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FILED PURSUANT TO
RULE 424(B)(3)
REGISTRATION NO. 33-91258
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1,200,000 SHARES
VISX, INCORPORATED
COMMON STOCK
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This Prospectus covers 1,200,000 shares of Common Stock, par value $0.01
per share (the "Common Stock"), of VISX, Incorporated ("VISX" or the "Company"),
which may be offered from time to time by one or all of the selling stockholders
named herein (the "Selling Stockholders"). The Company will receive no part of
the proceeds of such sales.
The Selling Stockholders intend to sell the shares offered hereby from time
to time in the over-the-counter market at prices prevailing therein, in
individually negotiated transactions at such prices as may be agreed upon or a
combination of such methods of sale immediately following the date of this
Prospectus. The Company will bear all expenses with respect to the offering of
the Common Stock, except any underwriting discounts, selling commissions, stock
transfer taxes, and fees and disbursements of counsel for the Selling
Stockholders. To the extent required, the specific shares of Common Stock to be
sold, the names of the Selling Stockholders, the public offering price, the
names of any agent, dealer or underwriter and any applicable commission or
discount with respect to any particular offer is set forth herein or will be set
forth in an accompanying Prospectus Supplement. See "Selling Stockholders" and
"Plan of Distribution." The Company's Common Stock is traded on the Nasdaq
National Market under the symbol VISX.
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SEE "RISK FACTORS" COMMENCING ON PAGE 4 FOR INFORMATION THAT SHOULD BE
CONSIDERED BY PROSPECTIVE INVESTORS.
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The Selling Stockholders and any broker executing selling orders on behalf
of the Selling Stockholders may be deemed to be an "underwriter" within the
meaning of the Securities Act of 1933, as amended (the "Securities Act").
Commissions received by any such broker may be deemed to be underwriting
commissions under the Securities Act. See "Plan of Distribution" for information
relating to indemnification of the Selling Stockholders.
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THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE SECURITIES
AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE
ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE
CONTRARY IS A CRIMINAL OFFENSE.
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THE DATE OF THIS PROSPECTUS IS OCTOBER 26, 1995
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No person is authorized in connection with any offering made hereby to give
any information or to make any representation not contained in this Prospectus,
and, if given or made, such information or representation must not be relied
upon as having been authorized by the Company or the Selling Stockholders. This
Prospectus does not constitute an offer to sell or a solicitation of an offer to
buy any security other than the shares of Common Stock offered hereby, nor does
it constitute an offer to sell or a solicitation of an offer to buy any of the
shares offered hereby to any person in any jurisdiction in which it is unlawful
to make such an offer or solicitation. Neither the delivery of this Prospectus
nor any sale made hereunder shall under any circumstances create any implication
that the information contained herein is correct as of any time subsequent to
the date hereof.
ADDITIONAL INFORMATION
This Prospectus constitutes a part of a Registration Statement on Form S-3
(herein, together with all amendments and exhibits, referred to as the
"Registration Statement") filed by the Company with the Securities and Exchange
Commission (the "Commission") under the Securities Act. This Prospectus does not
contain all of the information set forth in the Registration Statement, certain
parts of which are omitted in accordance with the rules and regulations of the
Commission. For further information with respect to the Company and the shares
of Common Stock offered hereby, reference is hereby made to the Registration
Statement. Statements contained herein concerning the provisions of any document
are not necessarily complete, and each such statement is qualified in its
entirety by reference to the copy of such document filed with the Commission.
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and in accordance
therewith files reports, proxy and information statements and other information
with the Commission. Such reports, proxy and information statements and other
information may be inspected and copied at the public reference facilities
maintained by the Commission at 450 Fifth Street, NW, Washington, D.C. 20549,
and at the following Regional Offices of the Commission: New York Regional
Office, Seven World Trade Center, New York, New York 10048, and Chicago Regional
Office, Northwest Atrium Center, 500 West Madison Street, Chicago, Illinois
60661. Copies of such material can be obtained from the Public Reference Section
of the Commission, 450 Fifth Street, NW, Washington, D.C. 20549 upon payment of
the prescribed fees. The Common Stock of the Company is quoted on the Nasdaq
National Market. Reports, proxy and information statements and other information
concerning the Company may be inspected at the Nasdaq Stock Market at 1735 K
Street, NW, Washington, D.C. 20006.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents filed by the Company with the Commission are hereby
incorporated by reference in this Prospectus:
(1) The Company's Annual Report on Form 10-K for the year ended
December 31, 1994.
