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 March 31, 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
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(Exact name of registrant as specified in its charter)
Delaware 65-0273162
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(State of Incorporation) (IRS Employer Identification No.)
3300 University Blvd., Suite 140, Winter Park, Florida 32792
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(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
May 14, 2001 is 23,563,111.
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 - Uncertainties and Other Issues"
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 March 31, 2001
and December 31, 2000
Condensed Consolidated Statements of Operations for the Three
Month Periods Ended March 31, 2001 and 2000
Condensed Consolidated Statements of Cash Flows for the Three
Month Periods Ended March 31, 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
March 31, December 31,
ASSETS 2001 2000
------------- -------------
Current assets: (Unaudited)
Cash and cash equivalents $ 11,682,866 8,593,858
Accounts receivable - trade, net 10,205,569 9,546,368
Notes receivable - current portion, net 4,079,394 4,065,958
Inventories 12,912,184 12,123,877
Deferred tax assets 55,522 55,522
Other current assets 957,743 272,745
------------- -------------
Total Current Assets 39,893,278 34,658,328
Notes receivable, less current portion, net 2,459,835 2,833,393
Property and equipment, net 2,135,460 2,398,292
Patents, net 4,712,259 7,204,981
Goodwill, net 3,170,442 3,232,425
Other assets, net 1,577,412 1,549,033
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$ 53,948,686 51,876,452
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 4,983,295 3,870,791
Accrued expenses 6,450,394 7,030,657
Accrued commissions 1,831,701 1,926,996
Deferred revenue 1,135,545 1,149,415
------------- -------------
Total Current Liabilities 14,400,935 13,977,859
Accrued expenses, less current portion 325,265 398,767
Deferred income taxes 55,522 55,522
Long-term obligations 112,130 109,730
Note payable, net of unamortized discount of $119,493
at March 31, 2001 2,880,507 --
Commitments and contingencies
Stockholders' equity:
Convertible preferred stock, authorized 10,000,000 shares;
par value $.001 per share
Series C - 2,000,000 issued and outstanding at
March 31,2001 and December 31, 2000 2,000 2,000
Common stock - par value $.001 per share; authorized
100,000,000 shares; 23,708,311 and 22,920,278 shares
issued at March 31, 2001and December 23,708 22,920
31, 2000, respectively
Additional paid-in capital 99,905,894 98,594,665
Stock subscription receivable (1,140,000) (1,140,000)
Accumulated deficit (62,074,628) (59,602,364)
Less treasury stock, at cost; 145,200 common shares at
March 31, 2001 and December 31, 2000 (542,647) (542,647)
------------- -------------
36,174,327 37,334,574
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$ 53,948,686 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
March 31,
--------------------------------
2001 2000
-------------- -------------
Revenues:
Products $ 3,998,047 7,832,478
Royalties 150,000 669,179
Services 245,857 193,345
-------------- -------------
4,393,904 8,695,002
Cost of revenues:
Product cost 1,924,557 3,408,524
Cost of services 108,177 85,072
-------------- -------------
Gross profit 2,361,170 5,201,406
Research, development and regulatory expenses 931,304 940,716
Other general and administrative expenses 6,627,894 5,028,035
Selling-related expenses 1,161,079 1,618,077
Amortization of intangibles 219,900 635,465
-------------- -------------
8,008,873 7,281,577
-------------- ------------
Loss from operations (6,579,007) (3,020,887)
Other income and expenses
Interest and dividend income 194,383 264,335
Interest expense (38,476) (2,400)
Gain on sale of patent 3,950,836 --
-------------- -------------
Net loss before income taxes (2,472,264) (2,758,952)
Income tax expense -- --
-------------- -------------
Net loss $ (2,472,264) (2,758,952)
============== =============
Loss per common share
Basic and diluted: $ (0.11) (0.14)
============== =============
Weighted average number of shares outstanding
Basic and diluted: 23,514,000 19,234,000
============== =============
See accompanying notes to the condensed consolidated financial statements.
