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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 10, 1999
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 February 4, 1999, Keravision, Inc. announced Fourth Quarter Financial
Results. Further details regarding this announcement are contained in the
Company's new release dated February 4, 1999, attached as exhibit hereto
and incorporated by reference herein.
On February 4, 1999, KeraVision, Inc. announced European Study On
Non-Laser Treatment for Hyperopia. Further details regarding this
announcement are contained in the Company's new release dated February 4,
1999, attached as exhibit hereto and incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.13 KeraVision, Inc. News Release dated February 4, 1999.
99.14 KeraVision, Inc. News Release dated February 4, 1999.
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: February 10, 1999
3
<PAGE>
Exhibit 99.13
KeraVision Reports
Fourth Quarter Revenues
Initial product, Intacs (trademark) for myopia, is recommended for FDA
approval
Fremont, CA (February 4, 1999) -- KeraVision, Inc. (Nasdaq: KERA), the
vision correction company, today reported financial results for the
fourth quarter and year ended December 31, 1998. Revenues totaled
$332,000 for the quarter and consisted largely of sales to Canadian
surgeons of surgical instruments and start-up inventories of Intacs
(trademark) for treating myopia, which followed the product's Canadian
launch in October. This compares to revenues of $94,000 for the fourth
quarter the year before.
Net loss for the quarter was $7.2 million versus $5.4 million for the
fourth quarter in 1997. The increase in losses was primarily due to
market development investments in North America. The net loss per share
applicable to common stockholders was 59 cents compared to 43 cents for
the same quarter a year before. The per share calculation includes the
effect of a Series B stock dividend of $383,000 to preferred
stockholders.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"During the fourth quarter KeraVision advanced to the final stage of
U.S. regulatory review with our initial product, Intacs for myopia. In
Canada, we began our professional training and marketing effort with a
core group of the country's leading vision correction surgeons. We also
continued our work on a consumer marketing program that the company
intends to test in a regional Canadian market in the second quarter."
Loarie continued, "In the research and development area, KeraVision
continued to see positive clinical results from our newest area of
product development, Intacs for the treatment of hyperopia -- the
second most common vision problem after myopia. We are now expanding
the hyperopia study beyond the initial clinical site in Mexico to three
new sites in Europe, with a goal of eventual commercial review and
approval in the European Union.
"Overall, 1998 was an important transition year for the company. With a
professional sales and marketing model now in place in Canada, a
consumer marketing model for Canada almost completed, and important
milestones achieved in the U.S. regulatory process, KeraVision is
laying the groundwork for entering the U.S. market and for revenue
growth in 1999."
Revenues for the year ended December 31, 1998 were $835,000 which
compared to $355,000 for the prior year. The net loss for the year was
$27.4 million compared to a loss of $19.4 million in 1997. The increase
in losses was primarily due to market development investments in
Canada, increased patent coverage and investments in manufacturing.
Highlights and Achievements
On January 12, 1999, Intacs for myopia were unanimously recommended for
approval, with certain conditions, by the Ophthalmic Devices Panel of
the U.S. Food and Drug Administration (FDA). Conditions had to do with
labeling and a post-market surveillance study, neither of which the
company believes should cause material delays for final regulatory
review. Approval to sell Intacs in the U.S. is subject to a final
decision by the FDA.
In the second half of 1998 KeraVision entered the North American market
following Canadian regulatory approval of Intacs, the first approved
non-laser treatment that is designed especially for people with mild to
moderate myopia, or nearsightedness.
In the U.S., the company's application for Pre-Market Approval (PMA) of
Intacs for myopia was accepted for "filing," thereby clearing the way
for last month's FDA panel meeting and for an anticipated final FDA
decision on selling Intacs in the U.S.
Some of the other key events during the year include:
U.S. market preparations -- In anticipation of possible FDA approval
to sell Intacs in the U.S., the company formed a blue-ribbon faculty of
leading ophthalmologists to help develop and oversee surgeon training
programs in the U.S. Subject to FDA product approval, the company
expects to be ready to begin offering surgeon training initially at
four medical centers across the country, including in Atlanta, Kansas
City, Minneapolis and San Diego.
Hyperopia study update -- In a feasibility clinical study for Intacs
for hyperopia, 85 percent of farsighted patients achieved 20/20 vision
or better and 100 percent achieved 20/40 or better, based on early
results that were reported to the American Academy of Ophthalmology in
November. The data were from 13 Intacs patients who were treated
abroad and monitored for one month. The study is currently being
expanded to three more international clinical sites.
Financing -- In June the company completed a private placement of
convertible stock with gross proceeds to the company of $18 million.
In December, KeraVision entered into a definitive merger agreement to
acquire Transcend Therapeutics, Inc. (Nasdaq: TSND) and its anticipated
net cash balance of about $8 million for use in KeraVision's market
development efforts, regulatory activities for products under
development, research and development, and working capital and general
corporate purposes. Transcend agreed to wind down its operations as a
drug development company, and no Transcend employees will be retained.
KeraVision, founded in 1986, is creating a new category of non-laser
vision correction products that are designed especially for mild to
moderate myopia (nearsightedness) and potentially for mild to moderate
hyperopia (farsightedness). These products are potential alternatives
to eyeglasses, contact lenses and vision correction surgeries that
permanently alter the eye's central optical zone. The initial product
is KeraVision Intacs for myopia, developed from a technology platform
that the company believes will potentially treat the most common forms
of vision problems.
