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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the Fiscal Year Ended December 31, 2004, |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the Transition period
from to . |
Commission File Number: 0-18053
Laserscope
(Exact name of Registrant as Specified in its Charter)
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California
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77-0049527 |
(State or Other Jurisdiction of
Incorporation or Organization) |
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(I.R.S. Employer
Identification No.) |
3070 Orchard Drive San Jose, California 95134-2011
(Address of Principal Executive Offices)
(408) 943-0636
Registrants telephone number, including area code:
Securities registered pursuant to Section 12(b) of the
Act:
None
Securities registered pursuant to Section 12(g) of the
Act:
Common Stock, no par value
Common Share Purchase Rights
(Title of Class)
Indicate by check mark whether the Registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the Registrant
was required to file such reports), and (2) has been
subject to such filing requirements for the past
90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers
pursuant to Item 405 of Regulation S-K is not
contained herein, and will not be contained to the best of
Registrants knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this
Form 10-K or any amendment to this
Form 10-K. þ
Indicate by check mark whether the registrant is an accelerated
filer (as defined in Rule 12b-2 of the
Act). Yes þ No o
The aggregate market value of the Registrants voting and
non-voting common equity held by non-affiliates of the
Registrant was approximately $502,185,257 as of June 30,
2004, based upon the closing sale price on the NASDAQ National
Market System reported for such date. Shares of Common Stock
held by each officer and director and by each person who owns 5%
of more of the outstanding Common Stock have been excluded in
that such persons may be deemed to be affiliates. This
determination of affiliate status is not necessarily a
conclusive determination for other purposes.
There were 22,006,738 shares of Registrants Common
Stock issued and outstanding as of March 1, 2005.
DOCUMENTS INCORPORATED BY REFERENCE
Part III of this Annual Report on Form 10-K
incorporates information by reference from the definitive proxy
statement for the Annual Meeting of Shareholders to be held on
June 10, 2005.
INTRODUCTORY STATEMENT AND REFERENCES
Some of the statements in this Annual Report on Form 10-K
(Form 10-K), including but not limited to the
Risk Factors, Managements discussion and
analysis of financial condition and results of operations,
Business and elsewhere in this document are
forward-looking statements within the meaning of the Private
Securities Litigation Act of 1995. These statements relate to
future events or our future financial performance and involve
known and unknown risks, uncertainties and other factors that
may cause our actual results, performance or achievements to be
materially different from those expressed or implied by any
forward-looking statements. In some cases, you can identify
forward-looking statements by terminology such as
may, will, could,
would, should, expect,
plan, anticipate, intend,
believe, estimate, predict,
potential or continue or the negative of
these terms or other comparable terminology. These statements
are only predictions. Actual events or results may differ
materially. Moreover, neither we nor any other person assumes
responsibility for the accuracy and completeness of those
statements. All forward-looking statements included in this
report are based on information available to us on the date
hereof, and we assume no obligation to update any such
forward-looking statements.
TABLE OF CONTENTS
REFERENCES
References made in this Report to Laserscope, the
Company, the Registrant, We,
Us, or Our refer to Laserscope and its
subsidiaries.
The following are registered trademarks of Laserscope, which may
be mentioned in this report:
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Laserscope; |
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Dermastat; |
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Opthostat; and |
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MicroBeam. |
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The following are common law trademarks and service marks of
Laserscope, which also may be mentioned in this report: |
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AccuStat;
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Lyra XP; |
ADD;
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MicronSpot; |
ADDStat,
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Microstat; |
Aura;
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Model 630 PDT Dye Module; |
Aura i;
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Model 630XP PDT Dye Module; |
Aura SL;
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Orion; |
Aura XP;
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SmartScan. |
Coolspot;
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SmartConnector; |
Dermastat;
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Solis |
Endostat;
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StarPulse; |
Gemini;
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StoneLight; |
GreenLight;
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Venus i; |
GreenLight PVP;
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Venus i; |
GreenLight PV;
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VersaStat; |
Lyra;
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VersaStat i; |
Lyra i;Venus; and
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800 Series KTP/YAG Surgical Laser System. |
1
PART I
General Overview of Business
Laserscope designs, manufactures, sells and services, on a
worldwide basis, an advanced line of medical laser systems and
related energy devices for the medical office, outpatient
surgical center and hospital markets. The Company is a pioneer
in the development and commercialization of lasers, and light
source and advanced fiber-optic devices for a wide variety of
applications. Our product portfolio consists of lasers and other
light-based systems and related energy delivery devices for
medical applications including KTP/532, Nd: YAG, and Er: Yag.
Our primary medical markets include urology, dermatology and
aesthetic surgery. Our secondary markets include ear, nose and
throat surgery, general surgery, gynecology, photo-dynamic
therapy and other surgical specialties.
Our corporate mission is to improve the quality and cost
effectiveness of health care by providing safe, innovative and
minimally invasive surgical systems.
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Basic Corporate Information |
Laserscope is a California corporation that was founded in 1982
and shipped its first product in 1984. During its initial years,
the Company was funded by several venture capital firms and by
E.I. du Pont de Nemours & Company. We received the
first in a series of United States regulatory clearances in 1987
and completed our initial public offering in December 1989.
Laserscope has three wholly owned subsidiaries, including
Laserscope UK, Ltd. a United Kingdom Corporation, Laserscope
France, S.A. a French Corporation and Laserscope International,
Inc., a Delaware corporation. Our principal executive offices
are located at 3070 Orchard Drive, San Jose, California
95134-2011. Our telephone number is (408) 943-0636. Our
website address is www.laserscope.com. Information on our
website, and websites linked to it, is not intended to be part
of this report.
Laserscope markets and sells products in two main market
segments including urology and aesthetics. The companys
aesthetic business focuses primarily on cosmetic treatments of
dermatology-related conditions.
The Companys principal urological product is the
GreenLighttm
laser system. In the first quarter of 2002, Laserscope began
selling the GreenLight laser system and
ADDStattm
disposable fiber-optic delivery device used to perform
photo-selective vaporization of the prostate (PVP)
for the treatment of benign prostatic hyperplasia
(BPH). Since that time, more than 700 urologists
collectively have performed more than 54,000 PVP procedures.
Adoption of this treatment continues to grow among urologists
within in the United States and international markets.
BPH affects more than 11 million men in the
U.S. According to the Millennium Research Group, in 2003
there were approximately 2.5 million men treated for the
condition in the United States and that number is expected to
grow to over 3 million men by 2008. Non-drug interventional
treatments in the U.S. during 2003 were estimated to be
over 293,000.
The PVP procedure using the
GreenLighttm
laser system has been clinically shown to often be a virtually
bloodless, minimally invasive, outpatient treatment that
typically provides dramatic improvement in urine flow and
symptom relief with a low incidence of side effects. Patients
are usually released within a few hours of the procedure, often
without a catheter. Patients can usually return to normal,
non-strenuous activities within a couple of days. Sales of the
GreenLight laser system represent approximately 20% of 2004
revenues and sales of ADDStat fibers for such system represents
approximately 26% of 2004 revenues. Sales of the GreenLight
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laser system and ADDStat disposable fibers are largely dependent
upon public and private health insurance reimbursement levels,
including Medicare and Medicaid and private health insurers,
which are subject to regular review and re-evaluation. Any
change in such reimbursement decisions would likely impact our
business significantly, and could substantially impact the
profitability of the GreenLight portion of the companys
business.
We entered the dermatology/aesthetic surgery market in the mid
1990s with several, highly versatile laser systems.
Laserscope has developed the unique VersaStat i hand
piece for use with its aesthetic lasers. It allows the operator
to continuously and easily adjust the spot size of the laser
from 1 to 5mm without changing hand pieces. The Aura
i is intended for the treatment of vascular lesions,
red veins on the face and legs, port wine stains and pigmented
lesions such as lentigos and sun-damage. Our Lyra i
is FDA cleared for the treatment of wrinkles, leg veins,
vascular lesions, pseudofolliculitis (shaving bumps) and hair
removal on all skin types. Another application for Laserscope
technology is the combined use of the Aura and the Lyra lasers
in a procedure known as Enhanced Skin Rejuvenation. Enhanced
Skin Rejuvenation uses both wavelengths to improve appearance by
addressing facial wrinkles as well as treating age spots and red
facial veins. Our Venus is used for skin resurfacing (wrinkle
removal) and laser peels to reduce wrinkles and improve skin
tone. Our
Geminitm
Laser System, introduced in February 2004, combines both the
wavelengths and pulsing characteristics of Laserscopes two
leading aesthetic products, the Aura and Lyra laser systems,
into a single, higher power and faster product platform. The
Gemini, is currently FDA-cleared for 21 different non-invasive
aesthetic applications. As a percentage of total revenues in
2004, the dermatology/aesthetic surgery market accounted for
approximately 37% of revenues.
Our products are also used in several other applications. Since
the early 1990s, the ear, nose and throat (ENT),
gynecology (OB/ GYN) and general surgery specialties have
continued to represent markets into which we sell our broad
range of laser systems and the majority of our energy delivery
devices and surgical instruments.
Our
GreenLighttm
laser system is a KTP single wavelength laser used for PVP, a
procedure to treat BPH. BPH is a non-cancerous enlargement of
the prostate gland. With age, the prostate, a walnut-size gland
located just below the bladder, squeezes the urethra as it grows
and restricts the flow of urine. BPH is a condition which
increases in incidence as the male population ages, and it is
estimated that 30 million men worldwide have this condition.
Our Lyra
itm
and Lyra
XPtm
laser systems are compact Nd:YAG, single wavelength lasers used
primarily for aesthetic procedures, including hair removal,
wrinkle treatments and leg vein treatments in physician offices.
Our Aura
itm
and Aura
XPtm
laser systems are compact, highly portable, KTP/532 single
wavelength lasers designed for office use. The Aura series
lasers integrated StarPulse feature is designed for the
treatment of benign vascular and pigmented lesions, including
leg and facial telangiectasia (spider-like veins) and pigmented
lesions such as age-spots or lentigos and acne. It can also be
used as a continuous wave laser for surgical applications that
include endoscopic blepharoplasty, rhinoplasty, facelifts,
tonsillectomy, wart removal and snoring cessation.
Our
Geminitm
laser system combines both the wavelengths and pulsing
characteristics of Laserscopes two leading aesthetic
products, the Aura and Lyra laser systems, into a single, higher
power and faster product platform. The Gemini is currently
FDA-cleared for 21 different clinical aesthetic applications.
Our Venus
itm
Erbium:YAG laser system is among the most compact and powerful,
commercially available Erbium lasers for micro-laser peels, skin
resurfacing and acne scar resurfacing. Venus is one-half the
size and weight of most other Erbium systems on the market.
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Our 800 Series KTP/ YAG Surgical Laser
Systemtm
is designed for use in hospitals. It is a high-power,
dual-wavelength system with applications in urology, general
surgery, and other surgical specialties. The 800
Series System, which provides up to 40 watts of KTP/532
energy and 100 watts of Nd:YAG energy, can also serve as a base
laser system for Laserscopes PDT laser dye module,
enabling photo-dynamic therapy applications.
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Laser Devices, Instruments and Disposables: |
We offer a broad line of surgical instrumentation, disposables,
kits and other accessories for use with our surgical laser
systems. These products include disposable optical fibers,
side-firing devices, individual custom hand pieces for specific
surgical applications, scanning devices, micromanipulators for
microscopic surgery, procedure-specific kits and accessories and
various other devices.
Laserscopes
ADDStattm
disposable fiber-optic delivery device is used primarily in the
PVP procedure by delivering over 80 watts of average power from
the
GreenLighttm
laser system to vaporize the soft tissue in the prostate gland.
Our disposable optical fibers are available in different lengths
and diameters for different surgical applications and
preferences. The hand pieces, which are used to hold and aim the
optical fiber, give the doctor the feel of a traditional
surgical tool. When used in contact with body tissue, they
provide tactile feedback similar to conventional surgery.
We concentrate much of our marketing efforts for our products on
high volume surgical procedures treating conditions of aging
such as the treatment of BPH, facial vascular lesions, the
treatment of leg veins and hair removal. We believe that
increased market awareness of both the benefits of
Laserscopes laser procedures and the drawbacks of
conventional procedures is one of the most important factors in
expanding the market for our laser and laser-based products. As
a result, we have designed our marketing and sales strategy
around a strong educational and clinical training effort to
promote awareness of the versatility, safety, and
cost-effectiveness of our surgical laser systems and to increase
the likelihood of positive clinical outcomes.
We promote our products through trade shows and exhibits
covering most of the surgical specialties, physician workshops
and seminars, medical journal advertising and direct mailings.
We support and participate in a substantial number of workshops
and seminars. For laser products, the workshops usually include
a demonstration of our laser systems and often provide surgeons
with hands-on experience using our products.
In the United States, we distribute our products to hospitals,
outpatient surgical centers and physician offices through our
own direct sales force and through the McKesson Corporation
Medical Group (McKesson). In December 2000, we
signed a distribution agreement that grants to McKesson the
exclusive distribution rights for our core aesthetic laser
products in the United States. In 2004, revenue from sales to
McKesson represented approximately 23% of total 2004 revenues.
McKessons Primary Care Division has a sales force of more
than 500 representatives throughout the United States who are
supported by our own direct sales force.
Our direct sales force at December 31, 2004 consisted of 39
representatives worldwide.
In the United Kingdom and France, we distribute our products to
hospitals, outpatient surgical centers and physician offices
through our own direct sales force. Elsewhere, we sell our
products through regional distributor networks throughout
Europe, the Middle East, Latin America, Asia and the Pacific
Rim. Laserscope is both ISO 9001 and CE certified.
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Revenues from Europe, Asia and the Pacific Rim continue to
account for a large percentage of total sales. Our international
operations, including export sales were 27% of total revenues in
the year ended December 31, 2004, and 26% of total revenue
in each of the years ended December 31, 2003 and 2002. We
expect that international sales will continue to represent a
significant percentage of net revenue in 2005 and beyond.
International revenues are heavily concentrated in Europe.
During 2004 revenues from sales in Europe represented
approximately 21% of total revenues compared to approximately
19% in 2003 and approximately 20% in 2002. Revenues from sales
in the Asia Pacific region represented approximately 5% of total
sales in 2004, compared to approximately 6% in 2003 and
approximately 5% in 2002. Revenues from sales in the rest of the
world represented approximately 1% of total revenues in each of
2004, 2003 and 2002.
We have more than 8,000 laser systems installed worldwide. The
installed base provides a market for service as well as the sale
of devices, instruments and disposables.
We have a direct field service organization that provides
service for our products. We generally provide a twelve month
warranty on our laser systems. After the warranty period,
maintenance and support is provided on a service contract basis
or on an individual call basis. Our warranties and premium
service contracts provide for a 99.0% Uptime
Guarantee on our laser systems. Under provisions of this
guarantee, at the request of the customer, we extend the term of
the related warranty or service contract if specified system
uptime levels are not maintained.
We operate in an industry that is subject to rapid technological
changes. Our ability to remain competitive in our industry
depends on, among other things, our ability to anticipate and
react to such technological changes. To this end, we have
assembled a team of engineers with significant experience in the
design and development of medical devices using lasers and
light-based energy sources. Therefore, we intend to continue to
invest significant amounts in research and development. Research
and development expenditures totaled $5.2 million in 2004,
$4.4 million in 2003 and $3.8 million in of 2002. At
December 31, 2004, we had 23 employees engaged in the
engineering related activities of research and development. We
expect to identify and hire additional technical personnel in
fiscal year 2005 to staff our planned research and development
activities, and we expect that these costs will increase in the
future in order to maintain a leading position in the market for
surgical laser systems.
Our current research and development programs are directed
toward the development of new laser systems and delivery
devices, enhancements to existing products and new clinical
applications in the aesthetic, urology and other specialties.
We manufacture in the United States the laser resonators, system
chassis and certain accessories including disposable products
and re-usable hand pieces used in our laser systems. Our laser
manufacturing operations concentrate on the assembly and test of
components and subassemblies manufactured to our designs and
specifications by outside vendors. Approximately 24% of our
employees work in manufacturing our products. We believe that we
have sufficient manufacturing capacity in our present facilities
to support current operations at least through the end of 2005.
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At December 31, 2004, Laserscope had 229 employees,
including 74 in sales and marketing, 23 in engineering, 95 in
manufacturing operations and service, 37 in general and
administrative functions. These numbers include 31 sales and
marketing and other employees located outside of the United
States. We believe that we maintain competitive compensation,
benefit, equity participation and work environment policies to
assist in attracting and retaining qualified personnel. We also
believe that the success of our business will depend, in part,
on our ability to attract and retain such personnel, who are in
great demand. We believe that our future success will depend in
part on our continued ability to attract, hire and retain
qualified personnel. None of our employees are represented by a
labor union, and we believe our employee relations are good.
We compete in the non-ophthalmic surgical segment of the
worldwide medical laser market. In this market, lasers are used
in hospital operating rooms, outpatient surgery centers and
individual physician offices for a wide variety of procedures.
This market is highly competitive with respect to both our
aesthetic and urology product lines. Our competitors are
numerous and include some of the worlds largest
organizations as well as smaller, highly specialized firms. Our
primary competition in the field of urology comes from
alternative procedures and technologies for the treatment of
PVP, principally those manufacturers producing technologies for
performance of the Transurethral Resection of the Prostate
(TURP) procedure, and the so-called thermal
therapies offered by large medical device manufacturers
such as Medtronic, Boston Scientific and Johnson &
Johnson. In addition, we face competition from other surgical
laser companies such as Lumenis and Trimedyne which offer what
we believe are less efficacious but less costly procedures for
the treatment of PVP such as Holmium Laser Ablation of the
Prostate. Our primary competition in the aesthetic market which
is marked by a growing number of competitive companies,
approximately similar clinical results between the various
products, and an increasingly wider variety of cosmetic services
includes companies such as Palomar, Candela, Cutera and Syneron.
Our ability to compete effectively depends on such factors as:
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market acceptance of our products; |
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product performance; |
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price; |
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customer support and technical service; |
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the success and timing of new product development; and |
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continued development of successful distribution channels. |
As we continue to introduce new technologies, we may face
competition from both existing surgical laser and other medical
device companies and new ones entering the market segments in
which we compete. We may also face competition from companies
that currently offer non-surgical solutions, such as
pharmaceutical companies. Some of our current and prospective
competitors have or may have significantly greater financial,
technical, research and development, manufacturing and marketing
resources than we have. To compete effectively, we will need to
continue to expand our product offerings, periodically enhance
our existing products and continue to enhance our distribution.
Certain surgical laser manufacturers have targeted their efforts
on narrow segments of the market, such as angioplasty,
orthopedics, and lithotripsy. Their products may compete for the
same capital equipment funds as our products, and accordingly,
these manufacturers may be considered our competitors as well.
Generally, surgical laser manufacturers such as Laserscope
compete with standard surgical methods and other medical
technologies and treatment modalities, such as the TURP
procedure and pharmaceuticals in the urology market and other
light based or radio frequency based products in the aesthetic
market. We cannot assure that we can compete effectively against
such competitors. In addition, we cannot assure that these or
other companies will not succeed in developing technologies,
products or treatments that are more effective than ours or that
would render our technology or products obsolete or
non-competitive.
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Proprietary and Intellectual
Property
We rely on a combination of nondisclosure agreements and other
contractual provisions, as well as patent, trademark, trade
secret and copyright law to protect our proprietary rights. Our
general policy has been to seek patent protection for those
inventions and improvements likely to be incorporated in our
technologies or otherwise expected to be of value. We have an
active program to protect our proprietary technology through the
filing of patents.
As of December 31, 2004, we had 35 U.S. patents issued
and 8 U.S. patent applications on file with the
U.S. Patent and Trademark Office (USPTO), which generally
cover surgical laser systems, delivery devices, calibration
inserts, and laser resonators. We expect that once granted, the
duration of patents covered by patent applications will be
approximately 20 years from the filing of the application.
These patents will allow us to prevent others from infringing on
some of our core technologies. We intend to continue to file
patent applications as appropriate in the future. We cannot be
sure, however, that our pending patent applications will be
allowed, that any issued patents will protect our IP or will not
be challenged by third parties, or that the patents of others
will not seriously harm our ability to do business. In addition,
others may independently develop similar or competing technology
or design around any of our patents. We also have not secured
patent protection in foreign countries, and we cannot be certain
that the steps we take to prevent misappropriation of our
intellectual property abroad will be effective.
While we believe the patents that we have and for which we have
applied are of value, other factors are of greater competitive
importance. In addition to patent protection, at
December 31, 2004, we had 5 U.S. trademarks
registered and 10 pending U.S. trademark applications
on file with the USPTO. If the applications mature to
registrations, these registrations would allow us to prevent
others from using other similar marks on similar goods and
services in the U.S. We cannot be sure, however, that the
USPTO will issue trademark registrations for any of our pending
applications. Further, any trademark rights we hold or may hold
in the future may be challenged or may not be of sufficient
scope to provide meaningful protection.
We protect our trade secrets and other proprietary information
through nondisclosure agreements with our employees and
customers and other security measures, although others may still
gain access to our trade secrets or discover them independently.
Although we believe that our technologies do not infringe on any
other proprietary rights of third parties, from time to time,
third parties, including our competitors, may assert patent,
copyright and other intellectual property rights to technologies
that are important to us.
For more information regarding patents and licenses, please see
Risk Factors regarding our reliance on patents and licenses.
Government regulation in the United States and other countries
is a significant factor in the development, manufacturing and
marketing of many of our products.
Laserscope and its products are regulated in the United States
by the Food and Drug Administration under the Federal Food, Drug
and Cosmetic Act (the FDC Act) and the Radiation
Control for Health and Safety Act. The FDC Act provides two
basic review procedures for medical devices. Certain products
qualify for a Section 510(k) (510(k)) procedure
under which the manufacturer gives the FDA pre-market
notification of the manufacturers intention to commence
marketing the product. The manufacturer must, among other
things, establish that the product to be marketed is
substantially equivalent to a previously marketed
product. In some cases, the manufacturer may be required to
include clinical data gathered under an investigational device
exemption (IDE) granted by the FDA allowing human
clinical studies.
There can be no assurance that the FDA will grant marketing
clearance for our future products on a timely basis, or at all.
Delays in receiving such clearances could have a significant
adverse impact on our ability to compete in our industry. The
FDA may also require post-market testing and surveillance
programs to monitor certain products.
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Certain other countries require medical device manufacturers to
obtain clearances for products prior to marketing the products
in those countries. The requirements vary widely from country to
country and are subject to change.
We are also required to register with the FDA and state
agencies, such as the Food and Drug Branch of the California
Department of Health Services (CDHS), as a medical device
manufacturer. We are inspected routinely by these agencies to
determine our compliance with the FDAs current Good
Manufacturing Practice regulations. Those regulations
impose certain procedural and documentation requirements upon
medical device manufacturers concerning manufacturing, testing
and quality control activities. If these inspections determine
violations of applicable regulations, the continued marketing of
any products manufactured by us may be adversely affected.
In addition, our laser products are covered by a performance
standard for laser products set forth in FDA regulations. The
laser performance standard imposes certain specific
record-keeping, reporting, product testing, and product labeling
requirements on laser manufacturers. These requirements also
include affixing warning labels to laser systems, as well as
incorporating certain safety features in the design of laser
products.
Complying with applicable governmental regulations and obtaining
necessary clearances or approvals can be time consuming and
expensive. There can be no assurance that regulatory review will
not involve delays or other actions adversely affecting the
marketing and sale of our products. We also cannot predict the
extent or impact of future legislation or regulations.
In addition, the prices we are able to charge for our urology
products are highly dependent on government reimbursement of
hospitals and physicians for health care costs, including, but
not limited to, reimbursement of capital equipment costs.
Reductions or delays in such insurance coverage or reimbursement
may negatively impact hospitals and physicians
decisions to purchase our products or adopt procedures such as
the PVP, adversely affecting our future sales. The Centers for
Medicare and Medicaid Services (CMS) has announced a
final rule with respect to Ambulatory Payment Classification
(APC) reimbursement codes used by hospitals to bill
Medicare for the PVP procedures. Additional APC codes for
reimbursement of the PVP procedure in other settings and by
other providers are currently under review. All APC codes are
subject to review and adjustment by CMS. In addition, government
reimbursement rates in the United States and abroad, strongly
influence the reimbursement rates provided by private health
insurance companies and, therefore, are critical to our success.
