<PAGE>
Filed Pursuant to Rule 424(b)(1)
Registration Statement No. 333-69207
2,000,000 Units
[LOGO OF CARESIDE]
This is an initial public offering of 2,000,000 units. The offering price per
unit is $7.50. Each unit consists of:
. one share of common stock; and
. one redeemable common stock purchase warrant.
This prospectus also relates to warrants to purchase up to 200,000 units,
exercisable for $9.00 each, which the representatives of the underwriters will
receive as part of their compensation in connection with the offering, and to
the 2,200,000 shares of common stock which will be received in the future if
warrants included in all of the units are exercised at $9.00 each. If all of
the warrants are exercised, Careside will receive $21,600,000.
The common stock, warrants and units have been approved for listing on the
American Stock Exchange under the symbols "CSA", "CSA.WS" and "CSA.U",
respectively. Prior to this offering, there has been no public market for the
common stock, warrants or units.
Investing in the units involves significant risks. See "Risk Factors"
beginning on page 7.
<TABLE>
<CAPTION>
Per Unit/Warrant Total
---------------- -----------
<S> <C> <C>
Offering price of units........................... $7.50 $15,000,000
Underwriting discount on units.................... $0.46 $ 920,000
Proceeds to Careside from the sale of units....... $7.04 $14,080,000
</TABLE>
In addition, we have granted a 45-day option to the underwriters to purchase
up to 300,000 additional units to cover over-allotments.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or determined if
this prospectus is truthful or complete. Any representation to the contrary is
a criminal offense.
----------------
Paulson Investment Company, Inc.
Millennium Financial Group, Inc.
marion bass securities corporation
June 16, 1999
<PAGE>
[Inside Front Cover]
[CARESIDE LOGO] THE CARESIDE SYSTEM IS A PROPRIETARY BLOOD TESTING
SYSTEM. IT INCLUDES THE CARESIDE ANALYZER(TM) AND
DISPOSABLE TEST CARTRIDGES.
CARESIDE ANALYZER(TM) [Photo of CareSide
Analyzer and
Cartridges]
(A) CHEMISTRY
The CareSide (B) ELECTROCHEMISTRY
Analyzer(TM) combines (C) IMMUNOCHEMISTRY
multiple testing (D) COAGULATION
methodologies.
[Photo Close-up of [Photo of Different
Cartridge] Cartridges]
THE CARESIDE CARTRIDGE
The proprietary test cartridges have unique design
features.
COMPREHENSIVE MENU LOW COST EASE OF USE
At launch, Careside The Careside system's A non-technical
expects to offer more approach to testing is individual with
than 50 tests. This designed to produce a simple training can
would be the most rapid test result at a easily operate the
comprehensive menu for a competitive price. CareSide
single point-of-care Analyzer(TM).
system.
----------------
We have not yet commercialized the Careside system. We currently have 31
tests cleared or exempt for professional laboratory use by the United States
Food and Drug Administration. We plan to complete development and seek to
obtain FDA clearance or exemption for additional tests and uses prior to
commercial introduction.
Careside(TM), CareSide Analyzer(TM) and Careside's logo are our trademarks
for which registration applications have been filed with the United States
Patent and Trademark Office. All other tradenames, trademarks or servicemarks
appearing in this prospectus are the property of their respective owners and
are not our property.
2
<PAGE>
PROSPECTUS SUMMARY
The following summary highlights information from this prospectus. Because
this is a summary, it does not contain all of the information that you should
consider before investing in the units. You should read the entire prospectus
carefully, including the "Risk Factors" section, the financial statements and
the notes to those financial statements.
Careside
Careside has developed and plans to sell a proprietary blood testing system
called the Careside system. It is designed to decentralize laboratory
operations. The system consists of a testing instrument called the CareSide
Analyzer and disposable test cartridges. It performs blood tests in the same
location as the patient, or what is commonly called point-of-care testing.
Blood testing is a significant part of routine and critical patient care.
Today, almost all blood testing is done by sending the blood samples to
hospital or commercial laboratories. Because of transportation time and several
processing steps, these central laboratories generally take between 4 and 24
hours to provide test results to the doctor. We believe that the Careside
system provides the platform for solving the limitations of central blood
testing laboratories and redefines the market for point-of-care testing. Here
are the reasons why:
. Cost-Effective Results -- Our system is designed to provide test results
that are cost competitive with both hospital and commercial
laboratories.
. Rapid Test Results -- Our system produces test results within 10 to 15
minutes from the time the blood is drawn from the patient.
. Comprehensive Test Menu -- We believe that our planned menu of tests
represents over 80% of all blood tests ordered on an out-patient basis,
including all of the most commonly ordered blood tests.
. Ease of Use -- Our system is designed for use by non-technical
personnel, with only simple training.
. Industry Standard Technology -- Our system uses the same test methods
and technology as large testing devices in hospital and commercial
laboratories.
. Embedded Quality Assurance/Quality Control -- Our system captures all
data required to comply with regulations governing laboratory
operations, including those under the Clinical Laboratory Improvement
Amendments of 1988.
. Ability for Practice Enhancement -- By providing rapid test results for
a broad menu of tests, our system will enable doctors to treat patients
more quickly, see more patients, improve office productivity and improve
patient satisfaction and quality of care. In addition, healthcare
providers can increase their revenue by performing and billing for tests
themselves.
Our goal is to make decentralized testing with the Careside system the
standard for routine and critical care blood testing.
The Careside System Status
The FDA has already granted pre-market clearance for the CareSide Analyzer
and clearance or exemption for 31 blood tests for professional laboratory use.
We recently filed three additional blood tests for clearance. Our commercial
product launch is planned for the fourth quarter of 1999. We expect to have the
CareSide Analyzer and a comprehensive menu of over 50 tests cleared or exempt
at that time.
3
<PAGE>
We intend to complete pilot site marketing studies by the end of the third
quarter of 1999. These studies will demonstrate our system's cost-effectiveness
and how potential customers will use it. We have arranged pilot site studies
with APRIA Healthcare in the home care services market, three hospitals
affiliated with Child Health Corporation of America in the hospital market,
Reliant Care Group, L.L.C. in the nursing home market and SmithKline Beecham
Clinical Laboratories, Inc. for its own use. We are also arranging pilot site
studies with several group practices located in Arizona and California.
Market Opportunity
The lack of timely test results from central laboratories has given rise to a
growing market for point-of-care tests. According to 1997 industry data and
estimates, the worldwide product market for testing of blood and other bodily
fluids and tissues was $18.3 billion in 1997 and was expected to grow to $20
billion in 2000. Based on their prior industry experience, our senior
management believes that the Careside system's 50 test menu will address over
38% of this market. The rest of the market includes complex and specialized
tests not performed by the Careside system. The U.S. and Canadian market is
approximately 40% of the worldwide market. Our initial marketing efforts will
be targeted towards converting U.S. and Canadian blood testing to point-of-care
testing.
Early History
SmithKline Beecham Clinical Laboratories, Inc. conducted extensive surveys of
the point-of-care market beginning in 1993. As a result, in 1994, SmithKline
started our predecessor business to develop the technology we use. We acquired
this business in November 1996. Several senior members of SmithKline's
management team, including the President of SmithKline Beecham Clinical
Laboratories, worked on this point-of-care project at SmithKline. They are now
part of the executive management team of Careside.
Careside was incorporated in the State of Delaware in July 1996 under the
name Exigent Diagnostics, Inc. In May 1998, we changed our name to Careside,
Inc. Our principal executive offices are located at 6100 Bristol Parkway,
Culver City, California 90230 and our telephone number is (310) 338-6767.
4
<PAGE>
The Offering
Except as otherwise indicated, all information in this prospectus assumes no
exercise of the underwriters' over-allotment option or the representatives'
warrants, and has been adjusted to give effect to a 1-for-5.2 reverse stock
split.
<TABLE>
<C> <S>
Securities Offered ....... 2,000,000 units. Each unit consists of one share of
common stock and one warrant to purchase an
additional share of common stock. The units will
automatically separate 30 days from the date of
this prospectus, after which the common stock and
warrants in the units will trade separately.
Warrants.................. The warrants included in the units will be
exercisable commencing 30 days after the offering.
The exercise price of a warrant is $9.00. They
expire on the fifth anniversary of the date of this
prospectus. If the closing price of our common
stock on each of the ten consecutive trading days
preceding our notice of redemption is at least
$14.00, we may redeem some or all of the
outstanding warrants if we provide the holders with
30 days' prior written notice. The redemption price
will be $0.05 per warrant. No redemption can occur
until six months after the date of this prospectus.
Common Stock Outstanding.. 5,084,340 shares of common stock were outstanding
before the offering. After the offering, there will
be 7,084,340 shares outstanding. Both of these
numbers exclude 2,108,377 shares of common stock
issuable upon exercise of options and warrants
which are outstanding or will be outstanding
immediately after the offering. After the offering,
there will also be another 2,000,000 shares of
common stock issuable upon exercise of warrants
included in the units.
Dividend Policy........... We do not plan to pay cash dividends in the
foreseeable future.
Use of Proceeds........... We expect to use the proceeds from the offering,
which will be approximately $12,480,000, to:
. complete product development, launch our product
and cover related expenses;
. purchase manufacturing equipment and expand our
facilities; and
. build inventory and provide working capital.
</TABLE>
<TABLE>
<S> <C>
American Stock Exchange Symbol for Common Stock.......................... CSA
American Stock Exchange Symbol for Warrants.............................. CSA.WS
American Stock Exchange Symbol for Units................................. CSA.U
</TABLE>
5
<PAGE>
Summary Financial Data
The following table presents summary financial information for Careside and
the predecessor business at SmithKline Beecham Clinical Laboratories, Inc. The
as adjusted balance sheet data reflects the sale by Careside of 2,000,000 units
in the offering at $7.50 per unit and the use of the net proceeds as set forth
in "Use of Proceeds" on page 15. You should read this data together with the
financial statements and related notes included in this prospectus.
<TABLE>
<CAPTION>
Predecessor Business
------------------------------------
Year ended Ten months
December 31, ended
----------------------- October 31,
1994 1995 1996
----------- ----------- -----------
(unaudited)
<S> <C> <C> <C>
Statement of
Operations Data:
Operating
expenses:
Research and
development..... $ 949,346 $ 2,109,802 $ 3,054,503
General and
administration.. 26,069 585,058 224,399
--------- ----------- -----------
Operating loss.. $(975,415) $(2,694,860) $(3,278,902)
========= =========== ===========
Net interest
income
(expense).......
Net loss.........
Net loss per
share...........
Shares used in
computing net
loss per share..
<CAPTION>
Careside, Inc.
-------------------------------------------------------------------------------
Period from Period from
Inception Inception
(July 10, Year ended Three months (July 10,
1996) to December 31, ended March 31, 1996) to
December 31, ------------------------- ------------------------- March 31,
1996 1997 1998 1998 1999 1999
------------- ------------ ------------ ------------ ------------ -------------
(unaudited) (unaudited)
<S> <C> <C> <C> <C> <C> <C>
Statement of
Operations Data:
Operating
expenses:
Research and
development..... $ 1,561,847 $ 5,895,465 $ 8,297,974 $ 1,541,119 $ 2,076,046 $ 17,831,332
General and
administration.. 55,515 640,574 850,129 196,595 569,907 2,116,125
------------- ------------ ------------ ------------ ------------ -------------
Operating loss.. (1,617,362) (6,536,039) (9,148,103) (1,737,714) (2,645,953) (19,947,457)
Net interest
income
(expense)....... (20,809) 205,256 211,814 17,857 (359,724) 36,537
------------- ------------ ------------ ------------ ------------ -------------
Net loss......... $(1,638,171) $(6,330,783) $(8,936,289) $(1,719,857) $(3,005,677) $(19,910,920)
============= ============ ============ ============ ============ =============
Net loss per
share........... $ (2.25) $ (2.04) $ (1.93) $ (0.49) $ (0.59)
============= ============ ============ ============ ============
Shares used in
computing net
loss per share.. 728,465 3,098,980 4,629,916 3,521,808 5,084,340
============= ============ ============ ============ ============
</TABLE>
<TABLE>
<CAPTION>
Careside, Inc.
----------------------------------------
March 31, 1999 (unaudited)
----------------------------------------
Pro Forma
Actual Pro Forma As Adjusted
------------ ------------ ------------
<S> <C> <C> <C>
Balance Sheet Data:
Cash and cash equivalents............ $ 2,051,786 $ 2,051,786 $14,531,786
Total assets......................... 7,248,753 7,248,753 19,728,753
Long-term debt, including current
portion............................. 3,996,763 2,996,763 2,996,763
Deficit accumulated during
development stage................... (19,910,920) (19,910,920) (20,241,034)
Total stockholders' equity........... 1,143,468 2,164,071 14,644,071
</TABLE>
6
<PAGE>
RISK FACTORS
An investment in the units involves many risks. These risks may be
substantial and are inherent in the business of Careside. You should carefully
consider the following information about these risks, together with the other
information in this prospectus, before buying units.
If any of the following risks actually occur, our business and prospects
could be materially adversely affected, the trading price of our units, common
stock or warrants could decline, and you might lose all or part of your
investment.
We Have a Limited Operating History and Have Not Generated any Revenue
Careside was formed in 1996 and has not generated any revenue. We have
incurred net losses of approximately $20 million from inception through March
31, 1999. We will not generate any revenue from product sales and will continue
to incur significant additional operating losses until we complete the
development of our test menu, receive necessary FDA clearances, expand our
manufacturing and marketing efforts, manufacture our products according to
regulations prescribed by the FDA, and begin selling the Careside system.
The Offering May Not Raise Sufficient Funds to Meet Our Goals
The offering may not provide sufficient funds to fully implement our business
plan. We anticipate that the estimated net proceeds from the offering, together
with revenue expected after 1999 and proceeds of our current equipment lease
financing, will be sufficient to fund our operating expenses and capital
requirements for at least 12 months. However, these expenses and requirements
may change. If sufficient funds are not raised or revenues are not sufficient,
we may have to reduce our initial marketing expenses or product development
activities. In addition, we may not be able to meet our obligations to our
suppliers and strategic partners during this 12 month period. See "Management's
Discussion and Analysis of Financial Condition and Results of Operations--
Liquidity and Capital Resources" on page 20.
Additional Funding May Not Be Available
We intend to draw on existing availability under our equipment lease facility
or, if necessary, seek additional lease financing, to fund our purchase of
equipment for our automated cartridge assembly line. Additional funding for our
activities may come from the exercise of warrants included in units sold in the
offering. We also may seek additional financing to build inventory and to
refinance our bridge loan. To support our current and any future funding
requirements, we may need to issue additional equity securities, incur more
debt, obtain added lease financing and/or seek third-party collaboration
opportunities. Additional funding may have unacceptable terms or may not be
available at all for reasons relating to:
.Careside's inability to meet its business plan, or
.changes in lenders' or investors' views of medical device or small
capitalization companies.
If adequate funds are not available, we may be required to delay, reduce or
eliminate product development programs or to license to third parties rights to
commercialize our products or technologies.
We May Never Be Profitable
Even if we are able to generate revenue from sales of the Careside system, we
may never be profitable. There are several reasons why this might happen:
.We could build up our overhead in anticipation of sales goals that are not
met.
.We may not be able to reduce our manufacturing costs to acceptable levels.
.We may have to lower our prices to remain competitive.
.We may experience delays in developing additional tests or product
upgrades.
.We may experience problems in production, distribution or marketing.
Medical Community May Not Accept the Careside System
The CareSide Analyzer and related test cartridges are our only products. We
will not be able to operate profitably unless these products achieve a
significant level of market acceptance. The following factors are the greatest
risks to our market acceptance:
7
<PAGE>
We May Fail to Develop the Comprehensive Test Menu Needed to Sell Our Product
If we are not able to fully develop our proposed comprehensive test menu,
customers may not buy our products. One of our major selling points to
potential customers will be the breadth of our menu.
We May Be Unable to Change How Tests are Ordered
We may not be able to demonstrate the economic or clinical benefits of the
Careside system sufficiently to convince members of the medical community to
change the way they order tests. Currently, physicians and hospitals typically
order blood tests from central laboratories.
Managed Care Contracts May Limit Our Market Penetration
Our ability to sell to healthcare providers may be limited by managed care
relationships. Many health maintenance and managed care organizations have
exclusive contracts with laboratories that require participating or employed
physicians to send patient specimens only to contracted laboratories.
Consequently, such physicians may be precluded from using the Careside system
unless they obtain a waiver from the relevant health maintenance or managed
care organization.
We May Be Unable to Keep Pace With Changing Technology
Blood testing technology is evolving. Other companies may develop products in
response to technological changes that make our products noncompetitive,
particularly if the development, introduction or marketing of our products is
delayed.
CLIA May Discourage Healthcare Providers from Using Point-of-Care Testing
Careside system users will be required to be licensed under the Clinical
Laboratory Improvement Amendments of 1988. While the Careside system is
designed to make licensure easy, CLIA licensing requirements may make
healthcare providers reluctant to initiate, continue or expand patient testing
using the Careside system.
Failure to Obtain Point-of-Care Use Designation Will Limit Our Market
Opportunity
The Careside system is not currently authorized for point-of-care use or
physician office laboratory use. It is authorized for professional laboratory
use. Professional laboratories include hospital, commercial and independent
laboratories. As a result, we are presently unable to sell to an important
segment of our market. Clearance for point-of-care use and physician office
laboratory use from the FDA is necessary to expand our potential market beyond
professional laboratories. We will seek these clearances for the CareSide
Analyzer in the third quarter of 1999.
We May Not Be Able to Develop Our Products
In order for us to expand our test menu, we must complete the development of
one of the four types of disposable cartridges. Factors outside our control may
delay our proposed development schedules by one year or more. These factors
include:
.delays in regulatory clearance,
.technological difficulties,
.restrictions on access to proprietary technology of strategic partners,
and
.changes in the healthcare, regulatory or reimbursement environment.
Reductions in Third-Party Reimbursement For Tests May Hurt Our Business
Government authorities, private health insurers and other third-party payers,
such as health maintenance organizations may not reimburse providers for our
products' tests. Current reimbursement amounts for diagnostic tests may not be
maintained. Any decrease in test reimbursement amounts may reduce the demand
for our products or force us to lower our sales prices. In addition,
legislative proposals to reform healthcare and the trend toward managed
healthcare in the United States may require lower prices for our products. See
"Business--Third Party Reimbursement" on page 40.
8
<PAGE>
We Have No Sales, Marketing or Distribution Experience
We may not be able to recruit or retain direct sales and marketing personnel
who will successfully implement our marketing strategy. We have no sales,
marketing or distribution experience. We intend to distribute our products in
the United States primarily through our own sales force, and internationally
through a limited number of distributors. Establishing a sales and marketing
capability will require substantial efforts and significant resources.
Third-Party Distributors May Not Be Effective
We will depend on third party distributors to assist us in promoting market
acceptance and creating demand for our products. We have an exclusive
distribution arrangement with SmithKline Beecham Clinical Laboratories, Inc.
for the commercial laboratory market in the United States and certain foreign
countries. We have also granted Fuji a right of first refusal to distribute the
Careside system exclusively in Japan and non-exclusively in some of the other
Asian countries. We will need additional arrangements to distribute our
products worldwide. We may not be able to maintain these arrangements or enter
into additional distribution arrangements. In addition, we have little control
over the resources that the distributors will devote to the marketing of the
Careside system. See "Business--Marketing Strategy" on page 34 and "Certain
Transactions--SmithKline Beecham" on page 53.
A Pending Acquisition of SBCL Adds to Uncertainties in Our Commercial
Laboratory Market
Quest Diagnostics Incorporated and SmithKline Beechem Clinical Laboratories,
Inc. have announced that Quest is acquiring all of the stock of SBCL. Quest
will succeed to our distribution agreement with SBCL. We have had no prior
business relationship with Quest and are currently discussing with Quest their
intentions with respect to distribution of our products under this agreement.
Just as SBCL could, Quest may choose to distribute our products, terminate the
SBCL agreement or refrain from distributing our products in select areas.