(2) The Company's Quarterly Reports on Form 10-Q for the quarters
ended March 31 and June 30, 1995.
(3) The Company's Current Report on Form 8-K dated October 16, 1995.
(4) The description of the Company's Capital Stock contained in its
Registration Statement on Form 8-A as filed with the Commission on February
4, 1991, as amended.
All reports and other documents subsequently filed by the Company pursuant
to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this
Prospectus and prior to the termination of this offering shall be deemed to be
incorporated by reference herein, to the extent required, and to be a part
hereof from the date of filing of such reports and documents. Any statement
incorporated herein shall be deemed to be
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modified or superseded for purposes of this Prospectus to the extent that a
statement contained herein or in any other subsequently filed document which
also is or is deemed to be incorporated by reference herein modifies or
supersedes such statement. Any statement so modified or superseded shall not be
deemed, except as so modified or superseded, to constitute a part of this
Prospectus.
The Company hereby undertakes to provide without charge to each person,
including any beneficial owner, to whom a copy of this Prospectus has been
delivered, upon written or oral request of such person, a copy of any or all of
the foregoing documents incorporated herein by reference (other than exhibits to
such documents, unless such exhibits are specifically incorporated by reference
into such documents). Requests for such documents should be submitted in writing
to Katrina J. Church, Vice President, General Counsel, VISX, Incorporated, 3400
Central Expressway, Santa Clara, California 95051 or by telephone at (408)
733-2020.
THE COMPANY
VISX is a leader in the design and development of proprietary technologies
and systems for laser vision correction ("LVC"), an outpatient surgical
procedure to treat refractive vision disorders such as nearsightedness,
astigmatism and farsightedness with the goal of eliminating or reducing reliance
on eyeglasses and contact lenses. In LVC, a computer-controlled excimer laser
ablates, or removes, submicron layers of tissue from the surface of the cornea
to reshape the eye, thereby improving visual acuity.
The Company is incorporated in Delaware. The Company's principal executive
offices are located at 3400 Central Expressway, Santa Clara, California 95051
and its telephone number at that location is (408) 733-2020. Unless otherwise
indicated by the context, all references to "VISX" or the "Company" include
VISX, Incorporated and its subsidiary, VISX Partner, Inc.
RECENT DEVELOPMENTS
On September 29, 1995, the Company received approval from the United States
Food and Drug Administration ("FDA") of its pre-market approval ("PMA")
application for its proprietary excimer laser system (the "VISX System") for
phototherapeutic keratectomy ("PTK") and has commenced United States
commercialization of the VISX System for this indication. PTK is a laser
surgical procedure for treating corneal pathologies.
On October 6, 1995, the Company filed a Registration Statement on Form S-3
with the Commission for a public offering of 2,875,000 shares of its Common
Stock (including an over-allotment option granted to the underwriters to
purchase 375,000 shares). All shares are to be sold by the Company. Dillon, Read
& Co. Inc. and PaineWebber Incorporated will serve as managing underwriters for
the offering.
On October 16, 1995, the Company received notice that the Federal Trade
Commission ("FTC") is requesting the production of certain documents in
connection with an investigation being conducted by the FTC relating to whether
or not Pillar Point Partners ("Pillar Point") and/or the companies that formed
Pillar Point, VISX and Summit Technology, Inc. ("Summit"), have engaged in any
unfair methods of competition in violation of federal trade regulation laws.
Pillar Point was formed in 1992 to resolve then-pending patent disputes between
VISX and Summit. Trade regulation issues were carefully considered in the
structuring of Pillar Point, and VISX believes that Pillar Point was structured
in compliance with federal trade regulation laws. In addition, VISX believes
that the operation of Pillar Point has been and will be consistent with such
laws.
On October 20, 1995, the FDA's Ophthalmic Devices Advisory Panel gave a
favorable recommendation for approval of the Company's PMA application to
commercially market and sell the VISX System in the United States for the
treatment of low-level myopia. The panel's recommendation is subject to VISX
providing the panel with updated follow-up data on patients previously treated
with the VISX System. FDA approval of the PMA application will be required prior
to United States commercial sale of the VISX System for treatment of low-level
myopia. Although the FDA is not bound by the advisory panel's recommendations
and there can be no assurance that approval will be received, the FDA tends to
accord significant weight to advisory panel recommendations in determining
whether to grant PMA.