Such government regulation of public healthcare financing
(including the establishment of reimbursement codes) does not
impact our laser sales for aesthetic procedures in the same way
as these procedures are generally not subject to reimbursement
by government or private health insurance.
Our operations are also subject to various federal, state and
local environmental protection regulations governing the use,
storage, handling and disposal of hazardous materials, chemicals
and certain waste products. In the United States, we are subject
to the federal regulation and control of the Environmental
Protection Agency. Comparable authorities are involved in other
countries. We believe that compliance with federal, state and
local environmental protection regulations will not have a
material adverse effect on our capital expenditures, earnings
and competitive and financial position.
Although we believe that our safety procedures for using,
handling, storing and disposing of such materials comply with
the standards required by state and federal laws and
regulations, we cannot completely eliminate the risk of
accidental contamination or injury from these materials.
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Dependence on Single-Source Suppliers and Certain Third
Parties |
Certain of the components used in our laser products, including
certain optical components, are purchased from single sources.
These single-source suppliers are located in both the United
States and overseas. During early 2003, we experienced a supply
disruption of certain key components. Since then we have not
experienced any significant disruptions. While we believe that
most of these components are available
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from alternate sources, an interruption of these or other
supplies could adversely affect our ability to manufacture
lasers.
We have from time to time experienced seasonal fluctuations in
our business. During the months of July and August, certain of
our international markets have exhibited slowdowns in the
aesthetics business.
As of December 31, 2004 and 2003, we had firm orders in our
backlog worth approximately $3.8 million and
$4.1 million, respectively. We completely exhausted in 2004
the backlog that existed at the end of 2003, and we plan to
completely exhaust during 2005 the backlog that existed at the
end of 2004.
Executive Officers of the Company
The following sets forth certain information with respect to the
executive officers of the Company as of December 31, 2004:
|
|
|
|
|
|
|
Name |
|
Age | |
|
Position |
|
|
| |
|
|
Robert J. Pressley, Ph.D.
|
|
|
72 |
|
|
Chairman of the Board of Directors |
Eric M. Reuter
|
|
|
43 |
|
|
President, Chief Executive Officer and Director |
Robert Mann
|
|
|
47 |
|
|
Group Vice President, Global Sales and Marketing |
Robert L. Mathews
|
|
|
59 |
|
|
Group Vice President, Operations and Product Development |
Ken Arnold
|
|
|
35 |
|
|
Vice President, Research and Development |
Van Frazier
|
|
|
52 |
|
|
Vice President, Quality and Regulatory Affairs |
Peter Hadrovic
|
|
|
38 |
|
|
Vice President, Legal Affairs and General Counsel |
Dennis LaLumandiere
|
|
|
51 |
|
|
Vice President, Finance, Chief Financial Officer and Secretary |
Kester Nahen, Ph.D.
|
|
|
34 |
|
|
Vice President, Professional Education and Clinical Applications |
Robert J. Pressley, Ph.D. is a co-founder of the
Company and has been a director since its founding.
Dr. Pressley was appointed Chairman of the Board of
Directors in June 1998. Dr. Pressley co-founded Candescent
Technologies Corporation (formerly named Silicon Video
Corporation), a developer of electronic products, and served as
its President and Chief Executive Officer from January 1991 to
January 1994. Dr. Pressley also founded XMR, Inc., a
manufacturer of excimer lasers and laser systems, and served as
its Chief Executive Officer from March 1979 until March 1990.
Dr. Pressley has been a self-employed technology consultant
since January 1995.
Eric M. Reuter joined Laserscope as Vice President,
Research and Development in September 1996 and was appointed
President and Chief Executive Officer of the Company in June
1999. Prior to joining Laserscope, from February 1994 to August
1996, Mr. Reuter was employed at the Stanford Linear
Accelerator Center at Stanford University (SLAC) as the
Project Engineer for the B-Factory High Energy Ring, an electron
storage ring used for high energy physics research. From
February 1991 to January 1994, he served as a Senior Staff
Engineer and Program Manager in digital imaging at Siemens
Medical Systems Oncology Care Systems, a medical
device company.
Robert Mann joined Laserscope in May 2001 as Director of
Physician Practice Enhancement. Mr. Mann served as Senior
Director of North American Aesthetic Sales from December 2001 to
October 2002, was appointed Vice President , North American
Sales and Marketing in October 2002 and was appointed Group Vice
President, Global Sales and Marketing in December 2004. Prior to
joining Laserscope, Mr. Mann served
9
as National Director of Operations for Vanishing Point Medical
Group, a Multi-Specialty Laser Aesthetics practice from January
1999 to May 2001, Vice President of Operations at Pasqua Coffee,
a retail food service company, from January 1989 to May 1998 and
as Vice President of Operations at Mrs. Fields Cookies, a
retail food service company, from April 1981 to January 1989.
Robert L. Mathews joined Laserscope as Executive Vice
President in August 1999 and was appointed Group Vice President,
Operations and Product Development in December 2004. Before
joining Laserscope, from December 1998 to August 1999, he was
Executive Vice President & General Manager of the
MasterPlan Division of COHR, Inc., a management consulting and
independent service organization. From April 1997 to December
1998, he was Vice President and General Manager of Diasonics
Vingmed Ultrasound, Inc., a medical device manufacturer. From
April 1996 to April 1997, he was Senior Director, Corporate
Accounts at Spacelabs Medical, Inc., a medical device
manufacturer. From May 1995 to April 1996, Mr. Mathews was
a self employed business consultant and from February 1994 to
May 1995 he was President and Chief Executive Officer of Resonex
Holdings Ltd., a medical device manufacturer.
Ken Arnold joined Laserscope as a Manufacturing Engineer
in March 1996. Mr. Arnold served as a Design Engineer from
April 1997 to July 1999, Director of Engineering and Technology
from July 1999 to October 2001 and as Vice President of Research
and Development since October 2001. Prior to joining Laserscope,
from 1993 to 1996, he was a Program Manager and Design Engineer
at United Defense LP, a major defense contractor.
Van Frazier joined Laserscope as Director of Quality
Assurance in January 1999 and was appointed Vice President,
Quality and Regulatory Affairs in June 1999. Before joining
Laserscope, from October 1997 to January 1999, he was Director
of Quality Assurance and Regulatory Affairs of St. Jude Medical,
a medical device manufacturer. From January 1996 to October
1997, Mr. Frazier held various regulatory management
positions at Telectronics Pacing Systems, a medical device
manufacturer and from November 1991 to January 1996, he was
Regulatory Compliance Manager for Physio-Control, a medical
device manufacturer.
Peter Hadrovic joined Laserscope in December 2004 as Vice
President, Legal Affairs and General Counsel. Prior to joining
the Company, he was a corporate, securities and mergers and
acquisitions attorney at Heller Ehrman/ Venture Law Group from
June 2000 to December 2004. From September 1997 to June 2000,
Mr. Hadrovic was a corporate transactional attorney at
White & Case LLP. Mr. Hadrovic received a J.D.
from Cornell Law School in 1997. From 1988 to 1991,
Mr. Hadrovic served as a Legislative Assistant, and from
1992 to 1994 as the District Representative, to
U.S. Congressman John LaFalce.
Dennis LaLumandiere joined Laserscope in September 1989
as Corporate Controller. Mr. LaLumandiere has served as
Vice President, Finance since February 1995, Chief Financial
Officer since February 1996, Assistant Secretary from November
1996 to October 2001 and Secretary since October 2001. Prior to
joining Laserscope, from 1983 to 1989, Mr. LaLumandiere
held various financial and operations management positions at
Raychem Corporation, a multinational materials science company.
Kester Nahen joined Laserscope as Laser Scientist in May
2001. Dr. Nahen served as Clinical Product Manager from
October 2002 to October 2003, as Director of Professional
Education and Clinical Applications from October 2003 to
December 2004 and was appointed Vice President of Professional
Education and Clinical Applications in December 2004. Prior to
joining Laserscope, from March 1996 to May 2001, he worked as
Scientist at the Medical Laser Center Lübeck an institute
of the Medical University of Lübeck in Lübeck, Germany
focusing on fundamental and applied research in biomedical
optics. Dr. Nahen received his M.S. in Physics from the
University of Hamburg, Germany in March 1996 and his Ph.D. in
Physics from the Medical University of Lübeck, Germany in
October 2001.
Available Information
We make available free of charge, on or through our website at
www.laserscope.com, our annual, quarterly and current reports,
and any amendments to those reports, as soon as reasonably
practicable after electronically filing such reports with the
Securities and Exchange Commission. Those reports are also
10
available on the SEC website located at www.sec.com. Information
contained on our website is not part of this report.
Laserscope leases two buildings aggregating approximately
69,000 square feet in San Jose, California under
leases expiring in October 2012. Laserscope occupies an
additional approximately 10,000 square feet in an adjacent
building in San Jose through a holdover tenancy which is
anticipated to run through the end of June 2005. We have options
to extend the leases at the then-current market rates. These
facilities house our research and development and manufacturing
operations as well as our principal sales, marketing, service
and administrative offices. We also lease offices in the United
Kingdom, France and South Korea where our local sales and
marketing staff are based. We believe that these facilities are
suitable for our current operations and are adequate to support
those operations beyond 2005.
|
|
Item 3. |
Legal Proceedings. |
Not Applicable.
|
|
Item 4. |
Submission of Matters to a Vote of Security
Holders. |
Not Applicable.
PART II
|
|
Item 5. |
Market for the Registrants Common Stock and Related
Shareholder Matters and Issuers Purchases of Equity
Securities. |
Our common stock is traded on the Nasdaq National Market under
the symbol LSCP. As of March 1, 2005, Laserscope had
approximately 550 shareholders of record and the last
reported sale of our Common Stock on the Nasdaq National Market
was $33.52 per share.
The following table shows Lasercopes high and low selling
prices for the years ended December 31, 2004 and
December 31, 2003 as reported by the Nasdaq National Market
System:
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
|
| |
|
|
High Bid | |
|
Low Bid | |
|
|
| |
|
| |
First Quarter
|
|
$ |
27.85 |
|
|
$ |
14.91 |
|
Second Quarter
|
|
$ |
34.18 |
|
|
$ |
22.54 |
|
Third Quarter
|
|
$ |
27.94 |
|
|
$ |
15.27 |
|
Fourth Quarter
|
|
$ |
36.68 |
|
|
$ |
18.83 |
|
|
|
|
|
|
|
|
|
|
|
|
2003 | |
|
|
| |
|
|
High Bid | |
|
Low Bid | |
|
|
| |
|
| |
First Quarter
|
|
$ |
5.30 |
|
|
$ |
3.76 |
|
Second Quarter
|
|
$ |
8.20 |
|
|
$ |
3.90 |
|
Third Quarter
|
|
$ |
12.99 |
|
|
$ |
7.50 |
|
Fourth Quarter
|
|
$ |
18.15 |
|
|
$ |
10.64 |
|
We have not paid dividends on our common stock and have no
present plans to do so. Provisions of our bank line of credit
prohibit the payment of dividends without the banks
consent.
To address our capital needs in 2000, we completed a private
placement of our Common Stock pursuant to Regulation D of
the Securities Act of 1933, as amended, to accredited investors
providing gross proceeds of approximately $1.9 million to
Laserscope. The transaction consisted of two closings. The first
was approximately $1.1 million in gross proceeds in
exchange for 1,505,000 shares of Laserscope common stock,
which closed on December 30, 1999. The second closing was
for approximately $0.8 million in exchange for
11
995,000 shares of Laserscope common stock which closed on
January 14, 2000. The shares had no par value and were
issued at a price of $0.80 per share. We also issued
warrants to purchase 218,875 shares of common stock on
the date of the second closing which were convertible into
shares of Laserscopes common stock at $1.25 per share
and which would expire in 2005. At December 31, 2004, no
warrants issued pursuant to the private placement of Common
Stock remained outstanding.
On February 11, 2000, we completed a private placement of
subordinate convertible debentures pursuant to Regulation D
of the Securities Act of 1933, as amended, to affiliates of
Renaissance Capital Group, Inc. (Renaissance) with
gross proceeds to Laserscope of $3.0 million. The
debentures were to mature seven years from issuance and had an
interest rate of 8.00%. The debentures were convertible into
Laserscope common stock with an initial conversion price, which
was subject to adjustment, of $1.25. The private placement also
included warrants to purchase 240,000 shares of Laserscope
common stock at $1.50 per share and expire in 2005. As of
December 31, 2004, 10,000 warrants issued pursuant to the
private placement of subordinate convertible debentures remained
outstanding.
The proceeds from both of these financings were used for general
corporate working capital purposes.
In the first six months of 2003, $400,000 of the debentures were
converted to 320,000 shares of Laserscope common stock by
Renaissance. During the last six months of 2003, Renaissance
converted the remaining $2.6 million of debentures into
2,080,000 shares of Laserscope common stock.
The equity compensation plan information required to be provided
in this Annual Report on Form 10-K is incorporated by
reference to the Companys proxy statement for the 2005
Annual Meeting of Stockholders to be filed with the Securities
and Exchange Commission within 120 days after the end of
our fiscal year ended December 31, 2004.
|
|
Item 6. |
Selected Financial Data. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31 | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
2000 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Thousands, except per share amounts) | |
Consolidated Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$ |
93,770 |
|
|
$ |
57,427 |
|
|
$ |
43,088 |
|
|
$ |
35,087 |
|
|
$ |
35,399 |
|
Net income (loss)
|
|
|
14,739 |
|
|
|
2,517 |
|
|
|
323 |
|
|
|
(829 |
) |
|
|
186 |
|
Basic net income (loss) per share
|
|
|
0.70 |
|
|
|
0.13 |
|
|
|
0.02 |
|
|
|
(0.05 |
) |
|
|
0.01 |
|
Diluted net income (loss) per share
|
|
|
0.65 |
|
|
|
0.13 |
|
|
|
0.02 |
|
|
|
(0.05 |
) |
|
|
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31 | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
2000 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Thousands, except per share amounts) | |
Consolidated Balance Sheet Data (at end of period): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash & cash equivalents
|
|
$ |
15,954 |
|
|
$ |
7,158 |
|
|
$ |
4,661 |
|
|
$ |
3,408 |
|
|
$ |
2,698 |
|
Working capital
|
|
|
38,566 |
|
|
|
20,722 |
|
|
|
15,652 |
|
|
|
13,336 |
|
|
|
14,793 |
|
Total assets
|
|
|
61,589 |
|
|
|
37,028 |
|
|
|
29,163 |
|
|
|
25,482 |
|
|
|
24,087 |
|
Capital leases (excluding current portion)
|
|
|
31 |
|
|
|
|
|
|
|
60 |
|
|
|
60 |
|
|
|
277 |
|
Other long term debt
|
|
|
|
|
|
|
|
|
|
|
2,853 |
|
|
|
3,000 |
|
|
|
3,000 |
|
Shareholders equity
|
|
|
42,911 |
|
|
|
23,198 |
|
|
|
15,482 |
|
|
|
13,412 |
|
|
|
14,114 |
|
|
|
Item 7. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations. |
Our discussion and analysis of Laserscopes financial
condition, results of operations, and cash flows are based upon
Laserscopes consolidated financial statements, which have
been prepared in accordance with accounting principles generally
accepted in the United States of America. The preparation of
these financial statements requires us to make estimates and
judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosure of
contingent assets and liabilities. On an on-going basis, we
evaluate these estimates, including those related to bad debts,
product returns, inventory valuation and obsolescence,
intangible assets, income taxes, warranty obligations,
contingencies and litigation. We base our
12
estimates on historical experience and on various other
assumptions that we believe to be reasonable under the
circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities
that are not readily apparent from other sources. Actual results
may differ from these estimates under different assumptions or
conditions.
Overview
Laserscope is a leading provider of medical laser systems for
surgical and aesthetic applications. Founded in 1984, we are a
pioneer developer of innovative technologies with over 8000
lasers installed worldwide in doctors offices, out-patient
surgical centers and hospitals. Our product portfolio consists
of lasers and other light-based systems and related energy
delivery devices for medical applications including KTP/532, Nd:
YAG, and Er: Yag.
Laserscope primarily serves the needs of two medical
specialties: urology and aesthetic surgery. Our GreenLight Laser
offers a breakthrough treatment for a urological disorder called
benign prostatic hyperplasia (BPH), an enlargement
of the prostate gland experienced by most men after the age of
fifty.
For aesthetic applications, we offer a full line of products
used to perform a wide variety of treatments including the
removal of leg and facial veins, unwanted hair,
pseudo-folliculitis and wrinkles.
In the United States, we distribute our products to hospitals,
outpatient surgical centers and physician offices through our
own direct sales force and through the McKesson Corporation
Medical Group (McKesson). In December 2000, we
signed a distribution agreement that grants to McKesson the
exclusive distribution rights for our core aesthetic laser
products in the United States. McKesson Medical Groups
Primary Care Division has a sales force of more than 500
representatives throughout the United States who are supported
by our own direct sales force.
In the United Kingdom and France we distribute our products to
hospitals, outpatient surgical centers and physician offices
through our own direct sales force. Elsewhere, we sell our
products through regional distributor networks throughout
Europe, the Middle East, Latin America, Asia and the Pacific
Rim. Laserscope is both ISO 9001 and CE certified.
We have from time to time experienced seasonal fluctuations in
our business. During the months of July and August, certain of
our international markets have exhibited slowdowns in the
aesthetics business.
During 2004, our revenues and net income grew substantially from
the prior year as a result of continued growth in sales of our
main urology products, the GreenLight laser system and
disposable fiber optic delivery devices, in addition to strong
aesthetic sales. Our reported revenue for the year ended
December 31, 2004 was $93.8 million, a 63% increase as
compared to total revenues of $57.4 million in 2003, and
net income in 2004 was $14.7 million, or $0.65 per
diluted share, a 486% increase when compared to net income of
$2.5 million, or $0.13 per diluted share, in 2003. An
increase of 182% in unit sales of disposable fibers over the
prior year was a key factor in our financial success. We expect
revenues in our urological products, fueled by sales of the
GreenLight laser system and disposable fibers, to grow at a
faster rate than our aesthetic products in 2005.
The market for light-based cosmetic treatment devices in which
we sell our aesthetic products is characterized by low barriers
to entry and marginal technological differentiation among
product offerings. We expect intense competition in the
aesthetic market will continue to create price pressure on our
aesthetic products. As a result, we intend to address this
challenge by focusing on the key features of, and the mix
within, our product offerings affecting the value proposition to
the customer, in particular the speed and comfort of light-based
aesthetic treatments. There can be no assurance that our
existing products and newly offered products will be competitive
in an increasingly difficult market for light-based cosmetic
treatment devices.
Adoption of the PVP procedure grew at a rapid rate in 2004 both
domestically and internationally and we expect this trend to
continue in 2005. Our priority in the urology segment of our
business is to establish the PVP procedure using the GreenLight
laser system as the worldwide standard for treating BPH.
Demonstrating and maintaining the clinical effectiveness and
safety of the PVP procedure using our product is essential to
13
achieving this goal. Demonstrating the cost-effectiveness of our
procedure as compared to other therapies will be important to
penetrate the two-tiered health care finance systems in the U.S.
and internationally. With that in mind, we expect to make
significant investments in sales, marketing and professional
education and training in 2005. Our efforts to increase adoption
of PVP using our product in the United States, Europe and the
Asia-Pacific region will be especially important to our
continued success. The international market for PVP, which we
believe to be substantially greater than the U.S. market
offers great promise but also a greater variety challenges and
uncertainties than our domestic efforts, which are discussed in
greater detail in the Risk Factors section below.
We enjoyed a significant event in March 2004, when the Centers
for Medicare and Medicaid Services (CMS) announced the
assignment of the companys PVP procedure to the New
Technology Ambulatory Payment Classification (APC) 1525
code. The new classification provided for a payment rate of
$3,750.00 for the PVP procedure performed in an outpatient
hospital site of service, which was approximately twice that of
the previous rate. This reimbursement rate is effective until
December 31, 2006. We believe that this development
encouraged performance of the PVP procedure at those hospitals,
where previously, due to economic considerations, it would not
have been made available to patients. As a result, PVP
procedural volume and purchases of our GreenLight laser system
and disposable fibers increased. Obtaining satisfactory heath
care reimbursement rates for the PVP procedure using the
GreenLight laser system from government and private insurers
will continue to be a critical factor for our success in the
domestic BPH market. Obtaining government approvals of the PVP
procedure as well as securing satisfactory reimbursement rates
from public and private payers in the various foreign countries
where we have introduced our GreenLight product will be
important for our future success in those markets. Our
sensitivity to public and private payer reimbursement rates
makes us subject to a variety of risks and uncertainties, which
are discussed in greater detail in the Risk Factors
section below.
Critical Accounting Policies
Our critical accounting policies are as follows:
|
|
|
|
|
revenue recognition; |
|
|
|
allowance for doubtful accounts; |
|
|
|
allowance for laser returns; |
|
|
|
warranty obligation; |
|
|
|
excess and obsolete inventory; |
|
|
|
valuation of long-lived and intangible assets and goodwill; |
|
|
|
litigation costs; |
|
|
|
functional currency; and |
|
|
|
income tax |
We derive our revenue from primarily two sources
(i) product revenue which includes lasers, instrumentation,
and disposables and (ii) service revenue. The Company
recognizes revenue on products and services when the persuasive
evidence of an arrangement is in place, the price is fixed or
determinable, collectibility is reasonably assured, remaining
obligations are insignificant, and title and risk of ownership
has been transferred. Transfer of title and risk of ownership
generally occurs when the product is shipped to the customer or
when the customer receives the product, depending on the nature
of the arrangement. Service revenue is recognized as the
services are provided and for service contracts on a
straight-line basis over the period of the applicable service
contract.
14
Allowance for Doubtful Accounts. We assess the credit
worthiness of our customers prior to making a sale in order to
mitigate the risk of loss from customers not paying us. However,
to account for the possibility that a customer may not pay us,
we maintain an allowance for doubtful accounts. We estimate
losses based on the overall business climate, our accounts
receivable aging profile, and an analysis of the circumstances
associated with specific accounts which are past due. Despite
the significant amount of analysis used to compute the required
allowance, if the financial condition of Laserscopes
customers were to deteriorate, resulting in an impairment of
their ability to make payments, additional allowances may be
required. As of December 31, 2004, 2003 and 2002 our
reserves for doubtful accounts totaled approximately $104,000,
$268,000 and $303,000 respectively.
Allowance for Laser Returns. We assess the credit
worthiness of our customers prior to making a sale in order to
mitigate the risk of loss from customers not paying us. However,
to account for the possibility that a customer may not pay us
and will instead return the laser system to us, we maintain an
allowance for losses on laser returns. We estimate losses based
on a two year history of actual laser returns. Despite the
significant amount of analysis used to compute the required
allowance, if the financial condition of Laserscopes
customers were to deteriorate, resulting in an impairment of
their ability to make payments, additional allowances may be
required. We estimate losses based on a two-year historical
analysis of the margin impact of returns. As of
December 31, 2004, 2003 and 2002 our reserves for laser
returns totaled approximately $99,000, $96,750 and $0,
respectively.
Warranty Obligation. We engage in extensive product
quality programs and processes, including actively monitoring
and evaluating the quality of our component suppliers. In
addition to these proactive measures, we also provide for the
estimated cost of product warranties at the time revenue is
recognized. We estimate the cost of our warranty obligation
based on product failure rates over the last twelve months and
the actual material usage and service delivery costs experienced
in correcting those failures. However, should actual product
failure rates, material usage or service delivery costs differ
from our estimates, revisions to the estimated warranty
liability would be required. Warranty reserves as of
December 31, 2004, 2003 and 2002 were $2.5 million,
$1.9 million and $1.1 million, respectively.
