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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2000
Commission file number 0-22332
INSITE VISION INCORPORATED
(Exact name of registrant as specified in its charter)
DELAWARE 94-3015807
(STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) IDENTIFICATION NO.)
965 ATLANTIC AVENUE
ALAMEDA, CA 94501
(Address of Principal Executive Offices, including Zip Code)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (510) 865-8800
Indicate by check mark whether the registrant: (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes [X] No [ ]
The number of shares of Registrant's common stock, $.01 par value,
outstanding as of June 30, 2000: 24,772,874.
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QUARTERLY REPORT ON FORM 10-Q
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2000
TABLE OF CONTENTS
<TABLE>
<CAPTION>
Page
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
<S> <C> <C>
Condensed Consolidated Balance Sheets at
June 30, 2000 and December 31, 1999............................... 3
Condensed Consolidated Statements of Operations
For the three and six months ended June 30, 2000 and 1999......... 4
Condensed Consolidated Statements of Cash Flows
For the six months ended June 30, 2000 and 1999................... 5
Notes to Condensed Consolidated Financial Statements ............ 6
Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations..................... 7
PART II. OTHER INFORMATION
Item 4. Submission of Matters to a Vote of Stockholders ................. 16
Item 6. Exhibits and Reports on Form 8-K
Exhibits......................................................... 16
Reports on Form 8-K.............................................. 16
</TABLE>
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PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements
INSITE VISION INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
<TABLE>
<CAPTION>
June 30, December 31,
(in thousands, except share and per share amounts) 2000 1999
----------- -----------
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 21,586 $ 6,746
Prepaid expenses and other current assets 1,023 598
----------- -----------
Total current assets 22,609 7,344
Property and equipment, at cost:
Laboratory and other equipment 532 204
Leasehold improvements 9 10
----------- -----------
541 214
Accumulated depreciation 113 95
----------- -----------
428 119
Note receivable from stockholder 181 -
----------- -----------
Total assets $ 23,218 $ 7,463
=========== ===========
LIABILITIES, REDEEMABLE PREFERRED STOCK AND COMMON
STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 193 $ 119
Deferred cost recovery 1,213 -
Accrued liabilities 368 534
Accrued compensation and related expense 612 524
----------- -----------
Total current liabilities 2,386 1,177
Long-term notes payable 30 -
Commitments
Redeemable preferred stock, $0.01 par value,
5,000,000 shares authorized; no shares issued and
outstanding at June 30, 2000 and December 31, 1999 32 30
Common stockholders' equity:
Common stock, $0.01 par value, 60,000,000 shares
authorized; 24,772,874 issued and
outstanding at June 30, 2000; 20,298,923 issued and
outstanding at December 31, 1999 248 203
Additional paid-in-capital 106,734 90,807
Note receivable from stockholder (76) -
Accumulated deficit (86,136) (84,754)
----------- -----------
Common stockholders' equity 20,770 6,256
----------- -----------
Total liabilities, redeemable preferred stock and
common stockholders' equity $ 23,218 $ 7,463
=========== ===========
</TABLE>
See accompanying notes to condensed consolidated financial statements.
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INSITE VISION INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
<TABLE>
<CAPTION>
Three months ended June 30, Six Months Ended June 30,
(in thousands, except per share amounts) 2000 1999 2000 1999
-------- -------- -------- --------
<S> <C> <C> <C> <C>
Royalty revenues $ 2 $ 1 $ 8 $ 8
Operating expenses:
Research and development 1,588 1,396 3,033 2,751
Cost reimbursement 1,525 900 2,726 1,800
-------- -------- -------- --------
Research and development, net 63 496 307 951
General and administrative 757 549 1,333 1,187
-------- -------- -------- --------
Total operating expenses 820 1,045 1,640 2,138
-------- -------- -------- --------
Loss from operations (818) (1,044) (1,632) (2,130)
Interest, other income and expense, net 170 22 252 34
-------- -------- -------- --------
Net loss (648) (1,022) (1,380) (2,096)
Non-cash preferred dividends (1) (8) (2) (20)
-------- -------- -------- --------
Net loss applicable to common
stockholders $ (649) $ (1,030) $ (1,382) $ (2,116)
======== ======== ======== ========
Basic and diluted net loss per share
applicable to common stockholders $ (0.03) $ (0.05) $ (0.06) $ (0.11)
======== ======== ======== ========
Shares used to calculate basic and
diluted net loss per share 23,601 18,886 22,329 18,574
======== ======== ======== ========
</TABLE>
No cash dividends were declared or paid during the periods.
