<PAGE> 1
Filed Pursuant to 424(b)(2)
Registration No. 333-38266
PROSPECTUS
4,857,097 SHARES
INSITE VISION INCORPORATED
COMMON STOCK
---------------
The stockholders that we name on pages thirteen through fourteen
(13-14) are selling 4,857,097 shares of our common stock.
Our common stock is traded on The American Stock Exchange under the
symbol "ISV." On August 4, 2000, the last sale price for our common stock as
quoted on The American Stock Exchange was $4.00 per share.
---------------
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. SEE "RISK
FACTORS" BEGINNING ON PAGE 6.
---------------
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or passed upon the
adequacy or accuracy of this prospectus. Any representation to the contrary is a
criminal offense.
---------------
================================================================================
The date of this prospectus is August 31, 2000
<PAGE> 2
INSITE VISION INCORPORATED
The more detailed information and financial statements appearing
elsewhere in this prospectus or incorporated by reference in this prospectus,
which includes notes to the previously mentioned detailed information and
financial statements, qualifies the following information in its entirety. This
prospectus contains certain forward-looking statements within the meaning of
Section 27A of the Securities Act and Section 21E of the Exchange Act. Actual
results could differ materially from those projected in the forward-looking
statements as a result of certain of the risk factors set forth elsewhere in
this prospectus. Investors should carefully consider the information set forth
under the heading "Risk Factors."
We are an ophthalmic product development company focused on genetic
research for diagnosis and prognosis of glaucoma and the development of
treatment products for opthalmic diseases using our proprietary DuraSite(R)
technology.
We are focusing our research and development on the following:
- expanding the ISV-900 technology for the prognosis, diagnosis
and management of glaucoma;
- providing on-going technical support to Pharmacia Corporation for
ISV-205 for the treatment of glaucoma;
- ISV-615 for the treatment of diabetic retinopathy and macular
degeneration;
- ISV-014, a retinal drug delivery device; and
- evaluating and developing several antibiotics not currently used in
ophthalmics.
We are collaborating with several academic researchers to develop new
diagnostic tools for both primary congenital glaucoma and primary open angle
glaucoma. Primary congenital glaucoma is an inherited eye disorder and is one of
the leading causes of blindness and visual impairment affecting infants. A
gene-based diagnostic kit may allow early detection of the disease before
considerable irreversible damage has occurred and may improve the ability to
treat it successfully. Primary open angle glaucoma usually affects people over
the age of forty. Current glaucoma tests are generally unable to detect the
disease before substantial damage to the optic nerve has occurred. Gene-based
tests may make it possible to identify patients at risk and initiate treatment
before permanent optic nerve damage and vision loss occurs.
Our glaucoma genetics program is being carried out in collaboration
with academic researchers and focuses on discovering genes that are associated
with glaucoma and the mutations on these genes that cause the disease. New
glaucoma diagnostic, prognostic and management tools may be developed by the
application of this genetic information. To date, our academic collaborators
have identified genes associated with primary open-angle glaucoma (the most
prevalent form of the disease in adults), juvenile glaucoma and primary
congenital glaucoma. We have developed a diagnostic/prognostic technology,
ISV-900, which may be capable of identifying multiple glaucoma genetic markers
from a single sample. We licensed ISV-900 to Pharmacia Corporation in November
1999.
The development of the ISV-205 product candidate is another result of
our glaucoma genetics research. This DuraSite formulation contains a drug that
has been shown in cell and organ culture systems to inhibit the production of a
protein that appears to cause glaucoma. In January 1999, we entered into a
transaction that granted Pharmacia Corporation an exclusive worldwide license
for ISV-205 for the treatment of glaucoma. In June 1999, we announced positive
results from our Phase II trial of ISV-205. Pharmacia Corporation has assumed
the continued development of the product with our continued technical support.
2
<PAGE> 3
Our DuraSite delivery system is a patented eyedrop formulation
comprising a cross-linked carboxyl-containing polymer which incorporates the
drug to be delivered to the eye. The formulation is instilled in the cul-de-sac
of the eye as a small volume eyedrop and remains in the eye for up to several
hours. The active drug ingredient is gradually released during this time. This
increased residence time is designed to permit lower concentrations of a drug to
be administered over a longer period of time, thereby minimizing the
inconvenience of frequent dosing and reducing potential adverse side effects.
Eyedrops delivered in the DuraSite system are a contrast to conventional
eyedrops because conventional eyedrops typically only last a few minutes in the
eye. Consequently, conventional eyedrops typically require the delivery of a
highly concentrated burst of drug and frequent administration to sustain
therapeutic levels. DuraSite can be customized to deliver a variety of compounds
with a broad range of molecular weights and other properties.
Our executive offices are located at 965 Atlantic Avenue, Alameda,
California 94501 and our telephone number is (510) 865-8800. InSite Vision
Limited, a United Kingdom corporation, is our wholly-owned subsidiary.
InSite, InSite Vision Incorporated, the InSite Vision Incorporated
logo, InSite Vision Limited, DuraSite, AquaSite(TM), MethaSite(TM), PilaSite(R),
BetaSite(R) and ToPreSite(TM) are our trademarks. All other brand names or
trademarks appearing or incorporated by reference in this prospectus are the
property of their respective holders.
3
<PAGE> 4
RISK FACTORS
The shares offered by this prospectus involve a high degree of risk.
The following risk factors should be considered carefully in addition to the
other information contained or incorporated by reference in this prospectus
before purchasing the shares of our common stock offered by this prospectus. In
addition to the historical information contained in this prospectus, the
discussion in this prospectus contains forward-looking statements within the
meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act
that involve risks and uncertainties, such as statements of our plans,
objectives, expectations and intentions. The cautionary statements made in this
prospectus should be read as being applicable to all related forward-looking
statements wherever they appear in this prospectus. Our actual results could
differ materially from those discussed in this prospectus. Factors that could
cause or contribute to such differences include those discussed below as well as
those cautionary statements and other factors set forth elsewhere herein.