Excess and Obsolete Inventory. We maintain reserves for
our estimated obsolete or unmarketable inventory. Inventory
reserves are recorded when conditions indicate that selling
price may be less than cost due to factors such as estimates
about future demand, reductions in selling prices, physical
deterioration, usage and obsolescence. The reserves are equal to
the difference between the cost of inventory and the estimated
market value. If actual market conditions are less favorable
than those projected by management, additional inventory
reserves may be required and gross margin could be adversely
impacted. As of December 31, 2004, 2003 and 2002, our
reserves were $1.8 million, $1.9 million and
$2.3 million, respectively.
Valuation of Long-Lived and Intangible Assets and
Goodwill. In July 2001, we adopted Statement of Financial
Accounting Standards (SFAS) No. 142,
Goodwill and Other Intangible Assets, and as a
result do not amortize goodwill. Instead, we test goodwill for
impairment at the reporting unit level, at least annually, by
determining the fair value of the reporting unit and comparing
it with its book value. A reporting unit is the lowest level of
an entity that is a business and can be distinguished from other
activities, operations, and assets of the entity. If, during the
annual impairment review, the book value of the reporting unit
exceeds the fair value, the implied fair value of the reporting
units goodwill is compared with the carrying amount of the
units goodwill. If the carrying amount exceeds the implied
fair value, goodwill is written down to its implied fair value.
SFAS No. 142 requires management to estimate the fair
value of the assets and liabilities of each reporting unit,
other than goodwill. The implied fair value of goodwill is
determined as the difference between the fair value of a
reporting unit, taken as a whole, and the fair value of the
assets and liabilities of such reporting unit.
We review other long-lived assets for impairment whenever events
or circumstances indicate that the carrying amount of an asset
may not be recoverable. Events which could trigger an impairment
review include, among others, a decrease in the market value of
an asset, the assets inability to generate income from
operations and positive cash flow in future periods, a decision
to change the manner in which an asset is used, a physical
change to the asset or a change in business climate. We
calculate estimated future undiscounted
15
cash flows, before interest and taxes, of the related operation
and compare it to the carrying value of the asset in determining
whether impairment potentially exists. If a potential impairment
exists, a calculation is performed to determine the fair value
of the long-lived asset. This calculation is based upon a
valuation model and discount rate commensurate with the risks
involved. Third party appraised values may also be used in
determining whether impairment potentially exists.
Future adverse changes in market conditions or poor operating
results of a related reporting unit may require us to record an
impairment charge in the future. The effect of a change in the
Companys estimates and assumptions related to goodwill
could be an impairment loss equal to as much as the total of
goodwill we have reported, which is $655,000.
Litigation. Our policy is to routinely assess the
likelihood of any adverse judgments or outcomes related to legal
matters, as well as ranges of probable losses. A determination
of the amount of the reserves required, if any, for these
contingencies is made after thoughtful analysis of each known
issue and an analysis of historical experience in accordance
with Statement of Financial Accounting Standards
(SFAS) No. 5, Accounting for
Contingencies, and related pronouncements. Also in
accordance with SFAS No. 5, we do not record gain
contingencies.
Functional Currency. We have a foreign subsidiary in
France which sells to customers in France, and we also have a
subsidiary in the United Kingdom which sells to customers in all
of Europe, except France, as well as customers in Pacific Rim
countries. In preparing our consolidated financial statements,
we are required to translate the financial statements of the
foreign subsidiaries from the currency in which they keep their
accounting records into United States Dollars. Our two
subsidiaries maintain their accounting records in their
functional currencies which are also their respective local
currencies, the Euro and the British Pound Sterling. The
functional currency is determined based on managements
judgment and involves consideration of all relevant economic
facts and circumstances affecting the subsidiary. Generally, the
currency in which the subsidiary transacts a majority of its
transactions, including billing, financing, payroll, and other
expenditures would be considered the functional currency but any
dependency upon the parent and the nature of the
subsidiarys operations must also be considered. Since our
two subsidiaries functional currencies are deemed to be
the local currencies, any gain or loss associated with the
translation of those subsidiaries financial statements is
included, as a component of shareholders equity, in
cumulative translation adjustments. If in the future we
determine that there has been a change in the functional
currency of a subsidiary from its local currency to the United
States Dollar, any translation gains or losses arising after the
date of change would be included within our statement of
operations.
Income Tax. In preparing our consolidated financial
statements we are required to estimate our income taxes in each
of the jurisdictions in which we operate. This process involves
us estimating our actual current tax exposure together with
assessing temporary differences resulting from differing
treatment of items such as deferred revenue, for tax and
accounting purposes. These differences result in deferred tax
assets and liabilities, which are included within our
consolidated balance sheet. We must then assess whether it is
more likely than not that our deferred tax assets
will be recovered from future taxable income and to the extent
we believe that recovery is not likely, we must establish a
valuation allowance. To the extent we establish a valuation
allowance or increase this allowance in a period, we must
include an expense within the tax provision in the statement of
operations. Management reviews its assumptions regarding the
realization of deferred tax assets on an ongoing basis.
Continued profitability and future changes in managements
assumptions may result in a partial or full release of the
deferred tax valuation allowance. A release of the valuation
allowance would have a favorable impact on the tax provision
within the statement of operations.
For the year ended December 31, 2004 the Company has
decided to not reverse its deferred tax valuation allowance
since the weight of evidence does not exceed the threshold of
more likely than not as required by SFAS
No. 109 that the Company would be able to realize its
deferred tax asset.
16
Financial Review Results of Operations
The following table sets forth certain data from
Laserscopes consolidated statements of operations,
expressed as a percentage of net revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Net revenues
|
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
Cost of products and services
|
|
|
41.7 |
|
|
|
47.6 |
|
|
|
47.7 |
|
|
|
|
|
|
|
|
|
|
|
Gross margin
|
|
|
58.3 |
|
|
|
52.4 |
|
|
|
52.3 |
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
5.6 |
|
|
|
7.7 |
|
|
|
8.9 |
|
|
Selling, general and administrative
|
|
|
36.3 |
|
|
|
39.9 |
|
|
|
41.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41.9 |
|
|
|
47.6 |
|
|
|
50.4 |
|
Operating income
|
|
|
16.4 |
|
|
|
4.7 |
|
|
|
1.8 |
|
Interest income (expense) and other, net
|
|
|
0.3 |
|
|
|
0.0 |
|
|
|
(0.9 |
) |
|
|
|
|
|
|
|
|
|
|
Income before income taxes
|
|
|
16.7 |
|
|
|
4.7 |
|
|
|
0.9 |
|
Provision for income taxes
|
|
|
1.0 |
|
|
|
0.3 |
|
|
|
0.2 |
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
15.7 |
% |
|
|
4.4 |
% |
|
|
0.7 |
% |
|
|
|
|
|
|
|
|
|
|
We generally sell our products to hospitals, outpatient surgery
centers and individual physicians in the United States, Europe,
the Middle East, Latin America and the Pacific Rim. In the
United States, we sell through our direct sales force as well as
through a distributor, McKesson. We also generate export sales
through our wholly owned subsidiaries in the United Kingdom and
France and sell to independent distributors in the rest of the
world.
We operate in a technologically advanced, dynamic and highly
competitive environment. Our future operating results are
subject to quarterly variations based on a variety of factors,
many of which are beyond our control. While we attempt to
identify and respond to these conditions in a timely manner,
these conditions represent significant risks to our performance.
International sales accounted for 27%, 26% and 26% of our net
revenues for 2004, 2003 and 2002, respectively. We believe that
international sales will continue to account for a significant
portion of our net revenues in the foreseeable future. A large
portion of our international sales occur through our foreign
subsidiaries and exports to foreign distributors. Our
international sales and operations are subject to the risks of
conducting business internationally, particularly the financial
impact of currency fluctuations, more limited intellectual
property protections, greater difficultly in monitoring and
ensuring positive clinical outcomes and regulation by foreign
governmental entities among others described in the Risk Factors
section below. These risks could harm our financial condition,
results of operations and future cash flows.
Through December 31, 2004, sales outside of the United
States have been denominated in the local currencies of the
United Kingdom and France and in United States Dollars for the
rest of the world. During 2004, 2003 and 2002, fluctuations in
foreign currencies did not materially affect the results of
operations reported by Laserscope. However, we are exposed to
foreign currency risk in a number of areas. Although our
revenues denominated in United States Dollars represented over
90% of total revenues in 2004, 91% in 2003 and 88% in 2002,
market risk exists in foreign countries where we sell in United
States Dollars, and a major strengthening of the United States
Dollar could have a material negative impact on our business.
Please refer to the Risk Factors section of this
Annual Report for further discussion on these and other risks
associated with our business.
17
The following table contains selected income statement
information for Laserscope for the years ended December 31,
2004, 2003 and 2002 (dollars, in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve Months Ended | |
|
|
|
|
|
|
| |
|
|
|
|
|
|
Dec. 31, 2004 | |
|
Dec. 31, 2003 | |
|
Dec. 31, 2002 | |
|
% Change | |
|
|
| |
|
| |
|
| |
|
| |
|
|
Amount | |
|
%(a) | |
|
Amount | |
|
%(a) | |
|
Amount | |
|
%(a) | |
|
2004 2003 | |
|
2003 2002 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Revenues from sales of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lasers & Instrumentation
|
|
$ |
56,958 |
|
|
|
61 |
% |
|
$ |
37,568 |
|
|
|
65 |
% |
|
$ |
29,842 |
|
|
|
69 |
% |
|
|
52 |
% |
|
|
26 |
% |
|
Disposable supplies
|
|
|
29,383 |
|
|
|
31 |
% |
|
|
13,536 |
|
|
|
24 |
% |
|
|
7,420 |
|
|
|
17 |
% |
|
|
117 |
% |
|
|
82 |
% |
|
Service
|
|
|
7,429 |
|
|
|
8 |
% |
|
|
6,323 |
|
|
|
11 |
% |
|
|
5,826 |
|
|
|
14 |
% |
|
|
17 |
% |
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues
|
|
$ |
93,770 |
|
|
|
100 |
% |
|
$ |
57,427 |
|
|
|
100 |
% |
|
$ |
43,088 |
|
|
|
100 |
% |
|
|
63 |
% |
|
|
33 |
% |
Gross margin:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
|
|
$ |
53,043 |
|
|
|
61 |
% |
|
$ |
28,162 |
|
|
|
55 |
% |
|
$ |
20,430 |
|
|
|
55 |
% |
|
|
88 |
% |
|
|
38 |
% |
|
Service
|
|
|
1,612 |
|
|
|
22 |
% |
|
|
1,924 |
|
|
|
30 |
% |
|
|
2,090 |
|
|
|
36 |
% |
|
|
(16 |
)% |
|
|
(8 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total gross margin
|
|
$ |
54,655 |
|
|
|
58 |
% |
|
$ |
30,086 |
|
|
|
52 |
% |
|
$ |
22,520 |
|
|
|
52 |
% |
|
|
82 |
% |
|
|
34 |
% |
Research & development
|
|
$ |
5,217 |
|
|
|
6 |
% |
|
$ |
4,443 |
|
|
|
8 |
% |
|
$ |
3,837 |
|
|
|
9 |
% |
|
|
17 |
% |
|
|
16 |
% |
Selling, general & admin
|
|
$ |
34,023 |
|
|
|
36 |
% |
|
$ |
22,936 |
|
|
|
40 |
% |
|
$ |
17,892 |
|
|
|
42 |
% |
|
|
48 |
% |
|
|
28 |
% |
Net income
|
|
$ |
14,739 |
|
|
|
16 |
% |
|
$ |
2,517 |
|
|
|
4 |
% |
|
$ |
323 |
|
|
|
1 |
% |
|
|
486 |
% |
|
|
679 |
% |
|
|
(a) |
expressed as a percentage of total net revenues except for gross
margins which are expressed as a percentage of either product or
service revenues as designated. |
2004 results compared to 2003
During 2004, total revenues increased approximately
$36.3 million, or 63%, from 2003.
During 2004, revenues from the sales of laser equipment and
instrumentation increased 52% to $57.0 million, or 61% of
total net revenues, compared to $37.6 million, or 65%, of
total net revenues in 2003. The increases in sales of these
products is attributed to higher sales of GreenLight laser
systems for the treatment of BPH as well as higher sales of
lasers and instrumentation for aesthetic applications.
During the year ended December 31, 2004, we sold 246
GreenLight laser systems compared to 98 in the corresponding
period of 2003. This increase is attributed to higher demand for
the product created by the growing popularity of the
photo-vaporization of the prostate (PVP) procedure
that uses the GreenLight laser system.
The increase in sales of lasers and instrumentation for
aesthetic applications is attributed to continued demand for
products used in these types of applications. Sales of these
products increased 24% during the year ended December 31,
2004 compared to 2003. The demand comes from growing numbers of
doctors (particularly family practice doctors and OB/ GYN
doctors) adding aesthetic procedures to their traditional
practices as well as the continued strong demand from patients
seeking these types of procedures.
We expect to see higher sales of GreenLight laser systems and
aesthetic laser systems and instrumentation during 2005 as we
expect demand for the procedures which use these systems to
continue to grow.
Net revenues from shipments of disposable supplies were 117%
higher in 2004 than 2003, and were approximately
$29.4 million, or 31%, of total revenues in 2004, compared
to approximately $13.5 million, or 24% of total revenues in
2003. These higher revenues are principally due to increasing
demand for the ADDstat disposable fiber-optic devices which are
used with the GreenLight laser system in the PVP procedure.
Since the introduction of the GreenLight laser system and the
PVP procedure, Laserscope has sold over 54,000 ADDstat devices
for use in the PVP procedure
18
We believe that our future sales of disposable supplies depend
on our ability to increase our installed base of systems and
also to develop and promote surgical procedures that use these
products including the PVP procedure and/or other procedures
that we may develop and commercialize.
Service revenues were 17% higher in 2004 than 2003, and were
approximately $7.4 million, or 8% of total revenues in
2004, compared to $6.3 million, or 11% of revenue in 2003.
Service revenues increased in all geographic regions, but the
growth rate was marginally higher at our foreign subsidiaries.
We believe that future revenues will depend on increases to the
installed base of lasers as well as customers purchasing service
contracts.
Product gross margin as a percentage of net product revenues was
61% in 2004, an improvement of 6 percentage points compared
to results for 2003. In 2004, gross margin increased due to a
shift in the product mix towards higher margin disposable
devices. We expect that product gross margin, as a percentage of
net revenues in 2005, will be marginally higher than the level
of 2004. However, we expect that these amounts may vary from
quarter to quarter during 2005 and will depend on product demand
and distribution mix.
Gross margin from service activities as a percentage of net
service revenues was 22% in 2004 compared to 30% in 2003. The
decrease reflects an increase in material costs. We expect that
gross margin, as a percentage of net revenues from service
activities in 2005, will be similar to 2004 levels.
Research and development expenses result from activities related
to the development of new laser, instrumentation and disposable
products, the enhancement of our existing products and the
development of surgical applications for new and existing
products. In 2004, amounts spent on research and development
increased 17% from amounts spent in 2003. We expect that amounts
spent in research and development during 2005 will be higher in
absolute terms than that spent in 2004 but lower as a percentage
of net revenues.
Selling, general and administrative expenses increased 48% in
2004 compared to 2003. This was due in part to higher
commissions paid commensurate with the increase in aesthetic and
surgical revenues, higher marketing and education expenses
related to expanding the presence of the Companys products
in both domestic and international markets, as well as increased
costs related to compliance with the new requirements of the
Sarbanes-Oxley Act of 2002. We expect selling, general and
administrative expenses in absolute terms will be higher during
2005 than in 2004 but lower as a percentage of net revenues.
This will be the result of direct selling expense increases
relating to higher revenues and continued investment in
educational programs and marketing initiatives for our products.
In 2004, we recorded an income tax provision of $940,000. While
the United States operations reported a book income before tax,
due to net operating loss carry forwards, the United States
entitys tax liability was limited to the alternative
minimum tax. The United Kingdom subsidiary incurred a charge of
$183,000 for income taxes due to its profitability. While the
French subsidiary reported a net income in 2004, no tax
provision was required due to that entitys net operating
loss carry forwards.
In 2003, we recorded an income tax provision of $202,000. While
the United States operations reported a book income before tax,
due to net operating loss carry forwards, the United States
entitys tax liability was limited to the alternative
minimum tax. The United Kingdom subsidiary incurred a charge of
$76,000 for income taxes due to its profitability. However, the
French subsidiary reported a net loss in 2003, and so no tax
provision was required due to utilization of that entitys
net operating loss carry forwards..
As of December 31, 2004, we had deferred tax assets of
approximately $22.9 million. We have evaluated the need for
a valuation allowance for the deferred tax assets in accordance
with Statement of Financial Accounting Standards No. 109,
Accounting for Income Taxes. As of December 31,
2004, we had no apparent near-term ability to realize our
deferred tax assets through carry backs or available tax
planning strategies. Additionally, based on cumulative pre-tax
losses we have sustained in the three years ended
December 31, 2004 and the current economic uncertainty in
our industry that limits our ability to generate verifiable
forecasts of future domestic taxable income, a valuation
allowance, in an amount equal to our deferred tax assets was
recorded as of December 31, 2004. The valuation allowance
increased by approximately $7.2 million in 2004 and
decreased by approximately $0.1 million and
$1.3 million in 2003 and 2002, respectively.
19
2003 results compared to 2002
During 2003, total revenues increased approximately
$14.3 million, or 33%, from 2002.
During 2003, revenues from the sales of laser equipment and
instrumentation increased 26% to $37.6 million, or 65% of
total net revenues, compared to $29.8 million, or 69%, of
total net revenues in 2002. Increases in revenues from sales of
laser equipment and instrumentation resulted from a commensurate
increase in unit shipments. The United States distributor
relationship which we formed with McKesson effective December
2000 contributed to the higher aesthetic laser sales. This also
enabled us to sell more instruments that are used with the
aesthetic lasers. McKesson made purchases from Laserscope of
approximately $17.7 million and $12.6 million which
was 31% and 29% of our total 2003 and 2002 revenue,
respectively. In addition, we saw growth in unit shipments of
GreenLight
PVtm
lasers which are used for BPH. Fiscal 2003 revenue shipments of
GreenLight PV lasers was 98 units, which is an approximate
three-fold increase over the 2002 shipments of 32 units.
Net revenues from shipments of disposable supplies were 82%
higher in 2003 than 2002, and were approximately
$13.5 million, or 24%, of total revenues in 2003, compared
to approximately $7.4 million, or 17% of total revenues in
2002. These higher revenues are principally due to increasing
demand for the disposable fiber-optic devices which are used
with the GreenLight PV laser.
Until recently, our sales had trended towards lower-priced
physician office-based lasers for aesthetic procedures and away
from lasers used in hospitals for non-aesthetic procedures. This
resulted in lower sales of disposable supplies since office
lasers used in aesthetic procedures, generally do not create a
stream of sales of disposable supplies such as the ADDStat
disposable fiber optic delivery device. However, with the
introduction of the
GreenLighttm
laser system in early 2002, we sold approximately 13,300 and
3,500 disposable fiber-optic delivery devices in 2003 and 2002
respectively, which increased our disposables revenue.
Service revenues were 9% higher in 2003 than 2002, and were
approximately $6.3 million, or 11% of total revenues in
2003, compared to $5.8 million, or 14% of revenue in 2002.
Service revenues increased in all geographic regions, but the
growth rate was marginally higher at our foreign subsidiaries.
Product gross margin as a percentage of net product revenues was
55% in 2003 which was even with that of 2002. In 2003, gross
margin increased due to
GreenLighttm
ADDStat fibers sold. However, this was offset by less favorable
manufacturing variances and higher warranty cost which was
driven by longer warranty periods associated with promoting
sales of
GreenLighttm
laser systems.
Gross margin from service activities as a percentage of net
service revenues was 30% in 2003 compared to 36% in 2002. The
decrease reflects an increase in material and overhead costs as
a percentage of revenue.
Research and development expenses result from activities related
to the development of new laser, instrumentation and disposable
products and the enhancement of our existing products.
In 2003, amounts spent on research and development increased 16%
from amounts spent in 2002. This was primarily due to an
increase in permanent staff and consultants to work on
development of the new Gemini laser as well as continuing
refinements to the GreenLight PV and aesthetic lasers.
Selling, general and administrative expenses increased 28% in
2003 compared to 2002. This was due in part to an increase in
headcount as we increased the size of our sales force and
marketing staff in the United States and in our foreign
subsidiaries primarily to promote the GreenLight laser system.
In addition, commission expenses were higher following from an
increase in revenue of both
GreenLighttm
and aesthetic lasers.
In 2003, we recorded an income tax provision of $202,000. Our
United Kingdom subsidiary incurred a charge of $76,000 for
income taxes due its profitability. However, while the United
States operations reported a profit, due to net operating loss
carry forwards, the United States entitys tax liability
was limited to the alternative minimum tax. The French
subsidiary reported a net loss in 2003, and so no tax provision
was required for that entity. The United States and the French
entity have significant net operating loss carry forwards. In
2002, we recorded a tax provision of $70,000 for our United
Kingdom subsidiary and recorded no
20
tax provision for France. In the United States in 2002 we
recorded a tax provision of $16,000 for state tax, none for
federal tax since tax law at that time permitted alternative
minimum tax to be offset 100% by tax loss carry forwards.
Financial Review Liquidity and Capital
Resources
The following table contains selected balance sheet information
at December 31, 2004 and 2003 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
December 31, | |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Cash and cash equivalents
|
|
$ |
15,954 |
|
|
$ |
7,158 |
|
Working capital
|
|
$ |
38,566 |
|
|
$ |
20,722 |
|
Total assets
|
|
$ |
61,589 |
|
|
$ |
37,028 |
|
The net increase in cash and cash equivalents in 2004 compared
to 2003 was due to cash provided by operating and financing
activities, partially offset by cash used in investing
activities.
Cash provided by operating activities totaled $7.4 million.
This was the combined result of the following sources: net
income $14.7 million; an increase in accrued
compensation $2.0 million due to an increase in
accrued salaries, wages and employee bonuses; an increase in
deferred revenue $1.5 million as a result of
higher volume of contract revenue bookings and higher
contractual obligations, which are the result of increased laser
sales; an increase in other accrued liabilities
$1.4 million primarily due to higher customer rebates,
audit and Sarbanes Oxley consulting costs coupled with accrued
travel expenses; depreciation and amortization
$1.1 million; an increase in warranty reserve
$0.6 million as a result of higher laser sales; an increase
in tax benefit of stock option exercises-$0.4 million; an
increase in tax payable $0.4 million. These
sources were partially offset by an increase in accounts
receivable $7.2 million which was a result of
higher sales volume; an increase in inventory
$5.8 million due to increased production to accommodate
growing demand for products; a decrease in accounts
payable $1.3 million due to the timing of
payments to suppliers; a decrease in provision for doubtful
accounts $0.2 million due to improved
collection activities; a decrease in reserve for excess and
obsolete inventory $0.1 million; and an
increase in prepayments and other current assets
$0.1 million.
Cash provided by financing activities in 2004 totaled
$4.2 million. This is the result of the sales of common
stock under stock option plans, employee stock purchase plans
and the exercise of warrants.
Cash used in investing activities totaled $2.9 million, of
which $2.8 million was due to capital expenditures. A
significant portion of total capital spending is attributable to
in-progress Enterprise Resourse Planning (ERP) costs.
Additional spending was in office equipment, test and production
equipment, licenses and intangibles, and capitalized laser
systems used by Service and Research and Development. In
addition, spending on acquisition of licenses or other
intangibles totaled $0.1 million.
Laserscope has in place an asset based line of credit that
provides up to $5.0 million in borrowings and expires in
September 2006. Credit is extended based on eligible accounts
receivable and inventory. Laserscopes assets collateralize
the credit line which bears an interest rate equivalent to the
banks prime rate plus 2.0%. The prime rate at
December 31, 2004 was 5.25%. Borrowings against the line of
credit are paid down as the Company collects its accounts
receivable. Provisions of the bank loan agreement prohibit the
payment of dividends on non-preferred stock, or the redemption,
retirement, repurchase or other acquisition of Laserscope stock.
The agreement further requires us to maintain a minimum tangible
net worth. As of December 31, 2004, we had no outstanding
borrowings under the line and were in compliance with all
covenants.
