<PAGE>
Total Number of Pages: 3
--
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: August 17, 1998
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 JULY 23, 1998, KERAVISION, INC. ANNOUNCED SECOND QUARTER FINANCIAL
RESULTS. FURTHER DETAILS REGARDING THIS ANNOUNCEMENT ARE CONTAINED IN THE
COMPANY'S NEW RELEASE DATED JULY 23, 1998, ATTACHED AS EXHIBIT HERETO AND
INCORPORATED BY REFERENCE HEREIN.
ON JULY 23, 1998, KERAVISION, INC. ANNOUNCED THE APPOINTMENT OF DAVID
F. HENIGES TO THE POST OF VICE PRESIDENT-EUROPE. FURTHER DETAILS
REGARDING THIS ANNOUNCEMENT ARE CONTAINED IN THE COMPANY'S NEWS RELEASE
DATED JULY 23, 1998, ATTACHED AS EXHIBIT HERETO AND INCORPORATED BY
REFERENCE HEREIN.
ON AUGUST 3, 1998, KERAVISION, INC. ANNOUNCED THE ELECTION OF PETER L.
WILSON TO ITS BOARD OF DIRECTORS. FURTHER DETAIL REGARDING THIS
ANNOUNCEMENT IN THE COMPANY'S NEWS RELEASE DATED AUGUST 3, 1998, ATTACHED
AS EXHIBIT HERETO AND INCORPORATED BY REFERENCE HEREIN.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.1 KeraVision, Inc. News Release dated July 23, 1998.
99.2 KeraVision, Inc. News Release dated July 23, 1998.
99.3 KeraVision, Inc. News Release dated August 3, 1998.
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: August 17, 1998
3
<PAGE>
Exhibit 99.1
KeraVision, Inc. Press Release dated July 23, 1998
KeraVision Reports
Second Quarter Results
KeraVision "Ring" selected for review under new FDA pilot program
FREMONT, CA (July 23, 1998) -- KeraVision, Inc. (Nasdaq: KERA), whose myopia
product has been selected for FDA review under a new pilot program for proposed
new medical technologies, today reported financial results for the second
quarter ended June 30, 1998. Revenues totaled $112,000 for the quarter and
$264,000 for the first six months on sales of the KeraVision (Registered
Trademark) Ring compared to $114,000 and $170,000 for the same periods a year
ago.
Net loss for the quarter was $5.6 million versus $5.3 million for the second
quarter in 1997. The increase in losses was primarily due to costs of expanded
patent coverage for KeraVision technologies and to market-development
investments, including in Canada. The net loss per share applicable to common
stockholders was 65 cents. This per share calculation includes the effect of a
deemed dividend of $2.6 million to preferred stockholders as part of a recently
completed financing.
The company announced that in the second quarter it was notified by the FDA that
its first potential product, the KeraVision Ring for myopia, will be reviewed
under a new FDA pilot program. The program, which was instituted as part of the
FDA's modernization efforts, is aimed at streamlining the review of premarket
approval (PMA) applications for new medical devices.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said, "We
believe this new FDA review process can be an improvement, and we are delighted
to be selected as one of the first medical technology companies to demonstrate
its viability. Potentially, the KeraVision Ring will create a new category of
vision correction, as different from existing vision surgeries as contact lenses
are different from eyeglasses."
The FDA's new "modular" pilot program allows participating companies to apply
for premarket approval by submitting sections as soon as they are completed
instead of all at once, enabling the FDA to begin evaluating applications
sooner.
Other Developments
In a separate news release today, the company announced that David F. Heniges, a
23-year veteran of Johnson & Johnson Co, has been appointed vice president-
Europe with responsibilities for market-development programs in Germany, France
and several other European Union countries. He succeeds Patrick Sabaria who
will be leaving the company.
Major second quarter developments included:
. In May, regulatory approval was received in Canada to sell the KeraVision
Ring for treating -1.0 to -5.0 diopters of myopia, the most common range of
nearsightedness. The company said it would initiate efforts at a limited number
of surgical sites across Canada, to be followed in the fourth quarter by a
broader geographic distribution. Since then, surgeon training has begun and a
concentrated program has been initiated to help key surgeons develop their
KeraVision Ring practice.
. In June, a private placement of convertible preferred stock was completed,
with gross proceeds to the company of $18 million. The offering involved a
limited group of institutional investors led by the Sprout Group, the venture
capital affiliate of Donaldson, Lufkin & Jenrette Securities Corp., and which
included, among others, Johnson & Johnson Development Corporation.
KeraVision, founded in 1986, is pioneering a new approach to treating common
vision problems, one that seeks to reshape the cornea by surgically adding
materials rather than cutting or removing tissue like other surgical methods.
