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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): July 26, 1999
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SUMMIT TECHNOLOGY, INC.
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(Exact name of registrant as specified in charter)
MASSACHUSETTS 0-16937 04-2897945
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(State or other jurisdiction (Commission File Number) (I.R.S. Employer
of incorporation) Identification No.)
21 Hickory Drive, Waltham, MA 02451
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (781) 890-1234
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This is page 1 of 12 pages.
Exhibit Index on page 2.
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ITEM 5. OTHER EVENTS.
This Form 8-K is being filed solely for the purpose of filing the Exhibits
attached hereto.
EXHIBIT NUMBER TITLE
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99.1 Press Release, dated July 28, 1999, regarding Summit's
financial results for the second quarter of 1999.
99.2 Press Release of Summit, dated July 27, 1999.
99.3 Press Release of Summit, dated July 26, 1999.
-2-
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SIGNATURE
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 hereunto duly authorized.
SUMMIT TECHNOLOGY, INC.
By: /s/ ROBERT J. KELLY
------------------------
Robert J. Kelly
Executive Vice President
Date: July 29, 1999
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<PAGE> 1
EXHIBIT 99.1
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SUMMIT TECHNOLOGY, INC.
21 HICKORY DRIVE
WALTHAM, MASSACHUSETTS 02451
(781) 890-1234
For Immediate Release
SUMMIT TECHNOLOGY ANNOUNCES SECOND QUARTER FINANCIAL RESULTS LED BY
RECORD PROCEDURE VOLUME GROWTH
-- PROCEDURE VOLUME UP 100% OVER SECOND QUARTER 1998 --
Waltham, MA, July 28, 1999- Summit Technology, Inc. (NASDAQ: BEAM) said today
that its revenues for the three months ended June 30, 1999 increased 14% to
$27.4 million from $24.1 million for the three months ended June 30, 1998. The
second quarter 1999 results include the effects of operations of Autonomous
Technologies Corporation from the date of acquisition which was April 29, 1999.
In connection with the acquisition, Summit recorded one-time charges of $19.8
million for acquired in-process research and development and $2.8 million to
write-down inventory to its net realizable value. Excluding one-time charges,
the net loss for the second quarter of 1999 was $1.3 million, or $.03 per
diluted share. The net loss for the second quarter of 1999, including one-time
charges was $23.9 million, or $.61 per diluted share, compared to net income of
$31.2 million, or $1.00 per diluted share, for the second quarter of 1998. In
the second quarter of 1998, Summit received a $29.9 million litigation
settlement, net of taxes and related expenses.
Revenues for the six months ended June 30, 1999 were $53.1 million, an increase
of 15% over revenues of $46.1 million for the six months ended June 30, 1998.
The net loss for the first half of 1999, including the one-time charges
described above, was $21.5 million, or $.61 per diluted share, compared to net
income of $21.5 million, or $0.69 per diluted share for the first half of 1998.
The 1998 first half results also include a one-time non-cash charge of $10.1
million, or $0.32 per share, representing the cumulative effect of adopting a
new accounting principle as of January 1, 1998.
Second quarter 1999 procedure volume in the US, measured by the Company's sale
of OmniCards, increased 100% over the second quarter of 1998 and 14% over the
first quarter of 1999.
Last week the FDA Ophthalmic Advisory Panel recommended approval of the
Company's PMA application for treatment of high myopia and high astigmatism with
LASIK using the Summit Apex Plus Excimer Laser Workstation. When approved by the
FDA, this would give Summit the broadest indication in the US marketplace for
the treatment of myopia with or without astigmatism. The FDA also granted Summit
an IDE to initiate studies for customized ablations using its patented
CustomCornea(R) measurement device and its LADARVision system. Summit is the
only manufacturer to offer a choice of two FDA-approved excimer laser systems.
"We are pleased with the increase in procedure volume we experienced this
quarter," stated Robert J. Palmisano, Chief Executive Officer of Summit. "We
recently announced a public
<PAGE> 2
offering to sell 4,000,000 shares of our common stock, and with the proceeds we
will continue to execute our business plan to grow our market share and regain
leadership in this industry," commented Palmisano. "We believe that with
Summit's leading technology, customer focus and a broadening of FDA approvals,
procedures performed on our systems will continue to grow," he concluded.
Founded in 1985, Summit Technology is a leading developer, manufacturer and
marketer of ophthalmic laser systems and related products designed to correct
common vision disorders such as nearsightedness, farsightedness and astigmatism.
In 1995, Summit was the first excimer laser company to receive FDA approval for
its excimer laser system for the correction of mild to moderate myopia in the
U.S. Autonomous, a wholly owned subsidiary, is engaged in the design and
development of next-generation excimer laser instruments for laser refractive
surgery. The Company's LADARVision System combines laser radar eye tracking with
narrow beam shaping technology. In addition, through its wholly owned
subsidiary, Lens Express, Summit sells contact lenses and related products.
