<PAGE>
As filed with the Securities and Exchange Commission on July 15, 1999
Registration No. 333-
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SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
------------
FORM S-3
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933
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KeraVision, Inc.
(Exact name of registrant as specified in its charter)
Delaware 3851 77-0328942
(State or other (Primary Standard Industrial (I.R.S. Employer
jurisdiction of Classification Code Number) Identification No.)
incorporation or
organization)
48630 Milmont Drive
Fremont, California 94538
(510) 353-3000
(Address, including zip code, and telephone number, including
area code, of registrant's principal executive offices)
------------
Thomas M. Loarie
Chairman, President and Chief Executive Officer
KeraVision, Inc.
48630 Milmont Drive
Fremont, California 94538
(510) 353-3000
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
------------
Please send copies of all communications to:
Michael W. Hall, Esq. Peter Lillevand, Esq.
Laura I. Bushnell, Esq. Brett Cooper, Esq.
Latham & Watkins Orrick, Herrington & Sutcliffe LLP
135 Commonwealth Drive 400 Sansome Street
Menlo Park, California 94025 San Francisco, California 94111
(650) 328-4600 (415) 392-1122
Approximate date of commencement of the proposed sale to the public: As soon
as practicable after the effective date of the Registration Statement.
If the only securities being registered on this form are being offered
pursuant to dividend or interest reinvestment plans, please check the
following box. [_]
If any of the securities being registered on this form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or
interest reinvestment plans, check the following box: [_]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following
box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [_]
If this Form is a post-effective amendment filed pursuant to Rule 462(d)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [_]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [_]
CALCULATION OF REGISTRATION FEE
<TABLE>
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<CAPTION>
Proposed Proposed
Amount Maximum Maximum Amount of
Title of Shares to be to be Offering Price Aggregate Registration
Registered Registered(1) Per Share(2) Offering Price Fee
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<S> <C> <C> <C> <C>
Common Stock, $.001 par
value(3).............. 4,600,000 $22.90 $105,368,750 $29,293
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</TABLE>
(1) Includes 600,000 which the underwriters have the option to cover over-
allotments, if any.
(2) Estimated solely for the purpose of calculating the registration fee
pursuant to Rule 457(c) under the Securities Act of 1933, as amended. The
maximum price per share is based on the average of the high and the low
sale prices of the registrant's common stock reported on the Nasdaq
National Market System on July 15, 1999.
(3) Each share of the registrant's common stock being registered hereunder, if
issued prior to the termination by the registrant of its preferred shares
rights agreement, will include a Series A participating preferred purchase
right. Prior to the occurrence of certain events, the Series A
participating preferred purchase rights will not be exercisable or
evidenced separately from the registrant's common stock and have no value
except as reflected in the market price of the shares to which they are
attached.
------------
The registrant hereby amends this registration statement on such date or
dates as may be necessary to delay its effective date until the registrant
shall file a further amendment which specifically states that this
registration statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act of 1933 or until the registration statement
shall become effective on such date as the Commission, acting pursuant to said
Section 8(a), may determine.
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<PAGE>
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
+We will amend and complete the information in this prospectus. Although we +
+are permitted by U.S. federal securities laws to offer these securities using +
+this prospectus, we may not sell them or accept your offer to buy them until +
+the registration statement filed with the SEC relating to these securities is +
+effective. This prospectus is not an offer to sell these securities or our +
+solicitation of your offer to buy these securities in any jurisdiction where +
+that would not be permitted or legal. +
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
SUBJECT TO COMPLETION--DATED JULY 15, 1999
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Prospectus
, 1999
[KeraVision, Inc. Logo]
4,000,000 Shares of Common Stock
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KeraVision: The Offering:
. KeraVision is develop- . KeraVision is offering 4,000,000 shares.
ing a new category of
non-laser vision cor- . The underwriters have an option to purchase an
rection products for additional 600,000 shares from us to cover
the treatment of common over-allotments.
vision disorders, in-
cluding myopia (near- . There is an existing market for our shares. On
sightedness), hyperopia July 14, 1999, the last reported sale price of
(farsightedness) and our common stock was $25.00 per share.
astigmatism, to offer
an alternative to eye- . Closing: , 1999
glasses, contact lenses
and other vision cor-
rection surgical proce-
dures. Our first prod-
uct, Intacs(TM), has
been approved by the
FDA for correcting mild
myopia.
. KeraVision, Inc.
48630 Milmont Drive
Fremont, California 94538
(510) 353-3000
www.keravision.com
. NASDAQ Symbol: KERA
-----------------------------------------------
<TABLE>
<CAPTION>
Per Share Total
--------------------------------------------
<S> <C> <C>
Public offering price: $ $
Underwriting fees:
Proceeds to KeraVision:
--------------------------------------------
</TABLE>
Investing in our common stock involves risks. See "Risk Factors" beginning on
page 5.
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Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or determined if
this prospectus is truthful or complete. Any representation to the contrary is
a criminal offense.
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Donaldson, Lufkin & Jenrette
Dain Rauscher Wessels
a division of Dain
Rauscher
Incorporated
Prudential Securities
SG Cowen
The undersigned is facilitating Internet distribution.
DLJdirect Inc.
<PAGE>
[Picture of an Intacs(TM) corneal ring segment held on a fingertip]
Intacs are made from a transparent polymer that has been widely used in
intraocular lenses since 1952.
[Bar chart showing the percentages of patients who achieved vision of 20/40 or
better, 20/20 or better and 20/16 or better, following the Intacs procedure]
53% of KeraVision patients achieved vision of 20/16, 20/12 or 20/10*.
[Picture of our Intacs(TM) logo]
Intacs(TM) is the first consumer branded vision correction surgery product.
* As measured at month 12 following Intacs insertion
<PAGE>
TABLE OF CONTENTS
<TABLE>
<CAPTION>
Page
<S> <C>
Prospectus Summary....................................................... 1
Risk Factors............................................................. 5
Use of Proceeds.......................................................... 12
Dividend Policy.......................................................... 12
Price Range of Common Stock.............................................. 13
Capitalization........................................................... 14
Dilution................................................................. 15
Selected Consolidated Financial Data..................................... 16
Management's Discussion and Analysis of Financial Condition and Results
of Operations........................................................... 17
</TABLE>
<TABLE>
<CAPTION>
Page
<S> <C>
Business................................................................... 21
Management................................................................. 36
Principal Stockholders..................................................... 39
Description of Capital Stock............................................... 41
Underwriting............................................................... 45
Legal Matters.............................................................. 47
Experts.................................................................... 47
Where You Can Find More Information........................................ 48
Index to Financial Statements.............................................. F-1
</TABLE>
<PAGE>
PROSPECTUS SUMMARY
This summary highlights information from this prospectus. To fully understand
this offering and its consequences to you, you should also read the more
detailed information and consolidated financial statements contained in this
prospectus and in the documents that we incorporate by reference into this
prospectus. Unless otherwise indicated, all information in this prospectus
assumes no exercise of the over-allotment option to purchase additional shares
of common stock granted to the underwriters. In this prospectus we will refer
to KeraVision, Inc. as "KeraVision," "we," "our" and "us."
KeraVision
Business
KeraVision is developing a new category of non-laser vision correction
products for the treatment of common vision disorders, including myopia
(nearsightedness), hyperopia (farsightedness) and astigmatism, to offer an
alternative to eyeglasses, contact lenses and other vision correction surgical
procedures. Our first product, Intacs(TM) corneal ring segments, based on our
proprietary patented technology, has been approved by the FDA for correcting
mild myopia. Intacs is the first surgical vision correction technology to be
approved by the FDA that is designed to permanently correct a patient's vision
while providing the option of removability. Intacs are composed of two thin
half-circles of polymer material that are inserted into the periphery of the
cornea to reshape the curvature of the cornea to correct vision. The polymer
material has been used in intraocular lenses to treat patients with cataracts
since 1952. The Intacs insertion process is a simple outpatient procedure that
typically can be performed in 15 minutes or less. KeraVision believes that the
Intacs technology is the first technology specifically designed to surgically
treat patients with low degrees of nearsightedness, a group estimated at
approximately 20 million people in the U.S. KeraVision is currently developing
other potential products to treat other vision correction disorders including
higher and lower levels of nearsightedness, as well as farsightedness and
astigmatism.
Recent Developments
Latest Financial Results. On July 15, 1999, we announced that our net sales
for the three months ended June 30, 1999 were $3.9 million compared to net
sales of $112,000 for the comparable 1998 period. This increase primarily
reflected purchases of instruments used to perform the procedure for the
placement of Intacs by the initial group of surgeons who participated in Intacs
training courses during the second quarter of 1999.
FDA Approval and Clinical Results. On April 9, 1999, KeraVision obtained FDA
approval to distribute and sell Intacs in the United States for the treatment
of mild myopia in the range of -1.0 to -3.0 diopters in patients who are 21
years of age or older, who have a stable refraction and who have up to +1.0
diopter of astigmatism. Results from the clinical trials of Intacs indicate
that 97% of the patients achieved vision of 20/40 or better, the vision
standard in most U.S. states for receiving a driver's license without the need
for corrective lenses. More significantly, 74% of the patients achieved vision
of 20/20 or better and 53% achieved vision of 20/16 or better as measured at 12
months.
Surgeon Training. Since April 1999, we have trained 243 surgeons to perform
the procedure for the placement of Intacs. In addition, KeraVision has
established sites to train surgeons to perform the procedure for the placement
of Intacs in Atlanta, Houston, Kansas City, Minneapolis, San Diego and Santa
Monica.
Distribution Partnerships and Salesforce Expansion. In April 1999, we entered
into purchase and distribution agreements with three eye care services
companies that focus on surgical vision correction, including Laser Vision
Centers, Inc., one of the largest providers of vision correction surgery in the
U.S., as well as NovaMed Eyecare, Inc. and ARIS Vision, Inc. Under these
agreements, these companies have agreed to purchase Intacs and related
instrumentation. There are approximately 600 surgeons located throughout the
U.S. who are affiliated with these companies. In addition, since the beginning
of 1999 we have hired 11 direct sales representatives and four manufacturers'
representatives, significantly expanding our salesforce capabilities.
1
<PAGE>
New Product Development. In April 1997, KeraVision began a clinical trial
outside the United States using Intacs technology for the treatment of
hyperopia. With encouraging initial results obtained from 52 patient eyes in
the initial trial, we have initiated a second clinical trial at several
European clinical sites. As of June 30, 1999, 25 additional patient eyes were
enrolled in this expanded study.
Industry Background
The surgical vision correction market has experienced rapid growth since the
introduction of the first laser technology for vision correction in the late
1980's. The majority of this growth is attributable to the introduction of the
laser in-situ keratomileusis, or LASIK, procedure in 1996. LASIK involves
cutting and peeling back a thin layer of corneal tissue, allowing the surgeon
to apply laser pulses directly to the exposed cornea. The laser pulses
permanently remove corneal tissue to alter the shape of the cornea and correct
the patient's vision. As a result of the significantly reduced pain and visual
recovery period associated with this procedure relative to previously
introduced surgical vision correction procedures, the market for refractive
surgery has increased dramatically. The number of surgical vision correction
procedures has grown from 80,000 procedures in 1996 to approximately 450,000
procedures in 1998. Furthermore, industry sources project that the number of
surgical vision correction procedures performed in 1999 will more than double
to approximately 950,000. At a typical price of $2,100 per procedure, based on
industry estimates consumers will spend nearly $2 billion in 1999 on vision
correction surgery.
Intacs Technology
We have positioned our Intacs technology to address the growing market for
refractive surgery by offering an alternative to laser-based vision correction.
While laser-based technologies require the permanent removal of corneal tissue,
Intacs can be removed if desired. Patients' refractions return to preoperative
levels by three months following removal, in most instances. We believe that
Intacs technology offers several other potential benefits to patients
including:
. long-term, convenient vision correction with predictable results
. rapid visual recovery
. a simple, minimally invasive outpatient procedure with minimal post-
operative pain in most cases
. easy to remove and replace in an outpatient procedure.
Strategy
We intend to commercialize our Intacs technology for the treatment of common
vision problems on a world-wide basis with an initial concentration on the U.S.
market for mild myopia. We began the U.S. product launch of Intacs for mild
myopia following FDA approval in April of this year. The product roll-out
tactics include the training of ophthalmic surgeons and monitoring of the
initial procedures performed by these surgeons, the integration of Intacs into
the practices of these surgeons, including office staff training and
optometrist outreach programs, and a public relations program to increase
consumer awareness of Intacs. The first marketing efforts are focused around
the ophthalmic surgeon and optometrist, to be followed later by additional
consumer awareness programs.
We are currently developing additional products based on our Intacs
technology platform to address other common vision problems, including expanded
ranges of myopia, myopia with higher levels of astigmatism, hyperopia, and pure
astigmatism. By using advanced development methods, including computer
simulations and tissue lab research, our strategy is to broaden our knowledge,
to continue to expand our patent coverage and to commence clinical trials with
the best designs possible to achieve commercialization.
2
<PAGE>
Our principal executive offices are located at:
KeraVision, Inc.
48630 Milmont Drive
Fremont, California 94538
(510) 353-3000
www.keravision.com
Our website is not part of this prospectus. KeraVision, Intacs, the
KeraVision and Intacs logos, Shaping the Way the World Sees and keravision.com
are registered trademarks or trademarks of KeraVision, Inc., in the U.S. and in
foreign countries. (C)1999 KeraVision, Inc. All rights reserved.
The Offering
<TABLE>
<C> <S>
Common stock offered by KeraVision.................. 4,000,000 shares
Common stock to be outstanding after this offering.. 18,078,476 shares
Use of proceeds..................................... We intend to use the net
proceeds of this offering
for the expansion of our
sales force and marketing
effort associated with
the U.S. launch of
Intacs, the continued
development and clinical
testing of additional
products based on our
Intacs technology, the
prepayment of short-term
debt and for working
capital and general
corporate purposes.
Dividend policy..................................... We intend to retain any
future earnings and we do
not anticipate paying
dividends on our common
stock in the foreseeable
future.
Risk factors........................................ For a discussion of
certain considerations
relevant to an investment
in our common stock, see
"Risk Factors."
Nasdaq National Market symbol....................... "KERA"
</TABLE>
The number of shares of common stock to be outstanding after this offering is
based on the 14,078,476 shares outstanding at June 30, 1999 and the 4,000,000
shares of common stock being sold by us in this offering and excludes:
. 1,579,778 shares of common stock issuable upon exercise of options
outstanding at June 30, 1999 at a weighted average exercise price of
$7.43 per share and 2,268,719 shares reserved for future grants under our
stock option plans;
. 55,492 shares of common stock issuable upon exercise of a warrant held by
a financial institution with an exercise price of $10.81 per share;
. 2,122,856 shares issuable upon conversion of the Series B preferred
stock; and
. any shares of common stock that may be sold by us to the underwriters
pursuant to the over-allotment option.
3
<PAGE>
Summary Consolidated Financial Data
In the table below, we provide you with summary historical financial data of
KeraVision, Inc. We have prepared this information using the consolidated
financial statements of KeraVision, Inc. for the three years ended December 31,
1998 and the six-month periods ended June 30, 1998 and 1999. The financial
statements for the three years ended December 31, 1998 have been audited. The
financial statements for the six-month periods ended June 30, 1998 and 1999
have not been audited.
When you read this summary historical financial data, it is important that
you read it along with the historical financial statements and related notes in
our annual and interim financial statements included and incorporated by
reference in this prospectus, as well as the section titled "Management's
Discussion and Analysis of Financial Condition and Results of Operations."
<TABLE>
<CAPTION>
Six months ended
Year Ended December 31, June 30,
---------------------------- ------------------
1996 1997 1998 1998 1999
(in thousands, except per share data)
<S> <C> <C> <C> <C> <C>
Statement of Operations Data
Net sales................... $ 137 $ 355 $ 835 $ 264 $ 4,381
Costs and expenses:
Cost of sales and
manufacturing expenses.... 319 3,701 4,386 1,949 4,615
Research and development... 10,888 10,774 11,356 6,016 4,201
Selling, general and
administrative............ 3,930 6,405 9,693 3,652 8,171
-------- -------- -------- -------- --------
Total costs and expenses.... 15,137 20,880 25,435 11,617 16,987
-------- -------- -------- -------- --------
Loss from operations........ (15,000) (20,525) (24,600) (11,353) (12,606)
Interest income (expense)
and other, net............. 2,121 1,129 563 179 (315)
-------- -------- -------- -------- --------
Net loss.................... $(12,879) $(19,396) $(24,037) $(11,174) $(12,921)
======== ======== ======== ======== ========
Net loss applicable to
common stockholders........ $(12,879) $(19,396) $(27,414) $(13,785) $(13,697)
======== ======== ======== ======== ========
Basic and diluted net loss
per share applicable to
common stockholders........ $ (1.04) $ (1.55) $ (2.16) $ (1.09) $ (1.05)
======== ======== ======== ======== ========
Shares used in calculation
of net loss per share...... 12,342 12,528 12,686 12,655 13,088
</TABLE>
<TABLE>
<CAPTION>
June 30, 1999
December 31, ----------------------
1998 Actual As adjusted
(in thousands)
<S> <C> <C> <C>
Balance Sheet Data
Cash, cash equivalents and available-for-
sale investments......................... $ 7,728 $ 8,330 $ 96,380
Working capital........................... 4,915 504 92,978
Total assets.............................. 11,184 13,544 101,594
Short-term debt........................... -- 4,424 --
Capital lease obligations, noncurrent..... 821 666 666
Series B redeemable convertible preferred
stock.................................... 17,489 18,265 18,265
Accumulated deficit....................... (90,092) (103,789) (104,665)
Total stockholders' equity (net capital
deficiency).............................. (11,447) (15,984) 76,490
</TABLE>
The as adjusted amounts reflect the issuance by KeraVision of 4,000,000
shares at an assumed offering price of $25.00 per share and the application of
the net proceeds from this offering.
4
<PAGE>
RISK FACTORS
You should carefully consider the following risk factors in evaluating
whether to participate in this offering. You should also consider these risk
factors in conjunction with the other information included or incorporated by
reference in this prospectus. They could materially and adversely affect our
financial condition and results of operation. They could cause the trading
price of our stock to decline, and you might lose all or part of your
investment.
These risks and uncertainties are not the only ones we face. Others that we
do not know about now, or that we do not now think are important, may impair
our business or the trading price of our stock.
KeraVision is incurring operating losses which may result in a substantial
reduction over time of the value of KeraVision shares you purchase in this
offering.
KeraVision has generated only limited revenues to date and has experienced
significant operating losses every year since its inception in 1986. We expect
to continue to experience increasing expenses as we expand our sales and
marketing efforts, and we expect to continue to incur substantial operating
losses until sufficient revenues can be generated to offset these expenses. We
cannot predict the amount of our future operating losses or the length of time
required for us to achieve and sustain profitability.
KeraVision may not be able to execute its business plan if a significant amount
of capital is not available to it in the near future.
KeraVision will be required to commit substantial resources to establish
production, marketing and sales capabilities in order to successfully
commercialize Intacs. In addition, KeraVision will be required to commit
additional resources to conducting the research and development, clinical
studies and regulatory activities necessary to bring additional products to
market. We currently anticipate that cash from operations and the net proceeds
from this offering will be sufficient to fund KeraVision's operations at least
through December 31, 2001.
If this offering is not completed, we will be required to seek other sources
for funding, and we cannot assure you that other sources of funding will be
available when needed or available on terms favorable to KeraVision. If we fail
to obtain sufficient funds, we may need to delay, scale back or eliminate some
or all of our sales and marketing efforts, research and product development
programs, clinical studies or regulatory activities or license third parties to
commercialize products or technologies that we would otherwise seek to develop.
Such actions would adversely affect our business and financial condition.
KeraVision needs market acceptance of Intacs and other products to be
successful.
KeraVision's future performance depends, to a substantial extent, upon the
degree of market acceptance of Intacs for correction of myopia, and on
KeraVision's ability to successfully manufacture, market, deliver and support
Intacs. We cannot assure you that Intacs or any future product that KeraVision
develops will achieve or maintain acceptance in their target markets. To be
successful Intacs will have to be accepted by ophthalmic surgeons as well as by
patients. Until recently, KeraVision has sold its product primarily in Canada,
France and Germany and generated only limited revenues. KeraVision has recently
begun the sale of Intacs in the United States. Many surgeons have already
invested significant time and resources in developing expertise in other
corrective ophthalmic surgical techniques and may be unwilling to devote the
time and resources necessary to incorporate the procedure for Intacs placement
into their practices.
We intend to market our products to people whose vision can be corrected with
eyeglasses or contact lenses. We cannot assure you that these persons will
elect to undergo surgical insertion of Intacs when nonsurgical vision-
correction alternatives are available. KeraVision believes that the inability
of some patients to afford the procedure and the psychological aversion of some
patients to refractive surgery may further limit the potential market for
Intacs. The extent of, and rate at which, Intacs and our future products
achieve market
5
<PAGE>
acceptance and penetration is a function of many variables including price,
safety, efficacy, reliability and sales and marketing efforts.
We have limited sales and marketing experience and may not be able to
successfully sell or market our products.
We have only sold products in the United States since April 1999, in Canada
since mid-1998 and in Europe since late 1996 and to date have generated only
limited revenues. We recently entered into several distribution agreements and
also plan to sell and market our products through a direct sales force. To
successfully market and sell our products, we will need to develop a sales
force which has established relationships with surgeons and which has consumer
marketing skills. We will need significant resources to recruit and retain
skilled sales management, direct sales persons and distributors. To the extent
that KeraVision has established or enters into distribution arrangements for
the sale of its products, KeraVision is and will be dependent on the efforts of
third parties. We cannot assure you that our sales and marketing efforts will
be successful.
KeraVision has limited manufacturing experience and may be unable to develop
commercial-scale manufacturing capabilities.
To be successful, we must manufacture our products and potential products in
commercial quantities in compliance with regulatory requirements at acceptable
costs. At the present time, we have limited manufacturing experience and
capabilities. We cannot assure you that KeraVision will be able to develop
commercial-scale manufacturing capabilities at acceptable costs or enter into
agreements with third parties with respect to these activities. Production of
commercial-scale quantities will involve technical challenges for us. As we
establish our own commercial-scale manufacturing capability for Intacs, we
could incur significant scale-up expenses including the need to expand our
facilities and hire additional personnel. We may seek collaborative
arrangements with other companies to manufacture products and potential
products, including Intacs. If we are dependent upon third parties for the
manufacture of our products, our profit margins and ability to develop and
deliver such products on a timely basis may be adversely affected. Moreover, we
cannot assure you that such third parties will adequately perform, and any
failures by these parties may impair our ability to deliver products on a
timely basis or otherwise impair our competitive position.
KeraVision may not be able to obtain additional regulatory approvals or
maintain current approvals, which could delay the sale and distribution of
current and future products and adversely affect our revenues.
The research, manufacture, sale and distribution of medical devices,
including KeraVision's current and planned products, is subject to regulations
imposed by numerous governmental authorities, principally the FDA and
corresponding state and foreign agencies. Securing regulatory approval for
KeraVision's additional products and new uses of existing products may entail a
lengthy, expensive and uncertain process involving, for example, submission to
the FDA of extensive clinical data and other supporting information. Unless an
exemption applies, each medical device that we wish to market in the U.S. must
receive either "510(k) clearance" or "PMA approval" in advance from the FDA
pursuant to the Federal Food, Drug, and Cosmetic Act. The current PMA approval
for Intacs is limited to mild myopia. A separate PMA approval or PMA supplement
approval supported by clinical data will be required to expand the indications
for use of Intacs to new ranges of myopia, and to hyperopia and astigmatism.
To generate revenue growth, KeraVision must continue to develop, obtain
regulatory approval for, and successfully commercialize new products. The time
frame to develop and successfully commercialize additional products and
modifications of existing products is long and uncertain. Although KeraVision
has received regulatory approval to market Intacs in the United States, the
European Union and Canada, we cannot assure you that we will successfully
complete our efforts to secure regulatory approval for this product to be
marketed
6
<PAGE>
elsewhere. Furthermore, we cannot assure you that KeraVision will successfully
complete research and development efforts and obtain regulatory approval in the
U.S. or elsewhere for marketing our future new or modified products or uses.
Having received approval from the FDA for the correction of mild myopia,
Intacs are subject to additional post-market testing, extensive record keeping
and other device follow up required by the FDA and other regulatory agencies.
In addition, to the extent KeraVision continues to perform the manufacturing
function, we will be required to adhere to additional FDA requirements for the
manufacture and distribution of Intacs. KeraVision's ongoing compliance with
Quality System Regulation, labeling and other applicable regulatory
requirements is monitored through periodic inspections by federal and state
agencies, including the FDA, and comparable agencies in other countries.
Current FDA enforcement policy strictly prohibits the marketing of medical
devices for unapproved ("off label") uses. Product approvals can be withdrawn
due to unforeseen safety or effectiveness problems following initial marketing.
Failure to comply with the applicable regulatory requirements can, among other
things, result in fines, injunctions, civil penalties, suspensions or
withdrawal of regulatory approvals, product recalls, product seizures,
including cessation of manufacturing and sales, operating restrictions and
criminal prosecution. Any such FDA enforcement actions could have a material
adverse effect on KeraVision's business, financial condition and results of
operations.
KeraVision will need to find a new supplier for the raw material we use in
manufacturing our products.
Our sole supplier of polymethylmethacrylate (PMMA), the polymer raw material
used in manufacturing Intacs, no longer provides the particular material we use
for Intacs, and has notified us that the material may be purchased by special
order only. We currently have what we estimate is at least a three-year supply
of PMMA. We have not yet made arrangements to obtain additional PMMA beyond
this supply. We have stored our current supply of PMMA in two separate
locations. Should the PMMA at either or both of these locations be damaged or
destroyed, our ability to continue to manufacture and distribute Intacs or
additional products may be seriously impaired. We would be required to find an
alternate source of PMMA or a similar polymer material, or commence
manufacturing the raw material ourselves. We would need to obtain FDA
regulatory approval for the use of new raw materials not previously approved
specifically for use in any of our products or to qualify a new PMMA supplier.
If we elected to manufacture PMMA ourselves, we would need to establish
manufacturing facilities for this purpose, hire additional personnel, and
obtain additional regulatory approvals, processes which would take up to
several years and require additional expenditures. We cannot assure you that:
. our supplier will be able to fulfill future special orders for PMMA;
. interruptions in supplies will not occur in the future;
. we will be able to obtain a new source for the supply of PMMA or
establish facilities to manufacture PMMA, both of which would require
approval of additional regulatory submissions; or
. our current supply will last as long as we anticipate.
