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Total Number of Pages: 3
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: February 15, 2000
Commission File Number: 0-26208
================================================================================
KERAVISION, INC.
(Exact name of Registrant as specified in its Charter)
DELAWARE 77-0328942
(State of Incorporation) (I.R.S. Employer
Identification No.)
48630 MILMONT DRIVE
FREMONT, CA 94538
(Address of principal executive offices)
(510) 353-3000
(Registrant's telephone number)
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ITEM 5. OTHER EVENTS
On February 10, 2000, KeraVision, Inc. announced Fourth Quarter and Year End
Financial Results. Further details regarding this announcement are
contained in the Company's new release dated February 10, 2000 attached
as exhibit hereto and incorporated reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.36 KeraVision, Inc. News Release dated February 10, 2000
2
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
KERAVISION, INC.
/s/Mark Fischer-Colbrie
-----------------------
Mark Fischer-Colbrie
Vice President, Finance and
Administration and Chief Financial
Officer(Principal Financial and
Accounting Officer)
Date: February 15, 2000
3
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Exhibit 99.36
KeraVision, Developer of Intacs, Reports Fourth Quarter and Year End Revenue
Intacs Named by CNN and Health Magazine to List of "Year's Top 10 Medical
Advances"
FREMONT, CA (Feb.10, 2000) -- KeraVision, Inc. (Nasdaq: KERA), developer
of Intacs corneal segments for treating common vision problems, today
reported financial results for the fourth quarter and year ended Dec.
31, 1999. Revenues totaled $1.9 million for the quarter and consisted
largely of sales from surgical instrument sets and start-up inventories
of Intacs for correcting mild nearsightedness (myopia). This compares to
revenues of $332,000 for the fourth quarter of 1998.
Net loss for the 1999 fourth quarter was $9.5 million versus $7.2
million for the fourth quarter in 1998. The increase in net loss was
primarily due to investments in professional and consumer market-
development activities in the U.S. The net loss per share applicable to
common stockholders was 52 cents compared to 59 cents for the same
quarter a year before.
Revenues for the year ended Dec. 31, 1999 were $10.5 million compared to
$0.8 million for the prior year. The net loss for the year was $27.3
million compared to a loss of $24.0 million in 1998. The increase in
losses was primarily due to market development activities in the U.S.
The net loss per share applicable to common stockholders was $1.88
compared to $2.16 for 1998.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"Since receiving FDA approval in April 1999 to sell our initial product,
Intacs for mild myopia, KeraVision has focused on penetrating the vision
correction market. Over 20 million adult nearsighted Americans are
believed to be in our initial treatment range. As of December 1999, the
company trained more than 600 surgeons and completed more than 2,300
Intacs procedures."
Loarie continued, "KeraVision is now transitioning from a `training'
company to a `procedures' company with programs designed to create
physician and consumer demand. We intend to grow procedure volume by
creating successful practice models and integrating these success models
into a core group of `fast track' surgical centers that have made the
commitment to Intacs as the procedure of choice for mild
nearsightedness.
"To support these practices, KeraVision has begun making investments in
programs that we believe will pull in our Intacs target group - that is,
people who depend on eyeglasses and contacts for everyday activities but
have been waiting for the next best thing after laser surgery," Loarie
said.
A surgeon's medical practice is considered integrated when Intacs are
performed in over half of a surgeon's mild myopia cases. KeraVision is
focusing its procedure-building programs on an initial core group of 30
`fast track' Intacs centers.
The company intends to refine and roll out a success model to additional
practices throughout the year. Included in the model are professional-
development initiatives such as co-management programs for referring
optometrists and consumer initiatives such as cooperative advertising,
among other steps.
One of the "Year's Top 10 Medical Advances"
Calling Intacs the "less frightening treatment for the myopic millions,"
CNN and its affiliate, Health magazine, named Intacs to their list of
"The Year's Top 10 Medical Advances". Describing their Top 10 list as
"the best of the breakthroughs," Health magazine said in its
January/February issue that the list was made up of "discoveries that
will help us live longer, healthier lives," including Intacs.
Other 1999 highlights and achievements include:
Management Additions
In August, John Galantic was appointed to the new position of KeraVision
president and chief operating officer. A former country manager for the
SmithKline Beecham franchise in Europe and brand manager for Proctor &
Gamble, Galantic, 37, played a strategic role in KeraVision's transition
from a surgeon-training company to a consumer marketing company.
Also added to the management team was Steven M. Henderson, 40, vice
president-sales. Henderson was sales director for Baush & Lomb's $50
million-a-year U.S. refractive surgery business where he helped
establish LASIK in the U.S., including the training of more than 1,000
LASIK surgeons.
New Product Development
In 1999, U.S. Phase III clinical studies were initiated for a wider
range of myopia treatment than was originally approved by the FDA. There
are already over 20 million nearsighted Americans who are within the
FDA-approved Intacs range, according to industry estimates. If Intacs
for wider ranges of correction are eventually approved for sale by the
FDA, several million consumers could be added to KeraVision's available
market.
