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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 30, 1999
Commission File Number: 0-26208
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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 April 22, 1999, Keravision, Inc. announced First Quarter Financial
Results. Further details regarding this announcement are contained in the
Company's new release dated April 22, 1999, attached as exhibit hereto
and incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.22 KeraVision, Inc. News Release dated April 22, 1999.
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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: April 30, 1999
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Exhibit 99.22
KeraVision Reports First Quarter Results
Revenue Increase Reflects Initial Market-Development Efforts for Intacs
(trademark) in Canada; U.S. Launch for Intacs Begins
Fremont, CA (April 22, 1999) -- KeraVision, Inc. (Nasdaq: KERA), which
this month received Food and Drug Administration approval to sell its
non-laser product to treat myopia in the U.S., reported revenues of
$472,000 for the first quarter ended March 31 -- up 40 percent from the
$332,000 in revenues for the previous quarter and up 220 percent from
the $152,000 in revenues for the first quarter a year ago. The increase
was based mostly on Canadian sales of Intacs and of related surgical
instruments and surgeon training in connection with the launch of Intacs
in Canada.
Net loss for the period was $7.3 million vs. $7.2 million for the
previous quarter and $5.5 million for the first quarter in 1998. The
net loss per share applicable to common stockholders was 60 cents per
share compared to 44 cents per share for the same period a year before.
The per share calculation includes the effect of a Series B stock
dividend of $411,000 to preferred stockholders. Increased losses were
primarily due to investments in market development in North America.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"Now that KeraVision has FDA approval to sell Intacs in the U.S., we
have begun our market launch and have the added momentum of two quarters
of non-U.S. revenue growth."
On April 9, Intacs became the first FDA-approved non-laser option for
the surgical correction of mild nearsightedness -- a condition affecting
an estimated 20 million adult Americans.
Since then, KeraVision has announced agreements with three vision
correction surgery companies to make Intacs available to their surgeons
and patients. The companies -- Laser Vision Centers, Inc. (Nasdaq:
LVCI), NovaMed Eye Care and ARIS Vision, Inc. -- represent more than 200
locations throughout the U.S.
In other developments during the first quarter:
The company accelerated efforts to develop a second potential
product, Intacs for hyperopia (farsightedness), by starting a multi-
center clinical study in Europe. In a Mexico study, 55 percent of
farsighted Intacs patients achieved 20/20 vision or better, 91 percent
saw 20/25 or better, and 100 percent saw 20/40 or better, based on 11
patients who were treated for mild farsightedness (+1.0 to +3.5
diopters) and monitored for 12 months.
KeraVision signed distribution agreements with several prominent
ophthalmic manufacturer's representatives: New Tech s.r.l. in Italy,
Oftalogic S.A. in Spain, and Visicare Ltd. in South Africa.
In Canada, the company launched a regional consumer advertising
campaign to test-market different strategies. Results will help shape
future Intacs advertising programs elsewhere in Canada as well as in the
U.S.
KeraVision, founded in 1986, is creating a new category of non-laser
vision correction products that are designed especially for mild myopia
(nearsightedness) and potentially for mild hyperopia (farsightedness)
and astigmatism. These products offer 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, market acceptance of
KeraVision Intacs, changes in regulatory review guidelines, procedures,
regulations or administrative interpretations, complications relating to
KeraVision Intacs or the surgical procedure, competitive products and
technology, and other risk factors described under the heading "Risk
Factors Affecting the Company, Its Business and Its Stock Price" set
forth in the company's Form 10-K for the year ended December 31, 1998,
as well as in other SEC filings.
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 are a registered
trademark or trademark
of KeraVision, Inc.
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KERAVISION, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data; unaudited)
<TABLE>
<CAPTION>
Three Months Ended
March 31,
---------------------
1999 1998
---------- ----------
<S> <C> <C>
Net sales........................... $472 $152
Costs and expenses:
Cost of sales and manufacturing
expenses........................ 1,588 961
Research and development......... 2,090 2,903
Selling, general and 3,979 1,911
administrative................ ---------- ----------
Total costs and expenses............ 7,657 5,775
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Operating loss...................... (7,185) (5,623)
Interest income (expense), net...... (71) 93
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Net Loss........................... (7,256) (5,530)
Quarterly dividend on preferred
stock............................. (411) --
---------- ----------
Net loss applicable to common
stockholders...................... ($7,667) ($5,530)
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Basic and diluted net loss per share
applicable to common stockholders.. ($0.60) ($0.44)
========== ==========
Shares used in calculation of
net loss per share................. 12,794 12,636
</TABLE>
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KERAVISION, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
<TABLE>
<CAPTION>
March 31, December 31,
1999 1998
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<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents................ $5,329 $1,449
Available-for-sale investments........... 874 6,279
Prepaid expenses and other current assets 2,464 1,508
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Total current assets....................... 8,667 9,236
Property and equipment, net 1,922 1,840
Other assets............................... 107 108
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Total assets............................... $10,696 $11,184
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities 10,154 4,321
Capital lease obligations - non-current.. 798 821
Redeemable Convertible Series B Preferred
Stock.................................. 17,900 17,489
Total stockholders' equity (deficit) .... (18,156) (11,447)
---------- ----------
Total liabilities and total stockholders'
equity (deficit)........................ $10,696 $11,184
========== ==========
</TABLE>