In the event we are unable to obtain alternative supplies of materials upon
the depletion of our current supply we will experience delays in the production
of Intacs and will need to obtain alternate materials. If we are required to
manufacture Intacs using alternate materials we will also be required to obtain
FDA approval of this material, a process that could take several years and
cause us to incur substantial costs. Furthermore, we cannot assure you that we
will be able to obtain FDA approval of a new material at all. Any interruption
of supply would have a material adverse effect on KeraVision's ability to
manufacture Intacs or future products which could have a material adverse
effect on our business, financial condition or results of operations.
KeraVision may not have the ability to obtain and maintain patents on Intacs
and our technology which could permit others to develop similar products or
more easily compete with our business.
KeraVision's commercial success depends in part on acquiring and maintaining
patent and trade secret protection of Intacs technology, Intacs and any other
potential products we seek to develop. We cannot assure
7
<PAGE>
you that KeraVision will be successful in obtaining additional necessary
patents or license rights; KeraVision's processes or products will not infringe
patents or proprietary rights of others; or that any issued patents will
provide KeraVision with any competitive advantages or will withstand challenges
by third parties.
KeraVision is aware of ongoing academic research on both solid and injectable
forms of corneal inserts. We cannot assure you that others will not
independently develop similar products or design products that circumvent any
patents used by KeraVision.
In addition, KeraVision could incur substantial costs in defending against
patent litigation or in bringing suits to protect its patents against
infringement. If the outcome of any such litigation is adverse to KeraVision,
our business could be adversely affected.
KeraVision also relies on trade secrets and proprietary knowledge which it
seeks to protect by confidentiality agreements with its employees, consultants,
investigators and advisors. We cannot assure you that these agreements will not
be breached, that KeraVision will have adequate remedies for any breach, or
that competitors will not otherwise discover KeraVision's trade secrets and
proprietary knowledge.
KeraVision may not be able to successfully compete in the highly competitive
field of vision correction.
KeraVision is engaged in a rapidly evolving field. Many public and private
companies, universities and research laboratories engage in activities relating
to research on vision correction alternatives. Our competitors could develop
technologies, procedures or products that are more effective or economical than
those KeraVision is developing or that would render our technology and products
obsolete or noncompetitive.
Most of the other companies in the vision correction market are larger and
better financed than KeraVision. Several companies have received approval to
market their laser systems for refractive surgery in the United States,
including VISX, Summit Technology, Inc. and Nidek, and others may receive
similar approvals in the future.
These companies and institutions represent significant long-term competition
for KeraVision. In comparison to KeraVision, they may have:
. substantially greater resources and better facilities;
. larger research and development staffs and more experience in research
and development;
. more experience in preclinical and human clinical studies;
. more experience obtaining regulatory approval;
. more experience manufacturing medical device products; and
. more experience in marketing, selling and developing a market for medical
device products.
Moreover, several companies are developing other non-laser approaches to
vision correction, including the use of radio frequency energy to reshape the
cornea, phakic intraocular lenses, and the use of enzymes to alter the shape of
the cornea. See "Business--Competition."
Long-term follow-up data may not demonstrate that Intacs are safe and
effective.
The Intacs technology is a relatively new technology, clinical data for which
dates back to 1991. KeraVision has developed only limited long-term clinical
data to date on the safety and efficacy of Intacs in correcting myopia, and
KeraVision has not yet developed any long-term safety or efficacy data. The FDA
is requiring KeraVision to provide data to assess the effects of Intacs on the
corneal endothelium after two years of implantation. If these and other long-
term data show that Intacs are not safe and effective, our ability to
commercialize Intacs may be adversely affected. We cannot assure you that
Intacs will prove to be safe or effective over the long term in correcting
vision. If Intacs fail to perform as anticipated our revenue growth will be
limited.
8
<PAGE>
Complications associated with Intacs may affect KeraVision's ability to gain
market acceptance for Intacs or to obtain additional regulatory approvals.
Some patients who have received Intacs have experienced various
complications. These complications include infection, shallow placement,
temporary loss of correctable vision, anterior chamber perforation,
overcorrection, reduction in central corneal sensation, difficulty with night
vision, undercorrection, induced astigmatism, blurry vision, double vision,
halos, glare, corneal blood vessels and fluctuating distance vision. We cannot
assure you that these complications or side effects will not be serious or
lasting, will not impair or preclude acceptance of the product by patients or
ophthalmologists, will not preclude KeraVision from obtaining regulatory
approval for additional products or will not cause withdrawal of approval for
Intacs.
In addition, negative publicity surrounding complications associated with
other surgical vision correction procedures could negatively impact market
acceptance for our product.
Our ability to operate our business may be adversely affected if we are unable
to retain our key personnel or to hire additional key personnel.
Our success depends in large part on our ability to attract and retain key
management, technical, manufacturing, sales and marketing and other operating
personnel. We cannot assure you that KeraVision will be able to attract and
retain the qualified personnel or develop the expertise in these areas as
needed for our business. The loss of the services of one or more members of
these groups or the inability to hire additional personnel and develop
expertise as needed could limit our ability to successfully commercialize
Intacs and additional products. Such persons are in high demand and often
receive competing employment offers.
KeraVision is subject to the risk that product liability litigation and
insurance may be unavailable.
KeraVision faces a risk of exposure to product liability claims and product
recalls if the use of Intacs or any future product is alleged to have resulted
in serious adverse effects. We cannot assure you that the precautions we take
with respect to these risks will prevent KeraVision from incurring significant
liability. We also cannot assure you that our current product liability
insurance policies will cover any or all material liabilities or that the
coverage we have obtained will continue to be available at an acceptable cost,
if at all, before or after commercialization of any of KeraVision's products. A
product liability claim, product recall or other claims with respect to
uninsured liabilities or in excess of insured liabilities could have a material
adverse effect on KeraVision's business and financial condition.
Year 2000 computer problems may affect KeraVision's computer systems and its
ability to operate.
The Year 2000 computer problem is caused by the inability of some software
and hardware to handle dates after December 31, 1999. Based on recent
assessments, we have determined that we would be required to replace a small
portion of our software so that those systems will properly utilize dates
beyond December 31, 1999. We have determined that all of our critical business
systems are already Year 2000 compliant.
KeraVision is actively working with critical suppliers of products and
services to determine that the suppliers' operations and the products and
services they provide are Year 2000 compliant and to monitor their progress
toward Year 2000 compliance. However, some of our computer systems or those of
our suppliers could fail or miscalculation could occur, causing disruptions in
our operations, including a temporary inability to process transactions, send
invoices or engage in similar, normal business activities.
We cannot assure you that any system of other companies on which KeraVision's
systems rely will be Year 2000 compliant in a timely fashion and would not have
an adverse effect on KeraVision's systems.
9
<PAGE>
Our stock price could be volatile.
Within the last 12 months our common stock has traded between a range of
$3.31 and $29.63 per share. The market price of our common stock could continue
to fluctuate substantially due to a variety of factors, including:
. quarterly fluctuations in results of our operations;
. our ability to successfully commercialize Intacs;
. announcements regarding results of regulatory approval filings, clinical
studies or other testing, technological innovations or new commercial
products by KeraVision or our competitors;
. developments concerning government regulations, proprietary rights or
public concern as to the safety of technology;
. market reaction to acquisitions and trends in sales, marketing, and
research and development;
. changes in earnings estimates by analysts;
. loss of key personnel;
. sales of common stock by existing stockholders; and
. economic and political conditions.
The market price for our common stock may also be affected by our ability to
meet analysts' expectations. Any failure to meet such expectations, even
slightly, could have an adverse effect on the market price of our common stock.
In addition, the stock market is subject to extreme price and volume
fluctuations. This volatility has had a significant effect on the market prices
of securities issued by many companies for reasons unrelated to the operating
performance of these companies. In the past, following periods of volatility in
the market price of a company's securities, securities class action litigation
has often been instituted against the company. If similar litigation were
instituted against us, it could result in substantial costs and a diversion of
our management's attention and resources, which could have an adverse effect on
our business, results of operations and financial condition. See "Price Range
of Common Stock."
Future sales by our current stockholders may cause the market price of our
stock to decline.
The market price of our common stock could decline as a result of sales by
our existing stockholders of a large number of shares of common stock in the
market after this offering, or the perception that these sales may occur. These
sales also might make it more difficult for us to sell equity securities in the
future at a time and at a price that we deem appropriate. A registration
statement on Form S-3 is currently on file with the SEC pursuant to which the
holders of our Series B preferred stock may publicly resell the shares of our
common stock that they will receive at the time they convert their shares of
Series B preferred stock.
Forward-looking statements are inherently uncertain.
We have made statements under the captions "Prospectus Summary," "Risk
Factors," "Use of Proceeds," "Management's Discussion and Analysis of Financial
Condition and Results of Operations," "Business" and elsewhere in this
prospectus that are forward-looking statements. You can identify these
statements by forward-looking words such as "may," "will," "expect,"
"anticipate," "believe," "estimate," and "continue" or similar words. Forward-
looking statements may also use different phrases. Forward-looking statements
address, among other things: (1) our future expectations; (2) projections of
our future results of operations or of our financial condition; or (3) our
"forward-looking" information.
10
<PAGE>
We believe it is important to communicate our expectations to our investors.
However, there may be events in the future that we are not able to accurately
predict or which we do not fully control that could cause actual results to
differ materially from those expressed or implied by our forward-looking
statements, including:
. our incurrence of substantial operating losses for periods longer than
currently expected and need for significant additional capital beyond the
amounts currently anticipated;
. our inability to manage our growth and successfully launch our products
and expand in new and existing markets;
. market acceptance of Intacs and the level of demand for our products;
. compliance with government standards and the obtaining of necessary
approvals;
. changes in general economic and business conditions;
. changes in our business strategies; and
. other factors discussed under "Risk Factors."
11
<PAGE>
USE OF PROCEEDS
The net proceeds to KeraVision from the sale of the 4,000,000 shares of
common stock, at an assumed public offering price of $25.00 per share, are
estimated to be approximately $93.3 million, or $107.4 million if the
underwriters' over-allotment option is exercised in full, after deducting
underwriting fees and estimated expenses of this offering. We expect to use a
significant amount of the proceeds from this offering for our sales and
marketing efforts related to the U.S. launch of Intacs, the continued
development and clinical testing of products based on the Intacs technology,
prepayment of short-term debt described below, and the remainder for working
capital and other general corporate purposes. Some of the net proceeds may also
be used to fund acquisitions. We have no current plans, agreements or
commitments with respect to any acquisition, and we are not currently engaged
in any negotiations with respect to any such transaction.
We plan to use approximately $5.3 million of the net proceeds from this
offering to prepay short term debt. At June 30, 1999, the outstanding balance
under our credit facility was $5.0 million (carried at $4.4 million, net of
related discount). These borrowings bear interest at 12.6% per annum, payable
monthly. This loan matures on September 30, 2001. As a result of this
prepayment, we expect to record a charge of approximately $876,000 in the
quarter in which the prepayment is made, which will be reflected as an
extraordinary item. This charge will include the prepayment premium and the
write-off of the remaining discount on the debt related to the fair value of
warrants issued in conjunction with the borrowing.
The amounts and timing of our actual expenditures will depend upon numerous
factors, including the level of our research and development efforts and sales
and marketing activities, and the amount of cash generated by our operations.
The sales and marketing needs directly relate to the market development efforts
required to launch Intacs and to build initial product sales, primarily in the
United States. In addition, we expect to invest significantly in our research
and development activities including patent development and filing costs,
research and development of potential new products and product enhancements,
and costs associated with clinical trials.
The foregoing discussion represents our best estimate of our allocation of
the net proceeds of this offering based upon our current plans and estimates
regarding our anticipated expenditures. Actual expenditures may vary
substantially from these estimates and we may find it necessary or advisable to
reallocate the net proceeds within the above-described categories or for other
purposes. Pending application of the net proceeds as described above, we intend
to invest the net proceeds of this offering in short-term, investment grade,
interest bearing securities.
DIVIDEND POLICY
Common stock. We have never paid cash dividends on our common stock and have
no plans to do so in the foreseeable future. In addition, the terms of our
credit facility and our Series B preferred stock contain restrictions on our
ability to pay cash dividends on our common stock. The declaration and payment
of any dividends in the future will be determined by our Board of Directors, in
its discretion, and will depend on a number of factors, including our earnings,
capital requirements and overall financial condition.
Series B preferred stock. To date, we have paid dividends on our Series B
preferred stock by issuing additional shares of preferred stock. In the future,
we may elect to pay dividends on the preferred stock in cash or additional
shares of preferred stock.
12
<PAGE>
PRICE RANGE OF COMMON STOCK
Our common stock has been listed on The Nasdaq National Market since July
1995. The trading symbol for our common stock is "KERA." The following table
sets forth, for the periods indicated, the high and low sales prices for our
common stock as reported on The Nasdaq National Market:
<TABLE>
<CAPTION>
High Low
<S> <C> <C>
Year Ended December 31, 1997
First Quarter............................................... $15.00 $10.00
Second Quarter.............................................. 10.75 6.63
Third Quarter............................................... 10.63 6.63
Fourth Quarter.............................................. 8.63 5.00
Year Ended December 31, 1998
First Quarter............................................... $ 8.25 $ 4.75
Second Quarter.............................................. 10.63 7.25
Third Quarter............................................... 8.06 3.31
Fourth Quarter.............................................. 14.63 3.69
Year Ended December 31, 1999
First Quarter............................................... $18.50 $10.50
Second Quarter.............................................. 17.50 8.25
Third Quarter (through July 14, 1999)....................... 29.63 15.75
</TABLE>
The last sale price of the common stock on The Nasdaq National Market on July
14, 1999 was $25.00 per share. As of July 7, 1999, the Company had 338
stockholders of record.
13
<PAGE>
CAPITALIZATION
The following table sets forth the capitalization of the Company:
. on an actual basis at June 30, 1999, and
. as adjusted to reflect this offering and the use of the net proceeds of
this offering.
You should read this table in conjunction with the consolidated financial
statements and the notes to those statements and the other financial
information included or incorporated by reference in this prospectus. The table
does not include the 1,579,778 shares of common stock issuable upon exercise of
stock options outstanding as of June 30, 1999 at a weighted average exercise
price of $7.43 per share, or the exercise of a warrant covering 55,492 shares
of common stock at an exercise price of $10.81 per share.
<TABLE>
<CAPTION>
At June 30, 1999
----------------------
Actual As Adjusted
(in thousands)
<S> <C> <C>
Short-term debt......................................... $ 4,424 $ --
========= =========
Capital lease obligations, less current portion......... $ 666 $ 666
Series B redeemable convertible preferred stock, $.001
par value; 662,500 shares authorized; 530,714 shares
issued and outstanding actual and as adjusted.......... 18,265 18,265
Stockholders' equity (net capital deficiency):
Common stock, $.001 par value; 30,000,000 shares
authorized; 14,078,476 shares issued and outstanding
actual, and 18,078,476 shares issued and outstanding
as adjusted........................................... 14 18
Additional paid-in capital............................. 89,257 182,603
Accumulated other comprehensive income................. 107 107
Accumulated deficit.................................... (103,789) (104,665)
Notes receivable from stockholders..................... (1,573) (1,573)
--------- ---------
Total stockholders' equity (net capital deficiency).... (15,984) 76,490
--------- ---------
Total capitalization................................ $ 2,947 $ 95,421
========= =========
</TABLE>
14
<PAGE>
DILUTION
Purchasers of the common stock offered hereby will experience immediate and
substantial dilution in the net tangible book value per share of their common
stock. At June 30, 1999, our net tangible book value (deficiency) was
approximately $(16.0) million, or $(1.14) per share of common stock. The net
tangible book value (deficiency) per share is equal to our total tangible
assets less total liabilities and Series B redeemable convertible preferred
stock, divided by the number of shares of common stock outstanding at June 30,
1999. After giving effect to the sale of 4,000,000 shares at an assumed initial
public offering price of $25.00 per share and after deducting underwriting fees
and other expenses of this offering, our pro forma net tangible book value at
June 30, 1999 would have been approximately $76.5 million, or $4.23 per share.
This represents an immediate increase in pro forma net tangible book value of
$5.37 per share to existing stockholders and an immediate and substantial
dilution of $20.77 per share to new investors purchasing shares of common stock
in this offering. Dilution to new investors is determined by subtracting pro
forma net tangible book value per share of common stock after giving effect to
this offering from the price to be paid by new investors in this offering for a
share of common stock. The following table illustrates the per share dilution
to investors in this offering:
<TABLE>
<CAPTION>
Per Share
--------------
<S> <C> <C>
Assumed offering price........................................... $25.00
Net tangible book value (deficiency) as of June 30, 1999....... $(1.14)
Increase attributable to new investors in this offering........ 5.37
------
Pro forma net tangible book value after this offering............ 4.23
------
Dilution to new investors in this offering....................... $20.77
======
</TABLE>
The following table summarizes on a pro forma basis as of June 30, 1999,
after giving effect to this offering, the number of shares of common stock
purchased from us, the total consideration paid to us and the average
consideration paid per share by the existing stockholders and by the new
investors in this offering:
. excluding the effect of 978,498 shares issued in connection with the
acquisition of Transcend Therapeutics, Inc. in May 1999; and
. including the effect of 667,295 shares issued in exchange for stockholder
notes receivable of $803,000.
<TABLE>
<CAPTION>
Shares Purchased Total Consideration
------------------ ----------------------
Amount Average Price
Number Percent (in thousands) Percent Per Share
---------- ------- -------------- ------- -------------
<S> <C> <C> <C> <C> <C>
Existing stockholders... 13,099,978 77% $ 83,766 46% $ 6.39
Investors in this
offering............... 4,000,000 23 100,000 54 25.00
---------- --- -------- ---
Total................. 17,099,978 100% $183,766 100% 10.75
========== === ======== ===
</TABLE>
The foregoing tables are based on the number of shares of common stock
outstanding as of June 30, 1999 and exclude:
. 1,579,778 shares of common stock issuable upon exercise of options
outstanding at June 30, 1999 at a weighted average exercise price of
$7.43 per share and 2,268,719 shares reserved for future grants under our
stock option plans;
. 55,492 shares of common stock issuable upon exercise of a warrant held by
a financial institution with an exercise price of $10.81 per share;
. 2,122,856 shares issuable upon conversion of the Series B preferred
stock; and
. any shares of common stock that may be sold by us to the underwriters
pursuant to the over-allotment option.
15
<PAGE>
SELECTED CONSOLIDATED FINANCIAL DATA
In the table below, we provide you with summary historical financial data of
KeraVision, Inc. We have prepared this information using the consolidated
financial statements of KeraVision, Inc. for the five years ended December 31,
1998 and the six-month periods ended June 30, 1998 and 1999. The financial
statements for the five years ended December 31, 1998 have been audited. The
financial statements for the six-month periods ended June 30, 1998 and 1999
have not been audited.
When you read this summary historical financial data, it is important that
you read it along with the historical financial statements and related notes in
our annual and interim financial statements included or incorporated by
reference in this prospectus, as well as the section titled "Management's
Discussion and Analysis of Financial Condition and Results of Operations."
<TABLE>
<CAPTION>
Six months ended
Year ended December 31, June 30,
---------------------------------------------- ------------------
1994 1995 1996 1997 1998 1998 1999
(in thousands, except per share data)
<S> <C> <C> <C> <C> <C> <C> <C>
Statement of Operations
Data
Net sales............... $ -- $ -- $ 137 $ 355 $ 835 $ 264 $ 4,381
Costs and expenses:
Cost of sales and
manufacturing
expenses.............. -- -- 319 3,701 4,386 1,949 4,615
Research and
development........... 5,146 6,527 10,888 10,774 11,356 6,016 4,201
Selling, general and
administrative........ 1,262 1,725 3,930 6,405 9,693 3,652 8,171
------- ------- -------- -------- -------- -------- --------
Total costs and
expenses............... 6,408 8,252 15,137 20,880 25,435 11,617 16,987
------- ------- -------- -------- -------- -------- --------
Loss from operations.... (6,408) (8,252) (15,000) (20,525) (24,600) (11,353) (12,606)
Interest income
(expense) and other,
net.................... 311 1,146 2,121 1,129 563 179 (315)
------- ------- -------- -------- -------- -------- --------
Net loss................ $(6,097) $(7,106) $(12,879) $(19,396) $(24,037) $(11,174) $(12,921)
======= ======= ======== ======== ======== ======== ========
Net loss applicable to
common stockholders.... $(6,097) (7,106) $(12,879) $(19,396) $(27,414) $(13,785) $(13,697)
======= ======= ======== ======== ======== ======== ========
Basic and diluted net
loss per share
applicable to common
stockholders........... $(4.52) $(1.05) $ (1.04) $ (1.55) $ (2.16) $ (1.09) $ (1.05)
======= ======= ======== ======== ======== ======== ========
Shares used in
calculation of net loss
per share.............. 1,348 6,757 12,342 12,528 12,686 12,655 13,088
</TABLE>
<TABLE>
<CAPTION>
December 31,
---------------------------------------------- June 30,
1994 1995 1996 1997 1998 1999
(in thousands)
<S> <C> <C> <C> <C> <C> <C>
Balance Sheet Data
Cash, cash equivalents
and available-for-sale
investments............ $5,909 $44,703 $ 32,065 $ 14,113 $ 7,728 $ 8,330
Working capital......... 4,935 43,205 30,435 11,820 4,915 504
Total assets............ 6,934 45,919 35,485 17,345 11,184 13,544
Capital lease
obligations,
noncurrent............. 210 114 793 850 821 666
Series B redeemable
convertible preferred
stock.................. 27,844 -- -- -- 17,489 18,265
Accumulated deficit..... (23,440) (30,403) (43,282) (62,678) (90,092) (103,789)
Total stockholders'
equity (net capital
deficiency)............ (22,144) 44,035 31,765 12,937 (11,447) (15,984)
</TABLE>
16
<PAGE>
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITIONS AND RESULTS OF OPERATIONS
Overview
Since its founding in November 1986, KeraVision has been engaged in the
research and development of technologies for surgical correction of vision
disorders. Although KeraVision recorded its first revenues in the quarter ended
December 31, 1996, we expect to continue to incur substantial losses until
sufficient revenues can be generated to offset expenses. Given the
uncertainties in developing a market for a new product, we may not be able to
achieve or sustain significant revenue growth in the foreseeable future.
Furthermore, we expect our overall expenses to increase as our sales and
marketing activities grow.
On April 9, 1999, KeraVision obtained FDA approval to distribute and sell
Intacs in the United States for the treatment of myopia in the range of -1.0 to
- -3.0 diopters in patients who are 21 years of age or older, who have a stable
refraction and who have up to +1.0 diopter of astigmatism. We are currently
conducting a Phase III clinical trial to expand our approved range of
indication for myopia to include -0.75 to -1.0 diopter and -3.1 to -4.5
diopters. In May 1998, we began limited commercial sales in Canada following
regulatory approval to sell Intacs to treat myopia in the range of -1.0 to -5.0
diopters. In late 1996, we were granted the right to affix the CE mark on
Intacs for myopia which allows KeraVision to sell products to treat myopia in
the range of -1.0 to -5.0 diopters in European Union countries.
The research, manufacture, sale and distribution of medical devices such as
Intacs are subject to numerous regulations, imposed by governmental
authorities, principally the FDA and corresponding state and foreign agencies.
The regulatory process is lengthy, expensive and uncertain. Prior to commercial
sale in the United States, most medical devices, including Intacs, must be
cleared or approved by the FDA. Securing FDA approvals and clearances requires
the submission to the FDA of extensive clinical data and supporting
information. Current FDA enforcement policy strictly prohibits the marketing of
medical devices for uses other than those for which the product has been
approved or cleared. Product approvals and clearances can be withdrawn for
failure to comply with regulatory standards or for the occurrence of unforeseen
problems following initial marketing. Foreign governments or agencies also have
review processes for medical devices which present many of the same risks. The
right to affix the CE mark can be withdrawn, resulting in an inability to sell
products in European countries.
We cannot be sure that we will achieve significant revenues from sales of
Intacs or any other potential products or become profitable. Although
KeraVision has received approval to sell Intacs in the United States, the
European Union and Canada, we cannot be sure that Intacs will prove to be safe
or effective over the long term in correcting vision, that Intacs will perform
in the manner we anticipate or that Intacs or any other product developed by us
will be commercially successful.
Results of Operations
Six months ended June 30, 1999 and 1998
Net sales for the six-month period ended June 30, 1999 totaled $4.4 million,
an increase of $4.1 million from $264,000 for the six-month period ended June
30, 1998. The increase in net sales primarily reflected the initial shipment of
instrument kits to surgeons subsequent to their completion of training in the
Intacs procedure during the second quarter of 1999. Each kit includes two sets
of proprietary instruments to perform the Intacs procedure and a supply of 18
Intacs correal ring segments. The predominant portion of the revenues received
from the sale of the kits was attributable to the proprietary instruments.
Significant growth of our net sales will be dependent upon our ability to sell
Intacs in increasing volumes.
Cost of sales and manufacturing expenses totaled $4.6 million in the 1999
period as compared to $1.9 million in the 1998 period. The increase in cost of
sales and manufacturing expenses reflected higher fixed costs associated with
the establishment of our manufacturing operations and higher variable costs as
a result of higher net sales.
17
<PAGE>
Research and development expenses, which include clinical and regulatory
expenses, for the 1999 period were $4.2 million, which represented a decrease
of $1.8 million from the 1998 period. The decrease was primarily due to reduced
clinical trial costs as a result of the completion of various studies, in
addition to reduced legal expenses related to patents.
Selling, general and administrative expenses were $8.2 million in the 1999
period, which represented an increase of $4.5 million from the 1998 period,
primarily due to increased marketing efforts related to market development in
the U.S. and Canada.
Interest income (expense) and other, net was $(315,000) in the 1999 period,
as compared to $179,000 in the 1998 period. The 1999 amount reflected a lower
level of interest income due to lower cash balances and a higher level of
interest expense reflecting a higher level of borrowings.
The net loss applicable to common stockholders for the 1999 period was $13.7
million versus $13.8 million for the 1998 period. Net loss applicable to common
stockholders included the effect of dividends, including deemed dividends, of
$776,000 and $2.6 million to preferred stockholders for the 1999 and 1998
periods, respectively.
Years ended December 31, 1998 and 1997
Net sales for 1998 increased to $835,000 from $355,000 in 1997, primarily as
a result of increased unit shipments associated with KeraVision's limited
product launch into the Canadian market.
Cost of sales and manufacturing expenses exceeded revenues in both years
reflecting low production volumes and fixed costs associated with our higher
volume manufacturing capabilities.
