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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-8
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
STAAR SURGICAL COMPANY
(Exact name of registrant as specified in its charter)
Delaware 95-3797439
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
1911 Walker Avenue
Monrovia, California 91016
(Address of principal executive offices) (Zip Code)
1996 STAAR Surgical Company Non-Qualified Stock Plan
(Full title of the plan)
Andrew F. Pollet
1911 Walker Avenue
Monrovia, California 91016
(Name and address of agent for service)
(626) 303-7902
(Telephone number, including area code, of agent for service)
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CALCULATION OF REGISTRATION FEE
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PROPOSED MAXIMUM PROPOSED MAXIMUM
TITLE OF SECURITIES AMOUNT TO BE OFFERING PRICE PER AGGREGATE OFFERING AMOUNT OF
TO BE REGISTERED REGISTERED(1) SHARE(2) PRICE(2) REGISTRATION FEE
----------------------- --------------------- -------------------- --------------------- --------------------
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Common Stock 173,500 $15.03 $2,607,705 $688.43
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(1) This Registration Statement shall also cover any additional shares of common
stock which become issuable under the 1996 STAAR Surgical Company Non-Qualified
Stock Plan by reason of any stock dividend, stock split, recapitalization or
other similar transaction effected without the Registrant's receipt of
consideration which results in an increase in the number of the outstanding
shares of Registrant's common stock.
(2) Estimated pursuant to Rule 457(c) solely for purposes of calculating amount
of registration fee, based upon the average of the high and low prices reported
on December 15, 2000, as reported on the Nasdaq Stock Market.
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[STARR SURGICAL LOGO]
STAAR SURGICAL COMPANY
173,500 SHARES
COMMON STOCK ISSUED PURSUANT TO THE
1996 STAAR SURGICAL COMPANY NON-QUALIFIED STOCK PLAN
This re-offer prospectus covers the offering of 173,500 shares of STAAR Surgical
Company common stock issued pursuant to the 1996 STAAR Surgical Company
Non-Qualified Stock Plan. Our common stock is listed on the Nasdaq National
Market under the symbol "STAA" and information on us can be inspected and copied
at Nasdaq at 1735 K Street, N.W., Washington, D.C. 20006.
AN INVESTMENT IN OUR SECURITIES INVOLVES A HIGH DEGREE OF RISK. YOU SHOULD
PURCHASE OUR SECURITIES ONLY IF YOU CAN AFFORD A COMPLETE LOSS OF YOUR
INVESTMENT. SEE "RISK FACTORS" BEGINNING ON PAGE 3.
NEITHER THE SEC NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED
THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY
REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The date of this prospectus is December 15, 2000.
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TABLE OF CONTENTS
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PAGE
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Prospectus Summary...................................1
Risk Factors.........................................3
Use of Proceeds.....................................15
Selling Shareholders and
Plan of Distribution................................15
Named Experts and Interest of Counsel...............16
Material Changes....................................17
Incorporation of Certain Documents
by Reference........................................18
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PROSPECTUS SUMMARY
THE COMPANY
We were incorporated in California in 1982 as the successor to a partnership
created for the purpose of developing, producing and marketing products for
minimally invasive ophthalmic surgery. We reincorporated in Delaware in April
1986. We develop, produce, market and globally distribute innovative products
for minimally invasive ophthalmic surgery. Our products are used by
ophthalmologists and other eye care professionals to improve or correct vision
in patients suffering from refractive conditions such as myopia, commonly known
as nearsightedness, and hyperopia, commonly known as farsightedness, cataracts
and glaucoma.
AVAILABLE INFORMATION
We are subject to the informational requirements of the Securities Exchange Act
of 1934 and must file reports, proxy statements and other information with the
Securities and Exchange Commission. The reports, information statements and
other information we file with the Commission can be inspected and copied at the
Commission at Room 1024, 450 Fifth Street, N.W. Washington, D.C. 20549, and at
its regional offices located at 7 World Trade Center, 13th Floor, New York, New
York 10048 and Northwestern Atrium Center, 500 West Madison Street, Suite 1400,
Chicago, Illinois 60661. You may obtain information on the operation of the
Public Reference Room by calling the SEC at (800) SEC-0330. The Commission also
maintains a Web site (http://www.sec.gov) that contains reports, proxy, and
information statements and other information regarding Registrants, such as us,
which file electronically with the Commission.
This prospectus constitutes a part of a Registration Statement on Form S-8 filed
by us with the Commission under the Securities Act of 1933. As permitted by the
rules and regulations of the Commission, this prospectus omits certain of the
information contained in the Registration Statement. We refer you to the
Registration Statement and related exhibits for further information with respect
to us and the securities offered. Statements contained in the prospectus
concerning the content of any documents filed as an exhibit to the Registration
Statement (or otherwise filed with the Commission) are not necessarily complete.
In each instance you may refer to the copy of the filed document. Each statement
is qualified in its entirety by such reference.
No person is authorized to give you any information or make any representation
other than those contained or incorporated by reference in this prospectus. Any
such information or representation must not be relied upon as having been
authorized. This prospectus does not constitute an offer to sell or a
solicitation of any offer to buy any of the securities offered hereby in any
jurisdiction to any person to whom it is unlawful to make such offer or
solicitation in such jurisdiction. Neither the delivery of this prospectus nor
any sale made hereunder shall, under any circumstances, create any implication
that there has been no change in our affairs since the date of the prospectus.
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DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, including all documents incorporated by reference, includes
"forward-looking statements" within the meaning of Section 27A of the Securities
Act and Section 21E of the Securities Exchange Act. All statements other than
statements of historical facts included in this prospectus, including without
limitation, statements under "Recent Developments," and "Risk Factors" regarding
our financial position, business strategy, and plans and objectives of our
management for future operations, are forward-looking statements. Although we
believe that the expectations reflected in such forward-looking statements are
reasonable, we can give no assurance that such expectations will prove to have
been correct. Important factors that could cause actual results to differ
materially from our expectations are disclosed under "Risk Factors" and
elsewhere in this prospectus. All subsequent written and oral forward-looking
statements attributable to us or persons acting on our behalf are expressly
qualified in their entirety by this section.
HOW TO CONTACT US
Our principal executive offices are located at 1911 Walker Avenue, Monrovia,
California 91016. Our telephone number is (626) 303-7902 and our website address
is http:\\www.staar.com.
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RISK FACTORS
AN INVESTMENT IN OUR COMMON STOCK IS HIGHLY SPECULATIVE, INVOLVES A HIGH DEGREE
OF RISK, AND SHOULD BE MADE ONLY BY INVESTORS WHO CAN AFFORD A COMPLETE LOSS OF
THEIR INVESTMENT. YOU SHOULD CAREFULLY CONSIDER, TOGETHER WITH THE OTHER MATTERS
REFERRED TO IN THIS PROSPECTUS, THE FOLLOWING RISK FACTORS BEFORE YOU DECIDE TO
BUY OUR COMMON STOCK.
WE HAVE GENERATED ONLY LIMITED REVENUES TO DATE AND WE MAY NOT BE ABLE TO
ACHIEVE OR MAINTAIN LONG-TERM PROFITABILITY. OUR FUTURE SUCCESS WILL DEPEND A
GREAT DEAL ON OUR ABILITY TO SUCCESSFULLY COMMERCIALIZE THE AQUA-FLOW-TM-
GLAUCOMA DEVICE AND THE ICL-TM-.