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RISK FACTORS
In evaluating the Company's business, prospective investors should
carefully consider the following risk factors in addition to the other
information in this Prospectus and the documents incorporated by reference
herein.
ABSENCE OF PROFITABLE OPERATIONS HISTORY; FLUCTUATIONS IN RESULTS OF OPERATIONS
The Company began operations in March 1986 and has recorded losses from
operations in all years since its inception. At June 30, 1995, the Company had
an accumulated deficit of $45.1 million. The Company anticipates continued
losses from operations due to ongoing research, development and clinical
expenditures as well as increased sales, marketing and manufacturing
expenditures to support United States commercial introduction of the VISX
System. In addition, the Company's results of operations have in the past
fluctuated substantially from period to period, due largely to the timing and
amount of orders received from Alcon, and its future results of operations may
vary significantly from quarter to quarter, as a result of the amount and timing
of revenues from use and equipment royalties paid to Pillar Point, royalties
under international licensing arrangements, international equipment sales to
Alcon and United States equipment sales. There can be no assurance that the
Company will achieve profitability in the future or that profitability, if
achieved, will be sustained. FDA approval of an LVC system is of critical
importance to the Company and failure of such approval to be granted would have
a material adverse effect on the Company's business, financial condition and
results of operations. In addition, failure to receive FDA approval for the VISX
System for LVC could materially affect the perception of the Company in the
marketplace, and could also have a material adverse effect on the Company's
business, financial condition and results of operations.
UNCERTAINTY OF MARKET ACCEPTANCE
The Company believes that its profitability and growth will depend upon
broad acceptance of LVC in the United States and key international markets
targeted by the Company. There can be no assurance that LVC will be accepted by
either the ophthalmic community or the general population as an alternative to
existing methods of treating refractive vision disorders. The acceptance of LVC
may be affected adversely by its cost, concerns relating to its safety and
efficacy, general resistance to surgery, the effectiveness of alternative
methods of correcting refractive vision disorders, the lack of long-term
follow-up data, the possibility of unknown side effects, and the lack of
third-party reimbursement for the procedure. Many consumers may choose not to
have LVC due to the availability of nonsurgical methods for vision correction.
Any future reported adverse events or other unfavorable publicity involving
patient outcomes from use of LVC systems manufactured by any participant in the
LVC market could also adversely affect acceptance of the procedure. Market
acceptance could also be affected by the ability of the Company and other
participants in the LVC market to train a broad population of ophthalmologists
in the procedure. Ophthalmologist acceptance could also be affected by the cost
of the excimer laser systems used to perform LVC. Promotional efforts by
suppliers of products or procedures which are alternatives to LVC, including
eyeglasses and contact lenses, may also adversely affect the market acceptance
of LVC. The failure of LVC to achieve broad market acceptance would have a
material adverse effect on the Company's business, financial condition and
results of operations.
RISKS RELATING TO PILLAR POINT PARTNERS
The agreements establishing Pillar Point (collectively, the "Pillar Point
Agreement") contemplate that royalties will be paid to Pillar Point each time a
laser system is used to perform LVC in the United States under licenses granted
to the Company, Summit or other manufacturers. Should the Company receive PMA
from the FDA for LVC, the Company will seek to establish and maintain
contractual arrangements permitting it to collect per procedure royalties from
use of VISX Systems. There can, however, be no assurance that the Company or
Summit will be able to collect such royalties. In forming Pillar Point, the
Company and Summit endeavored to structure the operations of the partnership in
a manner consistent with antitrust laws. The compliance of Pillar Point with
these laws will depend upon the activities of the partners, a determination of
what constitutes a relevant market for purposes of such laws, the nature of the
patents, the number and
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relative strength of competitors in such markets and numerous other factors,
many of which are presently unknown or are beyond the control of Pillar Point,
VISX and Summit. No assurance can be given that the activities of Pillar Point
will not be challenged under such laws. In March 1995, Pillar Point sued
LaserSight, Inc. for patent infringement in the Federal District Court for
Delaware. In that action, LaserSight has asserted several affirmative defenses
and has entered a declaratory judgment counterclaim asserting, among other
things, that the Pillar Point Agreement constitutes patent misuse. Any
successful challenge to the operation of Pillar Point or to its patents could
have a material adverse effect on the Company's business, financial condition
and results of operations.