Research and development expenses for 1998 were $11.4 million compared to
$10.8 million in 1997. Research and development expenses in both periods
consisted primarily of clinical trial expenses, product development expenses
and patent expenses.
Selling, general and administrative expenses in 1998 were $9.7 million, an
increase of $3.3 million from 1997. The increase in spending reflects increased
staffing and associated expenses, in addition to increased marketing efforts
related to our launch in Canada and in anticipation of our U.S. launch
following FDA regulatory approval.
Interest income (expense) and other, net was $563,000 in 1998 as compared to
$1.1 million for 1997, reflecting lower average cash and investment balances
from period to period.
The net loss in 1998 was $24.0 million, an increase of $4.6 million from the
net loss of $19.4 million in 1997. In 1998, the net loss applicable to common
stockholders was $27.4 million, including the effect of dividends, including
deemed dividends, of $3.4 million to preferred stockholders.
Years ended December 31, 1997 and 1996
Net sales for 1997 increased to $355,000 from $137,000 in 1996 as a result of
increased unit shipments. Results in 1997 included a full year of commercial
shipments to the European market.
Cost of sales and manufacturing expenses exceeded revenues in both years
reflecting low production volumes and fixed costs associated with KeraVision's
higher volume manufacturing capabilities.
Research and development expenses for 1997 were $10.8 million compared to
$10.9 million in 1996. Research and development expenses in both periods
consisted primarily of clinical trial expenses, product development expenses
and patent expenses.
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Selling, general and administrative expenses in 1997 were $6.4 million, an
increase of $2.5 million from 1996. The increase in spending reflects increased
staffing and associated expenses, in addition to increased marketing efforts
related to European commercialization of Intacs.
Interest income (expense) and other, net was $1.1 million for 1997, as
compared to $2.1 million for the previous year, reflecting lower cash and
investment balances from period to period.
Tax Matters
As of December 31, 1998, KeraVision had federal, state and foreign net
operating loss carryforwards of approximately $66.3 million, $16.9 million and
$3.7 million, respectively. We also had federal and state research and
experimentation credit carryforwards of approximately $1.3 million and $1.0
million, respectively. The net operating loss and credit carryforwards will
expire at various dates beginning in 1999 through 2018, if not utilized.
Utilization of the net operating loss and credit carryforwards may be subject
to a substantial annual limitation due to the "change of ownership" rules
provided by the Internal Revenue Code and similar state tax provisions.
KeraVision has not yet evaluated the potential impact of these provisions on
its ability to utilize the net operating loss and credit carryforwards.
Under Statement of Financial Accounting Standards No. 109, deferred tax
assets and liabilities are based on differences between financial reporting and
tax bases of assets and liabilities, and are measured using the enacted tax
rates and laws that will be in effect when the differences are expected to
reverse. We have provided a full valuation allowance against our net deferred
tax assets due to uncertainties surrounding their realization, primarily due to
our lack of an earnings history.
Liquidity and Capital Resources
KeraVision has financed its operations since incorporation primarily through
its initial public offering, private sales of preferred stock, interest income,
equipment financing arrangements and the Transcend acquisition described below.
Cash used in operating activities for the first six months of 1999 increased to
$11.9 million from $9.2 million in the comparable period of the prior year,
reflecting increased selling, general and administrative and manufacturing
expenses. Cash and investments were $8.3 million at June 30, 1999. Capital
expenditures for the first six months of 1999 and 1998 were $809,000 and
$597,000, respectively.
In March 1999, KeraVision entered into a loan agreement providing for
borrowings of $5.0 million. The full amount was advanced on March 25, 1999. The
loan bears interest at 12.6% per annum until KeraVision repays the loan due on
September 30, 2001. KeraVision has the right to prepay the loan subject to a
prepayment penalty of 6.0% of the amount being prepaid on the prepayment date.
Repayment of the loan is secured by KeraVision's assets except for intellectual
property. In connection with the loan, KeraVision granted to the lender
warrants to purchase 55,492 shares of the common stock at an exercise price of
$10.81, the closing price as of March 5, 1999, the date of the loan commitment.
These warrants are exercisable for 7 years from the date of issuance.
KeraVision recorded the fair value of the warrants as additional interest
expense to be amortized over the term of the related debt. The value of
immediately exercisable warrants was determined using a Black-Scholes valuation
model, based on the contractual term of the warrants.
In May 1999, KeraVision completed the acquisition of Transcend Therapeutics,
Inc. and its net cash balance of $8.5 million. Transcend has terminated its
activities as a drug development company and now is a wholly owned subsidiary
of KeraVision. No Transcend employees were retained. Transcend stockholders
received 978,498 shares of KeraVision's common stock. This transaction was
accounted for as an acquisition of assets.
KeraVision expects to continue to incur substantial expenses in support of
additional research and development and sales and marketing activities,
including cost of clinical studies, manufacturing costs, the expansion of its
sales and marketing organization and the support for ongoing administrative
activities. Management's planned expenditures for 1999 exceed current cash,
cash equivalents and available-for-sale investments, and the funds received
from the Transcend acquisition and the March 1999 loan agreement.
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Management believes that sufficient funds will be available from sales of its
products and from external financing sources to support planned operations at
least through December 1999. KeraVision may also enter into collaborative
arrangements with corporate partners that could provide KeraVision with
additional funding in the form of equity, debt or license fees in exchange for
rights with respect to KeraVision's technology. There can be no assurance that
KeraVision will be able to raise any additional funds or enter into any such
collaborative arrangements on terms favorable to KeraVision, or at all. If
KeraVision is unable to obtain the necessary additional capital, significant
reductions in spending and the delay or cancellation of planned activities or
more substantial restructuring options may be necessary. In such event,
KeraVision intends to implement expense reduction plans in a timely manner to
enable KeraVision to meet its operating cash requirements at least through
December 31, 1999. These actions would have material adverse effects on
KeraVision's business, results of operations and prospects.
KeraVision's cash requirements may vary materially from those now planned
because of results of research, development and clinical testing, establishment
of relationships with strategic partners, changes in focus and direction of
KeraVision's research and development programs, changes in the scale, timing,
or cost of KeraVision's commercial manufacturing facility, competitive and
technological advances, the FDA or other regulatory processes, changes in
KeraVision's marketing and distribution strategy, and other factors.
Year 2000
The Year 2000 Issue is the result of computer programs being unable to
correctly recognize dates beyond December 31, 1999. This could result in a
system failure or miscalculations causing disruptions of operations, including,
among other things, a temporary inability to process transactions, send
invoices, or engage in similar normal business activities.
Based on recent assessments, we have determined that we would be required to
replace a small portion of our software so that those systems will properly
utilize dates beyond December 31, 1999. We have determined that all of our
critical business systems are already Year 2000 compliant. Assessment, testing
and remediation are proceeding in tandem, and we currently plan to have all
modifications to systems completed and tested by September 1999. These
activities are intended to encompass all major categories of systems in use by
KeraVision, including manufacturing, sales, finance and human resources.
KeraVision is also actively working with critical suppliers of products and
services to determine that the suppliers' operations and the products and
services they provide are Year 2000 compliant or to monitor their progress
toward Year 2000 compliance. We reviewed our product line and determined that
all of the products we have sold and will continue to sell do not require
remediation to be Year 2000 compliant. KeraVision cannot guarantee that any
system of other companies, on which our systems rely and which are not Year
2000 compliant, will be Year 2000 compliant in a timely fashion and would not
have an adverse effect on our systems.
The costs incurred to date related to these programs are less than $17,000.
We currently expect that the total cost of these programs, including both
incremental spending and redeployed resources, will not exceed $60,000. The
total cost estimate does not include potential costs related to any customer or
other claims or the cost of internal software and hardware replaced in the
normal course of business. The total cost estimate is based on the current
assessment of the projects and is subject to change as the projects progress.
Due to the KeraVision's reliance on widely used software packages that have
been certified as Year 2000 compliant, we have not developed a formal
contingency plan for software. Should unforeseen problems surface during our
testing of those packages, we will evaluate our alternatives, such as utilizing
different software packages. We are currently working on developing contingency
plans to increase inventories and raw materials in preparation for the Year
2000. This plan is currently in the development stages and should be finalized
by September 1999.
Based on currently available information, we do not believe that the Year
2000 issue will have a material adverse effect on our financial condition or
overall results of operations; however, we cannot be certain to what extent we
may be affected by such matters. In addition, we cannot guarantee that the
failure to ensure Year 2000 compliance by a supplier or another third party
would not have a material adverse effect on us.
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BUSINESS
General
KeraVision is developing of a new category of non-laser vision correction
products for the treatment of common vision disorders, including myopia
(nearsightedness), hyperopia (farsightedness) and astigmatism, to offer an
alternative to eyeglasses, contact lenses and other vision correction surgical
procedures. Our first product, Intacs(TM) corneal ring segments, based on our
proprietary patented technology, has been approved by the FDA for correcting
mild myopia. Intacs are the first surgical vision correction technology to be
approved by the FDA that is designed to permanently correct a patient's vision
while providing the option of removability. Intacs are composed of two thin
half-circles of polymer material that are inserted into the periphery of the
cornea to reshape the curvature of the cornea to correct vision. The polymer
material has been used in intraocular lenses to treat patients with cataracts
since 1952. The Intacs insertion process is a simple outpatient procedure that
typically can be performed in 15 minutes or less. KeraVision believes that the
Intacs technology is the first technology specifically designed to surgically
treat patients with low degrees of nearsightedness, a group estimated at
approximately 20 million people in the U.S. KeraVision is currently developing
other potential products to treat other vision correction disorders including
higher and lower levels of nearsightedness, as well as farsightedness and
astigmatism.
We have positioned our Intacs technology to address the growing market for
refractive surgery by offering an alternative to laser-based vision correction.
While laser-based technologies require the permanent removal of corneal tissue,
Intacs can be removed if desired. Patients' refractions return to preoperative
levels by three months following removal in most instances. We believe that
Intacs technology offers several other potential benefits to patients
including:
. long-term, convenient vision correction with predictable results
. rapid visual recovery
. a simple, minimally invasive out-patient procedure with minimal post-
operative pain in most cases
. easy to remove and replace in an outpatient procedure
Recent Developments
Latest Financial Results. On July 15, 1999, we announced that our net sales
for the three months ended June 30, 1999 were $3.9 million compared to net
sales of $112,000 for the comparable 1998 period. This increase primarily
reflected purchases of instruments used to perform the procedure for placement
of Intacs by the initial group of surgeons who participated in Intacs training
courses during the second quarter of 1999.
FDA Approval and Clinical Results. On April 9, 1999, KeraVision obtained FDA
approval to distribute and sell Intacs in the United States for the treatment
of mild myopia in the range of -1.0 to -3.0 diopters in patients who are 21
years of age or older, who have a stable refraction and who have up to +1.0
diopter of astigmatism. Results from the clinical trials of Intacs indicate
that 97% of the patients achieved vision of 20/40 or better, the vision
standard in most U.S. states for receiving a driver's license without the need
for corrective lenses. More significantly, 74% of the patients achieved vision
of 20/20 or better and 53% achieved vision of 20/16 or better as measured at 12
months.
Surgeon Training. Since April 1999, we have trained 243 surgeons to perform
the procedure for placement of Intacs. In addition, KeraVision has established
sites to train surgeons to perform the procedure for placement of Intacs in
Atlanta, Houston, Kansas City, Minneapolis, San Diego and Santa Monica.
Distribution Partnerships and Salesforce Expansion. In April 1999, we entered
into purchase and distribution agreements with three eye care services
companies that focus on surgical vision correction, including
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Laser Vision Centers, Inc., one of the largest providers of vision correction
surgery in the U.S., as well as NovaMed Eyecare, Inc. and ARIS Vision, Inc.
Under these agreements, these companies have agreed to purchase Intacs and
related instrumentation. There are approximately 600 surgeons located
throughout the U.S. who are affiliated with these companies. In addition, since
the beginning of 1999 we have hired 11 direct sales representatives and four
manufacturers' representatives, significantly expanding our salesforce
capabilities.
New Product Development. In April 1997, KeraVision began a clinical trial
outside the United States using Intacs technology for the treatment of
hyperopia. With encouraging initial results obtained from 52 patient eyes in
the initial trial, we have initiated a second clinical trial at several
European clinical sites. As of June 30, 1999, 25 additional patient eyes were
enrolled in this expanded study.
Background
Vision and Vision Impairment
The eye functions much like a camera, incorporating a lens system consisting
of a cornea and a lens that focuses light, the iris which functions as an
aperture that regulates the amount of light that passes through the central
zone of the cornea, and the retina, a light-sensitive surface that, like film,
records the image. The cornea, lens and iris operate to focus light rays on the
retina, which contains the light-sensitive receptors that transmit the image
through the optic nerve to the brain. Nearly all light that reaches the retina
passes through the central portion of the cornea, called the optical zone.
Approximately 75% of the refractive, or focusing, power of the eye is provided
by the curvature of the cornea.
Most common refractive problems result from an inability of the optical
system to focus images on the retina properly. This inability to focus is known
as a refractive error. For instance, in the myopic (nearsighted) eye, light
rays focus in front of the retina when the curvature of the cornea is too
steep. People with myopia see nearby objects clearly, but distant objects
appear blurry. Conversely, in the hyperopic (farsighted) eye, light rays focus
behind the retina when the curvature of the cornea is too flat. People with
hyperopia see distant objects clearly, but may need correction so that nearby
objects do not appear blurry. In the astigmatic eye, the curvature of the
cornea is not uniform. This lack of uniform curvature makes it difficult for a
person to focus clearly on an object. Refractive surgery changes the cornea's
refractive power by altering the curvature of the cornea, so that light passing
through the eye can be properly focused on the retina, thereby improving
vision.
Vision Correction Market
KeraVision estimates that over one-half of the world's population suffers
from common vision problems such as myopia, hyperopia or astigmatism. In the
United States alone, approximately 161 million people currently use eyeglasses
or contact lenses to correct these common vision problems, with over $16
billion spent on corrective eyewear products annually. It is estimated that
over 70 million people of all ages are affected by myopia. Of these, an
estimated 20 million people with mild myopia fall within the currently approved
range of indications for Intacs.
Surgical techniques to correct common vision problems, known as refractive
surgery, or vision correction surgery, include laser assisted in-situ
keratomileusis ("LASIK"), photo refractive keratectomy ("PRK") and radial
keratotomy ("RK"). LASIK is currently the most commonly performed refractive
surgery technique used in the United States. Generally these procedures have
been used to treat myopia; however, laser-based technologies to treat hyperopia
have recently been approved by the FDA, and other procedures are under
development. LASIK and PRK both require the use of a laser system to remove
corneal tissue to achieve a flattening of the cornea to treat nearsightedness,
and a steepening of the cornea to treat farsightedness.
It is estimated that approximately 950,000 laser-based procedures will be
performed in 1999, a substantial increase over the estimated 450,000 procedures
performed in 1998, the estimated 220,000 procedures
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performed in 1997, and the estimated 80,000 procedures performed in 1996, the
first year after the approval of PRK in late 1995. Each procedure represents
one eye and requires permanent cutting or tissue removal in the central cornea.
KeraVision estimates that existing refractive procedure costs in the United
States average $2,100 per eye for a LASIK procedure and $1,800 per eye for a
PRK procedure, with a fairly wide range for each procedure. Ophthalmic surgeons
generally set the prices of refractive surgery procedures performed at their
medical offices. KeraVision anticipates that the Intacs procedure will be
competitively priced with existing laser-based procedures. Consumers generally
pay directly for currently available refractive surgery procedures, including
Intacs, and are generally not reimbursed by third-party payors.
Refractive Surgery Techniques
RK, developed in the 1970's, was the first refractive surgical technique for
vision correction. In RK, a diamond knife is used to make from four to eight
radial incisions that penetrate beyond 90% of the depth of the cornea. The
procedure is generally conducted using topical anesthesia in an outpatient
setting. As the incisions heal, the curvature of the cornea is altered and
vision may be improved. RK results can vary with the skill and experience of
the surgeon and can be relatively unpredictable for patients requiring greater
degrees of correction. In addition, the procedure can result in the instability
of the eye over a period of months to years. Because RK entails making cuts in
or near the optical zone of the eye, unwanted side effects, such as halos,
reduced night vision and other visual distortions may occur.
In both PRK and LASIK, a laser is used to permanently remove tissue within
the optical zone to reshape the cornea, with the amount of tissue to be removed
based upon the level of intended change sought. In PRK, the top layer of the
central cornea, known as the epithelium, is manually removed to expose the
stromal tissue. The patient is then asked to fixate on a light to minimize eye
movement while the laser removes or ablates tissue from the stromal tissue in
the central area of the cornea. While vision improvement is achieved, PRK
depends in part on a healing response to reach the desired level of flattening
of the cornea, which generally occurs over a three-month period, although the
cornea may continue to reshape itself over a 12 to 15-month period. The
equipment required to conduct this procedure is significantly more expensive
than the equipment required for use in RK. Because PRK, like RK, surgically
alters tissue in the optical zone, haze, halos, reduced night vision and other
vision problems have been observed in patients who have undergone the PRK
procedure.
LASIK involves using an automated cutting device called a microkeratome to
cut a thin corneal flap, which is then pulled back to expose the underlying
stromal tissue. A laser is then used to remove corneal tissue to either flatten
the cornea in the case of myopia or steepen the cornea in the case of hyperopia
to achieve vision correction. The corneal flap is then placed back on the
stromal tissue where it adheres back onto the eye. Primary complications with
this procedure arise from cutting of the corneal flap, including incorrect flap
thickness, haze, halos, reduced night vision and other vision problems.
The LASIK procedure offered several advantages over PRK, including reduced
post-operative pain and a shorter visual recovery time. Both PRK and LASIK are
performed in an outpatient setting under topical anesthetic.
Quality of Vision
The most common measurement of vision utilizes an eye chart. One of the
recent developments in ophthalmology involves the concept of quality of vision.
It has been observed that a patients can attain 20/20 vision, as measured with
an eye chart, and still be dissatisfied with their quality of vision. This
issue may play a role in the future in modifying current refractive surgery
techniques, which are known to affect the smooth shape of the cornea and to
create corneal scarring in ways that may induce unwanted visual aberrations.
Typical vision complaints include haze, halos, reduced night vision and other
visual distortions. At the current time, most assessments attribute undesirable
visual side-effects of refractive procedures either to a disturbance of corneal
tissue within the optical zone or to the interruption or distortion of the
smooth shape of the cornea.
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New measurement techniques, including corneal topography, contrast sensitivity
and night-vision testing, are emerging to better analyze the quality of vision
beyond the assessment available using standardized eye charts.
KeraVision Technology
In response to the perceived market need for an alternative to eyeglasses,
contact lenses and existing laser-based surgical procedures, KeraVision has
developed a proprietary technology to treat a broad range of vision disorders.
Intacs are a proprietary product designed to reduce or eliminate the need for
corrective eyewear by reshaping the curvature of the patient's cornea. Intacs
are inserted between the layers of the corneal stroma through a small incision
made in the periphery of the cornea. The presence of Intacs in the periphery of
the cornea creates a flattening of the central cornea, thereby improving the
focus of light onto the retina to correct myopia. The Intacs procedure does not
cut or remove tissue from the optical zone of the cornea and therefore may
reduce the risk of unwanted visual side-effects such as haze, halos and reduced
night vision.
KeraVision believes that Intacs provide the following potential benefits for
the treatment of myopia:
. Long term, convenient vision correction with predictable results. Intacs
provide a highly predictable long-term correction of myopia in a form
more convenient than eyeglasses or contacts lenses and without the risks
associated with laser alternatives.
. Rapid visual recovery. Patients achieve significant vision improvements
almost immediately. U.S. clinical trials showed that 81% of patients
achieved vision of 20/40 or better within 24 hours and 92% of patients
achieved vision of 20/40 or better within 30 days.
. A simple, minimally invasive outpatient procedure with minimal post-
operative pain. The Intacs procedure was designed to promote ease of
surgery utilizing standard instrumentation, with minimal trauma to the
eye, and can typically be performed in less than 15 minutes. Post-
operative pain experienced in the clinical trials was modest and was
typically treatable with only non-prescription pain relievers.
. Easy to remove and replace. Intacs can be removed in a brief outpatient
procedure. When removed during clinical trials, the patients' refractions
returned to approximately the same level as measured prior to the Intacs
placement by three months following removal, in most cases.
Strategy
KeraVision's objective is to commercialize Intacs technology for the
treatment of common vision problems on a worldwide basis. KeraVision's business
strategy for achieving this objective includes the following key elements:
Expand and promote surgeon acceptance of Intacs
We are developing and implementing a roll-out strategy designed to promote
the use of our Intacs technology by ophthalmic surgeons. As part of this
strategy, we have focused on working with leading surgeons and academic centers
in the design, development and clinical testing of our products. We believe
that these surgeons and institutions influence the awareness and adoption of
new technologies by other surgeons. To further promote physician awareness, we
have devoted significant resources to publishing research papers and presenting
clinical and technical data at major ophthalmology conferences. We have
established two distinct sales channels including:
. a direct sales force of 11 people and 4 manufacturers' representatives to
market Intacs directly to independent ophthalmic surgeons, and
. commercial agreements with three leading vision correction surgery
providers who are currently affiliated with approximately 600 ophthalmic
surgeons.
Our surgeon training and skills transfer program is designed to ensure the
standardization of the Intacs procedure and reduce the time required for a
surgeon to become proficient in the procedure thereby facilitating the
integration of Intacs in the surgeons' practices.
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Increase consumer awareness and demand for Intacs
We intend to increase awareness and demand for Intacs through the following
initiatives:
. Branding of Intacs. Intacs is the first consumer branded product that
addresses the vision correction surgery market.
. Generating word of mouth referrals. We believe that our emphasis on
providing standardized surgeon training and post-training guidance will
result in higher levels of patient satisfaction and therefore a greater
number of personal referrals.
. Consumer awareness and marketing campaign. Our public relations efforts
have resulted in a significant amount of publicity for Intacs including
coverage in over 300 television news programs and over 3,000 newspaper
articles in the U.S. since January 1999. We intend to expand our direct-
to-consumer marketing efforts to include regional consumer advertising
which could involve radio, print or television media.
Expand our existing product portfolio
We intend to develop additional products to treat a broad range of vision
disorders based on our Intacs technology. For example, we are currently
conducting a Phase III trial for a product to treat myopia in both higher
ranges (-3.1 to -4.5 diopters) and lower ranges (-0.75 to -1.0 diopter). In
addition, we have recently initiated a second feasibility trial for our initial
hyperopia product based on the promising results we achieved in an earlier
trial. We have also successfully treated a small number of patients with pure
astigmatism and are in the early stages of development with a product designed
to treat myopia concurrent with astigmatism greater than +1.0 diopter. We have
designed these products to retain the benefits of our Intacs technology
including maintaining the integrity of the central optical zone and the option
of removability.
Utilize advanced development methods to reduce new product development cycle
time
KeraVision seeks to use advanced scientific and engineering methods, which
include the use of sophisticated modeling techniques, to reduce our new product
development time. These advanced methods improve our ability to understand the
optical, mechanical and biological effects of inserting Intacs or other
potential products into the cornea to correct common vision disorders. We
believe that this approach allows us to improve the design of our existing and
potential products and increase our understanding of product performance prior
to commencing clinical trials.
Strengthen our proprietary position
We intend to continue to aggressively protect our proprietary Intacs
technology and to expand our patent portfolio as we develop additional
products. Our patent strategy involves thoroughly protecting the device,
instrumentation as well as the procedures required to insert Intacs. As of June
30, 1999, KeraVision had 25 U.S. and 51 foreign patents issued and 141 pending
patent applications worldwide. These issued patents and pending patent
applications cover various aspects of Intacs technology, including Intacs,
methods of use, instruments and related materials and other vision correction
technology.
Intacs and Instruments
The initial design of Intacs corneal ring segments consisted of an optically
clear split ring made of PMMA. In order to simplify the surgical procedure,
KeraVision modified the design of Intacs in 1995 into two, thin half-circles of
PMMA, each with an arc measurement of 150 degrees. The two half-circles are
placed in the periphery of the cornea at a diameter of approximately eight
millimeters. KeraVision has extensively studied the relationship between
physical parameters of Intacs and corneal curvature change. As a result of
these studies, KeraVision believes that a small number of Intacs sizes, with
minor variations in their dimensions, can produce a wide range of corneal
curvature change and could provide treatment for a substantial
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segment of those people with myopia. KeraVision has developed Intacs in six
different thicknesses ranging from 0.21 mm to 0.45 mm. At present, the FDA has
approved three of these thicknesses (0.25, 0.30 x and 0.35 mm) for commercial
use in the U.S.
KeraVision has developed proprietary surgical instruments to be used for the
insertion of Intacs. These stainless steel and titanium instruments include a
marking instrument, a centering guide and stromal separators. KeraVision's
instruments have been designed to standardize the Intacs procedure and reduce
the variability associated with differing levels of surgical skill by, among
other things, showing the surgeon where to make the corneal incision and aiding
the surgeon in placing Intacs at the desired depth. The purchase of
KeraVision's instruments represents a relatively small capital investment
compared to the cost of equipment required for surgeons performing LASIK or PRK
procedures.
The Intacs Insertion Procedure
The insertion of Intacs is a simple, minimally invasive procedure that can be
performed on an outpatient basis typically in 15 minutes or less. The procedure
is usually performed using topical anesthetic eyedrops. The Intacs procedure in
part includes surgical techniques and ophthalmic surgical instruments that are
widely used by and familiar to ophthalmic surgeons. The Intacs procedure
requires a single incision of less than two millimeters outside of the central
optical zone of the cornea. The incision is located at the top of the eye under
the eyelid.
The Intacs insertion procedure consists of the following steps. The
ophthalmic surgeon uses a guide to mark the geometric center of the cornea.
Using the reference mark, a marking instrument is used to mark the line of
incision on the cornea outside the central optical zone and the location where
the ring segments are to be placed. A small entry incision is then made to
approximately two-thirds of the depth of the cornea and the layers of the
stroma at the bottom of the incision are separated. The stroma, which comprises
90% of the cornea, consists of 500 to 700 overlapping layers of tissue that can
be easily separated. The surgeon places the centering guide over the eye,
introduces each stromal separator through the small entry incision and rotates
each stromal separator, spreading the layers of the stroma to create a circular
subsurface tunnel in the periphery of the cornea. The surgeon then removes the
stromal separator and the centering guide. Intacs are introduced into the
tunnel and rotated into place. Patients generally experience substantial and
immediate improvement in vision. The amount of postoperative pain experienced
by patients in Intacs clinical trials has been minimal for most patients and is
typically treated only with nonprescription pain relievers. In addition, since
Intacs are inserted below the nerve endings of the cornea, patients do not feel
the presence of Intacs in the eye.