Cautionary Statement under "Safe harbor" Provisions of the Private Securities
Litigation Reform Act of 1995: Statements made in this news release contain
information about the Company's future business prospects. These statements may
be considered "forward looking". These statements are subject to risks and
uncertainties that could cause actual results to differ materially from those
set forth in or implied by such forward looking statements. Among these risks
and uncertainties are: competition from other manufacturers and vision
correction technologies, delays in obtaining regulatory approvals, challenges to
patents owned and licensed by the Company affecting per procedure revenues,
adverse litigation results, difficulties in commercializing the LADARVision
system and dependence on sole source suppliers. For additional information and
risks associated with the Company's business prospects and future operating
results, please refer to Summit's public filings with the Securities and
Exchange Commission.
For more information contact:
Kate Sturgis Burnham
Director, Investor Relations & Corporate Communications
Summit Technology, Inc.
(781) 672-0517
[email protected]
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SUMMIT TECHNOLOGY, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
<TABLE>
<CAPTION>
THREE MONTHS SIX MONTHS
ENDED JUNE 30, ENDED JUNE 30,
-------------------- ------------------
1999 1998 1999 1998
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<S> <C> <C> <C> <C>
Revenues:
Systems $ 4,394 $ 5,395 $ 7,729 $ 8,683
License fees, service and other 11,300 7,459 21,485 14,294
Contact lens and related products 11,707 11,246 23,871 23,163
--------------------------------------------------------
Total revenues 27,401 24,100 53,085 46,140
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Cost of revenues:
Cost of revenues 14,716 14,155 28,094 27,463
Inventory write-down 2,800 -- 2,800 --
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Total cost of revenues 17,516 14,155 30,894 27,463
Gross profit 9,885 9,945 22,191 18,677
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Operating expenses:
Selling, general and administrative 10,512 7,242 19,137 14,417
Research, development and regulatory 3,844 1,761 5,930 3,599
Acquired in-process research and development 19,800 -- 19,800 --
--------------------------------------------------------
Total operating expenses 34,156 9,003 44,867 18,016
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Operating income (loss) (24,271) 942 (22,676) 661
Litigation settlement, net of related expenses -- 34,386 -- 34,386
Interest income 626 938 1,712 1,866
Interest expense (82) (208) (196) (448)
Other income (expense) (116) 46 (232) 40
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Income (loss) before provision for income taxes (23,843) 36,104 (21,392) 36,505
Provision for income taxes 92 4,896 157 4,920
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Income (loss) before cumulative effect of
accounting principle change (23,935) 31,208 (21,549) 31,585
Cumulative effect of accounting principle
change, net of tax -- -- -- (10,103)
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Net income (loss) $(23,935) $ 31,208 $(21,549) $ 21,482
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Basic and diluted earnings (loss) per share:
Income (loss) before cumulative effect of
accounting principle change $ (0.61) $ 1.00 $ (0.61) $ 1.01
Cumulative effect of accounting principle
change, net of tax -- -- -- (0.32)
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Net income (loss) per share $ (0.61) $ 1.00 $ (0.61) $ 0.69
- ------------------------------------------------------------------------------------------------------------
Weighted average number of common shares:
Basic 39,362 31,277 35,219 31,288
Effect of dilutive options outstanding -- 50 -- 31
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Diluted 39,362 31,327 35,219 31,319
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</TABLE>
<PAGE> 4
SUMMIT TECHNOLOGY, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
<TABLE>
<CAPTION>
JUNE 30, DECEMBER 31,
1999 1998
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<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 11,845 $ 31,314
Short-term investments 15,548 33,295
Receivables, net of allowances 16,421 12,764
Inventories 20,581 17,403
Other current assets 3,341 5,965
--------------------------
Total current assets 67,736 100,741
Long-term investments 66,139 25,253
Property and equipment, net 13,634 8,802
Patents and other intangibles, net 10,321 7,497
Purchased technologies, net 27,788 --
Goodwill, net 54,966 --
Other assets 3,773 2,632
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TOTAL ASSETS $244,357 $144,925
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 8,226 $ 4,132
Accrued expenses 8,580 5,081
Current maturities of long-term debt 2,720 6,431
Deferred revenue 6,212 6,144
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Total current liabilities 25,738 21,788
Deferred revenue - noncurrent 4,033 3,653
Deferred tax liabilities 17,630 --
Long-term debt, less current maturities 202 150
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Total liabilities 47,603 25,591
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Commitments and contingencies
Stockholders' equity:
Preferred stock, $.01 par value. Authorized 5,000,000 shares, none
issued -- --
Common stock, $.01 par value. Authorized 100,000,000 shares;
issued 42,719,730 shares in 1999 and 31,322,880 shares in 1998;
outstanding 42,555,015 shares in 1999 and 31,153,765 in 1998 427 314
Additional paid-in capital 209,570 149,482
Accumulated deficit (41,768) (20,219)
Accumulated other comprehensive income (loss) 29,333 (9,411)
Treasury stock, at cost, 164,715 shares
in 1999 and 169,115 shares in 1998 (808) (832)
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Total stockholders' equity 196,754 119,334
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $244,357 $144,925
- -------------------------------------------------------------------------------------------------
</TABLE>
<PAGE> 1
EXHIBIT 99.2
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SUMMIT TECHNOLOGY, INC.
