EXHIBIT 99
LASERSIGHT ANNOUNCES THIRD QUARTER RESULTS
Provides Update on Products
Announces Management Changes
Winter Park, FL (November 14, 2000) - LaserSight Incorporated
(NASDAQ: LASE) today announced financial results for the three months and nine
months ended September 30, 2000. The Company also provided an update on the
regulatory status of its products and announced two key management changes.
Revenues for the third quarter increased approximately 15% to $8.0
million from $6.9 million in the third quarter of 1999. Revenues for the nine
months ended September 30, 2000 increased approximately 65% to $28.2 million
from $17.1 million in the comparable period of 1999.
For the quarter ended September 30, 2000, the Company reported a net
loss of $4.5 million, or $0.21 per share, compared to a net loss of $3.0
million, or $0.17 per share, reported for the third quarter of 1999. The average
common shares outstanding were 21,689,000 during the third quarter of 2000
compared to 17,455,000 in the third quarter of 1999.
The net loss for the nine months ended September 30, 2000 was $9.4
million, or $0.46 per share, compared to a net loss of $9.8 million reported for
the nine months ended September 30, 1999, or $0.62 per share. The average common
shares outstanding were 20,420,000 during the nine months ended September 30,
2000 and 15,691,000 in the comparable period of 1999. The Company's loss in 2000
is attributed to the investment in building the infrastructure necessary to
support the introduction of the LaserScan LSX(R) excimer laser system into the
U.S. market, developing, testing and launching the Company's MicroShape(TM)
family of keratome products and developing and testing the Company's Astra
family of products for CustomEyes(TM).
In the third quarter, the Company sold a total of 19 laser systems,
including nine systems into the U.S. market. During the previous quarters
ending March 31 and June 30, 2000, the Company sold a total of 19 and 30
LaserScan LSX excimer laser systems, respectively, with 6 and 17 of those
systems sold in the U.S., respectively. The Company's sales of laser systems
for the nine months ended September 30, 2000 were 68, an increase of
approximately 31% from the 52 systems sold in the comparable period of 1999.
Compared to the second quarter of 2000, revenues decreased
approximately 30% from $11.5 million. Laser system sales were affected by
delays in the approval of the Company's PMA supplement for astigmatism. As
previously announced, this PMA supplement was filed earlier this year for
expansion of approved clinical indications for the LaserScan LSX to include
myopia with astigmatism. Subsequent to that filing the FDA asked the Company to
provide additional information and clarifications. While the Company believes
that its responses address all open issues regarding approval of astigmatism,
it is not possible to provide an exact time frame within which LaserSight
anticipates receipt of the astigmatism approval. The addition of
astigmatism to LaserSight's approved clinical indications will be a
significant milestone with the potential to open the U.S. market for the
LaserScan LSX to approximately 80% of the refractive corrections currently
performed with excimer laser systems.
<PAGE>
Michael R. Farris, president and chief executive officer of LaserSight
commented, "While sales during the third quarter reflect the still pending FDA
approval, our activities during the quarter continued to confirm the high level
of interest and acceptance of the LSX by individual physicians, academic medical
centers and corporate providers. I believe that the refractive surgical
community has come to recognize the advantages of LaserSight's state-of-the-art
technologies for the planning and execution of refractive procedures. The
LaserScan LSX incorporates the features of low fluence, small spot size, and
high repetition rate precision beam scanning technology into what is being
recognized as the ideal platform for refractive procedures. We anticipate that
in 2001, the LSX will be fully approved for refractive procedures that include
treatment of myopia, hyperopia, astigmatism and mixed astigmatism utilizing the
LASIK procedure, and that the Company will commence and conclude U.S. clinical
trials utilizing the AstraPro(TM) planning software for CustomEyes(TM) custom
ablations."
In related matters, the Company expects that during this month it will
submit to the FDA a PMA supplement requesting the Agency's approval to expand
the approved indications for the LaserScan LSX to include the treatment of
myopia, hyperopia, astigmatism and mixed astigmatism utilizing the LASIK
procedure. The Company also confirmed that it filed a PMA supplement
requesting FDA approval for its AccuTrack(TM) eye tracking system. The advanced
pattern recognition eye tracking system is an upgradable feature already
incorporated into the standard international version of the LSX excimer
laser.