The company believes its approach will be an alternative to eyeglasses and
contacts and to vision surgeries that
<PAGE>
permanently alter the eye's central optical zone. In addition to treating
nearsightedness, KeraVision's patented core technology is being developed to
potentially treat farsightedness (hyperopia) 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 significant unforeseen delays in the
regulatory approval process, changes in regulatory review guidelines,
procedures, regulations or administrative interpretations, complications
relating to the KeraVision Ring or the surgical procedure, competitive products
and technology, and other risk factors described under the heading "Factors
Affecting the Company, Its Business and Its Stock Price" set forth in the
company's Annual Report on Form 10-K for the year ended December 31, 1997 and on
Form 10-Q for the quarter ended March 31, 1998.
For further information:
Investors: Mark Fischer-Colbrie (510)353-3000
Media: Mick Taylor (510)353-3075
KeraVision, Inc.
48630 Milmont Drive
Fremont, CA 94538-7353
Fax: (510)353-3030
www.keravision.com
"Fax on Demand"
(800)448-8559
KeraVision Ring and
ICR are registered
trademarks or trademarks
of KeraVision, Inc. in
the U.S. and foreign
countries
<PAGE>
Consolidated Statements of Operations
-------------------------------------
(in thousands except per share amount)
<TABLE>
<CAPTION>
THREE MONTHS SIX MONTHS
ENDED JUNE 30, ENDED JUNE 30,
----------------------- ------------------------
1998 1997 1998 1997
----------------------- ------------------------
(UNAUDITED) (UNAUDITED)
<S> <C> <C> <C> <C>
Net sales $ 112 $ 114 $ 264 $ 170
Cost and expenses:
Cost and sales and manufacturing expenses 989 974 1,949 1,744
Research and development 3,113 3,033 6,016 5,406
Selling, general and administrative 1,740 1,700 3,652 3,079
------- ------- -------- -------
Total costs and expenses 5,842 5,707 11,617 10,229
------- ------- -------- -------
Operating loss (5,730) (5,593) (11,353) (10,059)
Interest income, net 86 292 179 668
------- ------- -------- -------
Net Loss (5,644) (5,298) (11,174) (9,391)
Deemed dividend on preferred stock (2,611) -- (2,611) --
------- ------- -------- -------
Net loss applicable to Common Stockholders $(8,255) $(5,298) $(13,785) $(9,391)
======= ======= ======== =======
Basic and diluted net loss per share
applicable to Common Stockholders $ (0.65) $ (0.42) $ (1.09) $ (.75)
======= ======= ======== =======
Shares used in calculation of net loss per share 12,673 12,532 12,655 12,495
</TABLE>
Condensed Consolidated Balance Sheet
------------------------------------
(in thousands)
<TABLE>
<CAPTION>
JUNE 30, DECEMBER 31,
1998 1997
----------- ------------
(UNAUDITED) *
<S> <C> <C>
Current assets:
Cash and cash equivalents $ 7,262 $ 2,574
Available-for-sale investments 13,946 11,539
Prepaid expenses and other current assets 913 1,265
------- -------
Total current assets 22,121 15,378
Property and equipment, net 2,121 1,869
Other assets 98 98
------- -------
Total assets $24,340 $17,345
======= =======
Current liabilities $ 5,037 $ 3,558
Capital lease obligations - noncurrent 770 850
Redeemable Convertible Series B Preferred Stock 16,760 --
Total stockholders' equity 1,773 12,937
------- -------
Total liabilities and total stockholders' equity $24,340 $17,345
======= =======
*-Derived from audited financial statements
KeraVision and ICR are
registered trademarks
</TABLE>
<PAGE>
EXHIBIT 99.2
KERAVISION, INC. PRESS RELEASE DATED JULY 23, 1998
For KERAVISION APPOINTMENTS
Further 23-YEAR J&J VETERAN AS VP-EUROPE
Information:
Investors: Mark FREMONT, CALIFORNIA (July 23, 1998) --
Fischer-Colbrie KeraVision, Inc. (Nasdaq: KERA) has appointed
(510) 353-3000 Davis F. Heniges, a 23-year veteran of Johnson
& Johnson Co. and past vice president of world-
wide business development for J&J's former
Media: Mick ophthalmic company, IOLAB Corp., to the post of
Taylor vice president-Europe.
(510) 353-3075
Effective immediately, Heniges will manage the
KeraVision, Inc. European market-development programs for the
48630 Milmont KeraVision (R) Ring, a tiny corneal inlay that
Drive when placed in the eye is designed to
Fremont, CA, 94538 permanently treat myopia (nearsightedness)
(510) 353-3030 without permanently altering the optical zone.
FAX The product is in Phase III clinical study in
the U.S. and is sold in Canada and in several
European Union countries including Germany and
France.
Keravision Chairman and Chief Executive Officer
Thomas M. Loarie said, "KeraVision has an
opportunity in Europe to use our technological
leadership to develop a largely undeveloped
market for vision correction surgery. Dave
Heniges is perfect for the task, having helped
build J&J's global ophthalmic franchise into a
$200 million-a-year business. Dave rose from
field sales at J&J to broad management
responsibilities in global market and business
development. We are pleased to have him on the
team."