Our Contract Manufacturers May Not Adequately Meet Our Future Product Demand
We will depend upon outside vendors to manufacture most of the Careside
system, including the CareSide Analyzer and components of the disposable
testing cartridges. We will have only limited control over third-party
manufacturers as to quality control and timing of production and delivery. We
cannot be certain that outside manufacturers will be able to provide us with a
sufficient number of instruments and cartridge components on a timely basis.
Our Lack of Manufacturing Experience Could Reduce Our Ability to Assemble
Cartridges
We will be assembling the cartridges at Careside. We have never operated a
manufacturing/assembly business. We will need to assemble significant and
increasing quantities of test cartridges on a timely basis, while maintaining
strict quality standards. As volume dictates, we will convert from manual
production of cartridge components and assembly to an automated system which we
are currently building. We may not be able to achieve and maintain product
accuracy and reliability when producing the cartridges in the quantities
required, on a timely basis or at an acceptable cost.
Our Third-Party Suppliers Could Interrupt Our Supply
We will purchase the materials used in the test cartridges from outside
suppliers, such as Fuji Photo Film Co., Ltd. Each of our supply agreements has
termination rights. Any interruption in supply would adversely affect our
schedule. See "Business--Manufacturing and Supply" on page 38.
9
<PAGE>
Our Ability to Add Hematology Testing Capabilities Depends on Third Parties
The CareSide Analyzer does not perform hematology tests, which are an
important part of point-of-care testing. We are negotiating arrangements for a
third party to supply hematology testing capabilities in an additional device.
We may not be able to agree upon pricing that will enable us to offer cost-
effective hematology testing. In addition, our third party developer has not
yet completed the interface between the hematology device and the CareSide
Analyzer. See "Business--The Careside System--Test Menu" on page 32.
Our CEO and Other Key Personnel Are Critical To Our Success
The loss of key employees or unsuccessful recruiting efforts will harm us.
Competition for qualified and talented individuals with experience in point-of-
care testing is intense. Our success depends on our ability to retain the
services of Mr. Stoughton, our Chairman of the Board of Directors and Chief
Executive Officer, and Dr. Grove, Executive Vice President--Research and
Development. Mr. Stoughton has over 20 years experience as a senior executive
of several large hospitals and over four years experience as President of
SmithKline Beecham Clinical Laboratories, Inc. Dr. Grove managed research and
development activities at SmithKline Beecham Clinical Laboratories, Inc. for 12
years and has extensive experience in the development of diagnostic tests. We
also need to attract additional sales and marketing, research and development,
and experienced manufacturing personnel. See "Management--Employment
Agreements" on page 49.
We May Not Be Able to Manage Our Expanding Operations
We will need to expand our operations if we are successful in achieving
market acceptance for the Careside system. This expansion will result in
additional responsibilities for management and place significant demand upon
our management, our operating and financial systems and our resources. To
accommodate this growth and to compete effectively, we will need to implement
and improve our internal operating systems and controls, and to hire and train
additional personnel.
Our Competitors Have Advantages Over Us
Our business may fail because our market is highly competitive. Our primary
competitors are large diagnostic device manufacturers, commercial and hospital
laboratories and other point-of-care device manufacturers. The large device
manufacturers and commercial and hospital laboratories have significant
marketing, manufacturing, financial and managerial resources, and have
substantially greater research and development capabilities than we do. We
expect that manufacturers of conventional blood testing products used in
centralized laboratories will compete intensely with us to maintain their
market share. Commercial and hospital laboratories may try to influence
providers against the Careside system to protect their revenue. Other point-of-
care companies have already sold their product in the marketplace. We
anticipate competition from these manufacturers in discrete tests using areas
such as critical care testing. Many of these companies offer tests that will
cost less than the Careside system and so may be attractive to some of our
customers. See "Business--Competition" on page 39.
Our Proprietary Technology is a Crucial Part of Our Business
The success of our business will depend on our ability to protect our
proprietary technology. Our business may fail if we are not able to do so.
We Do Not Have Any Patents on Our Proprietary Technology
We have two U.S. patent applications which have been allowed and are expected
to be issued as U.S. patents. We have submitted five additional U.S. and two
international patent applications, and one joint patent application with a
strategic contract partner. We intend to file additional U.S. and international
patent applications. We cannot be certain that any patent application will
result in the issuance of a patent or that our patents will withstand any
challenges by third parties.
10
<PAGE>
Our Technology May Infringe on the Proprietary Rights of Third Parties
Universities and government laboratories, physicians and other corporations
are conducting substantial research in point-of-care diagnostic blood testing
technology. Given the nature of our industry, it is possible that patent
applications have been filed by others, and patents may be issued to them,
relating to specific diagnostic products and processes. Patent applications in
the U.S. are secret until the patent is issued. We cannot know whether
competing applications have been filed. A prior conflicting patent application
would detract from the value of our patents. In addition, if we use
technologies, products or processes covered by patent applications filed by
others, or by patents issued to others, we may have to obtain licenses. We may
not be able to obtain such licenses on reasonable terms, or at all.
We May Be Unable to Build Brand Loyalty Because Our Trademarks and Trade Names
May Not Be Protected
Our registered or unregistered trademarks or trade names may be challenged,
canceled, infringed, circumvented or declared generic or determined to be
infringing on other marks. We may not be able to protect our rights to these
trademarks and trade names, which we need to build brand loyalty. Brand
recognition is critical to our short term and long term marketing strategies,
especially as we commercialize future enhancements to our products. See
"Business--Patents and Proprietary Rights" on page 39.
Our Trade Secrets May Be Disclosed
We also rely on unpatented trade secrets to protect our proprietary
technology. We attempt to protect our proprietary technology through an
employee handbook and agreements with our executive officers. Our employees
have not signed confidentiality agreements. The confidentiality provisions in
the handbook and executives' agreements may not be enforceable under applicable
law. Other companies may independently develop or otherwise acquire equivalent
technology or gain access to our proprietary technology.
Our Proprietary Rights May Fail to Protect Our Business
We may have to resort to litigation to protect or defend our rights. This
could result in substantial costs and the diversion of management's attention.
If we lost any such litigation, we could lose our competitive position, be
required to obtain licenses from third parties or be prevented from
manufacturing, selling or using certain of our products.
We Do Not Own all Necessary Intellectual Property
Some of the intellectual property we use in developing our test cartridges is
owned by others, such as Fuji Photo Film Co., Ltd., and licensed on a non-
exclusive basis to us. We believe alternative technology does exist. However,
if our access to our current technology terminated, our development efforts
could be delayed until we achieved access to the alternative technology. In
that circumstance, we cannot be sure that we would be able to achieve access to
alternative sources of technology. If alternative technology is unavailable, we
would have to change our testing methodologies. This would cause substantial
delay and cost in development of our product.
Extensive Government Regulation May Increase Our Expenses and Cause Delays in
our Product Commercialization
Our products are medical devices subject to extensive regulation by the FDA,
similar agencies in other countries, and to a lesser extent, by state
regulatory authorities. See "Business -- Government Regulation" page 40. In
addition to our need to obtain a point-of-care use designation, the following
are the greatest regulatory risks we face:
We Need Additional FDA Pre-Market Clearances to Successfully Commercialize Our
Products
FDA regulations require rigorous laboratory and clinical testing to establish
product performance before commercial marketing. Medical devices such as the
CareSide Analyzer are subject to pre-market clearance. Clearance is subject to
further review, such as when products are modified. We cannot be certain that
we will
11
<PAGE>
be able to obtain all necessary approvals on a timely basis, or at all.
Moreover, it is possible that one or more of our products will be subjected to
more extensive pre-market clinical testing and FDA pre-market approval.
We May Incur Substantial Expenses to Comply With GMP and Other Manufacturing
Regulations
Our manufacturing facilities and processes will be required to comply with
strict federal regulations, including Good Manufacturing Practices, or GMP, and
quality system requirements, regarding validation and quality of manufacturing.
We have limited experience in complying with regulations governing our products
and manufacturing facilities. We must devote substantial resources and
management attention to monitoring and maintaining compliance with governmental
regulations. If we, or our manufacturing partners, violate applicable
regulations, we may be sanctioned and our production or distribution may be
suspended. In addition, the FDA may withdraw the approval or clearance to
market any of our products.
Year 2000 Problems Could Interrupt Our Supply
Our receipt of key component products used in the Careside system may be
delayed if our suppliers' software systems are not able to read and apply
proper dates. We expect to have contingency plans in place in the event any of
our key suppliers are not Year 2000 compliant by the second half of 1999.
However, our contingency plans may not provide the same product or timing as
our current suppliers.
Significant Number of Shares Eligible for Future Sale Could Lower Market Price
Sales of large numbers of common stock after the offering, or even the
potential for those sales, are likely to lower the market price of common
stock. In addition, these sales may negatively affect our ability to raise
needed capital through the sale of our common stock. After the offering, we
will have 7,084,340 shares of common stock outstanding. In addition to the
2,000,000 shares that will be freely tradable after the offering, and the
2,000,000 additional shares that may be issued if the warrants sold in the
offering are exercised, 8,104,522 currently outstanding or reserved shares may
be sold in the future subject to compliance with the Securities Act.
<TABLE>
<CAPTION>
Number of Shares Description
<S> <C>
5,084,340 Common stock currently outstanding
422,403 Issuable upon exercise of currently outstanding options
761,805 Issuable upon exercise of options that may be granted in the future
150,000 Issuable pursuant to employee stock purchase plan
960,146 Issuable upon exercise of warrants outstanding upon completing the offering
325,828 Issuable upon conversion of Series A Convertible Preferred Stock and
exercise of warrants received on conversion beginning six months after
the effective date of the offering
400,000 Issuable upon exercise of the representatives' warrants for units beginning one
year after the effective date of the offering, and upon exercise of warrants
included in those units
---------
8,104,522
=========
</TABLE>
All of our directors, officers and principal stockholders are subject to
lock-up agreements. The parties to the lock-up agreements, other than S. R.
One, Limited, are not permitted to sell their shares until one year after the
offering without the prior written consent of Paulson Investment Company, Inc.
and Millennium Financial Group, Inc. S. R. One is subject to a six month lock-
up period. When a lock-up period expires, all of the shares previously subject
to the lock-up will become tradable. Given that over 95% of our currently
outstanding shares are subject to a lock-up, the expiration of the applicable
lock-up period could have a depressive effect on the market price of our common
stock. See "Shares Eligible for Future Sale" on page 63.
12
<PAGE>
Control of Careside By Our Management and Principal Stockholders Could Conflict
With Other Shareholders' Interests
The interests of our directors and executive officers, and our principal
stockholders could conflict with the interests of other Careside stockholders,
including the purchasers in the offering. Following completion of the offering,
our directors and executive officers, together with the principal stockholders
of Careside, will own or control approximately 28.04% of our outstanding common
stock. Accordingly, these stockholders may be able to influence the outcome of
stockholder votes, including votes concerning the election of directors,
certain amendments to our charter and bylaws, and the approval of significant
corporate transactions such as a merger or a sale of our assets. This influence
could have the effect of delaying, deferring or preventing a change in control
of Careside. See "Principal Stockholders" on page 52.
Future Issuances of Preferred Stock May Dilute Rights of Common Stockholders
Our Board of Directors will have the authority to issue up to 4,837,086
shares of preferred stock and to determine the price, privileges and other
terms of such shares. The Board may exercise this authority without the
approval of the stockholders. The rights of the holders of common stock may be
adversely affected by the rights of the holders of any preferred stock that may
be issued in the future. The issuance of preferred stock may make it more
difficult for a third party to acquire control of Careside. See "Description of
Capital Stock--Undesignated Preferred Stock" on page 57.
Statute, Charter and By-laws May Delay or Prevent an Acquisition of Careside
We will be subject to the anti-takeover provisions of Section 203 of the
Delaware General Corporation Law. Section 203 could delay or prevent a third
party or a significant stockholder from acquiring control of Careside. In
addition, our charter and by-laws may have the effect of discouraging, delaying
or preventing a merger, tender offer or proxy contest involving Careside. Any
of these anti-takeover provisions could lower the market price of the common
stock. See "Description of Capital Stock--Takeover Protection and Certain
Charter and By-Law Provisions" on page 61.
Our Units, Common Stock and Warrants May Trade Below the Unit Offering Price
Our units, shares of common stock and warrants may trade at prices
significantly below the initial public offering unit price. The initial public
offering unit price may bear no relationship to the future market price of our
units, common stock or warrants. The market prices may be highly volatile
depending on many factors, including:
. the success of our new products or new products introduced by our
competitors,
. developments with respect to our patents and other proprietary rights,
. our ability to meet sales and earnings expectations of securities
analysts, and
. changes in general market conditions.
Your Warrants Can Be Redeemed on Short Notice
We could redeem your warrants for $0.05 per warrant on 30 days' prior written
notice, provided that the closing price of our common stock has been at least
$14.00 for the ten consecutive trading days immediately preceding the date of
notice of redemption. If we give notice of redemption, a holder would be forced
to sell or exercise the warrants or accept the redemption price. This kind of
redemption cannot occur until six months after the date of this prospectus. See
"Description of Capital Stock--Unit Warrants" on page 57.
You Will Be Unable to Exercise Your Warrants in the Absence of an Effective
Registration Statement
We will be able to issue shares of our common stock upon exercise of your
warrants only if there is a then current prospectus relating to the common
stock under an effective registration statement filed with the
13
<PAGE>
Securities and Exchange Commission, and only if such common stock is qualified
for sale or exempt from qualification under applicable state securities laws.
Although we have agreed to use our best efforts to meet these requirements, we
cannot assure investors that we will be able to do so. The warrants may be
deprived of any value and the market for the warrants may be limited if we do
not meet these requirements.
Purchasers in the Offering Will Face Immediate and Substantial Dilution
The initial public offering unit price is substantially higher than the net
tangible book value per share of common stock. Given that 2,000,000 units are
being sold in the offering at $7.50 per unit, our net tangible book value per
share will be $2.07, $5.43 below the $7.50 offering price. The net tangible
book value after the offering will thus be 72% below the $7.50 offering price.
Sales of additional common stock in the future may reduce net tangible book
value per share, resulting in further dilution to purchasers of units sold in
the offering. See "Dilution" on page 17.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements contained in this prospectus discuss future events and
developments, including our ability to generate revenue, income and cash flows,
or state other "forward-looking" information. We generally identify these
forward-looking statements by using the words "anticipate," "believe,"
"estimate," "expect," and similar expressions. Those statements are subject to
known and unknown risks, uncertainties and other factors that could cause the
actual results to differ materially from those contemplated by the statements.
Important factors that may cause actual results to differ include those set
forth under "Risk Factors" beginning on page 7.
We do not promise to update forward-looking information to reflect actual
results or changes in assumptions or other factors that could affect those
statements.
14
<PAGE>
USE OF PROCEEDS
We will receive net proceeds from the sale of units in the offering of
approximately $12,480,000 after the deduction of underwriting discounts and
commissions and expenses payable by us. We will receive net proceeds of
approximately $14,592,000 if the underwriters' over-allotment option is
exercised in full. We expect to use the proceeds as follows:
<TABLE>
<CAPTION>
Approximate
Amount of
Net Approximate
Proceeds Percentage
(in of Net
millions) Proceeds
----------- -----------
<S> <C> <C>
Complete product development and launch and related
expenses ............................................ $10.7 85.6%
Purchase manufacturing equipment and expand our
facilities........................................... $ 0.8 6.4%
Build inventory and provide working capital........... $ 1.0 8.0%
----- -----
Total from unit sales............................... $12.5 100.0%
</TABLE>
If warrants included in units (including units issued upon exercise of the
representatives' warrants) are exercised, the total proceeds to us from the
exercise of the representatives' warrants and warrants included in all units to
us will be $21,600,000 ($24,300,000 if the over-allotment option is exercised
in full). We would expect to use the proceeds of warrant exercises to repay
debt. In addition, we would use remaining proceeds from warrant exercises for
further product development, such as the future enhancements described on page
34, and related expenses, to purchase manufacturing equipment and expand our
facilities and to build inventory and provide working capital, all in
approximately the same relative percentages as set forth above.
Pending use of the net proceeds, we intend to invest such funds in short-term
bank deposits and investment grade securities, United States government
securities, and other short-term, income-producing securities.
The foregoing discussion is merely an estimate based on our current business
plans. Our actual expenditures may vary depending upon circumstances not yet
known, such as the time actually required to reach a positive cash flow, or to
successfully develop our products. In addition, we expect to either repay the
$2 million of our bridge financing which matures in December 1999 with proceeds
of warrant exercises or of a new loan or to negotiate to convert it into
preferred or common equity. To the extent that warrant exercise proceeds, the
new loan or conversion is not available, we may use a portion of the net
proceeds of the offering for repayment which would reduce application of the
net proceeds to purchase equipment, build inventory and provide working capital
and, if necessary, to conduct research and development. If a portion of the net
proceeds were used to repay the bridge financing, we might need additional
financing for equipment.
DIVIDEND POLICY
We have never paid any cash dividends on our shares of common stock and do
not anticipate paying any cash dividends on our shares of common stock in the
foreseeable future. Currently, we intend to retain any future earnings for
reinvestment in our business. Any future determination to pay cash dividends
will be at the discretion of our Board of Directors and will be dependent upon
our financial condition, results of operations, capital requirements and other
factors our Board of Directors deems relevant.
15
<PAGE>
CAPITALIZATION
The following table sets forth as of March 31, 1999 for Careside:
. the actual capitalization,
. the pro forma capitalization which reflects the conversion of
$1,000,000 borrowed under the bridge financing, together with accrued
interest on the $1,000,000, into shares of Series A Convertible
Preferred Stock upon consummation of the offering, and
. the pro forma as adjusted capitalization which shows the effect of the
sale of 2,000,000 units in the offering at the initial public offering
price of $7.50 per unit and the use of the net proceeds of the
offering.
This table should be read in conjunction with our Financial Statements
included elsewhere in this prospectus.
<TABLE>
<CAPTION>
March 31, 1999
----------------------------------------
Pro Forma
Actual Pro Forma As Adjusted
------------ ------------ ------------
<S> <C> <C> <C>
Current portion of long-term debt:
Equipment loan due finance
company........................... $ 193,671 $ 193,671 $ 193,671
Note payable under bridge
financing(1)...................... 3,000,000 2,000,000 2,000,000
------------ ------------ ------------
Total current portion of long-
term debt....................... 3,193,671 2,193,671 2,193,671
============ ============ ============
Long-term debt:
Equipment loan due finance
company........................... 803,092 803,092 803,092
------------ ------------ ------------
Stockholders' equity:
Preferred Stock, $.01 par value --
5,000,000 shares authorized; none
issued and outstanding (actual);
160,095 shares Series A
Convertible Preferred Stock issued
and outstanding (pro forma and pro
forma as adjusted)................ -- 1,020,603 1,020,603
Common Stock, $.01 par value --
50,000,000 shares authorized;
5,084,340 shares issued and
outstanding (actual and pro forma)
and 7,084,340 shares issued and
outstanding (pro forma as
adjusted) (2)..................... 50,843 50,843 70,843
Additional paid-in capital......... 21,003,545 21,003,545 33,793,659
Deficit accumulated during
development stage................. (19,910,920) (19,910,920) (20,241,034)
------------ ------------ ------------
Total stockholders' equity....... 1,143,468 2,164,071 14,644,071
------------ ------------ ------------
Total capitalization............. $ 1,946,560 $ 2,967,163 $ 15,447,163
============ ============ ============
</TABLE>
- --------
(1) For a discussion of the note payable, see the description of the 1998
bridge financing under "Management's Discussion and Analysis of Financial
Condition and Results of Operations--Liquidity and Capital Resources" on
page 20 and "Certain Transactions--Financing Activities" on page 54.
(2) Excludes 1,782,549 shares of common stock issuable upon exercise of options
and warrants which will be outstanding upon completion of the offering.
Also excludes an aggregate of 325,828 shares of common stock issuable upon
conversion of the Series A Convertible Preferred Stock and exercise of
warrants received on conversion. The Series A Convertible Preferred Stock
will be outstanding upon completion of the offering and convertible after
six months.