Clinical Trials Results
Myopia. Since 1991, ophthalmic surgeons have utilized Intacs technology for
the treatment of myopia in 1,787 patient eyes in clinical trials conducted in
the United States and throughout the world. KeraVision's clinical trials have
been designed to demonstrate the safety and efficacy of Intacs and the safety
of the surgical procedure used to insert Intacs. The safety and efficacy of
Intacs was evaluated using standard ophthalmic techniques. KeraVision initiated
clinical trials using the initial design of Intacs in 1991 in both the United
States and Brazil. In September 1994, KeraVision completed enrollment of a 90-
patient FDA Phase II myopia trial using the initial design of Intacs. In
September 1996, KeraVision completed enrollment of the group of 150 United
States Phase II myopia patients, for a total of 195 patient eyes, with a
modified design of Intacs. In November 1996, KeraVision initiated an expanded
Phase II myopia trial involving 59 patient eyes to evaluate moderate myopia (-
3.5 to -5.0 diopters). In October 1996, KeraVision received FDA approval to
commence a ten-center, 360 patient Phase III clinical trial for myopia in the
United States and began that trial in December 1996. KeraVision completed the
enrollment for the trial in May 1997. Our initial Pre-Market Approval (PMA)
application was based on data from the PMA cohort, a group of 452 patients
enrolled in the Intacs Phase II and Phase III clinical trials. Three
thicknesses (0.25, 0.30 and 0.35mm) of Intacs were evaluated. Intacs were
successfully placed in 449 eyes out of 454 surgical attempts. After 12 months
of follow-up, data were available for 97.6% of the PMA cohort patients. In
19 , KeraVision received FDA approval
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to expand the Phase III trial to study three additional thicknesses (0.21,
0.40, and 0.45 mm). The approval permitted KeraVision to implant Intacs into
one eye each of 120 patients (40 patient eyes for each thickness), but required
KeraVision to obtain additional approval from the FDA before implanting the
second eye in those patients or enrolling any additional patients. In 82 of the
enrolled 118 patients, KeraVision inadvertently implanted Intacs into the
patients' second eye prior to obtaining the required approval. On July 8, 1999,
KeraVision reported these unauthorized implantations the patients' second eye
to the FDA in a filing that requested permission to enroll an additional 240
patients and approval to implant the second eyes of the 118 patients already
enrolled. The FDA has not yet responded to KeraVision's filing. No assurance
can be given that the FDA will respond favorably to KeraVision's request, or
that the FDA will not take some action because of the unauthorized
implantations, which could significantly delay the study and/or impose
substantial additional costs. KeraVision has also conducted two European
clinical trials to evaluate myopia. The results from these trials are
comparable with KeraVision's clinical trials in the United States. In addition,
KeraVision has begun a trial for myopia in Singapore.
Intacs have been removed from 39 patient eyes from the PMA cohort. Intacs can
be easily removed in a brief, outpatient procedure. The Intacs removal rate for
the Phase III trial was 4.3% as compared to 9.6% from the earlier Phase II
trial. Reasons for Intacs removals included: one for infection, 15 for patient
dissatisfaction with correction achieved (undercorrection, overcorrection or
induced astigmatism), 19 for patient dissatisfaction with visual symptoms
(glare, halos, difficulty with night vision, etc.) and four for other reasons.
There have been no clinically significant complications associated with Intacs
removal procedures. The removal results demonstrate that the refractions
returned to preoperative levels by three months following removal, in most
instances. Best spectacle-corrected visual acuity was 20/20 or better in all
cases following removal.
The first procedure for the treatment of myopia using Intacs was performed in
1991, and to date more than 1,700 procedures have been conducted using Intacs
technology in clinical trials. Although KeraVision has developed eight-year
clinical data on the safety and efficacy of Intacs in correcting myopia, it has
limited long-term safety and efficacy data. We cannot assure you that long-term
safety and efficacy data when collected will be consistent with these clinical
trial results and will demonstrate that Intacs can be used safely and
successfully to treat myopia in a broad segment of the population or on a long-
term basis.
All surgical procedures, including the Intacs procedure, involve some
inherent risk of complications. For the PMA cohort, five patients experienced
safety-related complications for an overall incident rate of 1.1%. All five
patients recovered with no clinically significant effects. Adverse events
include: one infection, one shallow Intacs placement, one temporary loss of 2
lines of best corrected visual acuity and two corneal perforations. During the
12 months of follow up, there was a 4.5% incidence of removal and a 0.9%
incidence of exchange. Other complications included: overcorrection, reduction
in central corneal sensation, difficulty with night vision, undercorrection,
induced astigmatism, blurry vision, double vision, halos, glare, corneal blood
vessels, and fluctuating distance vision. No patient has had a lasting injury
to the eye or sustained any material loss of best corrected vision.
All of these complications and visual side effects have also been observed in
connection with other refractive surgery techniques. Although KeraVision
believes these complications and side effects may be mitigated, KeraVision
cannot assure you that these or other complications or side effects will not be
serious or lasting or will not impair or preclude KeraVision from retaining
existing regulatory approvals or obtaining regulatory approvals for our
products or the acceptance of these products by patients or ophthalmologists.
In many patients, KeraVision has observed deposits in the stromal channel next
to Intacs. Although KeraVision believes that these deposits are not
complications and do not cause side effects, we cannot assure you that this
will be the case.
Hyperopia. Treatment for correction of hyperopia consists of implanting six
rectangular segments made of PMMA placed in the periphery of the cornea. These
segments steepen the center of the cornea and flatten the periphery. Each
segment is 2.0 mm long and 0.8 mm wide, with a thickness ranging from 0.25 to
0.45 mm. Patients requiring +1.0 to +3.0 diopters of correction have
experienced significant improvement. After 12
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months of following, 50% of patients achieved vision of 20/20 or better, 71%
saw 20/25 or better, and 100% saw 20/40 or better. Because only a limited
number of patients to date have received the treatment for hyperopia,
KeraVision will need to treat additional patients in order to characterize the
range and predictability of correction prior to moving to a large scale trial.
We have initiated a second feasibility trial at several additional sites in
Europe.
Astigmatism. KeraVision has studied a potential product that uses arc
segments of Intacs to treat pure astigmatism. This device utilizes the core
technology for the treatment of myopia and the segments are manufactured from
the same material as Intacs. A similar surgical technique is employed to
implant the segments in the eye. In August 1994 and March 1995, KeraVision
implanted arc segments in eight astigmatic patients. Clinical results showed
that these patients exhibited improvement in their vision. KeraVision is
pursuing broader experimentation and analysis, but has not enrolled further
patients due to the perceived smaller size of the potential market compared to
the markets for myopia and hyperopia.
Marketing and Sales
United States
Our U.S. marketing roll-out objective is to gain acceptance of Intacs by both
ophthalmic surgeons and consumers. We have established two distribution
channels to begin the initial marketing efforts to the estimated 8,000
ophthalmic surgeons, of which an estimated 2,000 are currently performing
refractive surgery. The first channel is our direct sales force. We have
recently added 11 refractive surgery business specialists and 4 manufacturers'
representatives to market directly to ophthalmic surgeons. These specialists
and representatives have extensive backgrounds in both the sales of ophthalmic
products and in new product introductions. The second channel involves the use
of newly-created Refractive Surgery Provider Groups. These groups have emerged
primarily to market laser-based refractive surgery procedures. We have signed
purchasing or distribution agreements with Laser Vision Centers, Inc., NovaMed
Eyecare, Inc. and ARIS Vision giving us access to approximately 600 ophthalmic
surgeons affiliated with these organizations.
Surgeon Acceptance
Our marketing program for ophthalmic surgeons involves several key elements,
including a Skills Transfer Program and a Practice Integration Program.
We believe our success depends on well-trained surgeons to ensure successful
outcomes from their first patients onward. High levels of patient satisfaction
will develop the critical mass of patients required to start and sustain the
word-of-mouth process, an established driver of refractive procedure volume
growth. Prior to performing the Intacs procedure, ophthalmologists are required
to go through KeraVision Surgeon Training. Our training program is guided by
six leading ophthalmologists who are part of the KeraVision's Senior Training
Faculty and are highly experienced with the Intacs technology. The classes
include a comprehensive lecture and a surgical wet lab that can accommodate up
to 20 ophthalmologists. A detailed training manual is provided to each of the
program attendees. Following the initial training, we provide experienced
personnel to provide on-site guidance for the ophthalmologists through their
first series of procedures. Through June 30, 1999, we have trained 243
surgeons, including both primary doctors and their associates.
KeraVision's marketing program includes significant post-training efforts to
ensure rapid integration of Intacs into each surgeon's practices. Our
integration process includes education of the office staff, development of
patient education materials, including brochures and videos and seminars with
optometrists in the region.
Prior to attending the training sessions, doctors are required to purchase an
initial kit consisting of two instrument sets, a vacuum system and 18 Intacs
for a total price of $45,000. If desired, the instrumentation may be leased at
a cost slightly less than $1,000 per month. We intend to derive our initial
revenues from kit sales while working to build underlying procedure volumes to
maintain and grow future revenues.
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Consumer Acceptance
In addition to personal referrals, we intend to increase awareness of Intacs
through several other approaches. First, we have engaged in a public relations
strategy that has resulted in coverage on over 300 TV news programs and 3,000
print articles since January 1999. Second, many ophthalmic practices currently
use extensive marketing efforts to market laser procedures. We believe that
practices which integrate Intacs will use their own resources to advertise and
perform other activities to build procedure volume. Third, we may elect to
conduct co-operative advertising in conjunction with these practices. Fourth,
once there is a sufficient number of doctors trained and an adequate level of
interest in Intacs established within a region, we believe that a regional
consumer marketing campaign can then be used to further increase market
acceptance. Part of our strategy is to create the Intacs brand, which is the
first branded product within the refractive surgery market. The development of
a brand identity can facilitate consumer adoption by allowing consumers to ask
for the product by name, enabling focused advertising and fostering general
awareness.
Our initial marketing effort will focus on the estimated 20 million Americans
who are within the treatment range of our first product. The number of people
in this range could potentially represent 40 million procedures. The current
market for refractive surgery procedures is estimated to be 950,000 in 1999. It
is estimated that as much as 20 % of these procedure volumes are within the
currently approved Intacs range of correction. Our efforts have focused on
enhancing consumer awareness, thus increasing Intacs procedure volumes to drive
sales of Intacs. We are also seeking to expand the market for refractive
surgery to reach those consumers who have an interest in refractive surgery but
are concerned with other vision correction surgical procedures that do not
allow for the option of removal and placement.
Canada
KeraVision received approval in Canada in May 1998 to sell Intacs for the
treatment of myopia in the range of -1.0 to -5.0 diopters of correction, along
with related instruments. KeraVision focused its initial marketing efforts on
developing seven sites to become proficient in the Intacs procedure, to be able
to discuss the Canadian experience with Intacs and to potentially serve as
training centers. KeraVision then formally announced the product launch in
October 1998. KeraVision targeted the Vancouver area for the purpose of
training a high percentage of the refractive surgeons in the region and testing
the effect of consumer advertising on patient flow to those centers.
Europe/Other
Upon obtaining the right in November 1996 to market Intacs in European Union
countries, KeraVision commenced a sales and marketing program concentrated in
parts of France, Germany and Austria. As part of this program, KeraVision
established a European headquarters in Paris, France. A small sales office in
France handles sales of Intacs in the French market. A distributor sells
KeraVision's products in Germany and Austria.
From information obtained in the course of conducting the training sessions
and from consumer marketing studies, KeraVision determined that the overall
refractive surgery market in France and Germany was significantly less than
that of the United States on a per capita basis, and that the refractive
surgery markets in those countries do not appear to be growing at a substantial
rate, if at all. This lack of growth may be related in part to the lack of a
delivery or referral channel whereby potential patients can easily reach the
ophthalmic surgeon, rather than the non-surgical ophthalmologists and opticians
who may tend to recommend that a patient not consider refractive surgery.
Further, restrictions on direct broad scale advertising hinders the expansion
of consumer awareness of refractive surgery. It is expected that because of
these and other factors the refractive surgery market and the market for Intacs
will be slow to develop in Europe. KeraVision, however, is seeking to expand
its reach to other European countries by adding additional distributors.
KeraVision has concluded or is near completion of agreements with distributors
in Spain, Switzerland, the Benelux region, Greece, and the United Kingdom.
KeraVision has also updated its agreement with its Italian distributor.
KeraVision has completed distribution agreements with companies in Israel,
South Africa and Mexico.
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Asia
In July 1998, KeraVision commenced our first clinical trial in Asia, with the
initiation of a trial in Singapore. We have signed a distribution agreement
with a South Korean distributor to begin the work on product registration in
South Korea. We are reviewing our plans for expanding into other areas in the
Pacific Rim.
Patents and Proprietary Rights
One of KeraVision's primary strategies has been to develop a strong
proprietary patent position with respect to Intacs technology. KeraVision has
141 pending patent applications worldwide and has been awarded 25 United States
patents and 51 foreign patents. These issued patents and pending patent
applications cover various aspects of Intacs technology, including Intacs,
methods of use, instruments and related materials and other vision correction
technology. The expiration dates of the United States issued patents range from
2002 to 2016. KeraVision's policy is to protect its technology by, among other
things, filing patent applications relating to important aspects of its Intacs
technology and other vision correction technology. KeraVision has entered into
confidentiality agreements with its contract manufacturers in order to protect
the proprietary nature of its technology.
Manufacturing
KeraVision manufactures Intacs in its facility in Fremont, California using a
computer-controlled machining process. KeraVision has limited volume
manufacturing capacity and is building experience in manufacturing medical
devices and other products. To be successful, KeraVision's proposed products
must be manufactured in commercial quantities in compliance with regulatory
requirements at acceptable costs. Production in clinical or commercial-scale
quantities may involve technical challenges for KeraVision. Establishing our
own manufacturing capabilities may require significant scale-up expenses and
additions to facilities and personnel. KeraVision may consider seeking
collaborative arrangements with other companies to manufacture some of our
current & potential products. The manufacturer of KeraVision's potential
products will be subject to periodic inspection by regulatory authorities. Any
such operations must undergo compliance inspections conducted by the FDA and
equivalent inspections conducted by state and foreign officials. We cannot
assure you that any KeraVision manufacturer will be able to successfully pass
these inspections on a timely basis or at all. In addition, we cannot assure
you that KeraVision will be able to develop clinical or commercial-scale
manufacturing capabilities at acceptable costs or enter into agreements with
third parties with respect to these activities. In many cases, instruments and
other purchased materials critical for production are sole-sourced.
KeraVision has several sole-sources for sterilization, tools and equipment,
PMMA and other elements necessary to manufacture Intacs and the related
instrumentation. Since KeraVision is dependent upon third parties for the
manufacture of its products, KeraVision's profit margins and its ability to
develop and deliver such products on a timely basis may be adversely affected
by the lack of alternative sources of supply. Moreover, we cannot assure you
that our sole suppliers will adequately perform and any failures by third
parties may delay the submission of products for regulatory approval, impair
KeraVision's ability to deliver products on a timely basis, or otherwise impair
KeraVision's competitive position.
Intacs are made from PMMA, a polymer widely used in implantable intraocular
lenses since 1952. PMMA cast sheet is purchased from a sole supplier and is
stored at KeraVision prior to release to production. KeraVision believes it
could develop the capability over a significant time period to manufacture PMMA
cast sheet internally if this sole source were to become unavailable. Any
change in materials used for Intacs would require additional testing,
regulatory review and approval, which could result in significant manufacturing
and shipping delays.
Research and Development
KeraVision has been engaged in the research and development of Intacs
technology since its inception in 1986. The development effort has incorporated
both extensive clinical testing as well as laboratory testing to
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determine the effect of various configurations and insertion techniques for
Intacs technology. Some of the analytical techniques employed include computer
modeling using finite element analysis, optical ray tracing and various corneal
topography measurement instruments. These approaches aid in determining the
expected change in the shape of the cornea, the pattern of light distribution
through the cornea and curvature of the cornea achieved with various designs.
The analytical approaches are used in conjunction with information determined
from both feasibility studies and expanded clinical trials to determine the
best design to move forward in the testing cycle. For the three years ended
December 31, 1998, our expenditures for research and development were
approximately $10.9 million, $10.8 million, and $11.4 million, respectively.
KeraVision has also used these approaches to begin work on potential products
for astigmatism and hyperopia. KeraVision has begun investigations into
refinements for the existing product for myopia, including myopia concurrent
with high level of astigmatism and potential treatments for slightly higher
levels of myopic correction.
Competition
Intacs compete with other treatments for refractive problems, including
eyeglasses, contact lenses, and other refractive surgery procedures such as PRK
and LASIK. In addition, other refractive surgery technologies are currently
under development, including the intraocular contact lens ("ICL"), radio
frequency keratoplasty ("RFK"), and "refractive" intraocular lenses. The ICL
seeks to correct refractive errors by placing a lens inside the eye between the
natural lens and the iris. The ICL is currently available for sale in Europe.
RFK uses radio-frequency energy to change the shape of the cornea. Currently,
this treatment has been approved for use in Canada but has not been approved
for use in the United States. Refractive intraocular lenses ("IOL") involve the
placement of an intraocular lens behind the cornea for the correction of vision
problems. Significant competitive factors in the industry include efficacy of
vision correction, safety, reliability, convenience and price. The healthcare
field is characterized by extensive research and rapid technological change. At
any time, competitors may develop and bring to market new products or surgical
techniques with vision correction capabilities superior to those of Intacs or
which would otherwise render Intacs technology obsolete.
Other companies, most of which are larger and better financed than
KeraVision, are engaged in the refractive surgery market. Several companies,
including Summit Technology, Inc. VISX and Nidek, Inc. have received approval
to market their products in the United States. In addition to Summit
Technologies and VISX, there are a number of other large entities that
currently market and sell laser systems overseas for use in refractive surgery,
several of whom are seeking to obtain approval with the FDA to sell their
products in the Unites States.
KeraVision's competition will be determined in part by those refractive
surgery products that are ultimately approved for sale by regulatory
authorities. The relative speed at which KeraVision is able to develop its
potential products, complete the necessary governmental and regulatory approval
processes for those products and manufacture and market commercial quantities
of the products will be important competitive factors.
Government Regulation
FDA's Premarket Clearance and Approval Requirements. Unless an exemption
applies, each medical device that we wish to market in the U.S. must receive
either "510(k) clearance" or "PMA approval" in advance from the U.S. Food and
Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act. The
FDA's 510(k) clearance process usually takes from four to 12 months, but it can
last longer. The process of obtaining PMA approval is much more costly, lengthy
and uncertain and generally takes from one to three years or even longer.
The FDA decides whether a device must undergo either the 510(k) clearance or
PMA approval process based upon statutory criteria. These criteria include the
level of risk that the agency perceives is associated with the device and a
determination whether the product is a type of device that is similar to
devices that are already
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legally marketed. Devices deemed to pose relatively less risk are placed in
either class I or II, which requires the manufacturer to submit a premarket
notification requesting 510(k) clearance, unless an exemption applies. The
premarket notification must demonstrate that the proposed device is
"substantially equivalent" in intended use and in safety and effectiveness to a
legally marketed "predicate device" that is either in class I, class II, or is
a "preamendment" class III device (i.e., one that was in commercial
distribution before May 28, 1976) for which the FDA has not yet decided to
require PMA approval.
After a device receives 510(k) clearance, any modification that could
significantly affect its safety or effectiveness, or that would constitute a
major change in its intended use, requires a new 510(k) clearance. The FDA
requires each manufacturer to make this determination in the first instance,
but the FDA can review any such decision. If the FDA disagrees with a
manufacturer's decision not to seek a new 510(k) clearance, the agency may
retroactively require the manufacturer to submit a premarket notification
requiring 510(k) clearance. The FDA also can require the manufacturer to cease
marketing and/or recall the modified device until 510(k) clearance is obtained.
Devices deemed by the FDA to pose the greatest risk, such as life-sustaining,
life-supporting or implantable devices, or devices deemed not substantially
equivalent to a legally marketed predicate device, are placed in class III.
Intacs are regulated by the FDA as a class III device. Such devices are
required to undergo the PMA approval process in which the manufacturer must
prove the safety and effectiveness of the device to the FDA's satisfaction. A
PMA application must provide extensive preclinical and clinical trial data and
also information about the device and its components regarding, among other
things, manufacturing and labeling.
Upon submission, the FDA determines if the PMA application is sufficiently
complete to permit a substantive review, and, if so, the application is
accepted for filing. The FDA then commences an in-depth review of the PMA
application. The review time is often significantly extended as a result of the
FDA asking for more information or clarification of information already
provided. The FDA also may respond with a "not approvable" determination based
on deficiencies in the application and require additional clinical trials that
are often expensive and time consuming and can delay approval for months or
even years. During the review period, an FDA advisory committee, typically a
panel of clinicians, likely will be convened to review the application and
recommend to the FDA whether, or upon what conditions, the device should be
approved. Although the FDA is not bound by the advisory panel decision, the
panel's recommendation is important to the FDA's overall decision making
process.
If the FDA's evaluation of the PMA application is favorable, the FDA
typically issues an "approvable letter" requiring the applicant's agreement to
specific conditions (e.g., changes in labeling) or specific additional
information (e.g., submission of final labeling) in order to secure final
approval of the PMA application. Once the approvable letter is satisfied, the
FDA will issue a PMA for the approved indications, which can be more limited
than those originally sought by the manufacturer. The PMA can include
postapproval conditions that the FDA believes necessary to ensure the safety
and effectiveness of the device including, among other things, restrictions on
labeling, promotion, sale and distribution. Failure to comply with the
conditions of approval can result in material adverse enforcement action,
including the loss or withdrawal of the approval.
After the approval of a PMA, a new PMA or PMA supplement is required in the
event of a modification to the device, its labeling or its manufacturing
process. Supplements to a PMA application often require the same type of
information as a premarket approval application, except that the supplement is
limited to the information needed to support any changes from the product
covered by the original premarket approval application, and may not require the
submission of clinical data or the convening of an advisory committee. A new
PMA or PMA supplement will be required to expand the Intacs approval beyond
mild myopia to new ranges of myopia, and to hyperopia and astigmatism.
A clinical trial may be required in support of a 510(k) submission or PMA
application. Such trials generally require an Investigational Device Exemption
application approved in advance by the FDA for a
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limited number of patients, unless the product is deemed a nonsignificant risk
device eligible for more abbreviated IDE requirements. The IDE application must
be supported by appropriate data, such as animal and laboratory testing
results. Clinical trials may begin if the IDE application is approved by the
FDA and the appropriate institutional review boards at the clinical trial
sites.
Pervasive and Continuing FDA Regulation. A number of regulatory requirements
apply to marketed devices, including Intacs. These requirements include
labeling regulations, the Quality System Regulation (which requires
manufacturers to follow elaborate design, testing, control, documentation and
other quality assurance procedures), the Medical Device Reporting regulation
(which requires that manufacturers report to the FDA certain types of adverse
events involving their products), and the FDA's general prohibition against
promoting products for unapproved or "off label" uses. Class II devices also
can have special controls such as performance standards, postmarket
surveillance, patient registries, and FDA guidelines that do not apply to class
I devices.
Other Regulation
KeraVision is also subject to regulation by the Occupational Safety and
Health Administration and the Environmental Protection Agency and to regulation
under the Toxic Substances Control Act, the Resource Conservation and Recovery
Act, the National Environmental Policy Act and other regulatory statutes, and
may in the future be subject to other federal, state or local regulations. In
addition, new or modified regulations may be promulgated governing Intacs or
KeraVision's potential products that may be more restrictive or that may
otherwise alter or affect KeraVision's research and development programs. We
cannot assure you that KeraVision will not be required to incur significant
costs to comply with these laws and regulations in the future or that such laws
and regulations will not have a materially adverse effect upon KeraVision's
ability to do business. KeraVision is unable to predict whether any agency will
adopt any regulation that would have a material adverse effect on KeraVision's
operations.
All of the above described government regulation and product approval risks
apply to Intacs and will apply to any future potential product of KeraVision.
Government regulation may become more restrictive in the future. We cannot
assure you that KeraVision will not be required to incur significant costs to
comply with such laws and regulations in the future or that such laws and
regulations will not have a material adverse effect upon KeraVision's ability
to conduct business.
European Government Regulation and Product Testing
Sales of medical devices outside the United States are subject to foreign
regulatory requirements that vary widely from country to country. The time
required to obtain approvals required by foreign countries may be longer or
shorter than that required for FDA approval, and requirements for licensing may
differ from FDA requirements. Export sales of investigational devices that have
not received FDA marketing approval may be subject to FDA export permit
requirements. As KeraVision begins to sell products in additional foreign
markets it will be required to obtain an FDA export permit and comply with
foreign regulations for each of these markets. A delay in obtaining the
necessary approvals or failing to comply with regulatory requirements could
have a material adverse effect on KeraVision's business, financial condition
and results of operations.
The regulatory environment in Europe for medical devices differs
significantly from that in the United States. A total of 19 European countries
are grouped in a union with the objective of establishing a single market
without internal borders among the member countries and eliminating divergent
national requirements. The members of the European Union include Austria,
Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg,
The Netherlands, Portugal, Spain, Sweden, the United Kingdom, Iceland, Norway,
Switzerland and Lichtenstein.
Products that comply with the requirements of a specified EC medical
directive are entitled to bear CE marking. Since July 14, 1998, all commercial
medical device products have been required to bear CE marking. It is illegal to
market these products in the European Union without a CE marking.
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To obtain a CE marking, the product must be assessed and found to conform to
the applicable directive. This assessment is carried out by the manufacturer,
in most cases with the assistance of a third party certification organization
known as a "notified body." The notified body assessment may consist of an
audit of the manufacturer's quality system or specific testing of the product.
A manufacturer can sell a product throughout the European Union once it secures
an assessment by a notified body in one of the European Union countries.
The European Union has adopted two directives to regulate medical devices,
including the "Active Implantable Medical Devices Directive" ("AIMDD") and the
"Medical Devices Directive," ("MDD") and has proposed a third directive, the
"In Vitro Diagnostic Directive," ("IVDD") to harmonize the regulatory
requirements for medical devices.