Capital expenditures totaled $2.8 million in 2004 and
$0.9 million in 2003. During 2004, Laserscope began the
implementation of a new Enterprise Resource Planning
(ERP) Software. Although we will still be incurring costs
related to the ERP implementation, we expect the level of
capital expenditures in 2005 to be lower than that of 2004.
21
Our research and development expenditures in 2004 and 2003 were
$5.2 million and $4.4 million respectively. We expect
the amounts spent in research and development during 2005 will
be higher in absolute terms than that spent in 2004 but lower as
a percentage of net revenues.
In the first six months of 2003, $400,000 of the debentures were
converted to 320,000 shares of Laserscope common stock by
Renaissance. During the last six months of 2003, Renaissance
converted the remaining $2.6 million of debentures into
2,080,000 shares of Laserscope common stock.
We anticipate that future changes in cash and working capital
will be dependent on a number of factors including:
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Our ability to effectively manage non-cash assets such as
inventory and accounts receivable; |
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Our ability to anticipate and adapt to the changes in our
industry such as new and alternative medical procedures; |
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Our ability to scale efficiently the companys
infrastructure to accommodate the current rapid growth in our
business; |
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Our level of profitability; and |
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Our determination to acquire or invest in products and
businesses complementary to ours. |
We have historically financed acquisitions using our existing
cash resources. While we believe our existing cash resources,
including our bank line of credit will be sufficient to fund our
operating needs for the next twelve months, additional financing
will likely be required for our currently envisioned long-term
needs.
There can be no assurance that any additional financing will be
available on terms acceptable to us, or at all. In addition,
future equity financings could result in dilution to our
shareholders, and future debt financings could result in certain
financial and operational restrictions
Contractual Obligations
The impact that our contractual obligations as of
December 31, 2004 are expected to have on our liquidity and
cash flow in future periods is as follows (in thousands):
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period | |
|
|
| |
|
|
|
|
Less Than | |
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|
|
More Than | |
Contractual Obligations |
|
Total | |
|
1 Year | |
|
1-3 Years | |
|
3-5 Years | |
|
5 Years | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Operating Leases
|
|
$ |
6,673 |
|
|
$ |
992 |
|
|
$ |
1,842 |
|
|
$ |
1,599 |
|
|
$ |
2,241 |
|
Capital Leases
|
|
$ |
52 |
|
|
$ |
21 |
|
|
$ |
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
6,725 |
|
|
$ |
1,013 |
|
|
$ |
1,873 |
|
|
$ |
1,599 |
|
|
$ |
2,241 |
|
Off-Balance Sheet Arrangements
As part of our ongoing business, we do not participate in
transactions that generate relationships with unconsolidated
entities or financial partnerships, such as entities often
referred to as structured finance or special purpose entities
(SPEs), which would have been established for the
purpose of facilitating off-balance sheet arrangements or other
contractually narrow or limited purposes. As of
December 31, 2004, we are not involved in any
unconsolidated SPE transactions.
Recent Accounting Pronouncements
In December 2004, the FASB issued SFAS No 123 (revised
2004) (SFAS No 123(R)), Share Based
Payment. SFAS No 123(R) requires all share-based
payments to employees, including grants of employee stock
options, to be recognized in the financial statements based on
their fair values and is effective for public companies for
interim or annual periods beginning after June 15, 2005.
Laserscope has not yet completely evaluated the impact of the
adoption of SFAS No 123(R).
22
In November 2004, The FASB issued SFAS No. 151,
Inventory Costs, an amendment of ARB No. 43.
Chapter 4. SFAS No. 151 clarifies the accounting
for abnormal amounts of idle facility expense, freight, handling
costs and wasted material. SFAS No. 151 is effective for
inventory costs incurred during fiscal years beginning in the
second quarter of fiscal 2006. The Company does not believe the
adoption of SFAS No. 151 will have a material effect on its
consolidated financial position, results of operations or cash
flows.
RISK FACTORS
In determining whether to invest in our Common Stock, you should
carefully consider the information below in addition to all
other information provided to you in this Report, including the
information incorporated by reference in this Report. The
statements under this caption are intended to serve as
cautionary statements within the meaning of the Private
Securities Litigation Reform Act of 1995. The following
information is not intended to limit in any way the
characterization of other statements or information under other
captions as cautionary statements for such purpose.
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Demand for our products in the United States and
internationally is highly dependent on satisfactory
reimbursement rates from private and governmental third-party
payers for procedures using our products. If we are unable to
obtain and maintain satisfactory reimbursement rates, demand for
our products would decline and our business, financial results
and cash flows would suffer. |
The ability of our customers to obtain satisfactory
reimbursement for our products and services using our products
from government and third-party payers is essential to our
success. Demand for certain of our products depends on
government and private insurance reimbursement of hospitals and
physicians for health care costs, including, but not limited to,
reimbursement of capital equipment costs. Reductions or delays
in such insurance coverage or reimbursement may negatively
impact hospitals, physicians and other health care
providers decisions to purchase our products, adversely
affecting our future sales.
A substantial portion of our laser sales are for aesthetic
procedures that are generally not subject to reimbursement by
government or private health insurance. The general absence of
insurance coverage for these cosmetic procedures may restrict
the development of this market. Major third-party payers for
health care services such as the PVP procedure using the
GreenLight laser system in the United States, such as Medicare,
Medicaid, private healthcare insurance and managed care plans,
and in our key international markets such as the European Union
and the Asia-Pacific region continue to work to contain
healthcare costs. Public and private initiatives to limit the
growth of healthcare costs, including price regulation, are
underway in the U.S. and our key international markets.
Implementation of healthcare reforms in these significant
markets may limit the price of, or the level at which
reimbursement is provided for our products.
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The current Facility Fee reimbursement for PVP in the United
States could be reduced, eliminated or utilized by a
competitor. |
Demand in the United States for our GreenLight laser system and
disposable fibers is highly dependent on the reimbursement rate
established for the PVP procedure when it is performed in the
hospital site of service, which is established by the Centers
for Medicare and Medicaid Services (CMS) under an
Ambulatory Payment Classification (APC)
reimbursement code. The APC code applicable to the PVP procedure
has varied in recent years. In November 2002, CMS announced its
final rule with respect to APC reimbursement codes to be
implemented in January 2003. One of the APC codes, known as the
Facility Fee, that was affected was used by
hospitals to bill Medicare for the PVP procedure. In February
2003, CMS issued a technical correction to this APC code which
represented the reimbursement under this code for 2003. The
reimbursement rate for this code reduced the amount paid to the
hospital for the PVP procedure by approximately 19% for the
hospital site of service for Medicare patients compared to the
reimbursement during 2002. In November 2003, CMS notified
Laserscope that its application for assignment of PVP to a new
technology APC had been accepted. CMS determined that PVP met
the new technology APC qualification criteria and assigned a new
APC code effective April 1, 2004 for PVP and other similar
procedures. The national average Facility Fee reimbursement rate
under the new technology APC is $3,750. The rate is
23
scheduled to be maintained until March 31, 2006, at which
time CMS may assign a new reimbursement value to the procedure
based on data accumulated during the two-year assessment period
or may re-assign PVP to an existing APC code. There can be no
assurance that the current rate will be maintained, raised or
lowered. Additionally, the new technology APC is not solely
specific to Laserscopes products and can be used by other
technologies that meet the requirements of the APC coding
guidelines. If a competitor were able to obtain reimbursement
under the current APC code for the PVP procedure using its
product, demand for our product could be reduced and our
financial results could suffer.
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Physician Fee Schedule reimbursement for PVP in the United
States remains uncertain. |
Demand in the U.S. for our GreenLight laser system and
disposable fibers is also highly dependent on the physician
reimbursement rates applicable to the PVP procedure under the
national physicians Fee Schedule determined by CMS. We
believe that physicians may obtain reimbursement for PVP
procedures pursuant to the Fee Schedule under two reimbursement
codes, including one applicable to the office site of service
and the other applicable to the hospital or ambulatory surgery
site of service. Each of these reimbursement codes may not
provide physicians a reimbursement level and reimbursement
structure reflecting the actual time, effort and resource costs
associated with the procedure, which would discourage physicians
from performing the PVP procedure. Should CMS reduce the current
codes under the Fee Schedule relative to other procedures it
will likely negatively affect PVP adoption. Failure to
adequately and fairly reimburse physicians, hospitals and
ambulatory surgery centers for the PVP procedure in all sites of
service will impair adoption of the PVP procedure, reduce demand
for our products and harm our financial performance. CMS
reimbursement decisions regarding the physician Fee Schedule for
PVP in any site of service remain uncertain and could result in
maintenance of the current reimbursement structure or a decrease
in reimbursement rates, or an upward adjustment, affecting PVP
procedural volume and sales of our products.
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PVP physician reimbursement is typically lower, on a
per-procedure basis, compared to other BPH therapies. |
The current national average rate of reimbursement paid to
physicians for performing the PVP procedure on a per-procedure
basis is, in some cases, substantially lower than the
reimbursement rate paid for performing certain other BPH
therapies on a per-procedure basis. While we believe that this
disparity results in physicians and hospitals not being
reimbursed commensurate with the necessary resources and work
required to do the PVP procedure in all sites of service
currently being used by physicians, there can be no assurance
that CMS will adjust reimbursement rates to address this
disparity. Further, there can be no assurance that physician
reimbursement for these other therapies will not be maintained
at current levels or raised relative to reimbursement for PVP or
that the physician reimbursement for PVP will be maintained at
current levels or increased relative to other BPH therapies. The
adoption rate of the PVP procedure in the United States is
highly dependent upon hospital and physician economics. A
substantial reduction in either the Facility Fee and/or a
continuation of the disparity which currently exists between the
physician reimbursement for certain other BPH therapies and that
for PVP could cause a reduction in the adoption of PVP by
hospitals and physicians, which would reduce demand for our
products and harm our business.
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If we are not able to protect our intellectual property
adequately, we will lose a critical competitive advantage, which
will reduce our revenues, profits and cash flows. |
Our patents, copyrights, trademarks, trade secrets and other
intellectual property are critical to our success. We hold
several patents issued in the United States, generally covering
surgical laser systems, delivery devices, calibration inserts
and the laser resonator. We have also licensed certain
technologies from others.
We cannot assure that any patents or licenses that we hold or
that may be issued as a result of our patent applications will
provide any competitive advantages for our products. Nor can we
assure that any of the patents that we now hold or may hold in
the future will not be successfully challenged, invalidated or
circumvented in the future. In addition, we cannot assure that
competitors, many of which have substantial
24
resources and have made substantial investments in competing
technologies, will not seek to apply for and obtain patents that
will prevent, limit or interfere with our ability to make,
issue, use and sell our products.
Furthermore, we cannot be certain that the steps we have taken
will prevent the misappropriation of our intellectual property,
particularly in foreign countries where the laws may not protect
our proprietary rights as fully as in the United States . We
have not attempted to secure patent protection in foreign
countries, and the laws of some foreign countries may not
adequately protect our IP as well as the laws of the United
States. As we increase our international presence, we expect
that it will become more difficult to monitor the development of
competing technologies that may infringe on our rights as well
as unauthorized use of our technologies.
We believe that we own or have the right to use the basic
patents covering our products. However, the laser industry is
characterized by a very large number of patents, many of which
are of questionable validity and some of which appear to overlap
with other issued patents. As a result, there is a significant
amount of uncertainty in the industry regarding patent
protection and infringement. Because patent applications are
maintained in secrecy in the United States until such patents
are issued and are maintained in secrecy for a period of time
outside the United States, we can conduct only limited searches
to determine whether our technology infringes any patents or
patent applications of others.
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If we are unable to protect the integrity, safety and proper
use of our ADDStat disposable fiber optic delivery device with
the GreenLight laser system, it could result in negative patient
outcomes and reduce our disposable fiber recurring revenue
stream. |
Ensuring the integrity, safety and proper use of the ADDStat
disposable fiber optical delivery device, referred to elsewhere
in this Report as the disposable fiber, used with
the GreenLight laser system is crucial to achieving optimal
patient outcomes from the PVP procedure. With this is mind, we
manufacture the ADDStat fiber using high quality materials and
exacting production standards. We inspect each unit carefully to
check that it conforms to our specifications and use diligent
efforts to ensure that the disposable fiber is used
appropriately in connection with the GreenLight laser system.
However, if a third party were to produce and distribute a
counterfeit version of the ADDStat fiber or an inferior
substitute fiber to our customers, use of inferior materials,
poor design, shoddy construction or improper handling or use of
such products could result in severe adverse patient events.
While we are constantly making diligent efforts to promote
positive clinical outcomes by protecting the safety, integrity
and proper use of our products, particularly the ADDStat fiber,
one or more third party manufacturers may produce counterfeit or
inferior quality fibers that our customers may, knowingly or
unknowingly, purchase for use with the GreenLight laser system.
In addition, it is possible that our customers may seek to
violate our prohibition on reuse of fibers (or reuse inferior
substitute fibers) on unwitting patients, reducing the efficacy
of the procedure and exposing such patients to the risk of
blood-borne pathogens such as HIV or Hepatitis C. Use of such
third party fibers or misuse of our genuine ADDStat fibers could
result in adverse clinical outcomes, reducing demand for PVP and
decreasing demand for our products. We use a variety of methods
to protect patients from inferior fibers and the reuse of our
ADDStat disposable fibers, including legal and regulatory
safeguards, system enabling, patient education and safety
packaging among other measures. Moreover, use of counterfeit or
substitute disposable fibers for use with the GreenLight laser
system or unauthorized reuse of fibers, would displace sales of
our ADDStat disposable fibers reducing our recurring disposable
fiber revenue stream and harming our business.
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We participate in competitive markets with companies that
have significantly greater technical, research and development,
manufacturing and marketing resources and/or who produce
standard, entrenched medical technologies. |
We compete in the non-ophthalmic surgical segment of the
worldwide medical laser market. In this market, lasers are used
in hospital operating rooms, outpatient surgery centers and
individual physician offices for a wide variety of procedures.
This market is highly competitive. Our competitors are numerous
and include
25
some of the worlds largest organizations as well as
smaller, highly specialized firms. Our ability to compete
effectively depends on such factors as:
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market acceptance of our products; |
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product performance; |
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price; |
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customer support; |
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the success and timing of new product development; and |
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continued development of successful distribution channels. |
Some of our current and prospective competitors have or may have
significantly greater financial, technical, research and
development, manufacturing and marketing resources than we have.
To compete effectively, we will need to continue to expand our
product offerings, periodically enhance our existing products
and continue to enhance our distribution.
Certain surgical laser manufacturers have targeted their efforts
on narrow segments of the market, such as angioplasty,
orthopedics, and lithotripsy. Their products may compete for the
same capital equipment funds as our products, and accordingly,
these manufacturers may be considered our competitors.
Generally, surgical laser manufacturers such as Laserscope
compete with standard surgical methods and other medical
technologies and treatment modalities. We cannot assure that we
can compete effectively against such competitors. In addition,
we cannot assure that these or other companies will not succeed
in developing technologies, products or treatments that are more
effective than ours or that would render our technology or
products obsolete or non-competitive.
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If we are unable to effectively manage our growth, our
business may be harmed. |
Our future success depends on our ability to successfully manage
our growth. Our ability to manage our business successfully in a
rapidly evolving and extremely competitive market requires an
effective planning and management process. Our rates of growth
in recent years have been high. Should our business continue to
grow and demand for our products continue to increase at similar
rates, it will increase the strain on our personnel in all
aspects of our business.
Our historical growth, international expansion, and our strategy
of being the provider of the leading solutions for the treatment
of BPH and aesthetic laser surgery, have placed, and are
expected to continue to place, a significant strain on our
managerial and financial resources as well as our financial and
management controls, reporting systems and procedures. Although
some new controls, systems and procedures have been implemented,
our future growth, if any, will depend on our ability to
continue to implement and improve operational, financial and
management information and control systems on a timely basis,
together with maintaining effective cost controls. Our inability
to manage any future growth effectively would be harmful to our
revenues and profitability.
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Our dependence on certain single-source suppliers and certain
other third parties, could adversely impact our ability to
manufacture lasers. |
Certain of the components used in our laser products, including
certain optical components, are purchased from single sources.
While we believe that most of these components are available
from alternate sources, an interruption of these or other
supplies could adversely affect our ability to manufacture
lasers.
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Problems associated with international business operations
could affect our ability to sell our products. |
As our international business has grown, we have become
increasingly subject to the risks arising from the unique and
potentially adverse factors in the countries in which we
operate. Our International revenues were 27% of total revenues
in the year ended December 31, 2004 and 26% in the year end
December 31, 2003. Our international sales are made through
international distributors and wholly-owned subsidiaries with
payments
26
to us typically denominated in the local currencies of the
United Kingdom and France, and in United States Dollars in the
rest of the world. We intend to continue our operations outside
of the United States and potentially to enter additional
international markets, We anticipate that sales to customers
located outside North America will increase and will continue to
represent a significant portion of our total revenues in future
periods. These activities, require significant management
attention and financial resources and further subject us to the
risks of operating internationally. These risks include, but are
not limited to:
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changes in regulatory requirements; |
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delays resulting from difficulty in obtaining export licenses
for certain technology; |
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customs, tariffs and other barriers and restrictions; and |
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the burdens of complying with a variety of foreign laws. |
We are also subject to general geopolitical risks in connection
with our international operations, such as:
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differing economic conditions; |
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changes in political climate; |
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differing tax structures; and |
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changes in diplomatic and trade relationships and war. |
In addition, fluctuations in currency exchange rates may
negatively affect our ability to compete in terms of price
against products denominated in local currencies.
Accordingly, if these risks actually materialize, our
international operations may be adversely affected and sales to
international customers, as well as those domestic customers
that use foreign fabrication plants, may decrease
We do not engage in hedging transactions for speculative or
trading purposes.
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Our business has significant risks of product liability
claims, which could drain our resources and exceed our insurance
coverage which is limited. |
Our business has significant risks of product liability claims.
We have experienced product liability claims from time to time,
which we believe are ordinary for our business. While we cannot
predict or determine the outcome of the actions brought against
us, we believe that these actions will not ultimately have a
material adverse impact on Laserscopes financial position,
results of operations, and future cash flows.
At present, we maintain product liability insurance on a
claims made basis with coverage of
$10.0 million in the aggregate with a deductible of
$0.1 million per occurrence and an annual maximum aggregate
deductible of $0.5 million. We cannot assure that such
insurance coverage will be available to us in the future at a
reasonable cost, if at all. Nor can we assure that other claims
will not be brought against us in excess of our insurance
coverage.
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Our products are subject to government regulation, and so we
cannot assure that all necessary regulatory approvals, including
approvals for new products or product improvements, will be
granted on a timely basis, if at all, and that we wont be
subject to product recalls or warnings and other regulatory
actions and penalties that could materially affect our operating
results. |
Government regulation in the United States and other countries
is a significant factor in the development, manufacturing and
marketing of many of our products.
Laserscope and its products are regulated in the United States
by the Food and Drug Administration under the Federal Food, Drug
and Cosmetic Act (the FDC Act) and the Radiation
Control for Health and Safety Act. The FDC Act provides two
basic review procedures for medical devices. Certain products
qualify for a Section 510(k) (510(k)) procedure
under which the manufacturer gives the FDA pre-market
notification of the manufacturers intention to commence
marketing the product. The manufacturer must,
27
among other things, establish that the product to be marketed is
substantially equivalent to a previously marketed
product. In some cases, the manufacturer may be required to
include clinical data gathered under an investigational device
exemption (IDE) granted by the FDA allowing human
clinical studies.
There can be no assurance that the FDA will grant marketing
clearance for our future products on a timely basis, or at all.
If the product does not qualify for the 510(k) procedure, the
manufacturer must file a pre-market approval application
(PMA) based on testing intended to demonstrate that
the product is both safe and effective. The PMA requires more
extensive clinical testing than the 510(k) procedure and
generally involves a significantly longer FDA review process.
Approval of a PMA allowing commercial sale of a product requires
pre-clinical laboratory and animal tests and human clinical
studies conducted under an IDE establishing safety and
effectiveness. Generally, because of the amount of information
required, the 510(k) procedure takes less time than the PMA
procedure.
To date, all of our products (except for the 600 Series Dye
Module) have been marketed through the 510(k) procedure. Future
products, however, may require clearance through the PMA
procedure. There can be no assurance that such marketing
clearances can be obtained on a timely basis, or at all. Delays
in receiving such clearances could have a significant adverse
impact on our ability to compete in our industry. The FDA may
also require post-market testing and surveillance programs to
monitor certain products.
Certain other countries require medical device manufacturers to
obtain clearances for products prior to marketing the products
in those countries. The requirements vary widely from country to
country and are subject to change. Obtaining necessary
regulatory approvals in key international markets and retaining
such regulatory licenses is essential to international expansion
of our business, which is an important strategic objective.
We are also required to register with the FDA and state
agencies, such as the Food and Drug Branch of the California
Department of Health Services (CDHS), as a medical device
manufacturer. We are inspected routinely by these agencies to
determine our compliance with the FDAs current Good
Manufacturing Practice regulations. Those regulations
impose certain procedural and documentation requirements upon
medical device manufacturers concerning manufacturing, testing
and quality control activities. If these inspections determine
violations of applicable regulations, the continued marketing of
any products manufactured by us may be adversely affected.
In addition, our laser products are covered by a performance
standard for laser products set forth in FDA regulations. The
laser performance standard imposes certain specific
record-keeping, reporting, product testing, and product labeling
requirements on laser manufacturers. These requirements also
include affixing warning labels to laser systems, as well as
incorporating certain safety features in the design of laser
products.
Complying with applicable governmental regulations and obtaining
necessary clearances or approvals can be time consuming and
expensive. There can be no assurance that regulatory review will
not involve delays or other actions adversely affecting the
marketing and sale of our products in the United States and
internationally. We also cannot predict the extent or impact of
future legislation or regulations in the United States and
abroad.
We are also subject to regulation under federal and state laws
regarding, among other things, occupational safety, the use and
handling of hazardous materials and protection of the
environment. While we believe that we are in material compliance
with these requirements, noncompliance with any such
requirements.
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As we have limited working capital, we may need additional
capital that may not be available to us and, if raised, may
dilute our stockholders ownership interest in us. |
We may need to raise additional funds to develop or enhance our
technologies, to fund expansion, to respond to competitive
pressures or to acquire complementary products, businesses or
technologies.
28
As of December 31, 2004, our total assets were
$61.6 million and our total liabilities were
$18.7 million. As of the same date, our working capital was
$38.6 million and our cash and cash equivalents totaled
$16.0 million. Current and anticipated demand for our
products as well as procurement and production affect our need
for capital. Changes in these or other factors could have a
material impact on capital requirements and may require us to
raise additional capital.
For example, to address our capital needs, on January 14,
2000 we completed a private placement of our common stock
providing net proceeds of approximately $1.9 million to
accredited investors. We issued 2.5 million shares of our
no par value Common Stock at a price of $0.80 per share. We
also issued warrants to purchase 218,875 shares of our
Common Stock.
Similarly, on February 11, 2000, we completed a private
placement of subordinate convertible debentures pursuant to
Regulation D of the Securities Act of 1933, as amended, to
affiliates of Renaissance with gross proceeds to Laserscope of
$3.0 million. The debentures were to mature seven years
from issuance and had an interest rate of 8.00%. The debentures
were convertible into Laserscope common stock with an initial
conversion price, which was subject to adjustment, of $1.25. The
private placement also included warrants convertible into
240,000 shares of Laserscope common stock at $1.50 per
share and expire in 2005.
In the first six months of 2003, $400,000 of the debentures were
converted to 320,000 shares of Laserscope common stock by
Renaissance. During the last six months of 2003, Renaissance
converted the remaining $2.6 million of debentures into
2,080,000 shares of Laserscope common stock.
In 2004, except for shares issued through the Companys
Employee Stock Purchase Plan and the Incentive Stock Option
Plans, the only other capital raised was through the exercise of
warrants, which resulted in the issuance of 363,212 shares.
