<PAGE>
INFORMATION CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT. A
REGISTRATION STATEMENT RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION. THESE SECURITIES MAY NOT BE SOLD NOR MAY
OFFERS TO BUY BE ACCEPTED PRIOR TO THE TIME THE REGISTRATION STATEMENT BECOMES
EFFECTIVE. THIS PROSPECTUS SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE
SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE ANY SALE OF THESE SECURITIES
IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR
TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH STATE.
<PAGE>
SUBJECT TO COMPLETION, DATED JUNE 7, 1996
2,500,000 SHARES
[LOGO]
COMMON STOCK
All of the 2,500,000 shares of Class A Common Stock (the "Common Stock")
offered hereby are being offered by Premier Laser Systems, Inc. (the "Company").
The Common Stock is quoted on the Nasdaq National Market under the symbol
"PLSIA." The last reported sale price of the Common Stock on June 3, 1996, as
reported by the Nasdaq National Market, was $10.00 per share. See "Price Range
of Common Stock."
FOR A DISCUSSION OF CERTAIN MATERIAL FACTORS THAT SHOULD BE CONSIDERED IN
CONNECTION WITH AN INVESTMENT IN THE COMMON STOCK, SEE "RISK FACTORS" COMMENCING
ON PAGE 6 HEREOF.
------------------------
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES
COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS
PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
<TABLE>
<CAPTION>
PRICE TO UNDERWRITING PROCEEDS TO
PUBLIC DISCOUNT (1) COMPANY (2)
<S> <C> <C> <C>
Per Share..................... $ $ $
Total (3)..................... $ $ $
</TABLE>
(1) The Company has agreed to indemnify the Underwriters against certain civil
liabilities, including certain liabilities under the Securities Act of 1933,
as amended. See "Underwriting."
(2) Before deducting offering expenses estimated to be approximately $550,000
payable by the Company.
(3) The Company has granted to the Underwriters a 30-day option to purchase up
to 375,000 additional shares of Common Stock solely to cover
over-allotments, if any, on the same terms and conditions as the shares
offered hereby. If such option is exercised in full, the total Price to
Public, Underwriting Discount and Proceeds to Company will be $ ,
$ and $ , respectively. See "Underwriting."
------------------------
The shares of Common Stock are offered by the several Underwriters named
herein, subject to receipt and acceptance by them and subject to their right to
reject any order in whole or in part. It is expected that delivery of such
shares will be made at the offices of Rodman & Renshaw, Inc., New York, New
York, on or about , 1996.
------------------------
RODMAN & RENSHAW, INC.
The date of this Prospectus is , 1996
<PAGE>
[LOGO]
IN CONNECTION WITH THIS OFFERING, THE UNDERWRITERS MAY OVER-ALLOT OR EFFECT
TRANSACTIONS WHICH STABILIZE OR MAINTAIN THE MARKET PRICE OF THE COMMON STOCK AT
A LEVEL ABOVE THAT WHICH MIGHT OTHERWISE PREVAIL IN THE OPEN MARKET. SUCH
TRANSACTIONS MAY BE EFFECTED ON THE NASDAQ NATIONAL MARKET, IN THE
OVER-THE-COUNTER MARKET OR OTHERWISE. SUCH STABILIZING, IF COMMENCED, MAY BE
DISCONTINUED AT ANY TIME. IN CONNECTION WITH THIS OFFERING, CERTAIN UNDERWRITERS
AND SELLING GROUP MEMBERS (IF ANY) OR THEIR RESPECTIVE AFFILIATES MAY ENGAGE IN
PASSIVE MARKET MAKING TRANSACTIONS IN THE COMMON STOCK ON NASDAQ IN ACCORDANCE
WITH RULE 10B-6A UNDER THE SECURITIES EXCHANGE ACT OF 1934 (THE "EXCHANGE ACT").
SEE "UNDERWRITING."
Altair, AngleTIPS, Arago, Arcturus, Aurora, Centauri, MOD, Orion, Pegasus,
Polaris, Premier Laser Systems, Proclosure-Registered Trademark-, Sirius and
TouchTIPS are trademarks of the Company. This Prospectus also includes
trademarks and trade names of companies other than the Company.
2
<PAGE>
PROSPECTUS SUMMARY
THE FOLLOWING SUMMARY SHOULD BE READ IN CONJUNCTION WITH, AND IS QUALIFIED
IN ITS ENTIRETY BY, THE MORE DETAILED INFORMATION AND FINANCIAL STATEMENTS
(INCLUDING THE NOTES THERETO) APPEARING ELSEWHERE IN THIS PROSPECTUS. UNLESS
OTHERWISE INDICATED, THE INFORMATION CONTAINED IN THIS PROSPECTUS ASSUMES (I) A
PUBLIC OFFERING PRICE OF $10.00 PER SHARE, (II) NO EXERCISE OF THE UNDERWRITERS'
OVER-ALLOTMENT OPTION AND (III) NO EXERCISE OF ANY OTHER OUTSTANDING WARRANTS OR
OPTIONS. THIS PROSPECTUS CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE RISKS
AND UNCERTAINTIES. THE COMPANY'S ACTUAL RESULTS MAY DIFFER SIGNIFICANTLY FROM
THE RESULTS DISCUSSED IN THE FORWARD-LOOKING STATEMENTS. FACTORS THAT MIGHT
CAUSE SUCH DIFFERENCES INCLUDE, BUT ARE NOT LIMITED TO, THOSE DISCUSSED IN "RISK
FACTORS."
THE COMPANY
Premier Laser Systems, Inc. develops, manufactures and markets several lines
of proprietary medical lasers, fiberoptic delivery systems and associated
products for a variety of dental, ophthalmic and surgical applications
principally for use in surgical centers and medical offices. The Company's
lasers and related products use the controlled application of thermal, acoustic
and optical energy to allow the physician or dentist to perform selected
minimally invasive procedures which, compared to conventional techniques not
involving the use of lasers, vaporize or sever tissue with minimal blood loss
and scarring, increase patient comfort and reduce patient treatment time and
treatment costs. To date, the Company has received clearance to market 19 models
of medical lasers, which are covered by 18 United States patents, 13 pending
United States patent applications, 11 foreign patents and 41 pending foreign
patents.
It is estimated that over 60 million soft tissue (gums) procedures are
performed by dentists or periodontists in the United States annually, many of
which the Company believes can be addressed with laser technology. The Company's
Aurora diode laser is currently used by dentists and periodontists to treat
periodontal disease and has been shown to postpone or in some cases eliminate
the need for conventional periodontal surgery. The Company's Arago and MOD
(Multi Operatory Dentalaser) argon lasers are currently used by dentists to
accelerate the curing of composites placed in cavity preparations. The use of
the laser for this application has been shown to result in a stronger
restoration than composites cured by traditional curing lights. The Company is
seeking clearance for additional dental applications to enable it to market its
Centauri Er:YAG laser for hard tissue (teeth) procedures, and is currently
initiating clinical trials for cavity prevention and teeth whitening.
Approximately two million cataract extractions were performed in the United
States in 1994 and approximately three million people suffered from glaucoma in
the United States in 1995. The Company's multiple application Centauri Er:YAG
laser is priced significantly below current single purpose refractive lasers and
has been cleared for anterior capsulotomy (one step in the cataract extraction
procedure) and occuloplastic and other cosmetic procedures, among other
indications. The Centauri laser is also currently being tested in clinical
trials and animal studies for cataract removal, glaucoma treatment and corneal
sculpting (treatment of myopia, hyperopia and astigmatism).
The suture, staple and wound closure market in 1994 was estimated to be
approximately $2 billion worldwide, a significant portion of which the Company
believes may be addressed with surgical lasers, either in conjunction with or
independent of traditional sutures or staples. The clinically demonstrated
benefits of the use of surgical lasers for tissue melding, as compared to
sutures and staples, include fluid-static seals, immediate closure strength and
reduced surgical time. The Company and its strategic partner are currently
conducting clinical and animal studies for tissue melding for ducts, arteries,
veins and skin, in support of future regulatory applications.
The Company's strategy is to seek to increase its market penetration in the
dental, ophthalmic and surgical markets by (i) expanding its marketing and
distribution efforts, (ii) creating market awareness through increased publicity
and the education of dentists and physicians, (iii) pursuing clearance for
additional laser applications, (iv) capitalizing on disposable aftermarket
related products, and (v) expanding domestically and internationally through
strategic alliances or acquisitions of companies with additional distribution
channels, complementary products or an international presence.
3
<PAGE>
The Company commenced operations in August 1991, after acquiring
substantially all of the assets of Pfizer Laser Systems, a division of Pfizer
Hospital Products Group, Inc. ("Pfizer HPG"), in an acquisition led by the
Company's Chief Executive Officer. The assets acquired by the Company included
the proprietary rights to a broad base of laser and fiberoptic technologies,
which the Company developed over the past four years into 19 laser models
cleared for market introduction. Following an initial public offering in
December 1994, the Company increased inventory and expanded its dental sales
force in December 1995 to include five area sales managers and 25 independent
marketing representatives. As a result of this expansion, the Company achieved
$723,000 in sales to the dental market for the fiscal year ended March 31, 1996.
The Company's principal executive offices are located at 3 Morgan, Irvine,
California 92718. The Company's telephone number is (714) 859-0656.
THE OFFERING
<TABLE>
<S> <C>
Common Stock Offered by the Company............. 2,500,000 shares
Common Stock to be Outstanding after the
Offering....................................... 7,223,758 shares (1)
Use of Proceeds................................. To fund the expansion of the Company's
marketing and distribution capabilities,
including distribution to international
markets, through acquisitions, strategic
alliances or internal development; to
invest in inventory and demonstration
equipment; to fund additional research and
development; to repay indebtedness; and
for general corporate and working capital
purposes.
Nasdaq National Market Common Stock Symbol...... "PLSIA"
</TABLE>
- ------------------------
(1) Does not include (i) 730,402 shares of Common Stock issuable upon exercise
of outstanding options as of June 3, 1996 granted under the Company's 1992
Employee Stock Option Plan, 1995 Stock Option Plan and 1996 Stock Option
Plans; (ii) 375,000 shares of Common Stock issuable upon exercise of the
Underwriters' over-allotment option; (iii) up to 250,000 shares of Common
Stock issuable upon exercise of Warrants to be granted to the Representative
of the Underwriters upon completion of this Offering; (iv) 688,547 shares of
Common Stock issuable upon exercise of other outstanding options and
warrants to purchase Common Stock; (v) 8,290,298 shares of Common Stock
issuable upon exercise of the Company's outstanding publicly-held Class A
Warrants and the underlying Class B Warrants; (vi) 3,102,049 shares of
Common Stock issuable upon exercise of the Company's outstanding
publicly-held Class B Warrants; (vii) 960,000 shares of Common Stock
issuable upon exercise of Unit Purchase Options (and the underlying Class A
Warrants and Class B Warrants) granted to the underwriters for the Company's
initial public offering in December 1994 (the "IPO") and to certain other
persons (the "IPO Unit Purchase Options") and (viii) 1,256,818 shares of
each of Class E-1 Common Stock and Class E-2 Common Stock. For a description
of the Class A Warrants, Class B Warrants, IPO Unit Purchase Options, Class
E-1 Common Stock and Class E-2 Common Stock, see "Description of
Securities." For a description of the Company's stock option plans and
options outstanding thereunder, see "Management -- Stock Option Plans."
4
<PAGE>
SUMMARY FINANCIAL DATA
<TABLE>
<CAPTION>
FISCAL YEAR ENDED MARCH 31,
----------------------------------------------
1994 1995 1996
-------------- -------------- --------------
<S> <C> <C> <C>
SELECTED STATEMENT OF OPERATIONS DATA:
Net sales....................................................... $ 2,079,335 $ 1,249,403 $ 1,704,390
Cost of sales................................................... 1,753,352 1,298,420 3,324,757
-------------- -------------- --------------
Gross profit (loss)............................................. 325,983 (49,017) (1,620,367)
Selling and marketing expenses.................................. 1,087,461 1,035,863 1,308,767
Research and development expenses............................... 678,279 1,035,705 1,213,471
General and administrative expenses............................. 1,322,888 1,747,090 1,709,327
-------------- -------------- --------------
Loss from operations............................................ (2,762,645) (3,867,675) (5,851,932)
Interest (expense) income, net.................................. (434,851) (322,540) 99,037
-------------- -------------- --------------
Loss before extraordinary items................................. (3,197,496) (4,190,215) (5,752,895)
Extraordinary gain from extinguishment of indebtedness.......... -- 381,730 --
-------------- -------------- --------------
Net loss........................................................ $ (3,197,496) $ (3,808,485) $ (5,752,895)
-------------- -------------- --------------
-------------- -------------- --------------
SELECTED PER SHARE DATA:
Net loss........................................................ $ (1.26)
--------------
--------------
Weighted average shares outstanding (1)......................... 4,556,959
Pro forma loss before extraordinary item (2).................... $ (2.45) $ (1.59)
Extraordinary gain from extinguishment of indebtedness.......... -- .15
-------------- --------------
Pro forma net loss (2).......................................... $ (2.45) $ (1.44)
-------------- --------------
-------------- --------------
Pro forma weighted average shares outstanding (1)(2)............ 1,288,751 2,584,722
</TABLE>
<TABLE>
<CAPTION>
AT MARCH 31, 1996
------------------------------
AS ADJUSTED
ACTUAL (3)
-------------- --------------
<S> <C> <C>
SELECTED BALANCE SHEET DATA:
Cash and cash equivalents...................................................... $ 35,463 $ 22,235,463
Working capital................................................................ 5,818,492 28,518,492
Total assets................................................................... 15,674,568 37,874,568
Total debt..................................................................... 481,195 --
Shareholders' equity........................................................... 13,797,046 36,497,046
</TABLE>
- ------------------------
(1) Does not include 1,256,818 shares of each of Class E-1 or Class E-2 Common
Stock outstanding as of March 31, 1996, which are subject to cancellation
under certain circumstances. See "Description of Securities -- Common Stock"
and Notes 2 and 16 of Notes to Financial Statements.
(2) Adjusted to give pro forma effect to the conversion of certain of the
Company's indebtedness which occurred upon completion of the Company's
initial public offering. The effect on net loss per common share from the
conversion of such indebtedness was to reduce historical net loss by $37,500
and $67,995, and to increase weighted average shares outstanding by 76,875
and 321,099 shares for the fiscal years ended March 31, 1994 and 1995,
respectively.
(3) Adjusted to reflect the receipt by the Company of estimated net proceeds
from the issuance of 2,500,000 shares hereby and the application of the net
proceeds thereof. See "Use of Proceeds" and "Capitalization."
5
<PAGE>
RISK FACTORS
In evaluating an investment in the Common Stock being offered hereby,
investors should consider carefully, among other things, the following risk
factors, as well as the other information contained in this Prospectus.
LIMITED OPERATING HISTORY; CONTINUING OPERATING LOSSES
The Company was formed in July 1991 and has not generated significant
revenues to date. As of March 31, 1996, the Company had an accumulated deficit
of $18,616,414. For the fiscal years ended March 31, 1994, 1995 and 1996, the
Company had operating losses of $2,762,645, $3,867,675 and $5,851,932,
respectively, resulting principally from costs incurred in research and
development and other costs of operations. The Company expects that operating
losses will continue until such time as product sales generate sufficient
revenues to fund its continuing operations, as to which there can be no
assurance.
INDEPENDENT ACCOUNTANTS' REPORT; GOING CONCERN QUALIFICATION
The report from the Company's independent accountants includes an
explanatory paragraph which describes substantial doubt concerning the ability
of the Company to continue as a going concern. The Company may incur losses for
the foreseeable future due to the significant costs associated with
manufacturing, marketing and distributing its laser products and due to
continual research and development activities which will be necessary to develop
additional applications for the Company's laser technology. See "Management's
Discussion and Analysis of Financial Condition and Results of Operations" and
"Financial Statements -- Report of Independent Accountants."
UNCERTAINTIES CONCERNING FUTURE PROFITABILITY
The Company's ability to achieve profitability will depend, in part, on its
ability to continue to successfully develop clinical applications and obtain
regulatory approvals for its products and to develop the capacity to manufacture
and market such products on a wide scale. There is no assurance that the Company
will be able to successfully make the transition from research and development
to manufacturing and selling commercial medical laser products on a broad basis.
While attempting to make this transition, the Company will be subject to all
risks inherent in a growing venture, including the need to produce reliable and
effective products, develop marketing expertise and enlarge its sales force. See
"Management's Discussion and Analysis of Financial Condition and Results of
Operations."
UNCERTAIN MARKET ACCEPTANCE
The Company's future sales are dependent, in part, on the Company's ability
to demonstrate to dentists, ophthalmologists and other physicians the potential
cost and performance advantages of its laser systems over traditional methods of
treatment and, to a lesser extent, over competitive laser systems. To date,
commercial sales of the Company's lasers have been limited, and no assurance can
be given that these laser products can be successfully commercialized on a broad
basis. Lasers have not been widely used in dentistry and their use requires
training and expertise. The acceptance of dental lasers may be adversely
affected by their high cost, concerns by patients and dentists relating to their
safety and efficacy, and the substantial market acceptance and penetration of
alternative dental tools such as the dental drill. Current economic pressure may
make dentists and physicians reluctant to purchase substantial capital equipment
or invest in new technology. The failure of medical lasers to achieve broad
market acceptance would have a material adverse effect on the Company's
business, financial condition and results of operations. No assurance can be
given that any of the Company's products will be accepted by the medical or
dental community or by patients, or that a significant market for the Company's
laser systems will be developed and sustained. The Company currently has a
limited sales force and will need to hire additional sales and marketing
personnel to facilitate the general acceptance of its products. See "Business --
Market Overview."
6
<PAGE>
DEPENDENCE ON SUPPLIERS
The Company purchases certain raw materials, components and subassemblies
included in the Company's products from a limited group of qualified suppliers
and does not maintain long-term supply contracts with any of its key suppliers.
The disruption or termination of these sources could have a material adverse
effect on the Company's business and results of operations. For example, during
fiscal 1994, the Company's sole supplier of the specialized optic fiber required
for use in the Company's Er:YAG lasers ceased to provide this fiber to the
Company. While the Company has since qualified the new suppliers of this fiber,
the Company's inability to obtain sufficient quantities of this specialized
optical fiber had a material adverse effect on the volume of Er:YAG lasers the
Company was able to sell during fiscal 1994 and 1995. The Company's arrangement
with the supplier of its Arago argon laser terminates in August 1996, and if
this arrangement is not renewed and the Company is unable to secure another
source for this argon laser, the Company's results of operations may be
adversely affected. While the Company believes that alternative suppliers could
be found for these products, there can be no assurance that any supplier could
be replaced in a timely manner. Any interruption in the supply of these and
other key components could have a material adverse effect on the Company's
ability to manufacture its products and on its business, financial condition and
results of operations. See "Business -- Manufacturing and Materials."
RISKS APPLICABLE TO FOREIGN SALES
Sales of the Company's products to foreign markets account for a substantial
portion of the Company's sales. Foreign sales expose the Company to certain
risks, including the difficulty and expense of maintaining foreign sales
distribution channels, barriers to trade, potential fluctuations in foreign
currency exchange rates, political and economic instability, availability of
suitable export financing, accounts receivable collections, tariff regulations,
quotas, shipping delays, foreign taxes, export licensing requirements and other
United States and foreign regulations that may apply to the export of medical
lasers. The regulation of medical devices worldwide also continues to develop,
and there can be no assurance that new laws or regulations will not have an
adverse effect on the Company. In addition, the Company may experience
additional difficulties in providing prompt and cost effective service of its
medical lasers in foreign countries. The Company does not carry insurance
against such risks. The occurrence of any one or more of these events may
individually or in the aggregate have a material adverse effect upon the
Company's business, financial condition and results of operations. See "Business
- -- Marketing, Sales and Service."
RISK OF TECHNOLOGICAL OBSOLESCENCE
The markets in which the Company's laser products compete are subject to
rapid technological change, as well as the potential development of alternative
surgical techniques or new pharmaceutical products. Such changes could render
the Company's products uncompetitive or obsolete. The Company will be required
to invest in research and development to attempt to maintain and enhance its
existing products and develop new products. No assurances can be given that such
research and development efforts will result in the introduction of new products
or product improvements. See "Business -- Research and Development."
DEPENDENCE ON PATENTS AND PROPRIETARY TECHNOLOGY
The Company's success will depend, in part, on its ability to obtain patent
protection for products and processes, to preserve its trade secrets and to
operate without infringing the proprietary rights of third parties. The Company
holds 18 U.S. patents and has other patent applications pending in the United
States. The Company also holds 11 foreign patents including two utility model
patents and has other foreign patent applications pending. No assurance can be
given that any additional U.S. or foreign patents will be issued, that the scope
of any patent protection will exclude competitors or that any of the Company's
patents will be held valid if subsequently challenged. Further, there can be no
assurance that others will not independently develop similar products, duplicate
the Company's products or design products that circumvent any patents used by
the Company. The Company is aware of certain patents which, along with other
patents that may exist or be granted in the future, could
7
<PAGE>
restrict the Company's right to market certain of its technologies without a
license, including, without limitation, patents relating to the Company's lens
emulsification product and ophthalmic probes for the Er:YAG laser. In the past,
the Company has received allegations that certain of the Company's laser
products infringe other patents. There has been significant patent litigation in
the medical industry in general, and in the medical laser industry in
particular. Adverse determinations in litigation or other patent proceedings to
which the Company may become a party could subject the Company to significant
legal judgments or other liabilities to third parties and could require the
Company to seek licenses from third parties that may or may not be economically
viable. Patent and other intellectual property rights disputes often are settled
through licensing arrangements. No assurance can be given that any licenses
required under these or any other patents or proprietary rights would be
available on terms acceptable to the Company, if at all. If the Company does not
obtain such licenses, it could encounter delays in product introductions while
it attempts to design around such patents, or it could find that the
development, manufacture or sale of products requiring such licenses could be
enjoined. If the Company is found, in a legal proceeding, to have infringed the
patents or other proprietary rights of others, it could be liable for
significant damages. The Company also relies upon unpatented trade secrets, and
no assurance can be given that others will not independently develop or
otherwise acquire substantially equivalent trade secrets. In addition, at each
balance sheet date, the Company is required to review the value of its
intangible assets based on various factors, such as changes in technology. Any
adjustment downward in such value may result in a write-off of the intangible
asset and a substantial charge to earnings, thereby adversely affecting the
operating results of the Company in the future. See "Business -- Patents and
Patent Applications" and Note 2 of Notes to Financial Statements.
NEED FOR FDA AND FOREIGN GOVERNMENTAL APPROVALS; GOVERNMENT REGULATION
The Company's products are regulated as medical devices by the FDA under the
Federal Food, Drug and Cosmetic Act (the "FDC Act") and the regulations
promulgated thereunder. As such, these devices require either Section 510(k)
premarket clearance ("510(k)") or approval of a premarket approval application
("PMA") by the FDA prior to commercialization. Satisfaction of applicable
regulatory requirements may take several years and varies substantially based
upon the type, complexity and novelty of such devices, as well as the clinical
procedure. Filings and governmental approvals may be required in foreign
countries before the devices can be marketed in these countries. There can be no
assurance that further clinical trials of the Company's medical lasers or of any
future products will be successfully completed or, if they are completed, that
any requisite FDA or foreign governmental clearances or approvals will be
obtained. FDA or other governmental clearances or approvals of products
developed by the Company in the future may require substantial filing fees which
could limit the number of applications sought by the Company and may entail
limitations on the indicated uses for which such products may be marketed. In
addition, approved or cleared products may be subject to additional testing and
surveillance programs required by the FDA and other regulatory agencies, and
product approvals and clearances could be withdrawn for failure to comply with
regulatory standards or by the occurrence of unforeseen problems following
initial marketing. Also, the Company has made modifications to certain of its
existing products which it does not believe require the submission of a new
510(k) notification to the FDA. However, there can be no assurance that the FDA
would agree with the Company's determination and not require the Company to
discontinue marketing one or more of the modified devices until they have been
cleared by the FDA. The Company is also required to adhere to applicable
requirements for current Good Manufacturing Practices ("cGMP") and radiological
health requirements, to engage in extensive record keeping and reporting and to
comply with the FDA's product labeling, promotional and advertising
requirements. Noncompliance with state, local, federal or foreign requirements
can result in fines, injunctions, civil penalties, recall or seizure of
products, total or partial suspension of production, delay, denial or withdrawal
of premarket clearance or approval of devices, recommendations by the FDA that
the Company not be allowed to enter into government contracts, and criminal
prosecution, all of which would have a material adverse effect on the Company's
business, financial condition and results of
8
<PAGE>
operations. The Company's manufacturing facilities are subject to periodic
inspections by state and federal agencies, including the FDA, the California
Department of Health Services, and comparable agencies in other countries. See
"Business -- Government Regulation."
DEPENDENCE ON KEY PERSONNEL
The Company depends to a considerable degree on a limited number of key
personnel, including Colette Cozean, Ph.D., its Chairman of the Board, Chief
Executive Officer, President and Director of Research. Dr. Cozean is also an
inventor of a number of the Company's patented technologies. During the
Company's limited operating history, many key responsibilities within the
Company have been assigned to a relatively small number of individuals. The loss
of Dr. Cozean's services or those of certain other members of management could
adversely affect the Company. The Company carries key person life insurance in
the amount of $3 million on Dr. Cozean. The Company has no long-term employment
agreements with its key personnel. The success of the Company will also depend,
among other factors, on the successful recruitment and retention of qualified
technical and other personnel. See "Management."
HIGHLY COMPETITIVE INDUSTRY
The medical laser industry is subject to intense competition and is
characterized by rapid technological change. The Company is and will continue to
be subject to competition in its targeted markets, principally from businesses
providing other traditional surgical and nonsurgical treatments, including
existing and developing technologies, and to a lesser extent competitors' CO(2),
argon, Er:YAG and Nd:YAG lasers. Many of the Company's competitors have
substantially greater financial, marketing and manufacturing resources and
experience than the Company. Furthermore, the Company expects other companies
will enter the market, particularly as medical lasers gain increasing market
acceptance. Significant competitive factors which will affect future sales in
the marketplace include regulatory approvals, performance, pricing and general
market acceptance. See "-- Dependence on Suppliers" and "Business --
Competition."
POTENTIAL FLUCTUATIONS IN QUARTERLY OPERATING RESULTS
Due to the relatively high sales price of the Company's laser systems and
the low sales unit volume, minor timing differences in receipt of customer
orders have produced and could continue to produce significant fluctuations in
quarterly results. In addition, if anticipated sales and shipments in any
quarter do not occur when expected, expenditures and inventory levels could be
disproportionately high, and the Company's operating results for that quarter,
and potentially for future quarters, would be adversely affected. Quarterly
results may also fluctuate based on a variety of other factors, such as
seasonality, production delays, product mix, cancellation or rescheduling of
orders, new product announcements by competitors, receipt of clearances or
approvals by the Company or its competitors, notices of product suspension or
recall, the Company's ability to manage product transitions, sales prices and
market conditions. In addition, if the Company expands or augments its
manufacturing capabilities in connection with the introduction of new products,
quarterly revenues and operating results are expected to fluctuate to an even
greater degree. See "Management's Discussion and Analysis of Financial Condition
and Results of Operations."