16
<PAGE>
DILUTION
As of March 31, 1999, our pro forma net tangible book value was $2,164,071,
or $0.43 per share of common stock. Pro forma net tangible book value per share
represents our total tangible assets less total liabilities after giving pro
forma effect to the conversion of $1,000,000 borrowed under the bridge
financiang into shares of Series A Convertible Preferred Stock, divided by the
total number of shares of common stock outstanding. Without taking into effect
any changes in the net tangible book value after March 31, 1999, other than to
give effect to the sale of 2,000,000 units in the offering at the initial
public offering price of $7.50 per unit and the application of the net proceeds
of the offering, the net tangible book value of Careside as of March 31, 1999
would have been $14,644,071 or $2.07 per share. This represents an immediate
increase of $1.64 per share of common stock to existing stockholders and an
immediate dilution of $5.43 per share of common stock to the new stockholders
who purchase units in the offering. The following table illustrates this per
share dilution:
<TABLE>
<S> <C> <C>
Initial public offering price................................... $7.50
Pro forma net tangible book value per share before the
offering....................................................... 0.43
Increase in net tangible book value per share attributable to
new stockholders............................................... 1.64
----
As adjusted net tangible book value per share after the
offering....................................................... 2.07
-----
Dilution in tangible book value per share to new stockholders... $5.43
=====
</TABLE>
If the underwriters' over-allotment option is exercised in full, dilution per
share to new stockholders would be $5.23 per share of common stock.
The following table summarizes as of March 31, 1999 the differences between
the existing stockholders and the new stockholders with respect to the number
of shares of common stock included in units purchased, the total consideration
paid, and the average price per share paid:
<TABLE>
<CAPTION>
Shares Purchased Total Consideration
----------------- ------------------- Average
Number Percent Amount Percent Price Per Share
--------- ------- ----------- ------- ---------------
<S> <C> <C> <C> <C> <C>
Existing stockholders..... 5,084,340 71.8% $23,318,075 60.9% $4.59
New stockholders.......... 2,000,000 28.2 15,000,000 39.1 $7.50
--------- ----- ----------- -----
Total................... 7,084,340 100.0% $38,318,075 100.0%
========= ===== =========== =====
</TABLE>
The above computations assume no exercise of outstanding options or warrants
to purchase common stock, the underwriters' over-allotment option, the warrants
included in units sold in the offering or the representatives' warrants. All of
these outstanding securities are described in "Description of Capital Stock" on
page 56. To the extent that these options and warrants are exercised, there
will be further dilution to new investors.
17
<PAGE>
SELECTED FINANCIAL DATA
The following selected financial data of Careside and the predecessor
business should be read in conjunction with "Management's Discussion and
Analysis of Financial Condition and Results of Operations" on page 19 and the
Financial Statements and notes thereto beginning on page F-7. The financial
data presented for the predecessor business at SmithKline Beecham Clinical
Laboratories, Inc. represents the research and development and related general
and administrative costs incurred by SmithKline Beecham Corporation in
connection with the development of technology and know-how acquired by Careside
on November 7, 1996. The selected financial data for Careside as of December
31, 1996 and the predecessor business as of December 31, 1995 and for the year
then ended are derived from the audited financial statements not included in
this prospectus. The selected financial data for Careside as of March 31, 1999
and for the three months ended March 31, 1998 and 1999 and for the period from
inception (July 10, 1996) to March 31, 1999 and for the predecessor business as
of December 31, 1994 and for the year then ended are unaudited, but, in our
opinion, include all adjustments necessary for a fair presentation of such
financial data.
<TABLE>
<CAPTION>
Predecessor Business
-----------------------------------
Year ended Ten months
December 31, ended
---------------------- October 31,
1994 1995 1996
--------- ----------- -----------
<S> <C> <C> <C>
Statement of
Operations Data:
Operating
expenses
Research and
development.... $ 949,346 $ 2,109,802 $ 3,054,503
General and
administration.. 26,069 585,058 224,399
--------- ----------- -----------
Operating loss.. $(975,415) $(2,694,860) $(3,278,902)
========= =========== ===========
Net interest
income
(expense).......
Net loss.........
Net loss per
share...........
Shares used in
computing net
loss per share..
<CAPTION>
Careside, Inc.
-------------------------------------------------------------------------------
Period from Period from
Inception Inception
(July 10, Year ended Three months (July 10,
1996) to December 31, ended March 31, 1996) to
December 31, ------------------------- ------------------------- March 31,
1996 1997 1998 1998 1999 1999
------------- ------------ ------------ ------------ ------------ -------------
<S> <C> <C> <C> <C> <C> <C>
Statement of
Operations Data:
Operating
expenses
Research and
development.... $ 1,561,847 $ 5,895,465 $ 8,297,974 $ 1,541,119 $ 2,076,046 $ 17,831,332
General and
administration.. 55,515 640,574 850,129 196,595 569,907 2,116,125
------------- ------------ ------------ ------------ ------------ -------------
Operating loss.. (1,617,362) (6,536,039) (9,148,103) (1,737,714) (2,645,953) (19,947,457)
Net interest
income
(expense)....... (20,809) 205,256 211,814 17,857 (359,724) 36,537
------------- ------------ ------------ ------------ ------------ -------------
Net loss......... $(1,638,171) $(6,330,783) $(8,936,289) $(1,719,857) $(3,005,677) $(19,910,920)
============= ============ ============ ============ ============ =============
Net loss per
share........... $ (2.25) $ (2.04) $ (1.93) $ (0.49) $ (0.59)
============= ============ ============ ============ ============
Shares used in
computing net
loss per share.. 728,465 3,098,980 4,629,916 3,521,808 5,084,340
============= ============ ============ ============ ============
</TABLE>
<TABLE>
<CAPTION>
Predecessor
Business(1) Careside, Inc.
---------------------- --------------------------------------------------
December 31, December 31,
---------------------- ------------------------------------ March 31,
1994 1995 1996 1997 1998 1999
--------- ----------- ---------- ---------- ------------ ------------
<S> <C> <C> <C> <C> <C> <C>
Balance Sheet Data:
Cash and cash
equivalents ........... $ -- $ -- $ 31,041 $1,237,149 $ 3,926,603 $ 2,051,786
Total assets............ 43,780 306,589 1,192,562 3,140,223 7,911,403 7,248,753
Long-term debt.......... -- -- -- -- 2,044,932 803,092
Deficit accumulated
during the development
stage.................. (975,415) (3,670,275) (1,638,171) (7,968,954) (16,905,243) (19,910,920)
Total stockholders'
equity (deficit)....... -- -- (1,066,818) 2,437,607 4,149,145 1,143,468
</TABLE>
18
<PAGE>
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Overview
Development of the point-of-care technology used in the Careside system began
in 1994 at SmithKline Beecham Clinical Laboratories, Inc., a subsidiary of
SmithKline Beecham Corporation. In November 1996, we acquired the predecessor
business, including intellectual property, equipment and other assets, from
SmithKline, to continue the development of point-of-care diagnostic technology
and to create a commercial product. As part of the consideration paid for the
acquisition, SmithKline Beecham Corporation became an equity owner in Careside.
The initial development of our point-of-care technology at SmithKline has been
reflected in the accompanying financial statements as a predecessor business.
Since November 1996, we have devoted substantially all of our resources to
research and development activities. We have incurred losses since inception.
As of December 31, 1998, the aggregate loss incurred was approximately $16.9
million. We expect to incur significant additional losses over at least the
next 18 months as we continue product development activities, complete a pilot
marketing program and initiate marketing efforts.
Although the CareSide Analyzer and 31 tests are cleared or exempt by the FDA
for use in professional laboratory testing, our commercial product launch is
not expected to take place until the fourth quarter of 1999. To date, we have
generated no revenue. We expect that our revenue will derive primarily from the
sale of disposable test cartridges rather than of the CareSide Analyzer itself.
Results of Operations
Three Months Ended March 31, 1999 and 1998
Research and Development Expenses. Research and development expenses
increased to approximately $2.1 million for the three months ended March 31,
1999 compared to approximately $1.5 million in the same period in 1998, an
increase of 35%. This increase reflects the expanded efforts to complete
production of the CareSide Analyzer and to support additional test submissions
to the FDA.
General and Administrative Expenses. General and administrative expenses
increased to $570,000 for the three months ended March 31, 1999 compared to
$197,000 in the same period in 1998. This increase reflects the increase in the
preliminary sales and marketing efforts associated with planned pilot market
testing in 1999.
Net Interest Income (Expense). Interest income was approximately the same
for the three months ended March 31, 1999 as compared to the same period in
1998 at $42,000 and $18,000, respectively. This reflects comparable levels of
cash and cash equivalents available for investment. Interest expense was
$402,000 for the three months ended March 31, 1999 which reflects interest paid
on the line-of-credit to purchase equipment initiated in late 1998, accrued
interest on the S.R. One bridge loan, and the non-cash interest charge
associated with the cost of warrants granted to S.R. One in connection with the
bridge loan facility.
Net Loss. The net loss increased to approximately $3.0 million for the three
months ended March 31, 1999 compared to $1.7 million in the same period in
1998. This increase reflects the increase in research and development expenses
and interest expense on the line-of-credit to purchase equipment and the S.R.
One bridge loan.
Years Ended December 31, 1998 and 1997
Research and Development Expenses. Research and development expenses
increased to approximately $8.3 million for the year ended December 31, 1998
compared to approximately $5.9 million in the same period in 1997, an increase
of 41%. This increase reflects increased payments to third parties for the
development of the CareSide Analyzer and increased staffing for additional test
development and submissions to the FDA.
19
<PAGE>
General and Administrative Expenses. General and administrative expenses
increased to $850,000 for the year ended December 31, 1998 compared to $641,000
in the same period in 1997, an increase of 33%. This increase reflects the
increase in the preliminary sales and marketing efforts associated with planned
pilot market testing in the second quarter of 1999.
Net Interest Income (Expense). Interest income was approximately the same
for the year ended December 31, 1998 as compared to the same period in 1997 at
$212,000 and $205,000, respectively. This reflects comparable levels of cash
and cash equivalents available for investment.
Net Loss. The net loss was approximately $8.9 million for the year ended
December 31, 1998 compared to approximately $6.3 million in the same period in
1997, an increase of 41%. This increase reflects the increase in research and
development expenses and preliminary sales and marketing efforts.
Years Ended December 31, 1997 and 1996
Research and Development Expenses. Research and development expenses
increased to approximately $5.9 million for the year ended December 31, 1997
compared to approximately $1.6 million for the period from inception through
December 31, 1996. This increase reflects a full year of spending as well as
the expanded efforts devoted to completing additional test development and
submissions of these tests to the FDA. Combined research and development
expenses for the year ended December 31, 1996 for both Careside and the
predecessor business were approximately $4.6 million.
General and Administrative Expenses. General and administrative expenses
increased to $641,000 for the year ended December 31, 1997 compared to $56,000
for the period from inception through December 31, 1996. This increase reflects
the full year impact of general and administrative expenses and the costs
associated with raising additional capital. Combined general and administrative
expenses for the year ended December 31, 1996 for both Careside and the
predecessor business were $280,000.
Net Interest Income (Expense). Net interest income was $205,000 for the year
ended December 31, 1997 compared to net interest expense of $21,000 for the
period from inception through December 31, 1996. This increase reflects the
impact of the resulting cash and cash equivalents available for investment
after an equity financing in 1997.
Net Loss. The net loss was approximately $6.3 million for the year ended
December 31, 1997 compared to approximately $1.6 million for the period from
inception through December 31, 1996. This increase reflects the increase in
research and development expenses, a full year of activity and preliminary
sales and marketing efforts.
Liquidity and Capital Resources
We have financed our operations since inception primarily through the net
proceeds generated from the issuance of common stock, long-term debt and
certain short-term borrowings that were subsequently converted into equity
securities. As of March 31, 1999, we have received net proceeds aggregating
approximately $24.0 million from these transactions.
Net cash used in operating activities was approximately $1.7 million for the
three months ended March 31, 1999 compared to approximately $1.4 million in the
same period in 1998. For the three months ended March 31, 1999, cash used in
operating activities represents the net loss for the period offset by an
increase in accounts payable and the non-cash amortization of imputed interest
in the S.R. One bridge loan. Net cash used in operating activities was
approximately $7.7 million for the year ended December 31, 1998. This
represents the net loss for the year partially offset by an increase in
accounts payable to the manufacturer of the CareSide Analyzer. Net cash used in
operating activities was approximately $6.5 million for the year ended December
31, 1997 and $0.9 million for the period from inception through December 31,
1996. Cash used for operations was primarily related to funding expansion of
research and development activities as well as the establishment of an
administrative infrastructure.
20
<PAGE>
Cash used in investing activities for the purchase of property and equipment
was approximately $1.2 million and $300,000 for the three months ended March
31, 1999 and 1998, respectively, $2.0 million and $0.9 million for the years
ended December 31, 1998 and 1997, respectively, and $345,000 for the period
from inception through December 31, 1996. The cash was used primarily for the
acquisition of laboratory equipment used in research and development.
At March 31, 1999, our principal source of liquidity was approximately $2.1
million in cash and cash equivalents.
In December 1998, we entered into an agreement with an equipment lease
financing company regarding a $2.5 million facility secured by specific
equipment. Each draw will be a separate loan under the facility. Approximately
$1.0 million of this facility was drawn in December 1998 and was secured by our
existing equipment. We anticipate drawing the remaining amount by the end of
1999 which will be secured by manufacturing equipment for cartridge assembly
which we purchase with the loan proceeds. Each equipment loan will have a 48-
month term and bears an interest rate of approximately 14% per annum adjusted
for an index rate based on four-year U.S. Treasury Notes at the time of
borrowing.
In addition, we entered into an agreement for the bridge financing with S.R.
One, Limited of which $1.5 million was funded in December 1998 and $1.5 million
was funded in January 1999. In April 1999, S.R. One, Limited agreed to convert
$1 million of the $3 million loan, together with accrued interest at the rate
of 8% on $1 million, upon consummation of the offering, into shares of Series A
Convertible Preferred Stock. The conversion price will be $6.375, which is 85%
of the initial public offering price per unit. This means that the number of
shares of our Series A Convertible Preferred Stock issued to S.R. One upon this
conversion will depend upon when the offering is completed and the initial
public offering price per unit. If the offering closes on June 21, 1999, S.R.
One will receive 162,914 shares of Series A Convertible Preferred Stock. Each
share of Series A Convertible Preferred Stock will in turn be convertible, at
the option of the holder, six months after the offering is completed, into one
share of our common stock and one warrant to purchase an additional share of
our common stock. All accrued and unpaid dividends with respect to shares of
Series A Convertible Preferred Stock that are converted by S.R. One will also
be converted into units at the initial public offering price per unit. The
exercise price and other terms of the warrant received on the conversion will
be the same as the warrants included in units sold in the offering. The
remaining $2 million of the loan matures in December 1999. At that time, we
expect either to repay the $2 million balance on the bridge financing with the
proceeds of a new loan or to negotiate to convert the balance of it into
preferred or common equity. The annual interest rate on the remaining $2
million will increase to 10% on July 1, 1999. If the remainder of the bridge
loan is not repaid by December 1, 1999, S. R. One will have the option to
convert all or any portion of the remaining loan, plus accrued interest
thereon, into shares of Series A Convertible Preferred Stock. This Series A
Convertible Preferred Stock will be issued to S.R. One on the same basis as the
Series A Convertible Preferred Stock that is issued to S. R. One as part of the
$1 million conversion at the completion of the offering.
We issued a bridge warrant to S.R. One, Limited in connection with the bridge
financing. The bridge warrant was exercisable for the number of shares of
common stock equal to $750,000 divided by 85% of the initial public offering
price of the common stock in an initial public offering. The number of warrants
doubled if the loan was not repaid by June 30, 1999. As part of the conversion
of a portion of the bridge financing into shares of Series A Convertible
Preferred Stock, the bridge warrant will be modified such that it will be
exercisable in all events for the number of shares of common stock which is
equal to $1,500,000 divided by $6.375, which is 85% of the initial public
offering price per unit in the offering. Upon completion of the offering, the
bridge warrant will be exercisable for 235,294 shares of common stock. The
bridge warrant has an exercise price of 85% of the initial public offering
price per unit. The bridge warrant will become exercisable on the earlier of
December 17, 1999 or six months after the completion of the offering. The
bridge warrant will expire on the earlier of December 17, 2005 or four years
after completion of the offering.
21
<PAGE>
We estimate that our current liquidity, when combined with the proceeds of
this offering, sales revenue expected after 1999 and equipment lease financing
proceeds (under our current equipment lease facility already in place), will be
sufficient to fund our operating expenses and capital requirements for at least
12 months. Our operating expenses will increase as we approach the market
launch of our product in the fourth quarter of 1999. To the extent that we need
additional funds in connection with our commercial product launch, we expect to
borrow funds to complete our automated cartridge assembly line and build
sufficient cartridge inventory for launch and subsequent sales. We also expect
that the development of additional tests will require research expenditures at
a level comparable to past spending for test development. Sales and marketing
activities will require hiring and training approximately 15 additional staff
in 1999. Initiation of manufacturing activities will require hiring
approximately 20 staff and capital expenditures to purchase the equipment
needed for the automated cartridge assembly line. This estimate of the period
for which we expect our available sources of cash to be sufficient to meet our
funding needs is a forward looking statement that involves risks and
uncertainties. There can be no assurance that we will be able to meet our
capital requirements for this period as a result of certain factors set forth
under "Risk Factors--Additional Funding May Not Be Available" and elsewhere in
this prospectus. In the event our capital requirements are greater than
estimated, we may need to raise additional capital to fund our research and
development activities, to scale-up manufacturing activities and to expand our
sales and marketing efforts. Our future liquidity and capital funding
requirements will depend on numerous factors, including the extent to which our
products under development are successfully developed and gain market
acceptance, the timing of regulatory actions regarding our products, the costs
and timing of expansions of sales, marketing and manufacturing activities,
procurement and enforcement of patents important to our business, and the
impact of competitors' products. There can be no assurance that such additional
capital will be available on terms acceptable to us, if at all. Furthermore,
any additional equity financing may be dilutive to stockholders, and debt
financing, if available, may include restrictive covenants. If adequate funds
are not available, we may be forced to curtail our operations significantly or
to obtain funds through entering into collaborative agreements or other
arrangements on unfavorable terms. Our failure to raise capital on acceptable
terms could have a material adverse effect on our business, financial condition
or results of operations.
Income Taxes
As of December 31, 1998, we had approximately $2,148,000 and $225,000 of net
operating loss and research and development credit carryforwards, respectively,
for federal income tax purposes, which expire on various dates between 2011 and
2013. These amounts reflect different treatment of expenses for tax reporting
than are used for financial reporting. As of December 31, 1998, we had
capitalized approximately $12.9 million of research and development expenses
for federal income tax purposes. The Tax Reform Act of 1986 contains certain
provisions that may limit our ability to utilize net operating loss and tax
credit carryforwards in any given year. We experienced a change in ownership
interest in excess of 50% as defined under the Tax Reform Act upon the first
closing of our 1997 equity financing. We will have another change in ownership
as defined in the Tax Reform Act upon completion of the offering. We do not
believe that this change in ownership will impact our ability to utilize our
net operating loss and tax credit carryforwards. There can be no assurance that
ownership changes in future periods will not significantly limit our use of
existing or future net operating loss and tax credit carryforwards.
Year 2000 Compliance
We have identified our Year 2000 risks in three major categories: internal
business operations software; software utilized within the CareSide Analyzer;
and software used by our external suppliers and distributor. A review of our
non-information technology systems did not identify any material risks.
With respect to internal operations, most of our computers and software
programs have been recently acquired. We have relied on the efforts of computer
and software vendors to make their latest hardware and software releases Year
2000 compliant. As a result, no incremental material compliance cost is
expected to be
22
<PAGE>
incurred in this area. Our management has contacted vendors to confirm the
status of their software that we use. In addition, we have utilized Year 2000
test software to evaluate compliance.