IT IS DIFFICULT TO EVALUATE OUR BUSINESS BECAUSE WE ARE IN AN EARLY STAGE OF
DEVELOPMENT AND OUR TECHNOLOGY IS UNTESTED
We are in an early stage of developing our business. We have only
received a small amount of royalties from the sale of one of our products, an
over-the-counter dry eye treatment. Before regulatory authorities grant us
marketing approval, we need to conduct significant additional research and
development and preclinical and clinical testing. All of our products are
subject to risks that are inherent to products based upon new technologies.
These risks include the risks that our products:
- are found to be unsafe or ineffective;
- fail to receive necessary marketing clearance from regulatory
authorities;
- even if safe and effective, are too difficult to manufacture
or market;
- are unmarketable due to the proprietary rights of third
parties; or
- are not able to compete with superior, equivalent or more
cost-effective products offered by competitors.
Therefore, our research and development activities may not result in any
commercially viable products.
WE WILL REQUIRE SIGNIFICANT ADDITIONAL FUNDING FOR OUR CAPITAL REQUIREMENTS
AND WE MAY HAVE DIFFICULTY RAISING ADDITIONAL FUNDING
We will require substantial additional funding to develop and conduct
testing on our potential products. We will also require additional funding to
manufacture and market any products which we develop. Our future capital
requirements depend upon many factors, including:
- the progress of our research and development programs;
- the progress of preclinical and clinical testing;
- our ability to establish additional corporate partnerships to
develop, manufacture and market our potential products;
- the time and cost involved in obtaining regulatory approvals;
- the cost of filing, prosecuting, defending and enforcing patent
claims and other intellectual property rights;
- competing technological and market developments;
- changes in our existing collaborative and licensing relationships;
and
- the purchase of additional capital equipment.
In addition, as part of the ISV-900 licensing activities, we received a
$5 million licensing fee from Pharmacia Corporation. The University of
California Regents alleged that they were entitled to receive up to $2.5 million
of this payment under the terms of the August 1994 license agreement between us
and the University of California Regents. We disputed this allegation and we
were able to resolve this conflict without making any additional payments from
the licensing fee. We did, however, agree to amend our 1994 license agreement
with the University of California Regents to provide for the payment of an
increased royalty to the University of California Regents for a limited period
of time.
4
<PAGE> 5
We may seek additional funding through public or private equity or debt
financing, collaborative or other arrangements, and from other sources. We may
not be able to secure additional funding from these sources, and any funding may
not be on terms acceptable to us.
Our stockholders will suffer substantial dilution if we raise
additional funds by issuing equity securities. However, if we cannot raise
additional funding, we may be required to delay, scale back or eliminate one or
more of our research, discovery or development programs, or scale back or cease
operations altogether. In addition, the failure to raise additional funding may
force us to enter into agreements with third parties on terms which are
disadvantageous to us, which may, among other things, require us to relinquish
rights to our technologies, products or potential products.
WE HAVE A HISTORY OF OPERATING LOSSES AND WE EXPECT TO CONTINUE TO HAVE LOSSES
IN THE FUTURE
We have incurred significant operating losses since our inception in
1986. As of June 30, 2000, our accumulated deficit was approximately $86.1
million. We expect to incur net losses for the foreseeable future or until we
are able to achieve significant royalties from sales of our licensed products
even though we achieved profitability in 1999.
Attaining significant revenue or profitability depends upon our
ability, alone or with third parties, to successfully develop our potential
products, conduct clinical trials, obtain required regulatory approvals and
successfully manufacture and market our products. We may not ever achieve or be
able to maintain significant revenue or profitability.
WE RELY ON THIRD PARTIES TO DEVELOP, MARKET AND SELL OUR PRODUCTS, WE MAY NOT BE
ABLE TO CONTINUE OR ENTER INTO THIRD PARTY ARRANGEMENTS, AND THESE THIRD
PARTIES' EFFORTS MAY NOT BE SUCCESSFUL
We have not established a dedicated sales and marketing organization,
and we rely on third parties for clinical testing. Therefore, if we are to
successfully develop and commercialize our product candidates, we will be
required to enter into arrangements with one or more third parties that will:
- provide for Phase III clinical testing;
- obtain or assist us in other activities associated with obtaining
regulatory approvals for our product candidates; and
- market and sell our products, if they are approved.
We plan to market and sell products through arrangements with third
parties with expertise in the ophthalmic drug or diagnostic industries. We may
not be able to enter into such arrangements on acceptable terms or at all. If we
are not successful in concluding such arrangements on acceptable terms, we may
be required to establish our own sales and marketing organization, despite the
fact that we have no experience in sales, marketing or distribution. We may not
be able to build such a marketing staff or sales force and our sales and
marketing efforts may not be cost-effective or successful.
Our strategy for research, development and commercialization of certain
of our products requires us to enter into various arrangements with corporate
and academic collaborators, licensors, licensees and others. Furthermore, we are
dependent on the diligent efforts and subsequent success of these outside
parties in performing their responsibilities.
5
<PAGE> 6
Even if we or those working with us obtain regulatory approvals, to the
extent we have entered into or will enter into co-marketing, co-promotion or
other licensing arrangements for the marketing and sale of our products, any
revenues that we receive will be dependent on the efforts of third parties, such
as Pharmacia Corporation, CIBA Vision and Bausch & Lomb. These partners may not
diligently or successfully market our products, and these efforts may not be
successful. We may not be able to conclude arrangements with other companies to
support the commercialization of our products on acceptable terms.
In addition, our collaborators may take the position that they are free
to compete using our technology without compensating or entering into agreements
with us. Furthermore, our collaborators may pursue alternative technologies
or develop alternative products either on their own or in collaboration with
others, including our competitors, as a means for developing treatments for the
diseases or disorders targeted by these collaborative programs.
OUR BUSINESS DEPENDS UPON OUR PROPRIETARY RIGHTS, AND WE MAY NOT BE ABLE TO
ADEQUATELY PROTECT, ENFORCE OR SECURE OUR INTELLECTUAL PROPERTY RIGHTS
Our success will depend in large part on our ability to obtain patents,
protect trade secrets, obtain and maintain rights to technology developed by
others, and operate without infringing upon the proprietary rights of others. A
substantial number of patents in the field of ophthalmology and genetics have
been issued to pharmaceutical, biotechnology and biopharmaceutical companies.