UNCERTAIN ABILITY TO MEET CAPITAL NEEDS
The Company will require substantial additional funds for its research and
development programs, preclinical and clinical testing, development of its sales
and distribution force, operating expenses, regulatory processes and
manufacturing and marketing programs. The Company's capital requirements will
depend on numerous factors, including the progress of its research and
development programs, results of preclinical and clinical testing, the time and
cost involved in obtaining regulatory approvals, the cost of filing,
prosecuting, defending and enforcing any patent claims and other intellectual
property rights, competing technological and market developments, developments
and changes in the Company's existing research, licensing and other
relationships and the terms of any new collaborative, licensing and other
arrangements that the Company may establish. The Company believes that the net
proceeds of this Offering, together with its available short-term assets
9
<PAGE>
and investment income, will be sufficient to meet its operating expenses and
capital expenditures through the next 24 months. See "Use of Proceeds" and
"Management's Discussion and Analysis of Financial Condition and Results of
Operations -- Liquidity and Capital Resources." However, the Company's cash
requirements may vary materially from those now planned due to potential future
acquisitions, the progress of research and development programs, results of
clinical testing, relationships with strategic partners, if any, competitive and
technological advances, the FDA and foreign regulatory processes and other
factors. There can be no assurance, however, that additional financing will be
available when needed, or if available, will be available on acceptable terms.
Insufficient funds may prevent the Company from implementing its business
strategy or may require the Company to delay, scale back or eliminate certain of
its research and product development programs or to license to third parties
rights to commercialize products or technologies that the Company would
otherwise seek to develop itself.
BROAD DISCRETION OVER USE OF PROCEEDS
The Company intends to use a substantial portion of the net proceeds of this
Offering to expand the Company's marketing and distribution capabilities through
internal development, strategic alliances and acquisitions. In addition, the
Company may use of a portion of the net proceeds to increase its available
technologies or products through acquisitions, capital and research and
development expenditures or a combination or both. Management's allocation
decisions concerning such net proceeds will be dependent upon a variety of
factors, including the progress and results of clinical trials, the timing of
receipt of regulatory approvals and potential strategic alliances and
acquisitions. The Company is not engaged in discussions relating to any
acquisitions and has not yet determined the extent to which it will expand its
marketing, distribution, technologies and products through acquisitions or
strategic alliances, as contrasted with internal growth. As a result, a
significant portion of the net proceeds will be available for acquisitions and
projects that are not yet identified, and the Board of Directors will have broad
discretion with respect to the application of such proceeds. There can be no
assurance that the Company will be able to consummate acquisitions or identify
and arrange projects that meet the Company's requirements. See "Use of
Proceeds."
POSSIBLE VOLATILITY OF STOCK PRICE
The stock market has from time to time experienced significant price and
volume fluctuations that are unrelated to the operating performance of
particular companies. These broad market fluctuations may adversely affect the
market price of the Company's Common Stock. In addition, the market price of the
Company's Common Stock has been and is likely to be highly volatile. Factors
such as fluctuations in the Company's operating results, announcements of
technological innovations or new products by the Company or its competitors, FDA
and international regulatory actions, developments with respect to patents or
proprietary rights, public concern as to the safety of products developed by the
Company or its competitors, changes in health care policy in the United States
and internationally, changes in analysts' recommendations regarding the Company,
other medical companies or the medical laser industry generally and general
market conditions may have a significant effect on the market price of the
Company's Common Stock. See "Price Range of Common Stock."
PRODUCT LIABILITY EXPOSURE
The sale of the Company's laser products involves the inherent risk of
product liability claims against the Company. The Company currently maintains
product liability insurance coverage in the amount of $5 million per occurrence
and $5 million in the aggregate, but such insurance is expensive, subject to
various coverage exclusions and may not be obtainable by the Company in the
future on terms acceptable to the Company. There can be no assurance that claims
against the Company arising with respect to its products will be successfully
defended or that the insurance carried by the Company will be sufficient to
cover liabilities arising from such claims. A successful claim against the
Company in excess of the Company's insurance coverage could have a material
adverse effect on the Company's business, financial condition and results of
operations. See "Business -- Product Liability and Insurance."
10
<PAGE>
LIMITATIONS ON THIRD PARTY REIMBURSEMENT
The Company's laser products are generally purchased by physicians, dentists
and surgical centers which then bill various third party payors, such as
government programs and private insurance plans, for the procedures conducted
with the Company's lasers. Third-party payors carefully review and are
increasingly challenging the prices charged for medical products and services.
Reimbursement rates from private companies vary depending on the procedure
performed, the third-party payor, the insurance plan and other factors. Medicare
reimburses hospitals a prospectively-determined fixed amount for the costs
associated with an in-patient hospitalization based on the patient's discharge
diagnosis, and reimburses physicians a prospectively-determined fixed amount
based on the procedure performed, regardless of the actual costs incurred by the
hospital or physician in furnishing the care and unrelated to the specific
devices used in that procedure. Third-party payors are increasingly scrutinizing
whether to cover new products and the level of reimbursement for covered
products. While the Company believes that the procedures using its laser systems
have generally been reimbursed, payors may deny coverage and reimbursement for
the Company's products if they determine that the device was not reasonable and
necessary for the purpose for which used, was investigational or not
cost-effective. As a result, there can be no assurance that reimbursement from
third party payors for these procedures will be available or if available, that
reimbursement will not be limited, thereby adversely affecting the Company's
ability to sell its products on a profitable basis. Moreover, the Company is
unable to predict what legislation or regulation, if any, relating to the health
care industry or third-party coverage and reimbursement may be enacted in the
future, or what effect such legislature or regulation may have on the Company.
UNCERTAINTIES REGARDING HEALTH CARE REFORM
Several states and the United States government are investigating a variety
of alternatives to reform the health care delivery system and further reduce and
control health care spending. These reform efforts include proposals to limit
spending on health care items and services, limit coverage for new technology
and limit or control the price health care providers and drug and device
manufacturers may charge for their services and products. If adopted and
implemented, such reforms could have a material adverse effect on the Company's
business, financial condition and results of operations. See "Business --
Government Regulation."
CHARGE TO EARNINGS IN THE EVENT OF RELEASE OF ESCROW SHARES
The Company has outstanding 1,256,818 shares of each of Class E-1 and Class
E-2 Common Stock (the "Escrow Shares") which are being held by the Company in
escrow, and which will be released from escrow and converted into shares of
Common Stock if certain criteria are met. In the event any of these criteria are
met and any shares are released from escrow to shareholders who are officers,
directors, employees or consultants of the Company, a substantial noncash
compensation expense will be recorded for financial reporting purposes. The
recognition of such compensation expense may have an adverse effect on the
market price of the Company's securities. See "Management's Discussion and
Analysis of Financial Condition and Results of Operations -- Potential Future
Charge to Income," "Principal Shareholders" and "Description of Securities --
Common Stock."
SHARES ELIGIBLE FOR FUTURE SALE; EFFECT OF OUTSTANDING OPTIONS AND WARRANTS
Sales of a substantial number of shares of Common Stock in the public market
following this Offering could adversely affect the market price for the Common
Stock. Other than 161,352 shares of Common Stock held by the Company's officers
and directors which are subject to 180 day lock-up agreements, substantially all
of the Company's 7,223,758 shares of Common Stock to be outstanding upon
completion of this Offering will be freely tradeable, including 993,831
unregistered shares of Common Stock which may be sold in the public market
subject to compliance with Rule 144 promulgated under the Securities Act. An
additional 11,392,347 shares of Common Stock are issuable upon the full exercise
of the Company's outstanding publicly traded Units, Class A Warrants and Class B
Warrants, and 2,378,949 shares of Common Stock are issuable upon exercise of
other outstanding warrants and options. The issuance of shares upon the exercise
of the Class A Warrants, Class B
11
<PAGE>
Warrants, the IPO Unit Purchase Options and options under the 1995 Stock Option
Plan has been registered under the Securities Act, and 720,499 shares of Common
Stock issuable upon exercise of the remaining options and warrants may be resold
pursuant to Rule 701 under the Securities Act. The existence of the Company's
outstanding warrants and options could adversely affect the Company's ability to
obtain future financing. The price which the Company may receive for the Common
Stock issued upon exercise of such options and warrants will likely be less than
the market price of the Common Stock at the time such options and warrants are
exercised. Moreover, the holders of the options and warrants might be expected
to exercise them at a time when the Company would, in all likelihood, be able to
obtain needed capital by a new offering of its securities on terms more
favorable than those provided for by the options and warrants. See "Management
- -- Stock Option Plans" and "Shares Eligible for Future Sale."
POTENTIAL ANTI-TAKEOVER EFFECTS
The Company's Articles of Incorporation authorize the issuance of 8,850,000
shares of "blank check" preferred stock, which will have such designations,
rights and preferences as may be determined from time to time by the Board of
Directors. Accordingly, the Board of Directors is empowered, without shareholder
approval, to issue preferred stock with dividend, liquidation, conversion,
voting or other rights which could adversely affect the voting power or other
rights of the holders of the Company's Common Stock. In the event of such
issuance, the preferred stock could be utilized, under certain circumstances, as
a method of discouraging, delaying or preventing a change in control of the
Company. See "Description of Securities -- Preferred Stock." In addition, the
Company has entered into Termination Agreements with each executive officer of
the Company, pursuant to which the Company will provide such officers in the
event of a termination of employment following a change in control of the
Company, as defined in such agreement, with (i) a lump sum cash payment equal to
two times the highest annual level of total cash compensation paid to that
officer during the three calendar years prior to the termination, (ii) immediate
vesting of all previously granted stock options, and (iii) continuing health
benefits for a period of 24 months. These agreements could also discourage,
delay or prevent a change in control of the Company.
12
<PAGE>
USE OF PROCEEDS
The net proceeds to the Company from the sale of the 2,500,000 shares of
Common Stock being offered hereby are estimated to be $22,700,000 (or
$26,187,500 if the Underwriters' over-allotment option is exercised in full)
after deducting underwriting discounts and estimated offering expenses payable
by the Company.
The Company intends to use the net proceeds of this Offering to fund the
expansion of the Company's marketing and distribution capabilities, including
distribution into international markets, through acquisitions, strategic
alliances or internal development. The Company also plans to invest in inventory
and demonstration or loaner equipment, and to fund additional research and
development including further clinical trials, regulatory activities and other
research and development projects, including corneal sculpting.
The Company also plans to use approximately $500,000 of the net proceeds of
this Offering to repay the outstanding principal and unpaid accrued interest on
a promissory note payable to Pfizer HPG representing acquisition indebtedness,
which note bears interest at the rate of 10.0% per annum, and matures on the
closing of this Offering.
The remaining proceeds are expected to be used for working capital and other
general corporate purposes, including possible strategic alliances with or
acquisitions of businesses that may provide distributor networks, complementary
products or an international presence. There are no present negotiations,
agreements or understandings with respect to any such acquisitions. Because a
significant portion of the net proceeds will be available for acquisitions and
projects that are not yet identified, the Board of Directors will have broad
discretion with respect to the application of such proceeds. There can be no
assurance that the Company will be able to identify and arrange projects that
meet the Company's requirements or to consummate any such acquisition.
Pending the application of such proceeds, the Company intends to invest the
net proceeds of this Offering in bank deposits and short-term, investment grade
securities.
13
<PAGE>
PRICE RANGE OF COMMON STOCK
The Company's Common Stock is quoted on the Nasdaq National Market under the
symbol "PLSIA." Prior to May 1, 1995, the Company's Common Stock was listed on
the Nasdaq SmallCap Market under the same symbol. The following table sets
forth, for the quarters indicated, the high and low bid prices of the Company's
Common Stock on the Nasdaq SmallCap Market through April 30, 1995, and the high
and low last sale prices of the Common Stock on the Nasdaq National Market
thereafter.
<TABLE>
<CAPTION>
HIGH LOW
-------- -------
<S> <C> <C>
FISCAL YEAR ENDED MARCH 31, 1995:
Third Quarter (commencing November 30, 1994).............. $ 4 $ 4
Fourth Quarter............................................ 4 1/2 3 1/2
FISCAL YEAR ENDED MARCH 31, 1996:
First Quarter*............................................ $ 6 3/4 $ 3 3/4
Second Quarter............................................ 7 5 5/8
Third Quarter............................................. 6 1/8 5
Fourth Quarter............................................ 8 5/8 3 7/8
FISCAL YEAR ENDED MARCH 31, 1997:
First Quarter (through June 3, 1996)...................... $ 10 3/4 $ 8
</TABLE>
- ------------------------
* For April 1 through April 30, 1995, the high and low bid prices of the
Common Stock were $5.00 and $3.50.
The quotations in the above table reflect inter-dealer prices without retail
markups, markdowns or commissions. In addition, for all periods prior to May 1,
1995, the quotations do not represent actual transactions.
On June 3, 1996, the last reported sale price for the Company's Common Stock
on the Nasdaq National Market was $10.00. The Company's Class A Warrants and
Class B Warrants are quoted on the Nasdaq National Market and the Company's
Units are listed on the Nasdaq SmallCap Market. The Company also has outstanding
Class E-1 Common Stock and Class E-2 Common Stock for which there is no public
market. See "Description of Securities." As of June 3, 1996, the approximate
number of holders of record of the Company's Common Stock, Class E-1 and Class
E-2 Common Stock were 277, 325 and 325, respectively.
DIVIDEND POLICY
The Company has not declared or paid any cash dividends on its capital stock
since its inception and for the foreseeable future intends to follow a policy of
retaining all of its earnings, if any, to finance the development and continued
expansion of its business. There can be no assurance that dividends will ever be
paid by the Company. Any future determination as to payment of dividends will
depend upon the Company's financial condition, results of operations and such
other factors as the Board of Directors deems relevant. In addition, the
Company's credit facility contemplated by the commitment letter with Silicon
Valley Bank would prohibit the Company's payment of any dividends without the
prior consent of such bank. See "Management's Discussion and Analysis of
Financial Condition and Results of Operations -- Liquidity and Captial
Resources."
14
<PAGE>
CAPITALIZATION
The following table sets forth the capitalization of the Company at March
31, 1996, and as adjusted to reflect the sale of 2,500,000 shares of Common
Stock offered by the Company hereby and the application of the net proceeds
therefrom. The following table should be read in conjunction with the financial
statements and related notes thereto appearing elsewhere in this Prospectus.
<TABLE>
<CAPTION>
AT MARCH 31, 1996
--------------------------------
ACTUAL AS ADJUSTED
--------------- ---------------
<S> <C> <C>
Short-term debt................................................................. $ 481,195 $ --
--------------- ---------------
--------------- ---------------
Shareholders' equity:
Preferred Stock, no par value; 8,850,000 shares authorized; no shares
outstanding.................................................................. -- --
Common Stock, no par value;
35,600,000 shares authorized; 4,702,203 shares outstanding; 7,202,203 shares
outstanding, as adjusted (1)................................................. 16,317,376 39,017,376
Class E-1 Common Stock, no par value; 2,200,000 shares authorized; 1,256,818
shares outstanding and as adjusted........................................... 4,769,878 4,769,878
Class E-2 Common Stock, no par value; 2,200,000 shares authorized; 1,256,818
shares outstanding and as adjusted........................................... 4,769,878 4,769,878
Class A Warrants, 4,166,099 warrants outstanding and as adjusted.............. 2,321,057 2,321,057
Class B Warrants, 3,081,099 warrants outstanding and as adjusted.............. 376,774 376,774
Warrants to purchase Common Stock............................................. 192,130 192,130
Unrealized holding gain on short-term investments............................. 3,666,367 3,666,367
Accumulated deficit........................................................... (18,616,414) (18,616,414)
--------------- ---------------
Total shareholders' equity.................................................. 13,797,046 36,497,046
--------------- ---------------
Total capitalization...................................................... $ 13,797,046 $ 36,497,046
--------------- ---------------
--------------- ---------------
</TABLE>
- ------------------------
(1) Does not include (i) 730,402 shares of Common Stock issuable upon the
exercise of outstanding options granted under the Company's 1992 Employee
Stock Option Plan, 1995 Stock Option Plan and 1996 Stock Option Plans; (ii)
375,000 shares of Common Stock issuable upon exercise of the Underwriters'
over-allotment option; (iii) up to 250,000 shares of Common Stock issuable
upon exercise of Warrants to be granted to the Representative of the
Underwriters upon completion of this Offering; (iv) 688,547 shares of Common
Stock issuable upon exercise of other outstanding options and warrants to
purchase Common Stock; (v) 8,332,198 shares of Common Stock issuable upon
exercise of the Company's outstanding publicly-held Class A Warrants and the
underlying Class B Warrants; (vi) 3,081,099 shares of Common Stock issuable
upon exercise of the Company's outstanding publicly-held Class B Warrants;
(vii) 960,000 shares of Common Stock issuable upon exercise of the IPO Unit
Purchase Options and the Class A Warrants and Class B Warrants included in
or underlying such securities, and (viii) 1,256,818 shares of each of Class
E-1 Common Stock and Class E-2 Common Stock. For a description of the Class
A Warrants, Class B Warrants, IPO Unit Purchase Options, Class E-1 Common
Stock and Class E-2 Common Stock, see "Description of Securities." For a
description of the Company's stock option plans and options outstanding
thereunder, see "Management -- Stock Option Plans."
15
<PAGE>
SELECTED FINANCIAL DATA
The following table sets forth for the periods indicated, the selected
financial data of the Company and should be read in conjunction with the
Company's Financial Statements and related notes thereto and "Management's
Discussion and Analysis of Financial Condition and Results of Operations"
appearing elsewhere in this Prospectus. The selected financial data of the
Company as of March 31, 1994, 1995 and 1996 and for each of the fiscal years
then ended are derived from financial statements of the Company audited by Price
Waterhouse LLP, independent accountants. The balance sheet at March 31, 1996 and
the related statements of operations, shareholders' equity and cash flows for
the fiscal years ended March 31, 1995 and 1996 and notes thereto are included in
this Prospectus. The report of Price Waterhouse LLP, which also appears herein,
contains an explanatory paragraph that describes uncertainty as to the ability
of the Company to continue as a going concern.
<TABLE>
<CAPTION>
FISCAL YEAR ENDED MARCH 31,
-------------------------------------------
1994 1995 1996
------------- ------------- -------------
<S> <C> <C> <C>
SELECTED STATEMENT OF OPERATIONS DATA:
Net sales........................................................ $ 2,079,335 $ 1,249,403 $ 1,704,390
Cost of sales.................................................... 1,753,352 1,298,420 3,324,757
------------- ------------- -------------
Gross profit (loss).............................................. 325,983 (49,017) (1,620,367)
Selling and marketing expenses................................... 1,087,461 1,035,863 1,308,767
Research and development expenses................................ 678,279 1,035,705 1,213,471
General and administrative expenses.............................. 1,322,888 1,747,090 1,709,327
------------- ------------- -------------
Loss from operations............................................. (2,762,645) (3,867,675) (5,851,932)
Interest (expense) income, net................................... (434,851) (322,540) 99,037
------------- ------------- -------------
Loss before extraordinary items.................................. (3,197,496) (4,190,215) (5,752,895)
Extraordinary gain from extinguishment of indebtedness........... -- 381,730 --
------------- ------------- -------------
Net loss......................................................... $ (3,197,496) $ (3,808,485) $ (5,752,895)
------------- ------------- -------------
------------- ------------- -------------
SELECTED PER SHARE DATA:
Net loss......................................................... $ (1.26)
-------------
-------------
Weighted average shares outstanding (1).......................... 4,556,959
Pro forma loss before extraordinary item (2)..................... $ (2.45) $ (1.59)
Extraordinary gain from extinguishment of indebtedness........... -- .15
------------- -------------
Pro forma net loss (2)........................................... $ (2.45) $ (1.44)
------------- -------------
------------- -------------
Pro forma weighted average shares outstanding (1)(2)............. 1,288,751 2,584,722
<CAPTION>
AT MARCH 31,
-------------------------------------------
1994 1995 1996
------------- ------------- -------------
<S> <C> <C> <C>
SELECTED BALANCE SHEET DATA:
Cash and cash equivalents........................................ $ 308,764 $ 5,888,237 $ 35,463
Working capital.................................................. 1,287,587 6,756,149 5,818,492
Total assets..................................................... 12,325,029 16,883,975 15,674,568
Total debt (3)................................................... 4,403,890 481,195 481,195
Shareholders' equity............................................. 6,022,174 15,002,260 13,797,046
</TABLE>
- --------------------------
(1) Does not include 1,256,818 shares of each of Class E-1 or Class E-2 Common
Stock outstanding as of March 31, 1996, which are subject to cancellation
under certain circumstances. See "Description of Securities -- Common Stock"
and Notes 2 and 16 of Notes to Financial Statements.
(2) Adjusted to give pro forma effect to the conversion of certain of the
Company's indebtedness which occurred upon completion of the Company's
initial public offering. The effect on net loss per common share from the
conversion of such indebtedness was to reduce historical net loss by $37,500
and $67,995, and to increase weighted average shares outstanding by 76,875
and 321,099 shares for the fiscal years ended March 31, 1994 and 1995,
respectively.
(3) Amounts for long-term debt at March 31, 1994 include $285,000 in mandatorily
redeemable warrants.
16
<PAGE>
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction with the
Selected Financial Data and the Company's Financial Statements and related notes
thereto appearing elsewhere in this Prospectus. This Prospectus contains
forward-looking statements including, without limitation, statements concerning
future cost of sales, which involve risks and uncertainties. The Company's
actual results may differ significantly from the results discussed in these
forward-looking statements. Factors that may cause such differences include, but
are not limited to, those discussed in "Risk Factors."
GENERAL
The Company develops, manufactures and markets several lines of proprietary
medical lasers, fiberoptic delivery systems and associated products for a
variety of dental, ophthalmic and surgical applications. The Company commenced
operations in August 1991, after acquiring substantially all of the assets of
Pfizer Laser Systems ("Pfizer Laser"), a division of Pfizer HPG which is a
wholly-owned subsidiary of Pfizer, Inc. The assets acquired by the Company
included the proprietary rights to a broad base of laser and fiberoptic
technologies developed by Pfizer Laser. This acquisition was led by the
Company's current Chief Executive Officer.
Since its formation and until its IPO in December 1994, the Company
principally focused on, and its research and development activities related to,
growing markets in dentistry, ophthalmology, cosmetic procedures and certain
surgical specialties to be used in surgical centers and medical offices. To
implement this strategy, the Company developed the Pegasus Nd:YAG dental laser
system from existing technology and introduced this laser to the dental market
in February 1992. In June 1993, the Company introduced the Centauri Er:YAG laser
for ophthalmology and initiated clinical trials for hard tissue procedures in
dentistry. In December 1993, the Company acquired from Proclosure, Inc., a
Florida corporation ("Proclosure"), certain technology, assets and proprietary
rights relating to a 1.32m Nd:YAG laser system for tissue melding. From its
formation in 1991 through its initial public offering, the Company developed and
received regulatory approvals for 15 models of lasers and sold certain of those
products for soft tissue applications in dentistry and as part of clinical
trials conducted by third parties.
After the Company's IPO in December 1994, the Company increased its
inventory, acquired the distribution rights to two new dental lasers and, in
December 1995, expanded its dental sales force. In September and November 1995,
the Company acquired rights to market and distribute the Arago and MOD argon
lasers, respectively for dental applications, and in February 1996, the Company
introduced and began shipping its Aurora diode laser for soft tissue dental
applications.
While the Company has received clearance to market laser products covering a
variety of medical applications, to date the Company has focused its research,
development and marketing efforts on a limited number of products or
applications (principally specific dental and ophthalmic applications). As
future resources permit, the Company may introduce certain products for
applications for which it already has all necessary approvals or may seek
strategic alliances to develop, market and distribute such products.
The Company has recorded operating losses in each of the fiscal years since
its formation, resulting principally from substantial costs incurred in research
and development activities and obtaining regulatory approvals, together with the
absence of significant revenues to date and limited commercial sales of its
products. The report of the Company's independent accountants includes an
explanatory paragraph describing substantial doubt concerning the ability of the
Company to continue as a going concern. The Company believes, however, that its
presently available short-term assets, expected revenues from operations and the
net proceeds of this Offering will provide sufficient working capital through
the next 24 months. See "-- Liquidity and Capital Resources."
17
<PAGE>
RESULTS OF OPERATIONS
FISCAL YEAR ENDED MARCH 31, 1996 COMPARED TO FISCAL YEAR ENDED MARCH 31,
1995
Net sales increased 36.4% to $1,704,390 in fiscal 1996 from $1,249,403 in
fiscal 1995. This increase was primarily attributable to an increase of $723,000
in sales to the dental market, related principally to the introduction of three
new products, the Aurora diode laser, the Arago argon laser and the MOD argon
laser, in the latter half of fiscal 1996. This increase was partially offset by
a decrease in sales to the surgical market of approximately $200,000, largely
due to a decline in the demand for the Company's 10 and 20 watt CO(2) lasers,
which are nearing the end of their product life cycle. The Company's arrangement
with the supplier of the Arago argon laser terminates in August 1996, and to the
extent the Company is unable to extend this arrangement or to secure another
source for this laser, the Company's results of operations may be adversely
affected.
Cost of sales increased 156.1% to $3,324,757 in fiscal 1996 from $1,298,420
in fiscal 1995. This increase in the cost of sales was due primarily to (i) a
write down of approximately $848,000 principally attributed to the Company's
CO(2) lasers and accessories obtained in the acquisition of Pfizer Laser, and
Nd:YAG lasers and accessories, which lasers were developed prior to March 31,
1992 and are nearing the end of their product life cycle, (ii) the
underabsorption of manufacturing costs due to low production volumes and an
increase in the number of manufacturing employees during fiscal 1996, and (iii)
increased costs associated with higher sales volumes in fiscal 1996. Cost of
sales for fiscal 1996 also included a fee of $122,000 to a third party pursuant
to the Company's manufacturing arrangement relating to the MOD argon laser. If
production volumes increase in future periods, management anticipates higher
absorption of manufacturing costs and increased utilization of the Company's
manufacturing personnel, which could lead to positive gross margins based upon
management's current calculation of the Company's standard cost of sales for
fiscal 1996. There can be no assurance that the Company will, in future periods,
achieve positive gross margins, or that the assumptions on which standard cost
of sales is computed will be realized by the Company.
Selling and marketing expenses increased 26.3% to $1,308,767 in fiscal 1996
from $1,035,863 in fiscal 1995. This increase was primarily attributable to
marketing efforts related to the Company's dental products, which included a
$219,000 expense related to the appointment of more than 25 new manufacturer's
representatives during the third quarter, and associated expenses including
training, promotional costs and commissions.
Research and development expenses increased 17.2% to $1,213,471 in fiscal
1996 from $1,035,705 in fiscal 1995. This increase resulted primarily from
increases in outside industrial and software design services of approximately
$305,000, and expenses of approximately $196,000 associated with the development
of new laser products. This increase was partially offset by a $175,000
reduction in clinical studies expense, due to the completion of the Company's
dental hard tissue clinical trials and a $250,000 payment received by the
Company under a Small Business Innovative Research ("SBIR") grant.
General and administrative expenses decreased 2.2% to $1,709,327 in fiscal
1996 from $1,747,090 in fiscal 1995. This decrease was the result of a reduction
in legal expenses associated with the Company's litigation with a former
supplier of optical fiber (the "Fiber Litigation"), partially offset by
increases associated with becoming a public company. In 1995, the Company
incurred legal expenses of approximately $400,000 in connection with the Fiber
Litigation. Future legal expenses in the Fiber Litigation (not including
out-of-pocket expenses) are expected to be limited in accordance with the
Company's agreement with its legal counsel, although if the litigation is
successful, counsel will be entitled to certain contingency fees.