With respect to the CareSide Analyzer, all development work has occurred
since the widespread recognition of the Year 2000 problem. We designed our
products and the software encoded in our system to be Year 2000 compliant. We
plan to issue software updates for the CareSide Analyzer on a routine basis to
add additional tests to the menu. If an unforeseen Year 2000 issue arises, we
could distribute compliant software to our customers at little or no
incremental cost as part of these routine updates. In the future, it will also
be necessary to link the CareSide Analyzer with customer systems. If these
systems are Year 2000 compliant, management's time addressing Year 2000 issues
on the CareSide Analyzer's interface with customer systems will be minimal. If
they are not, management's time may be more significant. As the specific
customers are not known at this time, it is not possible to measure the
opportunity cost.
Regarding our critical suppliers, the worst scenario that we might encounter
would be a short-term disruption of supply if a vendor were impacted by an
unforeseen Year 2000 failure. We inquire regularly regarding our suppliers'
Year 2000 compliance programs. To date, we believe that our suppliers either
are or will be Year 2000 compliant. We expect to establish appropriate
contingency plans by mid-1999 in the event certain key suppliers are not Year
2000 compliant. These contingency plans could include utilizing alternative
suppliers or building inventory of critical parts as appropriate. We do not
anticipate any incremental material costs if we are required to implement our
contingency plans.
We expect sales of our product to begin in the fourth quarter of 1999. This
may include sales pursuant to our distribution and supply agreement with SBCL.
Based on inquiries of SBCL, if the distribution of our product does commence
before the Year 2000, we do not believe that Year 2000 problems encountered by
SBCL would impact our ability to distribute our product. Distribution of our
products by other third parties is not anticipated before the year 2000.
23
<PAGE>
BUSINESS
General
We have developed and plan to sell a proprietary blood testing system. It is
designed to decentralize laboratory operations. The system provides cost-
effective, accurate test results within 10 to 15 minutes at the point-of-care,
for a comprehensive menu of routine blood tests. Because it provides rapid test
results, the Careside system can also perform blood tests required for critical
care testing. The Careside system performs chemistry, electrochemistry,
coagulation and immunochemistry tests within a single testing instrument. Tests
in these four different test categories, along with hematology tests, comprise
the vast majority of blood tests ordered. No other point-of-care product
currently in the market offers as broad a menu of tests or combines these four
test categories. Our goal is to make the Careside system the standard for
routine and critical care blood testing. If we are successful, diagnostic
information will travel more rapidly and healthcare costs for physicians,
providers and payers will be reduced.
The Careside system consists of the CareSide Analyzer and disposable test
cartridges. A separate, optional hematology testing device which has been
developed and is manufactured by a third party can be connected to the CareSide
Analyzer. We are currently developing the software that will allow data
interchange from the hematology testing device to the CareSide Analyzer. The
Careside system is easy to use and can be operated by a non-technical person
with appropriate training in connection with use of the device. Its software
will enable the user to capture all data required to comply with the Clinical
Laboratory Improvement Amendments of 1988. This law, commonly called CLIA,
governs quality assurance and quality control processes and reporting for
healthcare providers.
The FDA has granted pre-market clearance for the CareSide Analyzer and pre-
market clearance or exemption for 31 blood tests for professional laboratory
use. We recently filed three additional blood tests for clearance. Professional
laboratories include hospital, commercial and independent laboratories. As part
of our pilot marketing studies, we have arranged for clinical settings for
point-of-care and physician office laboratory validation studies to obtain FDA
designation of the Careside system for point-of-care and physician office
laboratory use by non-technical personnel with appropriate training. We have
developed protocols for these studies with guidance from the FDA. These
protocols will allow Careside to submit point-of-care validation studies for a
subset of tests for FDA point-of-care and physician office laboratory use
clearance rather than the full menu of individual tests. While the FDA has
reserved the right to request additional information on tests not included in
the protocol if it identifies issues in connection with the use of such tests
in a point-of-care setting, the FDA has informed us that if it approves the
subset of tests for point-of-care and physician office laboratory use, then the
full menu of 31 tests will be granted FDA clearance for point-of-care and
physician office laboratory use.
We intend to complete pilot site marketing studies by the end of the third
quarter of 1999. We expect the pilot studies to demonstrate how potential
customers will use the Careside system and its cost-effectiveness. At our
commercial product launch, planned for the fourth quarter of 1999, we expect to
have the CareSide Analyzer and over 50 tests, including nine hematology tests,
cleared or exempt for professional laboratory use. We expect to have all of our
tests cleared for point-of-care and physician office laboratory use as well by
the end of 1999. We believe that the Careside system's planned menu represents
over 80% of all blood tests ordered on an out-patient basis, including all of
the most commonly ordered out-patient blood tests. We plan to market and
distribute the Careside system in the United States through our own sales force
and through SBCL.
We have utilized strategic partners with specific design expertise and state-
of-the-art technology in order to develop the Careside system rapidly and on a
cost-effective basis. Many of our partners' expertise is in the area of test
reagents. Reagents are the materials within the test cartridges that react with
a patient's blood. The CareSide Analyzer then performs the test by analyzing
the reaction. Currently, we have agreements with:
. Fuji Photo Film Co., Ltd. for the supply of its dry film based chemistry
reagents,
. International Technidyne Corporation for the joint development of
coagulation reagents, and
. UMM Electronics, Inc. to design and manufacture the CareSide Analyzer.
24
<PAGE>
Currently, we are negotiating a long-term agreement with Diagnostic Reagents,
Inc. to supply reagents for the test cartridges. We previously contracted with
Hauser, Inc. for the design of the Careside system and with Battelle Memorial
Institute for the design of the system's disposable test cartridges and their
automated assembly manufacturing system.
In November 1996, we acquired the assets and contracts used in the
predecessor business, including intellectual property, equipment and other
assets, from SmithKline to continue the development of point-of-care diagnostic
technology and to create a commercial product. Several senior members of our
management team worked on this point-of-care project at SmithKline, including
our Chief Executive Officer and Executive Vice President--Research and
Development. We continue to have a business relationship with SmithKline
Beecham Clinical Laboratories, Inc. through a distribution and supply
agreement. This agreement gives SBCL distribution rights in the United States
and certain foreign countries, including the right to use the Careside system
in its commercial laboratory business.
The Laboratory Testing Market
According to 1997 industry data and estimates, the worldwide market for in
vitro testing was $18.3 billion in 1997 and was expected to grow to $20 billion
in 2000. In vitro testing is the testing of all bodily tissues and fluids,
including blood. Based on their experiences while at SmithKline, our senior
management believes that the Careside system's 50 test menu will address over
38% of this market. The rest of the market includes complex and specialized
tests not performed by the Careside system. The United States and Canadian
market for in vitro testing is approximately 40% of the worldwide market. We
will seek to convert a reasonable portion of the United States and Canadian
blood testing market to point-of-care testing and then expand into the
worldwide market.
Most routine blood tests are sent to a central location, either a commercial
or hospital laboratory, for processing. In these central laboratories, large
blood analyzers reduce individual test costs by producing high volumes of test
results. Commercial laboratories provide approximately 27% of all in vitro
diagnostic testing services, hospital laboratories provide approximately 63%,
and the balance is provided in physicians' offices.
Commercial laboratories are currently the low cost provider of blood testing
services due primarily to economies of scale in testing multiple samples in
large analyzers. Commercial laboratories' testing expenditures relate
predominantly to labor intensive functions such as distribution, customer
service, general administration, communication technology and preparation of
the blood sample. There are numerous steps involved in obtaining test results
from commercial laboratories. Blood samples are collected throughout the day
from a variety of sources including hospitals, physicians' offices, nursing
homes and home care agencies. The samples are transported to the laboratory,
usually with special care in packaging to preserve sample integrity. After the
samples arrive at the laboratory, several administrative tasks are necessary as
thousands of samples are processed daily. Each sample is split into tubes that
are then sorted for testing in multiple large analyzers. The high throughput
analyzers require the attention of highly skilled technicians to prepare
reagents, prime multiple pumps, calibrate, prepare and load blood samples,
conduct centrifuge operations, process measurement data and report results.
This complex process must be tightly controlled at each step to ensure both
administrative and analytical accuracy. Tests are generally run overnight and
results are sent back to the healthcare provider the following day. This
factory-like process limits the ability to provide test results in less than 24
hours. If results are required sooner, certain laboratory operations must be
interrupted, resulting in significantly increased costs.
The process in hospital laboratories is very similar. Blood samples are
typically collected in the early morning with tests performed late morning and
early afternoon. Results are generally returned within four to five hours.
However, in many instances, hospitals must respond to critical patient
conditions and conduct tests on an immediate basis in order to support the
healthcare provider when a patient's condition is life threatening. A hospital
must be able to process these critical care tests 24 hours a day. This requires
the hospital laboratory to remain open whether or not any tests are being
conducted. With insufficient testing volume to absorb laboratory operating
expenses and capital costs, tests performed in hospital laboratories are more
expensive.
25
<PAGE>
Many physicians' offices currently outsource their testing to commercial or
hospital laboratories. This practice is largely the result of the enactment of
the Clinical Laboratory Improvement Amendments in 1988. CLIA was an attempt to
ensure the quality and reliability of laboratory test results by placing more
stringent administrative and regulatory burdens on testing conducted in the
physician's office. Under CLIA, technicians conducting complex tests must meet
detailed proficiency requirements and must have established well-defined
quality assurance and quality control programs. As a result, for most
individual physicians, diagnostic testing became too burdensome and costly to
justify being done in the office.
Managed care has put substantial pressure on healthcare providers to reduce
costs and to treat patients using clinical treatment protocols that have been
developed for many chronic and acute illnesses. These protocols frequently
contain diagnostic tests that are used to help avoid the occurrence of acute
episodes of illness. Diagnostic blood and urine testing are two of the major
tools used in these protocols for early detection and ongoing evaluation of
treatment efficacy. Although these pressures should increase testing volume,
managed care providers and other payers are becoming more stringent by only
reimbursing tests for which there is a clear medical need. We expect these
pressures to continue to cause healthcare providers to order individual
diagnostic tests instead of "panels," or pre-determined groups, of tests
performed at one time. Managed care providers and payers will reimburse all
tests in a panel only if there is a clear medical need for each. As managed
care pressures mount to perform only medically necessary tests, reimbursement
rates for individual tests will decrease, requiring the healthcare provider and
the testing laboratory to be even more cost-effective. Therefore, we believe
that, because the Careside system performs single reagent testing and offers
packages of tests that are based on third-party payer approved panels, it will
be well received by managed care organizations and other payers.
The lack of timely test results from central laboratories has given rise to a
growing market for point-of-care tests. The initial products in the market have
targeted point-of-care tests for use in emergency rooms or critical care units.
While immediate test results benefit the patient and the healthcare provider,
current point-of-care testing devices have added costs to the system as the
hospitals must continue to operate a central laboratory using equipment that
conducts the same critical care tests as well as a much broader menu of tests
required for routine care. Furthermore, current point-of-care devices have not
attempted to provide customers with the quality assurance and quality control
data storage and retrieval capabilities necessary for CLIA requirements.
We believe that an easy-to-use diagnostic blood testing system offering a
broad menu of accurate point-of-care tests with built-in quality assurance and
quality control features can respond to the substantial unmet needs in the
diagnostic testing marketplace. We expect that the Careside system will be able
to perform all of the most commonly ordered out-patient blood tests.
Consequently, it will enable healthcare providers to decentralize laboratory
services to the point-of-care and outsource the less common tests as necessary.
Careside's Solution
We believe that the Careside system provides the platform for solving the
limitations of central blood testing laboratories and redefines the market for
point-of-care testing. In addition, we believe the features of the Careside
system will enable healthcare providers not currently conducting blood tests to
start providing this service. The following are the reasons why:
. Cost-Effective Results-- The Careside system is designed to provide test
results that are cost competitive with commercial laboratories, the
lowest cost alternative currently available in the market. This is true
even taking into consideration the initial purchase of the CareSide
Analyzer, laboratory set-up and training, and ongoing costs associated
with maintenance, cartridge and blood drawing supplies.
. Rapid Test Results--The Careside system furnishes test results within 10
to 15 minutes from the time blood is drawn from the patient. The Careside
system can test from one to six cartridges in this time period. By
comparison, 24 hours or more may elapse before a healthcare provider has
in hand the
26
<PAGE>
results of blood tests performed at commercial laboratories, and four to
five hours may elapse before results are in the provider's hands for a
blood test performed at a hospital laboratory.
. Comprehensive Test Menu--The Careside system will offer a broad menu of
the most commonly ordered blood tests, including critical care tests. The
Careside system performs chemistry, electrochemistry, coagulation and
immunochemistry tests, all within a single testing instrument. By the
time of product launch, over 50 tests, including nine hematology tests,
are expected to be available for professional laboratory use, which we
believe substantially exceeds the capabilities of any point-of-care
system currently on the market. The hematology tests will be available
through an optional separate hematology testing device, manufactured by a
third party, which can be electronically connected to the Careside
system.
. Ease of Use--The Careside system can be easily operated and maintained by
non-technical personnel with appropriate training in connection with use
of the device. The test process does not require separate centrifuging or
sample splitting, and automatically doses and mixes the patient's blood
sample with reagents within the cartridges.
. Industry Standard Technology--The Careside system uses many test methods
that are the same as those used in hospital and commercial laboratories.
The Careside system's technology is a miniaturization of the technology
in the largest testing devices utilized by centralized laboratories,
which is considered the best testing technology.
. Embedded Quality Assurance and Quality Control--The CareSide Analyzer has
operating software designed to assist in meeting the quality assurance
and quality control documentation requirements of the Clinical Laboratory
Improvement Amendments of 1988.
. Ability for Practice Enhancement--The Careside system's rapid test
results enable a provider to make clinical decisions more quickly, see
more patients, eliminate time spent reviewing records and making follow-
up calls, and improve patient satisfaction and quality of care.
Healthcare providers can also increase their revenue by performing and
billing for tests themselves.
Careside's Strategy
Our goal is to make point-of-care testing with the Careside system the
standard of care for routine and critical care blood testing. If we are
successful, diagnostic information will travel more rapidly and reduce
healthcare costs for physicians, providers and payers. The following are the
key elements of our strategy to achieve our objective:
Provide the Unique Point-of-Care Solution. Most point-of-care companies have
focused solely on the critical care testing market with a limited number of
tests. In contrast, we have developed the Careside system to replace large
analyzers and decentralize testing to the point-of-care. As an illustrative
analogy, we believe that centralized laboratory testing is like using a
mainframe computer, whereas point-of-care testing is like using a desktop
personal computer. Unlike the "mainframe computer-based" approach of large
hospital and commercial testing laboratories, the Careside system creates a
"personal computer-based" solution for blood testing. We believe this will
enable hospitals and other healthcare provider-sponsored laboratories to
substantially reduce their reliance on centralized testing services. Instead,
they could use decentralized point-of-care technology on a cost-effective basis
with test results available in 10 to 15 minutes.
More complex tests that are not supportable by our decentralized testing
system, such as microbiology, genetic and other less common tests, could then
be referred outside the hospital to commercial laboratories or to a core
laboratory supporting multiple hospitals. Centralized laboratories that
continue to provide such complex testing would be able to streamline
procedures. We expect that this would lower the cost of complex testing. With
lower costs of centralized testing and the Careside system for decentralized
testing, we expect that the entire testing process will become more efficient
and cost effective. After the Careside system's launch, we intend to continue
to build its test menu so as to have the broadest test menu of any point-of-
care system on the
27
<PAGE>
market. Its unique menu will combine the four different test categories of
chemistry, electrochemistry, coagulation and immunochemistry into a single
testing instrument.
Satisfy Healthcare System Needs. The Careside system is designed to meet the
various needs of each of our targeted customer markets. Important factors for
hospitals will include quality of test result, ease of use, impact on
personnel, benefits to patients and whether it provides a better cost
alternative than the central hospital laboratory. For physician group
practices, the Careside system will offer improvements in daily office routine,
greater convenience, enhanced patient satisfaction, and new revenue
opportunities. For the nursing home and home care markets, which traditionally
outsource testing services, the Careside system will offer improved turnaround
time on test results, individualized testing, cost savings or revenue
opportunities, and improved patient services. We believe that the Careside
system will enable each of these types of healthcare providers to replace their
centralized testing services with decentralized point-of-care technology on a
cost-effective basis. In pursuing this strategy, we will continue to benefit
from the over 20 years experience of our Chief Executive Officer as a senior
executive of several large hospitals where hospital laboratory costs were a
significant issue, as well as his more than four years experience as President
of SmithKline Beecham Clinical Laboratories, Inc. See "Management."
Leverage Expertise of Strategic Partners. We expect to continue to work with
our strategic partners, such as Fuji Photo Film Co., Ltd. and UMM Electronics,
Inc. who have already developed specific expertise and state-of-the-art
technology. Fuji supplies chemistry and electrochemistry test reagents for the
Careside system's proprietary test cartridges. UMM develops the software and
manufactures the device for our system. With these and other strategic
partners, we expect to be able to develop new tests on a rapid, cost-effective
basis.
Systematic Commercial Rollout. The CareSide Analyzer and 31 tests are cleared
for marketing in the United States for use in professional laboratories. We
recently filed three additional blood tests for clearance. Our commercial
product launch is planned for the fourth quarter of 1999, at which time over 50
tests are expected to be cleared or exempt by the FDA. By the end of the third
quarter of 1999, we intend to complete pilot site marketing studies in certain
of our targeted market segments to determine utilization patterns, demonstrate
cost-effectiveness and develop a "how-to" book. The how-to book will be a tool
for customers to follow in order to take the appropriate steps in establishing
diagnostic testing services using the Careside system. We have arranged pilot
site studies with APRIA Healthcare in the home care services market, three
hospitals affiliated with Child Health Corporation of America in the hospital
market, Reliant Care Group, L.L.C. in the nursing home market, and SmithKline
Beecham Clinical Laboratories, Inc. for its own use within its commercial
laboratory business. We are also in the process of arranging pilot site studies
with several group practices for the physician office market, including group
practices in Arizona and California. We plan to market and distribute the
Careside system in the United States through our own sales force and through
our distribution arrangement with SBCL. We believe that this systematic
commercial rollout improves the chances of having a successful product launch.
28
<PAGE>
Status of Careside Product Development
<TABLE>
<CAPTION>
Technology
Product Regulatory Status Partner
- --------------------------------------------------------------------------------------------------------------
<C> <S> <C> <C> <C>
CareSide Analyzer Cleared under Section 510(k) of the Federal Food, Drug and Cosmetic UMM
Act for use in professional laboratories. Section 510(k) clearance Electronics, Inc.
for point-of-care and physician office laboratory use will be applied Hauser, Inc.
for based on data to be gathered during the marketing pilot program.
- --------------------------------------------------------------------------------------------------------------
Disposable Test Test cartridges are integral to approval of the tests listed below. Battelle
Cartridges Chemistry, electrochemistry and coagulation cartridges have been Memorial
developed. The immunochemistry test cartridge is in development. Institute
- --------------------------------------------------------------------------------------------------------------
- --------------------------------------------------------------------------------------------------------------
Submitted Pending
Marketing
Clearance
Cleared/Exempt for for Professional Planned 1999
Test Category Professional Laboratory Use* Laboratory Use Submissions
- --------------------------------------------------------------------------------------------------------------
Chemistry Glucose Ammonia Carbon Dioxide Fuji Photo
BUN (Urea Magnesium Ionized Calcium Film Co., Ltd.
Nitrogen)
Creatinine Bilirubin,
Direct
BUN/Creatinine Hemoglobin
Ratio
Albumin Direct LDL-
A/G Ratio cholesterol
(calc.)
Globulin (calc.) Anion Gap
Total (Chem-Echem)
Cholesterol
HDL-Cholesterol
LDL-Cholesterol
(calc.)