21 HICKORY DRIVE
WALTHAM, MASSACHUSETTS 02451
(781) 890-1234
For Immediate Release
SUMMIT TECHNOLOGY, INC. ANNOUNCES FDA APPROVAL TO INITIATE CUSTOM CORNEA
STUDIES WITH AUTONOMOUS LADARVISION SYSTEM
Waltham, Massachusetts, July 27, 1999 - Summit Technology, Inc. (NASDAQ Symbol:
BEAM) announced today that its Autonomous Technologies subsidiary had been
granted an Investigational Device Exemption (IDE) by the U.S. Food and Drug
Administration to begin investigational feasibility studies for customized
ablations using the combination of its patented CustomCornea(R) measurement
device and its LADARVision(R) System. The Company believes that its
CustomCornea(R) technology will provide surgeons with the ability to treat
ocular aberrations that cannot be detected or compensated for by existing
refractive systems. This application has the potential to provide outstanding
results that consistently exceed 20/20 vision. The study will include the
treatment of nearsightedness as well as farsightedness and astigmatism with both
photorefractive keratectomy (PRK) and laser in-situ keratomileusis (LASIK).
The results of the feasibility IDE study will provide the basis for an expanded
U.S. clinical trial which is necessary for FDA approval. The study will include
the treatment of a limited number of eyes using both PRK and LASIK and is
scheduled to begin in August.
THE RIGHT SHAPE TO MAKE
When performing laser vision correction, today's surgeons use a laser to flatten
or steepen the curvature of the patients cornea to enhance the patients vision.
However, the amount of change and final shape of the cornea is still largely
dependent on the same nineteenth century trial lens technology used when a
contact lens or spectacle prescription is measured.
"We believe that CustomCornea(R) will greatly improve the way in which the
optimal cornea shape is determined and applied to the cornea. The goal of
CustomCornea(R) is to set a new level of expectations for refractive outcomes
and to provide a significant
<PAGE> 2
increase in visual quality for all refractive patients," said Randy Frey,
President of Autonomous and Executive Vice President of Summit.
CustomCornea(R) represents the integration of advanced measurement technologies
with the LADARVision(R) System, and is the result of three years of product
development. CustomCornea(R) begins by pulsing a beam of light into the eye and
onto the retina. The light pulse is then reflected back through the cornea,
gathering individual properties of the optical path. The reflected light pulse
is analyzed by CustomCornea(R) and used to develop a custom corneal shape. This
custom shape is then applied to the cornea using the LADARVision(R) System. The
LADARVision(R) System's unique small beam and active eye tracker enable it to
precisely sculpt the cornea to the custom shape.
Founded in 1985, Summit Technology is a leading developer, manufacturer and
marketer of ophthalmic laser systems and related products designed to correct
common vision disorders such as nearsightedness, farsightedness and astigmatism.
In 1995, Summit was the first excimer laser company to receive FDA approval for
its excimer laser system for the correction of mild to moderate myopia in the
U.S. Autonomous, a wholly owned subsidiary, is engaged in the design and
development of next generation excimer laser instruments for laser refractive
surgery. The Company's LADARVision system combines laser radar eye tracking with
narrow beam shaping technology. In addition, through its wholly-owned
subsidiary, Lens Express, Summit sells contact lenses and related products.
Cautionary Statement under "Safe Harbor" Provisions of the Private Securities
Litigation Reform Act of 1995: Statements made in this report contain
information about the Company's future business prospects. These statements may
be considered "forward-looking." These statements are subject to risks and
uncertainties that could cause actual results to differ materially from those
set forth in or implied by such forward-looking statements. Among these risks
and uncertainties are: competition from other manufacturers and vision
correction technologies, delays in obtaining regulatory approvals, challenges to
patents owned and licensed by the Company affecting per procedure revenues and
adverse litigation results. For additional information and risks associated with
the Company's business prospects, and future operating results, please refer to
Summit's annual report on Form 10-K for the year ended December 31, 1998.
FOR MORE INFORMATION CONTACT:
Kate Sturgis Burnham
Director, Investor Relations & Corporate Communications
Summit Technology, Inc.