See accompanying notes to condensed consolidated financial statements.
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'
INSITE VISION INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
<TABLE>
<CAPTION>
Six months ended June 30,
(in thousands) 2000 1999
-------- --------
<S> <C> <C>
OPERATING ACTIVITIES
Net loss $ (1,380) $ (2,096)
Adjustments to reconcile net loss to net cash used in
Operating activities:
Depreciation and amortization 143 310
Issuance of note receivable (181) -
Changes in:
Prepaid expenses and other current assets (425) 67
Accounts payable and accrued liabilities 1,202 344
-------- --------
Net cash used in operating activities (641) (1,375)
INVESTING ACTIVITIES
Purchases of property and equipment (307) (69)
-------- --------
Net cash used in investing activities (307) (69)
FINANCING ACTIVITIES
Issuance of common stock 15,790 2,011
Payment of capital lease obligation (2) -
-------- --------
Net cash provided by financing activities 15,788 2,011
Net increase (decrease) in cash and cash
equivalents 14,840 567
Cash and cash equivalents, beginning of period 6,746 1,037
-------- --------
Cash and cash equivalents, end of period $ 21,586 $ 1,604
======== ========
Supplemental disclosures:
Non-cash preferred dividends $ 2 $ 20
======== ========
Non-cash conversion of redeemable preferred
stock to common stock $ - $ 1,087
======== ========
Capital lease obligation incurred $ 39 $ -
======== ========
Common stock issued for note receivable
from stockholder $ 76 $ -
======== ========
</TABLE>
See accompanying notes to condensed consolidated financial statements.
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INSITE VISION INCORPORATED
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2000
(UNAUDITED)
NOTE 1 - BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated financial statements
have been prepared in accordance with generally accepted accounting principles
for interim financial information pursuant to the instructions to Form 10-Q and
Article 10 of Regulation S-X. Accordingly, they do not include all of the
information and footnotes required by generally accepted accounting principles
for complete financial statements. In the opinion of management, all
adjustments, consisting of normal recurring adjustments, considered necessary
for a fair presentation have been included. Operating results for the six month
period ended June 30, 2000, are not necessarily indicative of the results that
may be expected for any future period.
These financial statements and notes should be read in conjunction with
the Company's audited financial statements and notes thereto included in the
Company's Annual Report on Form 10-K for the year ended December 31, 1999.
NOTE 2 - NOTE RECEIVABLE FROM STOCKHOLDER
In May 2000, the Company issued loans to Dr. Chandrasekaran, the
Company's Chief Executive Officer (CEO) and Chairman of the Board, related to
his exercise of 126,667 options to acquire common stock. The loans are full
recourse, have a term of 4 years and bear interest at 7%. Interest payments are
due semi-annually and principal payments are due annually. While the 126,667
shares of common stock issued secure the loans the Company is not limited to
these shares to satisfy the loan.
NOTE 3 - DEFERRED COST RECOVERY
In January 2000, the Company received $2.0 million from Pharmacia
Corporation (Pharmacia) pursuant to the November 1999, ISV-900 Project
Agreement, to be used to reimburse the Company for costs incurred in support of
the ISV-900 project. As of June 30, 2000, $1.2 million of these funds were
included in current liabilities as deferred cost recovery. The Company directly
reduces expenses for amounts reimbursed pursuant to cost sharing agreements.
During the six month period ended June 30, 2000 and 1999, research and
development expenses were reduced by $2.7 million and $1.8 million,
respectively, for costs reimbursed by Pharmacia pursuant to ISV-205, ISV-900 and
ISV-402 agreements.
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following discussion should be read in conjunction with the
financial statements and notes thereto included in this Quarterly Report and in
our Annual Report on Form 10-K for the year ended December 31, 1999.