In addition, there can be no assurance that the Pillar Point Agreement will
preclude patent disputes with Summit relating to technology not included in
Pillar Point in the United States or relating to any technology outside the
United States. In particular, Summit has sued VISX in the United States under a
patent held by Summit and not licensed to Pillar Point, and VISX has sued Summit
in Canada for infringement of certain of VISX's Canadian patents. See
"-- Reliance on Patents and Proprietary Technology; Risks Related to Patent
Litigation."
RELIANCE ON PATENTS AND PROPRIETARY TECHNOLOGY; RISKS RELATED TO PATENT
LITIGATION
Protection of the Company's proprietary technology is important to its
business. In the United States, there are a number of patents covering methods
and apparatus for performing corneal surgery with ultraviolet lasers, including
patents owned by VISX and Summit. Pursuant to the Pillar Point Agreement VISX
and Summit each contributed their rights under United States patents previously
issued to them covering apparatus and methods for performing ultraviolet laser
corneal surgery. The Pillar Point Agreement also provides that certain other
patent rights obtained by either VISX or Summit must be contributed or offered
to Pillar Point, depending upon the nature of the particular patent rights
involved. In addition, there are also multiple foreign patents covering
apparatus for performing excimer laser corneal surgery, including patents or
patent rights held by VISX, Summit, and others.
There can be no assurance that the United States patent rights held by
Pillar Point or international patents held by VISX will afford any significant
degree of protection or provide the Company with a competitive advantage. In
particular, there can be no assurance that any such patents will not be
challenged, invalidated or circumvented in the future, either in the United
States or internationally. Failure to maintain the protection afforded by the
patents held by Pillar Point and the Company's international patents would have
a material adverse effect on the Company's future revenues and ability to become
profitable. Further, there can be no assurance that the patents held by Pillar
Point or the Company's international patents will ultimately be found to be
valid or enforceable or that the Company's patent rights will deter others from
developing substantially equivalent or competitive products.
In addition, the medical device industry, including the ophthalmic laser
sector, has been characterized by substantial litigation, both in the United
States and internationally, regarding patents and proprietary rights. The
Company is engaged in several pending patent proceedings, both in the United
States and internationally. In the United States, Summit has sued the Company
for infringement of a patent held by Summit and not licensed to Pillar Point.
Internationally, the Company has filed actions alleging infringement of its
patents against certain parties in Canada, is involved in opposition proceedings
challenging the issuance of certain patents in the European Patent Office
("EPO") and has filed an action alleging patent infringement against a company
in Germany. There can be no assurance that additional patent infringement claims
in the United States or in other countries will not be asserted against VISX by
Summit (limited in the United States to patent rights not included in Pillar
Point) or others, or, if asserted, that VISX will be successful in defending
against such claims. Furthermore, Pillar Point or VISX may undertake additional
infringement actions against others. Infringement actions with respect to United
States patents licensed to Pillar Point could be brought or defended by Pillar
Point, although the partners would have the right to initiate, pursue, defend or
participate in such actions if Pillar Point declined to do so. The defense and
prosecution of patent proceedings is costly and involves substantial commitments
of management time. Adverse determinations in litigation or other patent
proceedings to which the Company currently is or may become a party could
subject the Company to significant liabilities to third parties and require the
Company to seek licenses from third parties. Although patent and intellectual
property disputes in the medical device area have often been settled through
licensing
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or similar arrangements, costs associated with such arrangements may be
substantial and could include ongoing royalties. Furthermore, there can be no
assurance that necessary licenses would be available to the Company on
satisfactory terms or at all. Accordingly, an adverse determination in a
judicial or administrative proceeding or failure to obtain necessary licenses
could prevent the Company from manufacturing and selling its products in one or
more markets, which would have a material adverse effect on the Company's
business, financial condition and results of operations. In addition, the
Company's marketing agreement with Alcon is terminable if any of the Company's
patent rights is found to be unenforceable or invalid in the United States,
which could adversely affect the marketing of the VISX System.
LACK OF FDA APPROVAL FOR LVC; GOVERNMENT REGULATION
LVC systems, including the VISX System, are regulated in the United States
as medical devices by the FDA under the federal Food, Drug, and Cosmetic Act
("FDC Act") and, as such, require FDA approval of a PMA application prior to
commercial sale in the United States. The process of obtaining approval of a PMA
application is lengthy, expensive and uncertain, generally takes several years
or longer to complete, if approval is obtained at all, and requires the
submission of extensive clinical data and supporting information to the FDA. The
PMA process also typically requires a public hearing before an advisory panel
comprised of experts in the relevant field. The FDA is not bound by the advisory
panel's recommendations; however, it tends to accord them significant weight.