We have generated only limited revenues to date. We have earned only modest
profits in fiscal years 1997, 1998 and 1999. We cannot assure you that we will
not incur substantial losses in the future, particularly as we expand our sales
and marketing efforts for the Aqua-Flow-TM- Glaucoma Device and the ICL-TM-, if
approved, and increase research and development, clinical trial and
administrative activities.
Our ability to achieve and maintain long-term profitability depends to a
significant extent on obtaining regulatory approval for and successfully
commercializing the Aqua-Flow-TM- Glaucoma Device and the ICL-TM-, and also on
successfully completing preclinical and clinical trials, obtaining required
regulatory approvals and successfully developing, manufacturing and marketing
our other current and future product candidates. In order to successfully
commercialize the Aqua-Flow-TM- Glaucoma Device and the ICL-TM-, we must be able
to, among other things, obtain regulatory approval for these products. We cannot
assure you that the FDA will approve these products in a timely manner, if at
all. If we fail to successfully obtain regulatory approval for the Aqua-Flow-TM-
Glaucoma Device and the ICL-TM-, our business, financial condition and operating
results will be materially harmed and our stock price would be adversely
affected. We cannot assure you that we will be able to achieve any of the
foregoing or that we will be able to achieve and maintain long-term
profitability even if we successfully commercialize our products.
WE FACE INTENSE COMPETITION AND RAPID TECHNOLOGICAL CHANGE THAT COULD RESULT IN
PRODUCTS THAT ARE SUPERIOR TO THE PRODUCTS WE ARE COMMERCIALIZING OR DEVELOPING.
The market for ophthalmic products is intensely competitive and is subject to
rapid and significant technological change. We have numerous competitors in the
United States and abroad, including, among others, large companies such as
Alcon, Mentor, Summit, VISX, Bausch & Lomb, Merck & Company, Allergan, CIBA
Vision Corporation, Pharmacia, and Nidek Co., Ltd. These competitors may develop
technologies and products that are more effective or less costly than any of our
current or future products or that could render our products obsolete or
noncompetitive. Many of these competitors have substantially more resources and
marketing capabilities than we do. In addition, the medical technology and
device industry continues to experience consolidation, resulting in an
increasing number of larger, more diversified companies than us. Among other
things, these companies can spread their research and development costs over
much broader revenue bases than we can and can influence customer and
distributor buying decisions.
If our ICL-TM- receives required regulatory approval, we will also compete with
manufacturers of traditional vision correction techniques, such as contact
lenses and eyeglasses, and with alternative technologies, such as other surgical
and laser refractive procedures. If other surgical and laser refractive
procedures become increasingly accepted as effective and safe techniques for
permanent vision correction, or are perceived as more effective or safer than
our techniques, it could substantially impact
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the available market for our products generally, and the ICL-TM- in particular,
and have a material and adverse effect on our business.
Our ophthalmic products and techniques may not gain market acceptance among
physicians, patients, healthcare payors and the medical community. Significant
factors in determining whether we will be able to compete successfully include:
- the efficacy and safety of our products;
- our manufacturing and development capabilities;
- the time and scope of regulatory approval;
- reimbursement coverage from insurance companies and others;
- the price and cost-effectiveness of our products; and
- patent protection.
We will be required to continue to devote significant financial and other
resources to enhance our existing products and develop new products. If we are
unable to effectively compete, we may experience a decline in sales volume of
our existing products or an inability to attain sufficient market penetration
for new products and price reductions, either of which would materially harm us.
MANY OF OUR PRODUCTS AND PRODUCT CANDIDATES ARE BASED ON NOVEL TECHNOLOGY AND,
CONSEQUENTLY, ARE INHERENTLY RISKY. CONCERNS ABOUT THE SAFETY AND EFFICACY OF
OUR PRODUCTS COULD LIMIT OUR FUTURE REVENUES.
We are subject to the risks of failure inherent in the development of product
candidates and procedures based on new technologies. These risks include the
possibility that the products and technologies we use will not be effective, our
product candidates will be unsafe or otherwise fail to receive the necessary
regulatory approvals, our product candidates will be hard to manufacture on a
large scale or will be uneconomical to market or we will not successfully
overcome technological challenges presented by our products.
In particular, there is a risk that the marketplace will not accept, or be
receptive to, the potential benefits of the Aqua-Flow-TM- Glaucoma Device or the
ICL-TM-. Unless and until these new products are accepted by the market and
begin generating meaningful revenues, our financial condition and prospects will
continue to be solely dependent upon our line of cataract products. Acceptance
of our new products, including the Aqua-Flow-TM- Glaucoma Device and the
ICL-TM-, will depend on a number of factors, including:
- the efficiency, performance and attributes of these new products;
- our ability to obtain necessary regulatory approvals to market the new
products;
- the effectiveness of our marketing and sales efforts, including educating
ophthalmologists and other potential customers as to the distinctive
characteristics and benefits of these new products;
- the rate at which ophthalmologists attain the necessary surgical skills to
implant these new products;
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- our ability to meet manufacturing and delivery schedules;
- product pricing; and
- general economic conditions affecting customers' purchasing patterns.
In addition, physicians and consumers may have a number of concerns about the
safety and efficacy of our products, including the ICL-TM-, and general
acceptance among physicians and consumers regarding our products in development
may require even greater levels of research and information to allay concerns.
Most medical products and treatments, including ours, involve multiple potential
complications and side effects, not all of which can be predicted with accuracy
and many of which may vary from patient to patient. Long-term follow-up data may
reveal additional complications associated with our products. The responses of
potential physicians and others to information about complications could
materially affect the market acceptance of our products, which in turn would
materially harm our business.
LONG-TERM USE OF OUR PRODUCTS MAY NOT YIELD THE SAME RESULTS AS THOSE
DEMONSTRATED IN CLINICAL TRIALS OR OVER SHORT-TERM USE.
While our products are subject to substantial FDA scrutiny requiring multiple
clinical studies and are monitored regarding efficacy or safety over time, it is
possible that the same results shown in clinical studies and over short-term use
of our products may not be the same over long-term use. It is possible that
long-term effectiveness or safety will be less favorable than previously
experienced or projected. If long-term patient use or clinical experience
indicates that our products or procedures do not provide patients with sustained
benefits, or cause adverse side effects, our sales could decline and we could be
subject to significant liability.
OUR OPERATING RESULTS HAVE VARIED SIGNIFICANTLY IN THE PAST AND COULD VARY
SIGNIFICANTLY IN THE FUTURE BASED ON A NUMBER OF FACTORS.
Our operating results have fluctuated significantly in the past. We believe that
they may continue to fluctuate significantly in the future. A number of factors
have led to periodic variations in our operating results, including:
- competitors announcing technological innovations or new commercial
products;
- developments concerning proprietary rights, including patents;
- competitors' publicity regarding actual or potential products under
development;
- regulatory developments in the United States and foreign countries;
- period-to-period fluctuations in our financial results;
- litigation;
- economic and other external factors, including disasters and other crises.
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If in one or more future quarters our results of operations fall below
expectations of securities analysts and investors, our stock price could be
significantly harmed.
REGULATORY AND LEGAL UNCERTAINTIES COULD RESULT IN SIGNIFICANT COSTS OR
OTHERWISE HARM OUR BUSINESS.
