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 June 30, 2000.
or
[ ] Transition Report Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934. For the Transition period from
------------------------------ to ----------------------------------
Commission File Number: 0-19671
LASERSIGHT INCORPORATED
-----------------------
(Exact name of registrant as specified in its charter)
Delaware 65-0273162
-------- ----------
(State of Incorporation) (IRS Employer Identification No.)
3300 University Blvd., Suite 140, Winter Park, Florida 32792
------------------------------------------------------------
(Address of principal executive offices) (Zip Code)
(407) 678-9900
--------------
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes X No
-----
The Number of shares of the registrant's Common Stock outstanding as of
August 11, 2000 is 21,260,792.
<PAGE>
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, 1999. 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 June 30,
2000 and December 31, 1999
Condensed Consolidated Statements of Operations for the
Three Month Periods and Six Months Periods Ended June 30, 2000
and 1999
Condensed Consolidated Statements of Cash Flows for the
Three Month Periods and Six Months Periods Ended June 30, 2000
and 1999
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
<PAGE>
PART I - FINANCIAL INFORMATION
ITEM 1 - FINANCIAL STATEMENTS
LASERSIGHT INCORPORATED AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
<TABLE>
<CAPTION>
June 30, December 31,
ASSETS 2000 1999
------------ ------------
<S> <C> <C>
Current assets: (Unaudited)
Cash and cash equivalents $ 9,742,179 11,247,801
Accounts receivable - trade, net 13,060,484 6,400,980
Notes receivable - current portion, net 4,476,162 4,110,428
Inventories 9,629,921 8,409,823
Deferred tax assets 68,208 68,208
Other current assets 399,193 394,543
------------ ------------
Total Current Assets 37,376,147 30,631,783
Notes receivable, less current portion, net 2,975,861 2,721,229
Property and equipment, net 2,236,560 1,934,618
Patents, net 7,620,757 3,886,448
Pre-market approval application, net 2,299,858 2,754,394
Goodwill, net 5,765,921 6,028,235
Other assets, net 2,442,921 1,422,226
------------ ------------
$ 60,718,025 49,378,933
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 3,482,157 2,694,494
Accrued expenses 5,336,830 3,757,458
Accrued commissions 2,075,052 1,511,653
Deferred revenue 1,340,472 1,020,044
------------ ------------
Total Current Liabilities 12,234,511 8,983,649
Accrued expenses, less current portion 360,628 615,942
Deferred royalty revenue, less current portion -- 33,333
Deferred income taxes 68,208 68,208
Long-term obligations 104,930 100,130
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 June 30, 2000 and
December 31, 1999 2,000 2,000
Series D - zero and 2,000,000 issued and outstanding at June 30, 2000
and December 31, 1999, respectively -- 2,000
Common stock - par value $.001 per share; authorized 100,000,000 shares;
21,393,311 and 18,040,313 shares issued at June 30, 2000 and December
31, 1999, respectively 21,393 18,040
Additional paid-in capital 95,591,348 82,346,811
Issued shares held in escrow (2,936,250) (2,936,250)
Stock subscription receivable (1,140,000) (1,140,000)
Accumulated deficit (43,046,096) (38,172,283)
Less treasury stock, at cost; 145,200 common shares at June 30, 2000
and December 31, 1999 (542,647) (542,647)
------------ ------------
47,949,748 39,577,671
------------ ------------
$ 60,718,025 49,378,933
============ ============
</TABLE>
See accompanying notes to the condensed consolidated financial statements.
3
<PAGE>
LASERSIGHT INCORPORATED AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
<TABLE>
<CAPTION>
Three Months Ended Six Months Ended
June 30, June 30,
------------------------------ -------------------------------
2000 1999 2000 1999
------------ ------------ ------------ ------------
<S> <C> <C> <C> <C>
Revenues:
Products $ 10,653,445 4,834,635 18,485,923 9,235,850
Royalties 589,502 330,000 1,258,681 710,000
Services 218,100 96,922 411,445 204,005
------------- ------------ ------------ ------------
11,461,047 5,261,557 20,156,049 10,149,855
Cost of revenue:
Product cost 4,152,907 2,294,609 7,561,431 4,326,987
Cost of services 118,844 42,646 203,916 89,763
------------- ------------ ------------ ------------
Gross profit 7,189,296 2,924,302 12,390,702 5,733,105
Research, development and regulatory
expenses 1,309,514 708,979 2,250,230 1,490,170
Other general and administrative expenses 5,553,094 4,132,062 10,581,129 7,798,283
Selling related expenses 1,988,049 1,090,086 3,606,126 2,193,521
Amortization of intangibles 682,697 634,071 1,318,162 1,268,142
------------- ------------ ------------ ------------
8,223,840 5,856,219 15,505,417 11,259,946
------------- ------------ ------------ ------------
Loss from operations (2,344,058) (3,640,896) (5,364,945) (7,017,011)
Other income and expenses
Interest and dividend income 237,951 192,649 502,286 294,170
Interest expense (8,754) (2,415) (11,154) (48,185)
------------- ------------ ------------ ------------
Net loss before income taxes (2,114,861) (3,450,662) (4,873,813) (6,771,026)
Income tax expense -- -- -- --
------------- ------------ ------------ ------------
Net loss $ (2,114,861) (3,450,662) (4,873,813) (6,771,026)
============= ============ ============ ============
Loss per common share
Basic and diluted: $ (0.10) (0.21) (0.25) (0.46)
============= ============ ============ ============
Weighted average number of shares
outstanding
Basic and diluted: 20,340,000 16,155,000 19,787,000 14,794,000
============= ============ ============ ============
</TABLE>
See accompanying notes to the condensed consolidated financial statements.
4
<PAGE>
LASERSIGHT INCORPORATED AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
SIX MONTHS ENDED JUNE 30, 2000 AND 1999
(Unaudited)
<TABLE>
<CAPTION>
2000 1999
---- ----
<S> <C> <C>
Cash flow from operating activities
Net loss $ (4,873,813) (6,771,026)
Adjustments to reconcile net loss to net cash used in operating
activities:
Depreciation and amortization 1,812,697 1,625,341
Warrants issued in conjunction with consulting agreement -- 68,793
Changes in assets and liabilities:
Accounts and notes receivable (7,279,870) (366,138)
Inventories (1,220,098) 62,827
Accounts payable 787,663 (527,282)
Accrued expenses 1,887,457 127,460
Deferred revenue 287,095 (81,385)
Other (842,934) (347,214)
------------ ------------
Net cash used in operating activities (9,441,803) (6,208,624)
Cash flows from investing activities
Purchases of property and equipment, net (796,044) (345,603)
Acquisition of intangible assets (4,513,665) --
------------ ------------
Net cash used in investing activities (5,309,709) (345,603)
Cash flows from financing activities
Proceeds from common stock financing 13,202,452 8,850,000
Proceeds from exercise of stock options and warrants 43,438 7,950,056
Repayment of capital lease obligation -- (19,659)
------------ ------------
Net cash provided by financing activities 13,245,890 16,780,397
------------ ------------
Increase (decrease) in cash and cash equivalents (1,505,622) 10,226,170
Cash and cash equivalents, beginning of period 11,247,801 4,437,718
------------ ------------
Cash and cash equivalents, end of period $ 9,742,179 14,663,888
============ ============
</TABLE>
See accompanying notes to the condensed consolidated financial statements.