Medical devices such as Intacs are regulated under the MDD. A manufacturer
may affix CE marking after a determination that the product complies with the
essential requirements of this directive and completion of the appropriate
conformity assessment procedure as specified by the directive. The conformity
assessment requirements are based upon a given product's classification within
the directive. Products within the scope of the directive are grouped within
four classes: Class I, IIA, IIB and III. A product with a higher classification
is considered to have higher risk, and will therefore be subject to more
controls in order to obtain CE marking. Intacs has been designated as a Class
IIB device. Essential requirements under the directive include substantiating
that the device meets the manufacturer's performance claims and that any
undesirable side effects of the device constitute an acceptable medical risk
when weighed against the intended benefits of the device.
There are two basic options for assessing conformity of devices designated as
Class IIB. The first option allows a manufacturer to seek a decision from the
notified body that the processes employed in the design and manufacture of a
device qualify as a full quality system. Alternatively, manufacturers can seek
product certification based on various control schemes. KeraVision obtained
qualification of its processes as a full quality system. Approval of
KeraVision's full quality system has been achieved through ISO 9001 and
EN 46001 certification by an approved notified body. The full quality system
encompasses the organizational structure, responsibilities, procedures,
processes and resources necessary to assure quality assurance in design,
development, production, installation and servicing of its medical devices.
The Medical Devices Directive also covers the instrumentation supplied by
KeraVision for the purpose of implanting Intacs. These instruments are
classified as Class I and therefore are not subject to full quality assurance
system requirements.
Once a manufacturer has satisfactorily completed the regulatory compliance
tasks required by the directive and received a favorable decision from the
notified body, it may affix CE marking to its product. Based on the current
regulatory laws, no additional premarket approvals in the individual European
Union countries are required. Custom-made devices and devices intended for
clinical investigation do not bear CE marking and are subject to particular
requirements under the Directive. Manufacturers are required to report serious
adverse incidents concerning CE marked devices to the authorities of the
countries where the incidents take place. If such incidents occur, the
manufacturer may have to take remedial action, perhaps including withdrawal of
the product from the European market.
The directives must be transposed into national law in order to be applied.
All member states of the European Union have completed this transposition. This
transposition process has not created significant differences among the member
states of the European Union with respect to compliance with the essential
requirements and the conformity assessment process. However, meaningful
differences have emerged in at least the following areas: authorities'
evaluation of proposed clinical investigation, notification of products and
activities, handling of adverse event reporting and language requirements for
labels and instructions for use. As the directive does not cover distribution
practices, healthcare financing and purchasing, it is expected that there will
be significant regulatory variances from country to country in these areas.
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KeraVision obtained conformity certification under Annex II of the MDD in
October 1996 from a notified body and thus achieved the right to affix the CE
marking to Intacs in November 1996. The right to affix the CE mark can be
withdrawn by the notified body and no assurance can be given that it will be
obtained again in a timely fashion or at all. Furthermore, there can be no
assurance that KeraVision's notified body will retain its status as a "notified
body."
Data and Safety Monitoring Board
KeraVision has established an independent Data and Safety Monitoring Board to
serve in a medical monitoring capacity and to review the collective safety and
efficacy data generated from KeraVision's various clinical trials. In addition,
the members of the Monitoring Board examine representative patients from the
United States investigational sites, provide medical advice to the clinical
investigators, review any safety-related complications and provide suggested
guidelines for patient management to the investigators. The Monitoring Board
currently consists of three prominent ophthalmologists. Additional individuals
will be added to the Monitoring Board, as required. The members of the
Monitoring Board are not allowed to be clinical investigators for Intacs.
Employees
As of June 30, 1999, KeraVision had 140 full-time employees consisting of 51
in manufacturing, 38 in research and development, 36 in sales and marketing,
and 15 in general and administration. KeraVision also has contracts with
outside consultants. KeraVision considers relations with its employees to be
good. None of KeraVision's employees is covered by a collective bargaining
agreement.
KeraVision and its business strategy depends in large part on the ability of
KeraVision to attract and retain key management, scientific and operating
personnel. KeraVision will need to develop expertise and add skilled personnel
or retain consultants in such areas as research and development, clinical
testing, government approvals, sales, marketing and manufacturing in the
future. KeraVision currently has a small research and management group with
limited operating experience. The loss of the services of one or more members
of the research or management group or the inability to hire additional
personnel and develop expertise as needed could have a material adverse effect
on KeraVision. KeraVision has an employment agreement with one of its
employees.
Properties
KeraVision's primary facilities occupy a total of approximately 40,000 square
feet of space in two locations in Fremont, California. The facilities are
subject to leases which expire in December 1999 for the 13,000 square feet
facility, and July 2004 for the 27,000 square feet facility. The larger
facilities house the manufacturing, R&D and administrative departments. The
smaller facility houses the sales and marketing, regulatory and clinical
departments. The current monthly rent is approximately $41,000. KeraVision's
European sales facilities occupy approximately 3,300 square feet of space in
Chatenay-Malabry, France. The facility is subject to a lease which expires in
July, 1999. We have exercised our option to extend the term of this lease
through July 2005. The current monthly rent is approximately $4,500. KeraVision
believes that this space is adequate for its immediate needs, and that it will
be able to renew its lease or obtain additional space as necessary.
Legal Proceedings
There are no material legal proceedings to which KeraVision is a party or of
which any of its property is the subject.
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MANAGEMENT
Directors and Officers of KeraVision
The following table sets forth certain information concerning our directors
and executive officers:
<TABLE>
<CAPTION>
Name Age Position
<S> <C> <C>
Thomas M. Loarie/2/ ...... 53 Chairman of the Board, Chief Executive Officer
and President
Darlene E. Crockett- Vice President, Regulatory Affairs and Clinical
Billig................... 46 Research
Mark D. Fischer-Colbrie... 43 Vice President, Finance and Administration, and
Chief Financial Officer
David Heniges............. 55 Vice President, Europe
Richard Meader............ 53 Vice President, Quality Assurance
Edward R. Newill.......... 46 Vice President, North American Marketing and
Sales
Thomas A. Silvestrini..... 47 Vice President, Research and Development
Robert P. Wood............ 40 Vice President, Manufacturing
Kshitij Mohan/3/ ......... 54 Director
Arthur M. Pappas/3/,/4/ .. 51 Director
Peter L. Wilson/3/,/4/ ... 54 Director
Charles Crocker/1/,/5/ ... 60 Director
Lawrence A.
Lehmkuhl/1/,/5/ ......... 62 Director
</TABLE>
- ---------------------
/1/Term on board expires in 2000.
/2/Term on board expires in 2001.
/3/Term on board expires in 2002.
/4/Member of Audit Committee.
/5/Member of Compensation Committee.
Thomas M. Loarie has served as President, Chief Executive Officer and
Chairman of the board of directors of KeraVision since September 1987. From
1985 until joining KeraVision, Mr. Loarie served as President of ABA
BioManagement, a management service firm specializing in medical technology
start-ups, and from 1984 to 1985 he served as President of Novacor Medical
Corporation, a manufacturer of cardiovascular implants. Prior to 1984, Mr.
Loarie held management positions in four divisions of American Hospital Supply
Corporation, now Baxter International, a manufacturer of healthcare products,
serving most recently as President of the American Heyer-Schulte Division,
where he was responsible for bringing several new implantable devices to the
markets of neurosurgery, oncology, urology, plastic surgery and wound
management as well as rebuilding American Heyer-Schulte's international
business. Mr. Loarie holds a B.S. degree in engineering from the University of
Notre Dame and has completed graduate work in business administration at the
Universities of Chicago and Minnesota. Mr. Loarie also serves as a director of
the Health Industry Manufacturers Association and of the California Healthcare
Institute.
Darlene E. Crockett-Billig has served as Vice President, Regulatory Affairs
and Clinical Research of KeraVision since February 1988. From 1986 to 1988, she
served as Regulatory Affairs Manager for CooperVision Ophthalmic Products, an
ophthalmic device manufacturer, where she was responsible for all FDA
submissions, product approval strategies and regulatory compliance. Prior to
that time, Ms. Crockett-Billig spent ten years in management and laboratory
supervision positions with Miles Laboratories and
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<PAGE>
Medtronic, Inc., two healthcare products manufacturers. Ms. Crockett-Billig
received her B.A. in Biology from Augustana College and her M.B.A. from the
College of St. Thomas, Minnesota.
Mark D. Fischer-Colbrie has served as Vice President, Finance and
Administration and Chief Financial Officer of KeraVision since March 1992. From
1983 to 1992, Mr. Fischer-Colbrie held several senior financial positions, most
recently as Vice President, Controller, at Maxtor Corporation, a manufacturer
of computer disk drives. Prior to 1983, he worked for four years with a
subsidiary of Xerox Corp. in accounting and finance. Mr. Fischer-Colbrie holds
a B.A. from Stanford University and an M.B.A. in Finance and Marketing from the
University of California at Berkeley.
David Heniges has served as Vice President, Europe of KeraVision since July
1998. Mr. Heniges was most recently Vice President Global Marketing for Baxter
International's Cardiovascular Surgery Division. Prior to that position, Mr.
Heniges was Vice President Worldwide Business Development for IOLAB, a division
of Johnson & Johnson. Mr. Heniges worked for Johnson & Johnson for 23 years.
Mr. Heniges received his B.S. in Sociology with a minor in Science from Oregon
State University.
Richard Meader has served as Vice President, Quality Assurance of KeraVision
since September 1998. Prior to that time, Mr. Meader was most recently Vice
President Regulatory and Quality Affairs for B. Braun/McGaw Inc. During his 23-
year tenure with B. Braun/McGaw Inc., Mr. Meader was responsible for
introducing the company's Total Quality Management program and instituting
efficiencies that reduced quality related costs. Mr. Meader received his B.S.
in Chemistry from the University of California Los Angeles.
Edward R. Newill has served as Vice President, North American Marketing and
Sales of KeraVision since May 1996. Mr. Newill has 20 years of international
experience in a broad range of surgical specialties including plastic surgery,
which like vision correction surgery is consumer-based and non-reimbursed by
insurers. Mr. Newill held management positions with Mentor from 1990 to 1996.
Mr. Newill holds a B.S. in General Business from Miami University and a Masters
in International Management from American Graduate School of International
Management.
Thomas A. Silvestrini has served as Vice President, Research and Development
of KeraVision since July 1990. Prior to joining KeraVision, Mr. Silvestrini
spent 12 years in senior management and project positions, including Manager of
Research and Development, Project Leader, and Senior Research Scientist, with
the Corporate Research Center of the Hospital Products Group for the Pfizer
Corporation, a manufacturer of healthcare products. He has received 11 patents
for medical devices and has an additional 12 patents pending. Mr. Silvestrini
received his B.S. in Chemical Engineering and his M.S. in Organic Chemistry
from the University of Minnesota.
Robert P. Wood has served as Vice President, Manufacturing of KeraVision
since April 1996. From 1994 to 1996, Mr. Wood was operations manager of
Allergan, Inc.'s medical device and pharmaceutical facility. From 1987 to 1994
Mr. Wood held management positions with Abbott Laboratories. Mr. Wood holds a
B.S. in mechanical engineering from Texas A&M University.
Kshitij Mohan has served as a director of KeraVision since January 1997. From
1995 to present, Dr. Mohan has served as Corporate Vice President for research
and technical services at Baxter International Inc. Dr. Mohan previously served
as a director of device evaluation at the Food and Drug Administration's Center
for Devices and Radiological Health. Dr. Mohan holds a B.S. in Physics from
Patna University, a M.S. in Physics from University of Colorado, and a Ph.D. in
Physics from Georgetown University. Dr. Mohan also serves as a director of the
Health Industry Manufacturers Association.
Arthur M. Pappas has served as a director of KeraVision since January 1997.
Mr. Pappas is Chairman and Chief Executive Officer of A.M. Pappas & Associates,
LLC, an international consulting, investment and venture company that works
with early to mid-stage life science companies, technologies and products.
Prior to founding A.M. Pappas & Associates in 1994, he was a director on the
main board of Glaxo Holdings plc with
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<PAGE>
executive responsibilities for operations in Asia Pacific, Latin America, and
Canada. In this capacity, he was Chairman and Chief Executive of Glaxo Far East
(Pte) Ltd. and Glaxo Latin America Inc., as well as Chairman of Glaxo Canada
Inc. He has held various senior executive positions with Abbott Laboratories
International Ltd., Merrell Dow Pharmaceuticals, and the Dow Chemical Company,
in the United States and internationally. Mr. Pappas received a B.S. in biology
from Ohio State University and an M.B.A. in finance from Xavier University. Mr.
Pappas also serves as a director of Quintiles Transnational Corp., GeneMedicine
Inc., Embrex Inc., and AtheroGenics Inc.
Peter L. Wilson has served as a director of KeraVision since August 1998. He
is the former President of Procter & Gamble's Richardson Vicks USA. In 1972,
Mr. Wilson joined the marketing department of Richardson Vicks/Merrell
Pharmaceuticals, rising to President and General Manager of the Vidal Sassoon
Division in 1984 and President and General Manager of the Personal Care
Division in 1986. He was appointed president of Richardson Vicks in 1990. Mr.
Wilson holds a B.S. in Geology from Princeton University and an M.B.A. from
Columbia University.
Charles Crocker has served as a director of KeraVision since January 1987.
Mr. Crocker served as Chairman of the Board of BEI Electronics, Inc. from 1974
to September 1997. Since September 1997, Mr. Crocker has served as Chairman,
President and CEO of BEI Technologies, Inc., a diversified electronics company
specializing in electronic sensors and motion control products, and as Chairman
of the Board of BEI Medical Systems Company (formerly BEI Electronics, Inc.), a
medical device company specializing in diagnostic and therapeutic products for
the women's healthcare market. He has been President of Crocker Capital, a
private venture capital firm, since 1985. Mr. Crocker holds a B.S. degree from
Stanford University and a M.B.A. from the University of California at Berkeley.
Mr. Crocker also serves as a director of Fiduciary Trust Company International
and Pope & Talbot, Inc.
Lawrence A. Lehmkuhl has served as a director of KeraVision since August
1992. From 1985 to 1994, Mr. Lehmkuhl was the Chairman, President and Chief
Executive Officer of St. Jude Medical, Inc., a medical device manufacturer.
Prior to 1985, Mr. Lehmkuhl spent 18 years in management positions with
American Hospital Supply Corporation. Mr. Lehmkuhl holds a B.B.A. from the
University of Iowa. Mr. Lehmkuhl is also a director of Nutrition Medical, Inc.
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<PAGE>
PRINCIPAL STOCKHOLDERS
We have described the "beneficial ownership" of KeraVision's common stock in
the following table according to the Securities and Exchange Commission's
rules. Those rules treat a stockholder as owning any shares covered by a stock
option, warrant or other convertible security that the stockholder could
exercise within 60 days after the date of this prospectus, even if they have
not actually been exercised. Such shares, however, are not deemed outstanding
for the purposes of computing the percentage ownership of each other person.
Common stock
The following table sets forth the beneficial ownership of KeraVision's
common stock as of June 30, 1999 for:
. each person who is known by KeraVision to beneficially own more than five
percent of our common stock;
. each of our directors and named executive officers;
. all directors and executive officers as a group.
Unless otherwise indicated in the table, the address of each stockholder
identified in the table is 48630 Milmont Drive, Fremont, California 94538. Each
percent of ownership assumes that, in addition to the 14,078,476 shares
actually outstanding on June 30, 1999, any shares of common stock covered by an
option, warrant or other convertible security owned by the stockholder that
could be issued within 60 days, but no other stockholder, were also
outstanding. Information with respect to beneficial ownership provided in the
following table is based upon information furnished by each director and
officer or contained in filings made with the Securities and Exchange
Commission.
39
<PAGE>
<TABLE>
<CAPTION>
Number
beneficially Percent held
Name and Address held
<S> <C> <C>
Goldman Sachs & Co.................................. 1,454,139 10.3%
85 Broad Street
New York, NY 10004
Entities affiliated with Donaldson Lufkin &
Jenrette, Inc(1) .................................. 1,627,757 10.4%
3000 Sand Hill Road
Menlo Park, CA 94025
Sprout Capital VIII, L.P............................ 1,333,948 8.7%
3000 Sand Hill Road
Menlo Park, CA 94025
Capital Research & Mngt. Co.(2)..................... 795,000 5.6%
333 South Hope St.
Los Angeles, CA 90071
Charles Crocker(3).................................. 176,943 1.3%
Darlene E. Crockett-Billig(4)....................... 141,037 1.0%
Mark Fischer-Colbrie(5)............................. 104,118 *
Lawrence A. Lehmkuhl(6)............................. 27,000 *
Thomas M. Loarie.................................... 491,733 3.5%
Kshitij Mohan(7).................................... 5,000 *
Edward R. Newill.................................... 1,834 *
Arthur M. Pappas(8)................................. 27,000 *
Thomas A. Silvestrini(9)............................ 200,867 1.4%
Peter L. Wilson(10)................................. 14,500 *
All directors and officers as a group
(13 persons)(11)................................... 1,212,532 8.5%
</TABLE>
- ---------------------
* Less than 1%
(1) Includes shares issuable upon the conversion of Series B preferred stock
held by DLJ Capital Corporation, Sprout Capital VIII, L.P., Sprout CEO
Fund, L.P., Sprout Venture Capital, L.P. and DLJ ESC II, L.P. DLJ Capital
Corporation is the managing general partner of Sprout Capital VIII, L.P.,
and the general partner of the Sprout CEO Fund, L.P. and Sprout Venture
Capital, L.P. Donaldson, Lufkin & Jenrette, Inc. directly owns all of the
capital stock of DLJ Capital Corporation and is the ultimate parent of the
manager of DLJ ESC II, L.P., and, as such, may be deemed to beneficially
own indirectly all the shares held by DLJ Capital Corporation and DLJ ESC
II, L.P. As of March 31, 1999, the Equitable Companies Incorporated
beneficially owned directly and indirectly, 71.3% of Donaldson, Lufkin &
Jenrette, and, as such, may be deemed to beneficially own indirectly the
shares held by DLJ Capital Corporation and DLJ ESC II, L.P.
(2) Capital Research & Management Co. has sole investment power over such
shares. SMALLCAP World Fund, Inc. has sole voting power over such shares,
and, as such, may be deemed to beneficially own such shares.
(3) Shares attributable to Mr. Crocker include 55,215 shares held by Fund FBO
Charles Crocker. Includes 10,000 shares issauble upon options exercisable
within 60 days.
(4) Includes 31,267 shares issuable upon options exercisable within 60 days.
(5) Includes 27,501 shares issuable upon options exercisable within 60 days.
(6) Includes 10,000 shares issuable upon options exercisable within 60 days.
(7) Represents 5,000 shares issuable upon options exercisable within 60 days.
(8) Includes 5,000 shares issuable upon options exercisable within 60 days.
(9) Includes 2,975 shares issuable upon options exercisable within 60 days.
(10) Includes 2,500 shares issuable upon options exercisable within 60 days.
(11) Shares attributable to directors and officers as a group include 116,743
shares issuable upon options exercisable within 60 days.
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<PAGE>
DESCRIPTION OF CAPITAL STOCK
The following description of the material terms of the capital stock of
KeraVision is qualified by reference to the amended and restated certificate of
incorporation of KeraVision, the certificate of designation of rights,
preferences and privileges of Series A participating preferred stock, the
certificate of designation of rights, preferences and privileges of Series B
redeemable convertible preferred stock and the Preferred Shares Rights
Agreement, dated as of August 18, 1997. See "Where You Can Find More
Information."
The authorized capital stock of KeraVision currently consists of 30,000,000
shares of common stock, par value $0.001 per share, and 2,000,000 shares of
preferred stock, par value $0.001 per share. Each share of KeraVision common
stock trades with KeraVision rights. See "--Stockholder Rights Plan." As of
June 30, 1999, there were outstanding 14,078,476 shares of KeraVision common
stock, no shares of KeraVision Series A preferred stock and 530,714 shares of
KeraVision Series B preferred stock.
KeraVision Common Stock
Holders of KeraVision common stock are entitled to receive dividends or
distributions that are lawfully declared by the KeraVision board, to have
notice of any authorized meeting of stockholders, and to one vote for each
share of KeraVision common stock on all matters which are properly submitted to
a vote of KeraVision stockholders. As a Delaware corporation, KeraVision is
subject to statutory limitations on the declaration and payment of dividends.
In the event of a liquidation or other dissolution of KeraVision, holders of
KeraVision common stock will have the right to a ratable portion of the assets
that remain after the full payment of amounts owed to KeraVision's creditors,
the payment of all KeraVision liabilities and the aggregate liquidation
preferences of any outstanding shares of KeraVision preferred stock. The
holders of KeraVision common stock have no conversion, redemption, preemptive
or cumulative voting rights. All outstanding shares of KeraVision common stock
are, and the shares of KeraVision common stock proposed to be issued in this
offering will be, validly issued, fully paid and non-assessable.
KeraVision Preferred Stock
KeraVision's charter authorizes the KeraVision board to issue preferred stock
in one or more series, to establish the number of shares in any Series and to
set the designation, preferences, rights, qualifications and restrictions on
each series of preferred stock.
Series A Participating Preferred Stock
In connection with the adoption of the rights plan, the KeraVision board has
designated 30,000 shares of preferred stock as Series A participating preferred
stock. The Series A preferred shares purchasable upon exercise of the
KeraVision Rights will not be redeemable. Each share of Series A preferred
stock will be entitled to an aggregate dividend of 1,000 times the dividend
declared per KeraVision common share. If KeraVision is liquidated, the holders
of the Series A preferred shares will be entitled to a preferential liquidation
payment equal to accrued but unpaid dividends plus the greater of $1,000 per
share and 1,000 times the aggregate per share amount to be distributed to the
holders of KeraVision common stock. Each Series A preferred share will have
1,000 votes, voting together with the holders of the KeraVision common stock,
except as required by law or the certificate of designation relating to the
Series A preferred stock. In a merger, consolidation or other transaction in
which KeraVision common stock is changed or exchanged, each Series A preferred
share will be entitled to receive 1,000 times the amount received per share of
KeraVision common stock. These rights are protected by customary anti-dilution
provisions. Because of the nature of the dividend, liquidation and voting
rights of the Series A preferred shares, the value of the one one-thousandth
interest in a share of Series A preferred stock purchasable upon exercise of
each KeraVision right should approximate the value of one share of common
stock.
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<PAGE>
Series B Preferred Stock
KeraVision's board of directors designated 662,500 shares of preferred stock
as Series B convertible preferred stock. The Series B preferred stock is
entitled to receive preferential quarterly dividends at the rate of seven
percent per annum. These quarterly dividends are payable, at the election of
KeraVision, in either cash or additional shares of Series B preferred stock. No
dividends may be paid to the holders of KeraVision common stock, other than
dividends paid in KeraVision common stock, until all accrued but unpaid
dividends have been paid to the holders of the Series B preferred stock. As of
June 30, 1999, there were accrued dividends in the amount of $297,200,
calculated at a rate of $2.24 per share of Series B preferred stock per annum,
which will be paid in the form of 6,671 additional shares of Series B preferred
stock. The preferential nature of the Series B preferred shares may impair
KeraVision's ability to pay dividends on its common stock in the future.
Each Series B preferred share is convertible at the option of the holder into
four shares of common stock at $8.00 per share. The Series B preferred shares
are convertible at KeraVision's option after June 12, 2000 if the price of its
common stock exceeds $16.00 per share. The conversion rate is subject to
adjustment in the event of circumstances which are described in the certificate
of designation relating to the Series B preferred shares, including:
. if the then-current value of the common stock is below $8.00 per share on
June 12, 2000;
. If KeraVision issues additional stock, with limited exceptions such as
stock issued in connection with employee stock option plans, stock issued
upon the conversion of Series B preferred stock and various financing
transactions, without consideration or for less than the conversion rate
then in effect; or
. if KeraVision executes a stock split.
The rate of conversion of Series B preferred shares to shares of common stock
has no maximum limit. As a result, the conversion of the Series B preferred
shares into common stock may cause the interest of the holders of KeraVision
common stock to be diluted.
The Series B preferred shares are redeemable at the option of the holders
after June 12, 2003 for $32.00 per share plus all accrued and unpaid dividends.
Holders of the Series B shares are entitled to have notice of any authorized
meeting of stockholders. At a meeting of stockholders, holders of the Series B
preferred stock are entitled to vote together with holders of KeraVision common
stock on all matters upon which holders of KeraVision common stock are entitled
to vote. Each share of Series B preferred stock is entitled to one vote for
each share of KeraVision common stock into which a share of Series B preferred
stock is convertible. In addition, so long as there are 300,000 shares of
Series B preferred stock outstanding, the holders of Series B preferred shares
are entitled to elect one member of the KeraVision board.
The holders of Series B preferred stock received registration rights for
shares of our common stock, into which the preferred stock is convertible. A
registration statement on Form S-3 is currently on file with the SEC pursuant
to which the holders of our Series B preferred stock may publicly resell the
shares of our common stock that they will receive at the time they convert
their shares of Series B preferred stock.
Certain Anti-Takeover, Limited Liability and Indemnification Provisions
Delaware Anti-Takeover Law. We are a Delaware corporation subject to Section
203 of the Delaware General Corporation Law ("DGCL"). Under Section 203,
certain "business combinations" between a Delaware corporation whose stock
generally is publicly traded or held of record by more than 2,000 stockholders
and an "interested stockholder" are prohibited for a three-year period
following the date that such stockholder became an interested stockholder,
unless (i) the corporation has elected in its certificate of incorporation not
to be governed by Section 203 (we have not made such an election), (ii) the
business combination or the transaction which resulted in the stockholder
becoming an interested stockholder was
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<PAGE>
approved by the board of directors of the corporation before such stockholder
became an interested stockholder, (iii) upon consummation of the transaction
that made such stockholder an interested stockholder, the interested
stockholder owned at least 85% of the voting stock of the corporation
outstanding at the commencement of the transaction (excluding voting stock
owned by directors who are also officers or held in employee benefit plans in
which the employees do not have a confidential right to tender stock held by
the plan in a tender or exchange offer) or (iv) the business combination is
approved by the board of directors of the corporation and authorized at a
meeting by two-thirds of the voting stock which the interested stockholder did
not own. The three-year prohibition also does not apply to certain business
combinations proposed by an interested stockholder following the announcement
or notification of certain extraordinary transactions involving the corporation
and a person who had not been an interested stockholder during the previous
three years or who became an interested stockholder with the approval of a
majority of the corporation's directors. The term "business combination" is
defined generally to include mergers or consolidations between a Delaware
corporation and an interested stockholder, transactions with an interested
stockholder involving the assets or stock of the corporation or its majority-
owned subsidiaries, and transactions which increase an interested stockholder's
percentage ownership of stock. The term "interested stockholder" is defined
generally as a stockholder who becomes a beneficial owner of 15% or more of a
Delaware corporation's voting stock, together with the affiliates or associates
of that stockholder.