We anticipate that future changes in cash and working capital
will be dependent on a number of factors including:
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Our ability to manage effectively non-cash assets such as
inventory and accounts receivable; |
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Our ability to anticipate and adapt to the changes in our
industry such as new and alternative medical procedures; |
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Our level of profitability; and |
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Our determination to acquire or invest in products and
businesses complementary to ours. |
We have historically financed acquisitions using our existing
cash resources. While we believe our existing cash resources,
including our bank line of credit, will be sufficient to fund
our operating needs for the next twelve months, additional
financing may be required for our currently envisioned long term
needs.
Additional financing may not be available on terms that are
acceptable to us. If we raise additional funds through the
issuance of equity or convertible debt securities, the
percentage ownership of our stockholders would be reduced and
these securities might have rights, preferences and privileges
senior to those of our current stockholders. If adequate funds
are not available on acceptable terms, our ability to fund our
expansion, take advantage of unanticipated opportunities,
develop or enhance our products or services, or otherwise
respond to competitive pressures would be significantly limited.
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We may have difficulty sustaining profitability and may
experience additional losses in the future. |
Although we recorded net income of $14.7 million,
$2.5 million, and $0.3 million for fiscal years 2004,
2003, and 2002 respectively, prior to 2002, we had prolonged
periods of consecutive quarterly net losses. At
December 31, 2004, we had an accumulated deficit of
$22.3 million. In order to maintain and improve our
profitability, we will need to continue to generate new sales
while controlling our costs. As we plan on continuing the growth
of our business while implementing cost control measures, we may
not be able to successfully generate enough revenues to remain
profitable with this growth. Any failure to increase our
revenues and control costs as we pursue our planned growth would
harm our profitability and would likely negatively affect the
market price of our stock.
29
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We may be unable to respond to the rapid technological
changes that often affect the markets in which we compete. |
If we fail to rapidly develop, manufacture and market
technologically innovative products at acceptable costs, our
operating results will suffer.
We operate in an industry that is subject to rapid technological
change. Our ability to remain competitive and future operating
results will depend upon, among other things, our ability to
anticipate and respond rapidly to such change by developing,
manufacturing and marketing technologically innovative products
in sufficient quantities at acceptable costs to meet such
demand. As we introduce new products this may cause some of our
existing products to become obsolete, which may result in the
write-off of inventory. However, without new products and
enhancements, our existing products will likely become obsolete
due to technological advances by other companies, which could
result in the write-off of inventory as well as diminished
revenues. Therefore, we intend to continue to invest significant
amounts in research and development.
Our expenditures for research and development were
$5.2 million in 2004, $4.4 million and
$3.8 million in each year of 2003 and 2002, respectively.
We anticipate that our ability to compete will require
significant research and development expenditures with a
continuing flow of innovative, high-quality products. We cannot
assure that we will be successful in designing, manufacturing or
selling enhanced or new products in a timely manner. Nor can we
assure that a competitor could not introduce a new or enhanced
product or technology that could have an adverse effect on our
competitive position.
Our current research and development programs are directed
toward the development of new laser systems and delivery
devices. We cannot assure that these markets will develop as
anticipated or that our product development efforts will prove
successful. Nor can we assure that such new products, if
developed and introduced, will be accepted by the market.
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We may become a party to a patent infringement and other
intellectual property related actions or disputes, which could
result in significant royalty or other payments or in
injunctions that can prevent the sale of our products. |
Our industry has been characterized by frequent patent
infringement and other intellectual property related action,
including demands for licenses and litigation. Our competitors
or other patent holders may assert that our products and the
methods we employ are covered by their patents. In addition, we
do not know whether our competitors will apply for and obtain
patents that will prevent, limit or interfere with our ability
to make, use, sell or import our products. Although we may seek
to resolve any potential future claims or actions, we may not be
able to do so on reasonable terms, or at all. If, following a
successful third-party action for infringement, we cannot obtain
a license or redesign our products, we may have to stop
manufacturing and marketing our products, and our business would
suffer as a result.
We may become involved in litigation not only as a result of
alleged infringement of a third partys intellectual
property rights but also to protect our own intellectual
property. We have and may hereafter become involved in
litigation to protect the trademark rights associated with our
company name or the names of our products. If we have to change
the name of our products, we may experience a loss in goodwill
associated with customer confusion and a loss of sales.
Infringement and other intellectual property related claims,
with or without merit, can be expensive and time-consuming to
litigate, and could divert managements attention from our
core business. We do not know whether necessary licenses would
be available to us on satisfactory terms, or whether we could
redesign our products or processes to avoid infringement. If we
lose this kind of litigation, a court could require us to pay
substantial damages, and prohibit us from using technologies
essential to our products, any of which would have a material
adverse effect on our business, results of operations and
financial condition.
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Any acquisitions we make may not provide us the expected
benefits and could disrupt our business and harm our financial
condition. |
Any acquisitions we make may not provide us the expected
benefits and could disrupt our business and harm our financial
condition, results of operations and cash flows. We have
acquired businesses and technologies in the past, and we may
continue to acquire businesses or technologies that we believe
are a strategic fit with our business. Any future acquisitions
may result in unforeseen operating difficulties and expenditures
and may absorb significant management attention that would
otherwise be available for ongoing development of our business.
In addition, the integration of acquisition targets may prove to
be more difficult than expected, and we may be unsuccessful in
maintaining and developing relations with the employees,
customers and business partners and other acquisition targets.
Since we will not be able to accurately predict these
difficulties and expenditures, it is possible that these costs
may outweigh the value we realize from a future acquisition.
Future acquisitions could result in issuances of equity
securities that would reduce our stockholders ownership
interest, the incurrence of debt, contingent liabilities,
deferred stock based compensation or expenses related to the
valuation of goodwill or other intangible assets and the
incurrence of large, immediate write-offs.
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We may be unable to attract and retain key personnel who are
critical to the success of our business |
Our future success also depends on our ability to attract and
retain engineers and other highly skilled personnel and senior
managers. In addition, in order to meet our planned growth we
must increase our sales force, both domestic and international,
with qualified employees. Hiring qualified technical, sales and
management personnel is difficult due to a limited number of
qualified professionals and competition in our industry for
these types of employees. We have in the past experienced delays
and difficulties in recruiting and retaining qualified technical
and sales personnel and believe that at times our employees are
recruited aggressively by our competitors and start-up
companies. Our employees are at will and may leave
our employment at any time. As a result, we may experience
significant employee turnover. Failure to attract and retain
personnel, particularly sales and technical personnel would make
it difficult for us to develop and market our technologies.
In addition, our business and operations are substantially
dependent on the performance of our key personnel, including
Eric Reuter, our President and Chief Executive Officer, Bob
Mathews, Group Vice President, Operations and Product
Development, and Robert Mann, Group Vice President, Worldwide
Sales and Marketing. We do not have formal employment agreements
with Messrs. Reuter, Mathews and Mann and do not maintain
key person life insurance policies on their lives.
If such individuals were to leave or become unable to perform
services for our company, our business could be severely harmed.
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Our quarterly operating results may fluctuate significantly
and any failure to meet financial expectations for any fiscal
quarter may cause our stock price to decline. |
A number of factors affect our quarterly financial results
including the timing of shipments and orders. Our laser products
are relatively expensive pieces of medical capital equipment and
the precise shipment date of specific units can have a marked
effect on our results of operations on a quarterly basis.
Additionally, our fiber optic disposable devices are relatively
complex assemblies requiring components that can have long lead
times. Failure of suppliers to provide materials in a timely
manner or other disruptions in the continuous production of
these fiber optics components could have a substantially marked
effect on our results of operations on a quarterly basis. Any
delay in product shipments near the end of a quarter could cause
our quarterly results to fall short of anticipated levels.
Furthermore, to the extent we receive orders near the end of a
quarter, we may not be able to fulfill the order during the
balance of that same quarter. Moreover, we typically receive a
disproportionate percentage of orders toward the end of each
quarter. To the extent that we do not receive anticipated orders
or orders are delayed beyond the end of the applicable quarter,
our results may be adversely affected and may be unpredictable
from quarter to quarter. In addition, because a significant
portion of our revenues in each quarter result from orders
received in that quarter, we base our production, inventory and
operating expenditure levels on anticipated revenue levels.
Thus, if sales do not occur when expected, expenditure levels
could be disproportionately high and operating results for that
quarter and
31
potentially future quarters, would be adversely affected. We
cannot assure that Laserscope will accomplish revenue growth or
profitability on a quarterly or annual basis. Nor can we assure
that revenue growth or profitability will not fluctuate
significantly from quarter to quarter.
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If we are unable to continue our relationship with McKesson
on favorable contractual terms, our business may be harmed. |
In December 2000, Laserscope and McKesson entered into a
five-year agreement whereby McKesson would obtain exclusive
distribution rights for the Companys aesthetic product
lines to doctors offices in the United States. During
2004, Sales to McKesson accounted for approximately 23% of our
total revenues and at December 31, 2004, accounts
receivable from McKesson accounted for approximately 25% of our
total accounts receivable. If we are unable to maintain a
favorable relationship with McKesson or if McKesson encounters
financial difficulties, it would have a material adverse effect
on our business, financial condition, results of operations, and
future cashflows.
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If our products contain defects that harm our customers
patients, it would damage our reputation, subject us to
potential legal liability and cause us to lose customers and
revenue. |
Laser systems and fiber optic delivery devices are inherently
complex in design and manufacturing. Laser systems require
ongoing regular maintenance. The manufacture of our lasers,
laser products, disposable delivery devices, and systems involve
highly complex and precise processes. As a result of the
technical complexity of our products, changes in our or our
suppliers manufacturing processes or the inadvertent use
of defective materials by us or our suppliers could result in a
material adverse effect on our ability to achieve acceptable
manufacturing yields and product reliability. To the extent that
we do not achieve such yields or product reliability, our
business, operating results, financial condition and customer
relationships would be adversely affected.
Our customers may discover defects in our products after the
products have been fully deployed and operated under peak stress
conditions. In addition some of our products are combined with
products from other vendors, which may contain defects. As a
result, should problems occur, it may be difficult to identify
the source of the problem. If we are unable to fix defects or
other problems, we could experience, among other things:
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loss of customers; |
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increased costs of product, returns and warranty expenses; |
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damage to our brand reputation; |
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failure to attract new customers or achieve market acceptance; |
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diversion of development and engineering resources; and |
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legal actions by our customers. |
The occurrence of any one or more of the foregoing factors could
seriously harm our business, financial condition and results of
operations.
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Our financial results and stock price are affected by a
number of factors which are beyond our control. |
A number of factors affect our financial results and stock price
including, but not limited to:
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product mix; |
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competitive pricing pressures; |
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material costs; |
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revenue and expenses related to new products and enhancements to
existing products; |
32
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delays in customer purchases in anticipation of new products or
product enhancements by Laserscope or its competitors; and |
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the risk of loss or interruption to our operations or increased
costs due to earthquakes, the availability of power and energy
supplies and other events beyond our control. |
The market price of our common stock may be subject to
significant fluctuations. These fluctuations may be due to
factors specific to Laserscope, such as:
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quarterly fluctuations in our financial results; |
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changes in analysts estimates of future results; |
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changes in investors perceptions of our products; |
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announcement of new or enhanced products by us or our
competitors; |
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announcements relating to acquisitions and strategic
transactions by us |
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or our competitors; |
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general conditions in the medical equipment industry; and |
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general conditions in the financial markets. |
The stock market has from time to time experienced extreme price
and volume fluctuations, particularly among stocks of high
technology companies, which, on occasion, have been unrelated to
the operating performance of particular companies. Factors not
directly related to Laserscopes performance, such as
negative industry reports or disappointing earnings
announcements by publicly traded competitors, may have an
adverse impact on the market price of our common stock.
As of March 1, 2005, we had 22,006,738 shares of
outstanding common stock. The sale of a substantial number of
shares of common stock or the perception that such sales could
occur, could adversely affect prevailing market prices for our
common stock.
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We are a party to legal proceedings arising in the ordinary
course of business. |
Laserscope is a party to a number of legal proceedings arising
in the ordinary course of business. While it is not feasible to
predict or determine the outcome of the actions brought against
us, we believe that the ultimate resolution of these claims will
not ultimately have a material adverse effect on
Laserscopes financial position, results of operations, or
future cash flows.
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We typically assume warranty obligations in connection with
the sales of our products, which could cause a significant drain
on our resources if our products perform poorly. |
We have a direct field service organization that provides
service for our products. We generally provide a twelve month
warranty on our laser systems. After the warranty period,
maintenance and support is provided on a service contract basis
or on an individual call basis. Our warranties and premium
service contracts provide for a 99.0% Uptime
Guarantee on our laser systems. Under provisions of this
guarantee, at the request of the customer, we extend the term of
the related warranty or service contract if specified system
uptime levels are not maintained.
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Natural catastrophic events, such as earthquakes, or
terrorist attacks may reduce our revenues and harm our
business. |
Our corporate headquarters, including our research and
development operations, our manufacturing facilities, and our
principal sales, marketing and service offices, are located in
the Silicon Valley area of Northern California, a region known
for seismic activity. A significant natural disaster, such as an
earthquake or a flood, could have a material adverse impact on
our business, operating results, and financial condition. In
addition, despite our implementation of network security
measures, our servers are vulnerable to computer
33
viruses, break-ins, and similar disruptions from unauthorized
tampering with our computer systems. Any such event could have a
material adverse effect on our business, operating results, and
financial condition.
In addition, as our business has grown, we have become
increasingly subject to the risks arising from adverse changes
in domestic and global economic conditions. The effects of war
or acts of terrorism could have a material adverse effect on our
business, operating results, and financial condition. The
terrorist attacks in New York, Pennsylvania and
Washington, D.C. on September 11, 2001 disrupted
commerce throughout the world and intensified the uncertainty of
the United States and other economies. The continued threat of
terrorism and heightened security and military action in
response to this threat, or any future acts of terrorism, may
cause further disruptions to these economies and create further
uncertainties. To the extent that such disruptions or
uncertainties result in delays or cancellations of customer
orders, or the manufacture or shipment of our products, our
business, operating results, financial condition and cash flows
could be materially and adversely affected.
No Dividends.
We have never paid cash dividends on our common stock and do not
anticipate paying cash dividends on the common stock in the
foreseeable future. The payment of dividends on the common stock
will depend on our earnings, financial condition and other
business and economic factors affecting us at such time as the
Board of Directors may consider relevant.
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The exercise of outstanding options and warrants granted
under Laserscopes stock option plans and other options and
warrants may result in dilution of our shareholders equity
interests. |
Shareholders may experience dilution in the net tangible book
value of their investment upon the exercise of outstanding
options and warrants granted under Laserscopes stock
option plans and other options and warrants.
Other Risks.
Other risks are detailed from time to time in our press releases
and other public disclosure filings with the United States
Securities and Exchange Commission (SEC), copies of
which are available upon request from the Company.
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Item 7A. |
Quantitative and Qualitative Disclosures About Market
Risk. |
We are exposed to a variety of risks, including changes in
interest rates affecting the return on investments, outstanding
debt balances and foreign currency fluctuations. In the normal
course of business, we employ established policies and
procedures to manage exposure to fluctuations in interest rates
and foreign currency values.
Interest Rate Risk
Our exposure to market rate risk for changes in interest rates
relates primarily to our cash and cash equivalents. In 2004 and
2003, we did not use derivative financial instruments. We invest
our excess cash in money market funds. Our debt financings
generally consisted of convertible debentures and bank loans
requiring either fixed or variable rate interest payments.
Investments in and borrowings under both fixed-rate and
floating-rate interest-earning instruments carry a degree of
interest rate risk. On the investment side, fixed-rate
securities may have their fair market value adversely affected
due to a rise in interest rates, while floating-rate securities
may produce less income than expected if interest rates fall. In
addition, our future investment income may fall short of
expectations due to changes in interest rates or we may suffer
losses in principal if forced to sell securities that have
declined in market value due to changes in interest rates.
On the debt side, borrowings that require fixed-rate interest
payments require greater than current market rate interest
payments if interest rates fall, while floating rate borrowings
may require greater interest
34
payments if interest rates rise. Additionally, our future
interest expense may be greater than expected due to changes in
interest rates.
Foreign Currency Risk
International revenues were approximately 27% of total revenues
in 2004 and 26% of total revenues in 2003 and 2002. Our
international sales are made through international distributors
and wholly-owned subsidiaries with payments to us typically
denominated in the local currencies of the United Kingdom and
France, and in United States Dollars in the rest of the world.
We intend to continue our operations outside of the United
States and potentially to enter additional international
markets. These activities, require significant management
attention and financial resources and further subject us to the
risks of operating internationally. These risks include, but are
not limited to:
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changes in regulatory requirements; |
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delays resulting from difficulty in obtaining export licenses
for certain technology; |
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customs, tariffs and other barriers and restrictions; and |
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the burdens of complying with a variety of foreign laws. |
We are also subject to general geopolitical risks in connection
with our international operations, such as:
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differing economic conditions; |
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changes in political climate; |
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differing tax structures; and |
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changes in diplomatic and trade relationships and war. |
In addition, fluctuations in currency exchange rates may
negatively affect our ability to compete in terms of price
against products denominated in local currencies.
Accordingly, our future results could be materially adversely
affected by changes in these regulatory, geopolitical and other
factors.
We do not engage in hedging transactions for speculative or
trading purposes.
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Item 8. |
Consolidated Financial Statements and Supplementary
Data. |
Consolidated financial statements of Laserscope at
December 31, 2004 and 2003, and for each of the three years
ended December 31, 2004, the report of independent
registered public accounting firm thereon and Supplementary Data
are included as separate sections in this Annual Report on
Form 10-K in Item 6 Selected Financial
Data and Item 15, Exhibits, Financial Statement
Schedules and reports on Form 8-K.
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Item 9. |
Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure. |
None.
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Item 9A. |
Controls and Procedures. |
Evaluation of Disclosure Controls and Procedures. The
Company maintains disclosure controls and procedures that are
designed to ensure that information required to be disclosed in
the Companys Securities Exchange Act reports is recorded,
processed, summarized, and reported within the time periods
specified in the Securities Exchange Commissions rules and
forms, and that such information is accumulated and communicated
to the Companys management, including its Chief Executive
Officer and Chief Financial Officer, as appropriate, to allow
timely decisions regarding required financial disclosure.
As of the end of the period covered by this report, the Company
carried out an evaluation, under the supervision and with the
participation of the Companys Disclosure Committee and
management, including
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the Chief Executive Officer and the Chief Financial Officer, of
the effectiveness of the design and operation of our disclosure
controls and procedures pursuant to Exchange Act
Rules 13a-15(b) and 15d-15(b). Based upon, and as of the
date of, this evaluation, the Chief Executive Officer and the
Chief Financial Officer concluded that our disclosure controls
and procedures were effective.
Status of Managements Report on Internal Control Over
Financial Reporting. The Companys management is
responsible for establishing and maintaining adequate internal
control over financial reporting, as that term is defined in
Exchange Act Rules 13a-15(f) and 15d-15(f). Under the
supervision and with the participation of the Companys
management, including the principal executive officer and
principal financial officer, the Company is in the process of
conducting an evaluation of its internal control over financial
reporting based on the framework in Internal
Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission.
The Companys evaluation of its internal control over
financial reporting has not yet been completed. In connection
with this ongoing process, the Company has identified certain
significant deficiencies and other control deficiencies. As a
result of the ongoing evaluation of internal control over
financial reporting, additional control deficiencies may be
identified. Additionally, once we have completed our evaluation
of all deficiencies (those identified to date and those which
may be identified as we complete our evaluation) we may
determine that the deficiencies, either alone or in combination
with others, constitute one or more material weaknesses. A
material weakness is a control deficiency, or combination of
control deficiencies, that results in more than a remote
likelihood that a material misstatement of the annual or interim
financial statements will not be prevented or detected. The
existence of one or more material weaknesses at
December 31, 2004 precludes management from concluding that
the Companys internal control over financial reporting was
effective as of December 31, 2004, based on the criteria in
the Internal Control Integrated Framework.
Pursuant to Securities and Exchange Commission Release
No. 34-50754, which, subject to certain conditions,
provides up to 45 additional days beyond the due date of this
Form 10-K for the filing of managements annual report
on internal control over financial reporting required by
Item 308(a) of Regulation S-K, and the related
attestation report of the independent registered public
accounting firm, as required by Item 308(b) of
Regulation S-K, managements report on internal
control over financial reporting and the associated report on
the audit of managements assessment of the effectiveness
of the Companys internal control over financial reporting
as of December 31, 2004, are not filed herein and are
expected to be filed no later than May 2, 2005.
Changes in Internal Control Over Financial Reporting.
There have not been any changes in the Companys
internal control over financial reporting, as such term is
defined in Rules 13a-15(f) and 15d-15(f) under the Exchange
Act during the Companys fiscal quarter ended
December 31, 2004 that have materially affected, or are
reasonable likely to materially affect, the Companys
internal control over financial reporting.
Limitations on the Effectiveness of Controls. A
companys internal control over financial reporting is a
process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with
generally accepted accounting principles. A companys
internal control over financial reporting includes those
policies and procedures that (i) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the
company; (ii) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of
financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the
company are being made only in accordance with authorizations of
management and directors of the company; and (iii) provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the
companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
36
PART III
Certain information required by Part III is omitted from
this Annual Report on Form 10-K because the Company will
file a definitive proxy statement prior to April 30, 2005
pursuant to Regulation 14A (the Proxy
Statement) for its Annual Meeting of Shareholders to be
held June 10, 2005 and the information included in the
Proxy Statement is incorporated herein by reference.
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Item 10. |
Directors and Executive Officers of the Registrant. |
The information concerning the Companys directors and
executive officers required by this Item 10 is incorporated
by reference from the Companys Proxy Statement for the
2004 Annual Meeting of Shareholders under the headings
Election of Directors. Management and
Section 16(a) Beneficial Ownership Reporting
Compliance, respectively. See also Item 1 above.
Code of Ethics
The information required by this Item 10 is incorporated by
reference from the Companys Proxy Statement for the 2005
Annual Meeting of Shareholders under the heading Code of
Ethics.
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Item 11. |
Executive Compensation. |
The information required by this Item 11 is incorporated by
reference from the Companys Proxy Statement for the 2005
Annual Meeting of Shareholders under the heading Executive
Compensation.
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Item 12. |
Security Ownership of Certain Beneficial Owners and
Management. |
The information required by this Item 12 is incorporated by
reference from the Companys Proxy Statement for the 2005
Annual Meeting of Shareholders under the heading
Beneficial Ownership of Securities and Equity
Compensation Plan Information.
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Item 13. |
Certain Relationships and Related Transactions. |
The information required by this Item 13 is incorporated by
reference from the Companys Proxy Statement for the 2005
Annual Meeting of Shareholders under the heading Certain
Transactions.
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Item 14. |
Principal Accountant Fees and Services |
The information required by this Item 14 is incorporated by
reference from the Companys Proxy Statement for the 2005
Annual Meeting of Shareholders under the heading Principal
Auditor Fees and Services.
37
Part IV
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Item 15. |
Exhibits, Financial Statement Schedules, and Reports on
Form 8-K. |
(a) (1) Consolidated Financial Statements:
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Report of Independent Registered Public Accounting Firm on
Financial Statements
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F-1 |
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Consolidated Balance Sheets at December 31, 2004 and 2003
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F-2 |
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Consolidated Statements of Operations Years ended
December 31, 2004, 2003 and 2002
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F-3 |
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Consolidated Statements of Cash Flows Years ended
December 31, 2004, 2003 and 2002
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F-4 |
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Consolidated Statements of Shareholders Equity
Years ended December 31, 2004, 2003 and 2002
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F-5 |
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Notes to Consolidated Financial Statements
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F-6 through F-24 |
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(2) The following financial statement schedule for the
years ended December 31, 2004, 2003 and 2002 is submitted
herewith:
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Schedule II Valuation and Qualifying Accounts
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S-1 |
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All other schedules are omitted because they are not applicable
or the required information is shown in the consolidated
financial statements or notes thereto.