5
<PAGE>
LASERSIGHT INCORPORATED AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Six Month Periods Ended June 30, 2000 and 1999
NOTE 1 BASIS OF PRESENTATION
The accompanying unaudited, condensed consolidated financial
statements of LaserSight Incorporated and subsidiaries (LaserSight)
as of June 30, 2000, and for the three and six month periods ended
June 30, 2000 and 1999 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, 1999. 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 and six month periods ended June 30, 2000 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 June 30, 2000 and December 31, 1999
are summarized as follows:
June 30, 2000 December 31, 1999
------------- -----------------
Raw materials $ 6,735,342 6,381,980
Work-in-process 343,218 630,342
Finished goods 2,071,575 958,387
Test equipment - clinical trials 479,786 439,114
----------- -----------
$ 9,629,921 8,409,823
=========== ===========
6
<PAGE>
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; non-operating income; and the 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 June 30:
<TABLE>
<CAPTION>
Depreciation
Operating Operating and Capital
Revenues Profit (Loss) Assets Amortization Expenditures
-------- ------------ ------ ------------ ------------
<S> <C> <C> <C> <C> <C>
2000
----
Operating segments:
Refractive products $ 10,653,445 (2,046,698) 41,580,197 663,632 564,601
Patent services 589,502 460,172 3,342,326 129,330 --
Health care services 218,100 (86,491) 3,516,826 71,679 --
General corporate -- (601,853) 9,869,146 1,306 --
Developmental stage
company -
LaserSight Centers -- (69,188) 2,409,530 69,174 --
------------ ------------ ------------ ------------ ------------
Consolidated total $ 11,461,047 (2,344,058) 60,718,025 935,121 564,601
============ ============ ============ ============ ============
1999
----
Operating segments:
Refractive products $ 4,834,635 (3,118,480) 28,636,111 529,361 202,557
Patent services 330,000 200,670 3,600,144 129,330 --
Health care services 96,922 (138,469) 3,795,721 70,731 --
General corporate -- (515,443) 14,845,973 1,797 4,496
Developmental stage
company -
LaserSight Centers -- (69,174) 2,905,255 69,174 --
------------ ------------ ------------ ------------ ------------
Consolidated total $ 5,261,557 (3,640,896) 53,783,204 800,393 207,053
============ ============ ============ ============ ============
</TABLE>
7
<PAGE>
The table below summarizes information about reported segments as of
and for the six months ended June 30:
<TABLE>
<CAPTION>
Depreciation
Operating Operating and Capital
Revenues Profit (Loss) Assets Amortization Expenditures
-------- ------------- ------ ------------ ------------
<S> <C> <C> <C> <C> <C>
2000
----
Operating segments:
Refractive products $ 18,485,923 (4,921,855) 41,580,197 1,267,167 792,301
Patent services 1,258,681 1,000,021 3,342,326 258,660 --
Health care services 411,445 (193,247) 3,516,826 143,358 3,743
General corporate -- (1,111,502) 9,869,146 5,164 --
Developmental stage
company -
LaserSight Centers -- (138,362) 2,409,530 138,348 --
------------ ------------ ------------ ------------ ------------
Consolidated total $ 20,156,049 (5,364,945) 60,718,025 1,812,697 796,044
============ ============ ============ ============ ============
1999
----
Operating segments:
Refractive products $ 9,235,850 (6,024,397) 28,636,111 1,083,277 341,107
Patent services 710,000 451,340 3,600,144 258,660 --
Health care services 204,005 (268,238) 3,795,721 141,462 --
General corporate -- (1,037,368) 14,845,973 3,594 4,496
Developmental stage
company -
LaserSight Centers -- (138,348) 2,905,255 138,348 --
------------ ------------ ------------ ------------ ------------
Consolidated total $ 10,149,855 (7,017,011) 53,783,204 1,625,341 345,603
============ ============ ============ ============ ============
</TABLE>
NOTE 5 ACQUISITION
Intellectual Property
On March 8, 2000, LaserSight acquired all intellectual property related
to a development project designed to provide front-to-back analysis and total
refractive measurement of the eye from Premier Laser Systems, Inc. Of the total
consideration of $4,050,000 before transaction costs, $2,825,000 was paid at
closing, $500,000 was paid in April 2000 and $725,000 was paid in May 2000.
Assets purchased included two U.S. patents, six foreign patents, a pending
patent application and an exclusive license to nine patents that are intended to
be used to complete development of an integrated refractive diagnostic work
station. The total cost is included in the net costs of Patents and will be
amortized over the life of the patents.
8
<PAGE>
NOTE 6 LICENSE AGREEMENT
On January 18, 2000, the Company entered into a first amendment to a
keratome license and royalty agreement related to certain keratome
related products originally entered into in September 1997. Under the
terms of the amendment 555,552 shares of Common Stock issued to the
licensors were placed in escrow and are included in common shares
issued and outstanding on that date. If the Company raised equity
capital totaling $15 million or more by May 31, 2000, or otherwise
elected in its sole discretion to proceed with the amendment, the
shares would have been released from escrow and the Company would have
been obligated to pay $7.6 million in cash within the next six months.
Otherwise, the shares would be returned to the Company. In addition,
the Company paid the licensors $200,000 upon execution of the amendment
and $200,000 on April 1, 2000. The amendment eliminated the restriction
on the Company 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, would remain at 50% if the amendment was
not triggered and would have been reduced to10% if the amendment was
triggered. Through May 31, 2000, the Company raised equity capital
totaling $13.25 million and the Company did not elect to proceed with
the amendment. Effective on such date, the shares were returned to the
Company and cancelled.
In May 2000, the licensors offered to purchase $1.75 million of
LaserSight Common Stock to enable the company to reach the target of
$15 million of total equity capital raised. The Company did not accept
such offer on grounds that it was an attempt to alter the terms of the
amendment, and litigation between the Company and the licensors has
commenced. See Part II, Item 1 - Legal Proceedings.
9
<PAGE>
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 June 30, 2000, and the related condensed
consolidated statements of operations and cash flows for the three-month and
six-month periods ended June 30, 2000 and 1999. 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 generally accepted auditing standards, 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 generally accepted accounting principles.
We have previously audited, in accordance with generally accepted auditing
standards, the consolidated balance sheet of LaserSight Incorporated and
subsidiaries as of December 31, 1999, 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 11,
2000, 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, 1999, 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
July 22, 2000
10
<PAGE>
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 300 laser systems,
including approximately 130 of our LaserScan LSX(TM) laser systems. In March
2000, we began commercial shipments of our LaserScan LSX laser system to
customers in the U.S.
New Accounting Pronouncement
In December 1999, the SEC issued Staff Accounting Bulletin (SAB) No.