Limitation of Officer and Director Liability and Indemnification
Arrangements Our Amended and Restated Certificate of Incorporation provides
that an officer or director of ours will not be personally liable to us or our
stockholders for monetary damages for any breach of his fiduciary duty as an
officer or director, except in certain cases where liability is mandated by the
DGCL. The provision has no effect on any non-monetary remedies that may be
available to us or our stockholders, nor does it relieve us or our officers or
directors from compliance with federal or state securities laws. The
certificate also generally provides that we shall indemnify, to the fullest
extent permitted by law, any person who was or is a party or is threatened to
be made a party to any threatened, pending or completed action, suit,
investigation, administrative hearing or any other proceeding by reason of the
fact that he is or was a director or officer of ours, or is or was serving at
our request as a director, officer, employee or agent of another entity,
against expenses incurred by him in connection with such proceeding. An officer
or director shall not be entitled to indemnification by us if (i) the officer
or director did not act in good faith and in a manner reasonably believed to be
in, or not opposed to, our best interests, or (ii) with respect to any criminal
action or proceeding, the officer or director had reasonable cause to believe
his conduct was unlawful.
Transfer Agent and Registrar
Boston EquiServe, L.P. is the transfer agent and registrar for the common
stock.
Stockholder Rights Plan
The KeraVision board has adopted a rights plan. The rights plan is designed
to help our board maximize stockholder value in the event of a change of
control of KeraVision and otherwise to resist actions that the board considers
likely to injure our stockholders. KeraVision believes that the rights plan
will permit us to develop our business and foster our long-term growth without
disruptions caused by the threat of a takeover not deemed by our board to be in
our stockholder's best interests. Generally, the rights plan will encourage any
potential acquirer to negotiate directly with our board. As a result, the
rights plan may have the effect of deterring third parties from making
proposals involving an acquisition or change of control of KeraVision, although
such proposals, if made, might be considered desirable and beneficial by a
majority of our stockholders. The rights plan could have the further anti-
takeover effect of making it more difficult for third parties to acquire a
majority of our common stock or to cause the replacement of our board.
In August 1997, the KeraVision board declared a dividend of one preferred
share purchase right for each outstanding share of common stock. Each
KeraVision right entitles the holder to purchase one one-thousandth
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of a share of Series A preferred stock, at a price of $60.00 per share. The
KeraVision rights are not now exercisable, and may never be exercisable. The
KeraVision rights will expire on the earlier of (i) August 17, 2007, unless
extended, or (ii) their redemption or exchange as described below. Until a
KeraVision right is exercised, it confers no rights to a stockholder.
In general, until the KeraVision rights are exercisable, redeemed or
exchanged, each KeraVision Right will trade together with and cannot be
separated from the underlying share of common stock on which the right was
declared.
The KeraVision rights will separate from the common stock if there is a
"distribution date." A distribution date would occur on the tenth day after the
earlier of (i) a public announcement that someone has obtained the right to
acquire beneficial ownership of 20% or more of the outstanding shares of
KeraVision common stock or (ii) the commencement or public announcement of a
tender offer that would result in someone acquiring such ownership. If a
distribution date occurs, the KeraVision rights would become exercisable and
separately tradeable, and KeraVision would issue certificates for the
KeraVision rights as soon as possible. Any KeraVision rights which belong to an
acquiring person are null and void.
KeraVision rights will attach to and be evidenced by each share of KeraVision
common stock which is issued prior to a distribution date. Accordingly, the
shares of KeraVision common stock issued by KeraVision in this offering, will
evidence the related KeraVision rights and certificates representing these
shares will contain a notation incorporating the rights plan by reference.
The amount of Series A preferred stock that the holder of a KeraVision right
is entitled to receive upon exercise of the KeraVision right and the purchase
price payable upon exercise of the KeraVision right are both subject to
adjustment.
The KeraVision board may redeem the KeraVision rights in whole, but not in
part, at a redemption price of $0.01 per KeraVision right, at any time before a
distribution date. After a distribution date, the KeraVision rights may be
redeemed only in very limited circumstances.
44
<PAGE>
UNDERWRITING
Subject to the terms and conditions contained in an Underwriting Agreement
dated , 1999, the underwriters named below (the "underwriters"), who are
represented by Donaldson, Lufkin & Jenrette Securities Corporation, Dain
Rauscher Wessels, a division of Dain Rauscher Incorporated, Prudential
Securities Incorporated, and SG Cowen Securities Corporation, have severally
agreed to purchase from us the respective numbers of shares of common stock set
forth opposite their names below:
<TABLE>
<CAPTION>
Number of
Underwriters Shares
<S> <C>
Donaldson, Lufkin & Jenrette Securities Corporation..................
Dain Rauscher Wessels................................................
Prudential Securities Incorporated...................................
SG Cowen Securities Corporation......................................
---------
Total.............................................................. 4,000,000
=========
</TABLE>
The underwriting agreement provides that the obligations of the several
underwriters to purchase and accept delivery of the shares of common stock
offered hereby are subject to approval by their counsel of certain legal
matters and to certain other conditions. The underwriters are obligated to
purchase and accept delivery of all the shares of common stock offered hereby
(other than those shares covered by the over-allotment option described below)
if any are purchased.
The underwriters initially propose to offer the shares of common stock in
part directly to the public at the public offering price set forth on the cover
page of this prospectus and in part to certain dealers (including the
underwriters) at such price less a concession not in excess of $ per share.
The underwriters may allow, and such dealers may re-allow, to certain other
dealers a concession not in excess of $ per share. After the initial
offering of the common stock, the public offering price and other selling terms
may be changed by the representatives of the underwriters at any time without
notice.
DLJdirect Inc., an affiliate of Donaldson, Lufkin & Jenrette Securities
Corporation and a member of the selling group, is facilitating the distribution
of the shares sold in this offering over the Internet. The underwriters have
agreed to allocate a limited number of shares to DLJdirect Inc. for sale to its
brokerage account holders.
The following table shows the underwriting fees we will pay to underwriters
in connection with this offering. These amounts are shown assuming both no
exercise and full exercise of the underwriters' option to purchase additional
shares of our common stock.
<TABLE>
<CAPTION>
Paid by
KeraVision
-----------------
No Full
Exercise Exercise
<S> <C> <C>
Per share..................................................... $ $
Total......................................................... $ $
</TABLE>
We will pay the offering expenses, estimated to be $650,000.
We have granted to the underwriters an option, exercisable for 30 days from
the date of this prospectus, to purchase up to an additional 600,000 shares of
our common stock at the public offering price less the underwriting fees. The
underwriters may exercise their option solely to cover over-allotments, if any,
made in connection with this offering. To the extent that the underwriters
exercise their option, each underwriter will become obligated, subject to
conditions, to purchase a number of additional shares of our common stock
approximately proportionate to that underwriter's initial purchase commitment.
We have agreed to indemnify the underwriters against certain civil
liabilities, including liabilities under the Securities Act of 1933, or to
contribute to payments that the underwriters may be required to make in respect
to those liabilities.
45
<PAGE>
Each of KeraVision and our executive officers and directors will agree,
subject to certain exceptions, not to
. offer, pledge, sell, contract to sell, sell any option or contract to
purchase, purchase any option or contract to sell, grant any option,
right or warrant to purchase or otherwise transfer or dispose of,
directly or indirectly, any shares of common stock or any securities
convertible into or exercisable or exchangeable for common stock, or
. enter into any swap or other arrangement that transfers all or a portion
of the economic consequences associated with the ownership of any common
stock
for a period of 90 days after the date of this prospectus without the prior
written consent of Donaldson, Lufkin & Jenrette Securities Corporation. During
such 90-day period, KeraVision may grant stock options pursuant to KeraVision's
existing stock option plan and may issue shares of common stock upon the
exercise of an option or warrant or the conversion of a security outstanding as
of the date of this prospectus. In addition, during such 90-day period,
KeraVision has also agreed not to file any registration statement with respect
to, and each of its executive officers, directors and certain stockholders of
KeraVision has agreed not to make any demand for, or exercise any right with
respect to, the registration of any shares of common stock or any securities
convertible into or exercisable or exchangeable for common stock without the
prior written consent of Donaldson, Lufkin & Jenrette Securities Corporation.
Our shares of common stock are listed on The Nasdaq National Market under the
symbol "KERA."
The shares of common stock offered hereby may not be offered or sold,
directly or indirectly, nor may this prospectus or any other offering material
or advertisements in connection with the offer and sale of any such shares of
common stock be distributed or published in any jurisdiction, except under
circumstances that will result in compliance with the applicable rules and
regulations of such jurisdiction. Persons into whose possession this prospectus
comes are advised to inform themselves about and observe any restrictions
relating to the offering and the distribution of this prospectus. This
prospectus does not constitute an offer to sell or a solicitation of an offer
to buy any shares of common stock offered hereby in any jurisdiction in which
such an offer or a solicitation is unlawful.
Sprout Capital VIII, L.P., Sprout CEO Fund, L.P., Sprout Venture Capital,
L.P., DLJ ESC II, L.P. and DLJ Capital Corporation (collectively, the "Sprout
Entities") are affiliates of Donaldson, Lufkin & Jenrette Securities
Corporation, one of the underwriters. As described under "Principal
Stockholders," the Sprout Entities beneficially own an aggregate of 1,627,757
shares of the outstanding common stock, which represent more than 10% of the
outstanding common stock. All of these shares are expected to become subject to
a voting trust agreement prior to the completion of the offering and are
expected to be held and voted by an independent third party, as voting trustee.
The underwriters and dealers may engage in passive market making transactions
in the common stock in accordance with Rule 103 of Regulation M promulgated by
the Securities and Exchange Commission. In general, a passive market maker may
not bid for or purchase shares of common stock at a price that exceeds the
highest independent bid. In addition, the net daily purchases made by any
passive market maker generally may not exceed 30% of its average daily trading
volume in the common stock during a specified two month prior period, or 200
shares, whichever is greater. A passive market maker must identify passive
market making bids as such on the Nasdaq electronic inter-dealer reporting
system. Passive market making may stabilize or maintain the market price of the
common stock above independent market levels. Underwriters and dealers are not
required to engage in passive market making and may end passive market making
activities at any time.
In connection with this offering, the underwriters may engage in transactions
that stabilize, maintain or otherwise affect the price of KeraVision's common
stock. Specifically, the underwriters may over-allot the offering, creating a
syndicate short position. The underwriters may bid for and purchase shares of
common stock in the open market to cover such syndicate short position or to
stabilize the price of the common stock. In
46
<PAGE>
addition, the underwriting syndicate may reclaim selling concessions from
syndicate members and selected dealers if they repurchase previously
distributed common stock in syndicate covering transactions, in stabilizing
transactions or otherwise. These activities may stabilize or maintain the
market price of the common stock above independent market levels. The
underwriters are not required to engage in these activities, and may end any of
these activities at any time.
LEGAL MATTERS
The validity of the common stock being offered will be passed upon for
KeraVision by Latham & Watkins, Menlo Park, California. Orrick, Herrington &
Sutcliffe LLP, San Francisco, California has acted as counsel for the
underwriters in connection with this offering.
EXPERTS
Ernst & Young LLP, independent auditors, have audited KeraVision's
consolidated financial statements as of December 31, 1998 and 1997, and for
each of the three years in the period ended December 31, 1998. These
consolidated financial statements have been included in this prospectus in
reliance on the report of Ernst & Young LLP, independent auditors, given on
their authority as experts in accounting and auditing.
47
<PAGE>
WHERE YOU CAN FIND MORE INFORMATION
Available Information
KeraVision files annual, quarterly and special reports, as well as
registration and proxy statements and other information with the Securities and
Exchange Commission. You may read and copy any document filed with the SEC by
KeraVision, including this registration statement on Form S-3 and exhibits, at
the Public Reference Room at 450 Fifth Street, N.W., Washington, D.C. 20549 or
at the SEC's Regional Offices located at 7 World Trade Center, Suite 1300, New
York, New York 10048 and at Citicorp Center, 500 West Madison Street, Suite
1400, Chicago, Illinois 60661. You can get further information from the SEC's
Public Reference Room by calling 1-800-SEC-0330. The SEC also maintains a web
site at http://www.sec.gov which contains reports, registration statements and
other information regarding registrants like KeraVision that file
electronically with the SEC.
This prospectus is part of a registration statement on Form S-3 filed by
KeraVision with the SEC under the Securities Act of 1933 with respect to this
offering of common stock. As permitted by the SEC, this prospectus, which
constitutes part of the registration statement on Form S-3, does not contain
all of the information in the registration statement filed with the SEC. For a
fuller understanding of this offering, you can look at the complete
registration statement on Form S-3 which may be obtained from the locations
described above.
Incorporation by Reference
The SEC allows us to "incorporate by reference" the information we file with
the SEC, which means that we can disclose important information to you by
referring you to documents we filed with the SEC. We incorporate by reference
the documents listed below, and any additional documents filed by us with the
SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of
1934 until the offering of the securities is terminated. The information we
incorporate by reference is part of this prospectus, and any later information
that KeraVision files with the SEC will automatically update and supersede this
information.
The documents KeraVision incorporates by reference are:
1. KeraVision's Annual Report on Form 10-K for the fiscal year ended
December 31, 1998, as amended on May 3, 1999;
2. KeraVision's Quarterly Report on Form 10-Q for the quarter ended March
31, 1999;
3. KeraVision's Current Report on Form 8-K filed on January 14, 1999;
4. KeraVision's Current Report on Form 8-K filed on February 10, 1999;
5. KeraVision's Current Report on Form 8-K filed on February 18, 1999;
6. KeraVision's Current Report on Form 8-K filed on April 19, 1999;
7. KeraVision's Current Report on Form 8-K filed on April 30, 1999.
8. KeraVision's Current Report on Form 8-K filed on June 11, 1999;
9. KeraVision's Current Report on Form 8-K filed on July 1, 1999; and
10. The description of KeraVision's common stock set forth in its
registration statement on Form 8-A filed with the Commission on June
27, 1995.
Documents incorporated by reference are available from KeraVision without
charge, excluding all exhibits except those that have been specifically
incorporated by reference in this Prospectus. You may obtain documents
incorporated by reference by requesting them in writing or by telephone from
KeraVision, 48630 Milmont Drive, Fremont, California 94538 (telephone 510-353-
3000); attention: Investor Relations. Our internet address is
www.keravision.com.
48
<PAGE>
KERAVISION, INC.
INDEX TO FINANCIAL STATEMENTS
<TABLE>
<S> <C>
Report of Ernst & Young LLP, Independent Auditors........................ F-2
Consolidated Balance Sheets.............................................. F-3
Consolidated Statements of Operations.................................... F-4
Consolidated Statements of Redeemable Convertible Preferred Stock and
Stockholders' Equity (Net Capital Deficiency)........................... F-5
Consolidated Statements of Cash Flows.................................... F-6
Notes to Consolidated Financial Statements............................... F-7
Unaudited Condensed Consolidated Balance Sheets.......................... F-17
Unaudited Condensed Consolidated Statements of Operations................ F-18
Unaudited Condensed Consolidated Statements of Cash Flows................ F-19
Notes to Unaudited Condensed Consolidated Financial Statements........... F-20
</TABLE>
F-1
<PAGE>
REPORT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS
The Board of Directors and Stockholders
KeraVision, Inc.
We have audited the accompanying consolidated balance sheets of KeraVision,
Inc. as of December 31, 1998 and 1997, and the related consolidated statements
of operations, redeemable convertible preferred stock and stockholders' equity
(net capital deficiency), and cash flows for each of the three years in the
period ended December 31, 1998. These financial statements are the
responsibility of the Company's management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of
material misstatement. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a reasonable basis
for our opinion.
In our opinion, the consolidated financial statements referred to above
present fairly, in all material respects, the consolidated financial position
of KeraVision, Inc. at December 31, 1998 and 1997, and the consolidated results
of its operations and its cash flows for each of the three years in the period
ended December 31, 1998, in conformity with generally accepted accounting
principles.
/s/ Ernst & Young LLP
February 3, 1999,
except for Note 9,
as to which the date
is March 25, 1999
San Jose, California
F-2
<PAGE>
KERAVISION, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
<TABLE>
<CAPTION>
December 31,
------------------
1998 1997
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents................................ $ 1,449 $ 2,574
Available-for-sale investments........................... 6,279 11,539
Prepaid expenses and other current assets................ 1,508 1,265
-------- --------
Total current assets....................................... 9,236 15,378
Property and equipment, at cost:
Manufacturing and laboratory equipment................... 3,709 3,298
Office furniture and fixtures............................ 597 586
Leasehold improvements................................... 636 383
-------- --------
4,942 4,267
Accumulated depreciation and amortization.................. (3,102) (2,398)
-------- --------
Net property and equipment............................... 1,840 1,869
Other assets............................................... 108 98
-------- --------
Total assets............................................... $ 11,184 $ 17,345
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY (NET CAPITAL
DEFICIENCY)
Current liabilities:
Accounts payable......................................... $ 1,742 $ 1,089
Accrued payroll and related expenses..................... 581 489
Accrued clinical trial costs............................. 1,282 1,211
Other accrued liabilities................................ 204 414
Current portion of capital lease obligations............. 512 355
-------- --------
Total current liabilities.................................. 4,321 3,558
Capital lease obligations.................................. 821 850
Redeemable convertible series B preferred stock, no par
value:
Authorized shares--662,500;
Issued and outstanding shares--562,500 at December 31,
1998, aggregate liquidation preference of $20,520....... 17,489 --
Commitments and contingencies
Stockholders' equity (net capital deficiency):
Preferred stock, par value $.001, 2,000,000 shares
authorized, none issued and outstanding................. -- --
Common stock, par value $.001, 30,000,000 shares
authorized,
12,776,920 and 12,593,646 shares issued and outstanding
in
1998 and 1997, respectively............................. 13 13
Additional paid-in capital............................... 80,162 76,540
Deferred compensation.................................... (30) (179)
Accumulated other comprehensive income................... 109 44
Accumulated deficit...................................... (90,092) (62,678)
Notes receivable from stockholders....................... (1,609) (803)
-------- --------
Total stockholders' equity (net capital deficiency)........ (11,447) 12,937
-------- --------
Total liabilities and stockholders' equity (net capital
deficiency)............................................... $ 11,184 $ 17,345
======== ========
</TABLE>
See accompanying notes.
F-3
<PAGE>
KERAVISION, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
<TABLE>
<CAPTION>
Year Ended December 31,
----------------------------
1998 1997 1996
<S> <C> <C> <C>
Net sales....................................... $ 835 $ 355 $ 137
Costs and expenses:
Cost of sales and manufacturing expenses....... 4,386 3,701 319
Research and development....................... 11,356 10,774 10,888
Selling, general and administrative............ 9,693 6,405 3,930
-------- -------- --------
Total costs and expenses........................ 25,435 20,880 15,137
-------- -------- --------
Operating loss.................................. (24,600) (20,525) (15,000)
Interest income, net............................ 563 1,129 2,121
-------- -------- --------
Net loss........................................ (24,037) (19,396) (12,879)
-------- -------- --------
Preferred stock dividends:
Redeemable convertible series B................ (846) -- --
Deemed dividend (Note 5)....................... (2,531) -- --
-------- -------- --------
Net loss applicable to common stockholders...... $(27,414) $(19,396) $(12,879)
======== ======== ========
Basic and diluted net loss per share applicable
to common stockholders......................... $ (2.16) $ (1.55) $ (1.04)
Shares used in calculation of basic and diluted
net loss per share............................. 12,686 12,528 12,342
</TABLE>
See accompanying notes.
F-4
<PAGE>
KERAVISION, INC.
CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS' EQUITY (NET CAPITAL DEFICIENCY)
(In thousands, except share and per share amounts)
<TABLE>
<CAPTION>
Redeemable Convertible Accumulated
Preferred Stock Common Stock Additional Other
----------------------- ----------------- Paid-In Deferred Comprehensive Comprehensive Accumulated
Shares Amount Shares Amount Capital Compensation Income/(loss) Income Deficit
<S> <C> <C> <C> <C> <C> <C> <C> <C> <C>
Balance at
December 31,
1995............. -- $ -- 12,262,845 $12 $75,710 $ (477) $ -- $-- $ (30,403)
Issuance of
common stock upon
exercise of
options.......... -- -- 181,957 -- 404 -- -- -- --
Amortization of
deferred
compensation..... -- -- -- -- -- 149 -- -- --
Forgiveness of
notes receivable
from
stockholders, net
of accrued
interest......... -- -- -- -- -- -- -- -- --
Comprehensive
income (loss): -- --
Net loss......... -- -- -- -- -- -- (12,879) -- (12,879)
--------
Other
comprehensive
income (loss),
net of tax: -- --
Change in
unrealized gain
on available-
for-sale
securities, net
of
reclassification
adjustments..... -- -- -- -- -- -- 18 -- --
Foreign currency
translation
adjustments..... -- -- -- -- -- -- (1) -- --
--------
Other
comprehensive
income.......... -- -- -- -- -- -- 17 17 --
--------
Comprehensive
income (loss).... -- -- -- -- -- -- $(12,862) --
----------- ----------- ---------- --- ------- ------ ======== ---- ---------
Balance at
December 31, 1996 -- -- 12,444,802 12 76,114 (328) 17 (43,282)
Issuance of
common stock upon
exercise of
options.......... -- -- 148,844 1 426 -- -- -- --
Amortization of
deferred
compensation..... -- -- -- -- -- 149 -- -- --
Accrued interest
on notes
receivable from
stockholders..... -- -- -- -- -- -- -- -- --
Comprehensive
income (loss): -- --
Net loss......... -- -- -- -- -- -- (19,396) -- (19,396)
--------
Other
comprehensive
income, net of
tax: -- --
Change in
unrealized gain
on available-
for-sale
securities, net
of
reclassification
adjustments..... -- -- -- -- -- -- 26 -- --
Foreign currency
translation
adjustments..... -- -- -- -- -- -- 1 -- --
--------
Other
comprehensive
income.......... -- -- -- -- -- -- 27 27 --
--------
Comprehensive
income (loss).... -- -- -- -- -- -- $(19,369) -- --
----------- ----------- ---------- --- ------- ------ ======== ---- ---------
Balance at
December 31,
1997............. -- -- 12,593,646 13 76,540 (179) 44 (62,678)
Issuance of
common stock upon
exercise of
options.......... -- -- 183,274 -- 598 -- -- -- --
Issuance of
redeemable
convertible
series B
preferred stock,
net of issuance
costs............ 562,500 14,112 -- -- 2,531 -- -- -- --
Accretion of
dividends on
preferred stock.. -- 150 -- -- -- -- -- -- (150)
Dividends on
preferred stock
to be
distributed...... -- 696 -- -- -- -- -- -- (696)
Dividends on
series B
preferred stock
issuance related
to deemed
dividend (Note
5)............... -- 2,531 -- -- -- -- -- -- (2,531)
Amortization of
deferred
compensation..... -- -- -- -- -- 149 -- -- --
Issuance of
stockholder
notes............ -- -- -- -- -- -- -- -- --
Forgiveness of
notes receivable
from
stockholders, net
of accrued
interest......... -- -- -- -- -- -- -- -- --
Accrued interest
on notes
receivable from
stockholders..... -- -- -- -- -- -- -- -- --
Compensation
expense related
to employee stock
activity......... -- -- -- -- 493 -- -- -- --
Comprehensive
income (loss): -- --
Net loss......... -- -- -- -- -- -- (24,037) -- (24,037)
--------
Other
comprehensive
income (loss),
net of tax: -- --
Change in
unrealized gain
on available-
for-sale
securities, net
of
reclassification
adjustments..... -- -- -- -- -- -- (42) -- --
Foreign currency
translation
adjustments..... -- -- -- -- -- -- 107 -- --
--------
Other
comprehensive
income.......... -- -- -- -- -- -- 65 65 --
--------
Comprehensive
income (loss).... -- -- -- -- -- -- $(23,972) -- --
----------- ----------- ---------- --- ------- ------ ======== ---- ---------
Balance at
December 31,
1998............. 562,500 $ 17,489 12,776,920 $13 $80,162 $ (30) $109 $ (90,092)
=========== =========== ========== === ======= ====== ==== =========
<CAPTION>
Total
Notes Stockholders'
Receivable Equity
From (net capital
Stockholders deficiency)
<S> <C> <C>
Balance at
December 31,
1995............. $ (807) $ 44,035
Issuance of
common stock upon
exercise of
options.......... -- 404
Amortization of
deferred
compensation..... -- 149
Forgiveness of
notes receivable
from
stockholders, net
of accrued
interest......... 39 39
Comprehensive
income (loss):
Net loss......... -- (12,879)
Other
comprehensive
income (loss),
net of tax:
Change in
unrealized gain
on available-
for-sale
securities, net
of
reclassification
adjustments..... -- 18
Foreign currency
translation
adjustments..... -- (1)
Other
comprehensive
income.......... -- --
Comprehensive
income (loss).... -- --
------------ -------------
Balance at
December 31, 1996 (768) 31,765
Issuance of
common stock upon
exercise of
options.......... -- 427
Amortization of
deferred
compensation..... -- 149
Accrued interest
on notes
receivable from
stockholders..... (35) (35)
Comprehensive
income (loss):
Net loss......... -- (19,396)
Other
comprehensive
income, net of
tax:
Change in
unrealized gain
on available-
for-sale
securities, net
of
reclassification
adjustments..... -- 26
Foreign currency
translation
adjustments..... -- 1
Other
comprehensive
income.......... -- --
Comprehensive
income (loss).... -- --
------------ -------------
Balance at
December 31,
1997............. (803) 12,937
Issuance of
common stock upon
exercise of
options.......... -- 598
Issuance of
redeemable
convertible
series B
preferred stock,
net of issuance
costs............ -- 2,531
Accretion of
dividends on
preferred stock.. -- (150)
Dividends on
preferred stock
to be
distributed...... -- (696)
Dividends on
series B
preferred stock
issuance related
to deemed
dividend (Note
5)............... -- (2,531)
Amortization of
deferred
compensation..... -- 149
Issuance of
stockholder
notes............ (776) (776)
Forgiveness of
notes receivable
from
stockholders, net
of accrued
interest......... 46 46
Accrued interest
on notes
receivable from
stockholders..... (76) (76)
Compensation
expense related
to employee stock
activity......... -- 493
Comprehensive
income (loss):
Net loss......... -- (24,037)
Other
comprehensive
income (loss),
net of tax:
Change in
unrealized gain
on available-
for-sale
securities, net
of
reclassification
adjustments..... -- (42)
Foreign currency
translation
adjustments..... -- 107
Other
comprehensive
income.......... -- --
Comprehensive
income (loss).... -- --
------------ -------------
Balance at
December 31,
1998............. $(1,609) $(11,447)
============ =============
</TABLE>
See accompanying notes.