Net interest income increased to $99,037 in fiscal 1996 from net interest
expense of $322,540 in fiscal 1995, reflecting the investment of the Company's
remaining net proceeds from its IPO and the repayment in December 1994 of a
significant portion of the Company's outstanding debt.
18
<PAGE>
Net loss increased 51.1% to $5,752,895 in fiscal 1996 from $3,808,485 in
fiscal 1995. This increase was principally attributable to increases in cost of
sales, selling and marketing expenses and research and development expenses.
FISCAL YEAR ENDED MARCH 31, 1995 COMPARED TO FISCAL YEAR ENDED MARCH 31,
1994
Net sales decreased 39.9% to $1,249,403 in fiscal 1995 from $2,079,335 in
fiscal 1994. Net sales during fiscal 1994 included substantial revenue from the
introduction of the Company's Er:YAG laser. Sales in fiscal 1995 of Nd:YAG
lasers, Er:YAG lasers and other laser products were adversely affected by the
lack of working capital to fund the purchase of inventory components (some of
which require a three month lead time to supply) and manufacturing operations,
and the limited availability of optical fibers for the Er:YAG laser. The
decrease in sales of these products was partially offset by a general increase
in sales of the Company's other products.
Cost of sales decreased 25.9% to $1,298,420 in fiscal 1995 from $1,753,352
in fiscal 1994. This decrease was primarily attributable to reduced expenditures
of raw materials resulting from lower sales.
Selling and marketing expenses decreased 4.7% to $1,035,863 in fiscal 1995
from $1,087,461 in fiscal 1994.
Research and development expenses increased 52.7% to $1,035,705 in fiscal
1995 from $678,279 in fiscal 1994 primarily due to increased efforts directed
towards dental hard tissue clinical trials and the initial development efforts
associated with two potential products.
General and administrative expenses increased 32.1% to $1,747,090 in fiscal
1995 from $1,322,888 in fiscal 1994. This increase was primarily due to expenses
incurred in connection with the Fiber Litigation, which were partially offset by
reductions in management compensation.
Net interest expense decreased 25.8% to $322,540 in fiscal 1995 from
$434,851 in fiscal 1994.
Net loss increased 19.1% to $3,808,485 in fiscal 1995 from $3,197,496 in
fiscal 1994. This increase reflected the decreased level of sales and an
increase in research and development and general and administrative expenses
during fiscal 1995. The net loss for fiscal 1995 included a net extraordinary
gain of $381,730 from the extinguishment of indebtedness.
LIQUIDITY AND CAPITAL RESOURCES
The Company's operations have been financed through the proceeds from the
sale of the Company's equity securities, including the IPO, revenues from
operations and the proceeds from an SBIR grant. The Company's principal capital
requirements include the financing of inventory, accounts receivable, research
and development activities, the development of an ophthalmic and a surgical
sales force, the development of marketing programs and the acquisition and/or
licensing of patents.
At March 31, 1996, the Company had a minimal cash balance and its working
capital was $5,818,492. This represents a reduction from March 31, 1995 of
$5,852,774 in cash and cash equivalents. The decrease in cash and cash
equivalents was the result of net cash used in operating activities of
$5,312,384 and cash used in investing activities of $540,694, including a
$195,971 increase in patent expenditures, a $219,723 addition to capital
equipment primarily for molds for new products and a $125,000 note receivable
from International Biolaser Corporation.
At March 31, 1996, the Company's indebtedness consisted of a $481,195 note
payable to Pfizer HPG due in three installments commencing with a $240,598
principal reduction, plus accrued interest, in July 1996 and $120,299 quarterly
payments in October 1996 and January 1997. Upon completion of this Offering, any
remaining unpaid principal and accrued interest becomes immediately due and
payable.
At March 31, 1996, the Company had net operating loss carryforwards for
federal income tax purposes totaling approximately $16,319,249 which will begin
to expire in fiscal 2007. Net operating
19
<PAGE>
loss carryforwards for state income tax purposes totaling approximately
$7,895,167 at March 31, 1996 which will begin to expire in fiscal 1998. The Tax
Reform Act of 1986 includes provisions which may limit the net operating loss
carryforwards available for use in any given year if certain events occur,
including significant changes in stock ownership. Utilization of the Company's
net operating loss carryforwards to offset future income may be limited.
The Company has received from Silicon Valley Bank a commitment letter for a
credit facility ("the "Credit Facility") which would permit borrowings of up to
$1 million based on the value of the 1,150,000 shares of common stock of Mattan
Corporation (the "Mattan Shares") held by the Company. Borrowings under the
Credit Facility would be secured by the Mattan Shares, would bear interest at
the rate of 1.0% per annum over the prime rate of interest, and would be due and
payable in November 1996. The commitment letter also provides for the issuance
of warrants to the lender. There can be no assurance that the Company will enter
into a definitive agreement with respect to the proposed Credit Facility on
these or any other terms.
The Company's future capital requirements will depend on many factors,
including the progress of the Company's research and development activities, the
scope and results of preclinical studies and clinical trials, the costs and
timing of regulatory approvals, the rate of technology advances by the Company,
competitive conditions within the medical laser industry, the establishment of
manufacturing capacity and the establishment of collaborative marketing and
other relationships which may either involve cash infusions to the Company, or
require additional cash from the Company. Management believes that short term
assets, cash generated through expected future revenues and SBIR grants and the
net proceeds of this Offering will be adequate to satisfy its working capital
needs for at least the next 24 months. After that period the Company's ability
to meet its working capital needs will be dependent on its ability to achieve a
positive cash flow from operations and profitable operations, in addition to its
ability to secure additional debt or equity financing. No assurance can be given
that the Company will be able to achieve a positive cash flow from operations,
profitable operations or secure financing on acceptable terms.
SEASONALITY OF BUSINESS
To date, the Company's revenues have typically been significantly higher in
the second and fourth calendar quarters. This seasonality reflects the timing of
major medical and dental industry trade shows in these quarters, significantly
reduced sales during the summer and the effect of year end tax planning
influencing the purchasing of capital equipment for depreciation during the
fourth calendar quarter. The Company expects that this seasonality will continue
indefinitely.
GOVERNMENT GRANTS
The Company has been awarded a SBIR grant for approximately $750,000 for the
study of laser cataract emulsification. Approximately $250,000 of this amount
was drawn at March 31, 1996, and an additional approximately $398,000 has been
drawn since that date. The remainder of the grant can be drawn over the next six
months upon the achievement of specified criteria. The Company has also applied
for new Phase I research grants related to dentistry, orthopedics, tissue
melding, and ophthalmology. No assurance can be given that the Company will be
awarded any of these potential government grants.
POTENTIAL FUTURE CHARGE TO INCOME
The Commission has adopted a position with respect to arrangements such as
the one entered into among the Company and the holders of its outstanding Class
E-1 and Class E-2 Common Stock ("Escrow Shares") which provides that in the
event any shares are released from escrow to certain persons who are officers,
directors, employees or consultants of the Company, compensation expense will be
recorded for financial reporting purposes. Accordingly, the Company expects, in
the event of the release of the Escrow Shares from escrow, to recognize
substantial noncash charges to earnings during the periods in which the criteria
for release of the Escrow Shares are met, which would have
20
<PAGE>
the effect of significantly increasing the Company's loss or reducing or
eliminating earnings, if any, at such time. The recognition of such compensation
expense by the Company may have a depressive effect on the market price of the
Company's securities.
The Escrow Shares will be automatically converted into Common Stock (at a
conversion rate of one share of Common Stock for each Escrow Share) in the event
that the Company meets certain criteria relating to the market price of the
Common Stock or the achievement by the Company of certain levels of "income," as
defined. Different criteria relate to the Class E-1 Common Stock and Class E-2
Common Stock. For these purposes, "income" means the Company's net income before
provision for income taxes, including earnings from joint ventures, distribution
agreements and licensing agreements, but exclusive of any other earnings that
are classified as an extraordinary item, and exclusive of charges to income that
may result from conversion of the Escrow Shares into Common Stock, as stated in
the Company's financial statements audited by the Company's independent
accountants. See "Description of Securities -- Common Stock."
If none of the pretax net income or market price levels are attained, the
Escrow Shares, as well as any dividends or other distributions made with respect
thereto, will be cancelled. The pretax net income and market price levels were
determined by negotiation between the Company and the Company's underwriter for
the IPO and should not be construed to imply or predict any future earnings by
the Company or any increase in the market price of its securities. There can be
no assurance that such earnings and market price levels will be attained or that
any or all of the Escrow Shares will be converted into Common Stock.
21
<PAGE>
BUSINESS
OVERVIEW
Premier Laser Systems, Inc. develops, manufactures and markets several lines
of proprietary medical lasers, fiberoptic delivery systems and associated
products for a variety of dental, ophthalmic and surgical applications
principally for use in surgical centers and medical offices. The Company's
lasers and related products use the controlled application of thermal, acoustic
and optical energy to allow the physician or dentist to perform selected
minimally invasive procedures which, compared to conventional techniques not
involving the use of lasers, vaporize or sever tissue with minimal blood loss
and scarring, increase patient comfort and reduce patient treatment time and
treatment costs. To date, the Company has received clearance to market 19 models
of medical lasers, which are covered by 18 United States patents, 13 pending
United States patent applications, 11 foreign patents and 41 pending foreign
patents.
MARKET OVERVIEW
The use of laser technology in dentistry, ophthalmology and surgery involves
the controlled application of laser light to hard or soft tissue causing an
optical, thermal, acoustic or plasma interaction with the tissue. When applied
to tissue, the laser light is partially absorbed. This process of absorption
converts the light to heat, which in turn alters the state of the tissue. The
degree of tissue absorption varies with the choice of wavelength and is an
important variable in the application of laser technology in treating various
tissues. The laser energy can also form a gas bubble in a water medium which
provides an acoustic cutting effect as it bursts. The Company often uses its
proprietary delivery systems to control the relative proportions of acoustic,
thermal and optical energy applied to tissue resulting in enhanced cutting
effects. These delivery systems include flexible fiberoptics, waveguides,
articulated arms and micromanipulators which are used on a disposable or limited
reuse basis which the Company intends will provide a recurring revenue stream
for the Company. The Company's strategy is to target specific applications in
the dental, ophthalmic and surgical markets, where management believes that the
Company's technology and products have competitive strengths.
DENTAL AND PERIODONTAL MARKET
The current market for laser equipment in dental procedures is comprised of
soft tissue procedures, composite curing and teeth whitening. If clearance or
approval is obtained, this market may be expanded to include hard tissue and
cavity prevention procedures.
SOFT TISSUE. It is estimated that over 60 million periodontal procedures
are performed by dentists and periodontists annually in the United States, many
of which the Company believes can be addressed with laser technology. In a
clinical study involving more than 900 procedures, periodontists used the
Company's lasers during a new minimally invasive surgical technique used in lieu
of traditional periodontal flap surgery, for which technique the Company has
filed a patent application which is pending. The results demonstrated a
reduction in bacteria, improved periodontal pocket depth, minimal or no pain
when using the laser even without anesthesia, little or no prescription
medication following surgery and a substantial reduction in surgical time. This
study also demonstrated that the dental laser can also be used to treat early
gum disease, postponing or in some cases eliminating the need for conventional
periodontal surgery. While the Company has clearance to market six lasers for
soft tissue dental procedures, the Company focuses its marketing efforts on its
Aurora diode laser in this area. The Company's Aurora diode laser and Centauri
Er:YAG laser have been cleared to market for these soft tissue dental
procedures.
COMPOSITE CURING. Approximately 48% of all respondants in a recent survey
conducted by Clinical Research Associates use composites, an alternate material
to amalgams (gold and silver) for cavity filling. Composites are rapidly
replacing amalgams as the material of choice for restoration of cavities,
because they more closely match the color of teeth and because amalgams have
drawn increasing worldwide concern over safety due to the toxic gases which may
be released when the amalgams are removed from teeth. Composite fillings are
typically cured using a curing light which provides a broad spectrum of
wavelengths. The use of the argon laser for this application has been
22
<PAGE>
shown to result in a stronger restoration than composites cured by traditional
curing lights. The Company's argon lasers can also be used to cure the resins
used in placing veneers or to bond orthodontic brackets. The Company's Arago and
MOD argon lasers have received clearance for use in these applications.
TEETH WHITENING. In a recent survey conducted by Clinical Research
Associates, approximately 79% of dentists surveyed used light accelerated
bleaching materials with clinical success for teeth whitening. These materials
are traditionally applied at night over a six to eight week period to whiten a
patient's teeth while he or she sleeps. Lasers have been shown to facilitate the
use of these light sensitive materials in the dentist's office by accelerating
this process and resulting in an approximate three shade change in less than one
hour. The Company is currently conducting a marketing study with its Arago argon
laser for this application and has a 510(k) application pending before the FDA.
HARD TISSUE (CAVITY PREPARATION). The American Dental Association estimates
that more than 170 million hard tissue restorative procedures are performed each
year in the United States, many of which the Company believes could be addressed
by a dental laser which could reduce or eliminate the need for a high speed
dental hand drill, reduce the need for anesthesia and assist in the prevention
of dental caries. Potential dental laser applications for hard tissue procedures
include pit and fissure sealing, etching, caries removal and cavity preparation.
Based on user feedback from the Company's clinical sites, the Company believes
that the use of a laser in dentistry reduces the pain associated with various
traditional procedures performed with a dental drill. Although no lasers are
currently approved by the FDA for hard tissue procedures, the Company has
completed clinical trials to support its 510(k) application to the FDA for
clearance to market its Centauri Er:YAG laser on teeth. No assurance can be
given, however, that the FDA will not require the Company to submit a PMA
application for this use, or require the Company to conduct additional clinical
trials.
CAVITY PREVENTION. Studies performed by an outside university on human
extracted teeth have demonstrated that lasers used in conjunction with fluoride
treatments can be highly effective in the prevention of cavity formation. The
Company is currently initiating clinical trials to use its lasers for cavity
prevention applications. The Company's clinical trials are at an early stage and
there can be no assurance that the Company will obtain clearance for these
applications.
OPHTHALMIC MARKET
Lasers have been used for the treatment of eye disorders for many years and
are widely accepted in the ophthalmic community. The original and most widely
accepted use of lasers in ophthalmology has been for posterior capsulotomy. The
Company does not promote its lasers for this market, which it believes is
approaching saturation, but instead focuses on intraocular procedures including
anterior capsulotomy, cataract removal, glaucoma treatment, corneal sculpting
and occuloplastic or cosmetic procedures. The Company has developed the Centauri
Er:YAG laser which is capable of performing all of these procedures, which are
typically performed using several different types of medical lasers, although to
date, the Centauri laser has only been cleared for use in anterior capsulotomies
and certain cosmetic procedures.
CATARACT REMOVAL PROCEDURES. According to the American Society of Cataract
and Refractive Surgeons, approximately two million cataract extraction
procedures are performed annually in the United States. The Company believes
that no lasers have been approved to date for this application, and that lasers
may result in less trauma and inflammation than traditional surgical methods,
providing more comfort to the patient. The Company's Centauri Er:YAG laser has
been cleared to market for anterior capsulotomy, a procedure which opens the
capsule of the eye prior to the removal of the cataract. The Company is also
currently conducting clinical trials on the Centauri laser for lens
emulsification (the removal of the cataract itself), as an alternative to
phacoemulsification (the breakup of the cataract by ultrasonic energy). The
Company believes this patented technology for use in lens emulsification may
provide an easier and safer method of cataract removal.
23
<PAGE>
TREATMENT OF GLAUCOMA. According to the National Institutes of Health, in
1995, approximately three million people in the United States suffered from
glaucoma, a disease of the eye characterized by increased intraocular pressure
within the eyeball and progressive loss of vision. Traditionally, glaucoma has
been treated with drug therapy. When drug therapy is ineffective, periodic
invasive surgery may be required. In these cases, lasers may be used to open the
sclera and relieve pressure in the eye. This procedure, which must be repeated
periodically, can be performed under local anesthesia with a self closing
incision on an outpatient basis. The Company is currently conducting clinical
trials to support investigational device exemption ("IDE") submittals for
clearance to market its Centauri Er:YAG laser for this procedure. If clearance
is obtained, concerning which there can be no assurance, the Company's Er:YAG
laser could provide a viable alternative to the traditional invasive surgical
procedures.
CORNEAL SCULPTING. Medical Insight, Inc. estimated in 1993 that 170 million
people in the United States suffered from vision disorders including
nearsightedness (myopia), farsightedness (hyperopia) and astigmatism. The
Company believes that the recent approval of excimer lasers has resulted in
greater acceptance and recognition of laser refractive surgery in the ophthalmic
market. Medical lasers may be used for corneal sculpting (photorefractive
keratectomy), a procedure in which the laser is used to sculpt the cornea of the
eye to a desired curvature to correct the myopia, hyperopia or astigmatism. The
Company plans to seek FDA approval to market the Centauri laser for corneal
sculpting and has initiated animal studies for this application. No assurance
can be given, however, that FDA approval will be given for this application.
SURGICAL MARKET
Lasers have been approved for and are currently being used in a variety of
surgical applications including orthopedics, neurosurgery, urology,
gastroenterology, ophthalmology, cardiology, dermatology, gynecology and plastic
surgery. Although the Company's products are cleared to market in a number of
specialty areas within the surgical market, the Company has specifically
targeted tissue melding (tissue fusion) and cosmetic applications within the
surgical market.
TISSUE MELDING. The suture, staple and wound closure market represented
approximately $2 billion worldwide in 1994. The Company believes a significant
number of these procedures may be addressed with surgical lasers in conjunction
with or independent of traditional sutures or staples. The clinically
demonstrated benefits of the use of surgical lasers for tissue melding, as
compared to suture and staples, include fluid-static seals, immediate strength
of the closure and reduced surgical time. The Company and its strategic partner
have conducted animal tests to support IDE submittals for the use of the
Company's Polaris Nd:YAG laser in the areas of arteries, veins, blood vessels
and ducts, and are currently conducting clinical studies for skin and
hypospadias. The Company has also completed clinical trials for vasovasotomy
(reversal of vasectomies) which demonstrated a success rate of approximately
89%. The Company is also beginning Phase I clinical trials for the treatment of
hypospadias, the lengthening of the urethra to the end of the penis in infant
boys, in which it is anticipated that the laser's fluid-static seal may minimize
post-surgical complications such as the leakage of urine which requires
secondary surgical procedures. The Company has clearance for Phase II clinical
trials for skin closure following mastectomies and eyelid surgery at five
clinical sites. Artery and vein anastomosis is being tested in animals by the
Company's strategic partner in Japan in preparation for clinical studies.
COSMETIC SURGICAL PROCEDURES. The market for cosmetic laser surgery is
growing rapidly worldwide. Medical Laser Insight, Inc. estimates the procedural
fees for the aesthetic facial surgery market in the United States was $775
million in 1992. The Company entered into a Purchasing Agreement and a Share
Exchange Agreement dated December 20, 1995 with Mattan Corporation ("Mattan"),
the parent corporation of Medical Laser Institute of America ("MLIA"), pursuant
to which the Company made an investment in and formed an alliance with MLIA.
Mattan owns and operates or provides marketing support for a series of medical
laser cosmetic surgery centers, which centers focus on
24
<PAGE>
wrinkle removal, treatment of varicose veins, acne scar removal, tattoo removal
and refractive surgery. Pursuant to these agreements, Mattan has agreed to
purchase all laser equipment, accessories and disposable laser products for use
in its laser centers exclusively from the Company until December 31, 2005. To
the extent the Company is unable to provide a requested laser to Mattan, the
Company will act as purchasing agent for Mattan and purchase the lasers from a
third party for resale to Mattan.
The Company has regulatory clearance to market its products for a variety of
additional applications, including urology, orthopedics, gynecology,
gastroenterology, podiatry, pulmonary and neurosurgery, among other areas. In
areas where the Company's technology is not being fully utilized, the Company
may seek agreements to supply its products under private label for other
manufacturers or may enter into strategic alliances to develop and market the
Company's lasers for other applications.
BUSINESS STRATEGY
The Company's strategy is to seek to increase its market penetration in the
dental, ophthalmic and surgical markets. Key elements of the Company's strategy
include the following:
FOCUS ON THE OFFICE AND SURGICAL CENTER MARKETS. Recognizing the cost
containment environment of the medical industry, the Company intends to focus on
clinical applications for lasers which may be performed in a surgical center or
medical office. Management believes that the Company's compact and portable
lasers offer cost efficiencies and can be used to take advantage of industry
trends which favor minimally invasive medical procedures.
INCREASE DOMESTIC MARKETING AND ACCEPTANCE OF LASER TECHNOLOGY. The Company
intends to expand its domestic marketing organization through additional sales
representatives and distributors to target the dental, ophthalmic and surgical
markets in the United States. The Company also intends to continue to implement
a doctor awareness and education program to address the individual doctor's
training, practice management and marketing needs. The Company believes
increased publicity and additional publications are essential to educate
dentists, physicians and patients about the clinical benefits of medical lasers.
EMPHASIZE EXPANSION IN INTERNATIONAL MARKETS. Foreign sales account for a
substantial portion of the Company's revenues and the Company intends to devote
additional resources to expand the worldwide marketing of its products,
particularly in the Pacific Rim and Europe. The Company anticipates substantial
growth opportunity in these markets and will seek to enter into marketing
arrangements with recognized distributors who will aggressively market and
service the Company's products in each region. Such expansion may include
potential acquisitions of businesses which have a marketing presence in Europe
and the Pacific Rim. There are no present negotiations or agreements with
respect to any acquisitions, and no assurance may be given that the Company will
be able to identify or consummate any such acquisitions.
EXPAND CLINICAL APPLICATIONS FOR PROPRIETARY LASER TECHNOLOGY. The Company
manufactures lasers which are multidisciplinary in their surgical applications
and multifunctional in the specific procedures for which they have been cleared.
The Company holds 18 United States patents and 11 foreign patents, and has
pending 13 United States patents and 41 foreign patents. The Company intends to
expand its proprietary laser technology by developing and marketing lasers for
selected additional applications, which may include corneal sculpting, hard
tissue (teeth and bone) cutting, teeth whitening procedures and tissue melding
applications, subject to FDA approval or clearance.
CAPITALIZE ON DISPOSABLE AFTERMARKET SALES. The Company manufactures a
variety of disposable fiberoptic delivery systems and sculpted fiberoptic
probes, optical tips, waveguides and catheters which are designed for
single-patient use. The unique design of the Company's lasers, including the
patented connecters, encourages the users of the Company's products to purchase
the compatible disposable products distributed by the Company. The Company
believes that the increasing demand
25
<PAGE>
for product sterility and cost containment will result in an increase in
disposable product sales and will provide a recurring revenue stream. The
Company intends to market these products to existing customers, as well as to
hospital administrators on a custom basis for other surgical lasers.
DEVELOP NEW MARKETS THROUGH STRATEGIC ALLIANCES. The Company intends to
establish strategic alliances in order to expedite and lower the cost of
developing and bringing to market new products in current markets and existing
products in new markets. The Company believes a substantial potential market
exists for its laser technology and products both inside and outside the dental,
ophthalmic and surgical markets. Strategic alliances could accelerate the
Company's efforts to expand in several key areas including, but not limited to,
tissue melding, bone shaping, removal of bone cement and disectomy in
orthopedics, photo dynamic therapy, revascularization of the heart and
interstitial treatment of the prostate. The Company plans to seek strategic
alliances to develop additional clinical applications and markets. Pursuant to
this strategy, the Company entered into an Exclusive Marketing Agreement dated
July 26, 1994 with Nippon Shoji Kaisha, Ltd. ("NSK") to distribute the Company's
Polaris Nd:YAG laser for tissue melding applications in Japan, China and Taiwan,
subject to receipt of regulatory approval. The Company also entered into a
letter agreement dated October 19, 1995 to form a strategic alliance with
International Biolaser Corporation ("IBC") to manufacture and distribute the MOD
argon laser for dental use pursuant to the Company's joint marketing
relationship with IBC.
26
<PAGE>
LASER PRODUCTS
The Company's line of portable lasers are specifically designed for use in
outpatient surgical centers and medical offices. The Company believes that its
lasers are also well suited for the international market, particularly in
facilities with many surgical suites where easy transportation of equipment is
necessary. By employing techniques developed in the computer industry, the
Company has designed a laser system that (i) is modularly designed and uses
similar components for multiple laser systems thereby reducing their overall
cost, (ii) allows for efficient and inexpensive repair by replacing a board or
assembly in the field or through the mail, reducing the need for a field service
force, and (iii) can be easily moved from the office to surgical centers because
of its compact size and limited voltage requirements. The Company's Er:YAG
lasers are currently priced from $35,000 to $115,000 and its Nd:YAG lasers are
currently priced from $25,000 to $80,000. The Company's diode lasers are
currently priced from $20,000 to $30,000, its argon laser is priced from $8,000
to $20,000 and its CO(2) lasers are currently priced from $5,500 to $20,000. The
prices of lasers within these ranges depend upon each model's power capability
and the features offered.
The following table presents in summary form, the Company's lasers and
delivery systems, the principal applications for which the Company intends to
use them, and the FDA status of such products.
<TABLE>
<CAPTION>
PRODUCT MEDICAL APPLICATION FDA REGULATORY STATUS
- ----------------------------- ----------------------------------------------------------- ----------------------
<S> <C> <C>
Centauri (Er:YAG) Dental -- Soft Tissue...................................... Cleared to market
Dental -- Hard Tissue...................................... Clinical trials
completed
Pending 510(k)
Ophthalmology (e.g. Anterior Capsulotomy).................. Cleared to market
Ab-externo and Ab-interno Sclerostomy, Laser Lens
Emulsification............................................ Clinical trials
Corneal Sculpting.......................................... Preclinical animal
studies
General Surgery, Neurosurgery, Orthopedics,
Gastrointestinal and Genitourinary Procedures, Urology,
Gynecology and Oral Surgery............................... Cleared to market
Pegasus (Nd:YAG) 20W Dental -- Soft Tissue...................................... Cleared to market
Polaris (1.32m Nd:YAG) Tissue Melding............................................. Clinical trials
General Surgery, Ophthalmology, Arthroscopic Surgery,
Gastrointestinal and Genitourinary Procedures, Urology,
Gynecology and Oral Surgery............................... Cleared to market
Aurora (diode) Dental -- Soft Tissue...................................... Cleared to market
Dental and General Surgery, Ophthalmology, Arthroscopic
Surgery, Gastrointestinal and Genitourinary Procedures,
Urology, Dermatology, Plastic Surgery, Podiatry,
Neurosurgery, Gynecology, Pulmonary Surgery and Oral
Surgery................................................... Cleared to market
Arago and MOD (argon) Dental -- Composite and Resin Curing....................... Cleared to market
Dental -- Teeth Whitening.................................. Pending 510(k)
</TABLE>
CENTAURI ER:YAG LASER
The Company's Centauri Er:YAG laser is a portable Er:YAG pulsed solid state
laser which generates high frequencies (up to 30Hz) at relatively low peak
power. These high frequencies allow faster cutting at lower energies. The 2.9
micron wavelength of the Er:YAG is highly absorbed by water,
27
<PAGE>
producing a cut similar to the scalpel. The Er:YAG wavelength is delivered
through a fiber optic delivery system which enables the beams to be focused and
angled. These fiberoptic catheters are difficult to produce and the Company has
invested heavily in the technology to develop fibers which can handle adequate
power. The Company has experienced difficulties in securing a consistent source
for these fibers in the past, although it has recently procured two new sources
for these fibers. See "-- Legal Proceedings" and "Risk Factors -- Dependence on
Suppliers."