101, Revenue Recognition in Financial Statements. SAB No. 101 provides guidance
on applying generally accepted accounting principles to revenue recognition
issues in financial statements. We will adopt SAB No. 101 as required in the
fourth quarter of 2000 and are evaluating the effect, if any, that SAB No. 101
may have on our financial statements.
Results of Operations
The following table sets forth for the periods indicated information
derived from our statements of operations for those periods expressed as a
percentage of net sales, and the percentage change in such items from the
comparable prior year period. Any trends illustrated in the following table are
not necessarily indicative of future results.
<TABLE>
<CAPTION>
Percent Increase (Decrease)
As a Percentage of Net Revenues Over Prior Periods
------------------------------- ------------------
Three Months Six Months Three Months Six Months
Ended Ended Ended Ended
June 30, June 30, June 30, June 30,
2000 1999 2000 1999 2000 vs. 1999 2000 vs. 1999
---- ---- ---- ---- ------------- -------------
<S> <C> <C> <C> <C> <C> <C>
Statement of Operations Data:
Net Revenues:
Refractive products............ 93.0% 91.9% 91.7% 91.0% 120.4% 100.2%
Patent service................. 5.1 6.3 6.2 7.0 78.6 77.3
Healthcare services............ 1.9 1.8 2.1 2.0 125.0 101.7
----- ----- ----- -----
Net Revenues................... 100.0 100.0 100.0 100.0 117.8 98.6
Cost of Revenue................. 37.3 44.4 38.5 43.5 82.8 75.8
----- ----- ----- -----
Gross Profit (1)................ 62.7 55.6 61.5 56.5 145.8 116.1
Research, development and
regulatory expenses (2)...... 11.4 13.5 11.2 14.7 84.7 51.0
Other general and administrative
expenses..................... 48.5 78.5 52.5 76.8 34.4 35.7
Selling-related expenses (3).... 17.3 20.7 17.9 21.6 82.3 64.4
Amortization of intangibles..... 6.0 12.1 6.5 12.5 7.7 3.9
----- ----- ----- -----
Loss from operations............ (20.5) (69.2) (26.6) (69.1) (35.6) (23.5)
---------------
</TABLE>
(1) As a percentage of net revenues, the gross profit for refractive
products only for each of the three months ended June 30, 2000 and
1999, and the six months ended June 30, 2000 and 1999, were 61%, 53%,
59% and 53%, respectively.
(2) As a percentage of refractive product net sales, research, development
and regulatory expenses for each of the three months ended June 30,
2000 and 1999, and the six months ended June 30, 2000 and 1999, were
12%, 15%, 12% and 16%, respectively.
(3) As a percentage of refractive product net sales, selling-related
expenses for each of the three months ended June 30, 2000 and 1999, and
the six months ended June 30, 2000 and 1999, were 19%, 23%, 20% and
24%, respectively.
11
<PAGE>
SIX MONTHS ENDED JUNE 30, 2000, COMPARED TO SIX MONTHS ENDED JUNE 30, 1999
Revenues. Net revenues for the six months ended June 30, 2000 increased
by $10.0 million, or 99%, to $20.2 million from $10.2 million for the comparable
period in 1999.
During the six months ended June 30, 2000, refractive products revenues
increased $9.3 million, or 100%, to $18.5 million from $9.2 million for the
comparable period in 1999. This revenue increase was primarily the result of
increased sales of the LaserScan LSX due to our ability to sell laser systems in
the U.S., the higher price of the LaserScan LSX excimer laser system and the
introduction of our blade and keratome related products. See "Risk Factors and
Uncertainties--Industry and Competitive Risks--We cannot assure you that our
keratome products will achieve market acceptance, and we are significantly
dependent upon our marketing alliance with Becton Dickinson with respect to the
sale of our keratome products." During the six months ended June 30, 2000,
excimer laser system sales accounted for approximately $16.0 million in revenues
compared to $8.2 million in revenues over the same period in 1999. During the
six months ended June 30, 2000 and 1999, respectively, LaserScan LSX system
sales accounted for 100% and 85%, respectively, of total excimer laser system
sales. During the six months ended June 30, 2000, 49 laser systems were sold,
including 23 in the U.S., compared to 33 laser system sales over the comparable
period in 1999, of which five were sold in the U.S. for clinical trials. Of the
49 laser systems sold in the first half of 2000, two were discounted sales to
existing customers compared to 33 laser systems sold that included seven
discounted sales to existing customers during the comparable period in 1999.
Net revenues from patent services for the six months ended June 30,
2000 increased approximately $0.5 million, or 77%, to $1.2 million from $0.7
million for the comparable period in 1999, due to increased licensing fees.
Net revenues from health care services for the six months ended June
30, 2000 increased approximately $0.2 million, or 102%, to $0.4 million from
$0.2 million for the comparable period in 1999. This increase primarily resulted
from additional consulting services provided, partially attributable to the two
senior level consultants added during the third quarter of 1999.
Cost of Revenue; Gross Profits. For the six months ended June 30, 2000
and 1999, gross profit margins were 62% and 57%, respectively. The gross margin
increase during the six months ended June 30, 2000 was primarily attributable to
increased sales of the LaserScan LSX excimer laser system and higher patent and
health care services revenues. These increased sales were partially offset by
higher raw material costs relating to the LaserScan LSX excimer laser system and
an increase in our inventory obsolescence reserve of $0.5 million.
Research, Development and Regulatory Expense. Research, development and
regulatory expenses for the six months ended June 30, 2000 increased $0.8
million, or 51%, to $2.3 million from $1.5 million for the comparable period in
1999. We continued to develop our keratome systems, 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, we expect research
and development expenses during the remainder of 2000 to increase over levels
incurred during the first half of 2000. Regulatory expenses are expected to
remain constant as a result of our continued pursuit of FDA approval, protocols
added during 1999 related to the potential use of our laser systems for
treatments utilizing the LASIK procedure, pre-market approval supplements added
during 2000 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 six months ended June 30, 2000 increased $2.8
million, or 36%, to $10.6 million from $7.8 million for the comparable period in
1999. This increase was due to an increase in expenses incurred at our
refractive products subsidiary of approximately $2.7 million over the comparable
period in 1999. These included enhancements to the customer support and
training, quality assurance, marketing, software development, material control,
12
<PAGE>
manufacturing and engineering departments of $1.5 million, higher depreciation
costs of $0.2 million, $0.6 million of legal fees related to patent issues and
litigation and $0.3 million of bad debt expense, which represented a general
increase in reserves. See "Risk Factors and Uncertainties--Financial and
Liquidity Risks--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."
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 six months ended June 30, 2000
increased $1.4 million, or 64%, to $3.6 million from $2.2 million during the
comparable period in 1999. This increase was primarily attributable to a $0.5
million increase in sales commissions resulting from increased laser system
sales, an increase of $0.3 million in license fees primarily resulting from the
introduction of our keratome products and an increase of $0.6 million of
warranty expense primarily related to increased laser system sales.
Amortization of Intangibles. During the six months ended June 30, 2000,
costs relating to the amortization of intangible assets was $1.3 million,
approximately the same as for the comparable period in 1999. 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 six months ended June
30, 2000 was $5.4 million compared to the operating loss of $7.0 million for the
same period in 1999. This decrease in the loss from operations was primarily due
to the increase in sales of our LaserScan LSX excimer laser system and an
improvement in the operating gain generated by our patent services subsidiary,
partially offset by an increase in other general and administrative expenses
related to our refractive products operations.
