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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: April 19, 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)
<PAGE>
ITEM 5. OTHER EVENTS
On April 17, 2000, KeraVision, Inc. announced First Quarter Financial
Results. Further details regarding this announcement are contained in the
Company's new release dated April 17, 2000 attached as exhibit hereto and
incorporated reference herein.
On April 17, 2000, KeraVision, Inc. announced David Applegate Named VP for
Medical Marketing and Business Development. Further details regarding this
announcement are contained in the Company's new release dated April 17, 2000
attached as exhibit hereto and incorporated reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.37 KeraVision, Inc. News Release dated April 17, 2000
99.38 KeraVision, Inc. News Release dated April 17, 2000
2
<PAGE>
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: April 19, 2000
3
<PAGE>
Exhibit 99.37
KeraVision Reports First Quarter Results
Procedure growth rate continues to accelerate
FREMONT, CA (April 17, 2000) - Achieving a record number of estimated
procedures in the first quarter, KeraVision, Inc. (Nasdaq: KERA),
developer of IntacsT prescription inserts for correcting mild myopia
(nearsightedness), today reported revenues of $1.0 million for the first
quarter ended March 31 - up 112 percent over the $472,000 in revenues for
the same quarter a year ago.
As part of the planned reduction in surgeon training, training-related
surgeon kit sales were down from the fourth quarter which resulted in a
reduction from fourth quarter revenues of $1.9 million. The changing
revenue mix reflects a transition toward building on-going sales from
Intacs procedures, the focus in the first quarter, and away from one-time
sales from surgeon startup kits, which was the focus in 1999 following
FDA approval in April 1999.
Net loss for the period was $9.8 million vs. $9.5 million for the
previous quarter and $7.3 million for the first quarter in 1999. The net
loss per share applicable to common stockholders was 54 cents per share
compared to 60 cents per share for the same period a year before. The
increase in net loss was primarily due to investments in professional and
consumer market-development activities in the United States.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"We believe we have demonstrated with our `Fast Track' program that we
can develop successful Intacs distribution points. Our next step is to
implement several consumer marketing programs designed to create demand
for Intacs and to link consumers directly to the group of Fast Track
practices. By supporting Fast Track practices with consumer programs and
adding new Fast Track practices as we go, we feel KeraVision has the
right strategy to accelerate the rate of procedure growth."
Total procedures for the first quarter were estimated to be approximately
1,100. About 90 percent of these procedures were performed by surgeons
who already completed Intacs training and proctoring and were performing
Intacs on an ongoing basis. The record growth in "post-training"
procedures was led by the Fast Track group which was up 47 percent from
the previous quarter.
Loarie added, "KeraVision's record procedure volume in the first quarter
indicates that Intacs are gaining in the marketplace. The fact that nine
out of 10 of these procedures were post-training procedures means that a
growing number of surgeons are starting to perform Intacs on an ongoing
basis."
With Fast Track distribution points in place in a number of key markets
and ready to receive consumers, the company plans to launch a series of
consumer programs, starting in May, that are, (1) aimed at creating
demand among discontented contact lens and eyeglass wearers who are
apprehensive about laser surgery, and, (2) driving these discontented
consumers to local Fast Track clinical practices.
Fast Track practices benefit from special cooperative advertising and
practice-building programs once they commit to making Intacs the
procedure of choice for mildly nearsighted clients. The company plans to
announce details of the consumer programs over the next month.
As of March 31, there were a total of 38 Fast Track clinical practices.
KeraVision intends to add new Fast Track practices each quarter
KeraVision, founded in 1986, is the developer of Intacs prescription
inserts for correcting mild myopia, which was named one of "The Year's
Top 10 Medical Advances" by CNN and Health magazine. Approved by the FDA
in 1999, Intacs are a flexible and convenient option to eyeglasses,
contact lenses and vision correction surgeries that permanently alter
the eye's central optical zone. The company's patented Intacs
technology is also being developed for the possible treatment of
hyperopia (farsightedness); myopia (nearsightedness) in wider ranges
than presently approved by the FDA; astigmatism; and keratoconus, a
corneal thinning disease.