On October 31, 2000, the Company announced that the FDA approved
its PMA supplement related to its state-of-the-art manufacturing facility
in Winter Park, Florida. With receipt of this approval, LaserSight has
now resumed manufacturing and shipping its LaserScan LSX excimer laser systems
from this new manufacturing location.
LaserSight completed its quality evaluation for the 200 Hz
repetition rate version of the LaserScan LSX(R) precision beam scanning
spot excimer laser system, and by the end of this month will have provided
the 200 Hz upgrade to all LSX systems installed in the U.S. In commenting on
his experience with the 200 Hz version of the LSX, Gail Martin, M.D., of
Carolina Eye Associates, Southern Pines, NC, said, " Increasing the laser to
200 Hz really makes a flying spot scanning system extremely efficient. I am
seeing better quality and smoother interfaces, with 80 percent of the
patients treated at 200 Hz achieving one day post-operative best uncorrected
visual acuity (BUCVA) of 20/25 or better. The centration of ablations has
been excellent based on visual results and topographical analysis."
The Company's research and development in the Astra family of
products for CustomEyes(TM) custom ablation treatments further demonstrates
LaserSight's commitment to bringing innovative technology to the refractive
market. This family of products will include the AstraMax(TM) Diagnostic
Workstation designed to provide precise diagnostic measurements of the eye and
the AstraPro software, a surgical planning tool for planning custom treatments.
The Company has filed a 510(k) premarket notification for the AstraMax. Taking
diagnostic measurements of the cornea at advanced levels of precision is
critical for custom ablation planning. The AstraMax is a patented
stereo-camera based diagnostic instrument that utilizes a patent pending
polar grid image to acquire a number of diagnostic measurements of the cornea.
AstraPro is a surgical planning tool that will utilize advanced levels of
precise diagnostic measurements for the planning of custom ablation treatments
when approved. With an installed base of more than 350 systems, it is
LaserSight's intent to capture per procedure revenues related to the use of
CustomEyes(TM).
<PAGE>
Mr. Farris continued, "We have experienced delays in the commercial
launch of the Company's UltraShaper(TM) durable keratome and sales of the our
MicroShape keratome products. LaserSight's MicroShape product strategy is to
provide a full complement of keratome products centered around the UltraShaper
durable keratome and supported by the UniShaper(TM) single-use keratome
and UltraEdge(TM) keratome blades. The delays we have experienced in the
commercial launch of the durable keratome continue to impact sales of the
MicroShape product line. We are making significant progress with the field
evaluation of the UltraShaper, and during the AAO meeting one of the surgeons
evaluating the instrument reported his very positive results from an early
phase of our quality evaluation. As I have stated previously, LaserSight
remains committed to not only matching, but to advancing keratome technology
and will not commercially ship its durable keratome until it can satisfy this
commitment."
LaserSight is pleased to announce two important additions to its
management staff. Ms. Christine A. Oliver has joined the Company as senior
vice president with responsibility for sales, marketing, clinical
applications and training. Ms. Oliver brings to LaserSight a strong background
and experience in refractive technology, having spent the past four years with
Summit Autonomous Corporation initially as director of international
marketing & sales and then as vice president marketing & sales. Prior to
joining Summit Autonomous, Ms. Oliver was with Alcon Laboratories, where
she held several key positions including international marketing
management for Alcon's excimer refractive laser system project. Ms. Oliver
commented, "I believe that LaserSight's LaserScan LSX, with its precision beam
scanning spot technology and state-of-the-art eye tracking capability, is
the best platform for today's refractive surgical applications. In the future,
when the LSX is linked with the Company's Astra products for custom
ablations, the combination of precision scanning technology and the
CustomEyes(TM) approach to planning custom ablations will position LaserSight as
a leader in laser vision correction."