Except for the historical information contained herein, the discussion
in this Quarterly Report may be deemed to contain certain forward-looking
statements as defined in Section 21E of the Securities Exchange Act of 1934, as
amended, such as statements of our plans, objectives, expectations and
intentions, that involve risks and uncertainties. The cautionary statements made
in this Quarterly Report, including those set forth below under the heading
"Risk Factors," should be read as being applicable to all relevant
forward-looking statements wherever they appear in this Quarterly Report. Our
actual results could differ materially from those discussed herein.
OVERVIEW
InSite Vision Incorporated is developing genetically-based tools for the
diagnosis, prognosis and management of glaucoma and ophthalmic pharmaceutical
products based on its proprietary DuraSite(R) eyedrop-based drug delivery
technology.
We are focusing our research and development on the following:
- expansion of 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-401 and ISV-402, formulations of novel antibiotics not currently
used in ophthalmology;
- ISV-615 for the treatment of diabetic retinopathy and macular
degeneration;
- ISV-014, a retinal drug delivery device; and
- evaluation and development of several antibiotics not currently used
in ophtalmics.
We are collaborating with academic researchers to develop new
diagnostic, prognostic and management tools for primary congenital, juvenile and
primary open angle glaucomas. 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, which is being carried out in
collaboration with academic researchers, is focused on discovering genes that
are associated with glaucoma, and the mutations on these genes that cause the
disease. This genetic information then may be applied to develop new glaucoma
diagnostic, prognostic and management tools. 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, and have licensed ISV-900 to Pharmicia in November 1999.
Another result of the glaucoma genetics research has been the
development of the ISV-205 product candidate. 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, the
Company entered into a transaction that granted Pharmacia an exclusive worldwide
license for ISV-205 for the treatment of glaucoma. In June 1999, we announced
positive results from its Phase II trial of ISV-205. Pharmacia has assumed
continued development of the product with our continued technical support.
Our ISV-401 and ISV-402 product candidates are formulations of
antibiotics that have not previously been used in ophthalmology. ISV-401
contains an antibiotic, which is effective both for gram-negative and
gram-positive bacteria and may also provide reduced dosing frequency. Current
ophthalmic antibiotics must be dosed every two hours during the first day and
four times a day for the remainder of the treatment period, which may be up to
fourteen days. This may result in patient compliance issues that could be
minimized with an improved product. Also, a broad-spectrum antibiotic could be
used by physicians to treat a variety of ophthalmic diseases instead of
targeting each disease specifically. ISV-402 is a formulation of a novel
antibiotic recently developed by Pharmacia. The antibiotic is effective for
gram-positive bacteria and bacteria that have become resistant to current
treatments.
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Ophthalmic conditions that involve retinal damage include macular
degeneration, which affects 10 million or more people in the U.S., and diabetic
retinopathy, a common side effect of diabetes. Approximately ten to fourteen
million people in the U.S. are diabetics. Both macular degeneration and diabetic
retinopathy can lead to irreversible vision loss and blindness. Current
treatment of retinal diseases generally involves surgery and laser treatments
that can lead to loss of vision, retinal detachment and infection. There is no
effective drug therapy for these conditions.
Our ISV-615 product candidate is a DuraSite-based ophthalmic formulation
of batimastat that we are evaluating for its potential in preventing
neovascularization in the retina related to diabetic retinopathy and macular
degeneration. We obtained batimastat, the active ingredient of ISV-615, through
a 1992 agreement with British Biotech Pharmaceuticals Limited ("British
Biotech"), which in December 1996 advised us that it had discontinued
development and manufacturing of batimastat. We are in negotiations with British
Biotech on a new licensing agreement related to batimastat that provides for
continued supply of the drug. See "Risk Factors - 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."
Another technology platform is comprised of a device, ISV-014, for the
controlled, non-surgical delivery of ophthalmic drugs to the retina and
surrounding tissues. We are continuing to enhance the device and are
collaborating with various academic researchers to perform invivo experiments
delivering products with a variety of molecular sizes to retinal tissues. The
combination of this device technology with polymer-based drug platforms may
permit long term delivery of therapeutic agents to treat several retinal
diseases, most of which cannot be effectively treated at the present time.