The Company's Centauri Er:YAG laser has many potential applications in
different medical specialties, including cutting hard tissue such as bone and
teeth, which could replace or minimize the use of noisy, high speed dental hand
drills, and removing ocular structures or performing microsurgery with minimal
thermal damage. Although presently marketed only for soft tissue dental
procedures and anterior capsulotomy, the Centauri laser also has clearances to
market for hemostasis, excision and vaporization of tissues in ophthalmology,
general surgery, neurosurgery, orthopedics, gastroenterology, urology,
gynecology and oral surgery. See "-- Government Regulation." The Centauri laser
is highly effective in cataract ophthalmic procedures because its wavelength is
at the peak of the water absorption spectrum and water comprises greater than
60% of ophthalmic tissues. Therefore, the Centauri laser can emulsify cataracts,
surgically excise tissue in the treatment of glaucoma and can precisely remove
layers of cornea similarly to an excimer laser. This system, which currently is
cleared for anterior capsulotomy and other procedures in ophthalmology, is
estimated to be available for approximately one-third the price of refractive
excimer lasers currently on the market and requires substantially lower
maintenance costs than excimer lasers (an estimated annual expense of $10,000 as
compared to approximately $70,000). In addition, the multiple application
Centauri Er:YAG laser is completely portable, does not emit any toxic gases or
cause any potentially mutagenic effect which may result from the use of the
excimer laser.
The Company has recently introduced what it believes to be the industry's
first fully-integrated Er:YAG laser system for ophthalmic procedures. The new
system incorporates the Centauri Er:YAG laser and provides the option of either
a bi-manual or coaxial, uni-manual handpiece to accommodate an individual
physician's technique. The Company has also recently introduced a new
irrigation/ aspiration product for use in conjunction with the Centauri system,
which integrates with the laser in performing the cataract removal procedure,
and includes proprietary vacuum monitoring connectors that create a sterile
aspiration line.
While animal studies have been encouraging, there can be no assurance that
the FDA will approve the use of the Company's Centauri laser for corneal
sculpting, or that the laser will work effectively in clinical trials. Clinical
trials are estimated to continue for two to five years before approval can be
sought in the United States. There are several patents pending on this
technology and application, although no assurances can be given that these
patents will be approved or approved with the current claims.
POLARIS AND PEGASUS ND:YAG LASERS
The energy of Nd:YAG lasers is absorbed by blood in tissue and as a result
these systems are the preferred lasers to limit bleeding during surgery and for
procedures requiring fiberoptic delivery, such as laparoscopic surgery. The
Nd:YAG fiberoptic delivery system allows the surgeon to perform surgery through
small incisions, providing minimally invasive surgery to patients and usually
reducing treatment costs and the length of hospital stays.
The Company manufactures a variety of continuous wave solid state Nd:YAG
lasers which are designed for use in dentistry and a number of medical
specialties. The Company received its first clearance to market a continuous
wave Nd:YAG laser system for dental (soft tissue) applications and introduced
its 20 watt dental Pegasus Nd:YAG laser in February 1992. The Company also
manufactures 40, 60 and 100 watt Pegasus Nd:YAG lasers which have clearance to
market for various applications and procedures in general surgery, urology,
gastrointestinal procedures, pulmonary procedures, gastroenterology, gynecology
and ophthalmology.
28
<PAGE>
These lasers also utilize the Company's disposable and reusable unique
TouchTIPS, AngleTIPS and sculptured fibers. By using the Pegasus laser with
TouchTIPS, the surgeon is allowed direct contact with tissue and the tactile
feeling of the scalpel or other surgical instruments. The Company believes that
the availability of these technologies permits the use of lower power laser
systems (20 watt in dental, 40-60 watt in surgery).
In December 1993, the Company entered into an Asset Purchase Agreement with
Proclosure, pursuant to which the Company acquired from Proclosure the
proprietary rights, including several patents, to manufacture and sell the
Polaris laser, a 1.32 micron Nd:YAG laser (except in Japan, China and Taiwan),
together with specialized software and delivery systems, for tissue melding. The
Company is developing the Polaris laser for use in cosmetic skin closures,
vascular surgeries and minimally invasive surgical procedures normally performed
with sutures and staples. Although the use of the Polaris laser for tissue
melding is still in the development stage, and no clearance for this application
has been received, the Company believes that tissue melding offers clinical
advantages over traditional sutures and staples.
AURORA DIODE LASER
The Aurora diode laser is the Company's first semiconductor laser and is the
first truly portable diode laser designed for dentistry. The Aurora diode laser
replaces the 20 watt Pegasus laser for periodontal procedures, and is one-fourth
the size and one-half of the cost of that system. The diode wavelength is
absorbed by blood in pigmentation and has been cleared for use in multiple
specialties such as general surgery, ophthalmology, urology and plastic surgery.
The Aurora laser, which was introduced for soft tissue dental applications in
February 1996, is designed to utilize the Nd:YAG delivery systems, including
TouchTIPS, AngleTIPS and sculptured fibers, for soft tissue surgery with minimal
bleeding or anesthesia. The dental laser can also be used to treat early stage
gum disease, postponing or in some cases eliminating the need for periodontal
surgery and providing the opportunity for overall cost savings. The Company
believes the Aurora laser compares favorably with competitive products including
pulsed Nd:YAG lasers, which cannot produce the required laser settings for use
with TouchTIPs, or in the new technique for the treatment of periodontal
disease, as well as with CO(2) lasers (which cannot be delivered through a
fiber), and argon lasers (which tend to be slower in cutting and may produce
charring).
ARAGO AND MOD ARGON LASERS
The Arago and the MOD are argon gas lasers which have been cleared to market
in dentistry to accelerate the composite curing process. Composites are rapidly
replacing amalgams (gold and silver) as the material of choice for the
restoration of cavities. The argon wavelength penetrates through the composite
and has been shown to result in a stronger restoration than composites cured by
traditional curing lights. The Company's argon lasers can also be used to cure
the resins used in placing veneers or bonding orthodontic brackets.
The argon laser can also be used to enhance teeth whitening procedures using
light activated bleaching materials which have traditionally been applied at
night over a six to eight week period. Lasers have been shown to facilitate the
use of these light activated products in a dentist's office by accelerating this
process and resulting in an approximate three shade change in less than one
hour. The Company currently has a pending 510(k) for this application. No
assurance may be given, however, that the Company will be granted clearance to
market this laser for teeth whitening or that the use of the argon laser for
teeth whitening will become a widely accepted practice in the dental industry.
The Company plans to bundle its lasers with light activated whitening materials
and co-market these products with the manufacturers of these materials.
The MOD argon laser is manufactured by the Company pursuant to a letter
agreement dated October 19, 1995 with IBC which creates a joint marketing
relationship for the sale of this product. Pursuant to this agreement, the
Company has loaned IBC $125,000 and has the right to designate one member of
IBC's Board of Directors. The Company has also entered into a distribution
agreement dated March 8, 1996 with Lasermed, Inc., pursuant to which the Company
obtained the co-exclusive
29
<PAGE>
right to market the portable lightweight Arago argon laser. This agreement
terminates in August 1996. The Company will seek to extend this agreement or, if
no extension can be obtained on acceptable terms, to find an alternative source
for the argon laser, concerning which no assurance can be given. The Company's
inability to extend the agreement or find a suitable replacement product could
have a material adverse effect on the Company's business, results of operations
and financial condition.
ALTAIR CO(2) LASERS
The CO(2) laser was the first available and the early standard in surgical
laser applications. The 10.6 micron wavelength generated by the CO(2) laser is
absorbed by water in tissue. The CO(2) laser acts like a surgical scalpel to
vaporize tissue with minimal blood loss and scarring. The risk of infection is
reduced by thermal sealing of blood and lymphatic vessels in the adjacent
tissues. The characteristics of the CO(2) laser have provided a wide variety of
medical specialists a modality of treatment that has significantly changed
conventional invasive surgery in a number of clinical specialties.
The Company's hand-held 10 and 20 watt CO(2) lasers acquired from Pfizer
Laser are marketed primarily for office use by podiatrists, dermatologists,
orthopedists, dentists and gynecologists. The laser weighs less than 40 pounds
and packs in a suitcase. The Company and Pfizer Laser have sold a number of
these lasers and the Company continues to provide service and support for these
products. To expand its CO(2) laser product line, the Company has designed 35
watt and 65 watt Altair CO(2) lasers for hospital based surgeries. These lasers
are portable, and laser energy may be delivered through a waveguide arm,
reusable or disposable handpieces or more maneuverable flexible waveguide
delivery systems.
OTHER LASERS
The Company has developed other solid state pulsed lasers including the
Sirius .532m Nd:YAG laser and the Orion Ho:YAG laser, and other applications for
its existing lasers, but is not actively marketing these lasers at the present
time. The following table sets forth in summary form, certain additional lasers
owned by the Company which are not currently marketed by the Company, and the
principal applications for which the Company has clearance to market such
lasers.
<TABLE>
<CAPTION>
PRODUCT MEDICAL APPLICATION FDA REGULATORY STATUS
- ----------------------------- ----------------------------------------------------------- ----------------------
<S> <C> <C>
Altair (CO(2)) and a CO(2) Orthopedics, General and Plastic Surgery, Dermatology,
laser acquired from Pfizer Podiatry, Ear, Nose and Throat, Gynecology, Pulmonary
HPG Procedures, Neurosurgery and Ophthalmology................ Cleared to market
Dental -- Soft Tissue...................................... Cleared to market
Pegasus (Nd:YAG) 40W/60W General Surgery, Urology, Gastrointestinal Procedures,
Pulmonary Procedures, Gastroenterology, Gynecology and
Ophthalmology............................................. Cleared to market
Pegasus (Nd:YAG) 100W Oral, Arthroscopic and General Surgery, Gastroenterology,
Gastrointestinal and Genitourinary Procedures, Pulmonary
Procedures, Gynecology, Neurosurgery and Ophthalmology.... Cleared to market
Sirius (.532m Nd:YAG) Dermatology, General and Plastic Surgery, Podiatry and
Orthopedic Applications................................... Cleared to market
Orion (Ho:YAG) General Surgery, Orthopedics, Ear, Nose and Throat,
Ophthalmology, Gastroenterology, Pulmonary Procedures and
Urology................................................... Cleared to market
Er:YAG/Nd:YAG combination Various specialties........................................ Cleared to market
</TABLE>
30
<PAGE>
DELIVERY SYSTEMS AND DISPOSABLE PRODUCTS
An integral part of any laser system is the means of delivering laser energy
to the target tissue. Delivery systems commonly employed in laser surgery
include flexible fiberoptics, waveguides, articulated arms and
micromanipulators. The Company's proprietary delivery systems control the
relative proportions of acoustic, thermal and optical energy applied to tissue
resulting in enhanced cutting efforts. Flexible fibers are a preferred method of
delivery for most clinical procedures, but until recently were only available
for Nd:YAG and argon lasers. The end of a fiber may be shaped or used with a
detachable tip to control the mechanism of laser/tissue interaction, to give a
tactile feel, to provide certain mechanical effects and to angle or focus the
laser beam. The Company has also been granted a perpetual paid-up license to
manufacture, use and sell flexible waveguides to deliver CO(2) energy pursuant
to the Assignment and Modification Agreement dated July 26, 1991 among the
Company, Pfizer HPG and Medical Laser Technologies Limited.
While each laser system marketed by the Company consists of a laser and an
integral fiber, these fibers and other products, such as tubing sets, are used
by surgeons on a disposable or limited reuse basis for each clinical procedure.
The Company believes that expansion into this market could provide it with a
recurring revenue stream. The Company manufactures a variety of fiberoptic
delivery systems, sculpted fiberoptic probes, optical tips (AngleTIPS and
TouchTIPS), waveguides and catheters which are designed for single-patient use.
The patented connectors and need for product sterility encourage the users of
the Company's lasers to purchase only products which are compatible with this
system. The Company believes it can sell these products on a custom basis to
hospital administrators for other surgical laser systems at a significant
discount to competitors' published prices, while maintaining gross margins
through vertical integration and the extensive use of molds and tooling. The
Company also assembles and distributes a full line of laser accessories,
including glasses, goggles, laser signs and smoke evacuators.
MARKETING, SALES AND SERVICE
MARKETING AND SALES
The Company markets its products to the dental market in the United States
directly to dentists and periodontists through its direct sales force consisting
of five area sales managers and its recently expanded distributor and
manufacturer's representative network consisting of more than 25 people. The
Company markets its products primarily through conventions, educational courses,
direct mail, telemarketing and other dental training programs. In March 1994,
the Company entered into a sales and marketing arrangement for its dental lasers
with Burkhart Dental Supply Company, a member of the American Dental
Cooperative, Inc., which is one of the largest distributors of dental equipment
and supplies in the United States. This agreement is terminable by either party
at any time. If this strategic alliance is successful, the Company believes this
relationship may be expanded to the other members of the American Dental
Cooperative, Inc. which markets dental products to a significant number of the
approximately 129,000 practicing dentists in the United States. Such alliance is
expected to assist the Company if the Company receives clearance to market the
Centauri laser for hard tissue applications. The Company has also entered into a
joint marketing relationship with IBC, pursuant to which IBC will provide
marketing and technical support for the MOD argon laser.
Through an active program of educational courses and preceptorships, the
Company has trained dentists in ten countries during the past year using
industry recognized dentists and periodontists. In the past two years, more than
20 dental papers have been presented by the Company or clinicians using the
Company's products.
The Company markets its products in the ophthalmic market through two direct
sales managers who focus on sales to key ophthalmologists worldwide. The Company
has entered into Distribution Agreements with distributors in nine countries in
preparation for market introduction of the Centauri laser during calendar 1996.
The Company grants exclusive distribution rights in select territories to its
distributors who must maintain certain distribution minimums in order to retain
31
<PAGE>
their exclusive rights. The Company plans to expand its ophthalmic sales force
both by enlarging its domestic sales force, either internally or through
acquisition, and by acquiring or engaging additional international manufacturing
representatives.
In the surgical market, the Company intends to form strategic alliances in
any specialty area where the partner has an established presence in the market
selling to either the physician or the hospital. The Company has entered into
such a strategic alliance with NSK, one of the leading suppliers of sutures in
the Pacific Rim, pursuant to an Exclusive Marketing Agreement. Under this
agreement, Proclosure granted to NSK the exclusive rights to market and
distribute this Nd:YAG laser, and the Company granted manufacturing rights to
the Polaris, in Japan, China and Taiwan in exchange for a license fee to
Proclosure for the marketing rights and a $1.5 million fee and royalties to the
Company which is payable if NSK elects to manufacture the Polaris laser. NSK is
not required to and has not yet indicated whether it intends to manufacture
these products. There can be no assurance that the Company will receive any
payments under this agreement.
Sales to one customer in fiscal 1996 accounted for 10% of the Company's net
sales for that year. Sales to a different customer in fiscal 1995 accounted for
approximately 11% of the Company's net sales for that year.
CUSTOMER SERVICE AND SUPPORT
The Company is seeking to create a group of loyal customers by focusing on
customer service, quality and reliability. In addition to its educational
courses, the Company performs a complete installation of its lasers and trains
the customers' staff in its proper use. Educational videos and papers are
available upon request. The Company conducts service training courses for the
representatives of its distributors. Prior to shipping, every laser is subjected
to an extensive battery of quality control tests. The Company provides a one
year warranty with all lasers and extended warranties are available at an
additional cost. The Company generally provides service within one business day
to all of its customers in the United States. An owner is either sent a loaner
laser by overnight carrier or a service representative visits the owner to
repair the unit. International service is provided either by the foreign
distributor or by return of the laser to the Company. The Company has
experienced and may continue to experience difficulties in providing prompt and
cost-effective service of its medical lasers in foreign countries.
COMPETITION
The Company is and will continue to be subject to competition in its
targeted markets, principally from businesses providing other traditional
surgical and nonsurgical treatments, including existing and developing
technologies or therapies, some of which include medical lasers manufactured by
competitors. In the dental market, the Company competes primarily with dental
drills, traditional curing lights and other existing technologies, and to a
lesser extent competitors' CO(2), argon, Er:YAG and Nd:YAG lasers. In the
ophthalmic market, the Company is subject to competition principally from the
(i) traditional surgical treatments using a needle to tear a circle in the
anterior capsule, (ii) phacoemulsification, an ultrasound device used to break
up cataracts in cataract removal procedures, (iii) corrective eyewear (such as
eyeglasses and contact lenses) and surgical treatments for refractive disorders
such as photorefractive keratectomy which is typically performed with an excimer
laser and radial keratotomy which is performed with a scalpel, and (vi) drug
therapy or surgical treatment of glaucoma. In the surgical market, wound closure
procedures are usually performed using sutures and staples, and traditional
cosmetic surgical procedures may be performed with a scalpel or a CO(2) laser.
The Company believes that for many applications its proprietary methods and
fiberoptic delivery systems provide clinical benefits over other currently known
technologies and competitors' laser products.
The medical laser industry in particular is also subject to intense
competition and rapid technological changes. The Company believes that the
principal competitive factors in the medical laser industry are the products'
technological capabilities, proven clinical ability, patent protection, price
and scope of regulatory approval, as well as industry expert endorsements. Many
conventional laser
32
<PAGE>
systems target one particular application, while the Company's Er:YAG system is
designed to perform in multiple therapeutic applications. The Company's
self-contained units are significantly smaller than competitive surgical models,
have internal cooling devices and are powered primarily by dedicated readily
available 110 volt lines instead of the 220 volt lines used by most surgical
solid state lasers. The specialized menu-driven system software utilized in the
Company's lasers also enhances safety and ease of use of the lasers.
The Company believes that its ability to compete successfully against
traditional treatments, competitive laser systems and treatments that may be
developed in the future will depend on its ability to create and maintain
advanced technology, develop proprietary products, obtain required regulatory
approvals and clearances for its products, attract and retain scientific
personnel, obtain patent or other proprietary protection for its products and
technologies, and manufacture and successfully market products either alone or
through other parties. Certain of the Company's competitors have substantially
greater financial, technical and marketing resources than the Company. There can
be no assurance that such competition will not adversely affect the Company's
results of operations or its ability to maintain or increase market share.
RESEARCH AND DEVELOPMENT
During the last two fiscal years, the Company has invested an aggregate of
approximately $2.5 million in research and development programs. The Company's
research and development programs have capitalized on the research and
development activities conducted by Pfizer Laser wherein that company identified
key military and aerospace technologies and adapted these technologies to
portable, efficient, solid-state laser products that were modular in nature.
This investment in research and development has resulted in the development of
19 models of lasers, more than 1,000 types of custom delivery systems and
approximately 20 types of surgical tips and accessories. Approximately 41% of
the Company's net sales for fiscal 1996 were derived from sales of three new
lasers introduced during the last six months of that year. Five more lasers or
related products are scheduled for introduction in fiscal 1997, subject to
receipt of clearance to market such products, for which no assurance may be
given.
In order to maintain its technological advantage, the Company must continue
to invest in new product development. The Company seeks to augment its funding
of research and development through government grants. The Company has been
awarded a Phase II SBIR grant of $750,000, of which approximately $648,000 has
been drawn to date and the remainder of which can be drawn over the next six
months to fund additional research and clinical trials regarding laser
emulsification of cataracts. The Company has also applied for new Phase I
research grants related to dentistry, orthopedics, tissue welding, and
ophthalmology. No assurance can be given that the Company will be awarded any of
these potential government grants.
The Company's current research is focused on expanding the clinical
applications of its existing products, reducing the size and cost of current
laser systems, developing custom delivery systems and developing new innovative
products. The Company's in-house research and development efforts have focused
on the development of a systems approach to medical laser products with
proprietary delivery systems designed to allow the laser to interact with tissue
by a number of different mechanisms (e.g., acoustic, ablative and thermal) for
unique laser/tissue effects. These disposable fiberoptic delivery systems,
developed specifically for niche surgical applications, demonstrate the
principal focus of the Company's research efforts. Examples of patented or
patent pending products resulting from these research efforts include:
TouchTIPS, AngleTIPS, Er:YAG fiberoptics and CO(2) waveguides. Clinical research
has also yielded several new surgical procedures.
PATENTS AND PATENT APPLICATIONS
Patent protection is an important part of the Company's business strategy,
and the Company's success depends, in part, on its ability to maintain patents
and trade secret protection and on its ability to operate without infringing on
the rights of third parties. The Company has sought to protect
33
<PAGE>
its unique technologies and clinical advances through the use of the patent
process. Patent applications filed in the United States are frequently also
filed in selected foreign countries. The Company focuses its efforts on filing
only for those patents which the Company believes will provide it with key
defensible features instead of filing for all potential minor device features.
The Company holds 18 U.S. patents and has other patent applications pending in
the United States, including divisional applications. In addition, the Company
holds 11 foreign patents including two utility model patents and has other
foreign patent applications pending. No assurance can be given that any
additional U.S. or foreign patents will be issued, that the scope of any patent
protection will exclude competitors or that any of the Company's patents will be
held valid if subsequently challenged. The Company also has a nonexclusive
license to a number of basic laser technologies which are commonly licensed on
such basis in the laser industry.
The Company's success will depend in part on its ability to obtain patent
protection for its products and processes, to preserve trade secrets and to
operate without infringing the rights of others. The Company is aware of certain
patents which, along with other patents that may exist or be granted in the
future, could restrict the Company's right to market certain of its technologies
without a license, including, without limitation, patents relating to the
Company's lens emulsification product and ophthalmic probes for its Er:YAG
laser. In the past, the Company has received allegations that certain of the
Company's laser products infringe other patents. There has been significant
patent litigation in the medical industry in general, and in the medical laser
industry in particular. Adverse determinations in litigation or other patent
proceedings in which the Company may become a party could subject the Company to
significant legal judgments or liabilities to third parties, and could require
the Company to seek licenses from third parties that may or may not be
economically viable. Patent and other intellectual property rights disputes
often are settled through licensing arrangements. No assurance can be given that
any licenses required under these or any other patents or proprietary rights
would be available on terms acceptable to the Company, if at all. If the Company
does not obtain such licenses, it could encounter delays in product
introductions while it attempts to design around such patents, or it could find
that the development, manufacture or sale of products requiring such licenses
could be enjoined. If the Company is found, in a legal proceeding, to have
infringed the patents or other proprietary rights of others, it could be liable
for significant damages. The Company also relies on unpatented trade secrets,
and no assurance can be given that others will not independently develop or
otherwise acquire substantially equivalent trade secrets.
GOVERNMENT REGULATION
FDA REGULATION
The lasers that are manufactured by the Company are regulated as medical
devices by the FDA under the FDC Act. Satisfaction of applicable regulatory
requirements may take several years and requirements vary substantially based
upon the type, complexity and novelty of such devices as well as the clinical
procedure. Pursuant to the FDC Act and the regulations promulgated thereunder,
the FDA regulates the preclinical and clinical testing, manufacture, labeling,
distribution, and promotion of medical devices. Noncompliance with applicable
requirements can result in fines, injunctions, civil penalties, recall or
seizure of products, total or partial suspension of production, denial or
withdrawal of premarket clearance or approval for devices, recommendations by
the FDA that the Company not be allowed to enter into government contracts, and
criminal prosecution. The FDA also has the authority to request recall, repair,
replacement or refund of the cost of any device manufactured or distributed by
the Company.
The FDA classifies medical devices in commercial distribution into one of
three classes: Class I, II or III. This classification is based on the controls
the FDA deems necessary to reasonably ensure the safety and effectiveness of
medical devices. Class I devices are subject to general control (E.G., labeling,
premarket notification and adherance to GMPs) and Class II devices are subject
to general and special controls (E.G., performance standards, postmarket
surveillance, patient registries, and FDA guidelines). Generally, Class III
devices are those which must receive premarket approval by the FDA to
34
<PAGE>
ensure their safety and effectiveness (E.G., life-sustaining, life-supporting
and implantable devices, or new devices which have been found not to be
substantially equivalent to legally marketed devices). Lasers are classified as
Class II devices.
If a manufacturer or distributor of a medical device can establish that a
proposed device is "substantially equivalent" to a legally marketed Class I or
Class II medical device or to a pre-1976 Class III medical device for which the
FDA has not called for a PMA, the manufacturer or distributor may seek FDA
clearance for the device by filing a Section 510(k) premarket notification. If a
manufacturer or distributor of a medical device cannot establish that a proposed
device is substantially equivalent to another legally marketed device, whether
or not the FDA has made a determination in response to a 510(k) notification,
the manufacturer or distributor will have to seek premarket approval for the
proposed device. A 510(k) notification and the claim of substantial equivalence
will likely have to be supported by various types of data and materials,
possibly including test results or the results of clinical studies in humans. A
PMA would have to be submitted and be supported by extensive data, including
preclinical and clinical study data, to prove the safety and effectiveness of
the device.
If human clinical studies of a proposed device are required, whether for a
510(k) or a PMA, and the device presents a "significant risk," the manufacturer
or the distributor of the devices will have to file an IDE application with the
FDA prior to commencing human clinical trials. The IDE application must be
supported by data, typically including the results of animal and mechanical
laboratory testing. If the IDE application is approved by the FDA and one or
more appropriate Institutional Review Boards ("IRBs"), human clinical trials may
begin at a specific number of investigational sites with a specific number of
patients, as approved by the FDA. Submission of an IDE does not give assurance
that FDA will approve the IDE and, if it is approved, there can be no assurance
that the FDA will determine that the data derived from these studies support the
safety and efficacy of the device or warrant the continuation of clinical
studies. Sponsors of clinical studies are permitted to sell those devices
distributed in the course of the study provided such compensation does not
exceed recovery of the costs of manufacture, research, development and handling.
Clinical studies of nonsignificant risk devices may be performed without prior
FDA approval, but various regulatory requirements still apply, including the
requirement for approval by an Institutional Review Board, conduct of the study
according to applicable portions of the IDE regulations, and prohibitions
against commercialization of an investigational device.
The manufacturer or distributor may not place the device into interstate
commerce until an order is issued by the FDA granting premarket clearance for
the device. The FDA has no specific time limit by which it must respond to a
510(k) premarket notification. The FDA has recently been requiring more rigorous
demonstration of substantial equivalence in connection with 510(k) notifications
and the review time can take four to 12 months or longer for a 510(k). If a PMA
submission is filed, the FDA has by statute 180 days to review it; however, the
review time is often extended significantly by the FDA asking for more
information or clarification of information already provided in the submission.
During the review period, an advisory committee may also evaluate the
application and provide recommendations to the FDA as to whether the device
should be approved. In addition, the FDA will inspect the manufacturing facility
to ensure compliance with the FDA's good manufacturing practice requirements
prior to approval of a PMA.
Devices are cleared by 510(k) or approved by PMA only for the specific
intended uses claimed in the submission and agreed to by the FDA. Marketing or
promotion of products for medical applications other than those that are cleared
or approved could lead to enforcement action by the FDA. Labeling and
promotional activities are also subject to scrutiny by the FDA and, in certain
instances, by the Federal Trade Commission.