On September 29, 1995, the Company received FDA approval of its PMA
application for the VISX System for PTK. On October 20, 1995, the FDA's
Ophthalmic Devices Advisory Panel gave a favorable recommendation for approval
of the Company's PMA application for the VISX System for treatment of low-level
myopia. The panel's recommendation is subject to VISX providing the panel with
certain additional updated follow-up data on patients previously treated with
the VISX System. Although the FDA is not bound by the advisory panel's
recommendations and there can be no assurance that such approval will be
received, the FDA tends to accord significant weight to advisory panel
recommendations in determining whether to grant PMA. In light of the favorable
panel recommendation, the FDA will continue its review of the Company's PMA
application, particularly in light of the observations and recommendations made
by the panel. The favorable panel recommendation does not assure receipt of PMA,
and the time frame required to obtain a PMA following the panel recommendation
could be significant. Accordingly, there can be no assurance as to when or
whether the Company will receive PMA for the VISX System for LVC. Summit has
received FDA approval of its PMA application for treatment of nearsightedness
using LVC. The failure of LVC systems to be approved by the FDA would have a
material adverse effect on the Company's business, financial condition and
results of operations.
In June 1995, the FDA promulgated a draft proposal entitled "FDA Guidance
for Photorefractive Keratectomy Laser Systems: IDE Studies and PMA
Applications." The proposal, which would add substantial additional requirements
for LVC clinical trials, is intended to supersede prior draft guidelines
promulgated by the FDA in 1990 but never finalized. In July 1995, at a public
hearing regarding the draft proposal, the FDA and the Ophthalmic Devices
Advisory Panel heard recommendations from various industry sources. It is
uncertain as to whether the FDA will accept all or any of the recommended
changes to the draft proposal. FDA implementation of some or all of proposal's
recommendations could, particularly if such implementation is retroactive,
require the Company to submit additional clinical data, including data not
collected in the Company's United States clinical trials. Such implementation
could therefore substantially delay receipt of PMA for the VISX System for LVC
and increase the likelihood that the Company will not be able to obtain such
approval.
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Products manufactured or distributed by the Company pursuant to a PMA will
be subject to pervasive and continuing regulation by the FDA. The FDC Act also
requires the Company to manufacture its products in accordance with its Good
Manufacturing Practices ("GMP") regulations. The Company's facilities are
subject to periodic GMP inspections by the FDA. These regulations impose certain
procedural and documentation requirements upon the Company with respect to
manufacturing and quality assurance activities. The FDA has proposed amendments
to the GMP regulations which will likely increase the cost of compliance with
GMP requirements. Labeling and promotional activities are subject to scrutiny by
the FDA, and current FDA enforcement policy prohibits the marketing of approved
medical devices for unapproved uses. Noncompliance with applicable requirements
can result in, among other things, warning letters, fines, injunctions,
penalties, recall or seizure of products, total or partial suspension of
production, denial or withdrawal of premarket approval of devices, and criminal
prosecution. Changes in existing regulatory requirements or adoption of new
requirements could have a material adverse effect on the Company's business,
financial condition and results of operations. There can be no assurance that
the Company will not be required to incur significant costs to comply with laws
and regulations in the future or that laws and regulations will not have a
material adverse effect on the Company's business, financial condition or
results of operations.
International sales of LVC systems, including the VISX System, are subject
to regulations governing the sale of medical devices in the countries in which
these systems are sold, as well as to FDA export clearances. International
regulatory requirements vary by country and there can be no assurance that VISX
will receive additional international regulatory approvals or meet requirements
for ongoing commercial sales, or as to the associated cost or delay. Failure to
receive approval in, or meet the requirements of, any country would prevent the
Company from selling its products in such country, which could adversely affect
the Company's results of operations.
LACK OF LONG-TERM FOLLOW-UP DATA; UNDETERMINED MEDICAL RISKS
Concerns with respect to the safety and efficacy of LVC include
predictability and stability of results. Potential complications and side
effects include: post-operative discomfort; corneal haze during healing (an
increase in the light scattering properties of the cornea); glare/halos
(undesirable visual sensations produced by bright lights); decreases in contrast
sensitivity; temporary increases in intraocular pressure in reaction to
procedure medication; modest fluctuations in refractive capabilities during
healing; modest decrease in best corrected vision (i.e., with corrective
eyewear); unintended over- or under-corrections; regression of effect; disorders
of corneal healing; corneal scars; corneal ulcers and induced astigmatism. There
can be no assurance that long-term follow-up data will not reveal additional
complications that may have a material adverse effect on acceptance of LVC which
in turn would have a material adverse effect on the Company's business,
financial condition and results of operations. Concern over the safety of LVC or
other procedures could in turn adversely affect market acceptance of LVC and the
VISX System or result in adverse regulatory action, including product recalls,
any of which could have a material adverse effect on the Company's business,
financial condition and results of operations.
