Loss Per Share
15 Copy of letter from independent accountants' regarding unaudited
interim financial information
b) Reports on Form 8-K
On July 18, 2001, we filed a Current Report on Form 8-K
including a press release announcing that we had completed an
equity financing involving Series F convertible participating
preferred stock.
---------------------------
* Incorporated herein by reference. File No. 0-19671.
** Confidential treatment has been granted for portions of this document.
The redacted material has been filed separately with the commission.
*** Confidential treatment has been requested for portions of this
document. The redacted material has been filed separately with the
commission.
39
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the undersigned have duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
LaserSight Incorporated
Dated: November 14, 2001 By: /s/ Michael R. Farris
------------------------
Michael R. Farris,
Chief Executive Officer
Dated: November 14, 2001 By: /s/ Gregory L. Wilson
------------------------
Gregory L. Wilson,
Chief Financial Officer
40