4
LASERSIGHT INCORPORATED AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
THREE MONTHS ENDED MARCH 31, 2001 AND 2000
(Unaudited)
2001 2000
-------------- -------------
Cash flow from operating activities
Net loss $ (2,472,264) (2,758,952)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 573,238 877,576
Gain on sale of patent (3,950,836) --
Common stock issued for services 60,469 --
Changes in assets and liabilities:
Accounts and notes receivable (299,079) (3,479,354)
Inventories (788,307) (979,959)
Accounts payable 1,112,504 1,450,760
Accrued expenses (85,846) 1,028,812
Deferred revenue (13,870) 50,705
Other 26,777 (689,526)
-------------- -------------
Net cash used in operating activities (5,837,214) (4,499,938)
Cash flows from investing activities
Purchases of property and equipment, net (77,784) (231,443)
Proceeds from sale of intangible assets, net 6,365,000 --
Acquisition of intangible assets -- (2,825,000)
-------------- -------------
Net cash provided by (used in) investing activities 6,287,216 (3,056,443)
Cash flows from financing activities
Proceeds from common stock financing, net -- 13,202,452
Proceeds from exercise of stock options and ESPP 10,333 43,438
Proceeds from debt financing, net 2,628,673 --
-------------- -------------
Net cash provided by financing activities 2,639,006 13,245,890
-------------- -------------
Increase in cash and cash equivalents 3,089,008 5,689,509
Cash and cash equivalents, beginning of period 8,593,858 11,247,801
-------------- -------------
Cash and cash equivalents, end of period $ 11,682,866 16,937,310
============== =============
See accompanying notes to the condensed consolidated financial statements.
5
LASERSIGHT INCORPORATED AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Three Month Periods Ended March 31, 2001 and 2000
NOTE 1 BASIS OF PRESENTATION
The accompanying unaudited, condensed consolidated financial statements
of LaserSight Incorporated and subsidiaries(LaserSight) as of March 31,
2001, and for the three months ended March 31, 2001 and 2000 have been
prepared in accordance with generally accepted accounting principles
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
generally accepted accounting principles 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.
The results of operations for the three month period ended March 31,
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.
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 March 31, 2001 and December 31, 2000
are summarized as follows:
March 31, 2001 December 31, 2000
-------------- -----------------
Raw materials $ 7,812,779 6,704,447
Work-in-process 205,781 121,474
Finished goods 4,180,408 4,482,276
Test equipment - clinical trials 713,216 815,680
------------ ------------
$ 12,912,184 12,123,877
============ ============
6
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; non-operating income and income tax expense.
Identifiable assets by operating segment are those that are used by or
applicable to each operating segment. General corporate assets consist
primarily of cash, marketable equity securities and income tax accounts
The table below summarizes information about reported segments as of
and for the three months ended March 31:
Depreciation
Operating Operating and Capital
Revenues Profit (Loss) Assets Amortization Expenditures
-------- ------------- ------ ------------ ------------
2001
----
Operating segments:
Refractive products $ 3,998,047 (6,178,559) 38,268,413 489,541 74,168
Patent services 150,000 150,000 150,000 -- --
Health care services 245,857 (86,916) 3,362,509 68,267 3,616
General corporate -- (463,532) 12,167,764 2,708 --
----------- ---------- ----------- --------- ----------
Consolidated total $ 4,393,904 (6,579,007) 53,948,686 560,516 77,784
=========== ========== =========== ========= ==========
2000
----
Operating segments:
Refractive products $ 7,832,478 (2,875,157) 37,386,392 603,535 227,700
Patent services 669,179 539,849 2,982,154 129,330 --
Health care services 193,345 (106,756) 3,539,121 71,679 3,743
General corporate -- (509,649) 17,015,050 3,858 --
Developmental stage
company - LaserSight
Centers -- (69,174) 2,700,831 69,174 --
----------- ---------- ----------- --------- ----------
Consolidated total $ 8,695,002 (3,020,887) 63,623,548 877,576 231,443
=========== ========== =========== ========= ==========
Amortization of deferred financing costs and discount on note payable of
$12,722 for the three months ended March 31, 2001, is included as interest
expense.
7
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. 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 AGREEMENT
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 was
extended 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, including $250,000 that
was paid during the quarter ended March 31, 2001. The royalty rate was
reduced from 50% to 10% of gross profits in the amended and restated
license.
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). At March
31, 2001, receivables on U.S. sales totaled approximately $6.0 million.
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.
8
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 March 31, 2001, and the related condensed
consolidated statements of operations and cash flows for the three-month periods
ended March 31, 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
April 27, 2001
9
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.