DEPENDENCE ON THIRD-PARTY SALES AND MARKETING; RISKS ASSOCIATED WITH
INTERNATIONAL SALES
Alcon Laboratories, Inc. and its affiliates ("Alcon") serves as the
Company's exclusive international distributor and has exclusive domestic sales
and marketing rights. Accordingly, the Company is entirely dependent upon the
efforts of Alcon for international sales of VISX Systems and will be dependent
upon Alcon for domestic product sales. Furthermore, the Company's international
marketing agreement with Alcon does not contain specified minimum purchase
commitments and requires annual agreement on unit pricing and number of systems
to be purchased by Alcon. The agreement provides that disputes thereunder as to
pricing and certain other matters are to be resolved by binding arbitration. The
Company's domestic agreement provides that sales targets are also subject to
binding arbitration if not agreed upon by the parties. Both agreements also
require the Company to indemnify Alcon and its affiliates for damages, up to an
aggregate of $4.0 million, arising out of certain potential claims, including
personal injury and patent infringement claims. As part of ongoing settlement
discussions among VISX, Alcon and other participants in
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VISX's pending shareholder derivative litigation, it is possible that the
resolution of such litigation could include a restructuring of the existing
agreements and relationship between VISX and Alcon.
International sales may be limited or disrupted by the imposition of
government controls, export license requirements, political instability, trade
restrictions, changes in tariffs, difficulties in staffing and coordinating
communications among and managing international operations. Additionally, the
Company's business, financial condition and international results of operations
may be adversely affected by increases in duty rates, difficulties in obtaining
export licenses, ability to maintain or increase prices, and competition.
COMPETITION AND TECHNOLOGICAL CHANGE
The medical device and ophthalmic laser industries are subject to intense
competition and technological change. LVC using excimer laser systems for
treatment of refractive disorders competes with eyeglasses, contact lenses and
radial keratotomy ("RK"), as well as with other technologies and surgical
techniques currently under development, such as corneal implants and surgery
using different types of lasers. In the United States, the Company believes that
it and Summit are the leading manufacturers of excimer laser systems. In
September 1995, Summit announced that it received an approvable letter from FDA
for its PMA application for LVC for treatment of nearsightedness. Summit has
indicated that the approvable letter positions Summit to receive FDA approval to
market its LVC system for treatment of nearsightedness by the end of 1995. An
LVC approval would enable Summit to commence commercial sale of its laser system
for LVC in the United States prior to the Company, which, although the Company
would receive per procedure and equipment royalties through Pillar Point, would
afford Summit a competitive advantage with respect to equipment sales for LVC.
Use of the VISX System for PTK to treat corneal pathologies competes with
corneal transplants, surgery and drug treatments. The VISX System also competes
with products marketed or under development by other laser and medical equipment
manufacturers, many of which may have greater financial and other resources than
the Company. Additionally, competitors, both in the United States and abroad,
may enter the excimer laser equipment manufacturing business or acquire existing
companies. Such competitors may be able to offer their products at a lower cost
or may develop procedures that involve a lower per procedure cost. Competition
from new entrants may be particularly prevalent in those countries where
significant regulatory approvals are not required. In addition, medical
companies, academic and research institutions and others could develop new
therapies, including new medical devices or surgical procedures, for the
conditions targeted by the Company, which therapies could be more medically
effective and less expensive than LVC, and could potentially render LVC
obsolete. Any such developments could have a material adverse effect on the
business, financial condition and results of operations of the Company.
VOLATILITY OF STOCK PRICE
The Company's Common Stock has experienced substantial price volatility,
and such volatility may occur in the future. In addition, the stock market from
time to time has experienced extreme price and volume fluctuations that have
affected the market price of many companies and have often been unrelated to the
operating performance of particular companies. Factors such as developments with
respect to the Company's PMA applications and clinical trials, fluctuations in
the Company's operating results, announcements of technological innovations or
new products by the Company or its competitors, developments with respect to
patents or proprietary rights and litigation relating thereto, public concern as
to the safety of products developed by the Company or others, changes in
recommendations of securities analysts and general market conditions may have a
significant effect on the market price of the Company's Common Stock.