Cholesterol/HDL
Cholesterol
Ratio
GGT
ALT
Total Bilirubin
Phosphorus
Total Protein
Uric Acid
Triglycerides
LDH
Total Calcium
Alkaline
Phosphatase
Osmolality
Amylase
AST
ALT/AST Ratio
Creatine Kinase
Creatine
Kinase MB
%CKMB
- --------------------------------------------------------------------------------------------------------------
Electrochemistry Chloride Fuji Photo
Potassium Film Co., Ltd.
Sodium
- --------------------------------------------------------------------------------------------------------------
Coagulation PT aPTT International
Fibrinogen Technidyne
Thrombin Time Corporation
- --------------------------------------------------------------------------------------------------------------
Immunochemistry Digoxin Diagnostic
Theophylline Reagents, Inc.
Phenytoin
</TABLE>
* Clearance or exemption for point-of-care and physician office laboratory use
by non-technical personnel is expected based on submissions after our pilot
marketing studies.
<TABLE>
<CAPTION>
Technology
Product Regulatory Status Partner
- -----------------------------------------------------------------------------------------
<C> <S> <C>
Hematology Testing Cleared under Section 510(k) of the Federal Independent third
Device Food, Drug and Cosmetic Act for use in parties with whom we
professional laboratories. are negotiating
supply agreements
- -----------------------------------------------------------------------------------------
Careside Cable Development planned for second and third Advanced Medical
Interface between quarters of 1999. Information
the CareSide Technologies, Inc.
Analyzer and the
Hematology Testing
Device
- -----------------------------------------------------------------------------------------
- -----------------------------------------------------------------------------------------
Hematology Tests
Platelet count All hematology tests will be submitted with Independent third
Lymphocyte/Monocyte the filing of the hematology testing device parties with whom we
Count under Section 510(k) in 1999 for are negotiating
% professional laboratory, point-of-care and supply agreements
Lymphocyte/Monocyte physician office laboratory use.
Count
Total Granulocyte
Count
% Total Granulocyte
Count
White Blood Cell
Count
Hematocrit
Hemoglobin
MCHC
</TABLE>
29
<PAGE>
The Careside System
The Careside system is comprised of an instrument, the CareSide Analyzer, and
a series of disposable, diagnostic test cartridges designed for the accurate
determination of a wide variety of commonly ordered chemistry,
electrochemistry, immunochemistry and coagulation tests. In addition, the
Careside system will offer an optional separate hematology testing device
manufactured by a third party. The chart on page 28 summarizes the status of
tests that the CareSide Analyzer is intended to perform.
The CareSide Analyzer
The CareSide Analyzer is approximately 13 inches tall by 12 inches wide and
11 inches deep and weighs about 17 pounds. The exterior is made of high impact
resin plastic. The top of the CareSide Analyzer consists primarily of a touch
screen, on an ergonometric angle, on which the user inputs patient, physician
and billing information, the tests to be conducted and any desired commentary.
Alternatively, a separate keyboard is available for use if the operator so
chooses. We believe that the CareSide Analyzer's user interface software is a
significant strategic advantage. For example, its quality assurance and quality
control capabilities are equal to those required of central laboratories. The
quality assurance and quality control software stores and interprets the
quality control data generated using the embedded electronic quality control
system in the CareSide Analyzer as well as the traditional wet testing quality
control approach for test cartridges. After testing, quality control data is
flagged when out of limits and plotted on graphs for easy review. A set of five
re-usable and proprietary quality control test cartridges will be provided with
each instrument which allow the user to perform automated, electronic quality
control for all electrochemistry, chemistry, coagulation and immunochemistry
tests. These reusable quality control test cartridges will replace traditional
quality control which involved running multiple levels of commercial plasma
specimens for all the tests on the system. The software utilized by the
CareSide Analyzer is designed to govern testing of one patient at a time,
perform quality assurance and quality control documentation and conduct the
test ordering processes. It also contains a security system that is compliant
with the Clinical Laboratory Improvement Amendments of 1988. The user interface
system can be customized for each particular customer.
The process for using the CareSide Analyzer is streamlined and partially
automated compared to conducting tests in large commercial blood diagnostic
testing laboratories. The Careside system can be operated by non-technical
personnel with appropriate training in connection with the use of the device.
The operator will first select one or more test cartridges from inventory
depending on the tests ordered by the attending healthcare provider. Most
cartridges will contain one test, but some cartridges will contain two or three
tests. Up to six cartridges of a single patient's blood can be tested at the
same time. See "--Disposable Test Cartridges." The Careside system is currently
capable of conducting a maximum of eight tests per patient in a single 10 to 15
minute test cycle. When the development of additional multi-test cartridges is
completed, the Careside system will be able to handle 13 tests in a single 10
to 15 minute test cycle. To prepare a cartridge, the operator will place a
small amount of the patient's drawn blood into the test cartridge with a
pipette or other standard transfer device. The operator will then simply load
the test cartridges into the instrument. Any combination of cartridges can be
loaded in any order, thus enabling the operator flexibility to perform
individual tests or customized panels. This flexibility is designed to minimize
waste by allowing the operator to run only the tests ordered by the provider
rather than traditional pre-set panels that may contain unnecessary tests. This
feature is particularly responsive to the current and expected future
requirements of third-party payers. See "--Third-Party Reimbursement."
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ROUTINE BLOOD ANALYSIS PROCEDURE: THE CARESIDE SYSTEM
[Illustrations of Careside System]
1. Draw blood. Place a few 2. Using the touch-screen or 3. 10-15 minutes later,
drops of whole blood into keyboard, input demographic CareSise Analyser(TM)
the cartridge sample well. information and select tests provides test results
to be performed. Insert via print card, screen,
appropriate cartridge and and/or electronic data
press start. transfer. Caregiver
reviews test results
with patient.
After the operator inputs patient information and test orders, the instrument
will automatically perform the tests and record and display or print the
results. To perform the tests, the CareSide Analyzer undertakes cycles for
heating, centrifuging and several types of reading. The cycle time from the
moment the cartridge is dosed with whole blood and placed into the CareSide
Analyzer to final test result is approximately 10 to 15 minutes for chemistry,
electrochemistry, immunochemistry or coagulation tests, or any combination of
these tests. A standard Chem 7 panel, comprised of sodium, potassium, chloride,
carbon dioxide, glucose, creatinine and urea nitrogen tests, can be performed
in approximately ten minutes and will utilize five cartridges. Sodium,
potassium and chloride tests are on one cartridge and they are always ordered
in combination. At the conclusion of the test, the CareSide Analyzer ejects the
cartridges into a waste container for later disposal in appropriate biohazard
vessels.
The CareSide Analyzer provides test results to the healthcare professional in
several ways. A self-adhesive label can be printed with test results for direct
transfer to the patient's chart. Each CareSide Analyzer also incorporates a
floppy disk drive so that information can be downloaded from the instrument for
analysis. An additional electronic output method is through use of the rs-232
port on the rear of the machine. We expect to routinely work with our customers
to program an appropriate software interface into the CareSide Analyzer to
allow information to be transferred electronically into the user's data system.
Linkage software is being specially developed for us for this purpose by
Advanced Medical Information Technologies, Inc.
Disposable Test Cartridges
Each test cartridge is designed to facilitate the flow of the blood, serum or
plasma specimen onto chemicals packaged in the cartridge. These chemicals,
which are called reagents, react with the specimen and change. The changes are
then read by the CareSide Analyzer to yield the test result. Each test
cartridge is designed for a single use. Its various channels and pools assure
proper reagent and specimen temperature equilibration, sample separation,
sample metering, sample dispensing, test incubation and facilitate result
detection. Each cartridge contains all reagents necessary to perform a reagent
measurement on a serum, plasma or whole blood sample for a particular test. The
proprietary cartridges are each approximately 2.5 inches long and 1.5 inches
wide and are comprised of layers of molded plastic with channels for
application of the sample to the reagent. When stored in refrigerators, the
cartridges are expected to have a maximum of an 18 month shelf life. The
cartridges are placed in the CareSide Analyzer directly from the refrigerator
after sample dosing. The first four minutes of the test cycle warms the test
cartridges to the appropriate test temperature. If
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necessary, the CareSide Analyzer then spins the cartridges using centrifugal
force to push the sample through small channels, separating it into serum or
plasma. Excess sample is deposited in an overflow well. A measured amount of
sample remains in the metering passage and is dispensed onto the reagent film
or mixed with wet reagent pushed from an interior pouch. Each test cartridge is
designed to be airtight to prevent ventilation spoilage of the specimen sample.
The three basic types of measurements that will be made are spectral
transmittance, reflectance and electrochemical. In the case of the chemistry
cartridge, the CareSide Analyzer's platter spins the cartridge containing the
dry film, which will turn color from reaction with the blood element, over
LED/photodiode pairs. The LED lights reflect through the colors of the reagent.
Multiple reflectance tests are performed to yield a result. In the case of
coagulation and immunochemistry tests, the cartridge is spun over the same
LED/photodiode pairs which shine through a small rectangular hollowed prism,
called a prismatic cuvette, built into the cartridge. The light transmission is
then read by the CareSide Analyzer. In the case of electrochemistry, the test
is done on whole blood, before the other cartridges are centrifuged. For these
tests, the CareSide Analyzer contains ion specific electrodes which interact
with the proprietary electrochemistry cartridges to yield the test result.
The disposable test cartridges have a number of key features that we believe
contribute to the Careside system's reliability, speed, low cost and accuracy
of analysis. These include:
. Unique Cartridge Design. Specimen preparation, calibration and test
performance are incorporated in an inexpensive plastic cartridge. Where
necessary, the cartridge design incorporates storage and measured
delivery of reagents and electrolytes for mixing with the patient's
sample prior to analysis. Cartridges are loaded into the instrument
manually and are designed so that they can be inserted in only one
direction to avoid error.
. Ease of Sampling. Sampling is automatic and requires small volumes using
approximately 75 to 150 microliters ((mu)l) of whole blood, as compared
to current approaches requiring much larger amounts. The dosing process
requires the tester to fill the cartridge well to a point indicated on
the cartridge. No precise measurement of the blood sample is required by
the tester, as the cartridges' channels measure how much sample is
applied to the reagent.
. Built-in Centrifuge. Separation of plasma from whole blood, as required
for many tests, is accomplished in the cartridge after placement in the
CareSide Analyzer, so that a separate centrifugation step is
unnecessary.
. Flexibility in Testing. One, two or three tests may be contained in each
cartridge. Single test cartridges and a three test cartridge have been
designed, manufactured and used in testing. Two test cartridges have
been designed, but have not yet been manufactured and used in testing.
The added cost and complications of using test panels containing
unnecessary tests is avoided.
. Quality Assurance and Quality Control Features. All test cartridges are
bar-coded for test identification. The bar codes contain the type of
test cartridge, as well as a lot number, expiration date and self-
calibration information, which are all CLIA requirements. The data from
the cartridge's bar code will be read and stored in the CareSide
Analyzer. As each test is completed, it becomes part of the CLIA
documentation. Because each cartridge contains an identifying bar code
which is read by the instrument, the order in which the cartridges are
loaded is immaterial. The Careside system will check that the ordered
tests and the cartridges entered in the device match.
Test Menu
The CareSide Analyzer combines chemistry, electrochemistry, coagulation and
immunochemistry testing in a single testing instrument. In addition, the
Careside system will offer an optional separate hematology testing device
manufactured by a third party. We are not aware of any point-of-care blood
testing system on the market that has this combined capability.
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Chemistry Tests. Chemistry tests are used to assess general health status as
well as to diagnose and monitor diseases of the major organ systems such as the
heart, liver, kidney, blood, pancreas, endocrine and bone. The film chemistry
cartridges contain dry chemistry reagents which are stacked as required for the
test. Within a few minutes after the sample has been applied, a colored dye is
produced. The color intensity of the dye is measured by reflectance and,
through calibration information coded in the instrument and on the test
cartridge, a quantitative test result is generated.
We have recently executed a long-term supply agreement with Fuji Photo Film
Co., Ltd. for the use of its dry film chemistry reagent technology. Although in
dry form, the film uses the same technology as the wet reagent technology used
in high volume commercial analyzers. The agreement replaces an earlier
agreement with Fuji that was applicable only during the development stage of
the Careside system. The new agreement continues to provide us with an
exclusive supply of Fuji's dry film chemistry reagents for use in our point-of-
care system for more than 25 chemistry tests. We have agreed to purchase our
dry chemistry reagents exclusively from Fuji. See "--Sales--International."
Fuji is also developing four additional chemistry tests at its expense. Any
additional tests that Fuji develops may be available to us over the period of
the existing agreement, which runs through 2003 and thereafter is automatically
renewed on an annual basis. If we fail to obtain the necessary regulatory
clearances for 80% of the 39 tests specified in the contract by the end of
1999, our rights become non-exclusive.
Electrochemistry Tests. Like chemistry tests, electrochemistry tests
produced by Fuji pursuant to its agreement with us, are used to assess general
health status and to diagnose and monitor diseases of the major organ systems
such as the heart, liver, kidney, blood, pancreas, endocrine and bone. The
electrochemistry cartridge contains an ion specific electrode slide. When the
slide reacts with the sample, it generates values that correlate to the
concentration of sodium, potassium and chloride in the sample. The test
compares an electrochemical signal generated from a reference solution to a
similar signal generated from the patient's blood. The reference solution is a
liquid contained in a pre-filled pouch embedded in the cartridge. One side of
the ion specific electrode slide is exposed to a reference solution during the
testing sequence and the other side is exposed to the patient's whole blood.
The CareSide Analyzer reads the difference between the two, thereby generating
the test result.
Coagulation Tests. Coagulation testing assesses the ability of a patient's
blood to coagulate. Coagulation is the series of events that leads to the
formation of a blood clot. Tests of prothrombin time, or PT, and activated
partial thromboplastin time, or aPTT, are the primary coagulation tests used by
both physicians and hospitals.
Reagents from the coagulation test cartridge are contained inside a small
hollowed prism, called a prismatic cuvette, and in a pouch. Plasma is delivered
to the cuvette by pressurization of the membrane on the cartridge. A second
reagent, such as a buffer or calcium chloride, is added via the pouch. Light is
then transmitted through the cuvette. The coagulation reaction causes a change
in the cloudiness, or turbidity, of the plasma that is detected optically by
the CareSide Analyzer. The time it takes for this optical change to occur is
reported out as the coagulation time.
We have co-developed coagulation reagent technology for the PT test and we
are co-developing coagulation reagent technology for the aPTT test with
International Technidyne Corporation. International Technidyne has agreed to
provide such reagent technology to Careside on an exclusive basis for use in
multiple test category blood testing devices such as the CareSide Analyzer.
However, International Technidyne will retain the exclusive right to use the
technology in the field of point-of-care devices that perform only coagulation
testing. International Technidyne will also manufacture the coagulation reagent
and load it in the cuvette for us.
Immunochemistry Tests. Immunochemistry tests are used for the diagnosis of
drug effectiveness for heart, thyroid analysis and for other purposes. To date,
immunochemistry systems have had limited penetration in the point-of-care
market, because they are difficult to use, related instrumentation is
expensive, reagents are costly and assay times are long. We are in the process
of developing our immunochemistry test cartridge and are in the process of
performing our first validation studies using it.
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The immunochemistry test cartridge is identical in form and function to the
coagulation test cartridge except that a much smaller sample size is delivered
to the prismatic cuvette. The reagents in the cuvette and pouch are different
for each immunochemistry test. The CareSide Analyzer measures a rate of change
or endpoint in cloudiness depending on the test. The rate of change or endpoint
is converted from calibration information coded in the instrument and on the
test cartridge, generating a test result. We currently purchase immunochemistry
reagents from Diagnostic Reagents, Inc. and are currently negotiating a long-
term supply agreement with Diagnostic Reagents.
Hematology Tests. Hematology testing determines various attributes of a
patient's blood, such as how many platelets, monocytes or lymphocytes it has.
We expect to expand the Careside system's capabilities by adding nine or more
hematology tests, which will be performed on a separate optional device
manufactured and supported by a third party. While the hematology device we
intend to use has been developed, we are currently developing the software that
will allow data interchange from the hematology device to the CareSide
Analyzer. Our contract partner, Advanced Medical Information Technologies,
Inc., also known as AdMIT, is currently developing a link between the Careside
system and other medical devices, including the hematology device. The cabled
interface developed by AdMIT will enable users of the CareSide Analyzer to
connect hematology devices and other diagnostic test devices into the CareSide
Analyzer, thereby allowing the users to further avail themselves of the
CareSide Analyzer's extensive ordering, data storage, clinical records and
quality assurance and quality control capabilities.
Future Developments
We intend to have the broadest menu of any point-of-care blood testing device
and plan to continue to develop tests for the Careside system. At product
launch, the Careside system's menu is expected to include over 50 tests,
including an option for nine hematology tests, representing over 80% of all
blood tests ordered on an out-patient basis, including all of the most commonly
ordered out-patient blood tests. Even though our point-of-care technology will
not be capable of conducting every test potentially ordered by a healthcare
provider, we believe that, within five years, our planned menu will provide
over 90% of all out-patient tests in many clinical settings, and up to 60% of
tests commonly ordered in in-patient settings. For tests not performed by the
Careside system, healthcare providers could order tests from either a hospital
laboratory or a commercial laboratory.
We plan to add enhancements to the Careside system within the next five
years, including the ability for the blood sample to be loaded from a test tube
into a test cartridge automatically. This will eliminate the need for a person
to handle an open tube containing the patient's blood. In addition, we are
evaluating alternative methods of immunochemistry testing, such as the use of
high precision latex beads for the development, within five years, of large
molecule immunochemistry tests. Also designed and under development is a multi-
test cartridge that will be able to perform two or more film tests
simultaneously on one cartridge. The CareSide Analyzer's detection technology
is capable of extensive menu expansion. This gives us the ability to add
traditional chemistry, coagulation and small molecule immunochemistry tests
such as screening tests for drugs of abuse. We expect to develop additional
tests in the large molecule immunochemistry field such as prostate specific
antigen for prostate cancer and Troponin for heart attacks, as well as tests
for infectious diseases such as Strep A and Chlamydia.
In addition to linking the CareSide Analyzer and hematology or other
diagnostic testing devices, the AdMIT product is being designed to be connected
directly into laboratory or clinical information systems, physician practice
management systems or other information systems, either directly through a
local area network or via the Internet.
Marketing Strategy
Our marketing strategy is to position the Careside system as the blood
testing system of choice by demonstrating to hospitals the benefits of
decentralized blood testing, and by providing other healthcare providers with a
profitable and cost-effective alternative to central laboratory testing. By the
end of the third quarter of 1999, we intend to complete pilot site marketing
studies with hospitals, home care organizations and physician group practices
to determine utilization patterns, create a "how-to" book, and demonstrate
cost-
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effectiveness. We currently plan to rollout our system in SmithKline's
commercial laboratories pursuant to our distribution and supply agreement with
SmithKline Beecham Clinical Laboratories, Inc., and through our own sales force
to hospitals, nursing homes, home care organizations and larger physician group
practices. SmithKline has recently entered into an agreement to sell the stock
of SBCL to Quest Diagnostics Incorporated and take a 29.5% ownership interest
in Quest. Following the announcement of the sale of SBCL to Quest, we began
discussing the timing of our product launch with Quest. The discussions are
ongoing. Quest's acquisition of SBCL is anticipated to close in July 1999. We
believe that, allowing for time within Quest for internal planning, we should
be able to undertake our initial rollout to the commercial laboratory market
through SBCL, as a subsidiary of Quest, in the last quarter of 1999. At the
time of product rollout, our goal is to have the most comprehensive menu of
tests available in any single point-of-care system.
Our key targeted market segments are as follows:
Hospitals. There are over 5,000 acute care hospitals in the United States.