The 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. DuraSite can be customized to deliver a
wide variety of potential drug candidates with a broad range of molecular
weights and other properties. The DuraSite formulation remains in the eye for up
to several hours during which time the active drug ingredient is gradually
released. DuraSite extends the residence time of the drug due to a combination
of mucoadhesion, surface tension and viscosity. Eyedrops delivered in the
DuraSite system contrast to conventional eyedrops which typically only last in
the eye a few minutes, thus requiring delivery of a highly concentrated burst of
drug and frequent administration to sustain therapeutic levels. The increased
residence time for DuraSite 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 the potential related adverse side
effects.
To date, we have not received any revenues from the sale of products,
although we have received a small amount of royalties from the sale of products
using our licensed technology. Until 1999, we had been unprofitable since our
inception due to continuing research and development efforts, including
preclinical studies, clinical trials and manufacturing of our product
candidates. We have financed our research and development activities and
operations primarily through private and public placement of our equity
securities and, to a lesser extent, from collaborative agreements.
As of June 30, 2000, our accumulated deficit was approximately
$86.1 million. There can be no assurance that we will ever achieve either
significant revenues or profitable operations.
RESULTS OF OPERATIONS
We earned revenues of $8,000 in the first six months of 2000,
from sales of AquaSite(R) by CIBA Vision and certain key components of AquaSite
to Kukje Pharma Ind. Co., Ltd., the Company's AquaSite manufacturing partner in
Korea. We earned $8,000 in the first six months of 1999, from sales of AquaSite
by CIBA Vision. To date, we have not relied on such revenues to fund our
activities.
Research and development (R&D) expenses were $1.6 million and $1.4
million for the second quarters of 2000 and 1999, respectively, and $3.0 million
and $2.8 million for the six months ended June 30, 2000 and 1999, respectively.
These increases mainly reflect an increase in R&D headcount of 13% and
preclinical testing conducted outside of the Company related to our ISV-401 and
ISV-402 antibiotic programs. Reimbursement of research expenses increased to
$1.5 million from $900,000 in the second quarter of 2000 and 1999, respectively,
and to $2.7 million from $1.8 million for the six months ended June 30, 2000 and
1999, respectively. This reflects an increase in the programs that Pharmacia is
supporting from the January 1999, ISV-205 license agreement, to also include the
November 1999, ISV-900 license agreement and the ISV-402 pre-feasibility study.
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General and administrative expenses increased 38% during the second
quarter of 2000 to $757,000 from $549,000 during the second quarter of 1999.
This increase was primarily due to higher consulting and other outside service
costs, mainly related to financial, public and investor relation activities.
General and administrative expenses increased 8% to $1.3 million from $1.2
million for the six months ended June 30, 2000 and 1999, respectively. This
increase reflected the higher consulting and other outside services for
financial, public and investor relation activities.
Net interest and other income was $170,000 and $22,000 in the second
quarter of 2000 and 1999, respectively, and $252,000 and $34,000 for the six
months ended June 30, 2000 and 1999, respectively. These fluctuations are due
principally to changes in average cash balances. Interest earned in the future
will be dependent on our funding cycles and prevailing interest rates.
We incurred net losses applicable to common stockholders of $649,000 and
$1.0 million during the second quarter of 2000 and 1999, respectively, and $1.4
million and $2.1 million for the six months ended June 30, 2000 and 1999,
respectively. The decreases for both the second quarter of 2000 compared to
1999, and the six month periods then ended, was due primarily to the increased
reimbursement of research expenses by Pharmacia in 2000. We may incur additional
losses over the next several years. These losses are expected to fluctuate from
period to period based primarily on the level of our product development and
clinical activities, the level of third-party reimbursement and milestone
payments we receive and any royalties on the sale of sub-licensed products, if
any.
LIQUIDITY AND CAPITAL RESOURCES
Through 1995, we financed its operations primarily through private
placements of preferred stock, totaling approximately $32 million, and an
October 1993 public offering of Common Stock, which resulted in net proceeds of
approximately $30 million. After 1995, we financed our operations primarily
through a January 1996 private placement of Common Stock and warrants resulting
in net proceeds of approximately $4.7 million and an April 1996 public offering
which raised net proceeds of approximately $8.1 million. In accordance with a
July 1996 agreement with Bausch & Lomb Pharmaceuticals, Inc. (B&L), we received
a total of $2.0 million from the sale of Common Stock in August 1996 and 1997.