Moreover, competitors may have filed patent applications, may have been issued
patents or may obtain additional patents and proprietary rights relating to
products or processes competitive with ours. Our patent applications may not be
approved. We may not be able to develop additional proprietary products that are
patentable. Even if we receive patent issuances, those issued patents may not
be able to provide us with adequate protection for our inventions or may be
challenged by others. Furthermore, the patents of others may impair our ability
to commercialize our products. The patent positions of firms in the
pharmaceutical and genetic industries generally are highly uncertain, involve
complex legal and factual questions, and have recently been the subject of much
litigation. Neither the United States Patent and Trademark Office nor the courts
has developed, formulated, or presented a consistent policy regarding the
breadth of claims allowed or the degree of protection afforded under
pharmaceutical and genetic patents. Despite our efforts to protect our
proprietary rights, others may independently develop similar products, duplicate
any of our products or design around any of our patents. In addition, third
parties from which we have licensed or otherwise obtained technology may attempt
to terminate or scale back our rights.
A number of pharmaceutical and biotechnology companies and research and
academic institutions have developed technologies, filed patent applications or
received patents on various technologies that may be related to our business.
Some of these technologies, applications or patents may conflict with our
technologies or patent applications. Such conflicts could limit the scope of the
patents, if any, we may be able to obtain or result in the denial of our patent
applications. In addition, if the United States Patent and Trademark Office or
foreign patent agencies have issued or issue patents that cover our activities
to other companies, we may not be able to obtain licenses to these patents at
all, or at a reasonable cost, or be able to develop or obtain alternative
technology. If we do not obtain such licenses, we could encounter delays in or
be precluded altogether from introducing products to the market.
We may need to litigate in order to defend against or assert claims of
infringement, to enforce patents issued to us or to protect trade secrets or
know-how owned or licensed by us. Litigation could result in substantial cost to
and diversion of effort by us, which may harm our business. We have also agreed
to indemnify our licensees, including Pharmacia Corporation, against
infringement claims by third parties related to our technology, which could
result in additional litigation costs and liability for us. In addition, our
efforts to protect or defend our proprietary rights may not be successful or,
even if successful, may result in substantial cost to us.
6
<PAGE> 7
We also depend upon unpatented trade secrets to maintain our
competitive position. Others may independently develop substantially equivalent
proprietary information and techniques or otherwise gain access to our trade
secrets. Our trade secrets may also be disclosed, and we may not be able to
effectively protect our rights to unpatented trade secrets. To the extent that
we or our consultants or research collaborators use intellectual property owned
by others, disputes also may arise as to the rights in related or resulting
know-how and inventions.
IF WE ENGAGE IN ACQUISITIONS, WE WILL INCUR A VARIETY OF COSTS, AND THE
ANTICIPATED BENEFITS OF THE ACQUISITION MAY NEVER BE REALIZED
At some point in the future we may pursue acquisitions of companies,
product lines, technologies or businesses that our management believes are
complementary or otherwise beneficial to us. Any of these acquisitions could
have negative as well as positive effects on our business. Future acquisitions
may result in substantial dilution to our stockholders, the incurrence of
additional debt and amortization expenses related to goodwill, research and
development and other intangible assets. Any of these results could harm our
financial condition. In addition, acquisitions would involve several risks for
us, including:
- assimilating employees, operations, technologies and products from
the acquired companies with our existing employees, operation,
technologies and products;
- diverting our management's attention from day-to-day operation of
our business;
- entering markets in which we have no or limited direct experience;
and
- potentially losing key employees from the acquired companies.
WE HAVE NO EXPERIENCE IN COMMERCIAL MANUFACTURING AND NEED TO ESTABLISH
MANUFACTURING RELATIONSHIPS WITH THIRD PARTIES, AND IF CONTRACT MANUFACTURING IS
NOT AVAILABLE TO US OR DOES NOT SATISFY REGULATORY REQUIREMENTS, WE WILL HAVE TO
ESTABLISH OUR OWN REGULATORY COMPLIANT MANUFACTURING CAPABILITY.
We have no experience manufacturing products for commercial purposes.
We have a pilot facility licensed by the State of California to manufacture a
number of our products for Phase I and Phase II clinical trials. In July 1999,
we terminated our alliance under which Bausch & Lomb agreed to manufacture our
products. Any delays or difficulties that we may encounter in establishing and
maintaining a relationship with other qualified manufacturers to produce,
package and distribute our finished products may harm our clinical trials,
regulatory filings, market introduction and subsequent sales of our products.
Contract manufacturers must adhere to Good Manufacturing Practices
regulations which are strictly enforced by the Food and Drug Administration, or
FDA, on an ongoing basis through its facilities inspection program. Contract
manufacturing facilities must pass a pre-approval plant inspection before the
FDA will approve a new drug application. Some of the material manufacturing
changes that occur after approval are also subject to FDA review
7
<PAGE> 8
and clearance or approval. The FDA or other regulatory agencies may not approve
the process or the facilities by which any of our products may be manufactured.
Our dependence on third parties to manufacture our products may harm our ability
to develop and deliver products on a timely and competitive basis. Should we be
required to manufacture products ourselves, we:
- will be required to expend significant amounts of capital to
install a manufacturing capability;
- will be subject to the regulatory requirements described above;
- will be subject to similar risks regarding delays or difficulties
encountered in manufacturing any such products; and
- will require substantial additional capital.
Therefore, we may not be able to manufacture any products successfully or in a
cost-effective manner.
WE RELY ON A SOLE SOURCE FOR SOME OF THE RAW MATERIALS IN OUR PRODUCTS, AND THE
RAW MATERIALS WE NEED MAY NOT BE AVAILABLE TO US
We are dependent upon British Biotech for the supply of batimastat.
Batimastat is the active drug incorporated into our ISV-615 product candidate.
British Biotech has discontinued the clinical testing of batimastat and informed
us that it will no longer manufacture the product. We are currently searching
for a new source of batimastat. If we are unsuccessful in finding a new source
on acceptable terms, we may have no source of ongoing raw materials for ISV-615
and we may be forced to discontinue this program.
In addition, certain of the raw materials we use in formulating our
DuraSite drug delivery system are available from only one source. Any
significant interruption in the supply of these raw materials could delay our
clinical trials, product development or product sales and could harm our
business.