Laboratory testing services required by hospitals are usually provided by a
central hospital laboratory, which services all of the hospital's testing needs
as well as the testing service needs of hospital physician groups. Hospital
laboratories are expensive to maintain because they have to be maintained on a
24 hour basis, they require specially trained personnel to be present at all
times to operate high volume analyzers and they demand significant amounts of
capital to equip and maintain. Furthermore, hospitals are often reimbursed by
institutional payers for patient admissions based on specific diagnoses
reflecting the complexity of the care needed and a predetermined payment for
such care. While laboratory testing services are an essential part of diagnosis
and monitoring the beneficial results of treatment, they also represent a cost
to the hospital as it seeks to generate a profit by completing the care and
treatment of patients before their costs exceed the level of reimbursement. The
Careside system provides hospitals with the opportunity to decentralize
laboratory testing to the patient floors and bedside, as routine and stat tests
can be conducted at the time the patient is being evaluated by providers.
Consequently, the Careside system is expected to enable some hospitals to
eliminate their central laboratories or replace certain costly analyzers and
outsource non-routine testing not done on the CareSide Analyzer to a
centralized laboratory.
Physician Groups. There are over 3,500 physician groups in the United States
with practices in excess of 35 doctors. Excluding radiology groups, the target
market for the Careside system is over 2,200 groups. Physicians usually obtain
their laboratory testing services from the hospital laboratories with which the
physicians are affiliated or from a commercial laboratory. In either case,
patient samples are collected from the physician's office and sent via courier
to the applicable laboratory, with results delivered to the physician, either
electronically, by fax or by telephone. For physician group practices, the
Careside system will offer improvements in daily office routine, greater
convenience, enhanced patient satisfaction and new revenue opportunities.
Home Care. Industry data shows that the number of home care agencies and
patients receiving home care services has grown significantly in recent years.
We believe significant growth in this market segment will continue. Industry
data reported that the total number of Medicare certified home care agencies
rose from 11,000 in 1989 to over 20,000 by the end of 1996. In 1996, the Health
Care Financing Administration estimated that 3.9 million Medicare enrollees
would receive home care services during 1997. This is twice the number that
received such services in 1990. The number of home care visits increased from
70 million in 1990 to an estimated 306 million in 1997. On average, 30% of home
care patients visited each week require laboratory testing. Common laboratory
tests include, among others, Chem 7 panels, iron, blood glucose, magnesium,
prothrombin time and immunochemistry tests for monitoring phenobarbital,
phenytoin and digoxin. Patient samples are drawn from the patient, gathered
from the home care providers and delivered via courier to a commercial
laboratory for testing. Test results are made available the next day or on a
premium price basis by fax, telephone or written report delivered four or five
hours later. The CareSide Analyzer is expected to enable the home healthcare
provider to draw the patient's sample, run the test and deliver the results
without having the sample delivered via courier to a commercial laboratory.
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Nursing Homes. In 1994, the most recent year for which industry data has
been compiled, there were over 15,000 nursing homes in the United States with
more than 1.6 million licensed beds. The average occupancy rate was over 92%
with each nursing home averaging nearly 100 patients. Common diagnostic tests
ordered for nursing home patients are complete blood counts, Chem 7 panels,
electrolytes, blood glucose, prostate specific antigen, therapeutic drug
monitoring and urinalysis. Nursing homes generally obtain their testing
services from commercial laboratories and encounter the same delays and
reimbursement issues as physicians. The CareSide System provides a profit
opportunity to the nursing home by allowing it to conduct and bill for
laboratory services, while simultaneously enhancing the nursing home's ability
to provide better care.
Pilot Program
Prior to the commercial rollout of our system commencing in the fourth
quarter of 1999, we will have completed pilot studies of the Careside system in
multiple sites within certain targeted market segments. To date, we have
arranged for pilot studies with Children's Hospital of San Diego, Children's
Hospital--Los Angeles and the Seattle Children's Hospital, all through Child
Health Corporation of America, APRIA Healthcare, one of the largest United
States home care providers, Reliant Care Group, L.L.C., a chain of nursing
homes, and SBCL. We are currently arranging for pilot studies with several
group physician practices located in Phoenix, Arizona and Los Angeles,
California.
The purposes of piloting the Careside system are to collect data
demonstrating the economic benefit of the Careside system in each customer
segment, to create a how-to book that will be tailored to the needs of each
customer type and to provide validation testing necessary to obtain FDA
marketing clearance for point-of-care and physician office laboratory use. This
how-to book will explain the process of obtaining and maintaining a laboratory
license, train personnel to conduct testing and educate personnel about the
operation of the Careside system. With both a financial model and a how-to book
that are specific to customer segments, we then intend to introduce the
Careside system to the overall market in the fourth quarter of 1999.
Sales
Domestic
We intend to hire, train and regionally deploy our own domestic sales force
to sell the Careside system to hospitals, healthcare systems, large physician
group practices, managed care organizations, home care agencies and nursing
homes, either directly or through institutional pharmaceutical service
organizations which serve them. Because we intend to target customers who order
large volumes of tests, we anticipate building a direct sales force of
approximately 40 people.
As one of the largest commercial laboratories in the United States,
SmithKline Beecham Clinical Laboratories, Inc. conducts millions of tests for
small physician groups and individual physicians annually. We expect the
Careside system to be available to small or solo practices through in-patient
service centers owned and staffed by SBCL since it may be inefficient for such
practices to own and operate a CareSide Analyzer. SBCL owns and operates over
700 patient service centers across the United States. We have entered into a
distribution agreement with SBCL which gives SBCL, with respect to domestic
sales, an exclusive right, as a commercial laboratory, to use and distribute
the Careside system within the commercial laboratory industry and the non-
exclusive rights to sell the Careside system to hospitals and healthcare
systems, other health care providers, managed care organizations and insurers.
The agreement also obligates SBCL, upon FDA clearance or exemption of 30
specified tests, to purchase a minimum number of CareSide Analyzers and test
cartridges from us for the first five years following such FDA action.
SmithKline has informed us that no amendments to our distribution and supply
agreement with SmithKline Beecham Clinical Laboratories, Inc. will occur as a
result of the sale of SBCL to Quest Diagnostics Incorporated. We are currently
in discussions with Quest regarding the implementation of our distribution and
supply agreement. SBCL will continue to be the entity with which we deal. It
will, however, be a subsidiary of Quest after the transaction closes. See
"Certain Transactions--SmithKline Beecham."
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International
In international markets, we intend initially to enter into distribution
agreements and gradually to develop our own sales force as appropriate. Our
distribution and supply agreement with SBCL gives SBCL the same exclusive and
non-exclusive distribution rights as it has in the United States in any ten of
the following countries where SBCL owns, operates, manages a commercial
laboratory on or before December 31, 2000: Great Britain, Mexico, Spain, South
Africa, Singapore, Malaysia, Indonesia, Australia, Chile, Argentina, France and
Germany. In addition, Fuji Photo Film Co., Ltd. has a right of first refusal to
be our distributor on an exclusive basis in Japan and a non-exclusive basis in
other Asian countries. The current agreement with Fuji expires in 2003 and
permits automatic annual renewals thereafter subject to cancellation by either
party. In addition, we expect to partner with other diagnostic instrument
distributors in the international markets with an initial focus on Europe. See
"Certain Transactions--SmithKline Beecham."
Research and Development
As of June 15, 1999, we employed 26 scientists and technical staff who
supervise the development of the instrument and tests, validate test results,
and perform quality assurance and quality control documentation and regulatory
submissions.
After extensive review of available test technologies, we chose Fuji Photo
Film Co., Ltd. as our partner for chemistry and electrochemistry tests. Fuji
makes dry film based chemistry tests and uses them in large analyzers that it
produces and sells in Japan and Taiwan. In addition, Fuji has agreed to supply
this reagent technology during the Careside system's development stage for more
than 25 chemistry tests. Fuji has agreed to develop four additional tests at
its expense for the Careside system. See "--The Careside System--Test Menu."
The utilization of third parties to develop our tests has allowed us to focus
on creating a platform for delivery of a highly efficient test system. For
hospital environments, the CareSide Analyzer's software has a configuration
capability that facilitates a test order entry menu and security processes as
determined by laboratory management. Fields exist for extensive data capture
including patient, physician and billing information. All of these systems are
optional to the user other than the data requirements for compliance with the
Clinical Laboratory Improvement Amendments of 1988. In addition, the Careside
system easily accommodates test menu additions by downloading new test
algorithms into the device via a floppy disk. This eliminates the need to
remove the instrument from the field as new test capabilities receive FDA
clearance/approval.
We have entered into a series of research and development agreements for our
system. As is customary in the industry, these agreements are short term and
provide for termination for any reason by either party on relatively short
notice. Battelle Memorial Institute, a leader in developing industrial
technology, has designed the disposable testing cartridge according to
specifications which we provided. All applicable patent rights under this
contract have been assigned to us. To date, two patent applications on the
cartridges have been allowed and are expected to be issued as U.S. patents in
the near future. We have also filed a third U.S. patent application on our
cartridges. See "--Patents and Proprietary Rights." Pursuant to our
relationship with Battelle, Battelle is also designing a cost-effective
manufacturing process and quality assurance methods, based on federal Good
Manufacturing Practices protocols, for the disposable cartridges.
UMM Electronics, Inc., a contract engineering and manufacturing firm,
performed the design and development work of the CareSide Analyzer and
continues to provide development services for us to further enhance our
product. Other products developed by UMM include point-of-care blood glucose
monitors, point-of-care coagulation instruments, intravenous infusion pumps,
dialysis machines and infant care warmers. UMM is an FDA-registered
manufacturer of sophisticated medical products required to comply with federal
GMP regulations.
Hauser, Inc., an industrial design consultant, provided services for the
design and development of the entire Careside system. Hauser conducted focus
groups from each target market segment in order to obtain
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customer input on the design features and to assist in the development of an
instrument and software systems involving user interaction. Currently, Hauser
is providing packaging design services.
We continue to pursue development work with other contract partners. We are
further developing coagulation reagent technology with International Technidyne
Corporation. We recently filed a joint patent application with ITC for a
coagulation reagent. In addition, we are utilizing the services of AdMIT to
develop the cabled interfaces between the CareSide Analyzer and other medical
devices and information systems.
Manufacturing and Supply
We designed and outfitted a building in Culver City, California, of
approximately 16,000 square feet in December 1996 as our development facility
and offices. The building contains space for our automated assembly system
which Battelle Memorial Institute is designing. The assembly system will mount
the reagents in the test cartridges, and package and label the cartridges. This
facility has been set up to comply with all applicable state and federal
regulatory requirements, including registration with the state and federal
governments in accordance with applicable laws governing medical devices prior
to commercial distribution. The facility will be subject to periodic FDA
inspection to determine whether our manufacturing processes comply with federal
GMP regulations for medical devices.
We intend to assemble and package at our Culver City facility all cartridges
used by the instrument. The cartridges are assembled in two main stages.
Initially, those components which are not sensitive to humidity, such as
plastic parts, are assembled in a normal humidity environment. The second stage
of the cartridge assembly process involves the mounting of dry film chemistry
strips or pouched reagents in the cartridges, which must be done in a low
humidity environment to preserve the film. This step will be performed in an
automated assembly line at our facility. We are in the process of selecting and
purchasing the equipment necessary for this process. We expect our first
automated assembly line to be in place by the end of 1999 or as our cartridge
inventory needs increase. In addition, during the cartridge manufacturing
process, our equipment must test the pressure of the ultrasonic seal between
the base plate and the upper plates of the test cartridges. Our equipment
allows for several inspection steps during the assembly process. Battelle is
assisting us in developing the fully automated assembly line for the cartridges
with these steps built in. The production capacity of the pilot cartridge
production line for chemistry and immunochemistry will be approximately 1,800
units per hour or 13,000 units per shift. Depending on the specific tests
ordered, our current facility, with additional equipment, will support between
$40 and $60 million of test cartridge sales annually. The automated production
line will utilize proprietary process technology, designed by Battelle and
owned by us, and will be scalable to meet increasing demand.
We will outsource the manufacturing of the plastic components of our
cartridges. We have been using a third party to manufacture these components
using injection molding processes. Recently, we obtained bids from a number of
manufacturers of cartridge components and have selected a supplier to meet our
manufacturing needs based on competitive terms.
We have entered into an agreement with UMM Electronics, Inc. for the
manufacture of the CareSide Analyzer at UMM Electronics' facility in
Indianapolis. Certain aspects of the manufacturing agreement, including the
price at which UMM Electronics will manufacture the device, are subject to
further negotiation and will be finalized once tooling is completed and the
manufacturing line set up.
We expect to source our chemistry, electrochemistry, coagulation and
immunochemistry reagents from Fuji, International Technidyne Corporation and
Diagnostic Reagents, Inc. See "--The Careside System--Test Menu."
We intend to purchase and distribute a hematology testing device manufactured
by a third party and are currently negotiating a supply agreement.
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Competition
We will principally compete with manufacturers of traditional diagnostic
testing equipment used by centralized laboratories and current point-of-care
diagnostic companies whose products perform testing for patients in critical
condition. Historically, most clinical testing has been performed in a
centralized laboratory setting. These laboratories provide analyses similar to
those to be conducted by our system and have traditionally been effective at
processing large panels of tests using skilled technicians and complex
equipment. While the CareSide Analyzer will not be designed to provide the same
range of tests, we believe that our products will offer several advantages over
centralized laboratories, including lower costs, mobility, faster results,
simplified specimen preparation, reduced opportunity for error through
decreased specimen handling, ease of regulatory compliance and increased
patient satisfaction.
We are also aware of other companies with point-of-care analysis devices.
These companies have focused on the testing for critical care patients or tests
that are disease specific. Examples of disease specific tests are glucose and
digoxin which measure blood sugar levels in diabetic patients or heart
complications. In all cases, these companies perform a limited number of tests
and their systems are not designed to have their test menus increase.
Consequently, these devices add costs as the large analyzers in hospital or
commercial laboratories conduct these tests and many more. We believe that our
system will offer distinct competitive advantages over these products,
including the ability to conduct tests in multiple test categories in a single
device, internal centrifugation, convenience and ease of use. Several
companies, including i-STAT Corporation, Abaxis, Inc., Diametrics Medical, Inc.
and PharmaNetics, Inc., are currently making or developing products that will
compete with our tests although not with our system. Some of these companies
also provide disease specific tests that will not be available at the time of
launch on the CareSide Analyzer but which we expect will be added later.
Some large pharmaceutical companies also have point-of-care blood testing
devices and could, given their resources, develop systems which compete with
the Careside system. Abbott Laboratories, Inc., Clinical Diagnostic Systems (a
division of Johnson & Johnson) and Roche Diagnostic Systems, Inc. all have
products which perform point-of-care testing. To date, we believe that none has
developed a point-of-care testing system comparable to our system.
Patents and Proprietary Rights
Our policy is to seek patent protection, both in the United States and
abroad, for each of the areas of invention embodied in our CareSide Analyzer
and related cartridges. To date, we have filed three patent applications on our
cartridges with the U.S. Patent and Trademark Office. Two of these applications
have been allowed and are expected to be issued as U.S. patents. We have also
filed a joint U.S. patent application with International Technidyne Corporation
for a coagulation reagent. We have filed international applications
corresponding to two of our U.S. cartridge applications and intend to file an
additional international application corresponding to the remaining U.S.
cartridge application. We have also filed one design and three utility patent
applications on the CareSide Analyzer. Our agreements with Fuji Photo Film Co.,
Ltd., Battelle Memorial Institute and International Technidyne Corporation,
assign to us certain proprietary rights that result from the research conducted
under the agreements. The Fuji agreement gives us non-exclusive rights to use
Fuji's proprietary technology in the Careside system outside of Japan. Only
Fuji will sell our system in Japan. The other agreements provide that the
technology used in the Careside system is owned either by us or jointly by us
and our partner. These agreements do not restrict us, if we choose, from
seeking other suppliers of competitive technologies. We will seek to protect
any such proprietary rights assigned to us by our technology partners. Battelle
and International Technidyne have agreed to share expenses or otherwise assist
us in prosecuting patent applications. Upon completion of the offering, we
expect to proceed with the patent application process, and anticipate the
filing of additional applications. In addition to patent protection, if any, we
will rely upon trade secrets, know-how and continuing technological innovation.
Although our Chief Executive Officer, Executive Vice President--Research and
Development and Chief Financial Officer have agreed to maintain in confidence
our confidential information and proprietary technology, we have not otherwise
required our
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employees to sign confidentiality agreements. We plan on seeking the execution
of such confidentiality agreements by our current and future employees.
Third-Party Reimbursement
In April 1998, the federal government instituted a policy that, in connection
with Medicare reimbursement for large panel testing, will only reimburse four
different panels of chemistry tests, the largest of which has 13 tests. The
consequence of this policy has been that more single tests are ordered as
compared to large panels. The Careside system is currently capable of
conducting eight tests in a single 10 to 15 minute test cycle. At the time of
product launch, the 13 test panel can be accommodated in two test cycles. Upon
the completion of development of additional multi-test cartridges, the Careside
system will be able to handle a 13-test panel in a single 10 to 15 minute test
cycle. The Careside system is also configured to easily test any combination of
single test cartridges with similar cycle times for up to six single tests per
cycle. Payers have stated that they will only reimburse for panels that are
disease specific. With this change in policy and reimbursement practice, the
number of tests reimbursed as part of panels has begun to drop. The Careside
system, which places primary focus on single and disease specific testing, is
very competitive in light of these changes in payer practice related to test
panels. See "Risk Factors--Uncertainty Relating to Third-Party Reimbursement
May Impact Our Business."
Managed care provides physicians with incentives to treat patients using
clinical treatment protocols that have been developed for many chronic and
acute illnesses. These protocols frequently contain preventative diagnostic
interventions that are used to help avoid the occurrence of acute episodes of
illness. Diagnostic blood testing is one of the major tools used in these
protocols for early detection and for ongoing evaluation of treatment efficacy.
We believe that a diagnostic blood testing system that is cost effective and
adds convenience and rapid information will be well received by managed care
organizations and their physicians.
Even with the growth of managed care, more than 75% of all blood tests
continue to be reimbursed on a fee for service basis. This number has remained
steady in the commercial laboratory industry for the past three years. We
believe that in both the managed care and fee-for-service markets, our point-
of-care system will be responsive to incentives that drive the respective
markets. Many managed care entities dictate to their member physicians which
laboratories they must use for blood testing. Physicians have the opportunity
to utilize exceptions to these mandates to conduct in-office testing. The
Careside system will enable physicians to offer laboratory testing services and
take advantage of these exceptions to the managed care organizations' policies.
We expect to facilitate this by working closely with the physicians and the
managed care organizations to demonstrate cost effectiveness and cost reduction
of our system. This will be a critical component of the pilot site testing
strategy and is intended to position the Careside system as the new testing
standard and the blood testing system of choice over traditional laboratory
testing methods.
Government Regulation
The FDA regulates the development, manufacture, and marketing of medical
devices including diagnostic tests. The FDA requires testing of the Careside
system in accordance with regulatory requirements in the laboratory and, as
appropriate, in clinical settings to establish product performance before
marketing. After marketing has commenced, FDA clearance must be obtained before
making certain types of product changes. The CareSide Analyzer and certain
tests have already received marketing clearance for professional laboratory
use, but not for point-of-care or physician office laboratory use. We expect
that the CareSide Analyzer and tests will receive marketing clearance for
point-of-care and physician office laboratory use following clinical testing of
the instrument at clinical sites. Without the point-of-care and physician
office laboratory use clearance, the CareSide Analyzer could be used only at
professional laboratory sites with laboratory personnel, which would limit our
potential market. Professional laboratories include hospital, commerical and
independent laboratories. As part of our pilot marketing studies, we have
arranged for clinical settings for point-of-care and physician office
laboratory use validation studies commencing in June 1999. We expect point-of-
care and physician office laboratory use clearances prior to our commercial
product launch in the fourth quarter of 1999.
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The point-of-care designation depends upon the FDA's determination that the
results obtained from clinical studies for a number of representative tests,
selected by the FDA, have accuracy and reliability when performed by a non-
laboratory user that is equivalent to or better than test results obtained from
the same tests performed by a laboratory professional.
