<PAGE>
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: October 26, 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 October 22, 1998, Keravision, Inc. announced Third Quarter Financial
Results. Further details regarding this announcement are contained in the
Company's new release dated October 22, 1998, attached as exhibit
hereto and incorporated by reference herein.
On October 22, 1998, KeraVision, Inc. announced key new personnel.
Further details regarding this announcement are contained in the
Company's new release dated October 22, 1998, attached as exhibit
hereto and incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.5 KeraVision, Inc. News Release dated October 22, 1998.
99.6 KeraVision, Inc. News Release dated October 22, 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: October 26, 1998
3
<PAGE>
Exhibit 99.5
KeraVision, Inc. Press Release dated October 22, 1998.
KeraVision Reports
Third Quarter Results
Initial Product Is Poised for First Roll-Out In Canada
Fremont, CA (October 22, 1998) -- KeraVision, Inc. (Nasdaq: KERA),
which is pioneering a non-laser approach for the correction of low to
moderate myopia, today reported financial results for the third quarter
ended September 30, 1998. Revenues totaled $239,000 for the quarter on
sales of the company's initial vision-correcting product, the
KeraVision (Registered Trademark) Ring, and related surgical
instruments. This compares to $91,000 for the same period a year ago.
Net loss for the quarter was $5.7 million versus $4.6 million for the
third quarter in 1997. The increase in losses was primarily due to
market-development investments in Canada and expanded patent coverage
for the KeraVision technologies. The net loss per share applicable to
common stockholders was 48 cents. This per share calculation includes
the effect of a dividend of $383,000 to Series B preferred
stockholders.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"During the third quarter KeraVision achieved a major milestone in the
U.S. by having our Pre-Market Approval (PMA) application accepted for
full review by the FDA. This begins the final regulatory review
process for possible U.S. product approval.
"We also are encouraged by our recent market-development efforts in
Canada," Loarie said. "The company has established six 'alpha' sites
across Canada to lead in the commercial roll-out of the KeraVision
Ring. The plan is to roll out a region at a time, and we are now
training the surgeons who will be part of the first regional effort."
The six "alpha" sites were chosen by KeraVision because they are
considered professional and commercial leaders in their markets. They
are now performing the KeraVision Ring procedure on nearsighted
patients. They also have received practice management support from
KeraVision, including outreach programs to generate patient referrals
from optometrists and physicians.
This week the company formally unveiled its vision-correcting product
to the Canadian public through a series of media events across the
country. KeraVision representatives were joined by alpha site surgeons
and several of their initial KeraVision Ring patients to announce the
arrival of the KeraVision Ring in Canada. Numerous stories appeared as
a result in the Canadian press and on TV.
Loarie added, "Although we are in preliminary stages in Canada, we
believe this product could attract a new segment of eyeglass and
contact lens wearers who want a non-laser approach to correct low to
moderate myopia. KeraVision is uniquely positioned in this market."
Other activities that took place during the third quarter included:
The FDA action to "accept for filing" KeraVision's Pre-Market
Approval (PMA) application means that the regulatory review process for
the company's initial myopia product has entered its final phase. The
company expects the process to include a hearing by an FDA Ophthalmic
Devices Advisory Panel, inspections of KeraVision's manufacturing
facility and clinical study sites, and possibly other steps.
In September, clinical data were reported to the European Society
of Cataract and Refractive Surgeons showing that 51 percent of
nearsighted patients obtained 20/16 vision or better, 70 percent
obtained 20/20 or better, and 95 percent obtained 20/40 or better (the
vision standard for receiving a driver's license in most states).
These results are from a U.S. Phase III study of 350 KeraVision Ring
patients who were treated for -1.0 to -3.5 diopters of myopia and
monitored for at least six months.
The company acquired intellectual property rights from a major
U.S. university which will further strengthen KeraVision's patent
portfolio.
KeraVision, founded in 1986, is creating a new category of vision
correction with its KeraVision Ring, a non-laser treatment that is
designed to correct vision especially for people with low to moderate
myopia (nearsightedness). Presently under FDA review, this approach is
a potential alternative to eyeglasses, contacts and vision surgeries
that permanently alter the eye's optical zone. In addition to treating
myopia, KeraVision's patented core technology is being developed to
possibly 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, regulations or administrative
interpretations, complications relating to the KeraVision Ring or the
surgical procedure, competitive products and technology, market
acceptance of the KeraVision Ring, 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
June 30, 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 and ICR are registered
trademarks or trademarks of
KeraVision, Inc. in the U.S.