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.
Percent Increase (Decrease)
As a Percentage of Net Sales Over Prior Periods
Three Months Ended March 31, Three Months Ended March 31,
---------------------------- ----------------------------
2001 2000 2001 vs. 2000
---- ---- -------------
Statements of Operations Data:
Net revenues:
Refractive products................. 91.0% 90.1% (49.0)%
Patent services..................... 3.4 7.7 (77.6)
Healthcare services................. 5.6 2.2 27.2
----- ----
Net revenues..................... 100.0 100.0 (49.5)
Cost of revenue...................... 46.3 40.5 (41.8)
----- -----
Gross profit(1)...................... 53.7 59.8 (54.6)
Research, development and
regulatory expenses (2) ......... 21.2 10.8 (1.0)
Other general and administrative
expenses......................... 150.8 57.8 31.8
Selling-related expenses (3)......... 26.4 18.6 (28.2)
Amortization of intangibles.......... 5.0 7.3 (65.4)
----- -----
Loss from operations................. (149.7) (34.7) 117.8
---------------
(1) As a percentage of net revenues, the gross profit for refractive
products only for the three months ended March 31, 2001 and 2000, were
52% and 56%, respectively.
(2) As a percentage of refractive product net sales, research, development
and regulatory expenses for the three months ended March 31, 2001 and
2000, were 23% and 12%, respectively.
(3) As a percentage of refractive product net sales, selling-related
expenses for the three months ended March 31, 2001 and 2000, were 29%
and 21%, respectively.
THREE MONTHS ENDED MARCH 31, 2001, COMPARED TO THREE MONTHS ENDED MARCH 31, 2000
Revenues. Net revenues for the three months ended March 31, 2001
decreased by $4.3 million, or 49%, to $4.4 million from $8.7 million for the
comparable period in 2000.
10
During the three months ended March 31, 2001, refractive products
revenues decreased $3.8 million, or 49%, to $4.0 million from $7.8 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 March 31, 2001, excimer laser system sales accounted for
approximately $3.6 million in revenues compared to $6.1 million in revenues over
the same period in 2000. During the three months ended March 31, 2001, 13 laser
systems were sold compared to 19 laser systems sold during the comparable period
in 2000.
Net revenues from patent services for the three months ended March 31,
2001 decreased approximately $0.5 million, or 78%, to $0.2 million from $0.7
million for the comparable period in 2000, due to the 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 March
31, 2001 were up approximately $50,000 from the comparable period in 2000.
Cost of Revenues; Gross Profit. For the three months ended March 31,
2001 and 2000, gross profit margins were 54% and 60%, respectively. The gross
margin decrease during the three months ended March 31, 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 $1.0 million, partially offset by a decrease in our
inventory obsolescence reserve of $0.3 million from the comparable period in
2000.
Research, Development and Regulatory Expenses. Research, development
and regulatory expenses for the three months ended March 31, 2001, $0.9 million,
were unchanged from 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 a continuation of these efforts plus the anticipated development
of new technologies like our AstraMax diagnostic workstation, we expect research
and development expenses during the remainder of 2001 to approximate the levels
incurred during the first quarter 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 March 31, 2001 increased $1.6
million, or 32%, to $6.6 million from $5.0 million for the comparable period in
2000. This increase was due to an increase in expenses incurred at our
refractive products subsidiary of approximately $1.7 related to enhancements to
the customer support and training, sales and marketing and software development
departments of $0.4 million, higher depreciation costs of $0.1 million and $0.9
million of legal fees related to patent issues and litigation.
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 March 31, 2001
decreased $0.4 million, or 28%, to $1.2 million from $1.6 million during the
comparable period in 2000. This decrease was primarily attributable to a $0.3
million decrease in sales commissions resulting from lower sales and a decrease
of $0.1 million of warranty expense primarily related to decreased laser system
sales.
Amortization of Intangibles. During the three months ended March 31,
2001, costs relating to the amortization of intangible assets decreased $0.4
million, or 65%, 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
11
future amortization expenses, and the sale of a patent in March 2001 that had an
unamortized book value of approximately $2.4 million. Items directly related to
the amortization of intangible assets are acquired technologies, patents,
license agreements and goodwill.