Other Income and Expense. Interest and dividend income for the six
months ended June 30, 2000 was $0.5 million, an increase of $0.2 million over
the comparable period in 1999. 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 June 30, 2000 and 1999 was not material.
Income Taxes. For the six months ended June 30, 2000 and 1999,
LaserSight had no income tax expense.
Net Loss. Net loss for the six months ended June 30, 2000, was $4.9
million compared to a net loss of $6.8 million for the comparable period in
1999. The decrease in net loss for the six months ended June 30, 2000 can be
attributed to the increase in sales of our LaserScan LSX excimer laser system
and an improvement in the operating gain generated by our patent services
subsidiary, partially offset by an increase in other general and administrative
expenses related to our refractive products operations.
Loss Per Share. The loss per basic and diluted share was $0.25 for the
six months ended June 30, 2000 and $0.46 for the comparable period in 1999.
During the six months ended June 30, 2000, the weighted average shares of common
stock outstanding increased primarily due to private placements of common stock
and the exercise of options and warrants.
THREE MONTHS ENDED JUNE 30, 2000, COMPARED TO THREE MONTHS ENDED JUNE 30, 1999
Revenues. net revenues for the three months ended june 30, 2000
increased by $6.2 million, or 118%, to $11.5 million from $5.3 million for the
comparable period in 1999.
During the three months ended June 30, 2000, refractive products
revenues increased $5.8 million, or 120%, to $10.6 million from $4.8 million for
the comparable period in 1999. This revenue increase was primarily the result of
increased sales of the higher priced LaserScan LSX excimer laser system and an
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increased level of laser system sales. During the three months ended June 30,
2000, excimer laser system sales accounted for approximately $9.9 million in
revenues compared to $4.5 million in revenues over the same period in 1999.
During the three months ended June 30, 2000 and 1999, respectively, LaserScan
LSX system sales accounted for 100% and 94%, respectively, of total excimer
laser system sales. During the three months ended June 30, 2000, 30 laser
systems were sold, including 17 in the U.S., compared to 16 laser system sales
over the comparable period in 1999, of which five were sold in the U.S. for
clinical trials. Of the 30 laser systems sold in the second quarter of 2000, two
were discounted sales to existing customers compared to 16 laser systems sold
that included three discounted sales to existing customers over the comparable
period in 1999.
Net revenues from patent services for the three months ended June 30,
2000 increased approximately $0.3 million, or 79%, to $0.6 million from $0.3
million for the comparable period in 1999, due to increased licensing fees.
Net revenues from health care services for the three months ended June
30, 2000 increased approximately $0.1 million, or 125%, to $0.2 million from
$0.1 million for the comparable period in 1999. This increase primarily resulted
from additional consulting services provided, partially attributable to the two
senior level consultants added during the third quarter of 1999.
Cost of Revenue; Gross Profits. For the three months ended June 30,
2000 and 1999, gross profit margins were 63% and 56%, respectively. The gross
margin increase during the three months ended June 30, 2000 was primarily
attributable to increased sales of the LaserScan LSX excimer laser system. These
increased sales were partially offset by higher raw material costs relating to
the LaserScan LSX excimer laser system and an increase in our inventory
obsolescence reserve of $0.1 million.
Research, Development and Regulatory Expense. Research, development and
regulatory expenses for the three months ended June 30, 2000 increased $0.6
million, or 85%, to $1.3 million from $0.7 million for the comparable period in
1999. We continued to develop our keratome systems, 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, we expect research
and development expenses during the remainder of 2000 to increase over levels
incurred during the first quarter of 2000. Regulatory expenses are expected to
remain constant as a result of our continued pursuit of FDA approval, protocols
added during 1999 related to the potential use of our laser systems for
treatments utilizing the LASIK procedure, pre-market approval supplements added
during 2000 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 June 30, 2000 increased $1.4
million, or 34%, to $5.5 million from $4.1 million for the comparable period in
1999. This increase was due to an increase in expenses incurred at our
refractive products subsidiary of approximately $1.3 million over the comparable
period in 1999. These included enhancements to the customer support and
training, quality assurance, marketing, software development, material control,
manufacturing and engineering departments of $0.9 million, higher depreciation
costs of $0.1 million and $0.3 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 June 30, 2000
increased $0.9 million, or 82%, to $2.0 million from $1.1 million during the
comparable period in 1999. This increase was primarily attributable to a $0.3
million increase in sales commissions resulting from higher sales, an increase
of $0.1 million in license fees primarily resulting from the introduction of our
keratome products and an increase of $0.5 million of warranty expense primarily
related to increased laser system sales.
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Amortization of Intangibles. During the three months ended June 30,
2000, costs relating to the amortization of intangible assets was $0.7 million,
approximately the same as for the comparable period in 1999. 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
June 30, 2000 was $2.3 million compared to the operating loss of $3.6 million
for the same period in 1999. This decrease in the loss from operations was
primarily due to the increase in sales of our LaserScan LSX excimer laser system
and an improvement in the operating gain generated by our patent services
subsidiary, partially offset by an increase in other general and administrative
expenses related to our refractive products operations.
Other Income and Expense. Interest and dividend income for the three
months ended June 30, 2000 was $0.2 million, approximately the same as for the
comparable period in 1999. 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 June 30, 2000 and 1999 was not material.
Income Taxes. For the three months ended June 30, 2000 and 1999,
LaserSight had no income tax expense.
Net Loss. Net loss for the three months ended June 30, 2000, was $2.1
million compared to a net loss of $3.5 million for the comparable period in
1999. The decrease in net loss for the six months ended June 30, 2000 can be
attributed to the increase in sales of our LaserScan LSX excimer laser system
and an improvement in the operating gain generated by our patent services
subsidiary, partially offset by an increase in other general and administrative
expenses related to our refractive products operations.
Loss Per Share. The loss per basic and diluted share was $0.10 for the
three months ended June 30, 2000 and $0.21 for the comparable period in 1999.
During the three months ended June 30, 2000, the weighted average shares of
common stock outstanding increased primarily due to the private placements of
common stock and the exercise of options and warrants.
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 securities totaling
approximately $14.8 million in 1997, $15.8 million in 1998, $8.9 million in 1999
and $13.3 million to date in 2000, and received proceeds from the exercise of
stock options and warrants of approximately $98,000 in 1997, $0.5 million in
1998, $10.4 million in 1999 and $43,000 to date in 2000. In addition, we sold
subsidiaries and various patent rights, resulting in proceeds to us of
approximately $10.5 million in 1997 and $12.7 million in 1998. We have
principally used these capital resources to fund operating losses, working
capital requirements, capital expenditures, acquisitions and retirement of debt.
At June 30, 2000, we had an accumulated deficit of $43.0 million.