35
<PAGE>
There can be no assurance that the Company will be able to obtain necessary
regulatory approvals or clearances on a timely basis or at all, and delays in
receipt of or failure to receive such approvals or clearances, the loss of
previously received approvals or clearances, limitations on intended use imposed
as a condition of such approvals or clearances, or failure to comply with
existing or future regulatory requirements would have a material adverse effect
on the Company's business, financial condition and results of operations. FDA or
other governmental approvals of products developed by the Company in the future
may require substantial filing fees which could limit the number of applications
sought by the Company and may entail limitations on the indicated uses for which
such products may be marketed. In addition, approved or cleared products may be
subject to additional testing and surveillance programs required by the FDA and
other regulatory agencies, and product approvals and clearances could be
withdrawn for failure to comply with regulatory standards or by the occurrence
of unforeseen problems following initial marketing.
REGULATORY STATUS OF PRODUCTS
The Company has received 510(k) clearance to market the following lasers in
an aggregate of more than 100 specialty areas: CO(2) (four models: 10W, 20W,
35W, 65W); Nd:YAG (four models: 20W, 40W, 60W, 100W); Ho:YAG (one model); Er:YAG
(two models); 1.32m Nd:YAG (two models: 15W, 25W); .532m Nd:YAG (one model);
Argon (two models); diode (four models); Nd:YAG/Er:YAG combination laser (one
model). Each of these lasers has clearances in multiple specialty areas. The
Company also has received 510(k) clearance to market sculptured fiber contact
tip fibers, bare fibers, TouchTIPS, AngleTIPS and focusing tips for all cleared
wavelengths of the Company's lasers as well as argon lasers. If a device for
which the Company has already received 510(k) premarket clearance is changed or
modified in design, components, method of manufacture or intended use, such that
the safety or effectiveness of the device could be significantly affected, a new
510(k) premarket notification is required before the modified device can be
marketed in the United States. The Company has made modifications to certain of
its products which the Company believes do not require the submission of new
510(k) notifications. However, there can be no assurance that the FDA will agree
with the Company's determinations and not require the Company to discontinue
marketing one or more of the modified devices until they have been cleared by
the FDA.
The Company currently is conducting preclinical animal studies and clinical
trials, both under approved IDEs and as nonsignificant risk studies. There can
be no assurance that the results of any of these clinical studies will be
successful or that the FDA will not require the Company to discontinue any of
these studies in the interest of the public health or due to any violations of
the FDA's IDE regulations. There can be no assurance that the Company will
receive approval from the FDA to conduct any of the significant risk studies for
which the Company seeks IDE approval, or that the FDA will not disagree with the
Company's determination that any of its studies are "nonsignificant risk"
studies and require the Company to obtain approval of an IDE before the study
can continue.
ADDITIONAL REGULATORY REQUIREMENTS
Any products manufactured or distributed by the Company pursuant to a 510(k)
premarket clearance notification or PMA are or will be subject to pervasive and
continuing regulation by the FDA. The FDC Act also requires the Company to
manufacture its products in registered establishments and in accordance with
cGMP regulations, which include testing, control and documentation requirements.
The Company must also comply with Medical Device Reporting ("MDR") requirements
that a firm report to the FDA any incident in which its product may have caused
or contributed to a death or serious injury, or in which its product
malfunctioned and, if the malfunction were to recur, would be likely to cause or
contribute to a death or serious injury. The Company's facilities in the United
States are subject to periodic inspections by the FDA. The FDA may require
postmarketing surveillance with respect to the Company's products. The export of
medical devices is also subject to regulation in certain instances.
All lasers manufactured by the Company are subject to the Radiation Control
for Health and Safety Act administered by the Center for Devices and
Radiological Health of the FDA. The law
36
<PAGE>
requires laser manufacturers to file new product and annual reports and to
maintain quality control, product testing and sales records, to incorporate
certain design and operating features in lasers sold to end users pursuant to a
performance standard, and to comply with labeling and certification
requirements. Various warning labels must be affixed to the laser, depending on
the class of the product under the performance standard.
In addition, the use of the Company's products may be regulated by various
state agencies. For instance, the Company is required to register as a medical
device manufacturer with certain state agencies. In addition to being subject to
inspection by the FDA, the Company also will be routinely inspected by the State
of California for compliance with cGMP regulations and other requirements.
Although the Company believes that it currently complies and will continue
to comply with the applicable regulations regarding the manufacture and sale of
medical devices, such regulations are always subject to change and depend
heavily on administrative interpretations. There can be no assurance that future
changes in law, regulations, review guidelines or administrative interpretations
by the FDA or other regulatory bodies, with possible retroactive effect, will
not adversely affect the Company's business, financial condition and results of
operations. In addition to the foregoing, the Company is subject to numerous
federal, state and local laws relating to such matters as safe working
conditions, manufacturing practices, environmental protection, fire hazard
control and disposal of hazardous or potentially hazardous substances. There can
be no assurance that the Company will not be required to incur significant costs
to comply with such laws and regulations in the future, or that such laws or
regulations will not have a material adverse effect upon the Company's ability
to conduct business.
Furthermore, the introduction of the Company's products in foreign countries
may require obtaining foreign regulatory clearances, and additional safety and
effectiveness standards are required in certain other countries. The Company
believes that only a limited number of foreign countries currently have
extensive regulatory requirements. These countries include France, Germany,
Canada, Mexico and Japan. Domestic manufacturing locations of American companies
doing business in certain foreign countries, including European Community
countries, may be subject to inspection. The time required for regulatory
approval in foreign countries varies and can take a number of years. During the
period in which the Company will be attempting to obtain the necessary
regulatory approvals, the Company expects to market its products on a limited
basis in certain other countries that do not require regulatory approval. There
can be no assurance that the Company's products will be cleared or approved by
the FDA or other governmental agencies for additional applications in the United
States or in other countries or that countries that do not now require
regulatory approval will not require such approval in the future.
MANUFACTURING AND MATERIALS
Manufacturing consists of component assembly and systems integration of
electronic, mechanical and optical components and modules. The Company's product
costs are principally related to the purchase of raw materials while labor and
overhead have been reduced due to the use of customized tooling and automated
test systems. The Company believes that these manufacturing systems improve
quality and manufacturing reliability resulting in lower overall manufacturing
costs, and that these systems will allow the Company to expand production
rapidly.
The Company purchases certain raw materials, components and subassemblies
included in the Company's products from a limited group of qualified suppliers
and does not maintain long-term supply contracts with any of its key suppliers.
While multiple sources of supply exist for most critical components used in the
laser and fiberoptic delivery systems, the disruption or termination of these
sources could have a material adverse effect on the Company's business and
results of operations. Vendor delays or quality problems could also result in
production delays of up to six months as several
37
<PAGE>
components have long production lead times. These long lead times, as well as
the need for demonstration units, require a significant portion of working
capital to fund inventory growth. The Company has in the past experienced and
may continue to experience shortages in raw materials and certain supplies. See
"Risk Factors -- Dependence on Suppliers."
The Company owns the molds used to produce certain proprietary parts of its
laser products and owns the software used in the operation of its laser systems.
The Company designs and assembles its own fiberoptic delivery systems and laser
accessory equipment such as laser carts, smoke evacuation devices and associated
disposable supplies. The Company believes that its manufacturing practices are
in accordance with cGMP regulations.
PRODUCT LIABILITY AND INSURANCE
Since the Company's products are intended for use in the treatment of human
medical conditions, the Company is subject to an inherent risk of product
liability and other liability claims which may involve significant claims and
defense costs. The Company currently has product liability insurance with
coverage limits of $5.0 million per occurrence and $5.0 million in the aggregate
per year. Product liability insurance is expensive and subject to various
coverage exclusions, and in the future may not be available in acceptable
amounts, on acceptable terms, or at all. Although the Company does not have any
outstanding product liability claims, in the event the Company were to be held
liable for damages exceeding the limits of its insurance coverage or outside of
the scope of its coverage, the business and results of operations of the Company
could be materially adversely affected. The Company's reputation and business
could also be adversely affected by product liability claims, regardless of
their merit or eventual outcome.
FACILITIES
The Company leases approximately 28,000 square feet in one facility in
Irvine, California pursuant to a lease which expires in December 2000. This
facility contains the Company's executive offices, service center and
manufacturing space. The Company is required to lease an additional 13,000
square feet in the same facility commencing in January 1999, or on such earlier
date that the adjoining tenant's lease terminates. While the Company believes
that its manufacturing and administrative facilities are adequate to satisfy the
Company's needs through at least 2000, it may need to lease additional clean
room facilities in the future.
EMPLOYEES
As of June 3, 1996, the Company employed 44 people, two of whom are employed
on a part-time basis. None of these employees are represented by a union. Ten
employees perform sales, marketing and customer support activities. The
remaining employees perform manufacturing, financial, administration,
regulatory, research and development and quality control activities. The Company
believes that its relationship with its employees is good.
LEGAL PROCEEDINGS
In March 1994, the Company instituted litigation in the U.S. District Court,
Central District of California, against Infrared Fiber Systems, Inc., a Delaware
corporation ("IFS") which contracted to supply optical fiber to the Company for
the Company's Er:YAG laser. Two of IFS's senior officers are also named as
defendants. The Company's complaint in this matter alleges that IFS and two of
its officers made misrepresentations to the Company and that IFS breached its
agreement to supply fibers and certain warranties concerning the quality of the
fiber to be provided. The Company is seeking damages and an injunction requiring
IFS to subcontract the production of optical fiber to a third party, as provided
in the supply agreement. In April 1994, IFS filed a general denial and a cross-
complaint against the Company alleging breach of contract and intentional
interference with prospective economic advantage, seeking compensatory damages
"in excess of $500,000," punitive damages and a judicial declaration that the
contract has been terminated and that IFS is free to market its fibers to
others.
38
<PAGE>
IFS has agreed to license certain fiber technologies, to which the Company
claims exclusive license rights, to Coherent, Inc. ("Coherent"), a competitor of
the Company. Coherent joined the above litigation on behalf of IFS, seeking a
declaration that IFS had the legal right to enter into this license and supply
the fiber covered by that agreement.
In May 1995, the Company instituted litigation concerning this dispute in
the Orange County, California Superior Court against Coherent, Westinghouse
Electric Corporation ("Westinghouse") and an individual employee of Westinghouse
who was an officer of IFS from 1986 to 1993, when the events involved in the
federal action against IFS took place and while Westinghouse owned a substantial
minority interest in IFS. The complaint charges that Coherent conspired with IFS
in the wrongful conduct which is the subject of the federal lawsuit described
above and interfered with the Company's contracts and relations with IFS and
with prospective contracts and advantageous economic relations with third
parties. The complaint asserts that Westinghouse is liable for its employee's
wrongful acts as an IFS executive while acting within the scope of his
employment at Westinghouse. The lawsuit seeks injunctive relief and compensatory
damages. In October 1995, the federal action was stayed by order of the court in
favor of the California state court action, in which the pleadings have been
amended to include all claims asserted by the Company in the federal action. No
trial date has been set.
39
<PAGE>
MANAGEMENT
The following table sets forth certain information regarding the Company's
directors and executive officers.
<TABLE>
<CAPTION>
NAME AGE POSITION
- ----------------------------------- --- ------------------------------------------------------------
<S> <C> <C>
Colette Cozean, Ph.D............... 38 Chairman of the Board, Chief Executive Officer, President
and Director of Research
T. Daniel Caruso, Jr............... 53 Senior Vice President, Sales and Marketing
Ronald E. Higgins.................. 54 Vice President, Regulatory Affairs and Quality Assurance,
and Secretary
James S. Polentz................... 52 Vice President, Finance and Chief Financial Officer
Richard Roemer..................... 62 Vice President, Operations and Industrial Lasers
Patrick J. Day..................... 69 Director (1)
Grace Ching-Hsin Lin............... 46 Director (1)(2)
E. Donald Shapiro.................. 64 Director (1)(2)
</TABLE>
- ------------------------
(1) Member of the Audit Committee.
(2) Member of the Compensation Committee.
The business experience, principal occupations and employment, as well as
the periods of service, of each of the directors and executive officers of the
Company during at least the last five years are set forth below.
DIRECTORS AND OFFICERS
COLETTE COZEAN, PH.D. is a founder of the Company and has been Chairman of
the Board of Directors, President and Director of Research of the Company since
it began operations in August 1991 and became the Chief Executive Officer in
1994. From April 1987 to August 1991, Dr. Cozean served as Director of Research
and Development, Regulatory Affairs and Clinical Programs at Pfizer Laser and in
such capacities managed the development of the laser technologies which were
acquired by the Company from Pfizer Laser. Prior to April 1987, Dr. Cozean held
various research positions at Baxter Edwards, a division of Baxter Healthcare
Corporation ("Baxter"), and American Technology and Ventures, a division of
American Hospital Supply Company ("American Hospital"). Baxter and American
Hospital are manufacturers and suppliers of advanced medical products. Dr.
Cozean holds several patents, has published many articles and has served as a
member of the National Institutes of Health grant review committee. Dr. Cozean
holds a Ph.D. in biomedical engineering and an M.S. in Electrical Engineering
from Ohio State University, a B.S. in biomedical engineering from the University
of Southern California, and a B.A. in physical sciences from Westmont College.
T. DANIEL CARUSO, JR. has been Vice President, Sales and Marketing of the
Company since July 1992 and became a Senior Vice President in May 1996. From
July 1989 to April 1992, Mr. Caruso was Vice President, Sales and Marketing at
Hycor Biomedical, a laboratory diagnostics company. From March 1988 to July
1989, Mr. Caruso was President and Chief Executive Officer of Physicians Home
Infusion Care, a home health care company. Mr. Caruso has a B.S. in Biology and
Chemistry and an M.B.A. in marketing from the University of Southern California.
RONALD E. HIGGINS is a founder and the Vice President, Regulatory Affairs
and Quality Assurance of the Company, a position he has held since January 1995.
From the founding of the Company in August 1991 to January 1995, Mr. Higgins was
Vice President, Operations. From September 1989 to August 1991, Mr. Higgins was
Manager of Regulatory Affairs and Quality Assurance at Pfizer Laser. From
January 1987 to September 1989, Mr. Higgins was Director of Regulatory Affairs
at Cardio Pulmonics, a medical device company. Mr. Higgins holds a B.S. in
Zoology from the University of Utah and has completed post graduate work in the
areas of biochemistry, educational training, regulatory affairs, manufacturing
and engineering.
40
<PAGE>
JAMES S. POLENTZ joined the Company as Chief Financial Officer in April
1994. From October 1992 to April 1994, Mr. Polentz served as the Chief Financial
Officer with Spector Entertainment Group, a telecommunications service company.
From March 1991 through July 1992, Mr. Polentz served as the Vice President,
Finance and Chief Financial Officer for Commstruct International, Inc., a
telecommunications company. A subsidiary of Commstruct International, US
Commstruct, Inc., filed a petition under Chapter 11 of the United States
Bankruptcy Code within six months after the date Mr. Polentz left the employ of
Commstruct International, Inc. Mr. Polentz is a certified public accountant and
has a B.S. in Accounting from the University of Southern California and an
M.B.A. from California State University.
RICHARD ROEMER has been Vice President, Operations and Industrial Lasers of
the Company since February 1995. From 1994 to 1995, Mr. Roemer was an
independent consultant for the Company. From 1988 to 1994, Mr. Roemer was a
consultant to and general manager of California Labs, JMED, Inc. and Pineridge
Capital, which are manufacturers of laser-based medical products. Prior to 1988,
Mr. Roemer founded the laser group of Melles Griot and served as the Chief
Operating Officer of the laser division of Hughes Aircraft Corporation. Mr.
Roemer holds a B.S. degree in Mechanical Engineering from Rutgers University.
PATRICK J. DAY has served as a director of the Company since August 1991.
Mr. Day is a Certified Public Accountant and owns a CPA firm which he
established in 1967. He has served as a director for several organizations
including the First Presbyterian Church of Hollywood and many private companies.
Mr. Day is the father of Dr. Cozean, the Company's Chairman of the Board, Chief
Executive Officer and President. Mr. Day has a B.A. in accounting from the
University of Idaho.
GRACE CHING-HSIN LIN has served as a director of the Company since February
1992, representing a group of original investors in the Company. Ms. Lin has
been an agent providing real estate consulting services for Security Trust
Realty since April 1988 and an owner of South Pacific Investment, an investment
management company, since 1989.
E. DONALD SHAPIRO joined the Board of Directors in August 1994. Since 1983,
Mr. Shapiro has served as the Joseph Solomon Distinguished Professor of Law at
New York Law School where he served as both Dean and Professor of Law from 1973
to 1983. He is Supernumerary Fellow of St. Cross College at Oxford University,
England. Mr. Shapiro received a J.D. degree at Harvard Law School. He currently
serves on the Boards of Directors for several public companies including Loral
Space and Communications, Ltd., Eyecare Products PLC, Kranzco Realty Trust,
Group Health Incorporated, Vasomedical Corporation, MacroChem Corporation,
United Industrial, Telepad, Inc. and Food Entertainment, Inc. He also serves on
the Board of Directors of Bank Leumi NY. Mr. Shapiro is special counsel to the
law firm of Herzfeld and Rubin, which firm is representing the Company in the
litigation described in "Business -- Legal Proceedings." Mr. Shapiro is not a
partner of such firm and receives no compensation calculated by reference to
such firm's profits.
KEY CONSULTANTS
ROBERT J. FREIBERG, PH.D. is currently a Technical Advisor to the Company
and from August 1991 has provided consulting services to the Company. From 1986
to 1991, Dr. Freiberg served in various capacities for Pfizer Laser, most
recently holding the position of Director of Engineering and Manufacturing
Operations. From 1983 to 1986, Dr. Freiberg was Director of Minimally Invasive
Surgery Products for American Technology and Ventures, a division of American
Hospital. Dr. Freiberg has also managed projects/departments at Hughes Research
Laboratory, United Technologies and TRW. In addition to holding several patents,
Dr. Freiberg identified and developed emerging medical technologies for American
Hospital. Dr. Freiberg holds a Ph.D., M.S. and B.S. in physics from the
University of Illinois and Rensselaer Polytechnic Institute.
RICHARD P. KRATZ, M.D. became affiliated with the Company in April 1994 as a
Medical Director. Dr. Kratz is a clinical professor of ophthalmology at the
University of California, Irvine and a clinical professor emeritus at the
University of Southern California. Dr. Kratz is on the Board of Directors for
the University of California, Irvine, Beckman Laser Institute & Medical Clinic
and a member of the
41
<PAGE>
Board of Directors of the American Board of Eye Surgeons, and is on the
editorial boards for OCULAR SURGERY NEWS, OCULAR SURGERY NEWS INTERNATIONAL and
the EUROPEAN JOURNAL OF IMPLANT AND REFRACTIVE SURGERY. Dr. Kratz received a
M.D. from the University of Southern California. Dr. Kratz has published
numerous papers and frequently lectures on topics in ophthalmology, including
cataract surgery.
MEDICAL ADVISORY BOARDS
The Company is advised by three Medical Advisory Boards (the "Advisory
Boards") covering ophthalmology, dentistry and surgery, respectively. Each of
the Advisory Boards is comprised of up to fifteen members who are active
primarily in the Company's target markets and who are selected to provide a
balance of university deans, researchers and clinicians, different
subspecialties, and laser users of multiple wavelengths, users of the Company's
systems and users who do not use lasers in their practice at all. The Advisory
Board's function is to review clinical, regulatory, new product development and
marketing programs and proposals for the Company. Members of these boards often
serve as clinical investigators, course lecturers and perform research resulting
in published papers. Each Advisory Board is headed by a Chairman. Currently, the
Chairmen of the Company's Advisory Boards are as follows:
D. MICHAEL COLVARD, M.D., OPHTHALMOLOGY. Dr. Colvard is the founder of the
Center for Ophthalmic Surgery in Encino, California, and has been responsible
for its Outpatient Surgery Center for the past ten years. Dr. Colvard has also
been a clinical faculty member at the University of Southern California since
1991 and has published widely in the field of ophthalmology. Dr. Colvard
maintains a medical practice and is engaged by a major ophthalmic company to
review its clinical trials, procedures and results. Dr. Colvard also served as
the Medical Director for the Company during its first two years. The Company has
entered into an Assignment Agreement with Dr. Colvard, pursuant to which Dr.
Colvard assigned to the Company certain technology relating to the Er:YAG laser
for use on ocular structures. While this agreement provides for the payment of
royalties under certain circumstances to Dr. Colvard of 1.0% to 2.5% on sales of
the Er:YAG intraocular and refractive lasers, fiberoptic intraocular catheters
and intraocular probes, no royalties have been earned as of the date of this
Prospectus.
G. LYNN POWELL, D.D.S., DENTISTRY. Dr. Powell has been on the faculty at
the University of Utah since 1982, where he currently serves as the Assistant
Dean for Dental Education in the School of Medicine and Professor in the
Department of Pathology. He is a patent holder who has performed extensive
research in the field of dentistry serving as primary investigator on several
funded grants and is author or co-author of over 45 papers in journals, a
majority of which relate to the use of lasers in dentistry. He serves as a
reviewer for three dental and laser journals, has lectured nationally as well as
internationally and routinely presents his work at research meetings. Dr. Powell
is the current President of the International Society for Lasers in Dentistry.
Dr. Powell received his D.D.S. from the University of Washington and was on the
full time faculty in Restorative Dentistry for ten years.
WARREN SCOTT GRUNDFEST, M.D., GENERAL SURGERY. Dr. Grundfest, a Fellow of
the American College of Surgeons, has been the Director, Laser Research and
Technology Development Program at Cedars-Sinai Medical Center in Los Angeles
since 1985. He is also the holder of the Dorothy and E. Phillip Lyon Chair in
Laser Research at such hospital, as well as being an Assistant Director of
Surgery. In addition, he is an Assistant Clinical Professor of Surgery at the
UCLA School of Medicine, and the co-editor of the Journal of Laparoendoscopic
Surgery. Dr. Grundfest has published more than 100 papers, 30 book chapters and
conducted multiple courses in the fields of laser applications in medicine,
microendoscopy and minimally invasive surgery. His laboratory has been involved
in the development of minimally invasive surgery, from angioscopy to
laparoscopic transcystic duct common bile duct exploration. Dr. Grundfest
consults for a variety of governmental agencies including the FDA and the
National Institutes of Health.
42
<PAGE>
BOARD COMMITTEES AND DESIGNATED DIRECTORS
The Board's Audit Committee consists of Ms. Lin and Messrs. Day and Shapiro.
The Audit Committee meets periodically with management and the Company's
independent accountants to review the results and scope of the audit and other
services provided by the Company's independent auditors and the need for
internal auditing procedures and the adequacy of internal controls.
The Compensation Committee of the Board of Directors consists of Ms. Lin and
Mr. Shapiro. The Compensation Committee establishes salaries, incentives and
other forms of compensation for officers, directors and certain key employees
and consultants (including the Chairmen of the Advisory Boards), administers the
Company's various incentive compensation and benefit plans, including the
Company's 1992 Employee Stock Option Plan, 1995 Employee Stock Option Plan and
the 1996 Stock Option Plans and recommends policies relating to such plans.
The representative of the underwriters for the Company's IPO has certain
rights to designate one nominee to the Board of Directors. Until November 1999,
the Company has agreed, if requested by such underwriter, to nominate a designee
of such underwriter to the Company's Board of Directors. Such underwriter has
designated Mr. Shapiro, a current director of the Company, pursuant to this
provision.
EXECUTIVE COMPENSATION
The following table sets forth information concerning the annual
compensation paid by the Company for the fiscal years indicated to the Chief
Executive Officer and executive officers of the Company whose compensation
exceeded $100,000 during the fiscal year ended March 31, 1996.
SUMMARY COMPENSATION TABLE
<TABLE>
<CAPTION>
LONG-TERM
COMPENSATION
-------------------
ANNUAL COMPENSATION (1) SECURITIES
FISCAL ----------------------------- UNDERLYING ALL OTHER
NAME AND PRINCIPAL POSITION YEAR SALARY BONUS OPTIONS COMPENSATION
- ------------------------------------- --------- -------------- ------------- ------------------- -------------
<S> <C> <C> <C> <C> <C>
Colette Cozean, Ph.D. ............... 1996 $ 112,200 $ --(3) 140,000 $ 19,800(5)
Chairman of the Board, 1995 $ 97,500 $ 37,500 358,650(4) $ 4,800(6)
Chief Executive Officer, President 1994 $ 97,500(2) $ -- -- $ 5,376(6)
and Director of Research
T. Daniel Caruso, Jr. ............... 1996 $ $ --(3) 109,522 $ --
Senior Vice President, 90,625
Sales and Marketing
Ronald E. Higgins ................... 1996 $ 92,625 $ --(3) 90,000 $ --
Vice President, Regulatory
Affairs and Quality
Assurance and Secretary
</TABLE>
- ------------------------
(1) Excludes perquisites and other personal benefits, securities and properties
otherwise categorized as salary or bonuses which in the aggregate, for each
of the named persons did not exceed the lesser of either $50,000 or 10% of
the total annual salary reported for such person. Each of the named
executive officers entered into a Termination Agreement in May 1996 which
provides that in the event of a termination of employment following a change
in control of the Company, as defined in such agreement, the named executive
officer will receive (i) a lump sum cash payment equal to two times the
highest annual level of total cash compensation paid to that officer during
the three calendar years prior to the termination; (ii) immediate vesting of
all previously granted stock options, and (iii) continuing health benefits
for a period of 24 months.
(2) Includes $19,500 which was deferred until January 1995.
43
<PAGE>
(3) Bonuses for fiscal 1996 have not yet been determined, but the Company
anticipates paying such bonuses in July 1996. The Company estimates that
such bonuses will be between approximately $8,000 and $16,000.
(4) The exercise price for these options is $5.00 per share. One-half of such
options will vest in five equal annual installments commencing on August 8,
1995. The remaining options will vest on the earlier of August 8, 2005, or
when the Company attains certain financial criteria. Vesting of these
options is accelerated in the event of certain acquisitions of the Company.
(5) Represents the full amount of premiums paid by the Company ($15,000) for a
split-dollar life insurance policy in the amount of $2 million on the life
of Dr. Cozean, and an auto allowance for Dr. Cozean ($4,800).
(6) Represents an auto allowance for Dr. Cozean.
OPTIONS GRANTED IN LAST FISCAL YEAR
The following table sets forth certain information concerning stock options
granted to the named executive officers during the fiscal year ended March 31,
1996:
<TABLE>
<CAPTION>
NUMBER OF
SHARES OF PERCENT OF TOTAL
COMMON STOCK OPTIONS GRANTED EXERCISE OR
UNDERLYING TO EMPLOYEES BASE PRICE EXPIRATION
NAME OPTIONS DURING 1996 PER SHARE (1) DATE
- ------------------------------------------- -------------- ------------------- ------------- ----------
<S> <C> <C> <C> <C>
Colette Cozean, Ph.D....................... 140,000(2) 19.6% $ 4.625 02/23/06
T. Daniel Caruso, Jr....................... 60,000(3) 13.3% $ 4.625 02/23/06
35,000(4) $ 5.625 06/01/05
Ronald E. Higgins.......................... 45,000(3) 11.2% $ 4.625 02/23/06
35,000(4) $ 5.625 06/01/05
</TABLE>
- ------------------------
(1) The options were granted at an exercise price at least equal to the fair
market value of the Common Stock on the date of grant. The exercise price
may be paid by delivery of cash or already owned shares, subject to certain
conditions.