In his new capacity, Heniges will implement
strategies to increase sales in France and
Germany while expanding into additional European
Union countries this year and over the next
several years. He succeeds Patrick Sabaria who
will be leaving KeraVision.
Heniges, 54, joined J&J in 1972, rising in 1986
to vice president for marketing of J&J's former
ophthalmic device, equipment and pharmaceutical
company, IOLAB Corp. In 1991 he was appointed
vice president for KeraVision's New VP-Europe
Page 2 of 2
-more-
<PAGE>
worldwide business development of IOLAB. Most
recently he served as vice president, global
marketing for Baxter Healthcare's Cardiovascular
Surgery Division. A native of Portland, OR, he
received a bachelor of science degree from
Oregon State University.
KeraVision, founded in 1986, is pioneering a new
approach to treating common vision problems, one
that seeks to reshape the cornea by surgically
adding materials rather than cutting or removing
tissue like other surgical methods. The company
believes its approach will be an alternative to
eyeglasses and contacts and to vision surgeries
that permanently alter the eye's central optical
zone. In addition to treating nearsightedness,
KeraVision's patented core technology is being
developed to potentially treat farsightedness
(hyperopia) 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 significant unforeseen delays in the
regulatory approval process, changes in
KeraVision Ring regulatory review guidelines, procedures,
and ICR are regulations or administrative interpretations,
registered complications relating to the KeraVision Ring or
trademarks or the surgical procedures, regulations or
trademarks of administrative interpretations, complications
KeraVision, Inc. relating to the KeraVision Ring or the surgical
in the U.S. procedure, competitive products and technology,
and foreign and other risk factors described under the
countries heading "Factors Affecting the Company, Its
Business and Its Stock Price: set forth in the
www/keravision.com company's Annual Report on Form 10-K for the
"Fax On Demand" year ended December 31, 1997 and in the Form 10-
(800)448-8559 Q for the quarter ended March 31, 1998.
# # #
<PAGE>
EXHIBIT 99.3
KERAVISION, INC. PRESS RELEASE DATED AUGUST 3, 1998.
KeraVision Appoints to Board
Peter L. Wilson, Former President
of Richardson Vicks USA
Fremont, CA (August 3, 1998) -- KeraVision, Inc. (Nasdaq: KERA), a vision
correction company, has elected Peter L. Wilson, former president of Procter &
Gamble's Richardson Vicks USA, to its Board of Directors.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said, "Peter is
a marketing strategist who is responsible for leading some of the most
successful consumer over-the-counter brands of the past two decades. His
achievements in the health and beauty care industries make him an exceptional
addition to the KeraVision Board."
Wilson joined the marketing department of Richardson Vicks/Merrell
Pharmaceuticals in 1972, 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.
During his 20-year tenure, Wilson was credited with revitalizing and extending
the Oil of Olay brand and expanding the NyQuil franchise, including introducing
the Liquicaps technology. He also developed advertising and product strategies
for such brands as Clearasil, Fixodent and the Vicks Cough Cold line.
He succeeds Steven N. Weiss as a member of KeraVision's eight-member board.
Weiss, who joined the board in 1987, is a general partner of Montgomery Medical
Ventures, which was the company's original venture capital investor.
"It was Steve's vision that made KeraVision possible and his numerous
contributions that helped make the company viable. He saw the potential for a
new category of vision correction and took the gamble when others were afraid.
Steve has the thanks of employees, stockholders and the patients who are now
able to enjoy the benefits of KeraVision's pioneering approach to vision
correction."
KeraVision, founded in 1986, is pioneering a new approach to treating common
vision problems, one that seeks to reshape the cornea by surgically adding
materials rather than cutting or removing tissue as other surgical methods do.
The company believes its approach will be an alternative to eyeglasses, contacts
and vision correction surgeries that permanently alter the eye. In addition to
treating myopia, KeraVision's patented core technology is also being developed
to potentially treat 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 significant unforeseen delays in the
regulatory approval process, changes in regulatory review guidelines,
procedures, KeraVision Ring or the surgical procedure, competitive products and
technology, and other risk factors described under the heading "Factors
Affecting the Company, Its Business and Its Stock Price" set forth in the
company's Annual Report on Form 10-K for the year ended December 31, 1997 and on
Form 10-Q for the quarter ended March 31, 1998.
# # #
For further information:
Investors: Mark Fischer-Colbrie (510) 353-3000
Media: Mick Taylor (510) 353-3075
KeraVision, Inc.
48630 Milmont Drive
Fremont, CA 94548-7353
Fax: (510) 353-3030
www.keravision.com
"Fax on Demand"
(800) 448-8559
KeraVision and ICR are registered trademarks