(3) Exhibits included herein (numbered in accordance with
Item 601 of Regulation S-K):
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|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
3 |
.3 |
|
Eighth Amended and Restated Articles of Incorporation of
Registrant.(12) |
|
|
3 |
.4 |
|
By-laws of Registrant, as amended.(2) |
|
|
10 |
.1A |
|
1984 Stock Option Plan, as amended, and forms of Incentive Stock
Option Agreement and Non-statutory Stock Option Agreement.(2) |
|
|
10 |
.1B |
|
1994 Stock Option Plan and forms of Incentive Stock Option
Agreement and Non-statutory Stock Option Agreement.(3) |
|
|
10 |
.2 |
|
1984 Stock Purchase Plan and form of Common Stock Purchase
Agreement.(1) |
|
|
10 |
.3 |
|
1989 Employee Stock Purchase Plan and form of Subscription
Agreement.(2) |
|
|
10 |
.3A |
|
1999 Employee Stock Purchase Plan and form of Subscription
Agreement.(5) |
|
|
10 |
.4 |
|
401(k) Plan.(1) |
|
|
10 |
.6 |
|
Net Lease Agreement between the Registrant and Realtec
Properties dated June 20, 2000.(8) |
|
|
10 |
.6A |
|
Net Lease Agreement between the Registrant and Realtec
Properties dated October 18, 2000.(8) |
|
|
10 |
.10 |
|
Form of indemnification agreement.(1) |
|
|
10 |
.11G |
|
Loan and Security Agreement between the Registrant and Silicon
Valley Bank dated October 1, 1999.(5) |
|
|
10 |
.11H |
|
Amendment to Loan and Security Agreement between the Registrant
and Silicon Valley Bank dated September 25, 2000.(7) |
|
|
10 |
.11I |
|
Amendment to Loan and Security Agreement between the Registrant
and Silicon Valley Bank dated September 26, 2001.(9) |
|
|
10 |
.11J |
|
Amendment to Loan and Security Agreement between the Registrant
and Silicon Valley Bank dated September 26, 2002.(11) |
|
|
10 |
.11K |
|
Amendment to Loan and Security Agreement between the Registrant
and Silicon Valley Bank dated September 25, 2003.(13) |
38
|
|
|
|
|
Exhibit | |
|
|
Number | |
|
Description |
| |
|
|
|
|
10 |
.11L |
|
Amendment to Loan and Security Agreement between the Registrant
and Silicon Valley Bank dated September 24, 2004.(15) |
|
|
10 |
.13 |
|
1990 Directors Stock Option Plan and form of Option
Agreement.(2) |
|
|
10 |
.14 |
|
Form of Laserscope Management Continuity Agreement, as
amended.(6) |
|
|
10 |
.14A |
|
Form of Laserscope Management Continuity Agreement, as
amended.(10) |
|
|
10 |
.14B |
|
Form of Laserscope Management Continuity Agreement, as
amended.(14) |
|
|
10 |
.18 |
|
1995 Directors Stock Option Plan and form of Option
agreement.(4) |
|
|
10 |
.18A |
|
1999 Directors Stock Option Plan.(5) |
|
|
10 |
.19 |
|
Common Stock Placement Agreement.(5) |
|
|
10 |
.19A |
|
Form of Common Stock Purchase Agreement.(5) |
|
|
10 |
.20 |
|
Convertible Loan Agreement.(5) |
|
|
10 |
.20A |
|
Amendment to Convertible Loan Agreement.(12) |
|
|
10 |
.20B |
|
Amendment to Convertible Loan Agreement.(13) |
|
|
22 |
.1 |
|
Subsidiaries of Registrant, as amended.(8) |
|
|
23 |
.1 |
|
Consent of Independent Registered Public Accounting Firm.(16) |
|
|
25 |
.1 |
|
Power of Attorney (See page 41).(16) |
|
|
31 |
.1 |
|
Certification of Principal Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.(16) |
|
|
31 |
.2 |
|
Certification of Principal Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.(16) |
|
|
32 |
.1 |
|
Certification of Principal Executive Officer pursuant to
18 U.S.C. section 1350.(16) |
|
|
32 |
.2 |
|
Certification of Principal Financial Officer pursuant to
18 U.S.C. section 1350.(16) |
|
|
|
|
(1) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 16(a), Exhibits, of the
Registrants Registration Statement on Form S-1 and
Amendment No. 1 and Amendment No. 2 thereto (File
No. 33-31689), which became effective on November 29,
1989. |
|
|
(2) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 14(a)(3), Exhibits, of the
Registrants Annual Report on Form 10-K for the year
ended December 31, 1991. |
|
|
(3) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 14(a)(3), Exhibits, of the
Registrants Annual Report on Form 10-K for the year
ended December 31, 1994. |
|
|
(4) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 14(a)(3), Exhibits, of the
Registrants Annual Report on Form 10-K/ A for the
year ended December 31, 1995. |
|
|
(5) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 14(a)(3), Exhibits, of the
Registrants Annual Report on Form 10-K for the year
ended December 31, 1999. |
|
|
(6) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2000. |
|
|
(7) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2000. |
|
|
(8) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 14(a)(3), Exhibits, of the
Registrants Annual Report on Form 10-K for the year
ended December 31, 2000. |
|
|
(9) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2001. |
|
|
(10) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2002. |
39
|
|
(11) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2002. |
|
(12) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 14(a)(3), Exhibits, of the
Registrants Annual Report on Form 10-K for the year
ended December 31, 2002. |
|
(13) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2003. |
|
(14) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2004. |
|
(15) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2004. |
|
(16) |
Filed herewith. |
40
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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.
|
|
|
|
|
Eric M. Reuter |
|
President and Chief Executive Officer |
Date: March 31, 2005
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose
signature appears below constitutes and appoints Eric M. Reuter
and Dennis LaLumandiere as his attorneys-in-fact, each with the
power of substitution, for him in any and all capacities, to
sign any amendments to this Report on Form 10-K, and to
file the same, with exhibits thereto and other documents in
connection therewith with the Securities and Exchange
Commission, hereby ratifying and confirming all that each of
said attorneys-in-fact, or his substitute or substitutes, may do
or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of
1934, this Report has been signed below by the following persons
in the capacities and on the dates indicated.
|
|
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ Robert J. Pressley
(Robert
J. Pressley, Ph.D.) |
|
Chairman of the Board of Directors |
|
March 31, 2005 |
|
/s/ Eric M. Reuter
(Eric
M. Reuter) |
|
President, Chief Executive Officer
and Director
(Principal Executive Officer) |
|
March 31, 2005 |
|
/s/ Dennis LaLumandiere
(Dennis
LaLumandiere) |
|
Vice President, Finance, Chief
Financial Officer and Secretary
(Principal Financial and
Accounting Officer) |
|
March 31, 2005 |
|
/s/ James Baumgardt
(James
Baumgardt) |
|
Director |
|
March 31, 2005 |
|
/s/ Robert C. Pearson
(Robert
C. Pearson) |
|
Director |
|
March 31, 2005 |
|
/s/ Rodney Perkins
(Rodney
Perkins, M.D.) |
|
Director |
|
March 31, 2005 |
41
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM ON
FINANCIAL STATEMENTS
To the Board of Directors and Shareholders
of Laserscope:
In our opinion, the consolidated financial statements listed in
the index appearing under Item 15(a)(1) present fairly, in
all material respects, the financial position of Laserscope and
its subsidiaries at December 31, 2004 and 2003, and the
results of their operations and their cash flows for each of the
three years in the period ended December 31, 2004 in
conformity with accounting principles generally accepted in the
United States of America. In addition, in our opinion, the
financial statement schedule listed in the index appearing under
Item 15(a)(2) presents fairly, in all material respects,
the information set forth therein when read in conjunction with
the related consolidated financial statements. These financial
statements and financial statement schedule are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements and financial statement schedule based on our audits.
We conducted our audits of these statements in accordance with
the standards of the Public Company Accounting Oversight Board
(United States). Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements,
assessing the accounting principles used and significant
estimates made by management, and evaluating the overall
financial statement presentation. We believe that our audits
provide a reasonable basis for our opinion.
|
|
|
/s/ PricewaterhouseCoopers LLP |
San Jose, California
March 28, 2005
F-1
LASERSCOPE
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
(Thousands except | |
|
|
share amounts) | |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
15,954 |
|
|
$ |
7,158 |
|
|
Accounts receivable, net
|
|
|
20,342 |
|
|
|
12,711 |
|
|
Inventories, net
|
|
|
19,446 |
|
|
|
13,368 |
|
|
Other current assets
|
|
|
1,471 |
|
|
|
1,315 |
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
57,213 |
|
|
|
34,552 |
|
Property and equipment, net
|
|
|
3,457 |
|
|
|
1,645 |
|
Goodwill
|
|
|
655 |
|
|
|
655 |
|
Other assets
|
|
|
264 |
|
|
|
176 |
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
61,589 |
|
|
$ |
37,028 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
2,389 |
|
|
$ |
4,094 |
|
|
Accrued compensation
|
|
|
4,365 |
|
|
|
2,360 |
|
|
Warranty
|
|
|
2,536 |
|
|
|
1,947 |
|
|
Other accrued liabilities
|
|
|
5,761 |
|
|
|
3,347 |
|
|
Deferred revenue
|
|
|
3,575 |
|
|
|
2,022 |
|
|
Current obligations under capital leases
|
|
|
21 |
|
|
|
60 |
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
18,647 |
|
|
|
13,830 |
|
|
|
|
|
|
|
|
Long-term liabilities:
|
|
|
|
|
|
|
|
|
|
Obligations under capital leases
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term liabilities
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (Note 9)
|
|
|
|
|
|
|
|
|
Shareholders equity:
|
|
|
|
|
|
|
|
|
|
Common stock, no par value:
|
|
|
|
|
|
|
|
|
|
Authorized shares 30,000,000 at December 31,
2004 and 2003.
|
|
|
|
|
|
|
|
|
|
Issued and outstanding shares 21,966,117 and
20,131,781 at December 31, 2004 and 2003, respectively
|
|
|
65,009 |
|
|
|
60,427 |
|
|
Accumulated deficit
|
|
|
(22,263 |
) |
|
|
(37,002 |
) |
|
Accumulated other comprehensive income/(loss)
|
|
|
165 |
|
|
|
(227 |
) |
|
|
|
|
|
|
|
|
Total shareholders equity
|
|
|
42,911 |
|
|
|
23,198 |
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity
|
|
$ |
61,589 |
|
|
$ |
37,028 |
|
|
|
|
|
|
|
|
See notes to consolidated financial statements
F-2
LASERSCOPE
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(Thousands, except per share amounts) | |
Net revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Products
|
|
$ |
86,341 |
|
|
$ |
51,104 |
|
|
$ |
37,262 |
|
|
Services
|
|
|
7,429 |
|
|
|
6,323 |
|
|
|
5,826 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
93,770 |
|
|
|
57,427 |
|
|
|
43,088 |
|
|
|
|
|
|
|
|
|
|
|
Cost of products and services:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Products
|
|
|
33,298 |
|
|
|
22,942 |
|
|
|
16,832 |
|
|
Services
|
|
|
5,817 |
|
|
|
4,399 |
|
|
|
3,736 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
39,115 |
|
|
|
27,341 |
|
|
|
20,568 |
|
|
|
|
|
|
|
|
|
|
|
Gross margin
|
|
|
54,655 |
|
|
|
30,086 |
|
|
|
22,520 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
5,217 |
|
|
|
4,443 |
|
|
|
3,837 |
|
|
Selling, general and administrative
|
|
|
34,023 |
|
|
|
22,936 |
|
|
|
17,892 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
39,240 |
|
|
|
27,379 |
|
|
|
21,729 |
|
|
|
|
|
|
|
|
|
|
|
Operating income
|
|
|
15,415 |
|
|
|
2,707 |
|
|
|
791 |
|
Interest income
|
|
|
39 |
|
|
|
52 |
|
|
|
10 |
|
Interest expense and other income, net
|
|
|
225 |
|
|
|
(40 |
) |
|
|
(392 |
) |
|
|
|
|
|
|
|
|
|
|
Income before income taxes
|
|
|
15,679 |
|
|
|
2,719 |
|
|
|
409 |
|
Provision for income taxes
|
|
|
940 |
|
|
|
202 |
|
|
|
86 |
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$ |
14,739 |
|
|
$ |
2,517 |
|
|
$ |
323 |
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share
|
|
$ |
0.70 |
|
|
$ |
0.13 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share
|
|
$ |
0.65 |
|
|
$ |
0.13 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
Shares used in basic per share calculations
|
|
|
21,075 |
|
|
|
17,452 |
|
|
|
16,441 |
|
|
|
|
|
|
|
|
|
|
|
Shares used in diluted per share calculations
|
|
|
22,808 |
|
|
|
21,838 |
|
|
|
18,569 |
|
|
|
|
|
|
|
|
|
|
|
See notes to consolidated financial statements
F-3
LASERSCOPE
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$ |
14,739 |
|
|
$ |
2,517 |
|
|
$ |
323 |
|
|
Adjustments to reconcile net income to cash provided by
operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
1,055 |
|
|
|
1,222 |
|
|
|
1,051 |
|
|
|
Tax benefit of stock option exercises
|
|
|
383 |
|
|
|
|
|
|
|
|
|
|
|
Amortization of debt issuance costs
|
|
|
|
|
|
|
135 |
|
|
|
134 |
|
|
|
Provision for doubtful accounts
|
|
|
(165 |
) |
|
|
93 |
|
|
|
115 |
|
|
|
Provision for inventory
|
|
|
(73 |
) |
|
|
346 |
|
|
|
134 |
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(7,233 |
) |
|
|
(2,204 |
) |
|
|
(1,750 |
) |
|
|
Inventories
|
|
|
(5,867 |
) |
|
|
(3,025 |
) |
|
|
(1,149 |
) |
|
|
Prepayments and other current assets
|
|
|
(68 |
) |
|
|
(326 |
) |
|
|
305 |
|
|
|
Accounts payable
|
|
|
(1,271 |
) |
|
|
829 |
|
|
|
1,092 |
|
|
|
Accrued compensation
|
|
|
1,998 |
|
|
|
327 |
|
|
|
445 |
|
|
|
Warranty
|
|
|
589 |
|
|
|
820 |
|
|
|
379 |
|
|
|
Deferred revenue
|
|
|
1,539 |
|
|
|
614 |
|
|
|
377 |
|
|
|
Other accrued liabilities
|
|
|
1,361 |
|
|
|
235 |
|
|
|
366 |
|
|
|
Tax payable
|
|
|
397 |
|
|
|
136 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash provided by operating activities
|
|
|
7,384 |
|
|
|
1,719 |
|
|
|
1,822 |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(2,812 |
) |
|
|
(873 |
) |
|
|
(776 |
) |
|
Acquisition of licenses or other intangibles
|
|
|
(127 |
) |
|
|
(200 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash used in investing activities
|
|
|
(2,939 |
) |
|
|
(1,073 |
) |
|
|
(776 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment on obligations under capital leases
|
|
|
(10 |
) |
|
|
(117 |
) |
|
|
(101 |
) |
|
Proceeds from the sale of common stock under stock plans
|
|
|
3,691 |
|
|
|
1,565 |
|
|
|
1,197 |
|
|
Proceeds from the exercise of warrants
|
|
|
508 |
|
|
|
97 |
|
|
|
6 |
|
|
Repayment of shareholder notes
|
|
|
|
|
|
|
125 |
|
|
|
|
|
|
Proceeds from line of credit
|
|
|
|
|
|
|
200 |
|
|
|
7,020 |
|
|
Repayment of line of credit
|
|
|
|
|
|
|
(200 |
) |
|
|
(8,155 |
) |
|
|
|
|
|
|
|
|
|
|
|
Cash provided by (used in) financing activities
|
|
|
4,189 |
|
|
|
1,670 |
|
|
|
(33 |
) |
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash
|
|
|
162 |
|
|
|
181 |
|
|
|
240 |
|
|
Increase in cash and cash equivalents
|
|
|
8,796 |
|
|
|
2,497 |
|
|
|
1,253 |
|
|
Cash and cash equivalents, beginning of year
|
|
|
7,158 |
|
|
|
4,661 |
|
|
|
3,408 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of year
|
|
$ |
15,954 |
|
|
$ |
7,158 |
|
|
$ |
4,661 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes, net of refunds
|
|
$ |
224 |
|
|
$ |
67 |
|
|
$ |
79 |
|
|
Cash paid for interest
|
|
$ |
37 |
|
|
$ |
234 |
|
|
$ |
303 |
|
|
Non-cash financing, equipment lease
|
|
$ |
81 |
|
|
$ |
|
|
|
$ |
60 |
|
|
Debenture conversion
|
|
$ |
|
|
|
$ |
2,850 |
|
|
$ |
|
|
See notes to consolidated financial statements
F-4
LASERSCOPE
CONSOLIDATED STATEMENTS OF SHAREHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
|
|
|
|
|
|
Other | |
|
Notes | |
|
Total | |
|
|
|
|
Accumulated | |
|
Comprehensive | |
|
Receivable from | |
|
Shareholders | |
|
|
Common Stock | |
|
Deficit | |
|
Income/(Loss) | |
|
Shareholders | |
|
Equity | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(In thousands except share amounts) | |
|
|
Balance at December 31, 2001
|
|
$ |
54,712 |
|
|
$ |
(39,842 |
) |
|
$ |
(1,332 |
) |
|
$ |
(125 |
) |
|
$ |
13,413 |
|
Components of comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
323 |
|
|
|
|
|
|
|
|
|
|
|
323 |
|
|
Translation adjustments
|
|
|
|
|
|
|
|
|
|
|
543 |
|
|
|
|
|
|
|
543 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
866 |
|
Issuance of 737,526 shares plans
|
|
|
1,197 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,197 |
|
Issuance of 5,000 shares upon warrant exercises
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
55,915 |
|
|
|
(39,519 |
) |
|
|
(789 |
) |
|
|
(125 |
) |
|
|
15,482 |
|
Components of comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
2,517 |
|
|
|
|
|
|
|
|
|
|
|
2,517 |
|
|
Translation adjustments
|
|
|
|
|
|
|
|
|
|
|
562 |
|
|
|
|
|
|
|
562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,079 |
|
Issuance of 827,794 shares under stock plans
|
|
|
1,565 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,565 |
|
Issuance of 75,663 shares upon warrant exercises
|
|
|
97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
97 |
|
Debenture conversion into 2,400,000 shares, net of
unamortized issuance costs
|
|
|
2,850 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,850 |
|
Repayment of shareholder notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
125 |
|
|
|
125 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
60,427 |
|
|
|
(37,002 |
) |
|
|
(227 |
) |
|
|
|
|
|
|
23,198 |
|
Components of comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
14,739 |
|
|
|
|
|
|
|
|
|
|
|
14,739 |
|
|
Translation adjustments
|
|
|
|
|
|
|
|
|
|
|
392 |
|
|
|
|
|
|
|
392 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,131 |
|
Issuance of 1,471,124 shares under stock plans
|
|
|
3,691 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,691 |
|
Issuance of 363,212 shares upon warrant exercises
|
|
|
508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
508 |
|
Tax benefit of stock option exercise
|
|
|
383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
$ |
65,009 |
|
|
$ |
(22,263 |
) |
|
$ |
165 |
|
|
$ |
|
|
|
$ |
42,911 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to consolidated financial statements
F-5
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
1. |
Summary of Significant Accounting Policies |
Laserscope (the Company), operates in one business
segment, the medical systems business. The Company develops,
manufactures, markets and supports aesthetic and surgical lasers
and other surgical systems, related instrumentation and
disposable supplies. The Company markets its products and
services in over thirty-five countries worldwide to hospitals,
outpatient surgery centers and physicians.
The accompanying consolidated financial statements include the
Company and its wholly and majority-owned subsidiaries. All
inter-company transactions and balances have been eliminated.
Preparation of the accompanying financial statements in
conformity with accounting principles generally accepted in the
United States of America requires management to make certain
estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reported
period. Actual results could differ from those estimates.
|
|
|
Fair value of financial instruments |
Carrying amounts of the Companys financial instruments
including cash and cash equivalents, accounts receivable,
accounts payable and accrued liabilities, approximate their fair
values due to their short maturities. Based on the borrowing
rates currently available to the Company for loans with similar
terms, the carrying value of the capital lease obligations,
approximates its fair value.
|
|
|
Cash and cash equivalents |
The Company considers cash equivalents to be short-term
financial instruments that are readily convertible to cash,
subject to no more than insignificant interest rate risk and
that have original maturities of three months or less.
|
|
|
Accounts Receivable and Allowance for Doubtful
Accounts |
Trade receivables are recorded at the invoiced amount and do not
bear interest. We assess the credit worthiness of our customers
prior to making a sale in order to mitigate the risk of loss
from customers not paying us. However, to account for the
inevitability that a customer may not pay us, we maintain an
allowance for doubtful accounts. We estimate losses based on the
overall business climate, our accounts receivable aging profile,
and an analysis of the circumstances associated with specific
accounts which are past due. Account balances are charged off
against the allowance when we feel it is probable the receivable
will not be recovered. We do not have any off-balance-sheet
credit exposure related to our customers.
|
|
|
Revenue recognition and product warranty |
The Company recognizes revenue on products and services when the
persuasive evidence of an arrangement is in place, the price is
fixed or determinable, collectibility is reasonably assured,
remaining obligations are insignificant, and title and risk of
ownership has been transferred. Transfer of title and risk of
ownership generally occurs when the product is shipped to the
customer or when the customer receives the product, depending on
the nature of the arrangement. The Company currently provides
for the estimated cost
F-6
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
to repair or replace products under warranty at the time of
sale. Service revenue is recognized as the services are provided
and for service contracts on a straight-line basis over the
period of the applicable service contract.
The Companys standard terms and conditions do not allow
for product returns. However, in the past on a case by case
basis, the Company has allowed the return of a small number of
lasers, and as of December 31, 2004 the Company has booked
an allowance to cover such laser returns. In addition, the
Company is usually willing to accept returns of small-dollar
accessories if the customer ordered the wrong part or quantity.
The return of small-dollar accessories has an insignificant
impact on revenue. The Company is able to make reasonable
estimates of future returns and therefore the Company recognizes
revenue on all products as they are shipped, provided that Staff
Accounting Bulletin No. 104, Revenue
Recognition criteria have been met, namely; persuasive
evidence of an arrangement exists, delivery has occurred or
services have been rendered, the sellers price to the
buyer is fixed or determinable, collectibility is reasonably
assured.
Certain sales of lasers have post-sale obligations of
installation and advanced training. These obligations are
fulfilled after product shipment, and in these cases, the
Company recognizes revenue in accordance with the multiple
element accounting guidance set forth in Emerging Issues Task
Force No. 00-21, Revenue Arrangements with Multiple
Deliverables. As long as the Company has vendor objective
evidence of undelivered elements it defers revenue attributable
to the post-shipment obligations and recognizes such revenue
when the obligation is fulfilled. As of December 31, 2004,
the Company had deferred revenue of approximately $77,695 and
$346,365 for installations and advanced training, respectively;
and as of December 31, 2003, the Company had deferred
revenue of approximately $41,690 and $560,518 for installations
and advanced training, respectively.
The Company offers discounts to customers for volume purchases.
These discounts are treated as a reduction in the selling price
of the products purchased.
The Company offers customers a quarterly rebate for purchases of
disposable fiber optic devices for use with its GreenLight
laser. The rebate is based on the volume of fibers purchased by
the customer in a given quarter and the rebate rate increases as
the volume increases within the quarter. The value of the rebate
is treated as a reduction in revenue. Rebates are offered on a
calendar quarter basis and, consequently, the Company is able to
record the value of the rebates for each reporting quarter
without the need to make estimates.
The Company occasionally provides consideration (in the form of
cash or free products) to existing physician customers in
exchange for the existing customers performing training of
potential new customers. Such consideration is treated as a
sales and marketing expenses and not as a reduction of revenue.
In these instances, the Company is receiving an identifiable
benefit that is sufficiently separable from the original sale to
the physician. Further, the Company can reasonably estimate the
fair value of that benefit, based upon external market rates for
similar training and physicians services.