In order to manufacture and sell our products, we must comply with extensive
international and domestic regulation. In order to sell our products in the
United States, approval from the FDA is required. The FDA approval process is
expensive and time-consuming. We cannot predict which of our products that have
not received FDA approval will be approved. Even if they are approved, we cannot
predict the time frame for approval because it is subject to an independent
governmental agency over which we have no control. Delays in approval will
adversely affect the marketing and sale of our products. Foreign regulatory
requirements differ from jurisdiction to jurisdiction and may, in some cases, be
more stringent or difficult to obtain than FDA approval. In order to sell
products in the countries comprising the European Economic Union, we must
satisfy Union-wide regulatory requirements, even if we have previously received
approvals from individual member countries. As with the FDA, we cannot predict
if or when we will obtain these regulatory approvals. Delays in these approvals
will also have an adverse affect on the marketing and sale of our products. In
addition, approvals that are granted remain subject to continual review, which
could result in product labeling restrictions or withdrawal of products from the
market.
We are in the process of conducting clinical studies in the United States
relating to:
- using the Aqua-Flow-TM- Glaucoma Device for the treatment of glaucoma; and
- using the ICL-TM- for the treatment of myopia and hyperopia.
If future clinical trial results of these new products are not the same as the
clinical trial results to date we could be denied FDA approval. It is also
possible that long-term safety and efficacy data, when collected, will be
inconsistent with the clinical results to date. If this happens and we cannot
demonstrate that these products can be used safely and successfully in a broad
segment of the patient population on a long-term basis, we would likely be
denied FDA approval. Furthermore, there could be serious complications or side
effects that are unpredictable and could impair or delay our obtaining
regulatory approval for these new products in the United States and other key
markets.
In addition to the review and approval process for our products, our
manufacturing facilities and procedures are also subject to government
regulation, including "good manufacturing practice" regulations promulgated by
the FDA. We believe we are in compliance with all applicable regulations.
However, the FDA and comparable regulatory agencies in other countries have
substantial discretion in the interpretation and enforcement of applicable
regulations. Future interpretations could be made by any regulatory body that
could adversely affect us. At times, interpretations are applied retroactively.
It is not possible for us to predict the extent or impact of any future federal,
state, local or foreign legislation or regulation that will affect us and our
products adversely.
If the FDA believes that we are not in compliance with the law, they can do any
or all of the following:
- institute proceedings to detain or seize our products;
- prohibit future violations; and
- assess civil or criminal penalties against us and our officers or
employees.
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Although we have not been the subject of any FDA enforcement action, if we
become subject to an FDA enforcement action, it could result in a disruption of
our operations for an undetermined time.
IF WE ARE NOT ABLE TO COMPLETE OUR CLINICAL TRIALS SUCCESSFULLY OR OUR CLINICAL
TRIALS ARE DELAYED, WE MAY NOT BE ABLE TO OBTAIN REGULATORY APPROVALS TO MARKET
OUR PRODUCTS WITHIN OUR PROJECTED TIME FRAMES.
We currently have two products, the Aqua-Flow-TM- Glaucoma Device and the
ICL-TM-, in clinical studies and OTHER research and development programs in an
early stage of development. Clinical testing in satisfaction of regulatory
approval is a long, expensive and uncertain process. We cannot assure you that
our clinical trials will be completed on schedule. Delays in patient enrollment
in the trials may result in increased costs, program delays or both, which could
slow down our product development and approval process and materially harm our
business and financial condition. Even if initial results of preclinical studies
or clinical trial results are positive, we may obtain different results in later
stages of development, including failure to show desired safety and efficacy.
The clinical trials of any of our product candidates could be unsuccessful,
which would prevent us from commercializing the relevant product. Our failure to
develop safe and effective products would substantially impair our ability to
generate revenues and materially harm our business and financial condition.
WE ARE INVOLVED IN LITIGATION RELATED TO A JOINT VENTURE WITH CANON INC. AND
CANON SALES CO., INC. THAT, IF PROLONGED, COULD CONSUME OUR TIME AND RESOURCES
AND COULD SUBJECT US TO SIGNIFICANT LIABILITIES.
We formed a joint venture with Canon Inc. and Canon Sales Co., Inc. in 1988. We
recently filed an action against Canon, Canon Sales and a related party on
claims related to breach of the joint venture agreement with these parties,
including interference with contract and interference with prospective economic
advantage. After our action was filed against these parties, they instituted
arbitration proceedings against us before the Japanese Commercial Arbitration
Association alleging breach of joint venture and licensing agreements among the
parties and us, as well as other related claims. We filed counterclaims in the
arbitration claiming irregularities in holding required shareholder's meetings,
failure to fill vacant board positions and seeking an accounting. The
arbitration proceeding is scheduled to commence in mid-October. The outcome of
any litigation or arbitration proceeding is unpredictable, and if either, or
both, of these proceedings become prolonged, they could consume our time and
resources. Further, any unfavorable outcome could subject us to significant
liabilities.
IF THIRD-PARTY PAYORS DO NOT PROVIDE REIMBURSEMENT FOR OUR CURRENT OR FUTURE
PRODUCTS, OUR BUSINESS WOULD SUFFER MATERIALLY.
Our ability to sell our products is, in part, dependent upon policies of
government and private health insurance companies making reimbursement to
ophthalmic surgeons with respect to their use of our products. In recent years,
there have been numerous proposals to change the healthcare system in the United
States. Some of these proposals have included measures that would limit or
eliminate payments for medical procedures and treatments. In addition, as a
result of the trend towards managed healthcare in the United States, as well as
legislative proposals to reduce government insurance programs, third-party
payors are increasingly attempting to contain healthcare costs by limiting both
coverage and the level of reimbursement of new medical procedures and
treatments. Consequently, significant uncertainty exists as to the reimbursement
status of newly approved healthcare products.
If either government or private health insurance companies discontinue
authorization of reimbursement payments for use of our existing products
(principally our IOLs) at current levels, our business would suffer materially
and we could be hampered in our ability to develop new products. Various federal
and state programs, including Medicare and Medicaid, provide reimbursement
primarily at fixed rates. These
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programs are subject to statutory and regulatory changes, administrative
rulings, interpretations of policy and governmental funding restrictions, all of
which may have the effect of decreasing program payments, increasing costs or
requiring us to modify the way in which we operate our business. We are not able
to predict whether changes will be made in the rates prescribed by these
governmental programs. For example, reimbursement rates for IOLs by Medicare
have declined in recent years. These changes could have a material and adverse
effect on us, including our prospects for future sales of our products.
International market acceptance of our products and product candidates may
depend, in part, on the availability of reimbursement within prevailing health
care payment systems. Reimbursement and health care payment systems in
international markets vary significantly by country, and include both government
sponsored health care and private insurance. We cannot assure you that we will
obtain any international reimbursement approvals in a timely manner, if at all.
Failure to receive international reimbursement approvals could materially and
adversely affect market acceptance of our products in the international markets
in which these approvals are sought. We currently do not expect that ICLs-TM-
will be eligible for reimbursement, and there is no way to predict whether other
new products will be eligible for reimbursement by government or private health
insurance companies.
OUR LIMITED ABILITY OR FAILURE TO PROTECT OUR INTELLECTUAL PROPERTY MAY
ADVERSELY AFFECT OUR ABILITY TO COMPETE.