OUR PRODUCTS ARE SUBJECT TO GOVERNMENT REGULATIONS AND APPROVAL WHICH MAY DELAY
OR PREVENT THE MARKETING OF POTENTIAL PRODUCTS AND IMPOSE COSTLY PROCEDURES
UPON OUR ACTIVITIES
The FDA and comparable agencies in state and local jurisdictions and in
foreign countries impose substantial requirements upon preclinical and clinical
testing, manufacturing and marketing of pharmaceutical products. Lengthy and
detailed preclinical and clinical testing, validation of manufacturing and
quality control processes, and other costly and time-consuming procedures are
required. Satisfaction of these requirements typically takes several years and
the time needed to satisfy them may vary substantially, based on the type,
complexity and novelty of the pharmaceutical product. The effect of government
regulation may be to delay or to prevent marketing of potential products for a
considerable period of time and to impose costly procedures upon our activities.
The FDA or any other regulatory agency may not grant approval for any products
we develop on a timely basis, or at all. Success in preclinical or early stage
clinical trials does not assure success in later stage clinical trials. Data
obtained from preclinical and clinical activities are susceptible to varying
interpretations that could delay, limit or prevent regulatory approval. If
regulatory approval of a product is granted, such approval may impose
limitations on the indicated uses for which a product may be marketed. Further,
even after we have obtained regulatory approval, later discovery of previously
8
<PAGE> 9
unknown problems with a product may result in restrictions on the product,
including withdrawal of the product from the market. Moreover, the FDA has
recently reduced previous restrictions on the marketing, sale and prescription
of products for indications other than those specifically approved by the FDA.
Accordingly, even if we receive FDA approval of a product for certain indicated
uses, our competitors, including our collaborators, could market products for
such indications even if such products have not been specifically approved for
such indications. Delay in obtaining or failure to obtain regulatory approvals
would make it difficult or impossible to market our products and would harm our
business.
The FDA's policies may change and additional government regulations may
be promulgated which could prevent or delay regulatory approval of our potential
products. Moreover, increased attention to the containment of health care costs
in the United States could result in new government regulations that could harm
our business. Adverse governmental regulation might arise from future
legislative or administrative action, either in the United States or abroad. See
"Risk Factors -- Uncertainties regarding health care reform and third-party
reimbursement may impair our ability to raise capital, form collaborations and
sell our products."
WE COMPETE IN HIGHLY COMPETITIVE MARKETS AND OUR COMPETITORS' FINANCIAL,
TECHNICAL, MARKETING, MANUFACTURING AND HUMAN RESOURCES MAY SURPASS OR LIMIT
OUR ABILITY TO DEVELOP AND/OR MARKET OUR PRODUCTS AND TECHNOLOGIES
Our success depends upon developing and maintaining a competitive
advantage in the development of products and technologies in our areas of focus.
We have many competitors in the United States and abroad, including
pharmaceutical, biotechnology and other companies with varying resources and
degrees of concentration in the ophthalmic market. Our competitors may have
existing products or products under development which may be technically
superior to ours or which may be less costly or more acceptable to the market.
Competition from these companies are intense and expected to increase as new
products enter the market and new technologies become available. Many of our
competitors have substantially greater financial, technical, marketing,
manufacturing and human resources. In addition, they may also succeed in
developing technologies and products that are more effective, safer, less
expensive or otherwise more commercially acceptable than any which we have or
will develop. Our competitors may obtain cost advantages, patent protection or
other intellectual property rights that would block or limit our ability to
develop our potential products. Our competitors may also obtain regulatory
approval for commercialization of their products more effectively or rapidly
than we will. If we decide to manufacture and market our products by ourselves,
we will be competing in areas in which we have limited or no experience such as
manufacturing efficiency and marketing capabilities. See "Risk Factors -- We
have no experience in commercial manufacturing and need to establish
manufacturing relationships with third parties, and if contract manufacturing is
not available to us or does not satisfy regulatory requirements, we will have to
establish our own regulatory compliant manufacturing capability."
WE ARE DEPENDENT UPON KEY EMPLOYEES AND WE MAY NOT BE ABLE TO RETAIN OR ATTRACT
NEW KEY EMPLOYEES
We are highly dependent on Dr. Chandrasekaran and other principal
members of our scientific and management staff. The loss of services from these
key personnel might significantly delay the achievement of planned development
objectives. Furthermore, a critical factor to our success is recruiting and
retaining qualified personnel. Competition for skilled individuals in the
biotechnology business is highly intense, and we may not be able to continue to
attract and retain personnel necessary for the development of our business. The
loss of key personnel or the failure to recruit additional personnel or to
develop needed expertise could harm our business.
9
<PAGE> 10
OUR INSURANCE COVERAGE MAY NOT ADEQUATELY COVER OUR POTENTIAL PRODUCT LIABILITY
EXPOSURE
We are exposed to potential product liability risks inherent in the
development, testing, manufacturing, marketing and sale of human therapeutic
products. Product liability insurance for the pharmaceutical industry is
expensive. Our present product liability insurance coverage may not be adequate.
In addition, our existing coverage will not be adequate as we further develop
our products, and adequate insurance coverage against potential claims may not
be available in sufficient amounts or at a reasonable cost.
UNCERTAINTIES REGARDING HEALTH CARE REFORM AND THIRD-PARTY REIMBURSEMENT MAY
IMPAIR OUR ABILITY TO RAISE CAPITAL, FORM COLLABORATIONS AND SELL OUR PRODUCTS
The continuing efforts of governmental and third party payers to
contain or reduce the costs of health care through various means may harm our
business. For example, in some foreign markets the pricing or profitability of
health care products is subject to government control. In the United States,
there have been, and we expect there will continue to be, a number of federal
and state proposals to implement similar government control. The implementation
or even the announcement of any of these legislative or regulatory proposals or
reforms could harm our business by impeding our ability to achieve
profitability, raise capital or form collaborations.
In addition, the availability of reimbursement from third party payers
determines, in part, the amount of sales of health care products in the United
States and elsewhere. Examples of such third party payers are government and
private insurance plans. Significant uncertainty exists as to the reimbursement
status of newly approved health care products, and third party payers are
increasingly challenging the prices charged for medical products and services.
If we succeed in bringing one or more products to the market, reimbursement from
third party payers may not be available or may not be sufficient to allow us to
sell our products on a competitive or profitable basis.