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 KeraVision Intacs or the
surgical procedure, competitive products and technology, market
acceptance of KeraVision Intacs, 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
September 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
Intacs is a registered
trademark or trademark
of KeraVision, Inc. in
<PAGE>
KERAVISION, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data; unaudited)
<TABLE>
<CAPTION>
Three Months Ended Year Ended
December 31, December 31,
--------------------- ---------------------
1998 1997 1998 1997
---------- ---------- ---------- ----------
<S> <C> <C> <C> <C>
Net sales........................... $332 $94 $835 $355
Costs and expenses:
Cost of sales and manufacturing
expenses........................ 1,282 1,113 4,386 3,701
Research and development......... 2,500 2,772 11,356 10,774
Selling, general and 3,912 1,842 9,693 6,405
administrative................ ---------- ---------- ---------- ----------
Total costs and expenses............ 7,694 5,727 25,435 20,880
---------- ---------- ---------- ----------
Operating loss...................... (7,362) (5,633) (24,600) (20,525)
Interest income, net................ 162 197 563 1,129
---------- ---------- ---------- ----------
Net Loss........................... (7,200) (5,436) (24,037) (19,396)
Quarterly dividend on preferred
stock............................. (383) -- (766) --
Deemed dividend on preferred stock.. -- -- (2,611) --
---------- ---------- ---------- ----------
Net loss applicable to Common
Stockholders...................... ($7,583) ($5,436) ($27,414) ($19,396)
========== ========== ========== ==========
Basic and diluted net loss per share
applicable to Common Stockholders.. ($0.59) ($0.43) ($2.16) ($1.55)
========== ========== ========== ==========
Shares used in calculation of
net loss per share................. 12,745 12,567 12,686 12,528
</TABLE>
<PAGE>
KERAVISION, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
<TABLE>
<CAPTION>
December 31 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, net 1,840 1,869
Other assets.................................. 108 98
---------- ----------
Total assets.................................. $11,184 $17,345
========== ==========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities 4,321 3,558
Capital lease obligations - non-current..... 821 850
Redeemable Convertible Series B Preferred
Stock..................................... 17,489 --
Total stockholders' equity (deficit) ....... (11,447) 12,937
---------- ----------
Total liabilities and total stockholders'
equity (deficit)........................... $11,184 $17,345
========== ==========
</TABLE>
<PAGE>
Exhibit 99.14
KeraVision Begins European Clinical Study On Non-Laser Treatment for
Hyperopia
Technology used in "investigational" hyperopia device also used in new
Intacs (trademark) for myopia, recommended for FDA approval January 12
Fremont, CA (February 4, 1999) -- KeraVision, Inc. (Nasdaq: KERA), the
vision correction company, has begun clinical studies in Europe for
Intacs (trademark) for hyperopia -- a clear, micro-thin polymer that,
when surgically placed in the cornea, may offer a non-laser alternative
for correcting mild to moderate hyperopia, which affects an estimated 20
million adult Americans.
Since January 7, a total of eight patients have been treated for +1.0 to
+3.5 diopters of hyperopic correction at the Hospital of Neubrandenburg
in Neubrandenburg, Germany. This follows a Mexican study in which 85
percent of farsighted patients achieved 20/20 vision or better and 100
percent achieved 20/40 or better, based on preliminary data for 13
Intacs patients who were monitored for one month.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"While these positive clinical results from Europe are limited and
preliminary, they appear to be consistent with results from our study
in Mexico. Intacs for hyperopia could open a whole new category of
vision correction for people who want an alternative to glasses,
contact lenses and laser surgery. By being removable, Intacs for
hyperopia could offer the possibility for permanent vision correction
without making a permanent decision."
Intacs for hyperopia are based on the same patented core technology used
to develop KeraVision's initial product, Intacs for myopia, now
available in Canada and several European countries. In the U.S., Intacs
for myopia recently received a unanimous recommendation for approval,
with conditions, from the Ophthalmic Devices Panel of the U.S. Food and
Drug Administration.
Non-Laser Alternative to Vision Correction
Both product configurations -- Intacs for myopia and Intacs for
hyperopia -- are intended to mechanically reshape a cornea's curvature
and correct vision by adding material to the eye, not by cutting or
removing tissue. The procedures can be achieved without harming the
eye's central optical zone, which is the critical area for clear
vision.
The German study is being conducted by Helmut Hoh, MD, PhD, who heads
the Ophthalmology Department at the Hospital of Neubrandenburg which is
a university teaching hospital. His is the first of three clinical sites
that are scheduled to take part in a European study of up to 50
farsighted patients.
In November 1998, Mexican surgeon Arturo S. Chayet reported one-month
clinical results for 13 farsighted Intacs patients at the American
Academy of Ophthalmology. Previously, he treated 14 Intacs patients
with an earlier configuration of Intacs, resulting in 20/20 vision or
better for 71 percent of the patients and 20/40 or better for 100
percent, based on six months of clinical follow-up.
KeraVision, founded in 1986, is creating a new category of non-laser
vision correction products that are designed especially for mild to
moderate myopia (nearsightedness) and potentially for mild to moderate
hyperopia (farsightedness). These products are potential alternatives
to eyeglasses, contact lenses and vision correction surgeries that
permanently alter the eye's central optical zone. The initial product
is KeraVision Intacs for myopia, developed from a technology platform
that the company believes will potentially treat the most common forms
of vision problems.
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 KeraVision Intacs or the
surgical procedure, competitive products and technology, market
acceptance of KeraVision Intacs, 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
September 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
Intacs, KeraVision Ring
and ICR are registered
trademarks or trademarks
of KeraVision, Inc. in
the U.S. and foreign
countries