Our ability to compete effectively is materially dependent upon the proprietary
nature of the designs, processes, technologies and materials owned, used by or
licensed to us. Although we attempt to protect our proprietary property,
technologies and processes through a combination of patent law, trade secrets
and non-disclosure agreements, these may be insufficient. For example, in the
case of patents, it is possible that existing patents granted to us or our
licensors will be invalidated. Patents currently or prospectively applied for by
us or our licensors may not be granted. Even if patents are granted, this does
not assure that they will provide significant commercial benefits. Moreover, it
is possible that competing companies may circumvent our patents or our
licensors' patents by developing products that closely emulate but do not
infringe these patents. This would allow our competitors to market products that
compete with our products without obtaining a license from us. In addition to
patented or potentially patentable designs, technologies, processes and
materials, we also rely on proprietary designs, technologies, processes and
know-how not eligible for patent protection. While we believe we have adequate
procedures in place to protect against improper disclosure of these trade
secrets, it is possible that competitors could independently develop the same or
superior designs, technologies, processes and know-how. It is also possible that
our trade secrets could be improperly disclosed in spite of our protective
procedures.
We believe that the international market for our products is as important as the
domestic market, and therefore we seek patent protection for our products or
those of our licensors in foreign countries where we feel such protection is
needed. Because of the differences in foreign patent and other laws concerning
proprietary rights, our products may not receive the same degree of protection
in foreign countries as they would in the United States.
The fact that we have patents issued to us for our products does not mean that
we will always be able to successfully defend our patents and proprietary rights
against challenges or claims of infringement by our competitors. The
invalidation or circumvention of key patents (principally our core patents for
insertion of foldable or deformable IOLs or ICLs-TM- through minimally invasive
surgical techniques) or proprietary rights owned by or licensed to us could have
an adverse effect on our business prospects. We could be required to defend
against litigation involving our patents or proprietary rights of others. If we
cannot successfully defend against claims of infringement or license such rights
our business will be adversely
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affected. Legal and accounting costs relating to prosecuting or defending patent
infringement litigation may be substantial.
WE MAY BE SUBJECT TO COSTLY AND TIME-CONSUMING PRODUCT LIABILITY ACTIONS OR BE
REQUIRED TO RECALL ANY ONE OF OUR PRODUCTS, EITHER OF WHICH WOULD MATERIALLY
HARM OUR BUSINESS.
The testing and use of our products entail an inherent risk of physical injury
to patients and physicians and expose us to potential product liability and
other damage claims, including those that may arise from misuse or malfunction
of, or design flaws in, our products. We may be held liable if any of our
products causes injury or is found otherwise unsuitable during product testing,
manufacturing, marketing or sale. We cannot assure you that we will be able to
avoid product liability exposure. Product liability insurance for the medical
technology industry is generally expensive, if available at all. We have
obtained product liability insurance coverage in the amount of $1 million per
occurrence, subject to a $15 million aggregate limitation. However, we cannot
assure you that our present insurance coverage is now or will continue to be
adequate. We cannot assure you that we can obtain adequate insurance coverage at
a reasonable cost in the future. Our inability to obtain sufficient insurance
coverage at an acceptable cost or otherwise to protect against potential product
liability claims could prevent or inhibit us from commercializing our products.
If we are sued for any injury caused by our products, our liability could exceed
our total assets and our reputation could be damaged.
In addition, in the event there are deficiencies or defects in the design or
manufacture of any of our products, we may be required to recall the defective
products. In the event of a product recall, our cost and potential liability
could be significant and could significantly harm our business, financial
condition and operating results, particularly if the recall relates to a product
generating significant revenues and earnings for us. Potential negative
publicity from a recall could also adversely affect our sales and/or regulatory
approvals of our other products.
OUR RECENTLY ANNOUNCED RESTRUCTURING MAY NOT FULLY YIELD ALL OF ITS INTENDED
BENEFITS.
We have recently begun implementing a plan of restructuring that we announced in
June 2000. This restructuring was designed to strategically write down
non-performing assets to maximize our potential earnings. In June 2000, we
finalized our total one-time restructuring charge at $24 million including
non-cash charges of $19.9 million. The charges include discontinuing our
Japanese joint venture and certain subsidiaries, writing-off or down inventory,
patents and other assets that were considered questionable in providing us
future value and employee severance costs associated with changes in our
management. We have made several changes to our operations in an effort to
strengthen our focus on our core products and move our product candidates
through regulatory channels. We cannot assure you that these steps will succeed
in improving gross profit margin. The success of our restructuring depends, in
part, on whether we can continue to leverage sales of our core products, whether
sales of new products will result in a more favorable mix of products, and on
whether our anticipated cost savings can be achieved and sustained.
IF WE FAIL TO ATTRACT AND RETAIN KEY PERSONNEL AND PRINCIPAL MEMBERS OF OUR
MANAGEMENT STAFF, OUR ABILITY TO EFFECTIVELY COMPETE COULD BE IMPAIRED AND OUR
BUSINESS, FINANCIAL CONDITION AND OPERATING RESULTS COULD BE MATERIALLY HARMED.
Our success depends greatly on our ability to attract and retain qualified
management and technical personnel, as well as to retain the principal members
of our existing management staff. The loss of services of any of these persons
could adversely affect the commercialization of our current products and our
ability to develop and commercialize future products. Since May 2000, our Board
of Directors terminated several key management employees, including John R.
Wolf, who served as our President and
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Chief Executive Officer since September of 1989, as well as our Executive Vice
President of Marketing/Chief Technology Officer, Vice President of Finance,
Business Development and Corporate Strategy and our Vice President of
Manufacturing. In August 2000, Mr. William C. Huddleston gave notice of his
resignation from the Company's Board of Directors and in October 2000 Mr.
Huddleston gave notice of his intended resignation as our interim President and
Chief Executive Officer. Andrew F. Pollet, our Chairman of the Board, is
currently acting as our interim President and Chief Executive Officer. We
recently filled both the marketing and manufacturing positions. In order to
pursue our commercialization plans and to expand and develop our research and
development programs and pursue our product development plans, we will need to
integrate our new personnel into our current operations and hire a new President
and Chief Executive Officer. We cannot assure you that we will be able to find a
replacement for our Chief Executive Officer or that we will be able to integrate
any new personnel into our organization. Further, we cannot assure you that we
will not experience disputes relating to any of the terminations described
above. We are aware of claims that have been asserted against us relating to
some of these terminations. The outcome of these disputes is unpredictable and
could consume our time and resources and subject us to substantial liability. We
may also need to hire additional qualified research and development and sales
and marketing personnel, as well as personnel with technical expertise and
experience in clinical testing and government regulation. There is intense
competition for qualified staff, and we cannot assure you that we will be able
to attract and retain the necessary qualified staff to develop our business. If
we fail to attract and retain key management staff, or if we lose any additional
members of our current management team, our business, financial condition and
operating results would be materially harmed. We do not maintain, and do not
currently intend to obtain, key employee global life insurance on any of our
personnel.
WE MAY EXPERIENCE DIFFICULTIES IN MANAGING GROWTH. IF WE ARE NOT ABLE TO
EFFECTIVELY MANAGE OUR GROWTH, OUR BUSINESS, FINANCIAL CONDITION AND OPERATING
RESULTS COULD BE MATERIALLY HARMED.
If we succeed in our commercialization and product development efforts, our
growth could strain our operations, product development and other managerial and
operating resources. Future growth will impose significant added
responsibilities on members of management, including the need to identify,
recruit, maintain and integrate additional employees, including management. In
the future, our financial performance and our ability to compete effectively
will depend, in part, on our ability to manage any future growth effectively. To
that end, we must be able to:
- hire and train additional qualified personnel;
- expand the capacity, scalability and performance of our product
commercialization and development infrastructure;
- improve coordination among our marketing, operations, accounting and
financing personnel;
- develop our administrative, accounting and management information systems
and controls; and
- manage our future research and development efforts effectively.