We have a loan commitment from The Huntington National Bank to enter
into a $5.0 million revolving credit facility. We anticipate this facility will
be closed before the end of August 2000, however, there is no assurance the
facility will be completed until all documents have been prepared and signed by
both parties. If and when finalized, the commitment provides that we may borrow
amounts under this credit facility at an annual rate equal to 0.5% above the
prime rate for short-term working capital needs or for such other purposes as
may be approved by Huntington. Borrowings will be limited to 50% of qualified
accounts receivable related to U.S. sales. The credit agreement with Huntington,
when completed, will replace a $2.5 million credit facility that expired on June
30, 2000. The facility requires us to maintain both a specified liquidity level
and tangible net worth level. At June 30, 2000, we had no outstanding borrowings
under any credit facility.
Our working capital increased $3.5 million from $21.6 million at
December 31, 1999 to $25.1 million as of June 30, 2000. This increase in working
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capital resulted primarily from the private placements of common stock in
January and February 2000, which resulted in gross proceeds of $13.3 million,
offset primarily by cash used in operating activities of $9.4 million.
Operating activities used net cash of $9.4 million during the six
months ended, June 30, 2000, compared to $6.2 million of net cash used during
the same period in 1999, and $11.7 million during the year ended December 31,
1999. We expect to incur a loss and a deficit in cash flow from operations for
the third quarter of 2000. There can be no assurance that we can regain or
sustain profitability or positive operating cash flow in any subsequent fiscal
period. Net cash used in investing activities of $5.3 million during the six
months ended, June 30, 2000 can be attributed primarily to the purchase of
patents and property and equipment. As of June 30, 2000, we had no material
commitments for capital expenditures. Net cash provided from financing
activities during the six months ended June 30, 2000 of $13.2 million resulted
from the issuance of 1,346,030 shares of common stock in private placements to
five investors for gross proceeds of $13.3 million (including $10.0 million from
TLC).
We are currently exploring opportunities for additional debt financing
or equity financing through a private placement of our common stock. We believe
that, in addition to our existing balances of cash and cash equivalents and our
cash flows from operations, some form of equity or debt financing may be
necessary to fund our anticipated working capital requirements for the next 12
months in accordance with our current business plan. Our belief regarding future
working capital requirements is based on various factors and assumptions
including: the 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 astigmatism and other
supplemental FDA approvals for our LaserScan LSX excimer laser system, which
could impact our sales in the third quarter of 2000, the uncertain timing of the
market introduction of our UltraShaper(TM) durable keratomes, commercial
acceptance of our UltraEdge(TM) keratome blades and UniShaper(TM) single-use
keratomes, which we believe is partially dependent upon the successful
introduction of the UltraShaper, the 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 are significantly dependent upon our marketing alliance with Becton Dickinson
with respect to the sale of our keratome products." 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
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 $5.0 million credit facility
expected to be completed in August 2000 with Huntington, we currently do not
have any commitments for additional financing. There can be no assurance that we
can obtain financing that we believe may be necessary to finance our working
capital requirements for the next 12 months. See "Risk Factors and
Uncertainties--Financial and Liquidity Risks--We could require additional
financing which might not be available if we need it."
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RISK FACTORS AND UNCERTAINTIES
The business, results or operations and financial condition of LaserSight and
the market price of it's Common Stock may be adversely affected by a variety of
factors, including the factors listed 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 Food & Drug Administration 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 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 narrow beam 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 does not intend to 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 the
commercial launch of 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, AND WE ARE SIGNIFICANTLY DEPENDENT UPON OUR MARKETING ALLIANCE WITH
BECTON DICKINSON WITH RESPECT TO THE SALE OF OUR KERATOME PRODUCTS.
Keratomes are surgical devices used to create a corneal flap
immediately prior to LASIK laser vision correction procedures. We began to roll
out our MicroShape(TM) family of keratome products with the commercial launch of
our UltraEdge keratome blades in July 1999 and of our UniShaper single-use
keratomes and control consoles in December 1999. We anticipate the commercial
launch of our UltraShaper durable keratomes during the fourth quarter of 2000.
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 is 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 with new enhancements and
features. However, Bausch & Lomb has not aggressively marketed or serviced the
ACS since 1997 when we licensed the rights to commercially market keratomes
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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 that 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.
Successful implementation of our keratome product sales strategy is
significantly dependent upon our marketing and distribution alliance with Becton
Dickinson. Pursuant to our October 1999 agreement, Becton Dickinson is, subject
to limited exceptions, the exclusive distributor of our keratomes and keratome
related products in the U.S., the U.K., Ireland and Japan, and has a
non-exclusive right to distribute kits including keratome products in other
countries. While our agreement with Becton Dickinson has a five-year term, it is
subject to early termination in certain circumstances, including the failure of
Becton Dickinson to achieve minimum sales levels. If we cannot successfully
market and sell our keratome products or if our marketing and distribution
alliance with Becton Dickinson fails to benefit us as expected, 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 current industry leader for excimer laser system sales in the
U.S., sold laser systems which performed a significant majority of the laser
vision correction procedures performed in the U.S. in 1998 and 1999. Similarly,
Bausch & Lomb sold a significant majority of the keratomes used by refractive
surgeons in the U.S. in 1998 and 1999. Two of our other competitors, Summit
Technology, Inc. and Autonomous Technology Corporation merged in April 1999 to
become Summit Autonomous Inc. The merger resulted in a combined entity with
enhanced market presence, technology base and distribution capabilities and
provided Summit with a narrow beam laser technology platform which will enable
Summit to compete more directly with our narrow beam LaserScan LSX excimer laser
system. In addition, as a result of the merger, 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. In June 2000, Alcon Holdings, Inc.,
a subsidiary of Nestle SA, acquired through a tender offer, substantially all
the outstanding stock of Summit Autonomous Inc. We anticipate that Alcon will
leverage the sale of Summit's 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 Summit Autonomous/Alcon, each of
whom received FDA approval of excimer laser systems more than three years ago
and has substantial experience manufacturing, marketing and servicing laser
systems in the U.S. In addition to Visx, Summit Autonomous/Alcon, Nidek, and
Bausch & Lomb have all received FDA approval for their laser system.
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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 using
a pulse repetition rate of 100 Hz. Currently, excimer laser vision
correction systems manufactured by Visx, Summit Autonomous/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 Summit Autonomous/Alcon excimer laser systems are also approved for the
treatment of moderate farsightedness.
We have submitted an application to the FDA for approval for the
treatment of nearsightedness with astigmatism and have responded to an FDA
request for additional patient data related to our application. We anticipate
FDA approval of this application during the late third quarter or early fourth
quarter of 2000. If the FDA does not approve our pending application in a timely
manner or at all, our ability to sell our laser systems in the U.S. may be
severely impaired. We have also submitted an application to the FDA to permit
our laser systems sold to customers in the U.S. to operate at a 200 Hz pulse
rate and we anticipate FDA approval of this application during the third quarter
of 2000. If the FDA does not approve our pending application in a timely manner
or at all, our ability to sell our laser systems in the U.S. may be severely
impaired. We anticipate submitting an application to the FDA during the third
quarter of 2000 to permit our laser systems sold to customers in the U.S. to
include our latest eye tracking technology and anticipate FDA approval for this
application late in the third quarter of 2000 or early in the fourth quarter of
2000. If the FDA does not approve such application in a timely manner after
filing, or at all, our ability to sell our laser systems in the U.S. may be
severely impaired. In addition, in the third quarter of 2000 we anticipate
submitting an application to the FDA to permit our laser systems sold to
customers in the U.S. to utilize LASIK to treat myopic astigmatism, hyperopic
astigmatism and mixed astigmatism. FDA approval of this application is
anticipated in the first quarter of 2001.