The FDA has regulations that set varying requirements for medical devices
according to potential risk class. Class I devices represent the lowest
potential risk devices and are therefore subject only to the general controls
that include establishment registration, product listing, the prohibition of
mislabeling or adulteration, and a requirement to comply with federal Good
Manufacturing Practices regulations. Pre-market notification is required for
some Class I clinical diagnostic devices. Class II devices present greater risk
than Class I devices and are subject to special controls, such as guidelines or
performance standards, as well as the same general controls that are applicable
to Class I devices. Class II devices require pre-market clearance to
demonstrate that the FDA accepts the manufacturer's claims that the device is
substantially equivalent to other legally marketed devices, and meets generally
accepted performance criteria that may be required to demonstrate that the
device is safe and effective. Class III devices present a higher level of risk
and are additionally subject to rigorous demonstration of safety and
effectiveness through the pre-market approval process.
For some Class I and most Class II devices, a pre-market notification must be
submitted to the FDA. Usually within 90 days of the receipt of this
notification, the FDA makes the determination whether the device submitted is
substantially equivalent to a legally marketed device. A legally marketed
device is one which was marketed prior to the passage of the Medical Device
Amendments of 1976, or a post-1976 device that has been determined by the FDA
to be substantially equivalent to previously cleared devices. A determination
of substantial equivalence requires several FDA findings: first, that the
device has the same intended use as the legally marketed device; and second,
either that the device has the same technological characteristics as the
legally marketed device or, if it does not, that the device is as safe and
effective as the legally marketed device and does not present different
questions about safety and effectiveness. Class III devices require extensive
clinical testing to prove safety and effectiveness, and submission of the
resulting data to the FDA as a pre-market approval application. The FDA
ordinarily will refer a new device pre-market approval application to an
advisory panel of outside experts for a recommendation on whether to approve
the application or to request additional testing. The CareSide Analyzer and all
31 tests already cleared or exempt by the FDA have been classified in Class II.
We believe that all of the remaining tests currently expected to be performed
by the CareSide Analyzer will be similarly classified. If the FDA disagrees,
however, a pre-market approval application might be required for one or more
tests. Certain future tests, such as prostate specific antigen, are expected to
require pre-market approval.
The information required for a pre-market notification for the Company's
products will be generated by or for us. For tests that will be performed in a
clinical laboratory, validation may be performed in the manufacturer's
laboratory. For tests that are intended for use outside of the clinical
laboratory, such as physician offices or nursing homes, the FDA also requires
that validation data be gathered from at least three clinical sites. We believe
that the required laboratory or clinical studies do not constitute a
significant risk for patients. Non-significant risk device studies performed in
the clinic require institutional review board approval and may require patient
informed consent but do not require the clearance of an investigational device
exemption application by the FDA. If the FDA were to believe that such studies
constitute a significant risk, we would need to submit an investigational
device exemption application, containing an investigation and study monitoring
plan, and allow the FDA 30 days to review the investigational device exemption
application or request additional information prior to initiating an
investigation.
Where a pre-market approval application is required, FDA regulations require
the demonstration of safety and effectiveness, typically based upon extensive
clinical trials. Fulfilling the requirements of the pre-market approval
application are costly and both the preparation and review are time consuming,
commonly taking from one to several years. Before granting pre-market approval,
the FDA must inspect and find acceptable the proposed manufacturing procedures
and facilities. The pre-market approval regulations also require FDA approval
of most changes made after the tests have been approved.
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Manufacturing Regulation
For products either cleared through the pre-market notification process or
approved through the pre-market approval process, our manufacturing facility
must also be registered with the FDA. The manufacture of products subject to
Section 510(k) of the Federal Food, Drug, and Cosmetic Act or to Section 515
pre-market approval requirements must be in accordance with quality system
regulations and current federal Good Manufacturing Practices regulations. We
are also subject to various post-marketing requirements, such as complaint
handling and reporting of adverse events. Pre-market approval products are also
subject to annual reports. The FDA typically inspects manufacturing facilities
every two years. We intend to seek and maintain ISO 9001 certification. As a
result, inspections by notified bodies may be more frequent.
The CareSide Analyzer is being further developed and will be manufactured by
UMM Electronics, Inc. UMM is an FDA registered and inspected facility. UMM is
also ISO 9001 certified. In adherence to FDA and ISO 9001 requirements, UMM
follows a structured design control process.
Third-Party Safety
Third-party safety certification is not required for FDA marketing
permission, but will be required by our customers and to enter markets in other
countries. In this regard, we are in the process of obtaining an Underwriters
Laboratories, or UL, listing for the instrument. UL will review the CareSide
Analyzer according to UL 3101-1 that is equivalent to the international
standard IEC 1010. The CareSide Analyzer is also being designed to comply with
requirements that ultimately will facilitate marketing of the product in Europe
and Japan. These requirements include the Low Voltage Directive (73/23/EEC),
the Electromagnetic Compatibility Directive (89/336/EEC), and the In Vitro
Diagnostic Medical Device Directive (98/79/EC).
Clinical Laboratory Improvement Amendments of 1988
All medical testing in the United States is regulated by the Health Care
Financing Administration according to the complexity of the testing as
specified under the Clinical Laboratory Improvement Amendments of 1998. CLIA
regulations establish three categories of laboratory tests, for which
regulatory requirements become increasingly stringent as the complexity of the
test rises: (1) tests that require little or no operator skill, which allows
for a certificated waiver of the regulations; (2) tests of moderate complexity;
and (3) high complexity tests which require significant operator skill or
training. CLIA regulatory requirements apply to facilities such as clinical
laboratories, hospitals, and physician offices which perform laboratory tests.
All laboratories are subject to periodic inspection. In addition, all
laboratories performing tests of moderate or high complexity must register with
HCFA or an organization to whom HCFA has delegated such authority. They also
must meet requirements relating to personnel qualifications, proficiency
testing, quality assurance, and quality control. We expect all of the tests for
the CareSide Analyzer to be categorized as moderate or lower complexity. To
date, the tests performed by the CareSide Analyzer have been categorized within
the moderate complexity class as defined by current CLIA regulations. In
practical terms, performing a test of moderate complexity means that the
individual supervising the test, i.e., the physician, pathologist or laboratory
director, must be appropriately educated and trained, whereas the individual
who operates the CareSide Analyzer requires either formal laboratory education
or a high-school education and training in the skills required to perform
testing with the CareSide Analyzer, such as specimen collection and quality
control.
State Regulation
We and our products will be subject to a variety of state laws and
regulations in those states where our products are marketed, sold or used.
Thirteen states currently restrict or control, to varying degrees, the use of
medical devices such as the Careside system outside the clinical laboratory by
persons other than doctors or licensed technicians. For example, California,
New York and Florida all have unique requirements that define which steps in
the testing process can be performed by physicians, nursing or other personnel
who are not licensed technicians. We have designed our testing system to comply
with these requirements, while minimizing the need for higher cost labor to run
the test process. However, these restrictions may add labor
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costs to the customer, and such costs may hinder our ability to market our
products in these locations. Although we plan to seek interpretations, rulings
or changes in relevant laws and regulations to remove or ameliorate these
restrictions, there can be no assurance that we will be successful.
International Regulation
In addition to the United States market, we intend to pursue markets in Asia
and Europe through select strategic alliances. The recently published European
Community In Vitro Diagnostic Directive places our products within a category
that has a low regulatory burden. Manufacturers are allowed entry into the
market based upon self-certification that they complied with published
directives, similar to existing United States requirements, containing
performance, labeling, and other quality requirements. Japan has its own
requirements for in vitro diagnostics.
Product Liability and Property Insurance
Sale of our products entails risk of product liability claims. The medical
testing industry has historically been litigious, and we face financial
exposure to product liability claims in the event that use of our products
result in personal injury. We also face the possibility that defects in the
design or manufacture of our products might necessitate a product recall. There
can be no assurance that we will not experience losses due to product liability
claims or recalls in the future. We anticipate purchasing product liability
insurance in reasonable and customary amounts when we begin to sell products in
the third quarter of 1999. Such insurance can be expensive, difficult to obtain
and may not be available in the future on acceptable terms, or at all. No
assurance can be given that product liability insurance can be maintained in
the future at a reasonable cost or in sufficient amounts to protect us against
losses due to liability. An inability to maintain insurance at an acceptable
cost or to otherwise protect against potential product liability could prevent
or inhibit the commercialization of our products. We expect that our insurance
coverage will be adequate for the risks we face. However, a product liability
claim in excess of relevant insurance coverage or product recall could have a
material adverse effect on our business, financial condition and results of
operations.
We have liability insurance covering our property and operations with
coverage and deductible amounts and exclusions that we believe are customary
for companies of our size and adequate for our industry. There can be no
assurance that our current insurance coverage is adequate or that we will be
able to maintain insurance at an acceptable cost or otherwise to protect
against liability.
Employees
As of June 15, 1999, we had 31 full-time employees, of which 26 were engaged
in research and development and manufacturing activities and five were engaged
in administrative activities. None of our employees is covered by a collective
bargaining agreement, and we believe our relations with our employees are good.
Additionally, our contract strategic partners, Battelle Memorial Institute and
UMM Electronics, Inc. have provided approximately 40 full-time equivalent
employees on a contract basis to develop the Careside system.
Properties
We lease approximately 16,000 square feet of space in Culver City, California
as our executive offices and for the research and development, validation,
manufacture and assembly of test cartridges. The lease has a term of five
years, with a current monthly rent of $13,620, increasing to $15,220 per month
until the expiration of the lease in October 2001. We have an option to renew
the lease for one additional five-year term at 95% of the fair market rental
value. We believe that the Culver City facility will adequately serve our needs
for the immediate future.
Legal Proceedings
We are not a party to any material legal proceedings.
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MANAGEMENT
Directors, Executive Officers and Key Employees
The following table sets forth certain information concerning the individuals
who serve as our directors, executive officers and key employees:
<TABLE>
<CAPTION>
Name Age Position
---- --- --------
<C> <S> <C>
Directors and Executive Officers:
W. Vickery Stoughton (1)......... 53 Chairman of the Board of Directors and Chief Executive Officer
Thomas H. Grove.................. 50 Executive Vice President--Research and Development,
Secretary and Director
James R. Koch (2)................ 45 Chief Financial Officer, Treasurer, Executive Vice
President and Director
Anthony P. Brenner (1)........... 41 Director
William F. Flatley (2)........... 57 Director
Kenneth N. Kermes (2)............ 64 Director
C. Alan MacDonald (2)............ 66 Director
Diana Mackie (1)................. 52 Director
Philip B. Smith (1).............. 63 Director
Key Employees:
Kenneth Asarch................... 41 Vice President--Quality Systems and Regulatory Affairs
Marija N. Valentekovich.......... 67 Vice President--Manufacturing
</TABLE>
- --------
(1) Member of Compensation Committee
(2) Member of Audit Committee
Directors and Executive Officers
W. Vickery Stoughton, Chairman of the Board of Directors and Chief Executive
Officer. Mr. Stoughton has served as our Chairman of the Board of Directors and
the Chief Executive Officer since our formation in July 1996. Prior to that, he
served as President of SmithKline Beecham Diagnostics Systems Co., a diagnostic
services and product company, from October 1995 to July 1996, and was President
of SmithKline Beecham Clinical Laboratories, Inc., a provider of diagnostic
laboratory services, from August 1992 to September 1995. As President of SBDS,
Mr. Stoughton had responsibility for SBCL, SmithKline Beecham Clinical
Laboratories International and SBDS's genetic testing and point-of-care testing
projects. In addition, Mr. Stoughton served as Chief Executive Officer and Vice
Chancellor for Health Affairs of Duke University Hospital from 1991 to 1992,
Chief Executive Officer of Toronto Hospital in Toronto, Canada from 1981 to
1991, Chief Operating Officer of Brigham and Women's Hospital in Boston from
1980 to 1981 and Chief Executive Officer of Peter Bent Brigham Hospital in
Boston from 1978 to 1980. Mr. Stoughton holds a B.S. in Chemistry from St.
Louis University and a M.B.A. from the University of Chicago. He is currently a
director of Sun Life Assurance Company of Canada, a financial services company,
and Biomira, Inc., a pharmaceutical company.
Thomas H. Grove, Executive Vice President--Research and Development,
Secretary and Director. Dr. Grove has served as our Executive Vice President--
Research and Development, Secretary and as one of our directors since our
formation in July 1996. From April 1984 to July 1996, he served in a number of
management positions at SmithKline Beecham Clinical Laboratories, Inc.
involving research and development activities, including the position of Vice
President of Scientific Affairs from January 1991 to July 1996, where, among
other things, he was in charge of National Quality Control and Quality
Assurance for SBCL. Dr. Grove has received a number of awards, including a NATO
Science Fellowship to attend Oxford University from 1978 to 1979. He was also
named Young Investigator of the Year in 1980 by the American
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Association for Clinical Chemistry and was elected to the National Academy of
Clinical Biochemistry in 1977. Dr. Grove holds a B.S. in Biology from SUNY-
Albany and a Ph.D. in Biochemistry from Syracuse University.
James R. Koch, Chief Financial Officer, Treasurer, Executive Vice President
and Director. Mr. Koch has served as our Chief Financial Officer, Treasurer,
Executive Vice President and as one of our directors since July 1998. Prior to
joining us, Mr. Koch served as Vice President and Chief Financial Officer of
ILEX Oncology, Inc., a company which develops oncology drugs, from August 1996
to July 1998. In addition, Mr. Koch served as Vice President, Finance and Chief
Financial Officer for two start-up specialty pharmaceutical companies, Symphony
Pharmaceuticals, Inc., from September 1993 to August 1996, and Neose
Pharmaceuticals, Inc., currently Neose Technologies, Inc., from September 1991
to September 1993. His prior experience also includes ten years in senior
financial management positions with G.D. Searle Pharmaceutical, a manufacturer
of pharmaceutical products. Mr. Koch holds a B.S. in Mechanical Engineering
from General Motors Institute and a M.S. from the Krannert School of Management
at Purdue University.
Anthony P. Brenner, Director. Mr. Brenner has served as one of our directors
since November 1996. Since January 1998, he has served as a Managing Director
with Omega Ventures, a venture capital firm, where he oversees investment
activities in the information and business services industries. Prior to that,
Mr. Brenner served as Senior Managing Director of Advanta Partners LP, a
private equity investment partnership, and as a member of the Board of
Directors of Advanta Corporation, a financial services company, from 1992 to
1996. In addition, since 1989 Mr. Brenner has served as President of Cedar
Point Partners, a private equity investment partnership. Mr. Brenner earned a
B.A. from Yale University and a M.B.A. from Stanford University.
William F. Flatley, Director. Mr. Flatley has served as one of our directors
since November 1996. Since July 1997, he has served as the President and Chief
Executive Officer of Executive Health Group, a provider of preventive
healthcare services to corporations. From 1980 to December 1994, he held a
number of senior management positions with Bristol-Myers Squibb Corporation, a
pharmaceutical company, including President of a multi-division medical device
business, the Health Care Group, and President of the Drackett Company, a
household products manufacturer. Mr. Flatley retired from Bristol-Myers Squibb
at the end of 1994 but continued to provide the company with certain consulting
services after his retirement. Mr. Flatley obtained a B.S. from Villanova
University and a M.B.A. from the Wharton School of the University of
Pennsylvania.
Kenneth N. Kermes, Director. Mr. Kermes has served as one of our directors
since February 1997. Since June 1998, he has served as a principal of Riparian
Partners Limited and of Bay View Equity Partners, two related investment
banking and private equity investment partnerships. Prior to that, he served as
Vice President of Business and Finance for the University of Rhode Island from
December 1994 to June 1998 and as Chief Financial Officer for SmithKline
Beecham Corporation from October 1986 to July 1989. From 1991 to 1994, Mr.
Kermes was a consultant and an investor in the venture capital industry. Mr.
Kermes obtained a B.A. from Amherst College and attended the New York
University Graduate School of Business and the Harvard Business School Advanced
Management Program.
C. Alan MacDonald, Director. Mr. MacDonald has served as one of our directors
since November 1996. Since October 1997, Mr. MacDonald has served as a Managing
Director of Directorship, Inc., a consulting firm specializing in corporate
governance issues. Prior to that, he served as General Partner of the Marketing
Partnership, Inc., a full service marketing consulting firm, from January 1995
to July 1997 and as an acquisitions consultant with the Noel Group, a venture
capital firm, from July 1994 to December 1994. In addition, he served as
Chairman and Chief Executive Officer of Lincoln Snacks Co., a caramelized
popcorn snack company, from September 1992 to July 1994. Mr. MacDonald holds a
B.S. in Hotel Administration from Cornell University and is a member of the
Cornell Society of Hotelmen and the Dean's Advisory Committee at Cornell. Mr.
MacDonald is also a director of Lincoln Snacks Co.
Diana Mackie, Director. Ms. Mackie has served as one of our directors since
February 1997. She currently is a Vice President for Strategy and Business
Development at SmithKline Beecham Healthcare
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Services, the business development division of SmithKline Beecham Corporation,
a position she has held since October 1997, where her responsibilities include
developing business plans, long-range strategy and negotiating external
alliances and investments. Prior to that, Ms. Mackie served as Vice President,
Group Business Initiatives for SBHS from November 1996 to October 1997. From
March 1996 to November 1996, she was General Manager of Diversified
Prescription Delivery, a pharmaceutical mail services company and a wholly-
owned subsidiary of Diversified Pharmaceutical Services, a pharmaceutical
benefit management group. From March 1993 to March 1996, she served as Vice
President, Strategy Development, SmithKline Beecham Pharmaceuticals, a
pharmaceutical company. Ms. Mackie holds a B.S. in Chemistry from the
University of Illinois, a M.B.A. from The Massachusetts Institute of Technology
Sloan School of Management and a M.S. in Polymer and Fiber Engineering from The
Massachusetts Institute of Technology.
Philip B. Smith, Director. Mr. Smith has served as one of our directors since
November 1996. Since June 1998, Mr. Smith has served as a Vice Chairman of
Laird & Co., LLC, a merchant bank. In addition, from 1991 until August 1998,
Mr. Smith served as a Vice Chairman with Spencer Trask Securities Incorporated,
an investment banking firm. Mr. Smith served in a number of other senior
management positions. From June 1986 to June 1988, Mr. Smith served as Managing
Director of Prudential Securities, an investment firm, in its merchant bank
division. From December 1967 to December 1972, Mr. Smith served as President
and Chief Executive Officer of Citicorp Venture Capital, a venture capital
company which he founded. Mr. Smith currently serves on the board of directors
of Movie Gallery, Inc., Digital Video Systems, Inc., and KLS Enviro Resources,
Inc. Mr. Smith has a B.S.E. from Princeton University and a M.B.A. from the
Harvard Business School.
Key Employees
Kenneth Asarch, Vice President--Quality Systems and Regulatory Affairs. Dr.
Asarch has served as our Vice President--Quality Systems and Regulatory Affairs
since November 1996. From June 1995 to October 1996, Dr. Asarch served as
Director of Regulatory Affairs for SmithKline Beecham Clinical Laboratories,
Inc. and SmithKline Beecham Diagnostics Systems Co. Prior to that, he served as
Director of Regulatory Affairs, Quality Assurance and Clinical Affairs with
Diagnostic Products Corporation, an immuno-diagnostic testing company, from
1987 to 1995, where his duties included overseeing the FDA regulatory clearance
and approval process for approximately 150 blood testing products. Dr. Asarch
holds a B.S. in Biochemistry from the University of California at Los Angeles
and doctoral degrees in both Clinical Pharmacy (Pharm.D.) and Pharmaceutical
Sciences (Ph.D.) from the University of Southern California.
Marija N. Valentekovich, Vice President--Manufacturing. Dr. Valentekovich has
served as our Vice President--Manufacturing since January 1998 when she came
out of retirement to join us. Before that, Dr. Valentekovich served as a
Production Manager with Diagnostic Products Corporation from January 1989 to
July 1997. Dr. Valentekovich received a M.S. in Chemical Engineering and a
Ph.D. in Physical Organic Chemistry, using radioisotope techniques, from the
University of Zagreb, Croatia.