Loss From Operations. The operating loss for the three months ended
March 31, 2001 was $6.6 million compared to the operating loss of $3.0 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 three
months ended March 31, 2001 was $0.2 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
receivables related to laser system sales. Interest expense for the three months
ended March 31, 2001 and 2000 was not material. 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 $6.5 million and, prior
to the sale, had a book value of approximately $2.4 million.
Income Taxes. For the three months ended March 31, 2001 and 2000,
LaserSight had no income tax expense.
Net Loss. Net loss for the three months ended March 31, 2001, was $2.5
million compared to a net loss of $2.8 million for the comparable period in
2000. The decrease in net loss for the three months ended March 31, 2001 can be
attributed to the decrease in sales of our LaserScan LSX excimer laser system,
an increase in other general and administrative expenses related to our
refractive products operations and the gain generated by the sale of the Blum
Patent.
Loss Per Share. The loss per basic and diluted share was $0.11 for the
three months ended March 31, 2001 and $0.14 for the comparable period in 2000.
During the three months ended March 31, 2000, the weighted average shares of
common stock outstanding increased primarily due to the conversion of preferred
stock during 2000, the September 2000 private placement of common stock 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 and $19.1 million in 2000, 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 and
$85,000 in 2000 and $10,000 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. We have
principally used these capital resources to fund operating losses, working
capital requirements, capital expenditures, acquisitions and retirement of debt.
At March 31, 2001, we had an accumulated deficit of $62.1 million.
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. 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 1/2%)
12
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 1/4%) 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 qualified accounts
receivable related to U.S. sales. 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 May 14, 2001, we had no borrowings
under the credit facility.
Our working capital increased $4.8 million from $20.7 million at
December 31, 2000 to $25.5 million as of March 31, 2001. This increase in
working capital resulted primarily from the sale of a patent and the proceeds of
the term loan, for net proceeds of $9.0 million, offset primarily by cash used
in operating activities of $5.8 million.
Operating activities used net cash of $5.8 million during the first
quarter of 2001, compared to $4.5 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 second
quarter of 2001. There can be no assurance that we can regain or sustain
profitability or positive operating cash flow in any subsequent fiscal period.
Net cash provided by investing activities of $6.3 million during the first
quarter of 2001 can be attributed primarily to the sale of the Blum patent. As
of March 31, 2001, we had no significant commitments for capital expenditures.
Net cash provided from financing activities during the first quarter of 2001 of
$2.6 million can be primarily attributed to entering into the term loan
agreement.
We may explore opportunities for additional equity financing through a
private placement of our common stock. We believe that our existing balances of
cash and cash equivalents and our cash flows from operations will be adequate to
fund our anticipated working capital requirements for the next 12 months in
accordance with our current business plan. There can be no assurance that
the assumptions underlying our business plan will be met or that additional
financing will not be needed. Our belief regarding future working capital
requirements is based on various factors and assumptions including: the
uncertain timing of astigmatism and other supplemental FDA approvals for our
LaserScan LSX excimer laser system, that could continue to impact our sales
during 2001, potential growth in laser sales resulting from our entrance into
the U.S. market in March 2000 with corresponding increases in accounts
receivable and inventory purchases to date, the uncertain timing of the market
introduction and commercial acceptance 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 "Risk Factors and Uncertainties--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 with 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 $3.0 million term loan and $10.0 million credit
facility completed in March 2001 with Heller, we currently do not have any
commitments for additional financing. See "Risk Factors and Uncertainties--
Financial and Liquidity Risks--We could require additional financing, which
might not be available if we need it."
13
RISK FACTORS AND UNCERTAINTIES
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. Our previous
experience marketing and selling our LaserScan LSX excimer laser system in the
U.S. had been limited to cost-recovery sales to refractive surgeons
participating in our FDA clinical trials.
The required level of per procedure fees payable to us by refractive
surgeons upon receipt of anticipated FDA approval for treatment of myopia with
astigmatism may not be accepted by the marketplace or may exceed those charged
by our competitors. While we believe that gaining access to our recently
approved 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.
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 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. We anticipate the commercial launch of
our UltraShaper durable keratomes during the second quarter of 2001. We had
previously estimated the launch of this product during the second quarter of
2000. We cannot assure you that there will not be further unanticipated delays
in the launch of our UltraShaper durable keratome, which has continued a process
of engineering refinement and validity testing prior to commercial release. 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
keratome previously marketed by Bausch & Lomb, Inc. with new enhancements and
features. However, Bausch & Lomb has not aggressively marketed or serviced the
14
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 recently received notices from Becton
Dickinson claiming that they have the right to end our marketing arrangement in
six 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. 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."