Pricing to distributors is unilaterally set in a price list
generally once every two years by the Company. Volume discounts
are negotiated with each distributor individually. Payment is to
be made in US Dollars, unless otherwise specified by the
Company. In practice, the Company does not change the currency
of sale to be any currency other than US Dollars. Payment is due
45 days after product has shipped from the Companys
California plant or other such location as the Company may
notify the distributor from time to time and shall exclude
freight, taxes, insurance and all other transactional costs
which shall be paid by distributor. Furthermore regarding
payment, at its discretion the Company does not make any
shipments or deliveries until a letter of credit or equivalent
evidence of payment against shipping documents is available for
the Companys account at a bank or other financial
institution designated by the Company. The agreement does not
permit the distributor to return products, and the distributor
is obligated to pay the Company regardless of whether the
distributor is able to resell the product. The Company
recognizes revenue upon shipment to distributors, provided that
SAB 104 criteria have been met, namely: persuasive evidence
of an
F-7
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
arrangement exists, delivery has occurred or services have been
rendered, the sellers price to the buyer is fixed or
determinable, collectibility is reasonably assured. The
Companys only post-sale distributor obligations relate to
standard warranty terms. Additionally, the Company has reviewed
its write-off history for sales to international distributors
and determined them to be insignificant.
|
|
|
Research and development expenditures |
Costs related to research, design and development of products
are charged to research and development expense as incurred. The
types of costs included in research and development expenditures
include salaries, contractor fees, building costs, utilities,
clinical evaluation, and material costs.
Property and equipment is stated at cost less accumulated
depreciation and amortization. Equipment is depreciated using
principally accelerated methods over estimated useful lives of
three to seven years. Equipment under capital leases is
amortized over the period of the lease. Leasehold improvements
are amortized using the straight-line method over the remaining
term of the lease or useful life if shorter. Maintenance and
repairs are charged to operations as incurred.
Inventories are valued using standard costing and are stated at
the lower of cost (computed on a first-in, first-out basis) or
market.
Basic net income per share is calculated using the weighted
average number of shares of common stock outstanding. Diluted
net income per share is calculated using the weighted average
number of shares of common stock outstanding plus dilutive
common equivalent shares from stock options, warrants and
debentures.
F-8
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table sets forth the computation of basic and
diluted net income per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(Thousands, except per share data) | |
Basic earnings per share
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income used in computing basic and diluted net income per
share
|
|
$ |
14,739 |
|
|
$ |
2,517 |
|
|
$ |
323 |
|
|
Amount allocated to holders of convertible debentures
|
|
|
|
|
|
|
(267 |
) |
|
|
(41 |
) |
|
|
|
|
|
|
|
|
|
|
|
Income available to common stockholders-basic
|
|
$ |
14,739 |
|
|
$ |
2,250 |
|
|
$ |
282 |
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding used in computing
basic net income per share
|
|
|
21,075 |
|
|
|
17,452 |
|
|
|
16,441 |
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share
|
|
$ |
0.70 |
|
|
$ |
0.13 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income used in computing basic and diluted net income per
share
|
|
$ |
14,739 |
|
|
$ |
2,517 |
|
|
$ |
323 |
|
|
Amount allocated to holders of convertible debentures
|
|
|
|
|
|
|
|
|
|
|
(41 |
) |
|
Addback interest on debentures
|
|
|
|
|
|
|
219 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income available to common stockholders-diluted
|
|
$ |
14,739 |
|
|
$ |
2,736 |
|
|
$ |
282 |
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding used in computing
basic net income per share
|
|
|
21,075 |
|
|
|
17,452 |
|
|
|
16,441 |
|
Add dilutive potential shares used in computing dilutive net
income per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assumed exercise of stock options
|
|
|
1,463 |
|
|
|
1,881 |
|
|
|
1,676 |
|
|
Assumed exercise of warrants
|
|
|
270 |
|
|
|
437 |
|
|
|
452 |
|
|
Assumed conversion of debentures
|
|
|
|
|
|
|
2,068 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total weighted average number of shares used in computing
diluted net income per share
|
|
|
22,808 |
|
|
|
21,838 |
|
|
|
18,569 |
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share
|
|
$ |
0.65 |
|
|
$ |
0.13 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
The company adopted Emerging Issues Task Force Statement
No. 03-06 Participating Securities and the Two
Class Method Under FASB Statement No. 128, Earnings
Per Share during the period ended June 30, 2004
and in accordance with the standard has retroactively adjusted
reported earnings per share for prior periods. Amounts
previously reported as basic EPS were $0.14 and $0.02 for the
years ended December 31, 2003 and 2002, respectively. There
was no impact on previously reported diluted EPS.
F-9
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following outstanding options (prior to the application to
the treasury stock method) and convertible debentures were
excluded from the computation of diluted net income per common
share for the years ended December 31, 2004, 2003 and 2002
because including them would have had an antidilutive effect.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended | |
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(Thousands) | |
Options to purchase common stock
|
|
|
88 |
|
|
|
305 |
|
|
|
279 |
|
Debentures convertible to common stock
|
|
|
|
|
|
|
|
|
|
|
2,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
305 |
|
|
|
2,679 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
The functional currencies of the Companys foreign
subsidiaries are their local currencies. Accordingly, all assets
and liabilities related to their operations are translated at
the current exchange rates at the end of each period. The
resulting cumulative translation adjustments are recorded
directly to the translation adjustments account, a component of
the accumulated other comprehensive loss, and are included in
shareholders equity. Revenues and expenses are translated
at average exchange rates in effect during the period. Foreign
currency transaction gains and losses are included in the
statement of operations.
The Company accounts for income taxes under the provisions of
Statement of Financial Accounting Standards (SFAS)
No. 109, Accounting for Income Taxes. Under
this method, deferred tax assets and liabilities are determined
based on the differences between financial reporting and tax
bases of assets and liabilities, measured at tax rates that will
be in effect when the differences are expected to reverse.
Valuation allowances are established when necessary to reduce
deferred tax assets to the amounts expected to be realized.
The Company periodically assesses the impairment of its
long-lived assets in accordance with the provisions of
SFAS No. 141, Accounting for the Impairment or
Disposal of Long-Lived Assets. An impairment review is
performed whenever events or changes in circumstances indicate
that the carrying value of the Companys long-lived assets
may not be recoverable. Indicators which could trigger an
impairment review include, but are not limited to, significant
underperformance relative to past or planned operating results,
significant changes in the strategy for the overall business,
significant negative industry trends and/or a significant
decline in the stock price of the Company for a sustained period
of time. When it is determined, based on one or more of these
indicators, that the carrying value of the Companys
long-lived assets may not be recoverable, impairment is measured
using the projected discounted cash flow method and charged to
operations.
|
|
|
Goodwill and intangible assets related to
acquisitions |
On September 17, 2001, the Company purchased the remaining
25% minority interest in its subsidiary, Laserscope France S.A.
through the exercise of a buy-out option of $555,000 which was
paid through the assignment of accounts receivable. Goodwill of
$655,000 arose on the acquisition. The Company adopted the rules
of SFAS No. 142, Goodwill and Other Intangible
Assets (SFAS No. 142) that apply to
goodwill acquired after June 30, 2001 and has not amortized
this goodwill. The Company performs an annual assessment at the
reporting unit level, or earlier if an event occurs or
circumstances change that would reduce
F-10
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
the fair value of the reporting unit below its carrying amount,
as prescribed by SFAS No. 142. No impairment charges
have been recorded as of December 31, 2004.
The Company has acquired a technology license for use in its
laser products. In 2003 and 2004 the Company paid amounts of
$200,000 and $126,750, respectively in connection with the
license. The license covered certain product sales previous and
up to 2003. In 2003 and 2004 respectively the Company amortized
$155,556 and $38,889 of the license. The Company expects to
record amortization expense of approximately $38,889 per
year in 2005 through 2008, at which time the license will be
completely amortized. As of December 31, 2004 the net
unamortized value of the license was $132,305.
Advertising costs are expensed as incurred. Advertising costs
were not significant in 2004, 2003 or 2002.
During the year ended December 31, 2002, the Company
adopted SFAS No. 148, Accounting for Stock-Based
Compensation, Transition and Disclosure. The Company
accounts for stock-based compensation arrangements in accordance
with the provisions of Accounting Principles Board
(APB) Opinion No. 25, Accounting for
Stock Issued to Employees and its interpretations, and
complies with the disclosure provisions of
SFAS No. 123, Accounting for Stock-Based
Compensation. Under APB Opinion No. 25, compensation
expense is based on the difference, if any, on the date of
grant, between the fair value of the Companys stock and
the exercise price. SFAS No. 123 defines a fair
value based method of accounting for an employee stock
option or similar equity instrument. The Company accounts for
equity instruments issued to non-employees in accordance with
the provisions of SFAS No. 123 and EITF Issue
No. 96-18, Accounting for Equity Instruments That Are
Issued to Other Than Employees for Acquiring, or in Conjunction
with Selling, Goods and Services (EITF Issue
No. 96-18). Under SFAS No. 123 and EITF
Issue No. 96-18, the fair value of options granted to
non-employees is estimated using the Black-Scholes option
pricing model and is periodically re-measured as the options
vest.
F-11
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Had compensation cost for stock-based employee compensation
arrangements been determined based on the fair value at the date
of the awards consistent with the provisions of
SFAS No. 123, the impact on the Companys net
income would be as follows (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Net income as reported
|
|
|
14,739 |
|
|
$ |
2,517 |
|
|
$ |
323 |
|
|
Deduct: Total stock-based compensation expense determined under
fair value based method for all awards, net of related tax
effects
|
|
|
(2,244 |
) |
|
|
(1,352 |
) |
|
|
(956 |
) |
|
|
|
|
|
|
|
|
|
|
|
Pro forma net income (loss)
|
|
$ |
12,495 |
|
|
$ |
1,165 |
|
|
$ |
(633 |
) |
|
|
|
|
|
|
|
|
|
|
|
Amount allocated to holders of convertible debentures
|
|
|
|
|
|
|
(267 |
) |
|
|
(41 |
) |
|
|
|
|
|
|
|
|
|
|
|
Pro forma net income available to common stockholders-basic
|
|
$ |
12,495 |
|
|
$ |
898 |
|
|
$ |
(674 |
) |
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic-as reported
|
|
$ |
0.70 |
|
|
$ |
0.13 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic-pro forma
|
|
$ |
0.59 |
|
|
$ |
0.05 |
|
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Diluted-as reported
|
|
$ |
0.65 |
|
|
$ |
0.13 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted-pro forma
|
|
$ |
0.55 |
|
|
$ |
0.05 |
|
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma information regarding net loss and net loss per share
as if the Company accounted for its employee stock options
granted subsequent to December 15, 1994 under the fair
value method is calculated based on the fair value of the option
grants at the date of grant using a Black-Scholes single option
pricing model with the following weighted average assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Risk free interest rate
|
|
|
3.26 |
% |
|
|
2.60 |
% |
|
|
3.20 |
% |
Dividend yield
|
|
|
|
|
|
|
|
|
|
|
|
|
Volatility
|
|
|
0.84 |
|
|
|
0.85 |
|
|
|
1.16 |
|
Expected life (in years)
|
|
|
4.45 |
|
|
|
4.13 |
|
|
|
3.50 |
|
The weighted average per share grant date fair values of
employee stock options granted in 2004, 2003, and 2002 were
$16.01, $5.35 and $3.39, respectively.
Pro forma compensation expense with respect to the
Companys 1999 Employee Stock Purchase Plan is estimated
using the fair value of the employees purchase rights
under the Black-Scholes model with the following weighted
average assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Risk free interest rate
|
|
|
1.15 |
% |
|
|
1.12 |
% |
|
|
1.78 |
% |
Dividend yield
|
|
|
|
|
|
|
|
|
|
|
|
|
Volatility
|
|
|
0.66 |
|
|
|
0.63 |
|
|
|
0.87 |
|
Expected life (in years)
|
|
|
0.50 |
|
|
|
0.50 |
|
|
|
0.50 |
|
The weighted average per share fair values of those purchase
rights granted in 2004, 2003 and 2002 were $8.79, $1.66 and
$1.15, respectively.
F-12
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Comprehensive income is defined as the change in equity from
transactions and other events and circumstances other than those
resulting from investments by owners and distributions to
owners. For the years ended December 31, 2004, 2003 and
2002, comprehensive income comprised of net income and foreign
currency translation adjustments.
Certain amounts in prior fiscal years have been reclassified to
conform with the presentation adopted in the current fiscal year.
|
|
|
Recent Accounting Pronouncements |
In December 2004, the FASB issued SFAS No 123 (revised
2004) (SFAS No 123(R)), Share Based
Payment. SFAS No 123(R) requires all share-based
payments to employees, including grants of employee stock
options, to be recognized in the financial statements based on
their fair values and is effective for public companies for
interim or annual periods beginning after June 15, 2005.
The Company has not yet completely evaluated the impact of the
adoption of SFAS No 123(R).
In November 2004, The FASB issued SFAS No. 151,
Inventory Costs, an amendment of ARB No. 43.
Chapter 4. SFAS No. 151 clarifies the accounting
for abnormal amounts of idle facility expense, freight, handling
costs and wasted material. SFAS No. 151 is effective for
inventory costs incurred during fiscal years beginning in the
second quarter of fiscal 2006. The Company does not believe the
adoption of SFAS No. 151 will have a material effect on its
consolidated financial position, results of operations or cash
flows.
The Companys revenue base is derived from the sales of
interrelated products and services on a world-wide basis.
Although discrete components that earn revenues and incur
expenses exist, significant expenses such as research and
development and corporate administration are not incurred by or
allocated to these operating units but rather are employed by
the entire enterprise. Additionally, the chief operating
decision maker evaluates resource allocation not on a product or
geographic basis, but rather on an enterprise wide basis.
Therefore, the Company has concluded that it contains only one
reportable segment, which is the medical systems business.
F-13
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Revenues from sales to external customers by similar products
and services and by major geographic area for the years ended
December 31 were:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
By similar products and services
|
|
|
|
|
|
|
|
|
|
|
|
|
Lasers & instrumentation
|
|
$ |
56,958 |
|
|
$ |
37,568 |
|
|
$ |
29,842 |
|
Disposables
|
|
|
29,383 |
|
|
|
13,536 |
|
|
|
7,420 |
|
Service
|
|
|
7,429 |
|
|
|
6,323 |
|
|
|
5,826 |
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
93,770 |
|
|
$ |
57,427 |
|
|
$ |
43,088 |
|
|
|
|
|
|
|
|
|
|
|
By major geographic area(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
$ |
68,390 |
|
|
$ |
42,398 |
|
|
$ |
31,714 |
|
Europe(2)
|
|
|
19,893 |
|
|
|
11,221 |
|
|
|
8,584 |
|
Asia Pacific(2)
|
|
|
4,862 |
|
|
|
3,214 |
|
|
|
2,380 |
|
Rest of world(2)
|
|
|
625 |
|
|
|
594 |
|
|
|
410 |
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
93,770 |
|
|
$ |
57,427 |
|
|
$ |
43,088 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Based on the location of the external customer. |
|
(2) |
Individual countries within each of these geographic regions
represent less than 10% of total revenues. |
Location of long lived assets by major geographic area at
December 31 were:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
United States
|
|
$ |
3,461 |
|
|
$ |
1,553 |
|
|
$ |
1,957 |
|
France
|
|
|
820 |
|
|
|
859 |
|
|
|
710 |
|
United Kingdom
|
|
|
95 |
|
|
|
64 |
|
|
|
76 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
4,376 |
|
|
$ |
2,476 |
|
|
$ |
2,743 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3. |
Receivables and Allowance for Doubtful Accounts |
Accounts receivable at December 31 consisted of:
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
(In thousands) | |
Trade accounts receivable
|
|
$ |
20,359 |
|
|
$ |
12,967 |
|
Other
|
|
|
87 |
|
|
|
12 |
|
Less: allowance for doubtful accounts
|
|
|
(104 |
) |
|
|
(268 |
) |
|
|
|
|
|
|
|
Total receivables
|
|
$ |
20,342 |
|
|
$ |
12,711 |
|
|
|
|
|
|
|
|
F-14
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Inventories at December 31 consisted of:
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
(In thousands) | |
Raw materials
|
|
$ |
9,120 |
|
|
$ |
6,356 |
|
Work-in-process
|
|
|
6,330 |
|
|
|
3,213 |
|
Finished goods
|
|
|
3,996 |
|
|
|
3,799 |
|
|
|
|
|
|
|
|
|
|
$ |
19,446 |
|
|
$ |
13,368 |
|
|
|
|
|
|
|
|
|
|
5. |
Property and Equipment |
Property and equipment at December 31 consisted of:
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
(In thousands) | |
Machinery and equipment
|
|
$ |
5,436 |
|
|
$ |
4,773 |
|
Office equipment and furniture
|
|
|
9,189 |
|
|
|
7,950 |
|
Leasehold improvements
|
|
|
1,273 |
|
|
|
1,258 |
|
Software
|
|
|
3,551 |
|
|
|
2,601 |
|
|
|
|
|
|
|
|
|
|
|
19,449 |
|
|
|
16,582 |
|
Less accumulated depreciation and amortization
|
|
|
(15,992 |
) |
|
|
(14,937 |
) |
|
|
|
|
|
|
|
|
|
$ |
3,457 |
|
|
$ |
1,645 |
|
|
|
|
|
|
|
|
Depreciation and amortization expense for property and equipment
in 2004, 2003 and 2002 was approximately $1,087,000, $958,000
and $981,000 respectively.
|
|
6. |
Warranty and Service Contracts |
The Company has a direct field service organization that
provides service for products. The Company generally provides a
twelve month warranty on laser systems. After the warranty
period, maintenance and support is provided on a service
contract basis or on an individual call basis. The
Companys warranties and premium service contracts provide
for a 99.0% Uptime Guarantee on laser systems. Under
provisions of this guarantee, at the request of the customer, we
extend the terms of the related warranty or service contract if
specified system uptime levels are not maintained.
F-15
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The Company currently provides for the estimated cost to repair
or replace products under warranty at the time of sale. The cost
estimate is based on warranty costs experienced in the prior
12 months, and the outstanding warranty liability is
revalued on a quarterly basis.
|
|
|
|
|
|
|
|
(In thousands) | |
Warranty Reserve
|
|
|
|
|
Balance, December 31, 2002
|
|
$ |
1,127 |
|
Add: Accruals for warranties issued in 2003
|
|
|
2,659 |
|
|
Accruals related to pre-existing warranties
|
|
|
100 |
|
Less: Settlements made during the period
|
|
|
(1,939 |
) |
|
|
|
|
Balance, December 31, 2003
|
|
$ |
1,947 |
|
Add: Accruals for warranties issued in 2004
|
|
|
3,275 |
|
|
Accruals related to pre-existing warranties
|
|
|
|
|
Less: Settlements made during the period
|
|
|
(2,686 |
) |
|
|
|
|
Balance, December 31, 2004
|
|
$ |
2,536 |
|
|
|
|
|
Deferred service contract revenue is recognized on a
straight-line basis over the period of the applicable service
contract. Costs are recognized as incurred.
|
|
|
|
|
|
|
|
(In thousands) | |
Deferred Contract Revenue
|
|
|
|
|
Balance, December 31, 2002
|
|
$ |
1,391 |
|
Add: Payments received
|
|
|
4,117 |
|
|
Costs incurred under service contracts
|
|
|
2,527 |
|
Less: Revenue recognized
|
|
|
(3,673 |
) |
|
Settlements made during the period
|
|
|
(2,527 |
) |
|
|
|
|
Balance, December 31, 2003
|
|
$ |
1,835 |
|
Add: Payments received
|
|
|
5,992 |
|
|
Costs incurred under service contracts
|
|
|
3,526 |
|
Less: Revenue recognized
|
|
|
(4,891 |
) |
|
Settlements made during the period
|
|
|
(3,526 |
) |
|
|
|
|
Balance, December 31, 2004
|
|
$ |
2,936 |
|
|
|
|
|
The Company has in place an asset based line of credit which
provides up to $5.0 million in borrowings. The line of
credit expires September 2006. Credit is extended based on the
Companys eligible accounts receivable and inventory. At
December 31, 2004, the Company had approximately
$5.0 million in borrowing capacity and no borrowings,
resulting in $5.0 million of unused borrowing capacity. The
Companys assets collateralize the line of credit which
bears an interest rate equivalent to the banks prime rate
plus 2.0%. The prime rate at December 31, 2004 was 5.25%.
Borrowings against the line of credit are paid down as the
Company collects its accounts receivable. Provisions of the bank
loan agreement prohibit the payment of dividends on
non-preferred stock, or the redemption, retirement, repurchase
or other acquisition of Company stock. The agreement further
requires the Company to maintain a minimum tangible net worth.
As of December 31, 2004 and 2003, the Company was in
compliance with all covenants and had no outstanding borrowings
under the line of credit facility.
F-16
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
8. |
Commitments and Contingencies |
The Company leases certain equipment under lease agreements that
have been accounted for as capital leases. Leased equipment and
accumulated amortization related to assets under capital leases
at December 31 were as follows:
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
(In thousands) | |
Leased equipment (Primarily office equipment and software)
|
|
$ |
1,738 |
|
|
$ |
1,656 |
|
Accumulated amortization
|
|
|
(1,601 |
) |
|
|
(1,580 |
) |
|
|
|
|
|
|
|
|
|
$ |
137 |
|
|
$ |
76 |
|
|
|
|
|
|
|
|
There were $81,000 of additions to leased equipment in 2004,
zero in 2003 and $172,000 in 2002.
Amortization of equipment under capital leases of $21,000 is
included in depreciation expense.
The Company leases certain facilities and equipment under
non-cancelable operating leases. Rent expense under these leases
amounted to approximately $1,859,000, $1,938,000, and $1,746,000
in the years ended December 31, 2004, 2003 and 2002,
respectively.
Future minimum lease payments under capital and operating leases
were as follows at December 31, 2004:
|
|
|
|
|
|
|
|
|
|
|
|
Capital | |
|
Operating | |
|
|
Leases | |
|
Leases | |
|
|
| |
|
| |
|
|
(In thousands) | |
2005
|
|
$ |
21 |
|
|
$ |
992 |
|
2006
|
|
|
31 |
|
|
|
960 |
|
2007
|
|
|
|
|
|
|
882 |
|
2008
|
|
|
|
|
|
|
838 |
|
2009 and beyond
|
|
|
|
|
|
|
3,001 |
|
|
|
|
|
|
|
|
|
|
$ |
52 |
|
|
$ |
6,673 |
|
|
|
|
|
|
|
|
|
Less amount representing interest
|
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Present value of future minimum lease payments
|
|
|
51 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Less current portion
|
|
|
21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
30 |
|
|
|
|
|
|
|
|
|
|
|
|
In the ordinary course of business, the Company enters into
contractual arrangements under which the Company may agree to
indemnify the third party to such arrangement from any losses
incurred relating to the services they perform on behalf of the
Company or for losses arising from certain events as defined
within the particular contract, which may include, for example,
patents, litigation or claims relating to past performance. Such
indemnification obligations may not be subject to maximum loss
clauses. Historically, payments made related to these
indemnifications have been immaterial.
The Company has entered into indemnification agreements with its
directors and officers that may require the Company: to
indemnify its directors and officers against liabilities that
may arise by reason of their status or service as directors or
officers, other than liabilities arising from willful misconduct
of a culpable
F-17
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
nature; to advance their expenses incurred as a result of any
proceeding against them as to which they could be indemnified;
and to make good faith determination whether or not it is
practicable for the Company to obtain directors and
officers insurance. The Company currently has
directors and officers insurance.
The Company is at times a party to legal proceedings arising in
the ordinary course of its business. While it is not feasible to
predict or determine the outcome of the actions brought against
the Company, management believes that the ultimate resolution of
these claims will not ultimately have a material adverse effect
on the Companys financial position or results of
operations or future cash flows. Legal fees in connection with
loss contingencies are recognized as the fees are incurred.
|
|
9. |
Convertible Subordinated Debentures |
In February of 2000, the Company sold $3 million of
8.00% convertible debentures in a private placement. The
debentures were originally scheduled to mature in February 2007
and interest was paid monthly. The debentures were convertible
at the option of the holder at any time prior to the close of
business on the maturity date, unless previously repurchased,
into 2.4 million shares of common stock at a conversion
price of $1.25, subject to adjustment in certain circumstances.