Mr. Edward (Ned) Luce has joined LaserSight as vice president -
regulatory affairs. Mr. Luce joins the Company's regulatory department headed by
L. Stephen Dalton, Ph.D. and has assumed responsibility for all regulatory
matters, both in the U.S. and internationally. Ned Luce brings with him 24 years
of experience in medical devices and has spent the major part of his career in
the areas of regulatory affairs and quality assurance. Most recently, Mr. Luce
was employed by Alcon Laboratories where, since 1985, he held several positions,
the latest having been assistant director of regulatory affairs.
Mr. Farris commented, "We are pleased to welcome Christine and
Ned to the LaserSight team. They are outstanding people who bring to LaserSight
a depth of experience and understanding of ophthalmic device technology that
will prove invaluable as the Company continues to drive towards capturing a
significant share of both the U.S. and international markets for laser vision
correction. LaserSight is truly fortunate that they recognized the
opportunity our technology presents, and have made the decision to contribute
to the Company's success during this important stage of growth and development."
<PAGE>
Mr. Farris concluded, "With the unprecedented growth in the market
for refractive systems and refractive procedures expected to continue,
LaserSight sees a significant market opportunity for its precision beam
scanning spot technology. In addition, the development and introduction of the
CustomEyes(TM) family of products for custom ablation into the refractive
market should serve to further increase the total market and present a
significant opportunity for LaserSight to leverage its advanced
technologies into product sales and a recurring revenue stream from
procedure-related fees."
LaserSight is a leading supplier of quality technology solutions
for laser vision correction. Its products include the LaserScan LSX
precision beam scanning spot system, its international research and
development activities related to the Astra family of products used to
perform custom blation procedures know as CustomEyes(TM) and its
MicroShape family of keratome products. The Astra family of products
includes the AstraMax diagnostic work station designed to provide precise
diagnostic measurements of the eye and the AstraPro software, a surgical
planning tool that utilizes advanced levels of diagnostic measurements for the
planning of custom ablation treatments. In the United States, the Company's
LaserScan LSX excimer laser system operating at 200 Hz is approved for the
treatment of low to moderate myopia by photorefractive keratectomy. The
Company has filed a 510(k) premarket notification for its AstraMax
diagnostic workstation and has begun international clinical testing of its
AstraPro planning software. The MicroShape family of keratome products
includes the UltraShaper durable keratome, the UniShaper single-use keratome and
UltraEdge keratome blades.
This press release contains forward-looking statements regarding future
events and future performance of the Company, including statements with
respect to anticipated sales revenue, regulatory approvals and
commercialization of products, which involve risks and uncertainties that
could materially affect actual results. Investors should refer to documents
that the Company files from time-to-time with the Securities and Exchange
Commission for a description of certain factors that could cause the actual
results to vary from current expectations and the forward looking statements
contained in this press release. Such filings include, without limitation, the
Company's Form 10-K, Form 10-Q and Form 8-K reports.
<PAGE>
Following are selected LaserSight financial results (in 000s except per share
data):
<TABLE>
<CAPTION>
Three Months Ended Nine Months Ended
September 30, September 30,
2000 1999 2000 1999
---- ---- ---- ----
<S> <C> <C> <C> <C>
Total Revenues $ 8,009 $ 6,942 $ 28,165 $ 17,091
Cost of Revenues 3,507 2,800 11,272 7,216
Gross Profit 4,502 4,142 16,893 9,875
Research, Development and Regulatory 1,096 767 3,346 2,257
Selling, General & Administrative 8,120 6,618 23,626 17,878
Loss from Operations (4,714) (3,243) (10,079) (10,260)
Other Income, Net 197 220 688 466
Net Loss $(4,517) $(3,023) $ (9,391) $ (9,794)
Loss per Common Share - Basic and Diluted $ (0.21) $ (0.17) $ (0.46) $ (0.62)
Weighted Average Number of Shares Outstanding 21,689 17,455 20,420 15,691
Selected balance sheet data (in 000s):
September 30, 2000 December 31, 1999
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Cash and Cash Equivalents $ 12,042 $ 11,248
Accounts and Notes Receivable (Current), Net 17,164 10,511
Total Current Assets 42,370 30,632
Total Current Liabilities 15,049 8,984
Long-Term Obligations 107 100
Stockholders' Equity 49,374 39,578
</TABLE>