PRODUCT LIABILITY AND INSURANCE
Inherent in the testing and use of human health care devices is the
potentially significant risk of physical injury to patients which could result
in product liability or other claims based upon injuries or alleged injuries
associated with a defect in the product's performance, which may not become
evident for a number of years. The VISX System includes high-voltage power
supplies, cryogenic subsystems, high-pressure gases, toxic gases, and other
potentially hazardous factors. In the event of an accident, the Company could be
liable for
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any damages that result, and any such liability could exceed the resources of
the Company. VISX maintains a "claims made" product liability insurance policy
in the amount of $4.0 million, which is the maximum payout for all claims that
could be made during the policy period. The inability of the Company to maintain
adequate insurance coverage as well as any product liability or personal injury
claims in excess of the Company's insurance coverage could have a material
adverse effect on the Company's business, financial condition and results of
operations.
MANUFACTURING RISKS
The Company currently does not have experience manufacturing its VISX
System in large-scale, commercial quantities. In the event that the Company
receives FDA approval for LVC, the Company would need to hire and train
additional manufacturing personnel to meet increased production requirements. In
addition, the Company contracts with third parties for the manufacture or
assembly of certain components. Several of these components are currently
provided by a single vendor. If any of these suppliers were to cease providing
components to the Company, the Company would be required to locate and contract
with a substitute supplier, and there can be no assurances that such substitute
supplier could be located and qualified in a timely manner or could provide
required components on commercially reasonable terms. A failure to increase
production volumes in a cost-effective or timely manner, or an interruption in
the manufacturing of VISX Systems, could have a material adverse effect on the
Company's business, financial condition and results of operations.
FUTURE CAPITAL REQUIREMENTS
Although the Company anticipates that the net proceeds of this Offering
will be sufficient to meet the Company's capital requirements for at least the
next 24 months, there can be no assurance that the Company will not require
additional financing. The Company's future liquidity and capital requirements
will depend upon numerous factors, including the timing of FDA approval of an
LVC system. Future financings may result in the issuance of senior securities or
in dilution to holders of the Common Stock. Any such financing, if required, may
not be available on satisfactory terms or at all.
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SELLING STOCKHOLDERS
The following table sets forth certain information known to the Company
with respect to beneficial ownership of the Company's Common Stock as of March
27, 1995 by each Selling Stockholder. Since March 27, 1995, the beneficial
ownership of Selling Stockholders has changed due primarily to sales of shares
of Common Stock offered hereby and to other sales and purchases of Common Stock
by Selling Stockholders.
<TABLE>
<CAPTION>
BENEFICIAL OWNERSHIP BENEFICIAL OWNERSHIP
BEFORE OFFERING AFTER OFFERING
--------------------- SHARES ------------------------------
SELLING STOCKHOLDER SHARES PERCENT OFFERED SHARES PERCENT
- ------------------------------------- ------- ---------- ------- ------ --------------------
<S> <C> <C> <C> <C> <C>
Morgan Guaranty Trust Company of New
York............................... 250,000 2.1% 250,000 -- --
Allen & Company Incorporated(1)...... 250,000 2.1 200,000 50,000 *
Citiperformance Portfolio, S.A....... 200,000 1.7 200,000 -- --
Charles Moore........................ 150,000 1.3 150,000 -- --
PaineWebber Growth Fund.............. 130,354 1.1 92,500 37,854 *
Brae Group, Inc...................... 100,000 * 100,000 -- --
Gregory P. Shlopak................... 100,000 * 100,000 -- --
Patrick D. Brady..................... 25,000 * 25,000 -- --
Steven R. Berrard.................... 25,000 * 25,000 -- --
M.H. Whittier Corporation............ 20,000 * 20,000 -- --
PaineWebber Growth Portfolio......... 30,000 * 7,500 22,500 *
Laura Lee W. Woods 1966 Trust........ 7,000 * 7,000 -- --
Winifred W. Rhodes-Bea 1966 Trust.... 5,000 * 5,000 -- --
O. Whittier Testamentary Trust UDD
1-1-76 ............................ 5,000 * 5,000 -- --
Laure L. Woods 1983 Trust............ 5,000 * 5,000 -- --
H.W. Woodward 1966 Trust FBO M.