OUR USE OF HAZARDOUS MATERIALS MAY POSE ENVIRONMENTAL RISKS AND LIABILITIES
WHICH MAY CAUSE US TO INCUR SIGNIFICANT COSTS
Our research, development and manufacturing processes involve the
controlled use of small amounts of radioactive and other hazardous materials. We
are subject to federal, state and local laws, regulations and policies governing
the use, manufacture, storage, handling and disposal of radioactive and other
hazardous materials and waste products. Although we believe that our safety
procedures for handling and disposing of these materials comply with the
standards prescribed by current laws and regulations, we cannot completely
eliminate the risk of accidental contamination or injury from these materials.
In the event of such an accident, we could be held liable for any damages that
result, and any such liability could exceed our resources. Moreover, we may be
required to incur significant costs to comply with environmental laws and
regulations, especially to the extent that we manufacture our own products.
MANAGEMENT AND PRINCIPAL STOCKHOLDERS MAY BE ABLE TO EXERT SIGNIFICANT CONTROL
ON MATTERS REQUIRING APPROVAL BY OUR STOCKHOLDERS
As of June 30, 2000, our management and principal stockholders
together beneficially owned approximately 16% of our outstanding shares of
common stock. As a result, these stockholders, acting together, may be able to
effectively control all matters requiring approval by our stockholders,
including the election of a majority of our directors and the approval of
business combinations.
10
<PAGE> 11
THE MARKET PRICES FOR SECURITIES OF BIOPHARMACEUTICAL AND BIOTECHNOLOGY
COMPANIES SUCH AS OURS MAY BE HIGHLY VOLATILE DUE TO REASONS THAT ARE RELATED
AND UNRELATED TO THE OPERATING PERFORMANCE AND PROGRESS OF OUR COMPANY
The market prices for securities of biopharmaceutical and biotechnology
companies, including ours, have been highly volatile. The market has from time
to time experienced significant price and volume fluctuations that are unrelated
to the operating performance of particular companies. In addition, future
announcements, such as the results of testing and clinical trials, technological
innovations or new therapeutic products, governmental regulation, developments
in patent or other proprietary rights, litigation or public concern as to the
safety of products developed by us or others and general market conditions,
concerning us, our competitors or other biopharmaceutical companies, may have a
significant effect on the market price of our common stock. We have not paid any
cash dividends on our common stock, and we do not anticipate paying any
dividends in the foreseeable future.
WE HAVE ADOPTED AND ARE SUBJECT TO ANTI-TAKEOVER PROVISIONS THAT COULD DELAY OR
PREVENT AN ACQUISITION OF OUR COMPANY
Provisions of our certificate of incorporation and bylaws may constrain
or discourage a third party from acquiring or attempting to acquire control of
us. Such provisions could limit the price that investors might be willing to pay
in the future for shares of our common stock. The board of directors has the
authority to issue up to 5,000,000 shares of preferred stock, 7,070 of which
have been designated as Series A Convertible Redeemable Preferred Stock.
Furthermore, the board of directors has the authority to determine the price,
rights, preferences, privileges and restrictions of the remaining unissued
shares of preferred stock without any further vote or action by the
stockholders. The rights of the holders of common stock will be subject to, and
may be adversely affected by, the rights of the holders of any preferred shares
and of preferred stock that may be issued in the future. The issuance of
preferred stock, while providing desirable flexibility in connection with
possible acquisitions and other corporate purposes, could have the effect of
making it more difficult for a third party to acquire a majority of our
outstanding voting stock. Provisions of Delaware law applicable to us could also
delay or make more difficult a merger, tender offer or proxy contest involving
us, including Section 203 of the Delaware General Corporation Law, which
prohibits a Delaware corporation from engaging in any business combination with
any interested stockholder for a period of three years unless conditions set
forth in the Delaware General Corporation Law are met.
WE HAVE CONVERTIBLE, REDEEMABLE SECURITIES THAT MAY RESULT IN DILUTION FOR OUR
COMMON STOCKHOLDERS
Sales of shares of common stock issuable upon conversion of our Series
A convertible redeemable preferred stock could adversely affect the market value
of the common stock, depending on the timing of such sales, and may effect a
dilution of the book value per share of our common stock.
As of June 30, 2000, warrants for 70 shares of Series A convertible
redeemable preferred stock were issued and outstanding. The actual number of
shares of common stock issuable upon exercise and conversion of the warrants for
outstanding Series A convertible redeemable preferred stock will equal:
(i) the aggregate stated value of the Series A convertible
redeemable preferred stock then being converted ($1,000 per share) plus
a premium in the amount of 6% per annum accruing from September 12,
1997 through the date of conversion, divided by
(ii) a conversion price equal to the lower of $2.127 or the
product of the average of the lowest closing bid prices for our common
stock for any 5 trading days during the 22 consecutive trading day
period immediately preceding the date of conversion, subject to
adjustment in accordance with the terms of the Certificate of
Designations, Preferences and Rights for the Series A Convertible
Redeemable Preferred Stock, multiplied by a conversion percentage equal
to 82.5%.
11
<PAGE> 12
For a complete description of the relative rights, preferences, privileges,
powers and restrictions of the Series A convertible redeemable preferred stock,
see the Certificate of Designations, Preferences and Rights attached as Exhibit
4.1 to the Registration Statement on Form S-3 filed with the Securities and
Exchange Commission on September 29, 1997. Depending on market conditions at the
time of conversion, the number of shares of common stock issuable could increase
significantly in the event of a decrease in the trading price of the common
stock. Investors in common stock could therefore experience a dilution upon
conversion of the Series A convertible redeemable preferred stock. In addition,
in the event that the holder of the warrant for Series A convertible redeemable
preferred stock is unable to convert any such securities into common stock, the
holder may cause us to redeem in cash any such Series A convertible redeemable
preferred stock that cannot be so converted. In the event that we fail to so
redeem such shares, the holder of the Series A convertible redeemable preferred
stock is entitled to additional remedies as set forth in the Certificate of
Designations, Preferences and Rights.