The company also began a European clinical study using Intacs to treat
keratoconus, a degenerative thinning-of-the-cornea disease that could
affect as many as one in 1,000 people - or approximately 370,000 people
in the European Union and 272,000 Americans, according to some experts'
estimates.
In addition, European clinical trials were begun using Intacs to treat
hyperopia, or farsightedness. In October, clinical results from the
original international hyperopia study showed that 100 percent of Intacs
patients saw 20/40 or better and 90 percent saw 20/25 or better when
treated for mild-to-moderate hyperopia (+1.0 to +4.5 diopters). The
data, presented at the American Academy of Ophthalmology, were based on
results for the first 13 hyperopia patients and included one year of
clinical follow-up.
Financing
In August, the company completed a secondary public offering of its
common stock. A total of 4,600,000 shares were issued at $13 per share
with net proceeds (after underwriting discounts and expenses) of
approximately $55.6 million.
Commercial Roll-out of Intacs
Based on initial tracking analysis, clinical outcomes for Intacs
consumers since commercialization appear to be generally consistent with
the positive clinical results achieved in U.S. clinical trials. These
include good visual recovery, high levels of acuity and minor patient
discomfort.
For quality control purposes, the company hired additional field
proctors to reduce the backlog of surgeons who were trained to perform
the Intacs procedure but had not completed a series of Intacs procedures
under the supervision of a KeraVision proctor.
KeraVision, founded in 1986, is the developer of Intacs for the
treatment of myopia, which was named one of "The Year's Top 10 Medical
Advances" by CNN and Health magazine. Intacs, the first FDA-approved
non-laser option for surgically treating mild myopia, or
nearsightedness, are a safe and effective alternative to eyeglasses,
contact lenses and vision correction surgeries that permanently alter
the eye's central optical zone. The company's patented technology
platform is also being developed for the possible treatment of other
common vision problems including mild hyperopia (farsightedness) and
astigmatism.
Except for the historical information, the matters discussed in this
news release are forward-looking statements. Actual results may differ
materially due to a variety of factors, including market acceptance of
KeraVision Intacs, complications relating to the product or the surgical
procedure, competitive products and technologies, and other matters
contained under the heading "Risk Factors" in the registration statement
on Form S-3 dated Aug. 12, 1999, as well as in other SEC filings.
# # #
Note to Editors: Intacs are a registered trademark or trademark of
KeraVision, Inc. in the U.S. and foreign countries
KeraVision, Inc., Fremont
Mark Fischer-Colbrie, 510/353-3000 (Investors)
Mick Taylor, 510/353-3075 (Media)
www.keravision.com
Fax on Demand, 800/448-8559
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KERAVISION, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data; unaudited)
<TABLE>
<CAPTION>
Three Months Ended Year Ended
December 31, December 31,
---------------------- --------------------
1999 1998 1999 1998
---------- ----------- --------- ----------
<S> <C> <C> <C> <C>
Net sales........................... $1,925 $332 $10,494 $835
Costs and expenses:
Cost of sales and manufacturing
expenses........................ 2,414 1,282 9,945 4,386
Research and development......... 2,350 2,500 8,844 11,356
Selling, general and
administrative................ 7,062 3,912 19,491 9,693
---------- ----------- --------- ----------
Total costs and expenses............ 11,826 7,694 38,280 25,435
---------- ----------- --------- ----------
Operating loss...................... (9,901) (7,362) (27,786) (24,600)
Interest income and other, net...... 429 162 442 563
---------- ----------- --------- ----------
Net Loss............................ (9,472) (7,200) (27,344) (24,037)
Preferred stock dividends on:
Dividend on redeemable convertible
Series B Preferred stock.......... (359) (383) (1,503) (3,377)
---------- ----------- --------- ----------
Net loss applicable to common
stockholders...................... ($9,831) ($7,583) ($28,847) ($27,414)
========== =========== ========= ==========
Basic and diluted net loss per share
applicable to common stockholders.. ($0.52) ($0.59) ($1.88) ($2.16)
========== =========== ========= ==========
Shares used in calculation of
net loss per share................. 18,769 12,745 15,343 12,686
</TABLE>
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KERAVISION, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
<TABLE>
<CAPTION>
December 31, December 31,
1999 1998
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<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents................... $43,251 $1,449
Available-for-sale investments.............. 6,519 6,279
Accounts receivable, net.................... 567 365
Inventory................................... 2,403 427
Prepaid expenses and other current assets... 1,161 716
----------- ---------
Total current assets.......................... 53,901 9,236
Property and equipment, net 2,604 1,840
Other assets.................................. 634 905
----------- ---------
Total assets.................................. $57,139 $11,981
=========== =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities 11,132 4,321
Capital lease obligations - non-current..... 1,030 821
Redeemable Convertible Series B Preferred
Stock..................................... 16,964 17,489
Total stockholders' equity
(net capital deficiency).................. 28,013 (10,650)
----------- ---------
Total liabilities and total stockholders'
equity (net capital deficiency)............ $57,139 $11,981
=========== =========
</TABLE>