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
Incorporated, 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
15
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 PRK 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 only for the PRK treatment of
low to moderate nearsightedness (up to -6.0 diopters) without astigmatism. In
August 2000, we received FDA approval to operate our laser systems at a 200 Hz
pulse repetition rate, twice the originally approved rate. 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 and are also approved for the treatment of nearsightedness with astigmatism
for which the LaserScan LSX currently does not have approval. The Visx and Alcon
excimer laser systems are also approved for the treatment of moderate
farsightedness.
We have submitted a PMA supplement to the FDA for approval to utilize
LASIK for the treatment of nearsightedness with astigmatism and have responded
to FDA requests for additional patient data related to our submission. We
anticipate FDA approval of this application during the second or third quarter
of 2001, though we cannot ensure when the approval will be received. In
addition, 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 by the end of 2001, though we cannot ensure 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 of our application
for our LaserScan LSX to treat nearsightedness with astigmatism, our application
to permit our laser systems sold to customers in the U.S. to include our latest
eye tracking technology, or our application to permit our laser systems sold to
customers in the U.S. to utilize LASIK to treat myopic astigmatism, hyperopic
astigmatism and mixed astigmatism.
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 myopia (nearsightedness) with
or without astigmatism. The approvals for most of the systems are for the
correction of myopia in the range of 0 diopters to -14.0 diopters and myopia
with astigmatism generally in the range of -0.5 diopters to -5.0 diopters.
Bausch & Lomb's Technolas 217 excimer laser has also received FDA approval for
the treatment of myopia up to -7.0 diopters with up to -3.0 diopters of
astigmatism. These laser systems are currently the only laser systems
commercially available in the U.S. with FDA approval for use in LASIK. A
physician may decide, as part of the practice of medicine, to use a medical
device outside of its FDA-approved indications for an unapproved or "off-label"
use. Prior to these laser approvals, all LASIK procedures performed in the U.S.
with commercially available lasers were performed as the practice of medicine.
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'
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. or discourage physicians from using our or
other manufacturers' lasers off-label. 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
16
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:
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 possible future unfavorable publicity involving patient outcomes
from the use of laser vision correction.
17
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,
UniShaper single-use keratome, UltraShaper durable keratome, UltraEdge keratome
blades 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.
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.
18
COMPANY AND BUSINESS RISKS
WE ARE SUBJECT TO RISKS AND UNCERTAINTIES RELATING TO LITIGATION.
Visx commenced a lawsuit in November 1999 in the United States District
Court, District of Delaware, against us alleging that our LaserScan LSX laser
system infringes one of Visx's U.S. patents for equipment used in ophthalmic
surgery. The LaserScan LSX is the only laser system we are currently marketing
and is the only laser system manufactured by us that is approved for sale to
U.S. customers. The suit requests, among other things, injunctive relief, treble
damages and attorneys' fees and expenses. Management does not believe that our
LaserScan LSX laser system infringes the asserted Visx patent. However, we had
agreed to a stay of such litigation to pursue license negotiations with Visx in
an effort to help facilitate commercialization of the LaserScan LSX in the U.S.
market. We withdrew from license negotiations with Visx in February 2000, and
after the stay of the litigation was lifted, we filed suit against Visx,
claiming non-infringement and invalidity of the Visx patent and asserting that
Visx infringes U.S. Patent No. 5,630,810 to which we hold an exclusive license.
We also began to sell and ship our LaserScan LSX laser systems in the U.S.
during March 2000.
We believe that the claims Visx has made against us are without merit
and we intend to vigorously contest them. However, if we are unsuccessful in
defending this lawsuit, we may be enjoined from manufacturing and selling our
LaserScan LSX laser system in the U.S. without a license from Visx. In addition,
we may be subject to damages for past infringement. No assurance can be given as
to whether we will be subject to such damages or, if so, the amount of damages
that we may be required to pay. In addition, such patent litigation is
time-consuming, is causing us to incur substantial expense, could divert
management's attention, could cause product shipment delays or require us to
develop non-infringing technology or enter into license agreements in order to
market our products. Such license agreements, if required, may not be available
on acceptable terms, or at all. The outcome of patent litigation is inherently
uncertain, and an unfavorable outcome in the Visx litigation could have a
material adverse effect on our business, financial condition and results of
operations.