In September 1997, we completed a $7.0 million private placement of 7,000 shares
of Series A Redeemable Convertible Preferred Stock (Series A preferred stock)
for which net proceeds were approximately $6.5 million. In January 1999, we
entered into a transaction with Pharmacia and we received a total of $3.5
million from the sale of Common Stock in January 1999 and September 1999. In
November 1999, we entered into another transaction with Pharmacia and we
received a $5.0 million licensing fee and, in January 2000, received $2.0
million from the sale of 723,195 shares of Common Stock. In April 2000, we
received $625,000 from the issuance of Common Stock from the exercise of
warrants issued as part of the January 1996 private placement. In May 2000, we
completed a private placement of Common Stock and warrants resulting in net
proceeds of approximately $13.0 million.
At June 30, 2000, we had cash and cash equivalents totaling $21.6
million compared to $6.7 million as of December 31, 1999. It is our policy to
invest these funds in highly liquid securities, such as interest bearing money
market funds, Treasury and federal agency notes and corporate debt.
The decrease in net cash used in operating activities of $734,000 for
the six months ended June 30, 2000 compared to the same period in 1999 related
primarily to transactions with Pharmacia. In January 2000, we received $2.0
million from Pharmacia pursuant to the ISV-900 Project Agreement, to be used to
reimburse us for costs incurred in support of the ISV-900 project. As of June
30, 2000, $1.2 million of these funds were included in accounts payable and
accrued liabilities as deferred cost recovery. We also entered into a note
receivable with our CEO related to the exercise of stock options. The note is
full recouse, has a term of four years and bears a 7% interest rate. The
interest is payable semi-annually with annual principal payments. While the
126,667 shares of common stock issued secure the loans we are not limited to
these shares to satisfy the loan. The $425,000 change in prepaid expenses and
other current assets was primarily due to the increase in the receivable from
Pharmacia for technical support provided as part of the ISV-205 License
Agreement and the ISV-402 activities.
We purchased $307,000 of laboratory and other equipment in the first six
months of 2000 compared with $69,000 in the first six months of 1999. We also
entered into a $39,000 capital lease for certain laboratory equipment and began
making payments on the liability.
In addition to the $13.0 million net proceeds raised by the May 2000
private placement and the $625,000 received from the exercise of warrants in
April 2000 we received $2.0 million in January 2000 from the issuance of Common
Stock to Pharmacia
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as part of the November 1999 Stock Purchase Agreement. In addition, we received
$165,000 from the exercise of stock options by employees and purchases made as
part of the employee stock purchase plan.
Our future capital expenditures and requirements will depend on numerous
factors, including the progress of our research and development programs and
preclinical and clinical testing, the time and costs involved in obtaining
regulatory approvals, our ability to establish additional collaborative
arrangements, 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, acquisition of new businesses, products and technologies, the
completion of commercialization activities and arrangements, and the purchase of
additional property and equipment.
We anticipate no material capital expenditures for environmental
compliance in fiscal year 2000. Based on our good environmental compliance
record to date, and our current compliance with applicable environmental laws
and regulations, environmental compliance is not expected to have a material
adverse effect on our operations.
We believe that our cash and cash equivalents will be sufficient to meet
our operating expenses and cash requirements through the end of 2000. We may
require substantial additional funds prior to reaching sustained profitability
and we may seek private or public equity investments, future collaborative
agreements, and possibly research funding to meet such needs. Even if we do not
have an immediate need for additional cash, we may seek access to the private or
public equity markets if and when we believe conditions are favorable. There is
no assurance that such additional funds will be available for us to finance our
operations on acceptable terms, or at all.
RISK FACTORS
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, or OTC, 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
$5.0 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.
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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.
If we raise additional funds by issuing equity securities, our
stockholders will suffer substantial dilution. 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. Although we achieved profitability in 1999, 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.
Our ability to achieve 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, although 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.
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Even if regulatory approvals are obtained, 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 received
by us 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, we cannot be certain our collaborators will not take the
position that they are free to compete using our technology without compensating
or entering into agreements with us. Furthermore, we cannot be certain our
collaborators will not 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 are issued patents 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. No
consistent policy has emerged from the U.S. Patent and Trademark Office or the
courts 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.
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 patents that cover our activities have been or are
issued 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.