SELLING STOCKHOLDERS
The following table sets forth information, as of the date of this
prospectus, with respect to the number of shares of our common stock owned by
each of our stockholders selling pursuant to this prospectus. The shares of our
common stock being offered by this prospectus are being registered to permit
public secondary trading of the shares, and the selling stockholders may offer
the shares for resale from time to time. See "Plan of Distribution." None of the
selling stockholders has had a material relationship with us within the past
three years other than as a result of the ownership of the shares or other of
our securities. Because the selling stockholders may offer all or some of the
shares which they hold pursuant to the offering contemplated by this prospectus,
and because there are currently no agreements, arrangements or understandings
with respect to the sale of any of the shares of which we are aware, no estimate
can be given as to the amount of shares of our common stock that will be held by
the selling stockholders after completion of this offering. Except as indicated
in the notes to the table below, no selling stockholder beneficially owns 1% or
more of the outstanding shares of our common stock.
The shares being offered by this prospectus by the selling stockholders
were purchased, or may be acquired through the exercise of warrants acquired, in
a private placement of our securities pursuant to a stock and warrant purchase
agreement, dated as of May 1, 2000. As part of this stock and warrant purchase
agreement, accredited investors acquired 3,349,722 shares of our common stock.
For every one hundred shares of our common stock purchased by an investor, the
investor also received a warrant to acquire an additional 35 shares of our
common stock. The warrants will be exercisable commencing November 1, 2000 and
will be reduced on a share-for-share basis to the extent that an investor sells
our common stock or other of our securities during the six month period between
May 1, 2000 and November 1, 2000. Furthermore, we may redeem the warrants for a
price of $0.01 per warrant if the weighted average closing price per share of
our common stock has been at least $8.35 for ten consecutive trading days. The
shares issued under the Agreement were offered through a placement agent,
AmeriCal Securities, Inc., for which services we paid to the placement agent a
fee of $926,514.43 and a warrant to acquire 334,972 shares of our common stock.
This prospectus covers the resale by the selling stockholders of up to 4,857,097
Shares, which includes the number of shares of our common stock underlying the
warrants issued pursuant to the Agreement and to the placement agent.
Each selling stockholder that purchased shares of our common stock
pursuant to the stock and warrant purchase agreement mentioned in the previous
paragraph represented to us that it was acquiring the shares for investment and
with no present intention of distributing the shares. Pursuant to the selling
stockholders' registration rights set forth in this stock and warrant purchase
agreement, we have filed with the Commission, under the Securities Act of 1933,
a registration statement on Form S-3, of which this prospectus forms a part,
with respect to the resale of the shares from time to time on The American Stock
Exchange or in privately-negotiated transactions. We have agreed to prepare and
file amendments and supplements to the registration statement as may be
necessary to keep such registration statement effective until the earlier of May
1, 2002 or the date on which the shares are no longer required to be registered
for the sale of the shares by the selling stockholders.
12
<PAGE> 13
The shares covered by this prospectus may be offered from time to time
by the selling stockholders named below:
<TABLE>
<CAPTION>
NUMBER OF SHARES
BENEFICIALLY NUMBER OF SHARES
NAME OF SELLING STOCKHOLDER OWNED (1)(2) BEING OFFERED (3)
-------------------------------------- ---------------- ----------------
<S> <C> <C>
Piping & Co. (Capital Research and
Management Company) (4) 1,235,250 1,235,250
Band & Co. 194,011 194,011
Apollo Medical Partners (5) 405,000 405,000
Brandon Fradd 135,000 135,000
Bernard McDermott, Jr. 64,670 64,670
Bernard McDermott, Jr. - Roth IRA 64,670 64,670
Joyce McDermott - Roth IRA 64,670 64,670
Active Site Partners 64,670 64,670
A. Salam Qureishi 64,670 64,670
Charles Duck, Jr. 32,335 32,335
Michael K. Yap 16,168 16,168
Nancy & Chris Berg JTWROS 32,335 32,335
The Leonard and Dena Oppenheim Revocable 64,670 64,670
Trust dated Jan. 6, 2000
Claire Engelberg 24,251 24,251
Marc Adam Gelman & Ingrid E. Gelman 24,251 24,251
John Hillsman 16,168 16,168
Joseph Feinstein 16,168 16,168
Jacob Feinstein Trust 16,168 16,168
Richard F. Gaston 32,335 32,335
Winston T. Van 129,341 129,341
Dr. Leonard H. Cohen - IRA Rollover 16,168 16,168
Victor Breeze LTD. 64,670 64,670
John Chuang 16,168 16,168
Nelson Capital Corporation 145,508 145,508
Hofund Holdings Limited 80,838 80,838
Clarion Partners, L.P. 109,940 109,940
Clarion Offshore Fund 51,736 51,736
Clarion Capital Corporation 161,676 161,676
</TABLE>
13
<PAGE> 14
<TABLE>
<CAPTION>
NUMBER OF SHARES
BENEFICIALLY NUMBER OF SHARES
NAME OF SELLING STOCKHOLDER OWNED (1)(2) BEING OFFERED(3)
-------------------------------------- ---------------- ----------------
<S> <C> <C>
Permal U.S. Opportunities Limited 80,838 80,838
Daniel S. Calder 16,168 16,168
Patriot Group 19,401 19,401
Allan Fishbein, M.D. 32,335 32,335
Redwood Regional Medical Group 16,168 16,168
Charles Engelberg 32,335 32,335
Marksman Partners, L.P. 48,503 48,503
Kenneth S. Yamamoto MD Target Benefit 16,168 16,168
Pension Plan
Herbert C.V. Feinstein 16,168 16,168
Kronos Inc. 32,335 32,335
Jessica H. Pell 32,335 32,335
Candice N. Pell 32,335 32,335
Kahan Family Trust 40,419 40,419
Veron International Ltd. 242,514 242,514
Petros Capital 270,000 270,000
Baum Revocable Trust Dated 3/6/87 16,168 16,168
Stephen Yost 16,168 16,168
Sanford J. Colen - IRA Rollover 24,251 24,251
Sanford Colen 24,251 24,251
Joseph N. Katz - IRA Rollover 48,503 48,503
Daniel Katz - IRA Rollover 48,503 48,503
Kevin Chessen 16,168 16,168
Richard A. Bordow 19,401 19,401
Michael Powers 21,017 21,017
James R. Christensen 16,168 16,168
Charles B. Engelberg (6)(7) 334,972 334,972
Total...................................... 4,857,097 4,857,097
</TABLE>
14
<PAGE> 15
---------------
(1) Beneficial ownership is determined in accordance with the rules of the
Securities and Exchange Commission and generally includes voting or
investment power with respect to securities; provided, however, that the
shares underlying warrants (as described in footnote 2 below) are not
exercisable within 60 days, will not be exercisable until November 1, 2000
and therefore will not be beneficially owned within the rules of the
Securities and Exchange Commission until September 2, 2000.