Summit Autonomous/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 also recently
received FDA approval for the treatment of myopia up to -7.0 diopters with up to
-3.0 diopters of astigmatism. In March 2000, the FDA Ophthalmic Advisory Panel
recommended approval for Summit Autonomous/Alcon's Ladarvision system for the
correction of farsightedness of up to +6.0 diopters and an astigmatism range of
up to 6.0 diopters, and in May 2000, the panel recommended approval for Visx's
Star S2 system for the correction of farsightedness of up to +5.0 diopters and
an astigmatism range of up to 4.0 diopters. 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. Competitors' receipt of LASIK-specific FDA regulatory
approval could be a significant competitive advantage which could impede our
ability to successfully introduce our LaserScan LSX system in the U.S. or
discourage physicians from using our or other manufacturers' lasers off-label.
Our failure to successfully effect our product introduction in a timely manner
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.
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of previously-approved laser systems and keratome products, as well as the entry
of new competitors into the market upon receipt of new or expanded regulatory
approvals, could impede our ability to successfully introduce our LaserScan LSX
system in the U.S. and our keratome products worldwide and may have a material
adverse effect on our business, financial condition and results of operations.
WE DEPEND UPON OUR ABILITY TO ESTABLISH AND MAINTAIN STRATEGIC
RELATIONSHIPS.
We believe that our ability to establish and maintain strategic
relationships will have a significant impact on our ability to meet our business
objectives. These strategic relationships are critical to our future success
because we believe that these relationships will help us to:
o extend the reach of our products to a larger number of refractive
surgeons;
o develop and deploy new products;
o further enhance the LaserSight brand; and
o generate additional revenue.
Entering into strategic relationships is complicated because some of
our current and future strategic partners may decide to compete with us in some
or all of our markets. In addition, we may not be able to establish
relationships with key participants in our industry if they have relationships
with our competitors, or if we have relationships with their competitors.
Moreover, some potential strategic partners have resisted, and may continue to
resist, working with us until our products and services have achieved widespread
market acceptance. Once we have established strategic relationships, we will
depend on our partners' ability to generate increased acceptance and use of our
products and services. To date, we have established only a limited number of
strategic relationships, and many of these relationships are in the early stages
of development. There can be no assurance as to the terms, timing or
consummation of any future strategic relationships. If we lose any of these
strategic relationships or fail to establish additional relationships, or if our
strategic relationships fail to benefit us as expected, we may not be able to
execute our business plan, and our business will suffer.
BECAUSE THE SALE OF OUR PRODUCTS IS DEPENDENT ON THE CONTINUED MARKET
ACCEPTANCE OF LASER-BASED REFRACTIVE EYE SURGERY USING THE LASIK PROCEDURE, THE
LACK OF BROAD MARKET ACCEPTANCE WOULD HURT OUR BUSINESS.
We believe that whether we achieve profitability and growth will
depend, in part, upon the continued acceptance of laser vision correction using
the LASIK procedure in the U.S. and other countries. We cannot be certain that
laser vision correction will continue to be accepted by either the refractive
surgeons or the public at large as an alternative to existing methods of
treating refractive vision disorders. The acceptance of laser vision correction
and, specifically, the LASIK procedure may be adversely affected by:
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.
Unfavorable side effects and potential complications which 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.
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Potential patients may not distinguish between our narrow beam scanning
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 which is not typically covered by insurance
and which 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 which 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 which 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 render 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.
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 the Company alleging that our LaserScan LSX
laser system infringes one of Visx's U.S. patents for equipment used in
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ophthalmic surgery. The LaserScan LSX is the only laser system we are currently
marketing and is the only laser system manufactured by us which 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 Visx lawsuit is without merit and intend to
vigorously contest it. 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
which we may be required to pay. In addition, such patent litigation could be
time-consuming, result in costly litigation, divert management's attention and
resources, 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, particularly in jury trials, 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.
Additionally, we are currently involved in litigation with Luis A Ruiz,
M.D. and Sergio Lenchig related to the January 2000 amendment to an existing
license agreement. See Part II, Item 1 - Legal Proceedings.
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 intend to manufacture our LaserScan LSX laser systems for sale in
the U.S. at our manufacturing facility in Winter Park, Florida, and to 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 scaling up production of our laser systems at our
Florida facility, including problems involving production delays, quality
control or assurance, component supply and lack of qualified personnel. In
addition, we recently moved our U.S. manufacturing operations to another
location leased by us in Winter Park, Florida, which could result in
unanticipated problems and production delays. Any products manufactured or
distributed by us pursuant to FDA clearances or approvals are subject to
extensive regulation by the FDA, including recordkeeping requirements and
reporting of adverse experience with the use of the product. Our manufacturing
facilities are subject to periodic inspection by the FDA, certain state agencies
and international regulatory agencies. We require that our key suppliers comply
with recognized standards as well as our own quality standards, and we regularly
test the components and sub-assemblies supplied to us. Any failure by us or our
suppliers to comply with applicable regulatory requirements, including the FDA's
quality systems/good manufacturing practice (QSR/GMP) regulations, could cause
production and distribution of our products to be delayed or prohibited, either
of which could have a material adverse effect on our business, financial
condition and results of operations.
REQUIRED 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 keratome
limited exclusive license agreement. The January 2000 amendment to the license
agreement, as described below, was not triggered by May 31, 2000. Under the
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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 are 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.
As a result of our obligations under this license arrangement, the minimum
royalty payments we are required to make to the licensor may exceed our gross
profits from sales of our UniShaper and UltraShaper keratome products. On
January 18, 2000, we entered into a first amendment to a license and royalty
agreement related to certain keratome related products. Under the terms of the
amendment 555,552 shares of Common Stock were placed in escrow and were included
in common shares issued and outstanding on that date. If we raised equity
capital totaling $15 million from January 18, 2000 to May 31, 2000, or we
otherwise elected in our sole discretion to proceed with the amendment, the
shares would have been released from escrow and we would have been obligated to
pay $7.6 million in cash within the next six months. Because we had raised
equity capital totaling only $13.25 million, effective on May 31, 2000, the
shares were returned to us and cancelled. In addition, we paid the licensors
$200,000 upon execution of the amendment and $200,000 on April 1, 2000. 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, will remain 50% as certain provisions of
the amendment were not triggered. We agreed to pay the costs of the UniShaper
final production molds.
In May 2000, the licensors offered to purchase $1.75 million of Common
Stock to enable us to reach the target of $15 million of total equity capital
raised. We did not accept such offer on grounds that it was an attempt to alter
the terms of the amendment, and litigation between us and the licensors has
commenced. See Part II, Item 1 - Legal Proceedings.