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.
19
REQUIRED MINIMUM PAYMENTS UNDER OUR KERATOME LICENSE AGREEMENT MAY
EXCEED OUR GROSS PROFITS FROM SALES OF OUR KERATOME PRODUCTS.
In addition to the risk that the UniShaper single-use keratome or
UltraShaper durable keratome will not be accepted in the marketplace, we are
required to make certain minimum payments to the licensor under our amended and
restated keratome license agreement. Under the original agreement, we were
required to provide an excimer laser system and pay a total of $300,000 to the
licensor in two equal installments due six and 12 months after the date of our
receipt of the production molds for the UniShaper product. We provided the laser
system to the licensor during the quarter ended June 30, 1998, and we received
the molds in late 1999. We shipped the first UniShaper single-use keratome in
December 1999 and paid one-half of the $300,000 in July 2000. In addition,
beginning seven months after the first commercial shipment, we were required to
make royalty payments equal to 50% of our defined gross profits from the sale of
our UniShaper and UltraShaper keratomes, with a minimum royalty of $400,000 per
calendar quarter for a period of eight quarters. On January 4, 2001, we entered
into an amended and restated license and royalty agreement related to certain
keratome-related products. 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, minimum royalty
payments totaling approximately $6.2 million 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 the restriction on
us manufacturing, marketing and selling other keratomes, but the sale of such
other keratomes is included in the gross profit to be shared with the licensors.
The licensor's share of the gross profit, as defined in the agreement, decreased
from 50% to 10%.
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.
20
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 spot 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 "--We are subject to risks and uncertainties
relating to litigation."
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
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.
In 1992, Summit and Visx formed a U.S. partnership, Pillar Point
Partners, to pool certain of their patents related to corneal sculpting
technologies. As part of their agreement to dissolve Pillar Point in June 1998,
Summit and Visx granted each other a worldwide, royalty-free cross-license
whereby each party has full rights to license for use with its own systems all
existing patents owned by either company relating to laser vision correction. In
connection with our March 1996 settlement of litigation with Pillar Point
regarding alleged infringement by our lasers of certain U.S. and foreign
patents, we entered into a license agreement with Visx covering various foreign
patents and patent applications pursuant to which we pay royalties to Visx.
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 held by Visx, Alcon or any other person, Visx has asserted
that we infringe their intellectual property, and 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
21
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. See "--We are
subject to risks and uncertainties relating to litigation."
WE ARE SUBJECT TO CERTAIN RISKS ASSOCIATED WITH OUR INTERNATIONAL
SALES.
Our international sales accounted for 54% and 45% of our total revenues
during the three months ended March 31, 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 and
anticipated additional regulatory approvals to market our LaserScan LSX laser
system in the U.S. and the anticipated commercial launch of our UltraShaper
durable keratome in the second quarter of 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 Becton Dickinson and all of our UniShaper single-use keratome
products are manufactured exclusively by Frantz Medical Development Ltd.
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
22
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.
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 the loss of per
procedure fees.
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. 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.
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 FIRST HALF 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 three months
ended March 31, 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.
23
Year Ended December 31,
----------------------- Three Months Ended
1999 2000 March 31, 2001
---- ---- --------------
Net loss................... $14.4 million $21.4 million $2.5 million
Deficit in cash flow
from operations.......... $11.7 million $15.7 million $5.8 million
As of March 31, 2001, we had an accumulated deficit of $62.1 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 $4.9 million at March 31, 2001, will
be sufficient to cover the amount of our actual write-offs over time. At March
31, 2001, our net trade accounts and notes receivable totaled approximately
$16.7 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 March 31, 2001, we had extended the original payment terms of laser
customer accounts totaling approximately $1.4 million by periods ranging from 12
to 60 months. Such restructured receivables represent approximately 7% 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.
WE COULD REQUIRE ADDITIONAL FINANCING, WHICH MIGHT NOT BE AVAILABLE IF
WE NEED IT.