Constance ......................... 5,000 * 5,000 --
Frontiere Family Revocable Trust..... 3,000 * 3,000 -- --
</TABLE>
- ---------------
* Less than one percent of the outstanding Common Stock.
(1) Allen & Company Incorporated has served as financial advisor to the Company
and acted as Placement Agent on behalf of the Company for the private
placement of the Common Stock being offered hereby.
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PLAN OF DISTRIBUTION
Shares of Common Stock covered hereby may be offered and sold from time to
time by the Selling Stockholders. The Selling Stockholders will act
independently of the Company in making decisions with respect to the timing,
manner and size of each sale. The Selling Stockholders may sell the Shares being
offered hereby: (i) on the Nasdaq National Market, or otherwise at prices and at
terms then prevailing or at prices related to the then current market price; or
(ii) in private sales at negotiated prices directly or through a broker or
brokers, who may act as agent or as principal or by a combination of such
methods of sale. The Selling Stockholders and any underwriter, dealer or agent
who participate in the distribution of such shares may be deemed to be
"underwriters" under the Securities Act, and any discount, commission or
concession received by such persons might be deemed to be an underwriting
discount or commission under the Securities Act. The Company has agreed to
indemnify the Selling Stockholders against certain liabilities arising under the
Securities Act.
Any broker-dealer participating in such transactions as agent may receive
commissions from the Selling Stockholders (and, if acting as agent for the
purchaser of such shares, from such purchaser). Usual and customary brokerage
fees will be paid by the Selling Stockholders. Broker-dealers may agree with the
Selling Stockholders to sell a specified number of shares at a stipulated price
per share, and, to the extent such a broker-dealer is unable to do so acting as
agent for the Selling Stockholders, to purchase as principal any unsold shares
at the price required to fulfill the broker-dealer commitment to the Selling
Stockholders. Broker-dealers who acquire shares as principal may thereafter
resell such shares from time to time in transactions (which may involve crosses
and block transactions and which may involve sales to and through other
broker-dealers, including transactions of the nature described above) in the
over-the-counter market, in negotiated transactions or by a combination of such
methods of sale or otherwise at market prices prevailing at the time of sale or
at negotiated prices, and in connection with such resales may pay to or receive
from the purchasers of such shares commissions computed as described above.
The Company has advised the Selling Stockholders that the anti-manipulation
Rules 10b-6 and 10b-7 under the Exchange Act may apply to sales of Shares in the
market and to the activities of the Selling Stockholders and their affiliates.
In addition, the Company will make copies of this Prospectus available to the
Selling Stockholders and has informed them of the need for delivery of copies of
this Prospectus to purchasers on or prior to sales of the Shares offered hereby.
The Selling Stockholders may indemnify any broker-dealer that participates in
transactions involving the sale of the shares against certain liabilities,
including liabilities arising under the Securities Act. Any commissions paid or
any discounts or concessions allowed to any such broker-dealers, and any profits
received on the resale of such shares, may be deemed to be underwriting
discounts and commissions under the Securities Act if any such broker-dealers
purchase shares as principal.
In order to comply with the securities laws of certain states, if
applicable, the Common Stock will be sold in such jurisdictions only through
registered or licensed brokers or dealers. In addition, in certain states, the
Common Stock may not be sold unless such shares have been registered or
qualified for sale in the applicable state or an exemption from the registration
or qualification requirement is available and is complied with.
At the time a particular offer of the shares of Common Stock registered
hereunder is made, if required, a Prospectus Supplement will be distributed that
will set forth the number of shares being offered and the terms of the offering
including the name of any underwriter, dealer or agent, the purchase price paid
by any underwriter for securities purchased from, any discount, commission and
other item constituting compensation and any discount, commission or concession
allowed or reallowed or paid to any dealer, and the proposed selling price to
the public.
There can be no assurance that the Selling Stockholders will sell all or
any of the shares of Common Stock offered hereunder.
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LEGAL MATTERS
The validity of the shares of Common Stock offered hereby will be passed
upon by Wilson, Sonsini, Goodrich, & Rosati, Professional Corporation, Palo
Alto, California, counsel to the Company.
EXPERTS
The consolidated financial statements as of December 31, 1994 and 1993 and
for each of the three years in the period ended December 31, 1994 incorporated
by reference in this Registration Statement have been audited by Arthur Andersen
LLP, independent public accountants, as indicated in their report with respect
thereto, and are incorporated by reference herein in reliance upon the authority
of said firm as experts in giving said reports.
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