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 which 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.
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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 narrow-beam scanning 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 our patent litigation with Visx."
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.
We are currently involved in patent litigation with Visx, and such
allegations are common in our industry. 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 and agreed to notify Visx before we began manufacturing and selling our
laser systems in the U.S.
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
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you that one or more of our other competitors or other persons will not assert
that our products infringe their intellectual property, or that we will not in
the future be deemed to infringe one or more patents owned by them or some other
party. We could incur substantial costs and diversion of management resources
defending any infringement claims. Furthermore, a party making a claim against
us could secure a judgment awarding substantial damages, as well as injunctive
or other equitable relief that could effectively block our ability to market one
or more of our products. In addition, we cannot assure you that licenses for any
intellectual property of third parties that might be required for our products
will be available on commercially reasonable terms, or at all. See "--We are
subject to risks and uncertainties relating to our patent litigation with Visx."
WE ARE SUBJECT TO CERTAIN RISKS ASSOCIATED WITH OUR INTERNATIONAL
SALES.
Our international sales accounted for 35% and 72% of our total revenues
during the six months and year ended June 30, 2000 and December 31, 1999,
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
regulatory approval to market our LaserScan LSX laser system in the U.S., the
anticipated commercial launch of our UltraShaper durable keratome in the fourth
quarter of 2000, and the recent commercial launch of our UltraEdge keratome
blades and our UniShaper single-use keratome. See "--Industry and Competitive
Risks--We cannot assure you that our keratome products will achieve market
acceptance, and we are significantly dependent upon our marketing alliance with
Becton Dickinson with respect to the sale of our keratome products." The
majority of our international revenues for the six months ended June 30, 2000
were from customers in Korea, Mexico, and Italy, and for the year ended December
31, 1999 were from customers in Canada, Mexico, Spain, Italy, Belgium and
France.
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 manufactured exclusively by
Becton Dickinson pursuant to our agreement with them, 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 written
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 in a timely fashion, we
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would have to locate and contract with a substitute supplier and, in some cases,
such substitute supplier would need to be qualified by the FDA. If substitute
suppliers cannot be located and qualified in a timely manner or could not
provide required products on commercially reasonable terms, it would have a
material adverse effect on our business, financial condition and results of
operations.
UNLAWFUL TAMPERING OF OUR SYSTEM CONFIGURATIONS COULD RESULT IN REDUCED
REVENUES.
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 THIRD QUARTER OF 2000.
We experienced significant net losses and deficits in cash flow from
operations for the years ended December 31, 1999 and 1998 and the six months
ended June 30, 2000, 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.
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<TABLE>
<CAPTION>
Year Ended December 31, Six Months Ended
1998 1999 June 30, 2000
---- ---- -------------
<S> <C> <C> <C>
Net Loss................... $1.9 million $4.4 million $4.9 million
Deficit in Cash Flow from
Operations.............. $4.3 million $1.7 million $9.4 million
</TABLE>
As of June 30, 2000, we had an accumulated deficit of $43.0 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 $4.2 million at June 30, 2000, will
be sufficient to cover the amount of our actual write-offs over time. At June
30, 2000, our net trade accounts and notes receivable totaled approximately
$20.5 million, and accrued commissions, the payment of which generally depends
on the collection of such net trade accounts and notes receivable, totaled
approximately $2.4 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 customer's 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 June 30, 2000, we had extended the original payment terms of laser
customer accounts totaling approximately $0.8 million by periods ranging from 12
to 60 months. Such restructured receivables represent approximately 3% 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 six months ended June 30, 2000 and the year ended December
31, 1999, we experienced deficits in cash flow from operations of $9.4 million
and $11.7 million, respectively. We are currently exploring opportunities for
additional debt financing or equity financing through a private placement of our
common stock. We believe that, in addition to our existing balances of cash and
cash equivalents and our cash flows from operations, some form of equity or debt
financing may be necessary to fund our anticipated working capital requirements
for the next 12 months in accordance with our current business plan. Our belief
regarding future working capital requirements is based on various factors and
assumptions including: the 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 astigmatism
and other supplemental FDA approvals for our LaserScan LSX excimer laser system,
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which could impact our sales in the third quarter of 2000, 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 are significantly dependent upon our marketing
alliance with Becton Dickinson with respect to the sale of our keratome
products." 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.
We cannot be certain that we will not 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
$5.0 million credit facility expected to be completed in August 2000 with
Huntington, 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
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
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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 21,260,792 shares of common stock
outstanding at August 11, 2000 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 which 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 seven million 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.
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.
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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 June 30, 2000, approximately $17.1 million, or
28%, 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 MRF, Inc., d/b/a The Farris Group (TFG), our subsidiary
which 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.
In 1999, two senior consultants joined who are expected to develop new business
and help lead TFG towards financial improvement during 2000. The first six
months of 2000 reflected financial improvement over 1999. If TFG is unsuccessful
in continuing to improve its financial performance, some or all of the carrying
amount of goodwill recorded, $3.4 million at June 30, 2000, 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 June 30, 2000,
we had approximately $9.2 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.
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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, 1999.
Ruiz & Lenchig. In May 2000, LaserSight filed a declaratory
judgment and injunctive relief action in the U.S. District Court,
Eastern District of Virginia, Alexandria Division in connection with
its 1997 License and Royalty Agreement ("Agreement") with Luis A.
Ruiz, M.D. and Sergio Lenchig. The action relates to the January
2000 Amendment to the Agreement (the "Amendment") that provided for
the royalties payable under the Agreement to be reduced in exchange
for LaserSight making certain cash payments and issuing shares of
LaserSight common stock. The cash payments and stock issuance were
to be made only if LaserSight, using its reasonable best efforts,
raised $15 million in capital by May 31, 2000, or if LaserSight, at
its sole option, decided to make the payments and issuance despite
the fact that the $15 million had not been raised. Less than $15
million was raised and LaserSight elected not to exercise its
option. However, Dr. Ruiz and Mr. Lenchig offered to provide the
deficiency ($1.75 million) by purchase of LaserSight common stock at
$10 per share, and claim that LaserSight's failure to accept their
offer constitutes a material breach of the Amendment. LaserSight did
not accept the offer and filed for a declaratory judgment on the
basis that the offer was an attempt to alter the terms of the
Amendment and that LaserSight is not in breach. Dr. Ruiz and Mr.
Lenchig have filed a counterclaim alleging breach of contract and
requesting damages of $10 million. Management believes that
LaserSight has satisfied its obligations under the Agreement and the
Amendment and that the outcome of this litigation will not have a
material adverse effect on LaserSight's business, financial
condition or results from operations. However, the outcome of
litigation is inherently uncertain, and an unfavorable outcome in
this litigation could have a material adverse effect on LaserSight's
business, financial condition and results of operations. See "Part
I, Item 2--Management's Discussion and Analysis of Financial
Condition and Results of Operations--Risk Factors and
Uncertainties--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
third quarter of 2000" and "-We could require additional financing
which might not be available if we need it."
ITEM 2 CHANGES IN SECURITIES
Not applicable.