In connection with the sale of the convertible debentures, the
Company issued warrants to purchase 240,000 shares of
the Companys common stock at $1.50 per share. The
warrants expire in 2005. The value of the warrants of $311,000
was amortized as interest expense in the statement of operations
over the original term of the debentures.
In the first six months of 2003, $400,000 of the debentures were
converted to 320,000 shares of the Companys common
stock at $1.25 per share. During the last six months of
2003, the holders converted the remaining $2.6 million of
debentures into 2,080,000 shares of the Companys
common stock. Upon conversion, of the remaining debentures,
$150,054 of remaining unamortized issuance and warrants costs
were transferred to additional paid-in capital.
The Company has 30,000,000 shares of no par value common
stock authorized. In addition, the Company has authorized
5,000,000 shares of undesignated preferred stock with
rights, preferences and privileges to be determined by the
Companys Board of Directors.
In connection with common stock and convertible debenture
issuances in 2000, the Company issued 458,875 warrants to
purchase the Companys common stock at prices ranging from
$1.25 to $1.50 per share. The warrants expire in 2005. As
of December 31, 2004, there remained 10,000 warrants
outstanding.
During 1994, the Company adopted a stock option plan under which
the Board of Directors may grant incentive stock options to
purchase shares of common stock to employees of the Company at a
price not less than the fair value of the shares as of the date
of grant. The Board of Directors may also grant non-statutory
stock options to employees and consultants, including directors
who serve as employees or consultants, at not less than 85% of
the fair market value of the shares as of the date of grant.
Options issued pursuant to the 1994 plan vest and become
exercisable over periods of up to four years and expire five
years after the date of grant.
The 1994 Stock Option Plan expired by its term with respect to
future grants in 2004.
F-18
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
1999 Retention Stock Option Plan |
During 1999, the Company adopted a stock option plan under which
the Board of Directors may grant non-statutory options to
purchase shares of common stock to non-officer employees of the
Company at a price not less than the fair value of the shares as
of the date of grant. Options issued pursuant to the 1999 plan
vest and become exercisable over periods of up to four years and
expire five to ten years after the date of grant.
The Company has reserved 698,000 shares of common stock of
which there were 8,022 shares available for issuance
pursuant to its 1999 Retention Stock Option Plan as of
December 31, 2004.
During 2004, the Company adopted a stock option plan under which
the Board of Directors may grant incentive stock options to
purchase shares of common stock to employees of the Company at a
price not less than the fair value of the shares as of the date
of grant. The Board of Directors may also grant non-statutory
stock options to employees and consultants, including directors
who serve as employees or consultants, at not less than 85% of
the fair market value of the shares as of the date of grant.
Options issued pursuant to the 2004 plan vest and become
exercisable over periods of up to four years and expire five to
ten years after the date of grant.
The Company has reserved 400,000 shares of common stock of
which there were 133,025 shares available for issuance
pursuant to its 2004 stock option plan as of December 31,
2004.
|
|
|
Directors Stock Option Plans |
The Company has reserved an aggregate of 840,000 shares of
its common stock for issuance pursuant to its 1999 and
1995 Directors Stock Option Plans. Under these plans,
non-employee directors of the Company have been granted options
to purchase up to 105,000 shares (45,000 shares
pursuant to the 1995 plan and 60,000 shares pursuant to the
1999 plan) of the Companys common stock exercisable at the
fair market value of such shares on the respective grant dates.
Options issued pursuant to these plans vest and become
exercisable over three years from the respective original date
of issuance with respect to each optionee who remains a director
and expire five to ten years after the date of grant. Upon the
adoption of the 1999 Directors Stock Option Plan, the
1995 Directors Stock Option Plan expired with respect
to future grants. There were 260,000 shares available for
issuance pursuant to the 1999 Directors Stock Option
Plan at December 31, 2004.
F-19
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table summarizes activity in the Companys
stock option plans during the years ended December 31,
2004, 2003 and 2002:
|
|
|
|
|
|
|
|
|
|
|
Options | |
|
Weighted Average | |
|
|
Outstanding | |
|
Exercise Price | |
|
|
| |
|
| |
Balance, January 1, 2002
|
|
|
3,188,405 |
|
|
$ |
1.73 |
|
Granted
|
|
|
572,800 |
|
|
$ |
4.44 |
|
Exercised
|
|
|
(603,266 |
) |
|
$ |
1.42 |
|
Canceled
|
|
|
(302,623 |
) |
|
$ |
3.78 |
|
|
|
|
|
|
|
|
Balance, December 31, 2002
|
|
|
2,855,316 |
|
|
$ |
2.12 |
|
Granted
|
|
|
556,583 |
|
|
$ |
8.50 |
|
Exercised
|
|
|
(740,841 |
) |
|
$ |
1.49 |
|
Canceled
|
|
|
(77,701 |
) |
|
$ |
3.53 |
|
|
|
|
|
|
|
|
Balance, December 31, 2003
|
|
|
2,593,357 |
|
|
$ |
3.63 |
|
Granted
|
|
|
337,250 |
|
|
$ |
24.49 |
|
Exercised
|
|
|
(1,407,038 |
) |
|
$ |
2.09 |
|
Canceled
|
|
|
(66,076 |
) |
|
$ |
14.78 |
|
|
|
|
|
|
|
|
Balance, December 31, 2004
|
|
|
1,457,493 |
|
|
$ |
9.44 |
|
|
|
|
|
|
|
|
The following table displays a summary of relevant ranges of
exercise prices for options outstanding and options exercisable
for the Companys stock option plans at December 31,
2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding | |
|
|
|
|
| |
|
Options Exercisable | |
|
|
|
|
Weighted | |
|
|
|
| |
|
|
|
|
Average | |
|
Weighted | |
|
|
|
Weighted | |
|
|
|
|
Remaining | |
|
Average | |
|
|
|
Average | |
|
|
Number | |
|
Contractual | |
|
Exercise | |
|
Number | |
|
Exercise | |
Range of Exercise Prices |
|
Outstanding | |
|
Life (Years) | |
|
Price | |
|
Exercisable | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$ 1.03-$ 1.50
|
|
|
68,075 |
|
|
|
4.05 |
|
|
$ |
1.46 |
|
|
|
66,844 |
|
|
$ |
1.46 |
|
$ 1.60-$ 1.60
|
|
|
148,675 |
|
|
|
1.55 |
|
|
$ |
1.60 |
|
|
|
93,260 |
|
|
$ |
1.60 |
|
$ 1.62-$ 3.50
|
|
|
169,450 |
|
|
|
2.87 |
|
|
$ |
2.36 |
|
|
|
116,065 |
|
|
$ |
2.10 |
|
$ 3.66-$ 4.52
|
|
|
178,138 |
|
|
|
4.29 |
|
|
$ |
4.18 |
|
|
|
86,052 |
|
|
$ |
4.16 |
|
$ 4.65-$ 5.05
|
|
|
181,966 |
|
|
|
3.18 |
|
|
$ |
4.90 |
|
|
|
60,512 |
|
|
$ |
4.90 |
|
$ 5.25-$ 7.53
|
|
|
135,802 |
|
|
|
2.47 |
|
|
$ |
5.55 |
|
|
|
60,985 |
|
|
$ |
5.50 |
|
$ 9.91-$ 9.91
|
|
|
219,592 |
|
|
|
3.64 |
|
|
$ |
9.91 |
|
|
|
63,480 |
|
|
$ |
9.91 |
|
$14.33-$16.42
|
|
|
30,732 |
|
|
|
3.87 |
|
|
$ |
15.38 |
|
|
|
16,254 |
|
|
$ |
16.03 |
|
$21.33-$24.42
|
|
|
237,538 |
|
|
|
8.34 |
|
|
$ |
22.09 |
|
|
|
15,564 |
|
|
$ |
23.44 |
|
$31.20-$31.25
|
|
|
87,525 |
|
|
|
9.78 |
|
|
$ |
31.22 |
|
|
|
5,584 |
|
|
$ |
31.25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 1.03-$31.25
|
|
|
1,457,493 |
|
|
|
4.41 |
|
|
$ |
9.44 |
|
|
|
584,600 |
|
|
$ |
4.98 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1999 Employee Stock Purchase
Plan
During 1999, the Company adopted its 1999 Employee Stock
Purchase Plan under which qualified employees can purchase up to
a specified maximum amount of the Companys common stock
through payroll deductions at 85% of its fair market value. The
1999 Employee Stock Purchase Plan replaced the 1989 Employee
Stock Purchase Plan which expired in July 1999. The Company has
reserved 750,000 shares of
F-20
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
common stock for issuance pursuant to its 1999 Employee Stock
Purchase Plan. Under this plan, as of December 31, 2004,
approximately 615,000 shares had been purchased.
|
|
11. |
Employee Savings and Investment Plan |
In October 1989, the Company adopted a 401(k) savings and
investment plan, which covers all employees. The Companys
contributions to the plan have been 50% matching of employee
contributions up to 5% of each employees base compensation
and were approximately $226,000, $201,000, and $173,000 in the
years ended December 31, 2004, 2003 and 2002, respectively.
The geographic distribution of net income before provision for
taxes was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
United States income before provision for taxes
|
|
$ |
14,894 |
|
|
$ |
3,077 |
|
|
$ |
455 |
|
Foreign income before provision for taxes
|
|
|
785 |
|
|
|
(358 |
) |
|
|
(46 |
) |
|
|
|
|
|
|
|
|
|
|
Net income before provision for taxes
|
|
$ |
15,679 |
|
|
$ |
2,719 |
|
|
$ |
409 |
|
|
|
|
|
|
|
|
|
|
|
Significant components of the provision for income taxes were as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Current:
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal taxes
|
|
$ |
613 |
|
|
$ |
91 |
|
|
$ |
|
|
State taxes
|
|
|
144 |
|
|
|
35 |
|
|
|
16 |
|
Foreign taxes
|
|
|
183 |
|
|
|
76 |
|
|
|
70 |
|
|
|
|
|
|
|
|
|
|
|
Total Provision for Income Taxes
|
|
$ |
940 |
|
|
$ |
202 |
|
|
$ |
86 |
|
|
|
|
|
|
|
|
|
|
|
Income taxes differ from the amount computed by applying the
statutory federal income tax rate of 35% to income before taxes.
The reasons for the differences and the tax effect of each are
as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Computed expected tax
|
|
$ |
5,488 |
|
|
$ |
951 |
|
|
$ |
143 |
|
Operating loss with no carryback benefit
|
|
|
|
|
|
|
252 |
|
|
|
95 |
|
Benefit of net operating loss carryforward
|
|
|
(5,098 |
) |
|
|
(1,055 |
) |
|
|
(213 |
) |
State income tax
|
|
|
94 |
|
|
|
35 |
|
|
|
16 |
|
Foreign taxes in excess of U.S. rate
|
|
|
177 |
|
|
|
(53 |
) |
|
|
(9 |
) |
Other
|
|
|
279 |
|
|
|
72 |
|
|
|
54 |
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes
|
|
$ |
940 |
|
|
$ |
202 |
|
|
$ |
86 |
|
|
|
|
|
|
|
|
|
|
|
F-21
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The components of the net deferred tax asset consisted of the
following at December 31, 2004 and 2003 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Deferred tax assets:
|
|
|
|
|
|
|
|
|
|
Net operating loss carry forwards
|
|
$ |
17,645 |
|
|
$ |
8,505 |
|
|
General business credit carry forwards
|
|
|
1,732 |
|
|
|
2,483 |
|
|
Inventory reserves and adjustments
|
|
|
1,072 |
|
|
|
1,243 |
|
|
Other accruals and reserves not currently deductible for tax
purposes
|
|
|
1,708 |
|
|
|
2,012 |
|
|
Capitalized research and development
|
|
|
321 |
|
|
|
497 |
|
|
Depreciation & amortization
|
|
|
386 |
|
|
|
969 |
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
22,864 |
|
|
|
15,709 |
|
Less valuation allowance
|
|
|
(22,864 |
) |
|
|
(15,709 |
) |
|
|
|
|
|
|
|
Net deferred tax asset
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
The valuation allowance increased by approximately $7,155,000 in
2004 and decreased by approximately $61,000 in 2003. As of
December 31, 2004 the valuation allowance includes an
approximate $16,068,000 tax benefit associated with stock option
deductions. This amount will be credited to shareholders
equity when the tax benefit is realized.
Payment for the current year federal and state income tax will
be lower than the tax expenses of $613,000 and $144,000,
respectively, reduced by approximately $380,000 due to the tax
benefit of stock option deductions recorded in the current year.
The Company has evaluated the need for a valuation allowance for
the deferred tax assets in accordance with the requirements of
Statement of Financial Accounting Standards No. 109,
Accounting for Income Taxes.. As of
December 31, 2004, the company had no ability to realize
its deferred tax assets through carry backs or available tax
planning strategies. Additionally, based on cumulative taxable
losses (due primarily to tax impact from stock option exercises)
the Company has sustained in the three years ended
December 31, 2004 and the current economic uncertainty in
the Companys industry that limits the Companys
ability to generate verifiable forecasts of future domestic
taxable income, a valuation allowance, in an amount equal to the
Companys net deferred tax assets was recorded as of
December 31, 2004.
As of December 31, 2004, the Company has net operating loss
carry forwards of approximately $46.0 million and
$17.7 million for federal and state tax purposes,
respectively. If not utilized, these carry forwards will begin
to expire in 2006 for federal and in 2005 for state purposes. As
of December 31, 2004, the Company also has foreign net
operating loss carry forwards of approximately $1.9 million
that will begin to expire in 2005.
The Company has research and development tax credit carry
forwards of approximately $0.9 million and
$1.2 million for federal and state purposes, respectively.
If not utilized, the federal carry forward will expire in
various amounts beginning in 2005. The California credit can be
carried forward indefinitely.
The Tax Reform Act of 1986 limits the use of net operating loss
and tax credit carry forwards in certain situations where
changes occur in the stock ownership of a company. The Company
has performed a review of its changes in stock ownership and
does not believe the use of its net operating losses or tax
credit carry forwards would be restricted.
F-22
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
13. |
Financial Instruments With Market Risk and Concentrations of
Customer and Credit Risk |
The Companys trade receivables are made up of amounts due
from its health care industry customers, primarily in the United
States of America, Europe and the Pacific Rim. The
Companys credit evaluation and collection practices and
the relative lack of concentration as well as geographical
dispersion of customer accounts comprising its accounts
receivable in the opinion of management substantially alleviate
the concentration of credit risk. In 2004, 2003 and 2002, the
Companys United States distributor, McKesson, made
purchases from the Company of approximately $21.6 million,
$17.7 million and $12.6 million which was 23%, 31% and
29% of total 2004, 2003 and 2002 revenue, respectively. The
Company had no other customers whose purchases were 10% or more
of annual revenue. At December 31, 2004 and 2003,
McKessons accounts receivable balance was approximately
$5.1 million and $2.7 million which represented 25%
and 21% of the Companys total net accounts receivable
respectively. The Company performs ongoing credit evaluations of
its customers and maintains reserves for potential credit
losses. Historically, such losses have been within
managements expectations.
The Company also has an investment policy approved by its Board
of Directors related to its short-term cash investment
practices. That policy limits the amount of credit exposure to
any one financial institution and restricts investments to
certain types of financial instruments based on specified credit
criteria.
The Company invests cash that is not required for immediate
operating needs principally in a diversified portfolio of
financial instruments issued by institutions with strong credit
ratings. By policy, the amount of credit exposure to any one
institution, with the exception of United States government
backed securities, is limited.
The Company maintains its cash and cash equivalents in accounts
with major financial institutions in the United States of
America and in countries where subsidiaries operate, in the form
of demand deposits and money market accounts. Deposits in these
banks may exceed the amounts of insurance provided on such
deposits. The Company has not experienced any losses on its
deposits of cash and cash equivalents. The Company does not
engage in hedging or other derivative security transactions for
speculative or trading purposes.
The Company is subject to risks common to companies in the
medical device industry including, but not limited to dependence
on key personnel and component suppliers, protection of
proprietary technology, compliance with government regulations,
uncertainty of market acceptance of products, product liability
and the need to obtain additional financing.
F-23
LASERSCOPE
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
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14. |
Consolidated Quarterly Statement of Operations Data
(Unaudited): |
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Three Months Ended | |
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Mar. 31, | |
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Jun. 30, | |
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Sep. 30, | |
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Dec. 31, | |
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(In thousands, except per share data) | |
2004
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Net revenues
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$ |
18,750 |
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$ |
21,434 |
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$ |
24,156 |
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$ |
29,430 |
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Gross margin
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10,669 |
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12,329 |
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14,407 |
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|
17,250 |
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Net income
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2,214 |
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|
2,988 |
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4,353 |
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5,184 |
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Basic net income per share
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0.11 |
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0.14 |
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0.20 |
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0.24 |
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Diluted net income per share
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0.10 |
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0.13 |
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0.19 |
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0.23 |
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2003
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Net revenues
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$ |
12,456 |
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$ |
12,862 |
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$ |
14,293 |
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$ |
17,816 |
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Gross margin
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6,335 |
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6,522 |
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7,577 |
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9,652 |
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Net income
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135 |
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|
348 |
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533 |
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1,501 |
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Basic net income per share
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0.01 |
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0.02 |
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0.03 |
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0.08 |
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Diluted net income per share
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0.01 |
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0.02 |
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0.02 |
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0.07 |
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The company adopted Emerging Issues Task Force Statement
No. 03-06 Participating Securities and the Two
Class Method Under FASB Statement No. 128, Earnings
Per Share during the period ended June 30, 2004
and in accordance with the standard has retroactively adjusted
reported earnings per share for prior periods.
F-24
SCHEDULE II
LASERSCOPE
VALUATION AND QUALIFYING ACCOUNTS
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Balance at | |
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Balance at | |
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Beginning | |
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End of | |
Descriptions |
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of Period | |
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Additions | |
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Deductions | |
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Period | |
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(In thousands) | |
Allowance for doubtful accounts receivable:
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Year ended December 31, 2002
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$ |
374 |
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$ |
115 |
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$ |
186 |
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$ |
303 |
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Year ended December 31, 2003
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$ |
303 |
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$ |
93 |
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$ |
127 |
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$ |
268 |
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Year ended December 31, 2004
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$ |
268 |
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$ |
229 |
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$ |
394 |
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$ |
104 |
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Reserve for excess and obsolete inventory:
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Year ended December 31, 2002
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$ |
2,514 |
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$ |
134 |
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$ |
357 |
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$ |
2,291 |
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Year ended December 31, 2003
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$ |
2,291 |
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$ |
288 |
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$ |
713 |
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$ |
1,866 |
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Year ended December 31, 2004
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$ |
1,866 |
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$ |
151 |
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$ |
224 |
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$ |
1,793 |
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Valuation allowance for deferred tax assets:
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Year ended December 31, 2002
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$ |
17,070 |
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$ |
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$ |
1,300 |
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$ |
15,770 |
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Year ended December 31, 2003
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$ |
15,770 |
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$ |
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$ |
61 |
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$ |
15,709 |
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Year ended December 31, 2004
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$ |
15,709 |
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$ |
7,155 |
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$ |
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$ |
22,864 |
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S-1
EXHIBIT INDEX
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Exhibit |
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Number |
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Description |
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3 |
.3 |
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Eighth Amended and Restated Articles of Incorporation of
Registrant.(12) |
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3 |
.4 |
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By-laws of Registrant, as amended.(2) |
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10 |
.1A |
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1984 Stock Option Plan, as amended, and forms of Incentive Stock
Option Agreement and Non-statutory Stock Option Agreement.(2) |
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10 |
.1B |
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1994 Stock Option Plan and forms of Incentive Stock Option
Agreement and Non-statutory Stock Option Agreement.(3) |
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10 |
.2 |
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1984 Stock Purchase Plan and form of Common Stock Purchase
Agreement.(1) |
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10 |
.3 |
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1989 Employee Stock Purchase Plan and form of Subscription
Agreement.(2) |
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10 |
.3A |
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1999 Employee Stock Purchase Plan and form of Subscription
Agreement.(5) |
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10 |
.4 |
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401(k) Plan.(1) |
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10 |
.6 |
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Net Lease Agreement between the Registrant and Realtec
Properties dated June 20, 2000.(8) |
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10 |
.6A |
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Net Lease Agreement between the Registrant and Realtec
Properties dated October 18, 2000.(8) |
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10 |
.10 |
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Form of indemnification agreement.(1) |
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10 |
.11G |
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Loan and Security Agreement between the Registrant and Silicon
Valley Bank dated October 1, 1999.(5) |
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10 |
.11H |
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Amendment to Loan and Security Agreement between the Registrant
and Silicon Valley Bank dated September 25, 2000.(7) |
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10 |
.11I |
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Amendment to Loan and Security Agreement between the Registrant
and Silicon Valley Bank dated September 26, 2001.(9) |
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10 |
.11J |
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Amendment to Loan and Security Agreement between the Registrant
and Silicon Valley Bank dated September 26, 2002.(11) |
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10 |
.11K |
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Amendment to Loan and Security Agreement between the Registrant
and Silicon Valley Bank dated September 25, 2003.(13) |
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10 |
.11L |
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Amendment to Loan and Security Agreement between the Registrant
and Silicon Valley Bank dated September 24, 2004.(15) |
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10 |
.13 |
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1990 Directors Stock Option Plan and form of Option
Agreement.(2) |
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10 |
.14 |
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Form of Laserscope Management Continuity Agreement, as
amended.(6) |
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10 |
.14A |
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Form of Laserscope Management Continuity Agreement, as
amended.(10) |
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10 |
.14B |
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Form of Laserscope Management Continuity Agreement, as
amended.(14) |
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10 |
.18 |
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1995 Directors Stock Option Plan and form of Option
agreement.(4) |
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10 |
.18A |
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1999 Directors Stock Option Plan.(5) |
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10 |
.19 |
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Common Stock Placement Agreement.(5) |
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10 |
.19A |
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Form of Common Stock Purchase Agreement.(5) |
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10 |
.20 |
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Convertible Loan Agreement.(5) |
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10 |
.20A |
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Amendment to Convertible Loan Agreement.(12) |
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10 |
.20B |
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Amendment to Convertible Loan Agreement.(13) |
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22 |
.1 |
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Subsidiaries of Registrant, as amended.(8) |
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23 |
.1 |
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Consent of Independent Registered Public Accounting Firm.(16) |
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25 |
.1 |
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Power of Attorney (See page 41).(16) |
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31 |
.1 |
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Certification of Principal Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.(16) |
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31 |
.2 |
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Certification of Principal Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.(16) |
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32 |
.1 |
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Certification of Principal Executive Officer pursuant to
18 U.S.C. section 1350.(16) |
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32 |
.2 |
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Certification of Principal Financial Officer pursuant to
18 U.S.C. section 1350.(16) |
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(1) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 16(a), Exhibits, of the
Registrants Registration Statement on Form S-1 and
Amendment No. 1 and Amendment No. 2 thereto (File
No. 33-31689), which became effective on November 29,
1989. |
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(2) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 14(a)(3), Exhibits, of the
Registrants Annual Report on Form 10-K for the year
ended December 31, 1991. |
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(3) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 14(a)(3), Exhibits, of the
Registrants Annual Report on Form 10-K for the year
ended December 31, 1994. |
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(4) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 14(a)(3), Exhibits, of the
Registrants Annual Report on Form 10-K/ A for the
year ended December 31, 1995. |
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(5) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 14(a)(3), Exhibits, of the
Registrants Annual Report on Form 10-K for the year
ended December 31, 1999. |
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(6) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2000. |
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(7) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2000. |
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(8) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 14(a)(3), Exhibits, of the
Registrants Annual Report on Form 10-K for the year
ended December 31, 2000. |
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(9) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2001. |
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(10) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2002. |
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(11) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2002. |
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(12) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 14(a)(3), Exhibits, of the
Registrants Annual Report on Form 10-K for the year
ended December 31, 2002. |
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(13) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2003. |
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(14) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2004. |
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(15) |
Incorporated by reference to identically numbered exhibits filed
in response to Item 6(a), Exhibits, of the
Registrants Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2004. |
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(16) |
Filed herewith. |