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 risk factors
described under the heading "Risk Factors Affecting the Company, Its
Business and Its Stock Price" contained in Form 10-K for the year ended
Dec. 31, 1999, and 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: KeraVision and Intacs are registered trademarks or
trademarks of KeraVision, Inc. in the U.S. and foreign countries
For further information
Investors: Mark Fischer-Colbrie, (510) 353-3000
Media: Mick Taylor, (510) 353-3075
www.GetIntacs.com
"Fax On Demand"
(800) 448-8559
<PAGE>
KERAVISION, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data; unaudited)
<TABLE>
<CAPTION>
Three Months Ended
March 31,
----------------------
2000 1999
---------- -----------
<S> <C> <C>
Net sales........................... $1,000 $472
Costs and expenses:
Cost of sales and manufacturing
expenses........................ 1,977 1,588
Research and development......... 2,435 2,090
Selling, general and
administrative................ 6,747 3,979
---------- -----------
Total costs and expenses............ 11,159 7,657
---------- -----------
Operating loss...................... (10,159) (7,185)
Interest income and other, net...... 596 32
Interest expense.................... (276) (103)
---------- -----------
Net Loss............................ (9,839) (7,256)
Dividend on redeemable convertible
Series B Preferred stock.......... (374) (411)
---------- -----------
Net loss applicable to common
stockholders...................... ($10,213) ($7,667)
========== ===========
Basic and diluted net loss per share
applicable to common stockholders.. ($0.54) ($0.60)
========== ===========
Shares used in calculation of
net loss per share................. 18,816 12,794
</TABLE>
</PAGE>
KERAVISION, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
<TABLE>
<CAPTION>
March 31, December 31,
2000 1999
----------- ---------
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents................... $39,737 $43,251
Available-for-sale investments.............. 170 6,519
Accounts receivable, net.................... 454 567
Inventory................................... 2,144 2,403
Prepaid expenses and other current assets... 814 1,161
----------- ---------
Total current assets.......................... 43,319 53,901
Property and equipment, net 2,688 2,604
Other assets.................................. 945 634
----------- ---------
Total assets.................................. $46,952 $57,139
=========== =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities 10,526 11,132
Capital lease obligations - non-current..... 847 1,030
Redeemable Convertible Series B Preferred
Stock..................................... 17,338 16,964
Total stockholders' equity
(net capital deficiency).................. 18,241 28,013
----------- ---------
Total liabilities and total stockholders'
equity (net capital deficiency)............ $46,952 $57,139
=========== =========
</TABLE>
</PAGE>
<PAGE>
Exhibit 99.38
David Applegate Named VP for Medical Marketing and Business Development
Led product launches at Summit and Vistakon
FREMONT, CA (April 17, 2000) - KeraVision, Inc. (Nasdaq: KERA), developer
of Intacs? prescription inserts for correcting mild nearsightedness
(myopia), said it appointed David Applegate, former director of new
product marketing at Johnson & Johnson Co.'s Vistakon division, to the
position of Vice President - Medical Marketing and Business Development.
At Vistakon, Applegate was credited with leading the 1995 launch of One-
Day ACUVUET, the world's first daily disposable contact lens which now
accounts for an estimated $200 million in worldwide annual sales. He
later served as vice president of marketing at Summit Technology where,
also in 1995, he led the consumer launch for the first FDA-approved
excimer laser for vision correction.
The company said Edward R. Newill, vice president -- medical marketing,
has left the company.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"David Applegate brings to KeraVision an impressive set of skills in
eyecare marketing, both at the consumer and professional levels. He's a
strong addition to the management team."
One-Day ACUVUE ranks as one of the world's largest selling eyecare
products. Like Intacs, One-Day ACUVUE was launched as new eyecare
technology and marketed directly to consumers as well as to eyecare
practitioners who prescribed the product.
One of Applegate's initial goals at KeraVision will be to expand the
medical distribution channels that create client referrals for Intacs
surgeons. "The vast majority of mild myopes receive their primary eyecare
from optometrists, not ophthalmologists or surgeons," Applegate said.
"We want to expand KeraVision's ties with optometrists who we believe can
take a stronger role in establishing Intacs in the marketplace."
In addition to serving at Summit and Vistakon, Applegate held a number of
sales and marketing positions at Allergan Inc. from 1982 to 1990. He
received an MBA degree from the University of California at Berkeley.
KeraVision, founded in 1986, is the developer of Intacs prescription
inserts for correcting mild myopia, which was named one of "The Year's
Top 10 Medical Advances" by CNN and Health magazine. Approved by the FDA
in 1999, Intacs are a flexible and convenient option to eyeglasses,
contact lenses and vision correction surgeries that permanently alter
the eye's central optical zone. The company's patented Intacs
technology is also being developed for the possible treatment of
hyperopia (farsightedness); myopia (nearsightedness) in wider ranges
than originally approved by the FDA; astigmatism; and keratoconus, a
corneal thinning disease.
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 risk factors
described under the heading "Risk Factors Affecting the Company, Its
Business and Its Stock Price" contained in Form 10-K for the year ended
Dec. 31, 1999, and 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: KeraVision and Intacs are registered trademarks or
trademarks of KeraVision, Inc. in the U.S. and foreign countries
# # #
For further information
Investors: Mark Fischer-Colbrie, (510) 353-3000
Media: Mick Taylor, (510) 353-3075
www.GetIntacs.com
"Fax On Demand"
(800) 448-8559