ITEM 3 DEFAULTS UPON SENIOR SECURITIES
Not applicable.
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ITEM 4 SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On June 9, 2000, at the Company's annual meeting of shareholders, the following
members were elected to the Board of Directors:
Votes For Votes Against
--------- -------------
Michael R. Farris 20,505,810 582,866
Terry Fuller, Ph.D. 20,507,810 580,866
Gary F. Jonas 20,512,685 575,991
D. Michael Litscher 20,512,810 575,866
Guy W. Numann 20,512,810 575,866
Francis E. O'Donnell, Jr., M.D. 20,215,460 873,216
David T. Pieroni 20,505,810 582,866
Amendment to the Company's 1996 Equity Incentive Plan
adjusting the aggregate number of shares available for issuance
was ratified as follows:
Votes For 10,926,927
Votes Against 3,120,085
Abstain 157,781
Approval of the Company's Charter amendment to increase the
authorized number of common shares was ratified as follows:
Votes For 18,469,543
Votes Against 2,574,541
Abstain 44,592
A proposal to appoint KPMG LLP as auditors was ratified as
follows:
Votes for 20,647,656
Votes Against 419,727
Abstain 21,293
ITEM 5 OTHER INFORMATION
Not applicable.
ITEM 6 EXHIBITS AND REPORTS ON FORM 8-K
a) Exhibits
INDEX TO EXHIBITS
Exhibit
Number Description
------ -----------
2.1 See Exhibits 10.1, 10.2, 10.6, 10.7, 10.16, 10.22, 10.25, 10.26,
10.30 and 10.31 and 10.56.
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*).
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3.2 Bylaws, as amended (filed as Exhibit 3.2 to the Company's Form 8-K
filed on December 20, 1999*).
3.3 Rights Agreement, dated as of July 2, 1998, between LaserSight
Incorporated and American Stock Transfer & Trust Company, as Rights
Agent, which includes (i) as Exhibit A thereto the form of
Certificate of Designation of the Series E Junior Participating
Preferred Stock, (ii) as Exhibit B thereto the form of Right
Certificate (separate certificates for the Rights will not be issued
until after the Distribution Date) and (iii) as Exhibit C thereto
the Summary of Stockholder Rights Agreement (incorporated by
reference to Exhibit 99.1 to the Form 8-K filed by the Company on
July 8, 1998*).
3.4 First Amendment to Rights Agreement, dated as of March 22, 1999,
between LaserSight Incorporated and American Stock Transfer & Trust
Company, as Rights Agent (incorporated by reference to Exhibit 2 to
Form 8-A/A filed by the Company on March 29, 1999*).
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, 10.19, 10.23, 10.28, 10.29,
10.36, 10.37, 10.38, 10.39, 10.46, 10.48, 10.49, 10.50, 10.51,
10.52, 10.53, 10.54 and 10.55.
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*).
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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*).
10.11 LaserSight Incorporated Amended and Restated 1996 Equity Incentive
Plan.
10.12 LaserSight Incorporated Amended and Restated Non-Employee Directors
Stock Option Plan.
10.13 Agreement dated September 18, 1996 between David T. Pieroni and
LaserSight Incorporated (filed as Exhibit 10.35 to the Company's
Form 10-K for the year ended December 31, 1996*).
10.14 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*).
10.15 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*).
10.16 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*).
10.17 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's Form 8-K filed on
March 27, 1997*).
10.18 Employment Agreement dated September 16, 1996 by and between
LaserSight Incorporated and Richard L. Stensrud (filed as Exhibit
10.41 to the Company's Form 10-Q filed on May 9, 1997*).
10.19 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*).
10.20 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*).
10.21 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*).
10.22 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*).
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10.23 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*).
10.24 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*).
10.25 Stock Purchase Agreement, dated December 30, 1997, by and among
LaserSight Incorporated, LSI Acquisition, Inc., MEC Health Care,
Inc. and Vision Twenty-One, Inc. (filed as Exhibit 2.(i) to the
Company's Form 8-K filed on January 14, 1998*).
10.26 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*).
10.27 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*).
10.28 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*).
10.29 Securities Purchase Agreement, dated June 12, 1998, by and
between LaserSight Incorporated and Pequot Funds (filed as
Exhibit 99.5 to the Company's Form 8-K filed on June 25, 1998*).
10.30 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*).
10.31 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*).
10.32 Purchase Agreement, dated June 9, 1997, by and between
LaserSight Technologies, Inc. and TUI Lasertechnik Und
Laserintegration GmbH (filed as Exhibit 10.1 to the Company's
Form S-3, Pre-Effective Amendment No. 1 filed on February 1,
1999*).
10.33 License and Royalty Agreement, dated September 10, 1997, by and
between LaserSight Technologies, Inc. and Luis A. Ruiz, M.D. and
Sergio Lenchig (filed as Exhibit 10.2 to the Company's Form S-3,
Pre-Effective Amendment No. 1 filed on February 1, 1999*).
10.34 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*).
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<PAGE>
10.35 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*).
10.36 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*).
10.37 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*).
10.38 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*).
10.39 Revolving Credit Agreement, dated June 29, 1999, by and between
LaserSight Incorporated and The Huntington National Bank (filed as
Exhibit 10.39 to the Company's Form 10-Q filed on August 11, 1999*).
10.40 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*)**.
10.41 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*)**.
10.42 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*)**.
10.43 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*).
10.44 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*).
10.45 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*).
10.46 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*).
10.47 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*).
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<PAGE>
10.48 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*).
10.49 Registration Rights Agreement ated 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*).
10.50 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*).
10.51 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*).
10.52 First Amendment to License and Royalty Agreement dated as of
January 18, 2000 by and between LaserSight Technologies, Inc., Luis
A. Ruiz, M.D. and Sergio Lenchig (filed as Exhibit 10.52 to the
Company's Form 10-K filed on March 30, 2000*).
10.53 Registration Rights Agreement dated as of January 18, 2000 by and
between LaserSight Incorporated, Luis A. Ruiz, M.D.and Sergio
Lenchig (filed as Exhibit 10.53 to the Company's Form 10-K filed on
March 30, 2000*).
10.54 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*).
10.55 Registration Rights Agreement dated February 18, 2000 by and
between LaserSight Incorporated, Engmann Options, Inc. and MDNH
Partners, L.P (filed as Exhibit 10.55 to the Company's Form 10-K
filed on March 30, 2000*).
10.56 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*).
10.57 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*).
10.58 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*).
11 Statement of Computation of Loss Per Share
15 Copy of letter from independent accountants' regarding unaudited
interim financial information
27 Financial Data Schedule
99 Press release dated August 14, 2000
37
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b) Reports on Form 8-K
On June 1, 2000, we filed a Current Report on Form 8-K
including a press release describing the declaratory judgment and
injunctive relief action we filed in conjunction with a license and
royalty agreement.
---------------------------
*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.
38
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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: August 14, 2000 By: /s/ Michael R. Farris
---------------------
Michael R. Farris,
Chief Executive Officer
Dated: August 14, 2000 By: /s/ Gregory L. Wilson
---------------------
Gregory L. Wilson,
Chief Financial Officer
39