(2) Such options vest in four equal annual installments commencing March 31,
1996.
(3) Such options vest in three equal annual installments commencing March 31,
1997.
(4) 15,000 of the options held by each of Messrs. Caruso and Higgins vest on
September 21, 1997. The remaining 20,000 options held by each of Messrs.
Caruso and Higgins vest on the earlier of June 1, 2005, or when the Company
attains certain financial criteria.
44
<PAGE>
AGGREGATED OPTION EXERCISES IN LAST FISCAL YEAR
AND FISCAL YEAR END OPTION VALUES
The following table sets forth certain information regarding stock options
exercised by the named executive officers during the fiscal year ended March 31,
1996, as well as the number of exercisable and unexercisable in-the-money stock
options and their values at fiscal year end. An option is in-the-money if the
fair market value for the underlying securities exceeds the exercise price of
the option.
<TABLE>
<CAPTION>
NUMBER OF SECURITIES
UNDERLYING UNEXERCISED VALUE OF UNEXERCISED
OPTIONS AT IN-THE-MONEY OPTIONS
SHARES MARCH 31, 1996 AT MARCH 31, 1996 (1)
ACQUIRED ON VALUE ----------------------- ------------------------
EXERCISE REALIZED EXERCISABLE/UNEXERCISABLE EXERCISABLE/UNEXERCISABLE
------------- ----------- ----------------------- ------------------------
<S> <C> <C> <C> <C>
Colette Cozean, Ph.D......... -- -- 106,730/391,920 $400,021/$1,460,085
T. Daniel Caruso, Jr......... -- -- 2,500/102,500 $9,063/$372,188
Ronald E. Higgins............ -- -- 2,500/87,500 $9,063/$312,188
</TABLE>
- ------------------------
(1) Represents the last sale price of underlying securities at fiscal year end
as reported by the Nasdaq National Market, less the exercise price of the
options.
DIRECTOR COMPENSATION
All directors are elected annually and hold office until the next annual
meeting of the shareholders and until their successors are duly elected and
qualified. The Company pays to all nonemployee directors $1,000 per Board
meeting attended, $1,000 per committee meeting attended which is not in
conjunction with a Board meeting, $500 per committee meeting attended in
conjunction with a Board meeting, and $500 per telephonic Board or committee
meeting. Directors are also reimbursed for their out-of-pocket expenses incurred
in attending meetings of the Board of Directors and its committees. Mr. Shapiro
also receives a fee of $1,000 per month as compensation for additional
consulting services relating to the Company's pending litigation matter and to
new business issues. The Company may also periodically award options or warrants
to its Directors. On November 30, 1994, the Company granted to each nonemployee
director warrants to purchase, at an exercise price of $5.00 per share, (i)
45,000 shares of Common Stock, which warrants vest on the earlier of August 8,
2005 or when the Company attains certain financial conditions (subject to
earlier vesting upon certain acquisitions of the Company, and subject to the
requirement that the director remains on the Board through the vesting date);
and (ii) 20,000 shares of Common Stock, which warrants vested immediately upon
grant. On February 23, 1996, the Company also granted to Mr. Day, the only
nonemployee director of the Company not on the Board's Compensation Committee,
an option to purchase 10,000 shares at an exercise price of $4.63 per share.
The Company's 1996 Stock Option Plan provides that each person who was or is
a member of the Compensation Committee of the Board on February 23, 1996,
February 23, 1997 and February 23, 1998 will be issued on each such date, under
that plan, options to purchase 10,000 shares of the Company's Common Stock.
These options will have an exercise price equal to the fair market value of the
Company's Common Stock on the trading day prior to the grant date and a term of
ten years. These options are issued subject to approval by the Company's
shareholders at the 1996 Annual Meeting of Shareholders, and will terminate if
such approval is not given.
The Company's Articles of Incorporation and indemnification agreements
entered into between the Company and certain of the Company's directors and
officers require the Company to indemnify such officers and directors to the
fullest extent permitted by applicable law against liabilities incurred in
connection with their duties as officers and directors of the Company. Such
indemnification rights may extend to liabilities under the Securities Act.
Insofar as indemnification for liabilities arising under the Securities Act may
be permitted to directors, officers and controlling persons of the Company, the
Company has been advised that in the opinion of the Commission such
indemnification is against public policy as expressed in the Securities Act, and
is, therefore, unenforceable.
45
<PAGE>
STOCK OPTION PLANS
Each of the Company's Stock Option Plans is administered by the Board of
Directors which has sole discretion and authority, consistent with the
provisions of the plans, to determine which eligible participants will receive
options, the time when options will be granted, the terms of options granted and
the number of shares which will be subject to options. The Board may also
appoint a committee (the "Committee") to administer the plans and, subject to
applicable law, to exercise all of the powers of the Board under the plans.
1992 STOCK OPTION PLAN AND 1995 STOCK OPTION PLAN
The Company's 1992 Stock Option Plan and 1995 Stock Option Plan each provide
for the granting of "incentive stock options," within the meaning of Section 422
of the Internal Revenue Code of 1986, as amended ("Incentive Stock Options"),
and nonstatutory options. Under the 1992 Stock Option Plan, options covering an
aggregate of 54,264 shares of the Company's Common Stock may be granted and
under the 1995 Stock Option Plan options covering an aggregate of 225,000 shares
of the Company's Common Stock may be granted, in each case to directors,
employees and consultants of the Company, except that Incentive Stock Options
may not be granted to nonemployee directors or nonemployee consultants. The 1992
Stock Option Plan terminates in August 2002, and the 1995 Stock Option Plan
terminates in 2005. As of June 3, 1996 there were options to purchase an
aggregate of 31,952 shares of Common Stock and 1,728 shares of each of Class E-1
and Class E-2 Common Stock outstanding under the 1992 Stock Option Plan, at an
exercise price ranging from $1.00 to $11.06, which were held by 18 former and
current employees, and 179,250 options outstanding under the 1995 Stock Option
Plan at an exercise price of $5.625 per share, held by 31 employees and
consultants.
FEBRUARY 1996 STOCK OPTION PLAN AND 1996 STOCK OPTION PLAN
In February 1996, the Board of Directors adopted two option plans, the
February 1996 Stock Option Plan and the 1996 Stock Option Plan which provide for
the grant of options covering an aggregate of 550,000 shares and 500,000 shares,
respectively, of the Company's Common Stock to employees and directors of, and
consultants to the Company. Both plans terminate in February 2006. The 1996
Stock Option Plan provides for the granting of Incentive Stock Options and
nonstatutory stock options. The 1996 Stock Option Plan provides that each person
who was or is a member of the Company's Compensation Committee of the Board of
Directors on February 23, 1996, February 23, 1997 and February 23, 1998 will be
issued on each such date, options to purchase 10,000 shares of the Company's
Common Stock. These options will have a term of ten years and an exercise price
equal to the fair market value of the Company's Common Stock on the trading day
prior to the grant date. As of June 3, 1996, there were options to purchase an
aggregate of 499,200 shares of Common Stock outstanding under the February 1996
Stock Option Plan, at an exercise price of $4.625 per share, which options were
held by 52 employees, directors and consultants. As of June 3, 1996, there were
options to purchase an aggregate of 20,000 shares of the Company's Common Stock,
at an exercise price of $4.625 per share, which options were held by two
directors of the Company.
The exercise price of Incentive Stock Options must be not less than the fair
market value of a share of Common Stock on the date the option is granted (110%
with respect to optionees who own at least 10% of the outstanding Common Stock).
Except for formula grants under the 1996 Stock Option Plan the Board of
Directors has the authority to determine the time or times at which options
granted under the Stock Option Plans become exercisable, provided that options
expire no later than ten years from the date of grant (five years with respect
to optionees who own at least 10% of the outstanding Common Stock). Options are
nontransferable, other than by will and the laws of descent and distribution,
and generally may be exercised only by an employee while employed by the Company
or within 60 days after termination of employment (one year for termination
resulting from death or disability).
46
<PAGE>
PRINCIPAL SHAREHOLDERS
The following table sets forth certain information as of June 3, 1996, and
as adjusted to reflect the sale of 2,500,000 shares of common stock by the
Company in this Offering, regarding the beneficial ownership of the Company's
Common Stock by: (i) all persons known by the Company to beneficially own more
than 5% of the Company's Common Stock, (ii) each director and executive officer
of the Company, and (iii) all directors and executive officers as a group. The
following table treats the Common Stock, the Class E-1 Common Stock and the
Class E-2 Common Stock as a single class.
<TABLE>
<CAPTION>
PERCENT OF
OUTSTANDING
AMOUNT AND STOCK OWNED
NATURE OF ------------------------------
BENEFICIAL BEFORE AFTER
NAME AND ADDRESS OF BENEFICIAL OWNER (1) OWNERSHIP OFFERING OFFERING
- --------------------------------------------------------------------- ----------- --------------- -------------
<S> <C> <C> <C>
Colette Cozean, Ph.D. (2)............................................ 247,320 3.4% 2.5%
Patrick J. Day (3)................................................... 232,981 3.2 2.4
E. Donald Shapiro (4)................................................ 108,000 1.5 1.1
Ronald E. Higgins (5)................................................ 97,820 1.4 1.0
Grace Chin-Hsin Lin (6).............................................. 52,801 * *
T. Daniel Caruso, Jr. (7)............................................ 48,876 * *
James S. Polentz (8)................................................. 2,500 * *
Richard Roemer....................................................... -- * *
All directors and executive officers
as a group (8 persons) (9).......................................... 790,298 10.4% 7.8%
</TABLE>
- ------------------------
* Less than 1%.
(1) The address of each of Dr. Cozean, Ms. Lin and Messrs. Day, Caruso, Higgins
and Shapiro is 3 Morgan, Irvine, California 92718. Unless otherwise noted,
the Company believes that all persons named in the table have sole
investment and voting power with respect to all shares of Common Stock
beneficially owned by such person, subject to community property laws where
applicable.
(2) Includes 49,144 shares of Common Stock, 43,514 shares of Class E-1 Common
Stock and 43,514 shares of Class E-2 Common Stock held by Dr. Cozean and
1,594 shares of Common Stock, 1,412 shares of Class E-1 Common Stock and
1,412 shares of Class E-2 Common Stock held by Dr. Cozean as custodian for
her two minor children. Also includes 106,730 shares of Common Stock
issuable upon exercise of options which become exercisable within 60 days.
(3) Includes 54,263 shares of Common Stock, 48,047 shares of Class E-1 Common
Stock and 48,047 shares of Class E-2 Common Stock. Also includes 48,992
shares of Common Stock, 16,816 shares of Class E-1 Common Stock and 16,816
shares of Class E-2 Common Stock subject to warrants and options exercisable
within 60 days.
(4) Includes 108,000 shares of Common Stock subject to Class A Warrants and
other warrants and options exercisable within 60 days.
(5) Includes 34,400 shares of Common Stock, 30,460 shares of Class E-1 Common
Stock and 30,460 shares of Class E-2 Common Stock. Also includes 2,500
shares of Common Stock subject to options exercisable within 60 days.
(6) Includes 6,330 shares of Common Stock, 5,605 shares of Class E-1 Common
Stock and 5,605 shares of Class E-2 Common Stock held by Linco Investments,
a limited partnership in which Ms. Lin's husband serves as a general
partner, and 1,899 shares of Common Stock, 1,681 shares of Class E-1 Common
Stock and 1,681 shares of Class E-2 Common Stock held by the pension plan
for Ms. Lin's husband. Also includes 30,000 shares of Common Stock subject
to warrants and options exercisable within 60 days.
47
<PAGE>
(7) Includes 13,722 shares of Common Stock, 12,150 shares of Class E-1 Common
Stock and 12,150 shares of Class E-2 Common Stock. Also, includes 5,514
shares of Common Stock, 2,670 shares of Class E-1 Common Stock and 2,670
shares of Class E-2 Common Stock subject to options exercisable within 60
days.
(8) Includes 2,500 shares of Common Stock subject to options exercisable within
60 days.
(9) Includes 161,352 shares of Common Stock, 142,869 shares of Class E-1 Common
Stock and 142,869 shares of Class E-2 Common Stock. Also includes 304,236
shares of Common Stock, 19,486 shares of Class E-1 Common Stock and 19,486
shares of Class E-2 Common Stock subject to warrants and options exercisable
within 60 days.
CERTAIN TRANSACTIONS
As of September 30, 1994, the Company owed an aggregate of approximately
$226,000 to its officers for unreimbursed expenses and deferred salaries.
Included in that amount was $52,000 owed to an immediate family member of an
officer of the Company for consulting services rendered to the Company. All of
these amounts were paid in December 1994 and January 1995. In addition, between
June and September 1994, the Company borrowed an aggregate of $55,000 and
$25,000 from Messrs. Patrick J. Day (a director) and Irving M. Frankman (a
former director), respectively, pursuant to short-term promissory notes bearing
interest at 10% per annum (18% upon the occurrence of an event of a default).
These loans have been repaid in full.
In March 1994, the Company's Board of Directors agreed to extend Mr. Day's
outstanding warrants to purchase 100,000 shares of Series A Preferred Stock for
two years. In December 1994, the Company exchanged these warrants for warrants
to purchase 9,044 shares of Common Stock, and 8,008 shares of each of Class E-1
and Class E-2 Common Stock for an aggregate purchase price of $100,000. In May
1996, the Company's Board of Directors agreed to extend such warrants until
March 31, 1997.
In connection with the Company's private placement in August 1994, Mr.
Shapiro, a director of the Company, purchased $100,000 principal amount of
promissory notes and 70,000 warrants (which converted by their terms in December
1994 into Class A Warrants) for an aggregate purchase price of $100,000. These
promissory notes were repaid in full in December 1994.
48
<PAGE>
DESCRIPTION OF SECURITIES
The following description of the Company's capital stock and selected
provisions of its Articles of Incorporation and Bylaws is a summary and is
qualified in its entirety by the Company's Articles of Incorporation and Bylaws,
copies of which have been filed with the Securities and Exchange Commission as
exhibits to the Registration Statement of which this Prospectus is a part.
COMMON STOCK
The Company is authorized to issue 35,600,000 shares of Common Stock, no par
value, 2,200,000 shares of Class E-1 Common Stock, no par value, and 2,200,000
shares of Class E-2 Common Stock. The Common Stock, Class E-1 Common Stock and
the Class E-2 Common Stock have equal voting rights and are entitled to share
equally in dividends from sources available therefor when, as and if declared by
the Board of Directors, subject to certain escrow conditions pertaining to
dividends declared with respect to the Class E-1 and Class E-2 Common Stock. See
"Dividend Policy." Shareholders have no preemptive rights and no right to
convert their Common Stock into any other securities. The holders of Common
Stock are entitled to one vote for each share held of record on all matters
submitted to a vote of the shareholders, except that holders of Common Stock are
entitled to cumulative voting with respect to the election of directors upon
giving notice as required by law. In cumulative voting, the holders of Common
Stock are entitled to cast for each share held the number of votes equal to the
number of directors to be elected. In the event of a liquidation, dissolution or
winding up of the Company, holders of Common Stock are entitled to share ratably
in all assets remaining after payment of liabilities and the liquidation
preference of any then outstanding Preferred Stock. There are no redemption or
sinking fund provisions applicable to the Common Stock. All outstanding shares
are, and all shares to be sold and issued as contemplated hereby will be, fully
paid and nonassessable and legally issued. The Board of Directors is authorized
to issue additional shares of Common Stock within the limits authorized by the
Company's charter and without shareholder action. As of June 3, 1996 there were
4,723,758 shares of Common Stock outstanding.
CLASS E-1 COMMON STOCK
The Company is authorized to issue 2,200,000 shares of Class E-1 Common
Stock, no par value. As of June 3, 1996, there were outstanding 1,256,818 shares
of Class E-1 Common Stock and 1,256,818 shares of Class E-2 Common Stock (the
"Escrow Shares"). The Escrow Shares are not transferrable (but may be voted),
and each Escrow Share will automatically convert into one share of Common Stock
and be released to the owners thereof upon the achievement of the objectives
described below. On June 30, 2000, all Escrow Shares not previously converted
into Common Stock will be cancelled. This arrangement was required by the
representative of the underwriters for the Company's initial public offering as
a condition of such offering.
All of the shares of Class E-1 Common Stock will be automatically converted
into Common Stock in the event that: (a) the Company's net income before
provision for income taxes, including earnings from joint ventures, distribution
agreements and licensing agreements, but exclusive of any other earnings that
are classified as an extraordinary item, and exclusive of any charges to income
that may result from the conversion of the Escrow Shares into Common Stock (as
stated in the Company's financial statements audited by the Company's
independent accountants) ("Minimum Pretax Income") amounts to at least
$5,500,000 for the fiscal year ending March 31, 1997; (b) the Minimum Pretax
Income amounts to at least $6,850,000 for the fiscal year ending March 31, 1998;
(c) the Minimum Pretax Income amounts to at least $8,425,000 for the fiscal year
ending March 31, 1999; (d) the Minimum Pretax Income amounts to at least
$9,900,000 for the fiscal year ending March 31, 2000; or (e) the Closing Price
of the Company's Common Stock for any 30 consecutive business days shall average
in excess of $19.25 during the period commencing June 1996 and ending in
November 1997 (subject to adjustment in the event of any reverse stock splits or
similar events). The Closing Price shall be the closing sale price as reported
by the Nasdaq National Market. In the event additional shares are issued, all of
the Minimum Pretax Income amounts will be increased proportionately.
49
<PAGE>
CLASS E-2 COMMON STOCK
The Company is authorized to issue 2,200,000 shares of Class E-2 Common
Stock, no par value. All of the shares of Class E-2 Common Stock will be
automatically converted into Common Stock in the event that: (a) the Minimum
Pretax Income amounts to at least $11,800,000 for the fiscal year ending March
31, 1997; (b) the Minimum Pretax Income amounts to at least $14,750,000 during
the fiscal year ending March 31, 1998; (c) the Minimum Pretax Income amounts to
at least $20,475,000 during the fiscal year ending March 31, 1999; (d) the
Minimum Pretax Income amounts to at least $26,750,000 during the fiscal year
ending March 31, 2000; or (e) the Closing Price of the Company's Common Stock
for any 30 consecutive business days shall average in excess of $24.00 during
the period commencing June 1996 and ending November 1997. In the event any
additional shares are issued, all of the Minimum Pretax Income amounts
referenced above will be proportionately increased.
Any money, securities, rights or property distributed in respect of the
Escrow Shares, including any property distributed as dividends or pursuant to
any stock split, merger, recapitalization, dissolution or total or partial
liquidation of the Company, shall be held by the Company in escrow until
conversion of the Escrow Shares. If none of the foregoing earnings or market
price levels are attained, the Escrow Shares, as well as any dividends or other
distributions made with respect thereto, will be cancelled. The earnings and
market price levels set forth above were determined by negotiation between the
Company and the representative of the underwriter in the Company's initial
public offering and should not be construed to imply or predict any future
earnings by the Company or any increase in the market price of its securities.
There can be no assurance that such earnings and market price levels will be
attained or that any or all of the Escrow Shares will be converted into Common
Stock. However, the conversion to Common Stock of all or any portion of the
Escrow Shares may result in a charge to earnings to the extent that such shares
are held by management or employees. See "Management's Discussion and Analysis
of Financial Condition and Results of Operations -- Potential Future Charge to
Income."
PREFERRED STOCK
The Company's authorized preferred stock consists of 20,000,000 shares, no
par value (the "Preferred Stock"), of which 11,150,000 shares have been
cancelled or already designated. The Board of Directors has the authority,
without further action by the shareholders, to issue from time to time up to
8,850,000 shares of Preferred Stock in one or more series and to fix the
dividend rights and terms, conversion rights, voting rights (whole, limited or
none), redemption rights and terms, liquidation preferences, sinking funds and
any other rights, preferences, privileges and restrictions applicable to each
such series of Preferred Stock. The purpose of authorizing the Board of
Directors to determine such rights and preferences is to eliminate delays
associated with a shareholder vote on specific issuances. The issuance of the
Preferred Stock, while providing flexibility in connection with possible
acquisitions and other corporate purposes, could, among other things, adversely
affect the voting power of the holders of Common Stock and, under certain
circumstances, could make it more difficult for a third party to gain control of
the Company. Such issuance of Preferred Stock could also adversely affect the
distributions on and liquidation preference of the Common Stock by creating more
series of Preferred Stock with distribution or liquidation preferences senior to
the Common Stock. The Company has no present plan to issue any shares of
Preferred Stock.
REDEEMABLE WARRANTS
The Company has outstanding redeemable Class A Warrants and Class B Warrants
(collectively, the "Warrants") which are currently listed on the Nasdaq National
Market. These Warrants are in fully registrable form under a Warrant Agreement
(the "Warrant Agreement") between the Company and American Stock Transfer and
Trust Company, and are evidenced by Warrant certificates. These Warrants may be
exercised upon surrender of the Warrant certificate on or prior to the
respective expiration dates (or earlier redemption dates), accompanied by
payment of the full exercise price (by certified or bank check payable to the
order of the Company) for the number of shares with respect to which the
Warrants are being exercised. Holders of the Warrants do not have any voting or
other
50
<PAGE>
rights of a shareholder of the Company. Upon notice to the holders of the
Warrants, the Company has the right to unilaterally reduce the exercise price or
extend the expiration date of the Warrants. The Warrants provide for the
adjustment of the exercise price and for a change in the number of shares
issuable upon exercise to protect the holders of the Warrants against dilution
in the event of a stock dividend, stock split, combination or reclassification
of the Common Stock or upon issuance of additional shares of Common Stock at
prices lower than the market price then in effect other than issuances upon
exercise of options granted to employees, directors and consultants to the
Company.
CLASS A WARRANTS
Each Class A Warrant entitles the registered holder to purchase one share of
Common Stock and one redeemable Class B Warrant at an exercise price of $6.50 at
any time prior to November 30, 1999. As of June 3, 1996, the Company has
outstanding 4,145,149 Class A Warrants. The Company has the right to redeem all
of the Class A Warrants at a price of $0.05 per Class A Warrant upon not less
than 30 days' prior written notice at any time after November 30, 1997, provided
that before any such redemption can take place, the last sale price of the
Company's Common Stock in the over-the-counter market shall have averaged in
excess of $9.10 per share for 30 consecutive business days ending within 15 days
of the date of the notice of redemption. During the 30-day notice period, a
holder shall have the option to exercise his Class A Warrants. This right of
redemption shall not apply to the Class A Warrants that are components of the
IPO Unit Purchase Options.
CLASS B WARRANTS
Each Class B Warrant entitles the registered holder to purchase one share of
Common Stock at an exercise price of $8.00 per share at any time prior to
November 30, 1999. As of June 3, 1996, the Company had outstanding 3,102,049
Class B Warrants. The Company has a right to redeem all of the Class B Warrants
at a price of $.05 per Class B Warrant upon not less than 30 days' prior written
notice at any time after November 30, 1997, provided that before any such
redemption can take place, the last sale price of the Company's Class A Common
Stock in the over-the-counter market shall have averaged in excess of $11.20 per
share for 30 consecutive business days ending within 15 days prior to the date
of the notice of redemption. During the 30-day notice period, a holder shall
have the option to exercise his Class B Warrants. This right of redemption shall
not apply to the Class B Warrants that are components of the IPO Unit Purchase
Options.
UNITS
The Company also has outstanding Units which are currently listed on the
Nasdaq SmallCap Market. Each Unit consists of (i) one share of Class A Common
Stock, (ii) one Class A Warrant and (iii) one Class B Warrant. The Class A
Common Stock, Class A Warrants and Class B Warrants were separately transferable
immediately upon issuance.
IPO UNIT PURCHASE OPTIONS
In connection with the Company's IPO, the Company granted to the underwriter
for the IPO and three finders IPO Unit Purchase Options to purchase up to an
aggregate of 240,000 Units. The IPO Unit Purchase Options are exercisable at any
time prior to November 30, 1999 at an exercise price of $7.00 per Unit (140% of
the initial public offering price) subject to adjustment in certain events to
protect against dilution. These units will be identical to the publicly traded
Units except that the Class A Warrants and the Class B Warrants included in the
IPO Unit Purchase Options will not be subject to redemption by the Company,
except if at the time the Warrants are called for redemption, the IPO Unit
Purchase Options have been exercised and the underlying warrants are
outstanding. The IPO Unit Purchase Options cannot be transferred, sold, assigned
or hypothecated until November 30, 1997, except in the case of a transfer to any
officer of the underwriter for the IPO or a member of that selling group.
LIMITATION OF LIABILITY OF DIRECTORS AND INDEMNIFICATION OF DIRECTORS AND
OFFICERS
The Company's Bylaws provide that the Company will indemnify its directors
and officers to the fullest extent permitted by California law. The Company is
also empowered under its Bylaws to enter
51
<PAGE>
into indemnification contracts with its directors and officers and certain
others and to purchase insurance on behalf of any person it is required or
permitted to indemnify. Pursuant to this provision, the Company has entered into
indemnity agreements with each of its directors and executive officers and
certain key consultants.
In addition, the Company's Articles of Incorporation provides that, to the
fullest extent permitted by California law, the Company's directors will not be
liable for monetary damages for breach of the directors' fiduciary duty of care
to the Company or its shareholders. This provision in the Articles of
Incorporation does not eliminate the duty of care, and in appropriate
circumstances equitable remedies such as an injunction or other forms of
nonmonetary relief would remain available under California law. Each director
will continue to be subject to liability for breach of the director's duty of
loyalty to the Company, for acts or omissions involving intentional misconduct
or knowing and culpable violations of law, for acts or omissions that the
absence of good faith on the part of the director, for any transaction from
which the director derived an improper personal benefit, for acts or omissions
involving a reckless disregard for the director's duty to the Company or its
shareholders when the director was aware or should have been aware of a risk of
serious injury to the Company or its shareholders, for acts or omissions that
constitute an unexcused pattern of inattention that amounts to an abdication of
the director's duty to the Company or its shareholders, for improper
transactions between the director and the Company, for improper distributions to
shareholders and loans to directors and officers or for acts or omissions by the
director as an officer. This provision also does not affect a director's
responsibilities under any other laws, such as the federal securities laws or
state or federal environmental laws.
There is no pending litigation or proceeding involving a director or officer
of the Company concerning which indemnification is being sought, nor is the
Company aware of any pending or threatened litigation that may result in claims
for indemnification by any director or officer.
The Company believes the foregoing provisions are necessary to attract and
retain qualified persons as directors and officers.
Insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers and controlling persons of the Company
pursuant to the foregoing provisions, or otherwise, the Company has been advised
that in the opinion of the Commission such indemnification is against public
policy as expressed in the Securities Act and is, therefore, unenforceable.
TRANSFER AND WARRANT AGENT
The Transfer and Warrant Agent for the Company's securities is American
Stock Transfer & Trust Company, New York, New York.
52
<PAGE>
SHARES ELIGIBLE FOR FUTURE SALE
As of June 3, 1996, the Company had outstanding 4,723,758 shares of Common
Stock (excluding approximately 2,378,949 shares of Common Stock issuable upon
exercise of outstanding stock options and warrants, and approximately 11,392,347
shares of Common Stock issuable upon exercise in full of the Class A Warrants
and the Class B Warrants). Of these shares, the 2,760,000 shares of Common Stock
sold by the Company in its IPO are freely tradeable without restriction or
further registration under the Securities Act.