We cannot assure you that we will be able to accomplish these tasks. If we fail
to accomplish any of these tasks, our business, financial condition and
operating results would be materially harmed.
WE HAVE LIMITED MANUFACTURING EXPERIENCE.
10
<PAGE>
We manufacture our products in quantities sufficient to satisfy our current
level of product sales. If we were to experience increases in sales, we may need
to increase our production significantly beyond our present manufacturing
capacity. Accordingly, we may be required to increase our manufacturing
capacities or to contract with another party to manufacture our products. We
cannot assure you that we can successfully increase our capacity on a profitable
basis, or contract with another party on terms acceptable to us, if at all.
Furthermore, we cannot assure you that if we choose to scale-up our
manufacturing operations, we will be able to maintain compliance with FDA
standards that regulate our manufacturing facilities.
IF WE EXPERIENCE AN INTERRUPTION OF OUR MANUFACTURING OPERATIONS, OUR BUSINESS,
FINANCIAL CONDITION AND OPERATING RESULTS WOULD BE MATERIALLY HARMED.
We manufacture substantially all of the products we sell. As a result, any
prolonged disruption in the operation of our manufacturing facilities, whether
due to technical, labor or other difficulties, destruction of or damage to any
facility or other reasons, could materially harm our business, financial
condition and operating results.
BECAUSE WE HAVE OPERATIONS AND CUSTOMERS INTERNATIONALLY, OUR BUSINESS MAY BE
ADVERSELY AFFECTED BY FOREIGN POLITICAL AND ECONOMIC CONDITIONS.
A significant portion of our revenues relate to our international sales and
operations. We expect this to continue to be the case in the future. Our
international sales and operations subject us to several potential risks,
including;
- risks associated with fluctuating exchange rates;
- the regulation of fund transfers by foreign governments;
- United States and foreign export and import duties and tariffs; and
- political instability.
The occurrence of any of the foregoing could materially and adversely affect our
business. We have not previously engaged in activities to mitigate the effects
of foreign currency fluctuations, because historically we have been generally
paid in U.S. dollars with respect to our international operations. As earnings
from international operations increase, our exposure to fluctuations in foreign
currencies may increase, and we may utilize forward exchange rate contracts or
engage in other efforts to mitigate foreign currency risks. If we were to do
this, there can be no assurance as to the effectiveness of these efforts in
limiting any adverse effects of foreign currency fluctuations on our
international operations and overall results of operations.
Our continued growth is in part dependent on the expansion of international
sales of our products. This expansion will involve operations in markets where
we may not be experienced and we cannot assure you that we will be successful in
capturing a significant portion of these markets. In many of these markets, we
will continue to be dependent on the efforts of distributors, and we cannot
assure you that the distributors will be successful or that they will maintain
their relationships with us. In addition, we will not be able to market and sell
our products in certain international markets until we obtain regulatory
approval. We cannot assure you that we will be able to successfully
commercialize any of our products in any international market. If we cannot, our
business, financial condition and operating results will be materially harmed.
11
<PAGE>
WE ARE SUBJECT TO EXTENSIVE GOVERNMENT REGULATION CONCERNING ENVIRONMENTAL
MATTERS.
We are subject to a variety of local, state and federal government regulations
relating to the storage, discharge, handling, emission, generation, manufacture
and disposal of toxic and other hazardous substances used to manufacture our
products. We cannot be sure that we will be in compliance with governing
standards in the future or that we will not incur significant costs to comply
with environmental laws and regulations in the future. If we were to fail to
comply with any of these regulations, this failure could subject us to
significant liabilities. Furthermore, we cannot completely eliminate the risk of
accidental contamination or injury from these toxic or hazardous materials.
WE MAY NEED ADDITIONAL FINANCING IN THE FUTURE, BUT OUR ACCESS TO CAPITAL
FUNDING IS UNCERTAIN.
Our current and anticipated development activities require substantial
additional capital. We expect that our existing capital resources, together with
the net proceeds of this offering, will be adequate to fund our operations for
the foreseeable future, but we cannot guarantee that this will be the case. Our
future capital needs will depend on many factors, including, successfully
commercializing the Aqua-Flow-TM- Glaucoma Device and the ICL-TM-, changes in or
termination of our relationships with our distributors or suppliers, changes in
government regulations and policies, progress in our research and product
development activities and expansion of our international operations. Our
success may also depend on the magnitude and scope of these activities, the
progress and level of unreimbursed costs associated with clinical trials, the
costs associated with acquisitions, the costs of preparing, filing, prosecuting,
maintaining and enforcing patent claims and other intellectual property rights,
competing technological and market developments, the establishment of future
collaborations, the development of our marketing activities, and the costs of
manufacturing scale-up. We do not have committed external sources of funding and
we cannot assure you that we will be able to obtain additional funds on
acceptable terms, if at all. If adequate funds are not available, we may be
required to:
- delay, reduce the scope of or eliminate one or more of our
commercialization or development programs;
- obtain funds through arrangements with collaboration partners or
others that may require us to relinquish rights to technologies,
product candidates or products that we would otherwise seek to develop
or commercialize ourselves; or
- license rights to technologies, product candidates or products on
terms that are less favorable to us than might otherwise be available.
If we raise additional funds by issuing additional stock, our stockholders would
suffer further dilution and new investors could have rights superior to existing
stockholders. Further, if additional funds are raised through the issuance of
debt securities, these securities could contain covenants that would restrict
our operations. If we do not have sufficient funds at any time in the future, we
may be unable to develop or commercialize our products, take advantage of
business opportunities or respond to competitive pressures.
MARKET VOLATILITY MAY AFFECT OUR STOCK PRICE AND THE VALUE OF YOUR INVESTMENT
MAY BE SUBJECT TO SUDDEN DECREASES.
Our stock price has a history of volatility. This volatility has existed even in
the absence of significant news or developments about us. Moreover, the stocks
of medical technology and device companies in
12
<PAGE>
particular, and the stock market generally, have been subject to dramatic price
swings in recent years, with the stock of small capitalization companies, like
us, experiencing the greatest volatility. Factors that may have a significant
impact on the market price of our common stock include:
- variations in financial results;
- changes in earnings estimates by industry research analysts;
- investors' perceptions of us and our financial prospects;
- results of the governmental approval process for our medical devices or
techniques or for our competitors;
- results of clinical trials;
- changes in government regulations;
- announcements of new products, technologies or techniques by us or our
competitors;
- announcements regarding patent litigation or the issuance of patents to us
or our competitors;
- changes in reimbursement policies; and
- general economic, industry and market conditions.
These price swings, both as to our stock and as to our industry and the stock
market generally, are likely to continue. As a result, you could be subject to
significant losses in your investment in our stock even if we successfully
execute on our business strategy.
In the past, following periods of market volatility, security holders of other
companies have instituted class action litigation. If the market value of our
stock experiences adverse fluctuations and we become involved in this type of
litigation, we could incur substantial legal costs and management's attention
could be diverted, which could materially harm our business and the market price
of our common stock.
SALES OF COMMON STOCK MAY DEPRESS THE MARKET PRICE OF OUR COMMON STOCK.