and foreign countries
<PAGE>
KERAVISION, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data; unaudited)
<TABLE>
<CAPTION>
Three Months Ended Nine Months Ended
September 30, September 30,
--------------------- ---------------------
1998 1997 1998 1997
---------- ---------- ---------- ----------
<S> <C> <C> <C> <C>
Net sales........................... $239 $91 $503 $261
Costs and expenses:
Cost of sales and manufacturing
expenses........................ 1,155 843 3,104 2,588
Research and development......... 2,839 2,596 8,855 8,002
Selling, general and 2,129 1,485 5,781 4,563
administrative................ ---------- ---------- ---------- ----------
Total costs and expenses............ 6,123 4,924 17,740 15,153
---------- ---------- ---------- ----------
Operating loss...................... (5,884) (4,833) (17,237) (14,892)
Interest income, net................ 221 264 400 932
---------- ---------- ---------- ----------
Net Loss........................... (5,663) (4,569) (16,837) (13,960)
Quarterly dividend on preferred
stock............................. (383) -- (383) --
Deemed dividend on preferred stock.. -- -- (2,611) --
---------- ---------- ---------- ----------
Net loss applicable to Common
Stockholders...................... ($6,046) ($4,569) ($19,831) ($13,960)
========== ========== ========== ==========
Basic and diluted net loss per share
applicable to Common Stockholders.. ($0.48) ($0.36) ($1.57) ($1.12)
========== ========== ========== ==========
Shares used in calculation of
net loss per share................. 12,686 12,555 12,655 12,515
</TABLE>
<PAGE>
KERAVISION, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
<TABLE>
<CAPTION>
Sept. 30, Dec. 31,
1998 1997
---------- ----------
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents................... $3,250 $2,574
Available-for-sale investments.............. 10,580 11,539
Prepaid expenses and other current assets... 1,049 1,265
---------- ----------
Total current assets.......................... 14,879 15,378
Property and equipment, net 1,965 1,869
Other assets.................................. 122 98
---------- ----------
Total assets.................................. $16,966 $17,345
========== ==========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities 3,922 3,558
Capital lease obligations - non-current..... 667 850
Redeemable Convertible Series B Preferred
Stock..................................... 17,106 --
Total stockholders' equity (deficit) ....... (4,729) 12,937
---------- ----------
Total liabilities and total stockholders'
equity (deficit)........................... $16,966 $17,345
========== ==========
</TABLE>
<PAGE>
Exhibit 99.6
KeraVision, Inc. Press Release dated October 22, 1998.
KeraVision Announces
Key New Personnel
Company's Initial Product Is a Non-Laser Approach To Permanent Vision
Correction
Fremont, CA (October 22, 1998) -- KeraVision, Inc. (Nasdaq: KERA),
which is pioneering a non-laser approach for the correction of low to
moderate myopia, announced several key appointments in Canada and the
U.S.
The appointments include Richard J. Meader, vice president-quality;
Michael E. Allen, director of sales-North America; Gordon A. McLarty,
manager of sales-Canada; David Killien, manager of market development-
Canada; and Kathleen Edmison, clinical training consultant for Canada.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"KeraVision is strengthening the operations side of our business by
creating new positions in the quality, sales and marketing functions.
We have selected people for their outstanding experience and education
which directly relate to the company's goals."
Meader, vice president-quality, joins from B. Braun/McGaw Inc., a
$350 million-a-year maker of medical device systems for drug delivery
and a provider of pharmacy out-source services. During a 23-year
tenure with the company, nearly half was spent as vice president-
regulatory and quality affairs where he was responsible for introducing
the company's Total Quality Management program and instituting
efficiencies that reduced quality-related costs by an estimated 30
percent.
Allen, director of sales-North America, spent eight years with
Smith & Nephew's IOPTEX division selling intraocular lenses for
cataract surgery and developing and selling practice management
programs to ophthalmic surgeons.
McLarty, sales manager-Canada, spearheaded the launch in Canada
of the LASIK vision correction technology, the fastest growing segment
of vision correction surgery. From 1991-96, he served as national
sales manager first for Chiron Vision Canada and then for Chiron's
distributor, SACOR, Inc.
Killien, business development manager-Canada, introduced the
Visx, Inc. excimer laser to Canada as vice president for marketing at
Alcon Canada Inc. from 1992-96. He was honored as Visx's leading
seller of excimer lasers worldwide in 1994.
Edmison, clinical training consultant for Canada, served from
1992-97 as part of the Visx team that introduced the excimer laser
technology to Canadian surgeons. She previously managed a leading
vision correction surgery center in Ottawa.
KeraVision, founded in 1986, is creating a new category of vision
correction with its KeraVision Ring, a non-laser treatment that is
designed to correct vision especially for people with low to moderate
myopia (nearsightedness). Presently under FDA review, this approach is
a potential alternative to eyeglasses, contacts and vision surgeries
that permanently alter the eye's optical zone. In addition to treating
myopia, KeraVision's patented core technology is being developed to
possibly 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, regulations or administrative
interpretations, complications relating to the KeraVision Ring or the
surgical procedure, competitive products and technology, market
acceptance of the KeraVision Ring, 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
June 30, 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