F-5
<PAGE>
KERAVISION, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Increase (decrease) in cash and cash equivalents
(in thousands)
<TABLE>
<CAPTION>
Year Ended December 31,
----------------------------
1998 1997 1996
<S> <C> <C> <C>
Cash flows from operating activities:
Net loss........................................ $(24,037) $(19,396) $(12,879)
Adjustments to reconcile net loss to net cash
used in operating
activities:
Depreciation and amortization.................. 704 652 448
Issuance of stockholders' notes receivable..... (776) -- --
Interest receivable on stockholders' notes..... (76) (35) (41)
Expenses related to employee stock activity,
including amortization of deferred
compensation.................................. 688 149 229
Changes in operating assets and liabilities:
Prepaid expenses and other current assets.... (115) 32 (1,025)
Accounts payable............................. 653 116 528
Other accrued liabilities.................... (47) 504 391
-------- -------- --------
Net cash used in operating activities......... (23,006) (17,978) (12,349)
-------- -------- --------
Cash flows from investing activities:
Purchases of available-for-sale investments..... (22,214) (20,620) (40,402)
Sales of available-for-sale investments......... 25,210 11,408 10,790
Maturities of available-for-sale investments.... 2,201 21,474 5,855
Capital expenditures............................ (675) (545) (1,550)
Other assets.................................... (10) 49 (77)
-------- -------- --------
Net cash provided by (used in) investing
activities................................... 4,512 11,766 (25,384)
-------- -------- --------
Cash flows from financing activities:
Principal payments under capital lease
obligations.................................... (480) (427) (156)
Proceeds from sales-leaseback of capital
equipment...................................... 608 495 1,073
Proceeds from issuance of equity securities, net
of repurchases................................. 598 427 404
Proceeds from issuance of redeemable convertible
Series B
preferred stock, net of issuance costs......... 16,643 -- --
-------- -------- --------
Net cash provided by financing activities.... 17,369 495 1,321
-------- -------- --------
Net decrease in cash and cash equivalents........ (1,125) (5,717) (36,412)
Cash and cash equivalents at the beginning of the
year............................................ 2,574 8,291 44,703
-------- -------- --------
Cash and cash equivalents at the end of the
year............................................ $ 1,449 $ 2,574 $ 8,291
======== ======== ========
Supplemental disclosure of non-cash financing
activities:
Accrued and deemed dividends related to preferred
stock........................................... $ 3,227 $ -- $ --
======== ======== ========
Accretion related to preferred stock............. $ 150 $ -- $ --
======== ======== ========
Supplemental disclosures of cash flow information
Cash paid for interest........................... $ 123 $ 140 $ 25
======== ======== ========
</TABLE>
See accompanying notes.
F-6
<PAGE>
KERAVISION, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Organization and Summary of Significant Accounting Policies
Organization and Basis of Presentation
KeraVision, Inc. ("KeraVision" or the "Company") was incorporated on November
6, 1986 in the State of California and reincorporated in the State of Delaware
on July 25, 1995. On August 2, 1995, the Company completed its initial public
offering ("IPO") by issuing 3,600,000 shares of common stock in exchange for
net proceeds of $44.4 million.
The Company was founded to develop and commercialize proprietary medical
products for the treatment of common vision problems. On December 23, 1986, the
Company acquired certain equipment and patent rights from Kera Associates, a
partnership, in exchange for 425,000 shares of the Company's common stock
issued to the former partners of Kera Associates. The assets were recorded at
the predecessor's cost basis. As part of the transaction with Kera Associates,
the Company acquired the exclusive license, existing between Kera Associates
and an outside third party, to develop and market the licensor's "proprietary
rights," as defined, relating to the development of certain instruments used in
the insertion of KeraVision Intacs, the Company's initial potential product.
The term of the license agreement will continue until the expiration of the
last expiring patent then existing or developed thereafter by the licensor
relating to the proprietary rights. Royalties are payable based upon sales of
KeraVision Intacs or the instruments.
Management's Plans and Financing
The Company's financial statements are prepared and presented on a basis
assuming it continues as a going concern. At December 31, 1998, the Company had
an accumulated deficit of $90.0 million and incurred a net loss of $24.0
million for the year then ended.
On December 23, 1998, the Company announced that it had entered into a
definitive merger agreement to acquire Transcend Therapeutics, Inc. (Nasdaq:
TSND) and its anticipated net cash balance of about $8 million (see Note 8). In
March 1999, the Company entered into a senior term loan agreement providing for
borrowings of $5,000,000, which was advanced on March 25, 1999 (see Note 9--
Subsequent Events).
Management's planned expenditures for 1999 exceed current cash, cash
equivalents and available-for-sale investments and the funds from the Transcend
acquisition and the senior term loan. The Company will need to obtain
additional funds to continue its research and development activities, fund
operating expenses and pursue regulatory approvals for its products under
development. Management believes that sufficient funds will be available from
additional investors to support planned operations through December 1999. The
Company intends to raise additional funds through the sale of its equity
securities and/or debt financing. The Company may also enter into collaborative
arrangements with corporate partners that could provide the Company with
additional funding in the form of equity, debt or license fees in exchange for
the Company's rights with respect to certain markets or technology. There can
be no assurance that the Company will be able to raise any additional funds or
enter into any such collaborative arrangements on terms favorable to the
Company, or at all. If the Company is unable to obtain the necessary additional
capital, significant reductions in spending and the delay or cancellation of
planned activities or more substantial restructuring options may be necessary.
In such event, the Company intends to implement expense reduction plans in a
timely manner to enable the Company to manage operating cash requirements
through December 31, 1999. These actions would have material adverse effects on
the Company's business, results of operations, and prospects.
Comprehensive Income
In June 1997, the Financial Accounting Standards Board issued Statement of
Financial Accounting Standards No. 130, "Reporting Comprehensive Income" (FAS
130). FAS 130 establishes standards for the
F-7
<PAGE>
KERAVISION, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
reporting and display of comprehensive income and its components in a full set
of general purpose financial statements and is effective for fiscal years
beginning after December 15, 1997. The Company adopted FAS 130 in 1998. The
impact to the Company as a result of the adoption of FAS 130 was immaterial as
there was no significant difference between the Company's net loss reported and
the comprehensive net loss under FAS 130 for the periods presented.
Segment Information
The Company operates in one business segment, which is the development,
production and marketing of medical products for the treatment of common vision
problems. The Chief Executive Officer has been identified as the Chief
Operating Decision Maker (CODM) because he has final authority over resource
allocation decisions and performance assessment. The CODM does not receive
discrete financial information about individual components or geographical
information.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and
its wholly-owned subsidiary. Significant intercompany transactions and balances
have been eliminated in consolidation.
Concentration of Credit Risk and Other Risks
Financial instruments that potentially subject the Company to concentrations
of credit risk consist primarily of cash equivalents, short-term investments
and accounts receivables. The Company was founded to develop and commercialize
proprietary medical products for the treatment of common vision problems. The
Company generally does not require collateral. The Company maintains allowances
for credit losses, and such losses have been within management's expectations.
Use of Estimates
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions
that affect the amounts reported in the financial statements and accompanying
notes. Actual results could differ from these estimates.
Long-Lived Assets
In accordance with Statement of Financial Accounting Standards No. 121,
"Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets
to be Disposed Of," the Company continually reviews long-lived assets to assess
recoverability based upon undiscounted cash flow analysis. Impairments, if any,
are recognized in operating results in the period in which a permanent
diminuation in value is determined.
Depreciation and Amortization
Depreciation is provided on a straight-line basis over assets' estimated
useful lives of three to five years. Assets acquired under capital leases are
amortized on a straight-line basis over the lesser of the assets' useful life
or the term of the lease.
Cash, Cash Equivalents, and Available-for-Sale Investments
The Company considers all highly liquid investments with a maturity of three
months or less from the date of purchase to be cash equivalents. All other
liquid investments are classified as available-for-sale and consist
F-8
<PAGE>
KERAVISION, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
primarily of short-term investment grade securities, all of which mature within
the next twelve months. The Company is exposed to credit risk in the event of
default by the financial institutions or issuers of investments only to the
extent recorded on the balance sheet. At December 31, 1998 and 1997, the
Company's liquid assets were composed of deposits with banks and investments in
U.S. Government securities, corporate debt securities, certificates of
deposits, auction market preferred stocks and money market funds. Investments
include reverse repurchase agreements with major financial institutions. Due to
the short-term nature of the reverse repurchase agreements, the Company
generally does not take possession of the underlying securities.
Management determines the appropriate classification of investments at the
time of purchase and reevaluates such designation as of each balance sheet
date. At December 31, 1998 and 1997, all debt and equity securities are
designated as available-for-sale. Available-for-sale securities are carried at
fair value as determined by reference to quoted market prices, with the
unrealized gains and losses reported in stockholders' equity (net capital
deficiency). The amortized cost of debt securities in this category is adjusted
for the amortization of premiums and accretion of discounts to maturity. Such
amortization is included in interest income. Realized gains and losses and
declines in value judged to be other-than-temporary, if any, on available-for-
sale securities are included in other expense. The cost of securities sold is
based on the specific identification method. Interest and dividends on
securities classified as available-for-sale are included in interest income.
Revenue Recognition
The Company recognizes revenues from product sales upon shipment. The Company
provides allowances for estimated bad debts and sales returns, which have not
been material to date. Customers do not have significant return privileges.
Product sales in 1997 were composed principally of sales to the European market
through the Company's French sales office and German distributor. In 1998,
approximately 51% of the Company's sales were generated from its limited
product launch into the Canadian market, and the balance of the sales were in
Europe.
Net Loss Per Share
In 1997, the Financial Accounting Standards Board issued Statement No. 128,
"Earnings Per Share" (FAS 128). FAS 128 replaced the calculation of primary and
fully diluted earnings per share with basic and diluted earnings per share.
Unlike primary earnings per share, basic earnings per share excludes any
dilutive effects of options, warrants and convertible securities. Due to the
Company's net loss in all periods presented, net loss per share includes only
weighted average shares outstanding. All earnings per share amounts for all
periods have been presented, and where appropriate, restated to conform to the
FAS 128 requirements.
Advertising Expenses
The cost of advertising is recorded as an expense when incurred. Advertising
costs for the years ended December 31, 1998 were $1.7 million. Advertising
expenses for the years ended December 31, 1997, and 1996 were immaterial.
Accounting for Employee Stock Options
The Company accounts for stock-based compensation issued to employees and
directors, including outside directors, using the intrinsic value method
prescribed in Accounting Principles Board Opinion No. 25, "Accounting for Stock
Issued to Employees" (APB Opinion No. 25). No grants were made to outside
directors subsequent to December 15, 1998. The Company's policy is to grant
options with an exercise price equal to the
F-9
<PAGE>
KERAVISION, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
fair market value of the Company's common stock on the date of the grant.
Accordingly, no compensation cost, other than the compensation discussed in
Note 6, has been recognized in the Company's statements of operations. The
Company provides additional pro forma disclosures as required under Statement
of Financial Accounting Standards No. 123 "Accounting for Stock-Based
Compensation" (FAS 123) (see Note 6).
Income Taxes
Income taxes are calculated under the provisions of Statement of Financial
Accounting Standards No. 109, "Accounting for Income Taxes" (FAS 109). Under
FAS 109, the liability method is used in accounting for income taxes, which
includes the effects of temporary differences between financial and taxable
amounts of assets and liabilities.
2. Investments
At December 31, 1998, the Company's investments were composed of the
following (in thousands):
<TABLE>
<CAPTION>
Gross Estimated
Unrealized Fair
Cost Gains Value
<S> <C> <C> <C>
Money market instruments........................ $ 215 $ -- $ 215
Certificates of deposit......................... 165 -- 165
Auction rate preferred.......................... 1,875 -- 1,875
Corporate debt securities....................... 4,859 2 4,861
------ ----- ------
Available-for-sale investments.................. 7,114 2 7,116
Included in cash and cash equivalents........... (837) -- (837)
------ ----- ------
Included in available-for-sale investments...... $6,277 $ 2 $6,279
====== ===== ======
</TABLE>
The $7,116,000 included in available-for-sale investments matures in less
than one year. During 1998, 1997 and 1996 there were no gross realized gains or
losses.
At December 31, 1997, the Company's investments were composed of the
following (in thousands):
<TABLE>
<CAPTION>
Gross Estimated
Unrealized Fair
Cost Gains Value
<S> <C> <C> <C>
Money market instruments..................... $ 2,574 $ -- $ 2,574
Certificates of deposit...................... 659 -- 659
U.S treasury bills & other governmental
agency obligations.......................... 3,003 -- 3,003
Corporate debt securities.................... 7,835 42 7,877
------- ----- -------
14,071 42 14,113
Included in cash and cash equivalents........ (2,574) -- (2,574)
------- ----- -------
Included in available-for-sale investments... $11,497 $ 42 $11,539
======= ===== =======
</TABLE>
The $11,539,000 included in available-for-sale investments matures in less
than one year.
F-10
<PAGE>
KERAVISION, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
3. Capital Lease Obligations
The Company leases certain office and manufacturing equipment under
capitalized leases which expire in 2002. The total future minimum lease
payments under capital leases as of December 31, 1998 are as follows (in
thousands):
<TABLE>
<CAPTION>
Years ended December 31:
<S> <C>
1999............................................................. $ 646
2000............................................................. 563
2001............................................................. 233
2002............................................................. 150
------
Total minimum lease payments..................................... 1,592
Amounts representing interest.................................... (259)
------
Present value of minimum lease payments.......................... 1,333
Less current portion............................................. (512)
------
Noncurrent portion............................................... $ 821
======
</TABLE>
The cost of assets under capital leases at December 31, 1998 and 1997 were
$2,552,000 and $1,987,000 with related accumulated amortization amounting to
$1,293,000 and $851,000, respectively.
4. Commitments and Contingencies
Leases
The Company rents office facilities under operating lease agreements which
expire at various dates through 1999. The facility lease agreement provides for
an option for the Company to extend the lease for an additional five years.
Aggregate annual rental commitments under noncancelable operating leases as of
December 31, 1998 are as follows (in thousands):
<TABLE>
<S> <C>
1999............................................................... $261
2000............................................................... --
----
Total minimum lease payments....................................... $261
====
</TABLE>
Legal Matters
The Company is involved in a claim arising in the ordinary course of
business. The Company believes this matter will be resolved without material
adverse effect on the Company's financial position, results of operations or
cash flows.
5. Redeemable Convertible Preferred Stock
On June 12, 1998, the Company issued 562,500 shares of the Company's series B
redeemable convertible preferred stock (the "Series B Shares") at $32.00 per
share. The series B shares are entitled to receive quarterly dividends at the
rate of seven percent (7%) per annum, payable, at the election of the Company,
in either cash or additional series B shares, as described in the Certificate
of Designation of Rights, Preferences and Privileges of series B convertible
preferred stock (the "Certificate of Designation"). Each series B share is
immediately convertible, at the option of the holders, into four shares of
common stock at $8.00 per share. The series B shares are convertible at the
Company's option, at the applicable conversion rate which is currently $8.00
per share, after two years if the price of the Company's common stock exceeds
$16.00 per share. The
F-11
<PAGE>
KERAVISION, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
conversion rate is subject to adjustment in the event of certain circumstances
described in the Certificate of Designation, including if the then-current
value of the common stock is below $8.00 per share on June 12, 2000. The series
B shares are redeemable, at $32 per share, at the option of the holders after
five (5) years. The cumulative quarterly dividends as of December 31, 1998 were
approximately $696,000. For the year ended December 31, 1998, preferred
dividends of $696,000, accretion of $150,000 and the deemed dividends,
representing the difference, at the date of issuance, between the market value
of the Company's common stock of $9.125 at June 12, 1998 and the conversion
price of the Company's series B convertible preferred stock of $2.5 million are
added to the net loss to arrive at net loss applicable to common stockholders.
The difference between the carrying value of the preferred stock and the
aggregate redemption value is being accreted as preferred stock dividends over
the five year redemption period.
Upon any liquidation, dissolution or winding up of the Company, no
distribution shall be made to the holders of shares of stock ranking junior to
the series B convertible preferred stock unless, prior thereto, the holders of
shares of series B convertible preferred stock have received an amount equal to
accrued and unpaid dividends and distributions thereon, whether or not
declared, to the date of such payment, plus an amount equal to $32 per share
and in the event such payment is made on or before June 12, 2000, an amount
equal to $4.48 per share, less (i) the accrued dividends and (ii) dividends
previously paid. Preferred stockholders are additionally entitled to any
dividends distributed to common stockholders.
6. Stockholders' Equity
Stock Options
In June 1995, the Company adopted the 1995 Stock Plan (the "1995 Plan") and
the 1995 Directors' Option Plan (the "Directors' Plan"). A total of 800,000 and
150,000 shares were reserved for issuance under the 1995 Plan and the
Directors' Plan, respectively. Options outstanding under the Company's 1987
Stock Plan continue to be governed by such Plan. Common stock options may be
granted to employees, consultants and directors. Options granted under the 1995
Plan may be either incentive stock options or nonstatutory stock options,
determined at the compensation committees' discretion. Options granted under
the Directors' Plan must be nonstatutory options. In August 1997, the Company
adopted the 1997 Stock Plan (the "1997 Plan"). A total of 300,000 shares were
reserved for issuance under the 1997 Plan. Options granted under the 1997 Plan
must be nonstatutory stock options. Options are generally granted at an
exercise price (as determined by the compensation committee) equal to an amount
of not less than the fair value per share on the date of and become exercisable
pursuant to the applicable terms of the grant. The term of any option shall not
be greater than ten years from the date of grant.
In October 1998, the board of directors authorized the Company to offer all
employees the opportunity to cancel certain previously granted options in
exchange for new options with four year vesting and fair market value prices of
$5.938. The repriced options may not be exercised prior to October 28, 1999. In
connection with this offer, options to purchase 410,977 shares of common stock
with a weighted-average price of $11.72 were exchanged for 328,781 new options.
F-12
<PAGE>
KERAVISION, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
Information relative to stock option activity under all plans is as follows:
<TABLE>
<CAPTION>
Outstanding Options
--------------------------------
Weighted-
Average Aggregate
Available Number Exercise Exercise
for Grant of Shares Price Price
--------- --------- --------- -----------
<S> <C> <C> <C> <C>
Balance at December 31, 1995....... 876,500 806,770 $ 4.76 $ 3,844,095
Granted.......................... (463,500) 463,500 13.85 6,421,700
Canceled......................... 38,376 (72,996) 9.93 (724,720)
Exercised........................ -- (166,045) 1.43 (237,553)
-------- --------- -----------
Balance at December 31, 1996....... 451,376 1,031,229 9.02 9,303,522
Authorized....................... 300,000 -- -- --
Granted.......................... (515,342) 515,342 7.86 4,049,417
Canceled......................... 56,116 (59,411) 12.45 (739,954)
Exercised........................ -- (123,555) 2.13 (263,559)
-------- --------- -----------
Balance at December 31, 1997....... 292,150 1,363,605 9.06 12,349,426
Authorized....................... 590,000 -- -- --
Granted, including 328,781
repriced options................ (892,131) 949,731 6.14 5,859,373
Canceled......................... 601,164 (679,204) 11.36 (7,712,820)
Exercised........................ -- (152,556) 2.72 (415,491)
-------- --------- -----------
Balance at December 31, 1998....... 591,183 1,481,576 $ 6.80 $10,080,488
======== ========= ===========
</TABLE>
Options generally vest over a period of four years, up to a maximum of 5.5
years. Certain options granted in 1995 and 1997 have accelerated vesting
positions. At December 31, 1998 and 1997, approximately 284,926 and 514,656,
respectively, of the outstanding options were exercisable.
The following table summarizes information about options outstanding at
December 31, 1998:
<TABLE>
<CAPTION>
Options Outstanding Options Exercisable
- ------------------------------------------------------ -----------------------
Weighted
Number Average Weighted Number Weighted
Outstanding Remaining Average Exercisable Average
Range of at Contractual Exercise at Exercise
Exercise Prices 12/31/98 Life Price 12/31/98 Price
- --------------- ----------- ----------- -------- ----------- --------
<S> <C> <C> <C> <C> <C>
$1.875 - 5.438 492,089 8.19 $ 4.77 107,070 $ 3.82
5.75 - 6.25 374,981 8.49 5.97 3,411 5.96
7.125 - 8.75 440,169 7.05 7.74 131,645 8.25
9.125 - 15.50 174,337 8.78 11.97 42,800 13.01
--------- -------
$1.875 - 15.50 1,481,576 8.00 $ 6.80 284,926 $ 7.27
========= =======
</TABLE>
F-13
<PAGE>
KERAVISION, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
The Company has adopted the disclosure-only provisions of FAS 123.
Accordingly, no compensation cost has been recognized for stock options granted
in 1998, 1997 and 1996 with exercise prices equal to the fair value of the
Company's common stock on the date of grant. Had compensation cost for the
Company's stock option plans and employee stock purchase plan described below
been determined based on the fair value at the grant date for awards in 1998,
1997 and 1996 consistent with the provisions of FAS No. 123, the Company's net
loss and net loss per share would have increased to the pro forma amounts
indicated below:
<TABLE>
<CAPTION>
1998 1997 1996
<S> <C> <C> <C>
Net loss applicable to common stockholders--as
reported
(in thousands)............................... $(27,414) $(19,396) $(12,879)
Net loss applicable to common stockholders--
pro forma
(in thousands)............................... $(28,947) $(21,414) $(14,227)
Basic and diluted net loss per share--as
reported..................................... $ (2.16) $ (1.55) $ (1.04)
Basic and diluted net loss per share--pro
forma........................................ $ (2.28) $ (1.71) $ (1.15)
</TABLE>
Due to FAS No. 123 being applicable only to options granted subsequent to
December 31, 1994, its pro forma effect was not fully reflected until 1998.
The weighted average fair value of each option granted in 1998, 1997 and 1996
is $2.87, $6.31 and $8.27 respectively, estimated using the Black-Scholes
Multiple option-pricing model with the following weighted-average assumptions:
<TABLE>
<CAPTION>
1998 1997 1996
<S> <C> <C> <C>
Expected volatility..................................... .8669 .8068 .5318
Risk-free interest rate................................. 5.02% 6.06% 6.04%
Weighted-average expected life.......................... 4.60 4.53 4.46
Dividend yield.......................................... -- -- --
</TABLE>
Deferred and Other Compensation
For certain options granted prior to December 31, 1995, the Company
recognized as deferred compensation the excess of the deemed value for
financial reporting purposes of the common stock issuable upon the exercise of
such options over the aggregate exercise price of such options. Deferred
compensation of $597,000 recorded in 1995 is being amortized ratably over the
vesting period of such options. In connection with the modification of certain
employee stock arrangements and the forgiveness of employee notes receivable,
the Company recorded compensation expense of $539,000 in 1998.
Stock Purchase Plan
In June 1995, the Company adopted the 1995 Employee Stock Purchase Plan (the
"Purchase Plan") and reserved 200,000 shares for issuance. The Purchase Plan
permits eligible employees to purchase common stock through payroll deductions
at a price equal to the lower of 85% of the fair market value of the Company's
common stock at the beginning or end of the applicable offering period.
Employees purchased 30,718 and 25,289 shares in 1998 and 1997, respectively.
Under the Company's predecessor plan (the "1987 Purchase Plan"), the Company
sold 217,193, 105,533, and 346,302 shares of common stock at $1.875, $0.375,
and $0.625 per share, respectively, to employees in exchange for notes that
bear interest at 3.7% to 7.4% and are payable at various dates in 1999, 2000
and 2001.
F-14
<PAGE>
KERAVISION, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
The Company has the option to repurchase unvested shares, upon termination of
employment, at the original issuance price per share. Shares vest over a period
of four years. At December 31, 1998, there were no shares of common stock
subject to repurchase.
Common Stock Reserved for Issuance
The Company has reserved shares of common stock for the following at December
31, 1998:
<TABLE>
<S> <C>
Exercises under the 1987 Stock Option Plan........................ 242,558
Purchases under the 1995 Employee Stock Purchase Plan............. 128,080
Exercises under the 1995 Stock Option Plan........................ 1,283,720
Exercises under the 1995 Directors Option Plan.................... 150,000
Exercises under the 1997 Stock Option Plan........................ 396,461
Conversion of Redeemable Convertible Series B preferred stock..... 2,650,000
Conversion of undesignated preferred stock........................ 2,000,000
---------
6,850,819
=========
</TABLE>
Stockholder Rights Plan
On August 18, 1997, the Company's board of directors adopted a Stockholders'
Rights Plan (the "Rights Plan"). In conjunction with the Rights Plan, the board
of directors declared a dividend of one right ("Right") to purchase one one-
hundredth of a share of preferred stock on each share of common stock. Under
the terms of the Rights Plan, the Rights become exercisable only if a person or
group acquires 20% or more of the Company's common stock or announces a tender
offer that would result in ownership by a person or group of 20% or more of the
Company's common stock, subject to certain exceptions. Each Right has an
exercise price of $60.00 and, in certain circumstances, may become exercisable
or exchangeable for consideration. Each Right, following the time the Rights
become exercisable, may be redeemed for $0.01 at the option of the board of
directors.
7. Income Taxes
Due to the Company's loss position, there was no provision for income taxes
for the years ended December 31, 1998, 1997 and 1996.
A reconciliation of the income tax provision at the U.S. federal statutory
rate (34%) to the provision for income tax at the effective tax rate is as
follows:
<TABLE>
<CAPTION>
Years Ended December
31,
-------------------------
1998 1997 1996
(In Thousands)
<S> <C> <C> <C>
Income tax benefit computed at the federal
statutory rate................................ $(8,173) $(6,595) $(4,379)
Operating losses not utilized.................. 8,173 6,595 4,379
------- ------- -------
$ -- $ -- $ --
======= ======= =======
</TABLE>
As of December 31, 1998, the Company has federal, state and French net
operating loss carryforwards of approximately $66.3 million, $16.9 million and
$3.7 million, respectively, that will expire in fiscal years 1999 through 2018,
if not utilized. The Company also has federal and state research and
experimentation credit carryforwards of approximately $1.3 million and $1.0
million, respectively, that will expire in fiscal years 2002 through 2018, if
not utilized.
F-15
<PAGE>
KERAVISION, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
Utilization of the net operating loss and credit carryforwards may be subject
to an annual limitation due to ownership change limitations provided by the
Internal Revenue Code and similar state tax provisions.