A substantial number of outstanding shares of common stock and shares of common
stock issuable upon exercise of outstanding options and warrants are eligible
for sale in the public market. Sales of a substantial number of shares of our
common stock or the perception that such sales could occur could cause the
market price of our common stock to decline. Any sales by existing stockholders
or holders of options or warrants may have an adverse effect on our ability to
raise capital and may adversely affect the market price of our common stock.
IF YOU PURCHASE OUR COMMON STOCK, YOU WILL EXPERIENCE IMMEDIATE AND SUBSTANTIAL
DILUTION IN THE BOOK VALUE OF YOUR SHARES.
The price you will pay for our common stock will be substantially higher than
the net tangible book value per share of our common stock, which as of September
29, 2000 was $3.55 per share. If you purchase our common stock in this offering,
you will suffer immediate and substantial per share dilution. You will incur
additional dilution upon the exercise of outstanding stock options and warrants.
13
<PAGE>
SOME OF OUR EXISTING STOCKHOLDERS CAN EXERT SIGNIFICANT INFLUENCE OVER US. IF
THEY MAKE DECISIONS THAT ARE NOT IN THE BEST INTERESTS OF ALL STOCKHOLDERS, THEN
OUR STOCK PRICE MAY DECLINE.
Our directors and executive officers and their affiliates will beneficially own,
in the aggregate, approximately 19.77% of our outstanding common stock. As a
result, these stockholders as a group will significantly influence our
management and affairs and all matters submitted to our stockholders for
approval, including electing directors, any merger, consolidation or sale of all
or substantially all of our assets and any other significant corporation
transaction. This control could discourage others from initiating potential
merger, takeover or other change of control transactions, and may adversely
affect the market price of our common stock. In addition, if these stockholders
acted together, they could cause a result that may not be in the best interest
of all stockholders.
SOME PROVISIONS IN OUR CERTIFICATE OF INCORPORATION AND BYLAWS AND DELAWARE LAW
MAY DELAY OR PREVENT A TAKEOVER AND SUPPRESS OUR STOCK PRICE.
Some provisions in our certificate of incorporation and bylaws may have the
effect of delaying, deferring or preventing an acquisition, merger or other
change of control of the Company, despite the possible benefits to our
stockholders, or otherwise adversely affect the price of our common stock. These
provisions include the following:
- the ability of our board of directors to issue shares of preferred stock
and to determine the price and other terms, including preferences and
voting rights, of those shares without stockholder approval;
- a staggered board of directors and the limited ability of stockholders to
remove our directors;
- a limitation on who may call special meetings of stockholders; and
- advance notice requirements for nomination for election to our board of
directors or for proposing matters that can be acted on by stockholders at
stockholder meetings.
In addition to these provisions, we are subject to certain Delaware laws,
including provisions that prohibit us from engaging in any "business
combination" with a person who, together with affiliates and associates, owns
15% or more of our common stock (referred to as an interested stockholder) for a
period of three years following the date that such person became an interested
stockholder, unless the business combination is approved in the prescribed
manner. The provisions of our certificate of incorporation and bylaws and
Delaware law may discourage potential takeover attempts, discourage bids for our
common stock at a premium over market price or could adversely affect the market
price of, and the voting and other rights of the holders of, our common stock.
As a result, the market price of our common stock could be adversely affected.
14
<PAGE>
USE OF PROCEEDS
The Selling Security Holders will receive all of the proceeds from the sale of
the common stock offered. We will not receive any of the proceeds from the sale.
SELLING SHAREHOLDERS AND PLAN OF DISTRIBUTION
All of the shares of common stock registered for sale under this prospectus will
be owned prior to the offer and sale of such shares by our current or former
employees, officers, directors, consultants and/or advisors (the "selling
shareholders"). All of the shares owned by the selling shareholders were
acquired by them pursuant to the 1996 STAAR Surgical Company Non-Qualified Stock
Plan. The names of the selling shareholders are set forth below.
We are registering the common shares covered by this prospectus for the selling
shareholders. As used in this prospectus, "selling shareholders" includes the
pledgees, donees, transferees or others who may later hold the selling
shareholders' interests. We will pay the costs and fees of registering the
common shares, but the selling shareholders will pay any brokerage commissions,
discounts or other expenses relating to the sale of the common shares.
The selling shareholders may offer their common shares to or through brokers and
dealers and underwriters selected by the selling shareholders from time to time.
In addition, the common shares may be offered for sale through the Nasdaq Stock
Market, through a market maker, in one or more private transactions, or a
combination of such methods of sale, at prices and on terms then prevailing, at
prices related to such prices, or at negotiated prices. Each selling shareholder
may pledge all or a portion of the common shares owned by him or her as
collateral in loan transactions. Upon default by any such selling shareholder,
the pledgee in such loan transaction would have the same rights of sale as such
selling shareholder under this prospectus. Each selling shareholder may also
transfer common shares owned by him or her in other ways not involving market
makers or established trading markets, including directly by gift, distribution,
or other transfer without consideration, and upon any such transfer the
transferee would have the same rights of sale as such selling shareholder under
this prospectus. In addition, any securities covered by this prospectus that
qualify for sale pursuant to Rule 144 of the Securities Act of 1933 may be sold
under Rule 144 rather than pursuant to this prospectus. Finally, each selling
shareholder and any brokers and dealers through whom sales of the common shares
are made may be deemed to be "underwriters" within the meaning of the Securities
Act, and the commissions or discounts and other compensation paid to such
persons may be regarded as underwriters' compensation.
Additional information related to the selling shareholders and the plan of
distribution may be provided in one or more supplemental prospectuses.
The following table sets forth the names of the selling shareholders who may
sell their shares pursuant to this prospectus. The selling shareholders have, or
within the past three years have had, positions, offices or other material
relationships with us or with our predecessors or affiliates.
15
<PAGE>
The following table also sets forth certain information as of the date of this
prospectus, to the best of our knowledge, regarding the ownership of our common
stock by the selling shareholders and as adjusted to give effect to the sale of
all the common stock offered by the selling shareholders pursuant to this
prospectus.
<TABLE>
<CAPTION>
-------------------- ----------------------- ------------------ ------------ ------------------ ----------------
SHARES SHARES SHARES PERCENTAGE
SELLING RELATIONSHIP WITH THE HELD BEFORE THE BEING HELD AFTER THE OWNED AFTER
SHAREHOLDER COMPANY OFFERING OFFERED OFFERING THE OFFERING
-------------------- ----------------------- ------------------ ------------ ------------------ ----------------
<S> <C> <C> <C> <C> <C>
Vice President, Chief
John Santos Financial Officer 21,000 18,000 21,000 *
-------------------- ----------------------- ------------------ ------------ ------------------ ----------------
Sandra Wood Assistant Vice
President, Facilities 7,681 7,500 7,681 *
& Environmental
Matters
-------------------- ----------------------- ------------------ ------------ ------------------ ----------------
TOTAL 28,681 25,500 28,681
-------------------- ----------------------- ------------------ ------------ ------------------ ----------------
</TABLE>
* Less than 1%
NAMED EXPERTS AND INTEREST OF COUNSEL
Andrew F. Pollet, our Chairman of the Board and interim President and Chief
Executive Officer and one of the principals of the law firm of Pollet &
Richardson, a law corporation, is the owner of 1,014,880 shares of our common
stock and options to purchase an additional 212,000 shares. The validity of the
securities offered will be passed upon by Pollet & Richardson, our counsel,
whose address is 10900 Wilshire Boulevard, Suite 500, Los Angeles, California
90024.