Of the remaining 1,963,758 shares of outstanding Common Stock, 993,831 are
"restricted securities" (the "Restricted Shares") within the meaning of Rule 144
under the Securities Act and may not be sold in the absence of a registration
under the Securities Act unless an exemption from registration is available,
including an exemption contained in Rule 144. In general, under Rule 144 as
currently in effect, any person (or persons whose shares are aggregated for
purposes of Rule 144) who has beneficially owned "restricted securities," as
that term is defined in Rule 144, for at least two years (including, in the case
of a nonaffiliate holder, any period of ownership of preceding nonaffiliate
holders) is entitled to sell, within any three-month period, a number of shares
that does not exceed the greater of (i) 1% of the then outstanding shares of
Common Stock of the Company, or (ii) the average weekly trading volume in Common
Stock during the four calendar weeks preceding such sale, provided that certain
public information about the Company, as required by Rule 144, is then available
and the seller complies with the manner of sale and notification requirements of
the rule. A person who is not an affiliate and has not been an affiliate within
three months prior to the sale and has, together with any previous owners who
were not affiliates, beneficially owned restricted securities for at least three
years is entitled to sell such shares under Rule 144(k) without regard to any of
the volume limitations described above. Approximately 961,836 of the Restricted
Shares are presently eligible for sale upon compliance with Rule 144(k).
The issuance of shares of Common Stock upon exercise of the Class A Warrants
or Class B Warrants has been registered under the Securities Act, and 720,499
shares of Common Stock are issuable upon exercise of the remaining options and
warrants and may be resold pursuant to Rule 701 under the Securities Act. Rule
701 under the Securities Act provides an exemption from the registration
requirements of the Securities Act for offers and sales of securities issued
pursuant to certain compensatory benefit plans or written contracts of a company
not subject, at the time of issuance, to the reporting requirements of Section
13 or 15(d) of the Exchange Act of 1934. Securities issued pursuant to Rule 701
are defined as restricted securities for purposes of Rule 144. However, 90 days
after the issuer becomes subject to the reporting provisions of the Exchange
Act, the Rule 144 resale restrictions, except for the broker's transaction
requirements, are inapplicable for nonaffiliates. Affiliates are subject to all
Rule 144 restrictions after this 90-day period, but without the Rule 144 holding
period requirement. The officers and directors of the Company (who hold an
aggregate of 161,352 shares of Common Stock) have agreed not to sell or
otherwise transfer any shares of Common Stock, or any securities convertible
into or exercisable for shares of Common Stock, for the 180 days following the
effective date of this Prospectus without the consent of the Representative on
behalf of the Underwriters.
No predictions can be made of the effect, if any, that future sales of
shares of Common Stock, and grants of options to acquire shares of Common Stock,
or the availability of shares for future sale, will have on the market price of
the Common Stock prevailing from time to time. Sales of substantial amounts of
Common Stock in the public market, or the perception that such sales could
occur, could adversely affect the prevailing market prices of the Common Stock.
See "Principal Shareholders," "Description of Securities" and "Underwriting."
53
<PAGE>
UNDERWRITING
The Underwriters below, for whom Rodman & Renshaw, Inc., is acting as
Representative, have severally agreed, subject to the terms and conditions
contained in the Underwriting Agreement, to purchase from the Company the number
of shares of Common Stock set forth below opposite their respective names.
<TABLE>
<CAPTION>
UNDERWRITER NUMBER OF SHARES
- --------------------------------------------------------------------------- -----------------
<S> <C>
Rodman & Renshaw, Inc......................................................
-----------------
Total.................................................................. 2,500,000
-----------------
-----------------
</TABLE>
The Underwriting Agreement provides that the obligations of the several
Underwriters thereunder are subject to approval of certain legal matters by
counsel and to various other considerations. The nature of the Underwriters'
obligations is such that they are committed to purchase and pay for all of the
above shares of Common Stock if any are purchased.
The Underwriters, through the Representative, have advised the Company that
they propose to offer the Common Stock initially at the public offering price
set forth on the cover page of this Prospectus; that the Underwriters may allow
to selected dealers a concession of $ per share, and that such dealers may
reallow a concession of $ per share to certain other dealers. After the public
offering, the offering price and other selling terms may be changed by the
Underwriters. The Common Stock is included for quotation on the Nasdaq National
Market.
The Company has granted to the Underwriters a 30-day over-allotment option
to purchase up to an aggregate of 375,000 additional shares of Common Stock,
exercisable at the public offering price less the underwriting discount. If the
Underwriters exercise such over-allotment option, then each of the Underwriters
will have a firm commitment, subject to certain conditions, to purchase
approximately the same percentage thereof as the number of shares of Common
Stock to be purchased by it, as shown in the above table, bears to the 2,500,000
shares of Common Stock offered hereby. The Underwriters may exercise such option
only to cover over-allotments made in connection with the sale of the shares of
Common Stock offered hereby.
In connection with this Offering, the Company has agreed to sell to the
Representative, for nominal consideration, warrants to purchase a number of
shares of Common Stock equal to 10% of the shares of Common Stock sold in the
Offering excluding over-allotments, if any (the "Representative's Warrants").
The Representative's Warrants are initially exercisable at a price of $ per
share of Common Stock (120% of the public offering price of the shares offered
hereby) for a period of four years, commencing one year from the effective date
of the Offering and are restricted from sale, transfer, assignment or
hypothecation for a period of 12 months from the effective date of the Offering,
except to officers, partners or successors of the Representative. The exercise
price of the Representative's Warrants and the number of shares of Common Stock
issuable upon exercise thereof are subject to adjustment under certain
circumstances. The Representative's Warrants grant to the holders thereof
certain rights of registration for the securities issuable upon exercise of the
Representative's Warrants. The Representative's Warrants are redeemable by the
Company, on prior notice, if the price of the Common Stock three years after the
closing of the Offering, exceeds $20.00 for 30 consecutive business days within
a period of 15 days prior to the date of the notice of redemption.
In addition, the Company has granted to the Representative a right of first
refusal to perform services for the Company with respect to certain future
transactions for a period of one year after the closing date of the Offering,
subject to certain rights granted to the underwriter in the IPO.
The officers and directors of the Company have agreed that they will not
sell or dispose of any shares of Common Stock of the Company for a period of 180
days after the later of the date on which the Registration Statement is declared
effective by the Commission or on the first date on which the shares are bona
fide offered to the public, without the prior written consent of the
Representative on behalf of the Underwriters.
54
<PAGE>
The Company has agreed to indemnify the Underwriters against certain
liabilities, losses and expenses, including liabilities under the Securities Act
of 1933, as amended, or to contribute to payments that the Underwriters may be
required to make in respect thereof.
The Representative was retained by the Company in April 1996 for a 12-month
period to provide certain financial advisory services related to general
strategic financial advice, including in connection with serving as the managing
underwriter of this Offering, valuation and potential mergers and acquisitions.
The Company has agreed to pay the Representative (i) $250,000 for such services,
$150,000 of which will be paid upon consummation of this Offering, and the
balance will be payable in 12 equal monthly installments commencing the month
following the closing of the Offering, and (ii) a transaction fee with respect
to consummated restructurings, mergers or acquisitions.
In connection with the Offering made hereby, certain Underwriters and
selling group members (if any) or their respective affiliates who are qualified
registered market makers on the Nasdaq National Market may engage in passive
market making transactions in the Common Stock on the Nasdaq National Market in
accordance with Rule 10b-6A under the Exchange Act, during a specified period
before commencement of offers or sales of the Common Stock. The passive market
making transactions must comply with applicable volume and price limits and be
identified as such. In general, a passive market maker may display its bid at a
price not in excess of the highest independent bid for such security; if all
independent bids are lowered below the passive market maker's bid, however, such
bid must then be lowered when certain purchase limits are exceeded.
LEGAL MATTERS
The validity of the issuance of the shares of Common Stock offered by this
Prospectus will be passed upon for the Company by Rutan & Tucker, LLP, Costa
Mesa, California. Certain matters in connection with the sale of Common Stock
offered hereby will be passed on for the Underwriters by Squadron, Ellenoff,
Plesent & Sheinfeld, LLP, New York, New York.
EXPERTS
The financial statements of the Company as of March 31, 1996 and for each of
the two fiscal years in the period ended March 31, 1996 included in this
Prospectus have been so included in reliance on the report (which contains an
explanatory paragraph relating to the Company's ability to continue as a going
concern as described in Note 4 to the financial statements) of Price Waterhouse
LLP, independent accountants, given on the authority of said firm as experts in
auditing and accounting.
Certain statements in this Prospectus under the captions "Risk Factors --
Dependence on Patents and Proprietary Technology" and "Business -- Patents,"
specifically the second sentence under the former caption and the fifth sentence
under the latter caption, have been reviewed and approved by Knobbe, Martens,
Olson & Bear, LLP, Newport Beach, California, patent counsel for the Company,
and are included herein in reliance upon that review and approval.
AVAILABLE INFORMATION
The Company has filed with the Commission, 450 Fifth Street, N.W.,
Washington, D.C. 20549, a Registration Statement on Form SB-2 under the
Securities Act of 1933, as amended, with respect to the Common Stock being
offered pursuant to this Prospectus. This Prospectus does not contain all the
information set forth in the Registration Statement and the exhibits thereto,
certain parts of which are omitted in accordance with the rules and regulations
of the Commission. For further information, reference is hereby made to the
Registration Statement and the exhibits and financial statements filed as a part
thereof. Statements made in this Prospectus as to the contents of any contract,
agreement or other document referred to are not necessarily complete. With
respect to each such contract, agreement or other document filed as an exhibit
to the Registration Statement, reference is made to the exhibit for a complete
description of the matter involved, and each such statement shall be
55
<PAGE>
deemed qualified in its entirety by such reference. All of these documents may
be inspected without charge at the Commission's principal office at 450 Fifth
Street, N.W., Washington, D.C. 20549, and copies may be obtained therefrom at
prescribed rates.
The Company is subject to certain informational requirements of the
Securities Exchange Act of 1934 and in accordance therewith files periodic
reports, proxy statements and other information with the Commission. Such
reports, proxy statements and other information can be inspected and copied at
the public reference facilities maintained by the Commission at Room 1024, 450
Fifth Street, N.W., Washington, D.C. 20549 or at the Regional Offices of the
Commission at 210 South Dearborn Street, Room 1204, Chicago, Illinois 60604;
5670 Wilshire Boulevard, 11th Floor, Los Angeles, California 90036-3648; and 7
World Trade Center, 13th Floor, New York, New York 10048. Copies of such
material can be obtained at prescribed rates from the Public Reference Section
of the Commission, Room 1024, 450 Fifth Street, N.W., Washington, D.C. 20549. In
addition, copies of such reports, proxy statements and other information
concerning the Company may also be inspected and copied at the library of the
Nasdaq National Market, 1735 K Street, N.W., Washington, D.C. 20006, upon which
the Common Stock of the Company is listed.
The Company intends to furnish its security holders with annual reports
containing audited financial statements and such interim unaudited reports as it
deems appropriate.
56
<PAGE>
INDEX TO FINANCIAL STATEMENTS
<TABLE>
<CAPTION>
PAGE
-----
<S> <C>
Report of Independent Accountants.......................................................................... F-2
Balance Sheet at March 31, 1996............................................................................ F-3
Statement of Operations for the Years Ended March 31, 1995 and 1996........................................ F-4
Statement of Shareholders' Equity for the Years Ended March 31, 1995 and 1996.............................. F-5
Statement of Cash Flows for the Years Ended March 31, 1995 and 1996........................................ F-6
Notes to Financial Statements.............................................................................. F-7
</TABLE>
F-1
<PAGE>
REPORT OF INDEPENDENT ACCOUNTANTS
To the Board of Directors
and Shareholders of
Premier Laser Systems, Inc.
In our opinion, the accompanying balance sheet and the related statements of
operations, shareholders' equity and cash flows present fairly, in all material
respects, the financial position of Premier Laser Systems, Inc. at March 31,
1996, and the results of its operations and its cash flows for each of the two
years in the period ended March 31, 1996, in conformity with generally accepted
accounting principles. These financial statements are the responsibility of the
Company's management; our responsibility is to express an opinion on these
financial statements based on our audits. We conducted our audits of these
statements in accordance with generally accepted auditing standards which
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 the opinion expressed above.
The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. As discussed in Note 4 to the
financial statements, the Company has suffered recurring losses from operations
which raises substantial doubt about its ability to continue as a going concern.
Management's plans in regard to these matters are also described in Note 4. The
financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
PRICE WATERHOUSE LLP
Costa Mesa, California
May 17, 1996
F-2
<PAGE>
PREMIER LASER SYSTEMS, INC.
BALANCE SHEET
<TABLE>
<CAPTION>
MARCH 31,
1996
--------------
<S> <C>
ASSETS
Current assets:
Cash and cash equivalents....................................................................... $ 35,463
Short-term investments (Note 6)................................................................. 4,547,377
Accounts receivable, net of allowance for doubtful accounts of $154,677......................... 508,315
Inventories (Note 7)............................................................................ 2,185,355
Prepaid expenses and other current assets....................................................... 419,504
--------------
Total current assets........................................................................ 7,696,014
Property and equipment, net (Note 8)............................................................ 493,942
Intangibles, net (Note 9)....................................................................... 7,353,462
Other assets (Note 6)........................................................................... 131,150
--------------
$ 15,674,568
--------------
--------------
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable................................................................................ $ 1,208,219
Accrued liabilities (Note 10)................................................................... 188,108
Notes payable to related party (Notes 11 and 12)................................................ 481,195
--------------
Total current liabilities................................................................... 1,877,522
--------------
Commitments and contingencies (Note 14)
Shareholders' equity (Notes 5 and 16):
Preferred stock -- 8,850,000 shares authorized, no shares issued and outstanding
Common stock -- Class A -- no par value, 35,600,000 shares authorized;
4,702,203 shares issued and outstanding........................................................ 16,317,376
Common stock -- Class E-1 -- no par value, 2,200,000 shares authorized;
1,256,818 shares issued and outstanding........................................................ 4,769,878
Common stock -- Class E-2 -- no par value, 2,200,000 shares authorized;
1,256,818 shares issued and outstanding........................................................ 4,769,878
Class A warrants................................................................................ 2,321,057
Class B warrants................................................................................ 376,774
Warrants to purchase Class A common stock....................................................... 192,130
Unrealized holding gain on short-term investments............................................... 3,666,367
Accumulated deficit............................................................................. (18,616,414)
--------------
Total shareholders' equity.................................................................. 13,797,046
--------------
$ 15,674,568
--------------
--------------
</TABLE>
The accompanying notes are an integral part of these statements.
F-3
<PAGE>
PREMIER LASER SYSTEMS, INC.
STATEMENT OF OPERATIONS
<TABLE>
<CAPTION>
YEAR ENDED MARCH 31,
------------------------------
1995 1996
-------------- --------------
<S> <C> <C>
Net sales......................................................................... $ 1,249,403 $ 1,704,390
Cost of sales..................................................................... 1,298,420 3,324,757
-------------- --------------
Gross (loss)...................................................................... (49,017) (1,620,367)
Selling and marketing expenses.................................................... 1,035,863 1,308,767
Research and development expenses................................................. 1,035,705 1,213,471
General and administrative expenses............................................... 1,747,090 1,709,327
-------------- --------------
Loss from operations.......................................................... (3,867,675) (5,851,932)
Interest income (expense), net.................................................... (322,540) 99,037
-------------- --------------
Loss before extraordinary items............................................... (4,190,215) (5,752,895)
Extraordinary gain from extinguishment of indebtedness............................ 381,730
-------------- --------------
Net loss...................................................................... $ (3,808,485) $ (5,752,895)
-------------- --------------
-------------- --------------
Loss per share:
Net loss........................................................................ $ (1.26)
--------------
--------------
Weighted average number of shares outstanding................................... 4,556,959
--------------
--------------
Pro forma loss per share (unaudited):
Loss before extraordinary items................................................. $ (1.59)
Extraordinary gain from extinguishment of indebtedness.......................... .15
--------------
Net loss........................................................................ $ (1.44)
--------------
--------------
Weighted average number of shares outstanding................................... 2,584,722
--------------
--------------
</TABLE>
The accompanying notes are an integral part of these statements.
F-4
<PAGE>
PREMIER LASER SYSTEMS, INC.
STATEMENT OF SHAREHOLDERS' EQUITY
FOR THE YEARS ENDED MARCH 31, 1996 AND 1995
<TABLE>
<CAPTION>
COMMON STOCK COMMON STOCK COMMON STOCK
CLASS A CLASS E-1 CLASS E-2
---------------------- ---------------------- ----------------------- CLASS A CLASS B
SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT WARRANTS WARRANTS
--------- ----------- --------- ----------- ---------- ----------- ---------- ----------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
Balance, March 31, 1994.... 1,432,636 $ 5,372,022 1,268,488 $ 4,756,528 1,268,488 $ 4,756,528
Exercise of common stock
options................. 4,936 2,848 3,011 1,081 3,011 1,081
Common stock issued in
lieu of cash payments... 1,635 13,046 1,447 11,552 1,447 11,552
Common stock forfeited
due to cessation of
employment.............. (7,798) (20,124) (6,905) (17,818) (6,905) (17,818)
Warrants issued in
connection with private
placement units.........
Repurchase of common
stock................... (17,681) (6,910) (15,752) (6,119) (15,752) (6,119)
Initial public offering
of units, net
proceeds................ 2,400,000 7,633,504 $1,622,222 $ 286,274
Conversion of warrants... 186,000
Conversions of certain
related party notes and
associated accrued
interest................ 7,072 28,448 6,260 24,596 6,260 24,596
Conversion of debentures
and associated accrued
interest................ 321,099 1,284,397 272,934 48,165
Exercise of over-
allotment option........ 360,000 1,128,947 239,901 42,335
Net loss.................
--------- ----------- --------- ----------- ---------- ----------- ---------- ----------
Balance, March 31, 1995.. 4,501,899 15,436,178 1,256,549 4,769,820 1,256,549 4,769,820 2,321,057 376,774
Common stock issued for
investment in Mattan
(Note 6)................ 200,000 881,010
Exercise of stock
options................. 304 188 269 58 269 58
Unrealized holding gain
on short-term
investments.............
Net loss.................
--------- ----------- --------- ----------- ---------- ----------- ---------- ----------
Balance, March 31, 1996.... 4,702,203 $16,317,376 1,256,818 $ 4,769,878 1,256,818 $ 4,769,878 $2,321,057 $ 376,774
--------- ----------- --------- ----------- ---------- ----------- ---------- ----------
--------- ----------- --------- ----------- ---------- ----------- ---------- ----------
<CAPTION>
COMMON UNREALIZED
STOCK HOLDING ACCUMULATED
WARRANTS GAIN DEFICIT TOTAL
--------- ---------- ------------ ------------
<S> <C> <C> <C> <C>
Balance, March 31, 1994.... $ 192,130 $ (9,055,034) $ 6,022,174
Exercise of common stock
options................. 5,010
Common stock issued in
lieu of cash payments... 36,150
Common stock forfeited
due to cessation of
employment.............. (55,760)
Warrants issued in
connection with private
placement units......... 186,000 186,000
Repurchase of common
stock................... (19,148)
Initial public offering
of units, net
proceeds................ 9,542,000
Conversion of warrants... (186,000)
Conversions of certain
related party notes and
associated accrued
interest................ 77,640
Conversion of debentures
and associated accrued
interest................ 1,605,496
Exercise of over-
allotment option........ 1,411,183
Net loss................. (3,808,485) (3,808,485)
--------- ---------- ------------ ------------
Balance, March 31, 1995.. 192,130 (12,863,519) 15,002,260
Common stock issued for
investment in Mattan
(Note 6)................ 881,010
Exercise of stock
options................. 304
Unrealized holding gain
on short-term
investments............. $3,666,367 3,666,367
Net loss................. (5,752,895) (5,752,895)
--------- ---------- ------------ ------------
Balance, March 31, 1996.... $ 192,130 $3,666,367 $(18,616,414) $ 13,797,046
--------- ---------- ------------ ------------
--------- ---------- ------------ ------------
</TABLE>
The accompanying notes are an integral part of these statements.
F-5
<PAGE>
PREMIER LASER SYSTEMS, INC.
STATEMENT OF CASH FLOWS
<TABLE>
<CAPTION>
YEAR ENDED MARCH 31,
------------------------------
1995 1996
-------------- --------------
<S> <C> <C>
Cash flows from operating activities:
Net loss........................................................................ $ (3,808,485) $ (5,752,895)
Adjustment to reconcile net loss to net cash used in operating activities:
Depreciation and amortization................................................. 812,196 814,401
Extraordinary gain from extinguishment of debt................................ (381,730)
Amortization of debt discount................................................. 119,230
Exchange of product for clinical studies...................................... (158,250)
Amortization of clinical program expense...................................... 227,000 31,367
Issuance of stock options and stock in lieu of consulting payments............ 36,150
Common stock forfeited upon cessation of employment........................... (55,760)
Provision for doubtful accounts receivable.................................... (151,751)
Changes in operating assets and liabilities:
(Increase) decrease in accounts receivable.................................... 142,591 (92,716)
Increase in inventories....................................................... (21,880) (14,665)
Decrease (increase) in prepaid expenses and other current assets.............. (320,569) 22,468
(Increase) decrease in other assets........................................... 230,793 (6,150)
Increase (decrease) in accounts payable....................................... (411,197) 594,654
(Decrease) increase in accrued liabilities.................................... 28,907 (598,847)
-------------- --------------
Net cash used in operating activities....................................... (3,402,754) (5,312,384)
-------------- --------------
Cash flows from investing activities:
Purchases of property and equipment............................................. (45,785) (219,723)
Note receivable pursuant to strategic alliance agreement (Note 6)............... (125,000)
Patent expenditures............................................................. (204,838) (195,971)
-------------- --------------
Net cash used in investing activities......................................... (250,623) (540,694)
-------------- --------------
Cash flows from financing activities:
Proceeds from exercise of common stock options.................................. 304
Proceeds from issuance of common stock prior to initial public offering......... 5,010
Proceeds from issuance of common stock warrants................................. 186,000
Proceeds from initial public offering and exercise of over-allotment option..... 10,953,183
Cash paid for repurchase of common stock........................................ (19,148)
Proceeds from issuance of notes payable......................................... 1,519,000
Cash paid for repurchase of mandatorily redeemable warrants..................... (285,000)
Principal payments on notes payable............................................. (3,126,195)
-------------- --------------
Net cash provided by financing activities..................................... 9,232,850 304
-------------- --------------
Net (decrease) increase in cash................................................... 5,579,473 (5,852,774)
-------------- --------------
Cash and cash equivalents, beginning of period.................................... 308,764 5,888,237
-------------- --------------
Cash and cash equivalents, end of period.......................................... $ 5,888,237 $ 35,463
-------------- --------------
-------------- --------------
</TABLE>
The accompanying notes are an integral part of these statements.
F-6
<PAGE>
PREMIER LASER SYSTEMS, INC.
NOTES TO FINANCIAL STATEMENTS
1. ORGANIZATION AND NATURE OF OPERATIONS
Premier Laser Systems, Inc. (the Company) was incorporated in July 1991 and
commenced operations in August 1991 after acquiring substantially all of the
assets and certain liabilities of Pfizer Laser Systems (Pfizer), a division of
Pfizer Hospital Products Group, Inc. The Company designs, develops, manufactures
and markets several lines of lasers for surgical and other medical purposes,
laser waveguides and fiber optic devices, disposables and associated accessory
products for the medical market.
The financial statements as of March 31, 1996 and for each of the two years
in the period ended March 31, 1996 give effect to the Company's recapitalization
and reverse stock splits discussed in Note 16.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
REVENUE RECOGNITION
Revenues are recognized when products are shipped to customers.
CASH EQUIVALENTS
Cash equivalents represent short-term, highly liquid investments that have
original maturities of three months or less and are readily convertible to cash.
Such investments consist primarily of U.S. Treasury Notes and commercial paper.
Cost of such investments is equal to the related fair value at March 31, 1996.
SHORT-TERM INVESTMENTS
In fiscal 1995, the Company adopted SFAS 115, "Accounting for Certain
Investments in Debt and Equity Securities." Under SFAS 115, the Company's
investments are classified as "available-for-sale" securities and are reported
at fair market value. Any unrealized holding gains or losses are reported as a
separate component of stockholders' equity. Realized gains and losses are
reported on the specific identification method and are reported in income. The
Company's marketable securities portfolio at March 31, 1996 consists of its
investments in the common stock of Mattan Corporation (see Note 6).
INVENTORIES
Inventories are stated at the lower of cost or market and include material,
labor, and related manufacturing overhead. The Company determines cost using the
first-in, first-out (FIFO) method.
PROPERTY AND EQUIPMENT
Property and equipment are stated at cost. Expenditures for replacements and
improvements are capitalized and expenditures for repairs, maintenance and
routing replacements are charged to operating expense as incurred. When assets
are sold or otherwise disposed of, the cost and related accumulated depreciation
are eliminated from the accounts and any resulting gain or loss is included in
operations.
Depreciation of furniture, machinery and equipment is calculated on a
straight-line basis over the estimated useful lives of the assets ranging from
three to eight years.
INTANGIBLES
Intangible assets consists primarily of patents, technology rights and
license agreements. The costs assigned to acquired intangible assets, based in
part upon independent appraisals, are being amortized on a straight-line basis
over the estimated useful lives of the assets ranging from 2 to 15 years.
Periodically, the Company evaluates the recoverability of intangibles based on
estimated undiscounted future cash flows from operating activities compared with
the carrying values of the intangibles.
F-7
<PAGE>
PREMIER LASER SYSTEMS, INC.
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
RESEARCH AND DEVELOPMENT COSTS
Research and development costs are expensed as incurred. A substantial
portion of the research and development expense is related to developing new
products, improving existing products or processes, and clinical research
programs.
The Company enters into agreements with certain doctors to exchange a
portion of a product's sales price for completion of certain portions of
clinical studies necessary for obtaining product approval by the U.S. Food and
Drug Administration. Typically, the amounts consist of a portion of the product
sales price which is equal to the fair value of the services to be rendered by
the doctor. Pursuant to the agreements, in the event the doctor is unable to
complete the agreed upon clinical study, the doctor is required to remit cash
payment for the entire amount. The amounts are capitalized as prepaid research
and development expense and amortized upon completion of certain milestones of
the clinical study. These studies are generally completed within one year.
Research and development expenses included in prepaid expenses totaled $204,000
at March 31, 1996.
INCOME TAXES
The Company accounts for income taxes in accordance with Statement of
Financial Accounting Standards No. 109 (SFAS 109), ACCOUNTING FOR INCOME TAXES.
SFAS 109 requires the liability method for accounting for income taxes. This
method mandates the recognition of deferred tax liabilities and assets for
expected future tax consequences of temporary differences between the carrying
amounts and tax bases of assets and liabilities.
NET LOSS PER SHARE
Net loss per share was computed based on the weighted average number of the
Company's common shares outstanding during fiscal 1996 and excludes all shares
of Class E-1 and Class E-2 Common Stock, discussed in Note 16, outstanding, or
subject to option, because all such shares of stock are subject to escrow and
the conditions for the release of shares from escrow have not been satisfied.