During the three months ended March 31, 2001 and year ended December
31, 2000, we experienced deficits in cash flow from operations of $5.8 million
and $15.7 million, respectively. We may explore opportunities for additional
equity financing through a private placement of our common stock. We believe
that our existing balances of cash and cash equivalents and our cash flows from
operations will be adequate to fund our anticipated working capital requirements
24
for the next 12 months in accordance with our current business plan. There can
be no assurance that the assumptions underlying our business plan will be met or
that additional financing will not be needed. Our belief regarding future
working capital requirements is based on various factors and assumptions
including: the uncertain timing of astigmatism and other supplemental FDA
approvals for our LaserScan LSX excimer laser system, which could continue to
impact our sales during 2001, potential growth in laser sales resulting from our
entrance into the U.S. market in March 2000 with corresponding increases in
accounts receivable and inventory purchases to date, the uncertain timing 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 1/2%)
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 1/4%) 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 qualified accounts
receivable related to U.S. sales. 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 May 14, 2001, we had no borrowings
under the 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 credit facility with
Heller described above, 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.
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
25
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 23,563,111 shares of common stock
outstanding at May 14, 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 7,800,000 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.
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.
26
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 March 31, 2001, approximately $8.8 million, or
16%, 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 SFAS 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 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
27
its financial performance, some or all of the carrying amount of goodwill
recorded, $3.2 million at March 31, 2001, may be subject to an impairment
adjustment.
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 March 31,
2001, we had approximately $10.4 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.
ITEM 2 CHANGES IN SECURITIES
a) Not applicable.
b) Not applicable.
c) During the first quarter ended March 31, 2001, the Company sold
the following unregistered securities:
1) In January 2001, LaserSight issued 730,552 shares of Common
Stock to Luis A. Ruiz, M.D. and Sergio Lenchig as consideration
for an amendment to a license agreement. Reference is made to
the Amended and Restated License and Royalty Agreement dated as
of January 3, 2001 filed as an exhibit to Form 10-K for the year
ended December 31, 2000, for more detailed information regarding
this amendment.
2) In March 2001, LaserSight issued 50,000 shares of Common Stock
to The Lowenbaum Partnership, L.L.C. in exchange for legal
services provided to LaserSight.
3) In March 2001, LaserSight granted Heller Healthcare Finance,
Inc. a three year warrant to purchase 243,750 shares of Common
Stock as partial consideration for the extension of credit by
Heller. The warrant is exercisable at any time before March 12,
2004 at a price of $3.15 per share and the investor received
certain rights to have the shares registered by LaserSight at a
later date.
28
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
Not applicable.
ITEM 5 OTHER INFORMATION
The date of the 2001 Annual Meeting of Stockholders of LaserSight
will be held on July 12, 2001, a date that is more than 30 calendar
days past the anniversary of LaserSight's 2000 Annual Meeting of
Stockholders. If a stockholder intends to present a proposal at the
2001 Annual Meeting, the proposal must be received by LaserSight no
later than May 25, 2001, and LaserSight will consider including
stockholder proposals received by such date in LaserSight's proxy
materials for the 2001 Annual Meeting of Stockholders.
ITEM 6 EXHIBITS AND REPORTS ON FORM 8-K
a) Exhibits
INDEX TO EXHIBITS
Number
Exhibit 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.5) filed by the Company on
August 1, 2000*).
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*).
29
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*).
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*).
4.1 See Exhibits 3.1, 3.2, 3.3, 3.4, 3.5, 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 and 10.60.
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*).
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*).
30
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*).
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*).
31
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*)**.
32
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*).
33
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*).
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 Employment Agreement, by and between LaserSight Technologies, Inc. and
L. Stephen Dalton dated March 6, 2000 (filed as Exhibit 10.58 to the
Company's Form 10-Q filed on May 12, 2000*).
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*).
34
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*).
11 Statement of Computation of Loss Per Share
15 Copy of letter from independent accountants' regarding unaudited
interim financial information
99 Press release dated May 15, 2001
b) Reports on Form 8-K
On March 16, 2001, we filed a Current Report on Form 8-K describing our
sale of a patent.
---------------------------
*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.
35
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: May 15, 2001 By: /s/ Michael R. Farris
----------------------------
Michael R. Farris,
Chief Executive Officer
Dated: May 15, 2001 By: /s/ Gregory L. Wilson
----------------------------
Gregory L. Wilson,
Chief Financial Officer
36