(2) Represents issued and outstanding shares of our common stock (74.074% of
the shares listed as beneficially owned) and shares underlying
unexercised warrants to acquire our common stock at a price per share of
$5.64 (25.926% of the shares listed as beneficially owned).
(3) This Registration Statement shall also cover any additional shares of our
common stock which become issuable in connection with the shares registered
for sale under this prospectus by reason of any stock dividend, stock
split, recapitalization or other similar transaction effected without the
receipt of consideration which results in an increase in the number of our
outstanding shares of common stock.
(4) Based on 24,625,907 shares of our common stock outstanding as of May 30,
2000, the beneficial ownership of Piping & Co. (Capital Research)
represented approximately 3.72% of our outstanding shares of common stock.
Shares of our common stock subject to warrants currently exercisable or
exercisable within 60 days of May 30, 2000 are deemed outstanding for
computing the percentage of the person holding such warrant but are not
deemed outstanding for computing the percentage of any other person.
(5) Based on 24,625,907 shares of our common stock outstanding as of May 30,
2000, the beneficial ownership of Apollo Medical Partners represented
approximately 1.22% of our outstanding shares of common stock. Shares of
our common stock subject to warrants currently exercisable or exercisable
within 60 days of May 30, 2000 are deemed outstanding for computing the
percentage of the person holding such warrant but are not deemed
outstanding for computing the percentage of any other person.
(6) Based on 24,625,907 shares of our common stock outstanding as of May 30,
2000, the beneficial ownership of Charles B. Engelberg represented
approximately 1.34% of our outstanding shares of common stock. Shares of
our common stock subject to warrants currently exercisable or exercisable
within 60 days of May 30, 2000 are deemed outstanding for computing the
percentage of the person holding such warrant but are not deemed
outstanding for computing the percentage of any other person.
(7) AmeriCal Securities, of which Charles B. Engelberg is the Director of
Corporate Finance, acted as placement agent for the issuance of the
securities being offered by this prospectus and received as part of its
compensation a warrant to acquire 334,972 Shares at an exercise price per
share of $5.01. Americal instructed us to issue the warrant in Mr.
Engelberg's name.
15
<PAGE> 16
PLAN OF DISTRIBUTION
The shares covered by this prospectus are being offered on behalf of
the selling stockholders, and we will not receive any proceeds from the
offering. The shares covered by this prospectus may be sold or distributed from
time to time by the selling stockholders, or by pledgees, donees or transferees
of, or other successors in interest to, the selling stockholders, directly to
one or more purchasers (including pledgees) or through brokers, dealers or
underwriters who may act solely as agents or may acquire shares as principals,
at market prices prevailing at the time of sale, at prices related to such
prevailing market prices, at negotiated prices, or at fixed prices, which may be
changed. The distribution of the shares covered by this prospectus may be
effected in one or more of the following methods:
- ordinary brokers' transactions, which may include long or short
sales;
- transactions involving cross or block trades or otherwise on The
American Stock Exchange;
- purchases by brokers, dealers or underwriters as principal and
resale by such purchasers for their own accounts pursuant to this
prospectus;
- "at the market" to or through market makers or into an existing
market for the shares;
- in other ways not involving market makers or established trading
markets, including direct sales to purchasers or sales effected
through agents;
- through transactions in options, swaps or other derivatives
(whether exchange-listed or otherwise), or
- any combination of the above methods, or by any other legally
available means.
In addition, the selling stockholders or their successors in interest
may enter into hedging transactions with broker-dealers who may engage in short
sales of shares in the course of hedging the positions they assume with the
selling stockholders. The selling stockholders or their successors in interest
may also enter into option or other transactions with broker-dealers that
require the delivery by such broker-dealers of the shares, which shares may be
resold thereafter pursuant to this prospectus.
Brokers, dealers, underwriters or agents participating in the
distribution of the shares covered by this prospectus as agents may receive
compensation in the form of commissions, discounts or concessions from the
selling stockholders and/or purchasers of the shares for whom such
broker-dealers may act as agent, or to whom they may sell as principal, or both,
which compensation as to a particular broker-dealer may be less than or in
excess of customary commissions. The selling stockholders and any broker-dealers
who act in connection with the sale of shares covered by this prospectus may be
deemed to be "Underwriters" within the meaning of the Securities Act of 1933,
and any commissions they receive and proceeds of any sale of shares may be
deemed to be underwriting discounts and commissions under the Securities Act of
1933. Neither we nor any selling stockholder can presently estimate the amount
of such compensation. We know of no existing arrangements between any selling
stockholder, any other stockholder, broker, dealer, underwriter or agent
relating to the sale or distribution of the shares covered by this prospectus.
16
<PAGE> 17
We will pay substantially all of the expenses incident to the
registration, offering and sale of the shares covered by this prospectus to the
public other than commissions or discounts of underwriters, broker-dealers or
agents. We have also agreed to indemnify the selling stockholders and some
related persons against some liabilities, including liabilities under the
Securities Act of 1933.
We will keep a registration statement of which this prospectus
constitutes a part effective until the earlier of May 1, 2002 or the date on
which the shares covered by this prospectus are no longer required to be
registered for the sale of the shares by the Selling Stockholders. After such
period, if we choose not to maintain the effectiveness of the registration
statement of which this prospectus constitutes a part, the securities offered by
this prospectus may not be sold, pledged, transferred or assigned, except in a
transaction which is exempt under the provisions of the Securities Act of 1933
or pursuant to an effective registration statement under the Securities Act of
1933.