16
<PAGE>
MATERIAL CHANGES
RESTRUCTURING
In May 2000, we announced our plans to strategically write down non-performing
assets to maximize our potential earnings as we prepare to launch a number of
new products. In June 2000, we finalized our total one-time restructuring charge
at $24 million including non-cash charges of $19.9 million. The charges include
discontinuing our Japanese joint venture and certain subsidiaries, writing-off
or down inventory, patents and other assets that were considered questionable in
providing us future value and employee severance costs associated with changes
in our management. We recorded these charges against our second quarter of
fiscal year 2000 earnings, before tax benefit.
CANON LITIGATION
On May 23, 1988 we formed a joint venture with Canon Inc. and Canon Sales Co.,
Inc. On May 8, 2000, we filed a complaint in the United States District Court of
the Central District of California against Canon, Inc., Canon Sales, Inc., and a
Japanese individual. The complaint seeks damages for tortious interference with
contractual relations and tortious interference with actual and prospective
business advantage. The federal lawsuit arises from the named defendants'
attempt to gain distribution rights and access to our proprietary technology and
ophthalmic product lines for the Japanese market. Pursuant to our consent, the
court stayed the federal lawsuit pending further proceedings in the arbitration
matter described below.
CANON ARBITRATION
Canon Inc., and Canon Sales Co. Inc., referred to as the "Canon Companies" filed
a Request for Arbitration with the Japan Commercial Arbitration Association on
or about May 31, 2000 initiating an arbitration against us. The Request for
Arbitration relates to a joint venture we formed with Canon Companies in which
Canon Staar Co., Inc., a Japanese corporation was formed. The Canon Companies
have alleged that we have breached the joint venture agreement and certain
distributor and license agreements and are seeking monetary damages. We filed an
answer in July 2000 denying the allegations. We believe the allegations are
without merit and intend to vigorously defend the action. We filed a
counterclaim against the Canon Companies on August 2, 2000, which alleges among
other claims, that the Canon Companies entered into unfair dealings with the
joint venture. The counterclaim seeks a complete accounting and the transfer of
the Canon Companies interest in the joint venture or the liquidation of the
joint venture itself. Discovery is currently proceeding in this arbitration
matter.
MANAGEMENT REORGANIZATION
In May 2000, we appointed William C. Huddleston as our interim President and
Chief Executive Officer. Mr. Huddleston replaced John R. Wolf, our former
President and Chief Executive Officer, who separated from service as our
employee in May 2000. At that time, we also elected Andrew F. Pollet as our
Chairman, replacing Mr. Wolf, who continues to serve as one of our Directors.
In August 2000, Mr. Huddleston gave notice of his resignation from the Company's
Board of Directors and in October 2000 Mr. Huddleston gave notice of his
intended resignation as our interim President and Chief Executive Officer. The
Board of Directors has appointed Andrew F. Pollet to act as our interim
President and Chief Executive Officer until these positions are permanently
filled.
17
<PAGE>
In November 2000, the Board of Directors appointed Joseph Priske as the Class I
Director to serve until the 2002 Shareholders Meeting or until a new Class I
director is elected and duly qualified. Mr. Priske, age 50, is the
brother-in-law of Andrew F. Pollet and is currently the principal partner of the
real estate development firm of Priske & Jones. Mr. Priske also serves on the
Board of Directors of American Commercial Bank, a public reporting company.
AMENDED 10-Q FILING
On September 29, 2000, we filed a Quarterly Report on Form 10-Q/A for the
quarterly period ended June 30, 2000. The reason for filing the amendment
related to the accounting for the restructuring costs we incurred. Part of our
restructuring plan included the discontinuance of both our joint venture in
Japan and our operations in Brazil. The discontinuance of these operations was
reported as discontinued operations in the originally filed Form 10-Q. After
further investigation and analysis of Generally Accepted Accounting Principles,
we concluded that these restructuring costs should be classified differently
from what was presented in the Form 10-Q as originally filed. We reclassified
the charge from the discontinuance of the joint venture in Japan to equity in
operations in the joint venture, which is included in other income (expense) in
the consolidated statements of operations. The related income tax benefit has
been reclassified from discontinued operations to income tax benefit in the
accompanying statements of operations. We reclassified the charge from the
discontinuance of the operations in Brazil to restructuring, impairment, and
other non-recurring charges, which are included in operating loss in our
consolidated statements of operations. There was no change to our net loss or
the loss per share amounts that were previously reported.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
We filed the following documents with the Commission and they are hereby
incorporated by reference into this prospectus: (i) Annual Report on Form 10-K
for the fiscal year ended December 31, 1999, filed by us on March 30, 2000,
which contained audited consolidated financial statements for the most recent
fiscal year for which such statements were filed, (ii) a Proxy Statement dated
May 1, 2000, (iii) the Quarterly Report on Form 10-Q for the quarter ended March
31, 2000, filed with the Commission on May 15, 2000, (iv) the Quarterly Report
on Form 10-Q/A for the quarter ended June 30, 2000, filed with the Commission on
September 29, 2000, (v) the Quarterly Report on Form 10-Q for the quarter ended
September 29, 2000 filed with the Commission on November 13, 2000, and (vi) the
description of our common stock, which is contained in a Registration Statement
filed on Form S-18, registration number 2-83434. All other documents and reports
filed by us pursuant to Sections 13(a), 14 and 15(d) of the Securities Exchange
Act subsequent to the date of this prospectus and prior to the termination of
this offering shall be deemed to be incorporated by reference into this
prospectus.
Any statement contained in a document incorporated or deemed to be incorporated
by reference in this prospectus shall be deemed to be modified or superseded for
purposes of this prospectus to the extent that a statement contained in this
prospectus or in any subsequently filed document which also is or is deemed to
be incorporated by reference modifies or supersedes such statement. Any
statement modified or superseded by this incorporation procedure shall not be
deemed, except as so modified or superseded, to constitute a part of this
prospectus.
We will provide without charge to each person to whom a copy of this prospectus
is delivered, upon the written or oral request of such person, a copy of any or
all documents that are incorporated by reference (not including the exhibits to
such documents, unless the exhibits are specifically incorporated by reference
in the document which this prospectus incorporates). Requests should be directed
to Mr. Andrew F. Pollet, Interim Chief Executive Officer, at our principal
executive offices located at 1911 Walker Avenue, Monrovia, California 91016,
telephone number (626) 303-7902.
18
<PAGE>
No person is authorized to give any information or to make any representation
other than those contained in this prospectus, and if made such information or
representation must not be relied upon as having been given or authorized. This
prospectus does not STAAR SURGICAL COMPANY constitute an offer to sell or a
solicitation of an offer to buy any securities other than the securities offered
by this prospectus or an offer to sell or a solicitation of an offer to buy the
securities in any jurisdiction to any person to whom it is unlawful to make such
offer or solicitation in such jurisdiction.
The delivery of this prospectus shall not, under any circumstances, create any
implication that there has been no change in the affairs of the Company since
the date of this prospectus. However, in the event of a material change, this
prospectus will be amended or supplemented accordingly.
[STARR SURGICAL LOGO]
STAAR SURGICAL COMPANY
173,500 SHARES
COMMON STOCK
PROSPECTUS
December 15, 2000
<PAGE>
PART II
INFORMATION REQUIRED IN THE REGISTRATION STATEMENT
ITEM 3. INCORPORATION OF DOCUMENTS BY REFERENCE.