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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, all of which 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. Should we encounter delays or difficulties in establishing and
maintaining a relationship with other qualified manufacturers to produce,
package and distribute our finished products, then clinical trials, regulatory
filings, market introduction and subsequent sales of our products will be
harmed.
Contract manufacturers must adhere to Good Manufacturing Practices, or
GMP, regulations which are strictly enforced by the Federal 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, or NDA. Some of the material
manufacturing changes that occur after approval are also subject to FDA review
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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, the
active drug incorporated into our ISV-615 product candidate. British Biotech
has discontinued 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
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
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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 U.S. could result in new government regulations that could harm our
business. We cannot predict the likelihood of adverse governmental regulation
that might arise from future legislative or administrative action, either in the
U.S. 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 U.S. 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,
or may obtain regulatory approval for commercialization of their products more
effectively or rapidly than we will. To the extent we decide to manufacture and
market our products by ourselves, we will also compete with respect to
manufacturing efficiency and marketing capabilities, areas in which we have
limited or no experience. 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 whose services might
significantly delay the achievement of planned development objectives.
Furthermore, recruiting and retaining qualified personnel will be critical to
our success. 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.
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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 U.S., there have
been, and we expect there will continue to be, a number of federal and state
proposals to implement similar government control. While we cannot predict
whether any of these legislative or regulatory proposals or reforms will be
adopted, the announcement and implementation of these proposals or reforms could
harm our business, including our ability to achieve profitability, to raise
capital or to form collaborations.
In addition, in the United States and elsewhere, sales of health care
products are dependent in part on the availability of reimbursement from third
party payers, such as 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 such 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.
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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, and 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 concerning InSite, our competitors or other
biopharmaceutical companies, including 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, 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
Certain provisions of our certificate of incorporation and bylaws may
have the effect of making it more difficult for a third party to acquire, or
discouraging a third party from attempting to acquire, control of InSite. Such
provisions could limit the price that certain 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. Certain 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 upon 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%.
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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.
PART II OTHER INFORMATION
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF STOCKHOLDERS
On June 12, 2000, the Company held its Annual Meeting of Stockholders at which
the stockholders approved:
(1) The election of S. Kumar Chandrasekaran, Ph.D., Mitchell H. Friedlaender,
M.D., John L. Mattana, Jon S. Saxe and Anders P. Wiklund to the Board of
Directors to serve until the next annual meeting or until their successors
are elected and qualified. The following directors received the number of
votes set opposite their respective names:
<TABLE>
<CAPTION>
For Election Withheld
------------ --------
<S> <C> <C>
S. Kumar Chandrasekaran, Ph.D. 15,455,141 1,578,958
Mitchell H. Friedlaender, M.D. 16,468,643 565,456
John L. Mattana 16,462,843 571,256
Jon S. Saxe 16,467,143 566,956
Anders P. Wiklund 16,467,143 566,956
</TABLE>
(2) An amendment to the Company's 1994 Employee Stock Purchase Plan (the
"Plan") to increase by 85,000 the total number of shares of the Company's
Common Stock authorized for issuance under the Plan. Such proposal received
15,337,102 votes for the amendment, 1,613,347 against the amendment, and
83,650 abstaining.
(3) An amendment to the Company's Restated Certificate of Incorporation
increasing the number of shares of the Company's Common Stock authorized
for issuance by 30,000,000 to a total of 60,000,000 shares. Such proposal
received 15,621,399 votes for the amendment, 1,343,250 against the
amendment and 69,450 abstaining.
(4) The ratification of the Company's appointment of Ernst & Young LLP as the
Company's independent certified public accountants for the 2000 fiscal
year. Such proposal received 16,943,974 votes for ratification, 63,735
against ratification and 26,390 abstaining.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
a) Exhibits
27 Financial Data Schedule
b) Reports on Form 8-K
No Reports on Form 8-K were filed in the quarter ended June 30, 2000.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended
the registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
INSITE VISION INCORPORATED
Dated: August 14, 2000 by: /s/ S. Kumar Chandrasekaran
---------------------------------------------
S. Kumar Chandrasekaran, Ph.D.
Chairman of the Board,
Chief Executive Officer and
Chief Financial Officer
(on behalf of the registrant and as
principal financial and accounting officer)
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EXHIBIT INDEX
Exhibits Description
27 Financial Data Description