No dealer, salesperson or other person has been authorized to give any
information or to make any representations other than those contained in this
prospectus and, if given or made, such information or representations must not
be relied upon as having been authorized by us, by any Selling Stockholders or
by any other person. This prospectus does not constitute an offer to sell or a
solicitation of an offer to buy any securities other than the shares of our
common stock offered by this prospectus, 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 such offer or solicitation would be
unlawful. Neither the delivery of this prospectus nor any sale made under this
prospectus shall under any circumstances create any implication that the
information contained in this prospectus is correct as of any date subsequent to
the date of this prospectus.
AVAILABLE INFORMATION
This prospectus, which constitutes a part of a Registration Statement
on Form S-3 filed by us with the Securities and Exchange Commission (the
"Commission") under the Securities Act of 1933 omits certain of the information
set forth in the registration statement. For further information with respect to
us and our common stock offered by this prospectus, reference is made by this
prospectus to such registration statement, exhibits and schedules. Statements
contained in this prospectus regarding the contents of any contract or other
document are not necessarily complete; with respect to each such contract or
document filed as an exhibit to the registration statement, reference is made to
the exhibit for a more complete description of the matter involved, and each
such statement shall be deemed qualified in its entirety by such reference. A
copy of the registration statement, including the exhibits and schedules to the
registration statement, may be inspected without charge at the public reference
facilities of the Securities and Exchange Commission described below, and copies
of such material may be obtained from such office upon payment of the fees
prescribed by the Securities and Exchange Commission.
We are subject to the informational requirements of the Securities
Exchange Act of 1934 and in accordance with the Securities and Exchange Act of
1934 file reports, proxy statements and other information with the Securities
and Exchange Commission. Such reports, proxy statements and other information
filed by us with the Securities and Exchange Commission can be inspected and
copied at the public reference facilities maintained by the Securities and
Exchange Commission at Judiciary Plaza, 450 Fifth Street, N.W., Room 1024,
Washington, D.C. 20549, and the following regional offices of the Securities and
Exchange Commission: New York Regional Office, Seven World Trade Center, 13th
Floor, New York, New York 10048; and Chicago Regional Office, Citicorp Center,
500 West Madison Street, Suite 1400, Chicago, Illinois 60661. Copies of such
material can also be obtained from the Public Reference Section of the
Securities and Exchange Commission at 450 Fifth Street, N.W., Washington, D.C.
20549, upon payment of prescribed rates. Furthermore, the Securities and
Exchange Commission maintains a Web site that contains reports, proxy and
information statements and other information regarding registrants that file
electronically with the Securities and Exchange Commission. This Web site is
located at http://www.sec.gov. Our common stock is quoted on The American Stock
Exchange.
17
<PAGE> 18
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents or portions of documents filed by us (File No.
0-22332) with the Securities and Exchange Commission are incorporated in this
prospectus by reference: (a) our Annual Report on Form 10-K for the year ended
December 31, 1999; (b) our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2000; (c) our Definitive Proxy Statement dated May 1, 2000 filed in
connection with our 2000 Annual Meeting of Stockholders held June 12, 2000; and
(d) the description of our common stock contained in our Registration Statement
on Form 8-A, as amended, filed with the Securities and Exchange Commission on
August 27, 1993, including any amendments or reports filed for the purpose of
updating such description.
All reports and other documents subsequently filed by us pursuant to
Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, prior
to the filing of a post-effective amendment which indicates that all securities
offered by this prospectus have been sold or which deregisters all securities
remaining unsold, shall be deemed to be incorporated by reference in this
prospectus and to be a part of this prospectus from the date of filing of such
reports and documents. Any statement contained in a document incorporated by
reference in this prospectus shall be deemed modified or superseded for purposes
of this prospectus to the extent that a statement contained or incorporated by
reference in this prospectus 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.
We will provide without charge to each person to whom this prospectus
is delivered, upon written or oral request of such person, a copy of any and all
of the information that has been or may be incorporated by reference in
this prospectus, other than exhibits to such documents (unless such exhibits are
specifically incorporated by reference into such documents). Such requests
should be directed to InSite Vision Incorporated, 965 Atlantic Avenue, Alameda,
California 94501, telephone (510) 865-8800, Attn: S. Kumar Chandrasekaran,
Ph.D., Chairman of the Board, President and Chief Executive Officer.
---------------
LEGAL MATTERS
The legality of the securities offered hereby will be passed upon for
us by Brobeck, Phleger & Harrison LLP, Palo Alto, California.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our consolidated
financial statements included in our Annual Report (Form 10-K) for the year
ended December 31, 1999, as set forth in their report, which is incorporated by
reference in this prospectus and elsewhere in the registration statement. Our
financial statements are incorporated by reference in reliance on Ernst & Young
LLP's report, given on their authority as experts in accounting and auditing.
18
<PAGE> 19
================================================================================
YOU SHOULD RELY ONLY ON THE INFORMATION CONTAINED IN THIS PROSPECTUS. WE HAVE
NOT AUTHORIZED ANYONE TO PROVIDE YOU WITH INFORMATION DIFFERENT FROM THAT
CONTAINED IN THIS PROSPECTUS. INFORMATION CONTAINED ON INSITE VISION'S WEB SITE
DOES NOT CONSTITUTE PART OF THIS PROSPECTUS. THIS PROSPECTUS DOES NOT CONSTITUTE
AN OFFER TO SELL OR A SOLICITATION OF AN OFFER TO BUY TO ANY PERSON IN ANY
JURISDICTION IN WHICH SUCH OFFER OR SOLICITATION WOULD BE UNLAWFUL OR TO ANY
PERSON TO WHOM IT IS UNLAWFUL. THE INFORMATION CONTAINED IN THIS PROSPECTUS IS
ACCURATE ONLY AS OF THE DATE OF THIS PROSPECTUS, REGARDLESS OF THE TIME OF
DELIVERY OF THIS PROSPECTUS OR OF ANY SALE OF THE COMMON STOCK.
---------------
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
----
<S> <C>
InSite Vision Incorporated........................2
Risk Factors......................................4
Selling Stockholders.............................12
Plan of Distribution.............................16
Available Information............................17
Incorporation of Certain Documents by
Reference........................................18
Legal Matters....................................18
Experts..........................................18
</TABLE>
4,857,097 SHARES
INSITE VISION
INCORPORATED
COMMON STOCK
---------------
PROSPECTUS
---------------
August 31, 2000
================================================================================
