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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: October 21, 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)
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ITEM 5. OTHER EVENTS
On October 19, 1999, KeraVision, Inc. announced Third Quarter
Financial Results. Further details regarding this announcement are
contained in the Company's new release dated October 19, 1999 attached
as exhibit hereto and incorporated reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.32 KeraVision, Inc. News Release dated October 19, 1999
2
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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: October 21, 1999
3
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Exhibit 99.32
For Immediate Release
KeraVision Reports Record Revenues for 3rd Quarter
Doctors Trained Reaches 448 As Acceptance of Intacs (trademark) Grows
Fremont, CA (October 19, 1999) -- KeraVision, Inc. (Nasdaq: KERA),
developer of Intacs -- the first FDA-approved non-laser option for
surgically treating mild myopia (nearsightedness) -- today announced
financial results for the quarter ended September 30, 1999.
Revenues were $4.2 million compared to $239,000 for the same period a
year ago and $3.9 million for the second quarter of 1999. Revenues in
the quarter were primarily driven by sales of Intacs start-up kits,
which include surgical instruments and a small initial inventory of
Intacs, and by Intacs reorders. The net loss for the third quarter was
$5.0 million, or $0.32 per common share, compared to $5.7 million, or
$0.48 per common share, for the third quarter of 1998.
KeraVision said it trained 205 doctors during the quarter, bringing the
total number of U.S. ophthalmic surgeons who are credentialed to
perform the Intacs procedure to 448. The mix of surgeons completing
Intacs training shifted during the quarter to accommodate more doctors
belonging to corporate partner groups as well as associates of doctors
previously trained. Since Intacs start-up kits already were purchased
in these instances, revenues from these "associate" doctors were for
training only.
Revenues for the first nine months of 1999 totaled $8.6 million
compared to $503,000 for the same period in 1998. The net loss for the
first nine months of 1999 was $17.9 million, or $1.34 per common share
compared to $16.8 million or $1.57 per common share for the same period
a year ago. The per share calculations for the first nine months of
1999 include the effect of a Series B deemed dividend of $1.1 million
to preferred stockholders.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"During the quarter, KeraVision continued to see strong surgeon demand
for Intacs training and procedure growth in line with our upwardly
revised expectations. I am also pleased to announce that the 20/20
visual outcomes being achieved by surgeons who are performing their
first-ever Intacs procedures are as high as we saw in U.S. clinical
trials." Noting that the first Intacs outcomes data from the
commercial launch will be presented next week at the American Academy
of Ophthalmology meeting, Loarie added, "These early commercial results
point to the strength of our training and proctoring program."
Loarie said the company is closing the gap between initial
certification training and final skills transfer to surgeons by adding
skilled specialists and capacity - additions made possible by the
recent secondary financing.
He continued, "We are focusing on the building blocks: training,
proctoring, practice integration and marketing. We are continuing to
expand our core group of surgical sites by training new independent
surgeons and their associates as well as doctors who are part of
refractive surgery provider groups. In the fourth quarter, we intend
to concentrate on developing several integration models that can be
tailored to local market conditions for roll-out next year," Loarie
concluded.
During the third quarter, John Galantic was appointed to the new
position of KeraVision president and chief operating officer.
Galantic, 37, who most recently served as SmithKline Beecham's Belgium
country manager, is credited with the successful European launch of
that company's smoking cessation brand, Niquitin, and for revitalizing
the over-the-counter franchise in Belgium with 17 percent annual growth
- - the most of any consumer healthcare company in that market.
In addition, Steven M. Henderson, 40, former sales director for Bausch
& Lomb's $50 million-a-year U.S. refractive surgery business and
director of training for more than 1,000 LASIK surgeons, has been named
to the new post of KeraVision vice president-sales.
About KeraVision
On April 9, the FDA approved Intacs for surgically treating mild
nearsightedness - a condition that affects an estimated 20 million
adult Americans. Since then, surgeon training has been initiated at
six sites across the U.S. In addition, several surgeon practice groups
that represent more than 200 vision surgery locations in the U.S. --
including Laser Vision Centers, Inc. (Nasdaq: LVCI), NovaMed Eyecare
(Nasdaq: NOVA) and ARIS Vision, Inc. -- have begun in-house training in
the Intacs procedure for their own doctors.
KeraVision, founded in 1986, is the developer of Intacs, the first FDA-
approved non-laser option for surgically treating mild myopia
(nearsightedness). Intacs are a safe and effective alternative to
eyeglasses, contact lenses and vision correction surgeries that
permanently alter the eye's central optical zone. The company's
patented technology platform is also being developed for the possible
treatment of other common vision problems including mild 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 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" set forth in Form 10-Q for
the quarter ended June 30, 1999, and Form 10-K for the year ended
December 31, 1998, as well as in other SEC filings.
# # #
Note to Editors: Intacs are a registered trademark or trademark of
KeraVision, Inc. in the U.S. and foreign countries
Contact:
KeraVision, Inc., Fremont
Mark Fischer-Colbrie, 510/353-3000 (Investors)
Mick Taylor, 510/353-3075 (Media)
www.keravision.com
Fax on Demand, 800/448-8559
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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,
--------------------- --------------------
1999 1998 1999 1998
---------- ---------- --------- ----------
<S> <C> <C> <C> <C>
Net sales........................... $4,188 $239 $8,569 $503
Costs and expenses:
Cost of sales and manufacturing
expenses........................ 2,915 1,155 7,530 3,104
Research and development......... 2,293 2,839 6,494 8,855
Selling, general and
administrative................ 4,258 2,129 12,429 5,781
---------- ---------- --------- ----------
Total costs and expenses............ 9,466 6,123 26,453 17,740
---------- ---------- --------- ----------
Operating loss...................... (5,278) (5,884) (17,884) (17,237)
Interest income and other, net...... 555 196 619 387
Interest expense.................... (227) 25 (607) 13
---------- ---------- --------- ----------
Net Loss............................ (4,950) (5,663) (17,872) (16,837)
Preferred stock dividends on:
Dividend on redeemable convertible
Series B Preferred stock.......... (369) (383) (1,144) (2,994)
---------- ---------- --------- ----------
Net loss applicable to common
stockholders...................... ($5,319) ($6,046) ($19,016) ($19,831)
========== ========== ========= ==========
Basic and diluted net loss per share
applicable to common stockholders.. ($0.32) ($0.48) ($1.34) ($1.57)
========== ========== ========= ==========
Shares used in calculation of
net loss per share................. 16,428 12,686 (14,201) 12,655
</TABLE>
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KERAVISION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
<TABLE>
<CAPTION>
September 30 December 31,
1999 1998
---------- ---------
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents................... $51,671 $1,449
Available-for-sale investments.............. 6,733 6,279
Accounts receivable, net.................... 663 365
Inventory................................... 1,705 427
Prepaid expenses and other current assets... 745 716
---------- ---------
Total current assets.......................... 61,517 9,236
Property and equipment, net 2,377 1,840
Other assets.................................. 100 108
---------- ---------
Total assets.................................. $63,994 $11,184
========== =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities 9,935 4,321
Capital lease obligations - non-current..... 568 821
Redeemable Convertible Series B Preferred
Stock..................................... 16,534 17,489
Total stockholders' equity
(net capital deficiency).................. 36,957 (11,447)
---------- ---------
Total liabilities and total stockholders'
equity (net capital deficiency)............ $63,994 $11,184
========== =========
</TABLE>