(781) 672-0517
[email protected]
<PAGE> 1
EXHIBIT 99.3
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SUMMIT TECHNOLOGY, INC.
21 HICKORY DRIVE
WALTHAM, MASSACHUSETTS 02451
(781) 890-1234
For Immediate Release
FDA PANEL RECOMMENDS APPROVAL OF SUMMIT LASER FOR WIDEST RANGES OF
MYOPIA AND ASTIGMATISM WITH LASIK
--FINAL APPROVAL PENDING FOR STATE-OF-THE-ART TECHNIQUE--
Waltham, Massachusetts, July 26, 1999 - Summit Technology, Inc. (NASDAQ
Symbol: BEAM) announced today that the Food and Drug Administration (FDA)
Ophthalmic Advisory Panel on July 23, 1999 recommended approval of the Company's
PMA (Pre-Market Approval) application for treatment of high myopia and high
astigmatism with LASIK using the Summit Apex Plus Excimer Laser Workstation. The
Panel recommended approval of the Summit system for up to 14.0 diopters (D) of
nearsightedness as well as an extended astigmatism range of up to 5.0 diopters.
Final acceptance of the Panel's recommendation by the FDA would result in Summit
having approval to treat the highest range of nearsightedness and astigmatism in
the industry. The Panel also recommended that the treatment ranges be made
available to persons 18 years of age or older. Summit is currently approved for
those older than age 21; this extension would expand the reach of Summit
physicians across the country, allowing them to treat more patients. The FDA
usually accepts the Panel's recommendations.
The Panel also endorsed the LASIK technique for treatment within
these expanded ranges. LASIK (laser-assisted in-situ keratomileusis) is a
technique that is already being widely practiced by a high percentage of
refractive surgeons and is gaining increasing acceptance because of high success
rates, minimal patient discomfort and low complication levels. During the
procedure, a skilled surgeon uses a special device called a microkeratome to
create a thin flap of tissue, about a third of the thickness of the
<PAGE> 2
cornea. Next, the laser is applied to resculpt the corneal surface beneath the
flap. Finally, the flap is repositioned over the treated area.
"We are extremely pleased with the Panel's recommendation. In addition
to the LASIK recommendation, the range of treatments available to surgeons using
our Apex Plus system will approximately double for myopic patients when approved
by the FDA. Every such approval increases our ability to compete and to succeed
in the very dynamic and exciting laser vision correction market," said Robert J.
Palmisano, Chief Executive Officer of Summit Technology. "We thank the Summit
physicians and study coordinators who participated in the clinical trials for
their dedication and strong commitment to this effort," he added.
The following table depicts the increased ranges that will be available
to Summit customers and their patients following final FDA approval.
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CURRENTLY UPON FDA APPROVAL
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Myopia 7.0D 14.0D
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Astigmatism +4.0D 5.0D
(with some limitations)
- ------------------------------------------------------------------------
Age 21 18
- ------------------------------------------------------------------------
Lower range of treatment 1.0D 0.0D
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"The LASIK technique has revolutionized refractive eye surgery," said
Dan Durrie, M.D. of Hunkeler Eye Centers, Kansas City, MO, who was a medical
monitor of the clinical studies and a presenter on Summit's behalf to the Panel.
"This procedure often provides immediate visual results with little or no
discomfort, resulting in a high degree of patient satisfaction."
Founded in 1985, Summit Technology is a leading developer, manufacturer
and marketer of ophthalmic laser systems and related products designed to
correct common vision disorders such as nearsightedness, farsightedness and
astigmatism. In 1995, Summit was the first excimer laser company to receive FDA
approval for its excimer laser system for the correction of mild to moderate
myopia in the U.S. Autonomous, a wholly owned subsidiary, is engaged in the
design and development of next generation excimer laser instruments for laser
refractive surgery. The Company's LADARVision
<PAGE> 3
system combines laser radar eye tracking with narrow beam shaping technology.
In addition, through its wholly-owned subsidiary, Lens Express, Summit sells
contact lenses and related products.
Cautionary Statement under "Safe Harbor" Provisions of the Private
Securities Litigation Reform Act of 1995: Statements made in this report contain
information about the Company's future business prospects. These statements may
be considered "forward-looking". These statements are subject to risks and
uncertainties that could cause actual results to differ materially from those
set forth in or implied by such forward-looking statements. Among these risks
and uncertainties are: competition from other manufacturers and vision
correction technologies, delays in obtaining regulatory approvals, challenges to
patents owned and licensed by the Company affecting per procedure revenues and
adverse litigation results. For additional information and risks associated with
the Company's business prospects, and future operating results, please refer to
Summit's annual report on Form 10-K for the year ended December 31, 1998.
For more information contact:
Kate Sturgis Burnham
Director, Investor Relations & Corporate Communications
Summit Technology, Inc.
(781) 672-0517
[email protected]