Common stock equivalents were not considered in the net loss per share
calculation because the effect on the net loss would be antidilutive.
PRO FORMA NET LOSS PER SHARE (UNAUDITED)
Net loss per common share was computed based on the weighted average number
of the Company's common shares outstanding during the fiscal year ended March
31, 1995 after giving retroactive adjustment for the recapitalization discussed
in Note 16 and the conversion of the Company's debentures into units (as defined
in Note 5) which occurred upon completion of the Company's initial public
offering (see Note 5). The effect on net loss per common share of the conversion
of the Company's debentures was to reduce historical net loss by $67,995 and to
increase weighted average shares outstanding by 321,099 shares for the fiscal
year ended March 31, 1995. Class E-1 and E-2 common stock shares, discussed in
Note 16, were excluded from the net loss per share calculation because the
conditions for release of shares from escrow have not been satisfied. Other
common stock equivalents were not considered in the net loss per share
calculation because the effect on the net loss per share would be antidilutive.
Pursuant to Securities and Exchange Commission Staff Accounting Bulletin No. 83,
all stock options and warrants granted and common shares issued within one year
of the Company's initial public offering and not in escrow have been included as
outstanding for the six months ended September 30, 1994 (the date of the most
recent financial statements included in the Company's initial public offering
prospectus) using the treasury stock method.
F-8
<PAGE>
PREMIER LASER SYSTEMS, INC.
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
ACCOUNTING FOR STOCK-BASED COMPENSATION
The Financial Accounting Standards Board has issued Statement of Financial
Accounting Standards No. 123, "Accounting for Stock-Based Compensation" ("SFAS
123"), effective for years beginning after December 15, 1995, which establishes
a fair value-based method of accounting for stock-based compensation plans. The
statement allows companies to continue to use the intrinsic value-based
approach, supplemented by footnote disclosure of the pro forma net income and
earnings per share of the fair value-based approach. The Company intends to
follow this method allowed by SFAS 123.
USE OF ESTIMATES BY MANAGEMENT
The preparation of financial statements in conformity with generally
accepted accounting principles 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
reporting period. Actual results could differ from those estimates.
Significant estimates and assumptions include those made surrounding
inventory valuation and the realizability of certain intangible assets. The
Company's inventory and intangibles largely relate to technologies which have
yet to gain wide spread market acceptance. Management believes no loss will be
incurred on the disposition of its inventory and that the remaining economic
life of the Company's tangible assets is reasonable. If wide spread market
acceptance of the Company's products is not achieved, the carrying amount of
inventory and intangible assets could be materially reduced.
3. SUPPLEMENTAL CASH FLOW INFORMATION
Supplemental disclosures of cash flows information:
<TABLE>
<CAPTION>
YEAR ENDED MARCH 31,
----------------------
1995 1996
----------- ---------
<S> <C> <C>
Cash paid for:
Interest................................................. $ 550,962 $ 52,129
Income taxes............................................. 800 800
</TABLE>
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING ACTIVITIES
In fiscal 1996, the Company issued 200,000 shares of Class A Common Stock in
connection with the acquisition of 1,150,000 shares of Mattan Corporation's
common stock. The value of the Mattan Corporation common stock shares was
$881,010 on the date of the transaction (see Note 6).
Concurrent with the completion of the Company's initial public offering,
certain notes payable to shareholders totaling $66,500 and convertible
debentures totaling $1,500,000, plus related accrued interest, were converted
into 7,072 shares of Class A Common Stock and 6,260 shares of each Class E-1 and
E-2 Common Stock, and 321,099 Units, respectively.
4. BASIS OF PRESENTATION
The Company has suffered recurring losses from operations and may continue
to incur losses for the foreseeable future due to the significant costs
anticipated to be incurred in connection with manufacturing, marketing and
distributing its laser products. In addition, the Company intends to conduct
continuing research and development activities, including regulatory submittals
and clinical trials to develop additional applications for its laser technology.
The Company operates in a highly competitive environment and is subject to all
of the risks inherent in a new business enterprise. The Company is presently
attempting to borrow funds and/or complete a public offering of its common stock
to provide working capital for operations in the near term. The outcome of such
efforts to raise
F-9
<PAGE>
PREMIER LASER SYSTEMS, INC.
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
4. BASIS OF PRESENTATION (CONTINUED)
working capital cannot be assured. The ultimate timeframe in which a sufficient
level of product or market acceptance can be achieved is uncertain. As such,
there is substantial doubt about the Company's ability to continue as a going
concern.
The Company's financial statements have been prepared on the basis of
accounting principles applicable to a going concern. Accordingly, they do not
purport to give effect to adjustments, if any, that may be necessary should the
Company be required to realize its assets and liquidate its liabilities,
contingent liabilities and commitments in other than the normal course of
business at amounts different from those disclosed in the financial statements.
5. INITIAL PUBLIC OFFERING
On December 7, 1994, the Company completed an initial public offering
consisting of 2,400,000 Units of the Company's securities, each unit consisting
of one share of Class A Common Stock, one redeemable Class A Warrant and one
redeemable Class B Warrant (the "Units"). The Company realized net proceeds of
$9,542,000 from this offering. Each Class A Warrant consists of the right to
purchase one share of Class A Common Stock and one Class B Warrant at any time
through the fifth anniversary date of the initial public offering at an exercise
price of $6.50. Each Class B Warrant consists of the right to purchase one share
of Class A Common Stock from the date of issuance through the fifth anniversary
date of the initial public offering's effective date at an exercise price of
$8.00.
On January 12, 1995, the underwriter in the initial public offering
exercised its over-allotment option to purchase 360,000 Units at the initial
public offering price, resulting in net proceeds of $1,411,183 to the Company.
6. STRATEGIC ALLIANCES
In December 1995, the Company entered into a strategic marketing alliance
with Mattan Corporation (Mattan), a Canadian Corporation whose stock is publicly
traded on the Alberta Stock Exchange. The strategic marketing alliance agreement
(the Agreement) stipulates that the Company will supply all laser equipment and
associated disposables for all laser surgery centers to be designed and opened
by Mattan in Canada and the United States. It is anticipated that these surgery
centers will be operated under the name of Medical Laser Institute of America.
In connection with entering into the Agreement, the Company issued 200,000
shares of the Company's Class A Common Stock to certain parties affiliated with
Mattan, who purchased 1,150,000 shares of Mattan's common stock for
approximately $881,010 on the Company's behalf. Prior to March 31, 1996, the
Mattan affiliates sold the 200,000 shares of the Company's Class A Common Stock
and released the shares of the Mattan common stock to the Company. At March 31,
1996, the fair value of this investment totaled approximately $4,547,377 and the
related unrealized holding gain totaled approximately $3,666,367.
In October 1995, the Company entered into a strategic business alliance with
International Biolaser Corporation (IBC). This agreement specifies that the
Company will manufacture IBC's CO(2) and argon lasers and that such products
will be jointly marketed by the two companies. Pursuant to the agreement, the
Company advanced $125,000 to IBC in exchange for a convertible note payable due
in October 1997, bearing interest at 10% per annum and secured by substantially
all of IBC's intangible assets. This note payable is convertible, at the
Company's sole option, into an 80% ownership interest in IBC only after IBC has
repaid certain pre-existing indebtedness.
F-10
<PAGE>
PREMIER LASER SYSTEMS, INC.
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
7. INVENTORIES
Inventories at March 31, 1996 consist of the following:
<TABLE>
<S> <C>
Raw materials.................................. $ 938,560
Work-in-progress............................... 276,998
Finished goods................................. 969,797
----------
$2,185,355
----------
----------
</TABLE>
8. PROPERTY AND EQUIPMENT
Property and equipment at March 31, 1996 consist of the following:
<TABLE>
<S> <C>
Machinery, equipment, molds and tooling........ $1,032,188
Furniture, fixtures and office equipment....... 433,286
----------
1,465,474
Less: accumulated depreciation............... 971,532
----------
$ 493,942
----------
----------
</TABLE>
9. INTANGIBLES
Intangibles at March 31, 1996 consist of the following:
<TABLE>
<S> <C>
Patents and technology rights.................. $9,413,088
License agreements............................. 255,000
Other.......................................... 201,000
----------
9,869,088
Less: accumulated amortization................. 2,515,626
----------
$7,353,462
----------
----------
</TABLE>
10. ACCRUED LIABILITIES
Accrued liabilities at March 31, 1996 consist of the following:
<TABLE>
<S> <C>
Accrued payroll, vacation and related taxes.... $ 96,132
Accrued other.................................. 91,976
----------
$ 188,108
----------
----------
</TABLE>
11. RELATED PARTY TRANSACTIONS
As discussed in Note 1, the Company commenced operations after acquiring
substantially all of the assets and certain liabilities of Pfizer in August
1991. At March 31, 1996, notes payable to Pfizer totaled $481,195 (see Note 12).
Consulting fees aggregating $12,000 and $26,000 for the fiscal years ended
March 31, 1996 and 1995, respectively, were paid to a consultant of the Company,
directly related to an officer of the Company.
12. NOTES PAYABLE TO RELATED PARTY AND EXTRAORDINARY GAIN
Prior to the completion of the initial public offering described in Note 5,
the Company's notes payable to Pfizer amounted to $2,517,390. Pursuant to an
agreement between the Company and Pfizer, the Company paid $1,386,195 of the
notes payable to Pfizer immediately subsequent to the closing of the initial
public offering and Pfizer forgave $650,000 of the total indebtedness. The
remaining balance of $481,195, bearing interest at 10% per annum at March 31,
1996, and related
F-11
<PAGE>
PREMIER LASER SYSTEMS, INC.
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
12. NOTES PAYABLE TO RELATED PARTY AND EXTRAORDINARY GAIN (CONTINUED)
accrued interest are payable in quarterly installments commencing July 8, 1996
with the first principal payment totaling $240,598, plus accrued interest, and
the remaining two quarterly principal payments totaling $120,299, plus accrued
interest. If the Company completes a private or public equity offering which
raises net proceeds of at least $3 million, the note payable balance outstanding
at the time of that offering becomes immediately due and payable. The note
payable to Pfizer is secured by substantially all of the tangible assets and
certain patents of the Company.
In June 1994, notes payable to third parties of $1,500,000 were converted
into convertible debentures. These debentures and related accrued interest were
converted into 321,099 Units concurrent with the closing of the initial public
offering. Also concurrent with the close of the offering, notes payable to
shareholders totaling $66,500 plus related accrued interest were converted into
7,072 shares of Class A Common Stock and 6,260 shares of each Class E-1 and E-2
Common Stock.
In August 1994, the Company completed a private placement of debt units,
whereby $1,550,000 of notes payable bearing interest at 10% per annum (the
"Bridge Notes") and warrants to purchase 1,085,000 shares of Class A common
stock were issued. In connection with this private placement, the Company
incurred placement costs of $201,500 and issued the notes at a discount totaling
$186,000. These notes payable were also paid in full in December 1994.
In connection with the debt forgiven by Pfizer and the extinguishment of the
bridge notes, the Company recognized a net extraordinary gain on extinguishment
of debt totaling $381,730.
13. GRANTS
In September, 1995, the Company obtained a Small Business Innovative
Research Grant totaling approximately $750,000 for the study of laser
emulsification. Pursuant to the terms of the grant, the Company is eligible to
receive reimbursement for research and development costs incurred in connection
with the laser emulsification study up to $750,000 upon the achievement of
certain deliverables, as defined. During fiscal 1996, the Company received
approximately $250,000 under the grant. The amounts received under the grant
were offset against research and development costs incurred in the study.
14. COMMITMENTS AND CONTINGENCIES
COMMITMENTS
The Company leases its facilities and certain equipment under noncancellable
operating leases. Total rental expense for operating leases was $348,059 and
$387,055 for the fiscal years ended March 31, 1996 and 1995, respectively. At
March 31, 1996, future minimum lease payments under noncancellable operating
leases are as follows:
<TABLE>
<CAPTION>
YEAR ENDING MARCH 31,
- -----------------------------------------------------------
<S> <C>
1997................................................... $ 241,536
1998................................................... 244,634
1999................................................... 247,811
2000................................................... 252,448
2001................................................... 250,488
-------------
$ 1,236,917
-------------
-------------
</TABLE>
Pursuant to the Company's facility lease, effective January 1997, the
Company becomes guarantor of a lease agreement between the Company's lessor and
a third party lessee. The guaranteed future minimum lease payments relating to
the third party are $108,456, $111,624, and $85,500 for the years ended March
31, 1997, 1998 and 1999, respectively.
F-12
<PAGE>
PREMIER LASER SYSTEMS, INC.
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
14. COMMITMENTS AND CONTINGENCIES (CONTINUED)
The Company entered into employment agreements with three members of its
executive management team. These agreements provide for two to four months of
severance benefits upon termination of employment. Based upon salary levels as
of March 31, 1996, such severance benefits range from approximately $15,000 to
$33,000 for each of the above members of management.
CONTINGENCIES
The Company entered into an agreement with Infrared Fiber Systems, Inc.
(IFS), as a supplier of certain fiberoptics that expires in the fiscal year
ending March 31, 2002 and requires the supplier to sell exclusively to the
Company fiberoptics for medical and dental applications as long as the Company
purchases defined minimum amounts.
In March 1994, the Company initiated litigation against IFS. The Company's
complaint alleges that IFS and two of its officers misrepresented IFS' ability
to supply optical fibers, and that IFS breached its supply agreement and certain
warranties. In April 1994, IFS filed a cross-complaint alleging breach of
contract and intentional interference with prospective economic advantage,
seeking declaratory relief that the contract has been terminated and that IFS is
free to market its fibers to others. In July 1994, Coherent, Inc., a major
shareholder of IFS and a manufacturer of medical lasers which employ IFS optical
fibers, joined the lawsuit for the express purpose of defending their rights to
the IFS optical fibers. In May 1995, the Company instituted litigation
concerning this dispute in the Orange County, California Superior Court against
Coherent, Westinghouse Electric Corporation ("Westinghouse") and an individual
employee of Westinghouse who was an officer of IFS from 1986 to 1993, when the
events involved in the federal action against IFS took place and while
Westinghouse owned a substantial minority interest in IFS. The complaint charges
that Coherent conspired with IFS in the wrongful conduct which is the subject of
the federal lawsuit and interfered with the Company's contracts and relations
with IFS and with prospective contracts and advantageous economic relations with
third parties. The complaint asserts that Westinghouse is liable for its
employee's wrongful acts as an IFS executive while acting within the scope of
his employment at Westinghouse. The lawsuit seeks injunctive relief and
compensatory damages. In October 1995 the federal action was stayed by order of
the court in favor of the California state court action, in which the pleadings
have been amended to include all claims asserted by the Company in the federal
action. No trial date has been set. The Company believes that the likely
liability of the Company, if any, arising from this litigation would not have a
materially adverse impact upon the Company.
The Company is involved in various disputes and other lawsuits from time to
time arising from its normal operations. The litigation process is inherently
uncertain and it is possible that the resolution of the IFS litigation, disputes
and other lawsuits may adversely affect the Company. It is the opinion of
management, that the outcome of such matters will not have a material adverse
impact on the Company's financial position, results of operations, or cash
flows.
15. INCOME TAXES
The Company incurred losses totaling $5,752,895 and $3,808,485 for fiscal
years ended March 31, 1996 and 1995, respectively. As a result, no provision for
income taxes has been charged to continuing operations during these periods.
F-13
<PAGE>
PREMIER LASER SYSTEMS, INC.
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
15. INCOME TAXES (CONTINUED)
Deferred tax assets at March 31, 1996 are comprised as follows:
<TABLE>
<S> <C>
Accounts receivable reserves........................... $ 62,084
Research and development expenditures capitalized for
tax purposes.......................................... 410,247
Research and development federal tax credits........... 187,436
Depreciation of property and equipment................. 40,289
Net operating loss carryforwards....................... 6,033,150
Other.................................................. 852,876
-----------
Gross deferred tax assets.............................. 7,586,082
Deferred tax asset valuation allowance................. (7,586,082)
-----------
$ --
-----------
-----------
</TABLE>
The net change in the valuation allowance for deferred tax assets was an
increase of approximately $2,634,142 from the balance at March 31, 1995. The
change primarily relates to additional net operating loss carryforwards
generated as well as changes in other deferred assets in fiscal 1996, which were
fully reserved for at March 31, 1996.
At March 31, 1996, the Company had net operating loss carryforwards for
federal income tax purposes totaling approximately $16,319,249 which begin to
expire in fiscal 2007. Operating loss carryforwards for state income tax
purposes totaling approximately $7,895,167 at March 31, 1996 begin to expire in
fiscal 1998. Pursuant to provisions in the Tax Reform Act of 1986, the net
operating loss carryforwards and research and development credits available for
use in any given year may be limited as a result of the significant changes in
stock ownership attributable to the initial public offering.
16. SHAREHOLDERS' EQUITY
COMMON STOCK AND RECAPITALIZATION
On June 11, 1994, the Company effected a recapitalization pursuant to an
Amendment of its Articles of Incorporation. In this recapitalization: (i) the
Company authorized for issuance three new classes of Common Stock, designated as
Class A Common Stock, Class E-1 Common Stock and Class E-2 Common Stock, of
which 35,600,000 shares of Class A Common Stock were authorized, 2,200,000
shares of Class E-1 Common Stock were authorized and 2,200,000 shares of Class
E-2 Common Stock were authorized; (ii) the Company authorized for issuance a new
class of Preferred Stock (having rights, preferences and privileges to be
determined in the future) of which 8,850,000 shares were authorized for
issuance; (iii) the Common Stock outstanding immediately prior to the
recapitalization was reclassified as Class A Common Stock; and (iv) each share
of Common Stock outstanding immediately prior to the recapitalization was
converted, through a reverse stock split, into 0.1292 shares of Class A Common
Stock.
Following the above Amendment of the Articles of Incorporation, the Company
declared a stock split effected as a stock dividend to the holders of its Common
Stock, providing for the issuance of approximately 0.1144 shares of Class E-1
Common Stock and 0.1144 shares of Class E-2 Common Stock for each share of
Common Stock held immediately prior to the recapitalization.
As a result of this recapitalization and stock split, each share of the
Company's outstanding Series A Preferred Stock and Series B Preferred Stock was
converted into 0.1292 shares of Class A Common Stock, 0.1144 shares of Class E-1
Common Stock and 0.1144 shares of Class E-2 Common Stock. Conversion of Series A
and Series B Preferred Stock into Class A Common Stock, Class E-1 Common Stock
and Class E-2 Common Stock was effected upon the closing of the Company's
initial public offering.
F-14
<PAGE>
PREMIER LASER SYSTEMS, INC.
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
16. SHAREHOLDERS' EQUITY (CONTINUED)
On October 20, 1994, the Company voted to effect a 7:1 reverse stock split
pursuant to an amendment of its Articles of Incorporation. As a result thereof,
the shares of Series A Common Stock, E-1 Common Stock, and E-2 Common Stock,
discussed above, were reduced in number by a factor of 0.7.
STOCK OPTION PLANS AND WARRANTS
The Company has adopted several stock option plans that authorize the
granting of options to employees, officers and/or consultants to purchase shares
of the Company's Class A Common Stock. The stock option plans are administered
by the Board of Directors or a committee appointed by the Board of Directors,
which determines the terms of the options, including the exercise price, the
number of shares subject to option and the exercisability of the option. The
options are generally granted at the fair market value of the shares underlying
the options at the date of the grant and expire within ten years of the grant
date.
In addition to options granted pursuant to the stock option plans, the
Company has issued to certain Board of Directors members, consultants and former
notes payable holders warrants to purchase shares of the Company's Class A
Common Stock.
A summary of the activity related to stock options and warrants for the
fiscal years ended March 31, 1995 and 1996 is as follows:
<TABLE>
<CAPTION>
WARRANT/OPTION
PRICE PER
SHARES SHARE
----------- --------------
<S> <C> <C>
Outstanding at March 31, 1994......................... 228,590 $ 1.00-17.69
Granted............................................... 1,733,650 5.00- 6.50
Exercised............................................. (1,535) 1.00- 1.77
Cancelled............................................. (50,872) 8.85
----------- --------------
Outstanding and exercisable at March 31, 1995......... 1,909,833 1.00-17.69
Granted............................................... 705,700 4.63- 5.63
Exercised............................................. (304) 1.00
Cancelled............................................. (31,236) 1.00-11.06
----------- --------------
Outstanding at March 31, 1996......................... 2,583,993 $ 1.00-17.69
----------- --------------
----------- --------------
</TABLE>
Warrants to purchase 89,357 shares of the Company's common stock issued in
connection with the acquisition of certain patents and technology rights during
fiscal 1994 will expire by December 31, 1998 and the warrants to purchase 9,044
shares of common stock issued to a related party will expire by March 31, 1997.
Effective December 30, 1993, the Company issued warrants to purchase 50,872
shares of common stock, under the 1993 Limited Warrant Plan, with an exercise
price of $8.85 per share for services rendered by consultants in connection with
the acquisition of technology rights. In January 1995, the warrant holders
exercised their right to receive a cash payment of $285,000, an amount equal to
the liability owed to the consultants on the date of issuance in exchange for
and cancellation of the warrants.
In connection with the initial public offering in December, 1994 and
exercise of the underwriter's over-allotment option, the Company issued
2,760,000 of each of Class A Warrants and Class B Warrants. Both the Class A and
Class B Warrants will expire in November 1999.
F-15
<PAGE>
PREMIER LASER SYSTEMS, INC.
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
16. SHAREHOLDERS' EQUITY (CONTINUED)
The Company has the right, commencing three years from the November 30,
1994, the effective date of the initial public offering, to redeem the Class A
and Class B Warrants at a price of $.05 per warrant subject to certain
conditions regarding the bid price of the Class A Common Stock.
CLASS E-1 AND CLASS E-2 COMMON STOCK
The Company's Class E-1 Common Stock and Class E-2 Common Stock are held in
escrow, are not transferable, can be voted and will be converted into Class A
Common Stock only upon the occurrence of specified events. All the Class E-1
Common Stock shares will be automatically converted into Class A Common Stock
shares in the event that: (1) the Company's net income before provision for
income taxes, as defined, amounts to at least $4,800,000 for the years ending
March 31, 1995 or 1996, or at least $5,500,000, $6,850,000, $8,425,000,
$9,900,000 for the fiscal years ending March 31, 1997 through 2000,
respectively, provided that if additional shares are issued earnings must
increase proportionately; or (2) the closing price, as defined, of the Company's
Class A Common Stock shall average in excess of $15.00 for any 30 consecutive
trading days during the 18 months following the November 30, 1994 effective date
of the Company's initial public offering or average in excess of $19.25 for any
30 consecutive trading days during the period commencing with the nineteenth
month after November 30, 1994 and ending 36 months from that date. If none of
the above events occur, the Class E-1 Common Stock shares will be cancelled by
the Company on June 30, 2000. All of the Class E-2 Common Stock shares will be
automatically converted into Class A Common Stock shares in the event that: (1)
the Company's net income before provision for income taxes, as defined, amounts
to at least $8,625,000 for the years ending March 31, 1995 or 1996 or at least
$11,800,000, $14,750,000, $20,475,000 or $26,750,000 for the years ending March
31, 1997 through 2000, respectively, provided that if additional shares are
issued earnings must increase proportionally; or (2) the closing price, as
defined, of the Company's Class A Common Stock shall average in excess of $19.75
for any 30 consecutive trading days during the 18 months following the November
30, 1994 effective date of the Company's initial public offering or average in
excess of $24.00 for any 30 consecutive trading days during the period
commencing with the nineteenth month after November 30, 1994 and ending 36
months from November 30, 1994. If none of the above events occur, the Class E-2
Common Stock shares will be cancelled by the Company on June 30, 2000.
The Company will, in the event of the release of the Class E-1 Common Stock
and Class E-2 Common Stock, recognize during the period in which the earnings
thresholds are met or such minimum bid prices are achieved, a substantial
noncash charge to earnings equal to the fair value of such shares on the date of
their release, which would have the effect of significantly increasing the
Company's loss or reducing or eliminating earnings, if any, at such time.
17. CONCENTRATION OF CREDIT RISK AND FOREIGN SALES
The Company generates revenues principally from sales in the medical field.
As a result, the Company's accounts receivable are concentrated primarily in
this industry. In addition, sales to one customer represented 10% of the
Company's sales in fiscal 1996 and 11% to a different customer in fiscal 1995.
Sales in foreign countries accounted for approximately 40% and 63% of the
Company's total sales in fiscal 1996 and 1995, respectively. These foreign sales
related almost entirely to sales in Asia and Europe.
The Company performs ongoing credit evaluations of its customers and
generally does not require collateral. Generally, letters of credit are obtained
on international sales. The Company maintains reserves for potential credit
losses and such losses have been within management expectations.
F-16
<PAGE>
PREMIER LASER SYSTEMS, INC.
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
17. CONCENTRATION OF CREDIT RISK AND FOREIGN SALES (CONTINUED)
INSIDE BACK COVER
CORPORATE COMMITMENTS
From Research and Development To Customer Satisfaction, Premier Laser Systems,
Inc. ...
Four photographs, including corporate headquarters
F-17
<PAGE>
- -------------------------------------------
-------------------------------------------
- -------------------------------------------
-------------------------------------------
NO DEALER, SALESPERSON OR ANY OTHER PERSON HAS BEEN AUTHORIZED TO GIVE ANY
INFORMATION OR TO MAKE ANY REPRESENTATION IN CONNECTION WITH THIS OFFERING OTHER
THAN THOSE CONTAINED IN THIS PROSPECTUS AND, IF GIVEN OR MADE, SUCH INFORMATION
OR REPRESENTATION MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE
COMPANY OR ANY OF THE UNDERWRITERS. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER
TO SELL OR SOLICITATION OF ANY OFFER TO BUY BY ANYONE IN ANY JURISDICTION IN
WHICH SUCH OFFER TO SELL OR SOLICITATION IS NOT AUTHORIZED, OR IN WHICH THE
PERSON MAKING SUCH OFFER OR SOLICITATION IS NOT QUALIFIED TO DO SO, OR TO ANY
PERSON TO WHOM IT IS UNLAWFUL TO MAKE SUCH OFFER OR SOLICITATION. NEITHER THE
DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE HEREUNDER SHALL UNDER ANY
CIRCUMSTANCES CREATE ANY IMPLICATION THAT THE INFORMATION CONTAINED HEREIN IS
CORRECT AS OF ANY TIME SUBSEQUENT TO THE DATE HEREOF.
------------------
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
-----
<S> <C>
Prospectus Summary............................. 3
Risk Factors................................... 6
Use of Proceeds................................ 13
Price Range of Common Stock.................... 14
Dividend Policy................................ 14
Capitalization................................. 15
Selected Financial Data........................ 16
Management's Discussion and Analysis of
Financial Condition and Results of
Operations.................................... 17
Business....................................... 22
Management..................................... 40
Principal Shareholders......................... 47
Certain Transactions........................... 48
Description of Securities...................... 49
Shares Eligible for Future Sale................ 53
Underwriting................................... 54
Legal Matters.................................. 55
Experts........................................ 55
Available Information.......................... 55
Index to Financial Statements.................. F-1
</TABLE>
[LOGO]
2,500,000 SHARES
COMMON STOCK
--------------
PROSPECTUS
--------------
RODMAN & RENSHAW, INC.
, 1996
- -------------------------------------------
-------------------------------------------
- -------------------------------------------
-------------------------------------------