Deferred income taxes reflect the net tax effects of temporary differences
between the carrying amounts of assets and liabilities for financial reporting
purposes and the amounts used for income tax purposes. Significant components
of the Company's deferred tax assets are as follows:
<TABLE>
<CAPTION>
December 31,
------------------
1998 1997
(In Thousands)
<S> <C> <C>
Deferred tax assets:
Net operating loss carryforwards........................ $ 25,109 $ 15,186
Capitalized research costs.............................. 7,556 8,772
Research credit carryforwards........................... 1,901 1,535
Other................................................... 368 506
-------- --------
Total deferred tax assets............................... 34,934 25,999
Valuation allowance..................................... (34,934) (25,999)
-------- --------
Net deferred tax assets................................. $ -- $ --
======== ========
</TABLE>
The deferred tax asset valuation allowance increased $8,935,000, $8,048,000
and $5,108,000 in 1998, 1997 and 1996, respectively.
8. Recent Acquisitions (unaudited)
On May 28, 1999, pursuant to an Agreement and Plan of Reorganization dated as
of December 22, 1998 (the "Merger Agreement"), by and among the Company and
Transcend Therapeutics, Inc., ("Transcend"), the Company acquired all of the
capital stock of Transcend (the "Merger"). Transcend's only material asset is a
net cash balance of $8.5 million.
Pursuant to the terms of the Merger Agreement, at the effective time of the
Merger, each outstanding share of Transcend common stock was converted into the
right to receive 0.16486 shares of KeraVision common stock (the "Merger
Shares"). Transcend stockholders received approximately 978,498 shares of
KeraVision common stock. Transcend has terminated its activities as a drug
development company and now is a wholly owned subsidiary of the Company. No
Transcend employees were retained. The Merger Shares are registered under the
Securities Act of 1933 on a registration statement on Form S-4.
9. Subsequent Events
In March 1999, KeraVision entered into a senior term loan agreement providing
for borrowings of $5,000,000, which were advanced on March 25, 1999. Borrowings
under the loan are secured by substantially all of KeraVision's assets except
for intellectual property. In connection with the loan, KeraVision granted to
the lender warrants to purchase 55,492 shares of the common stock at an
exercise price of $10.8125, the closing price as of March 5, 1999, the date of
the loan commitment. The respective warrants are exercisable for 7 years from
the date of issuance. The Company will record the fair value of the warrants as
additional interest expense to be amortized over the term of the related debt.
The value of the immediately exercisable warrants will be determined using a
Black Scholes valuation model, based on the contractual term of the warrants.
F-16
<PAGE>
KERAVISION, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
<TABLE>
<CAPTION>
June 30, December 31,
1999 1998
(Note 1)
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents............................ $ 8,164 $ 1,449
Available-for-sale investments....................... 166 6,279
Accounts receivable, net............................. 1,144 365
Inventory............................................ 1,140 427
Prepaid expenses and other current assets............ 487 716
-------- -------
Total current assets................................... 11,101 9,236
Property and equipment, at cost:
Manufacturing and laboratory equipment............... 4,448 3,709
Office furniture and fixtures........................ 607 597
Leasehold improvements............................... 696 636
-------- -------
5,751 4,942
Accumulated depreciation and amortization.............. (3,408) (3,102)
-------- -------
Net property and equipment........................... 2,343 1,840
Other assets........................................... 100 108
-------- -------
Total assets........................................... $ 13,544 $11,184
======== =======
LIABILITIES AND STOCKHOLDERS' EQUITY (NET CAPITAL DEFICIENCY)
Current liabilities:
Accounts payable..................................... $ 2,785 $ 1,742
Accrued payroll and related expenses................. 773 581
Accrued clinical trial costs......................... 1,176 1,282
Other accrued liabilities............................ 899 204
Current portion of capital lease obligations......... 540 512
Short-term debt...................................... 4,424 --
-------- -------
Total current liabilities.............................. 10,597 4,321
Capital lease obligations.............................. 666 821
Redeemable convertible series B preferred stock........ 18,265 17,489
Commitments and contingencies
Stockholders' equity:
Common stock......................................... 14 13
Additional paid-in capital........................... 89,257 80,162
Deferred compensation................................ -- (30)
Accumulated other comprehensive income............... 107 109
Accumulated deficit.................................. (103,789) (90,092)
Notes receivable from stockholders................... (1,573) (1,609)
-------- -------
Total stockholders' equity (net capital deficiency).... (15,984) (11,447)
-------- -------
Total liabilities and total stockholders' equity (net
capital deficiency)................................... $ 13,544 $11,184
======== =======
</TABLE>
See accompanying notes to unaudited condensed consolidated financial
statements.
F-17
<PAGE>
KERAVISION, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except per share data)
<TABLE>
<CAPTION>
Six Months Ended June 30,
--------------------------
1999 1998
<S> <C> <C>
Net sales......................................... $ 4,381 $ 264
Costs and expenses:
Cost of sales and manufacturing expenses......... 4,615 1,949
Research and development......................... 4,201 6,016
Selling, general and administrative.............. 8,171 3,652
------------ ------------
Total costs and expenses.......................... 16,987 11,617
------------ ------------
Operating loss.................................... (12,606) (11,353)
Interest income and other, net.................... (5) 241
Interest expense.................................. (310) (62)
------------ ------------
Net loss.......................................... (12,921) (11,174)
Dividends on redeemable convertible Series B
preferred stock.................................. (776) (2,611)
------------ ------------
Net loss applicable to common stockholders........ $ (13,697) $ (13,785)
============ ============
Basic and diluted net loss per share applicable to
common stockholders.............................. $ (1.05) $ (1.09)
============ ============
Shares used in calculation of basic and diluted
net loss per share............................... 13,088 12,655
</TABLE>
See accompanying notes to unaudited condensed consolidated financial
statements.
F-18
<PAGE>
KERAVISION, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
Increase (decrease) in cash and cash equivalents
(in thousands)
<TABLE>
<CAPTION>
Six Months Ended
------------------
June 30, June 30,
1999 1998
-------- --------
<S> <C> <C>
Cash flows from operating activities:
Net loss.................................................. $(12,921) $(11,174)
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation............................................. 306 345
Amortization of debt discount............................ 85 --
Issuance of stockholders' notes.......................... -- (251)
Payment on stockholders' notes........................... 36 --
Forgiveness of stockholders' notes....................... -- 45
Amortization of deferred compensation.................... 30 74
Changes in operating assets and liabilities:
Accounts receivable.................................... (779) (10)
Inventory.............................................. (713) (2)
Prepaid expenses and other current assets.............. 229 364
Accounts payable....................................... 1,043 1,544
Other accrued liabilities.............................. 779 (104)
-------- --------
Net cash used in operating activities................... (11,905) (9,169)
-------- --------
Cash flows from investing activities:
Purchases of available-for-sale investments............... (297) (17,226)
Sales of available-for-sale investments................... 6,410 12,572
Maturities of available-for-sale investments.............. -- 2,201
Capital expenditures...................................... (809) (597)
Other assets.............................................. 8 --
-------- --------
Net cash provided by (used in) investing activities..... 5,312 (3,050)
-------- --------
Cash flows from financing activities:
Principal payments under capital lease obligations........ (259) (221)
Proceeds from sales-leaseback of capital equipment........ 132 180
Proceeds from issuance of short-term debt and warrants.... 5,000 --
Proceeds from issuance of equity securities, net of
repurchases.............................................. 8,435 268
Proceeds from issuance of redeemable convertible Series B
shares................................................... -- 18,000
Fees incurred to obtain additional financing.............. -- (1,320)
-------- --------
Net cash provided by financing activities............... 13,308 16,907
-------- --------
Net increase in cash and cash equivalents.................. 6,715 4,688
Cash and cash equivalents at the beginning of the period... 1,449 2,574
-------- --------
Cash and cash equivalents at the end of the period......... $ 8,164 $ 7,262
======== ========
Supplemental disclosure of non-cash financing activities:
Accrued dividends to preferred stock....................... $ 708 $ 2,597
======== ========
Accretion related to preferred stock....................... $ 68 $ 14
======== ========
</TABLE>
See accompanying notes to unaudited condensed consolidated financial
statements.
F-19
<PAGE>
KERAVISION, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 1999
1. Basis of Presentation
The accompanying unaudited condensed financial statements of KeraVision, Inc.
(the "Company" or "KeraVision"), have been prepared in accordance with
generally accepted accounting principles for interim financial information and
with the instructions for Form 10-Q and Article 10 of Regulation S-X. The
balance sheet as of June 30, 1999, the statements of operations and cash flows
for the six-month periods ended June 30, 1999 and 1998 are unaudited but
include all adjustments (consisting only of normal recurring adjustments) which
the Company considers necessary for a fair presentation of the financial
position at such date and the operating results and cash flows for those
periods. Although the Company believes that the disclosures in these financial
statements are adequate to make the information presented not misleading,
certain information normally included in financial statements and related
footnotes prepared in accordance with generally accepted accounting principles
have been condensed or omitted pursuant to the rules and regulations of the
Securities and Exchange Commission. The accompanying financial statements
should be read in conjunction with the Company's annual financial statements
and notes thereto included separately herein. The accompanying condensed
consolidated balance sheet at December 31, 1998 is derived from audited
financial statements at that date.
Results for the six-months ended June 30, 1999 and 1998 are not necessarily
indicative of results for any other interim period or for any year.
2. Management's Plans and Financing
The Company's financial statements are prepared and presented on a basis
assuming it continues as a going concern. At June 30, 1999, the Company had an
accumulated deficit of $103.8 million and incurred a net loss of $12.9 million
for the six months then ended.
In March 1999, the Company entered into a senior term loan agreement
providing for borrowings of $5,000,000, which was advanced on March 25, 1999.
In May 1999, the Company completed an acquisition of Transcend Therapeutics,
Inc. and its net cash balance of $8.5 million. Transcend has terminated its
activities as a drug development company and now is a wholly owned subsidiary
of the Company. No Transcend employees were retained. Transcend stockholders
received 978,498 shares of the Company's common stock. This transaction was
accounted for as an acquisition of assets.
Management's planned expenditures for 1999 exceed current cash, cash
equivalents and available-for-sale investments and the funds received from the
Transcend acquisition and the senior term loan. The Company will need to obtain
additional funds to continue its research and development activities, fund
operating expenses, initiate sales and marketing activities in the U.S. for its
approved products and pursue regulatory approvals for its products under
development. Management believes that sufficient funds will be available from
sales of the Company's products and from financing from additional investors to
support planned operations through December 1999. The Company intends to raise
additional funds through the sale of its equity securities and/or debt
financings. The Company may also enter into collaborative arrangements with
corporate partners that could provide the Company with additional funding in
the form of equity, debt or license fees in exchange for the Company's rights
with respect to certain markets or technology. There can be no assurance that
the Company will be able to raise any additional funds or enter into any such
collaborative arrangements on terms favorable to the Company, or at all. If the
Company is unable to obtain the necessary additional capital, significant
reductions in spending and the delay or cancellation of planned activities or
more substantial restructuring options may be necessary. In such event, the
Company intends to implement expense reduction plans in a timely manner to
enable the Company to meet its operating cash requirements through December 31,
1999. These actions would have material adverse effects on the Company's
business, results of operations and prospects.
F-20
<PAGE>
KERAVISION, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
3. Net Loss Per Common Share
Net loss per common share is computed based on the weighted average number of
common shares outstanding and excludes common stock equivalents as their effect
would be antidilutive. For the period ended June 30, 1999 dividends and
accretion related to the redeemable preferred stock are added to the net loss
to arrive at net loss applicable to common stockholders. Options and warrants
to purchase 1,579,778 and 55,492 shares of common stock were outstanding at
June 30, 1999 but were not included in the computation of diluted net income
per share as the Company incurred a net loss in the periods presented and the
effect of the securities would have been anti-dilutive.
4. Inventory
Inventories are stated at the lower of cost or market. Cost is determined by
the first-in, first-out method. The Company's inventory was composed of the
following (in thousands):
<TABLE>
<CAPTION>
June 30, December 31,
1999 1998
-------- ------------
<S> <C> <C>
Raw materials........................................ $ 614 $182
Finished goods....................................... 526 245
------ ----
Total.............................................. $1,140 $427
====== ====
</TABLE>
5. Use of Estimates
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions.
These assumptions affect the reported amounts of assets and liabilities, the
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. Management believes that all of the assumptions used in the
preparation of these unaudited condensed consolidated financial statements are
reasonable and have a reasonable basis. Actual results could differ from these
estimates.
6. Issuance of Debt
In March 1999, the Company entered into a senior term loan agreement
providing for borrowings of $5,000,000, which were advanced on March 25, 1999.
The loan bears interest at 12.6% per year until the Company repays the loan on
September 30, 2001. Borrowings under the loan are secured by substantially all
of the company's assets except for intellectual property. In conjunction with
the loan, the Company granted to the lender warrants to purchase 55,492 shares
of the common stock at an exercise price of $10.8125, the closing price as of
March 5, 1999, the date of the loan commitment. The respective warrants are
exercisable for 7 years from the date of issuance. The Company recorded the
fair value of the warrants as additional interest expense to be amortized over
the term of the related debt. The value of the immediately exercisable warrants
was determined using a Black Scholes valuation model, based on the contractual
term of the warrants.
F-21
<PAGE>
KERAVISION, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
7. Comprehensive Income (Loss)
The components of comprehensive income (loss) are as follows (in thousands):
<TABLE>
<CAPTION>
Six Months Ended
June 30,
------------------
1999 1998
-------- --------
<S> <C> <C>
Net loss............................................. $(12,921) $(11,174)
Change in unrealized gain on available-for-sale
investments......................................... -- (35)
Foreign currency translation adjustment.............. -- (10)
-------- --------
Total comprehensive income (loss).................. $(12,921) $(11,219)
======== ========
</TABLE>
Accumulated other comprehensive income presented in the accompanying
consolidated condensed balance sheets consists of the accumulated net
unrealized gain on available-for-sale investments.
8. Recent Acquisitions
On May 28, 1999, pursuant to an Agreement and Plan of Reorganization dated as
of December 22, 1998 (the "Merger Agreement"), by and among and Transcend
Therapeutics, Inc. ("Transcend"), the Company acquired all of the capital stock
of Transcend (the "Merger"). This transaction was accounted for as an
acquisition of assets. Transcend's only material asset is a net cash balance of
$8.5 million.
Pursuant to the terms of the Merger Agreement, at the effective time of the
Merger, each outstanding share of Transcend common stock was converted into the
right to receive 0.16486 shares of KeraVision common stock (the "Merger
Shares"). Transcend stockholders received approximately 978,498 shares of
KeraVision common stock. Transcend has terminated its activities as a drug
development company and now is a wholly owned subsidiary of the Company. No
Transcend employees were retained. The Merger Shares are registered under the
Securities Act of 1933 on a registration statement on Form S-4.
F-22
<PAGE>
[Magnified 3-dimensional view of cornea showing the Intacs in place in the
eye]
Intacs are placed in the periphery of the cornea at two-thirds depth.
[Picture of 1 of our Intacs(TM) corneal ring segments for our hyperopia
product held on a fingertip]
Intacs(TM) for potentially treating hyperopia are currently undergoing
feasibility studies.
<PAGE>
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
, 1999
[KeraVision, Inc. logo]
4,000,000 Shares of Common Stock
----------------------
PROSPECTUS
----------------------
Donaldson, Lufkin & Jenrette
Dain Rauscher Wessels
a division of Dain Rauscher Incorporated
Prudential Securities
SG Cowen
------------
DLJdirect, Inc.
- -------------------------------------------------------------------------------
We have not authorized any dealer, salesperson or other person to give you
written information other than this prospectus or to make representations as
to matters not stated in this prospectus. You must not rely on unauthorized
information. This prospectus is not an offer to sell these securities or our
solicitation of your offer to buy the securities in any jurisdiction where
that would not be permitted or legal. Neither the delivery of this prospectus
nor any sales made hereunder after the date of this prospectus shall create an
implication that the information contained herein or the affairs of KeraVision
have not changed since the date hereof.
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The following table sets forth the various expenses, all of which will be
borne by the registrant, in connection with the sale and distribution of the
securities being registered, other than the underwriting discounts and
commissions. All amounts shown are estimates except for the Securities and
Exchange Commission registration fee and the NASD filing fee.
<TABLE>
<S> <C>
SEC Registration Fee............................................... $ 29,293
NASD Filing Fee.................................................... 12,460
Nasdaq National Market Listing Fee................................. 17,500
Transfer Agent Fees................................................ 3,750
Accounting Fees and Expenses....................................... 150,000
Legal Fees and Expenses............................................ 235,000
Printing and Mailing Expenses...................................... 150,000
Miscellaneous...................................................... 51,997
--------
Total............................................................ $650,000
========
</TABLE>
Item 15. Indemnification of Directors and Officers
Section 145 of the General Corporation Law of the State of Delaware
("Section 145") permits a Delaware corporation to indemnify any person who was
or is a party or is threatened to be made a party to any threatened, pending,
or completed action, suit, or proceeding, whether civil, criminal,
administrative, or investigative (other than an action by or in the right of
the corporation) by reason of the fact that such person is or was a director,
officer, employee, or agent of the corporation, or is or was serving at the
request of the corporation as a director, officer, employee, or agent of
another corporation, partnership, joint venture, trust, or other enterprise,
against expenses (including attorneys' fees), judgments, fines and amounts
paid in settlement actually and reasonably incurred by such person in
connection with such action, suit, or proceeding if such person acted in good
faith and in a manner such person reasonably believed to be in or not opposed
to the best interests of the corporation, and, with respect to any criminal
action or proceeding, had no reasonable cause to believe such person's conduct
was unlawful.
In the case of an action by or in the right of the corporation, Section 145
permits the corporation to indemnify any person who was or is a party or is
threatened to be made a party to any threatened, pending, or completed action
or suit by or in the right of the corporation to procure a judgment in its
favor by reason of the fact that such person is or was a director, officer,
employee or agent of the corporation, or is or was serving at the request of
the corporation as director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise against
expenses (including attorneys' fees) actually and reasonably incurred by such
person in connection with the defense or settlement of such action or suit if
he acted in good faith and in a manner such person reasonably believed to be
in or not opposed to the best interest of the corporation. No indemnification
may be made in respect of any claim, issue, or matter as to which such person
shall have been adjudged to be liable to the corporation unless and only to
the extent that the Court of Chancery or the court in which such action or
suit was brought shall determine upon application that, despite the
adjudication of liability but in view of all the circumstances of the case,
such person is fairly and reasonably entitled to indemnity for such expenses
which the Court of Chancery or such other court shall deem proper.
To the extent that a present or former director or officer of a corporation
has been successful on the merits or otherwise in defense of any action, suit
or proceeding referred to in the preceding two paragraphs, Section 145
requires that such person be indemnified against expenses (including
attorneys' fees) actually and reasonably
II-1
<PAGE>
incurred by such person in connection therewith; and that indemnification
provided by, or granted pursuant to, Section 145 shall not be deemed exclusive
of any other rights to which those seeking indemnification may be entitled.
Section 145 provides that expenses (including attorneys' fees) incurred by
an officer or director in defending any civil, criminal, administrative, or
investigative action, suit or proceeding may be paid by the corporation in
advance of the final disposition of such action, suit or proceeding upon
receipt of any undertaking by or on behalf of such director or officer to
repay such amount if it shall ultimately be determined that such person is not
entitled to be indemnified by the corporation as authorized in Section 145.
Section 145 further empowers the corporation to purchase and maintain
insurance on behalf of any person who is or was serving at the request of the
corporation as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust or other enterprise, against any liability
asserted against him and incurred by him in any such capacity, or arising our
of his status as such, whether or not the corporation would have the power to
indemnify him against such liabilities under Section 145.
The Registrant's Amended and Restated Certificate of Incorporation limits
the liability of directors for monetary damages arising from breach of their
fiduciary duty to the maximum extent permitted by the Delaware General
Corporate Law ("the Law") and provides for the indemnification of directors,
officers and employees of the Registrant to the fullest extent permitted by
the Law.
The Registrant's Amended and Restated Bylaws also provide that Registrant
shall indemnify its directors and officers to the fullest extent permitted by
the Law, including circumstances in which indemnification is otherwise
discretionary under the Law.
The Registrant has entered into indemnification agreements with its
directors containing provisions which are in some respects broader than the
specific indemnification provisions contained in the Law. The indemnification
agreements may require the Registrant to indemnify its directors against
certain liabilities that may arise by reason of their status or service as
directors (other than liabilities arising from willful misconduct of a
culpable nature), to advance their expenses incurred as a result of any
proceeding against them as to which they could be indemnified, and to obtain
director's insurance if available on reasonable terms.
The Registrant believes that the limitation provision in its Amended and
Restated Certificate of Incorporation and the indemnification provisions in
its Amended and Restated Certificate of Incorporation, Amended and Restated
Bylaws and indemnification agreements will facilitate the Registrant's ability
to continue to attract and retain qualified individuals to serve as directors
of the Registrant. It is the opinion of the Securities and Exchange Commission
that indemnification provisions such as those contained in the Certificate,
the Bylaws and these agreements have no effect on a directors' or officers'
ability under the federal securities laws. The Registrant has also obtained
directors' and officers' liability insurance covering, subject to exceptions,
actions taken by the Registrant's directors and officers in their capacities
as such.
II-2
<PAGE>
Item 16. Exhibits and Financial Statement Schedules
(a) Exhibits
The following exhibits are filed herewith or incorporated herein by
reference.
<TABLE>
<CAPTION>
Exhibit
Number Description
<C> <S>
*1.1 Underwriting Agreement
4.1 Preferred Shares Rights Agreement, dated as of August 18, 1997,
between Registrant and Bank Boston, N.A. (Filed as Exhibit 4.1 to
Registrant's registration statement on Form 8-A, filed with the SEC on
August 25, 1997 and incorporated by reference herein)
*5.1 Opinion of Latham & Watkins as to the legality of the securities being
registered
23.1 Consent of Ernst & Young LLP, independent auditors
*23.2 Consent of Latham & Watkins (included in Exhibit 5.1)
24.1 Power of Attorney (included on signature page hereto)
27.1 Financial Data Schedule
</TABLE>
- ---------------------
* to be filed by amendment
Item 17. Undertakings
A. Insofar as indemnification for liabilities arising under the Securities
Act of 1933, as amended, may be permitted to directors, officers and
controlling persons of the registrant pursuant to the foregoing provisions, or
otherwise, the registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public
policy as expressed in the Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other than the
payment by the registrant of expenses incurred or paid by a director, officer,
or controlling person of the registrant in the successful defense of any
action, suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being registered, the
registrant will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Act and will be governed by the final adjudication
of such issue.
B. The undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
registrant's annual report pursuant to Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to Section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
C. The undersigned registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities Act of
1933, the information omitted from the form of prospectus filed as part of
this registration statement in reliance upon Rule 430A and contained in a
form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or
(4) or 497(h) under the Securities Act shall be deemed to be part of this
registration statement as of the time it was declared effective.
(2) For the purpose of determining any liability under the Securities Act
of 1933, each post-effective amendment that contains a form of prospectus
shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that
time shall be deemed to be the initial bona fide offering thereof.
II-3
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-3 and has duly caused this registration
statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Fremont, State of California, on July 15, 1999.
KeraVision, Inc.
/s/ Thomas M. Loarie
By: _________________________________
Thomas M. Loarie
Chairman, President and
Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears
below does hereby constitute and appoint Mark Fischer-Colbrie with full power
of substitution and full power to act without the other, his true and lawful
attorney-in-fact and agent to act for him in his name, place and stead, in any
and all capacities, to sign a registration statement on Form S-3 and any or
all amendments thereto (including without limitation any post-effective
amendments thereto), and any registration statement for the same offering that
is to be effective under Rule 462(b) of the Securities Act, and to file each
of the same, with all exhibits thereto, and other documents in connection
therewith, with the Securities and Exchange Commission, granting unto said
attorney-in-fact and agent full power and authority to do and perform each and
every act and thing requisite and necessary to be done in and about the
premises in order to effectuate the same as fully, to all intents and
purposes, as he might or could do in person, hereby ratifying and confirming
all that said attorney-in-fact and agent may lawfully do or cause to be done
by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
registration statement has been signed by the following persons in the
capacities and on the dates indicated:
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
/s/ Thomas M. Loarie President, Chief Executive July 15, 1999
______________________________________ Officer and Chairman of
Thomas M. Loarie the board of directors
(Principal Executive
Officer)
/s/ Mark Fischer-Colbrie Vice President Finance and July 15, 1999
______________________________________ Administration and Chief
Mark Fischer-Colbrie Financial Officer
(Principal Financial
Officer)
/s/ Charles Crocker Director July 15, 1999
______________________________________
</TABLE> Charles Crocker
II-4
<PAGE>
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
/s/ LA Lehmkuhl Director July 15, 1999
______________________________________
Lawrence A. Lehmkuhl
Director
______________________________________
Kshitij Mohan, Ph.D.
/s/ AM Pappas Director July 15, 1999
______________________________________
Arthur M. Pappas
Director
______________________________________
Peter Wilson
</TABLE>
II-5
<PAGE>
<TABLE>
<CAPTION>
Exhibit
Number Description
<C> <S>
*1.1 Underwriting Agreement
4.1 Preferred Shares Rights Agreement, dated as of August 18, 1997,
between Registrant and Bank Boston, N.A. (Filed as Exhibit 4.1 to
Registrant's registration statement on Form 8-A, filed with the SEC on
August 25, 1997 and incorporated by reference herein)
*5.1 Opinion of Latham & Watkins as to the legality of the securities being
registered
23.1 Consent of Ernst & Young LLP, independent auditors
*23.2 Consent of Latham & Watkins (included in Exhibit 5.1)
24.1 Power of Attorney (included on signature page hereto)
27.1 Financial Data Schedule
</TABLE>
- ---------------------
* to be filed by amendment
<PAGE>
EXHIBIT 23.1
CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS
We consent to the reference to our firm under the caption "Experts" and to
the use of our report dated February 3, 1999, except for Note 9, as to which
the date is March 25, 1999, in the Registration Statement (Form S-3) and
related Prospectus of KeraVision, Inc. for the registration of 4,600,000
shares of its common stock.
/s/ Ernst & Young LLP
San Jose, California
July 13, 1999
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 6-MOS
<FISCAL-YEAR-END> DEC-31-1999
<PERIOD-START> JAN-01-1999
<PERIOD-END> JUN-30-1999
<CASH> 8,164
<SECURITIES> 166
<RECEIVABLES> 1,601
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0
18,265
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</TABLE>