The following documents are hereby incorporated by reference into this
Registration Statement:
(a) The Annual Report on Form 10-K for the fiscal year ended December 31,
1999, filed by the Registrant with the Securities and Exchange Commission (the
"Commission") on March 30, 2000, which contains audited consolidated financial
statements for the most recent fiscal year for which such statements have been
filed.
(b) The Registrant's Proxy Statement dated May 1, 2000.
(c) The Quarterly Report on Form 10-Q for the quarter ended March 31, 2000,
filed by the Registrant with the Commission on May 15, 2000.
(d) The Quarterly Report on Form 10-Q/A for the quarter ended June 30,
2000, filed by the Registrant with the Commission on September 29, 2000.
(e) The Quarterly Report on Form 10-Q for the quarter ended September 29,
2000, filed by the Registrant with the Commission on November 13, 2000.
(f) The description of the Registrant's common stock, which is contained in
a registration statement filed on Form S-3, registration number 333-47820.
(g) In addition, all documents subsequently filed by the Registrant
pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Securities Exchange Act,
prior to the filing of a post-effective amendment which indicates that all
securities offered have been sold or which deregisters all securities then
remaining unsold, shall be deemed to be incorporated by reference into this
registration statement and to be a part hereof from the date of filing of such
documents.
ITEM 4. DESCRIPTION OF SECURITIES.
Not applicable. The class of securities to be offered is registered under
Section 12 of the Exchange Act.
ITEM 5. INTERESTS OF NAMED EXPERTS AND COUNSEL.
Andrew F. Pollet, one of the principals of the law firm of Pollet &
Richardson, is the owner of 1,014,880 shares of the Registrant's common stock
and
II-1
<PAGE>
options to purchase an additional 212,000 shares of the Registrant's common
stock. The validity of the securities offered will be passed upon by Pollet &
Richardson, the Registrant's counsel, whose address is 10900 Wilshire Boulevard,
Suite 500, Los Angeles, California 90024.
ITEM 6. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
As permitted by Section 102(b)(7) of the Delaware General Corporation Law,
the Registrant's Certificate of Incorporation, as amended, includes a provision
that eliminates the personal liability of each of its directors for monetary
damages for breach of such director's fiduciary duty as a director, except for
liability: (i) for any breach of the director's duty of loyalty to the
Registrant or its stockholders; (ii) for acts or omissions not in good faith or
which involve intentional misconduct or a knowing violation of the law; (iii)
under Section 174 of the Delaware General Corporation Law; or (iv) for any
transaction from which the director derived an improper personal benefit.
In addition, the Registrant's Certificate of Incorporation, as amended, and
its Bylaws provide that the Registrant must, to the fullest extent permitted by
Section 145 of the Delaware General Corporation Law, indemnify its directors,
officers and employees, and persons serving in such capacities in other business
enterprises (including, for example, subsidiaries of the Registrant) at the
Registrant's request, including those circumstances in which indemnification
would otherwise be discretionary. The rights conferred are not exclusive and the
Registrant is authorized, pursuant to Section 145 of the Delaware General
Corporation Law, to enter into indemnification agreements with its directors,
officers and employees. The Registrant maintains director and officer liability
insurance. The indemnification provisions in the Certificate of Incorporation,
as amended, and the Bylaws may be sufficiently broad to permit indemnification
of the Registrant's directors and officers for liabilities arising under the
Securities Act of 1933, as amended.
ITEM 7. EXEMPTION FROM REGISTRATION CLAIMED.
The Registrant is registering 7,500 shares of common stock owned by Sandra
Wood. Ms. Wood is the Assistant Vice President, Facilities & Environmental
Matters, of the Registrant. Ms. Wood exercised her right to purchase 250 shares
of the Registrant's common stock. The Registrant is relying on Section 4(2) of
the Securities Act of 1933 for its exemption from registration.
ITEM 8. EXHIBITS.
4.1 Certificate of Incorporation, as amended(1)
4.2 Bylaws(1)
4.3 Stockholders Rights Plan(2)
5. Opinion regarding legality
23.1 Consent of BDO Seidman LLP
II-2
<PAGE>
23.2 Consent of Pollet & Richardson (included in Exhibit 5)
-----------------
(1) Incorporated by reference from the Registrant's Annual Report on Form 10-K
for the year ended December 31, 1999, as filed on March 30, 2000, SEC file
number 000-11634.
(2) Incorporated by reference from the Registrant's Annual Report on Form 10-K
for the year ended January 3, 1997, as filed on April 2, 1997, SEC file number
000-11634.
ITEM 9. UNDERTAKINGS.
(a) The undersigned Registrant hereby undertakes to file, during any period
in which offers or sales are being made, a post-effective amendment to this
registration statement (1) to include any material information with respect to
the plan of distribution not previously disclosed in the registration statement
or any material change to such information in the registration statement; (2)
that, for the purpose of determining any liability under the Securities Act of
1933, each such post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof; and (3) to remove from registration by means of a
post-effective amendment any of the securities being registered which remain
unsold at the termination of the offering.
(b) The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
Registrant's annual report pursuant to Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
(c) Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to directors, officers and controlling persons of
the Registrant pursuant to the foregoing provisions, or otherwise, the
Registrant has been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the Act
and is, therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the Registrant of expenses
incurred or paid by a director, officer, or controlling person of the Registrant
in the successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the Registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Act and will be governed by the final adjudication of
such issue.
II-3
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-8 and has duly caused this registration
statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Monrovia, State of California, on this 14th day of
December, 2000.
STAAR SURGICAL COMPANY
By: /s/ Andrew F. Pollet
-------------------------------------------
Andrew F. Pollet, its Interim President and
Interim Chief Executive Officer
<PAGE>
Pursuant to the requirements of the Securities Act of 1933, this Form S-8
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated:
<TABLE>
<S> <C> <C>
Dated: December 14, 2000 /s/ Andrew F. Pollet
-------------------------------------------
Andrew F. Pollet,
Interim President and
Interim Chief Executive Officer
Dated: December 15, 2000 /s/ John Santos
-------------------------------------------
John Santos, Vice President,
Chief Financial Officer and
Chief Accounting Officer
Dated: December 14, 2000 /s/ Andrew F. Pollet
-------------------------------------------
Andrew F. Pollet, Director and
Chairman of the Board
Dated: December 14, 2000 /s/ Peter J. Utrata, M.D.
-------------------------------------------
Peter J. Utrata, M.D., Director
Dated: December 7, 2000 /s/ Volker D. Anhaeusser
-------------------------------------------
Volker D. Anhaeusser, Director
Dated: December 13, 2000 /s/ Joseph Priske
-------------------------------------------
Joseph Priske, Director
</TABLE>
<PAGE>
INDEX TO EXHIBITS
<TABLE>
<CAPTION>
Exhibit Number Description
<S> <C>
4.1 Certificate of Incorporation, as amended(1)
4.2 Bylaws(1)
4.3 Stockholders Rights Plan(2)
5. Opinion regarding legality
23.1 Consent of BDO Seidman LLP
23.2 Consent of Pollet & Richardson (included in Exhibit 5)
</TABLE>
--------------
(1) Incorporated by reference from the Registrant's Annual Report on Form 10-K
for the year ended December 31, 1999, as filed on March 30, 2000, SEC file
number 000-11634.
(2) Incorporated by reference from the Registrant's Annual Report on Form 10-K
for the year ended January 3, 1997, as filed on April 2, 1997, SEC file number
000-11634.