Agreement Relating to Election of Directors
Each of our directors was nominated and elected pursuant to the terms and
conditions of a stockholders' agreement we entered into with our stockholders
and warrantholders in connection with two private placements of our common
stock in 1997 and 1998. Pursuant to this stockholders' agreement, SmithKline
Beecham Corporation was granted the right to nominate an individual to our
Board of Directors to serve as its representative. Spencer Trask Securities
Incorporated was also granted the right in the stockholders' agreement to
nominate one individual to our Board of Directors to serve as its
representative. Currently, Ms. Mackie serves as SmithKline's representative and
Mr. Smith serves as Spencer Trask's representative. Mr. Stoughton and Dr. Grove
were nominated and elected to our Board of Directors pursuant to this
stockholders' agreement. In addition, the stockholders' agreement requires that
three individuals who are independent of us and hold no more than five percent
of our common stock serve on our Board of Directors. The number of directors
permitted by the stockholders' agreement was increased from seven to nine with
the consent of Spencer Trask
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<PAGE>
as called for in the stockholders' agreement. This stockholders' agreement
expires by its terms upon the completion of the offering.
Classified Board of Directors
Upon completion of the offering, our Board of Directors will be divided into
three classes. Each class will contain, as nearly as possible, an equal number
of directors. Directors within each class will be elected to serve three-year
terms and approximately one-third of the directors will sit for election at
each annual meeting of our stockholders. Mr. Koch, Mr. Kermes and Mr. Smith
will serve in the class whose term expires in 2000. Dr. Grove, Mr. Flatley and
Ms. Mackie will serve in the class whose term expires in 2001. Mr. Stoughton,
Mr. Brenner and Mr. MacDonald will serve in the class whose term expires in
2002. A classified board of directors may have the effect of deterring or
delaying any attempt by any group to obtain control of us by a proxy contest
since such third party would be required to have its nominees elected at two
separate annual meetings of our Board of Directors in order to elect a majority
of the members of our Board of Directors. See "Description of Capital Stock--
Takeover Protection and Certain Charter and By-Law Provisions."
Director Compensation
Our non-employee directors receive an annual fee of $5,000 payable semi-
annually, plus $1,000 for each Board of Directors or committee meeting they
attend in person and $500 for those meetings they attend telephonically. Ms.
Mackie is precluded by SmithKline policy from receiving any fees or stock
options for her service as a director. We reimburse all reasonable expenses
incurred by the directors in attending Board of Directors or committee
meetings. In addition, the non-employee directors, other than the SmithKline
representative, Ms. Mackie, participate in our 1996 Incentive and Non-Qualified
Stock Option Plan. For each year that Mr. Brenner, Mr. Flatley, Mr. Kermes, Mr.
MacDonald and Mr. Smith served as directors, we granted each an annual option
to purchase 2,163 shares of common stock at the then applicable market price.
The options granted after the end of 1996 were issued at $5.20 per share. The
options granted after the end of 1997 were issued at $6.76 per share. The
options granted after the end of 1998 were issued at $7.50 per share. Upon
completion of the offering, options granted to non-employee directors will only
be made under our 1998 Director Stock Option Plan. Under our 1998 Director
Stock Option Plan, we will grant each non-employee director an annual option to
purchase 2,000 shares of common stock at the then applicable market price.
See " --Stock Option Plans" and "Certain Transactions."
Committees of the Board of Directors
The Compensation Committee of the Board of Directors presently consists of
Mr. Stoughton, Mr. Brenner, Ms. Mackie and Mr. Smith. The Compensation
Committee makes recommendations to the Board of Directors concerning salaries
and incentive compensation for our officers and employees other than our Chief
Executive Officer, whose compensation is determined by the Board of Directors
after consultation with the non-employee directors on the Compensation
Committee. The Audit Committee of the Board of Directors presently consists of
Mr. Koch, Mr. Flatley, Mr. Kermes and Mr. MacDonald. The Audit Committee
reviews our financial statements and accounting practices, makes
recommendations to the Board of Directors regarding the selection of
independent auditors and reviews the results and scope of all audits and other
services provided by our independent auditors.
Compensation Committee Interlocks and Insider Participation
While Mr. Stoughton, a member of our Compensation Committee, is our Chairman
of the Board of Directors and Chief Executive Officer, Mr. Brenner, Ms. Mackie
and Mr. Smith, the other members of our Compensation Committee, have not been,
at any time since our formation, an officer or employee of ours. In addition,
none of our executive officers serves as a member of the board of directors or
compensation committee of any entity that has one or more executive officers
serving on our Board of Directors or Compensation Committee. Cedar Capital
Investors, an entity owned and controlled by Mr. Brenner, provided certain
financial consulting services to us immediately following our formation and up
to the completion of our private placement of common stock in
47
<PAGE>
1997. As consideration for such services, we reimbursed Cedar Capital's out-of-
pocket expenses and granted Cedar Capital an option to purchase 1,154 shares of
common stock at an exercise price of $.052 per share. Ms. Mackie, who serves as
Vice President for Strategy and Business Development at SmithKline Beecham
Healthcare Services, the business development division of SmithKline Beecham
Corporation, was nominated to serve on the Board of Directors by SmithKline
Beecham Corporation pursuant to the terms of a stockholders' agreement by and
among us and our stockholders and warrantholders prior to the offering. Mr.
Smith, who served as a Vice Chairman of Spencer Trask Securities Incorporated
until August 1998, was nominated to serve on the Board of Directors by Spencer
Trask Securities and was formerly a partner in Exigent Partners L.P. See "--
Agreement Relating to Election of Directors" and "Certain Transactions."
Executive Compensation
The following table sets forth information regarding compensation awarded to,
earned by, or paid to our Chief Executive Officer and executive officers whose
salary and bonus exceeded $100,000 for all services rendered to us during the
years ended December 31, 1997 and 1998. No executive officer who would
otherwise have been includable in such table on the basis of salary and bonus
earned during the years ended December 31, 1997 and 1998 has resigned or
otherwise terminated employment during such years.
Summary Compensation Table
<TABLE>
<CAPTION>
Long-Term
Annual Compensation
Compensation Awards
----------------- ------------
Securities
Name and Principal Underlying All Other
Position Year Salary Bonus(1) Options Compensation(2)
------------------ ---- -------- -------- ------------ ---------------
<S> <C> <C> <C> <C> <C>
W. Vickery Stoughton...... 1998 $203,481 -- 9,135 $20,797
Chairman of the Board of 1997 $195,281 $27,000 158,655 $20,547
Directors and Chief
Executive Officer
Thomas H. Grove........... 1998 $163,880 -- 5,529 $ 8,603
Executive Vice 1997 $154,013 $25,000 79,327 $ 8,353
President--Research and
Development
</TABLE>
- --------
(1) Bonus earned in 1997 and paid in 1998.
(2) Includes $4,750 contributed under our 401(k) Plan for the benefit of each
of Mr. Stoughton and Dr. Grove in 1997 and $5,000 for the benefit of each
of Mr. Stoughton and Dr. Grove in 1998. Also includes $15,797 and $3,603 of
premiums paid for life insurance for Mr. Stoughton and Dr. Grove, in each
year, respectively.
Stock Options Granted to Executive Officers During 1998
The following table sets forth information regarding options for the purchase
of common stock that were granted to certain executive officers during the year
ended December 31, 1998:
Option Grants in 1998
<TABLE>
<CAPTION>
Potential Realizable
Number of Percent of Value at Assumed
Shares Total Annual Rates of Stock
Underlying Options Exercise or Price Appreciation for
Options Granted Base Price Option Term (4)
Granted to Employees Per Share Expiration -----------------------
Name (1) in 1998 (2) (3) Date 5% 10%
---- ---------- ------------ ----------- ---------- ----------- -----------
<S> <C> <C> <C> <C> <C> <C>
W. Vickery Stoughton.... 7,212 7% $6.76 7/30/08 $ 30,661 $ 77,700
1,923 2% $7.28 11/05/08 $ 8,804 $ 22,312
Thomas H. Grove......... 3,606 4% $6.76 7/30/08 $ 15,330 $ 38,850
1,923 2% $7.28 11/05/08 $ 8,804 $ 22,312
</TABLE>
- --------
(1) All options were granted under our 1996 Incentive and Non-Qualified Stock
Option Plan. The first listed grant for each person vested or will vest 12%
on December 31, 1998, 1999, 2000, 2001 and 2002 and
48
<PAGE>
40% on July 30, 2007. The second listed grant vested or will vest 20% on
each December 31, commencing December 31, 1998. See "--Stock Option Plans."
(2) Based on an aggregate of 101,135 shares of common stock underlying options
granted to employees in 1998.
(3) Options were granted at fair market value, as determined by our Board of
Directors, based on all factors available to them on the date of grant.
These factors included our history and prospects, as well as the history
and prospects of our industry, an assessment of our past and present
operations and financial performance, the prospects for our future
earnings, the present state of our development, the possibility of an
initial public offering by us and market prices of publicly traded common
stocks of comparable companies in recent periods.
(4) Assumes stock price appreciation of 5% and 10% compounded annually from the
date the respective options were granted to their expiration date, as
mandated by the rules of the Securities and Exchange Commission, and does
not represent our estimate or projection of the future appreciation of our
stock price. Actual gains, if any, on stock option exercises and common
stock holdings, are dependent upon the timing of such exercise and the
future performance of the common stock and may be greater or less than the
potential realizable value set forth in the table.
The following table sets forth certain information regarding options held as
of December 31, 1998 by certain executive officers. None of such executive
officers exercised options during the year ended December 31, 1998.
Fiscal Year-End Option Values
<TABLE>
<CAPTION>
Number of Shares
Underlying Unexercised Value of Unexercised
Options at Fiscal Year- In-The-Money Options at
End Fiscal Year-End (1)
------------------------- -------------------------
Name Exercisable Unexercisable Exercisable Unexercisable
---- ----------- ------------- ----------- -------------
<S> <C> <C> <C> <C>
W. Vickery Stoughton....... 80,577 87,213 $164,477 $166,312
Thomas H. Grove............ 40,481 44,375 $ 89,383 $ 90,536
</TABLE>
- --------
(1) There was no public trading market for the common stock as of December 31,
1998. Accordingly, these values have been calculated on the basis of the
initial public offering price of $7.50 per unit minus the applicable per
share exercise price.
Employment Agreements
We are party to employment agreements with each of Mr. Stoughton, Dr. Grove
and Mr. Koch. On the anniversary date of each employment agreement, the
agreement is automatically extended for three-year rolling terms unless either
party, at least 60 days prior to the annual extension date, gives notice that
the employment agreement shall not be extended or otherwise terminates the
agreement. Mr. Stoughton, Dr. Grove and Mr. Koch may resign upon 90 days notice
to us. Under the employment agreements, Mr. Stoughton, Dr. Grove or Mr. Koch
will be entitled to have his base salary, bonus and stock options continue to
accrue through the end of the then current term if he is terminated without
cause, or becomes disabled. "Cause" includes disloyalty, dishonesty, fraud,
conviction of a felony or the disclosure of confidential information. He will
also be entitled to such amounts if he terminates his employment agreement as a
result of a reduction in his duties, our breach of the employment agreement or
a transaction resulting in our sale. The employment agreements prohibit Mr.
Stoughton, Dr. Grove and Mr. Koch from engaging in the point-of-care
diagnostics business during the term of such employment agreements. These non-
compete clauses will remain in effect for one year after the expiration or
termination of employment. If, however, the term of employment had continued
for at least two years then the non-compete clauses have no effect when
employment is terminated or expires. However, if we terminate employment
without cause or if the employee terminates his employment following our breach
of the agreement or because of a change of control, the non-compete clause
terminates.
Under their respective employment agreements, Mr. Stoughton serves as our
Chairman of the Board of Directors and Chief Executive Officer, and currently
earns an annual base salary of $210,893, Dr. Grove serves
49
<PAGE>
as Executive Vice President--Research and Development, and currently earns an
annual base salary of $167,633, and Mr. Koch serves as our Chief Financial
Officer, Treasurer and Executive Vice President, and currently earns an annual
base salary of $160,000. In addition, Mr. Koch received a $15,000 relocation
allowance in connection with entering into his employment agreement. At the
discretion of our Board of Directors, an annual bonus may be paid to Mr.
Stoughton, Dr. Grove and Mr. Koch. In each case, we may agree to future raises
and other compensation for each of Mr. Stoughton, Dr. Grove and Mr. Koch. In
addition, Mr. Stoughton, Dr. Grove and Mr. Koch are eligible to receive stock
options pursuant to the 1996 Incentive and Non-Qualified Stock Option Plan, the
1996 Key Executive Stock Option Plan and the 1998 Incentive and Non-Qualified
Stock Option Plan. Such executive officers are also entitled to reimbursement
for certain travel and entertainment expenses incurred in connection with the
performance of their duties.
Stock Option Plans
We currently have two stock option plans in place: the 1996 Incentive and
Non-Qualified Stock Option Plan and the 1996 Key Executive Stock Option Plan.
These plans provide for the grant of stock options to purchase up to 576,923
shares of common stock. To date, we have granted options to purchase 441,130
shares of common stock under these plans. Of these, options to purchase 422,403
shares are outstanding. The weighted average exercise price of options
outstanding under the plans is $5.85. To date, we have granted Mr. Stoughton,
Dr. Grove, Mr. Koch, Dr. Asarch, and Dr. Valentekovich options to purchase
167,790, 84,856, 41,586, 21,875 and 5,769 shares of common stock, respectively,
at a weighted average exercise price of $5.69. We have also granted options to
purchase an aggregate of 30,282 shares of common stock to non-employee
directors for their service as directors. We may grant options to purchase
136,805 shares of common stock in the future under the 1996 Incentive and Non-
Qualified Stock Option Plan.
Upon completion of the offering, two additional option plans will take
effect: the 1998 Incentive and Non-Qualified Stock Option Plan and the 1998
Director Stock Option Plan. These 1998 plans provide for the grant of stock
options to purchase up to 565,000 and 60,000 shares of common stock,
respectively.
The purpose of our stock option plans is to promote our long-term growth and
profitability by providing key personnel with incentives to improve stockholder
value and to contribute to our growth and financial success. After completion
of this offering, options may be awarded under the 1996 plans and the 1998
Incentive and Non-Qualified Stock Option Plan to our executive officers,
employees and consultants. Only non-employee directors will be eligible for
awards under the 1998 Director Stock Option Plan.
Our option plans are administered by our Board of Directors or a committee of
the Board. They decide the types of options to be granted, the number of shares
to be covered, the exercise price of each stock option, the expiration date of
each stock option, the vesting schedule and any other material provisions.
Non-employee directors have received automatic, fully-vested option grants
under the 1996 Incentive and Non-Qualified Stock Option Plan. After completion
of the offering, each year, we will automatically grant each non-employee
director an option to purchase 2,000 shares of common stock under the 1998
Director Stock Option Plan. Director options always have a fair market value
exercise price. Such options vest at the end of the year of service as a
director to which the option relates. All director options under the 1998
Director Stock Option Plan generally will be exercisable for a period of five
years.
Option grants to our employees may take the form of either incentive stock
options, which are intended to qualify for preferential tax treatment under
Section 422 of the Internal Revenue Code, or non-qualified stock options, which
do not qualify for such treatment. Directors may receive only non-qualified
stock options. The exercise price of an incentive stock option generally must
not be less than the fair market value of the common stock on the date the
option is granted. The exercise price of a non-qualified stock option will be
stated in the option agreement governing the non-qualified stock option and is
not required by the option plans to be the fair market value of the common
stock on the date the option is granted.
50
<PAGE>
In the event of any stock dividend, stock split, reverse stock split,
recapitalization or reclassification, involving us, appropriate proportional
adjustments will be made in the number of shares reserved for issuance under
the option plans, and the number, kind and price of shares covered by
outstanding grants. The option plans also provide for the ability of the Board
of Directors or a committee to accelerate the exercise date of any options
granted thereunder. Options may not be exercised more than 10 years after the
date of grant. In some cases, shorter periods apply. Shares underlying options
that lapse or expire are returned to the pool of shares available under the
plans. Grants under any option plan may only be made during the 10 year period
after the plan's adoption.
Our stock option plans may be amended by the Board of Directors so long as
such amendment does not change the terms of any outstanding option without the
affected optionee's consent or increase the number of shares that are the
subject of the plans.
Employee Stock Purchase Plan
Our Board of Directors adopted an Employee Stock Purchase Plan in November
1998. This plan qualifies as an employee stock purchase plan under Internal
Revenue Code Section 423 and will be effective upon completion of the offering.
It allows employees to purchase, in the aggregate, up to 150,000 shares of our
common stock at a discount through payroll deductions. The purchase price per
share offered under the Employee Stock Purchase Plan will be 85% of the lesser
of the fair market value per share of common stock on the first or last trading
day of the quarter. Stock purchased will not be subject to taxes until sold.
The plan is designed to encourage and facilitate the purchase of common stock
by our employees and thereby to provide our employees with both a personal
stake in our business and a long range inducement to remain our employee. Each
of our full-time employees is eligible to participate in the Employee Stock
Purchase Plan.
The number and price of shares of common stock available for purchase under
the plan is subject to adjustment in the event the outstanding shares of common
stock are increased or decreased through stock dividends, recapitalizations,
reorganizations or similar changes. The plan is to be administered by our Board
of Directors or a committee of the Board of Directors.
All funds we hold or receive under the Employee Stock Purchase Plan may be
used for any corporate purpose until applied to the purchase of shares of
common stock or refunded to employees and will not be segregated from our
general assets. We will pay all fees and expenses incurred (excluding
individual federal, state, local or other taxes) in connection with the
Employee Stock Purchase Plan.
Unless stockholder approval is required by law, the Board of Directors or a
committee of the Board of Directors has the right to amend, modify or terminate
the Employee Stock Purchase Plan at any time without notice, provided that no
employee's then existing rights are adversely affected without his or her
consent.
401(k) Plan
We have a 401(k) Salary Reduction Plan and Trust for eligible employees.
Eligible employees may contribute up to 15% of their current compensation, up
to a statutorily prescribed annual limit, to the 401(k) plan. Each participant
is fully-vested in his or her deferred salary contributions. A participant's
contributions are held in trust and invested pursuant to his or her directions
from among 20 or more investment funds made available under the 401(k) plan. We
may make matching contributions of 50% of each participant's deferred salary
contributions, up to a maximum of 4% of such participant's compensation. Our
matching contributions vest after a participant has completed three years of
service with us, or earlier upon attainment of age 55, death while in service,
retirement for disability or termination of the 401(k) plan. Payment of 401(k)
plan benefits are made in a single lump-sum payment. Distribution of a
participant's vested interest in his or her account generally occurs after a
participant's termination of employment for any reason, including retirement,
death or disability.
51
<PAGE>
PRINCIPAL STOCKHOLDERS
The following table sets forth certain information regarding the beneficial
ownership of common stock as of June 15, 1999, by (1) each person or group of
affiliated persons known by us to be the beneficial owner of more than 5% of
our outstanding common stock, (2) each of our directors, (3) each of our
executive officers and (4) all of our executive officers and directors as a
group. As of such date, there were 5,084,340 shares of common stock outstanding
before giving effect to the sale of units in the offering.
The number of shares of common stock actually owned by each principal
stockholder is listed in Column A, entitled "Shares of Common Stock." In
addition, each principal stockholder is deemed to be the beneficial owner of
common stock that such stockholder can acquire upon the exercise of warrants or
options on or within 60 days after June 15, 1999, including options or warrants
which vest upon consummation of the offering. These option and warrant shares
are listed separately in Column B, entitled "Shares Underlying
Options/Warrants." The total of these two columns is then set forth in Column
C. Each principal stockholder's percentage ownership before the offering is in
Column D and is based on the share numbers in Column C. Column E presents their
percentage ownership of outstanding common stock immediately after the offering
taking into account the 2,000,000 shares of common stock issued as part of
units sold in the offering and assuming no over-allotment option is exercised.
The warrants included in units sold in the offering and the warrants to
purchase units issued to the underwriters' representatives are disregarded for
purposes of calculating the percentages in Column E. Unless otherwise noted, we
believe that all persons named in the table have sole voting and investment
power with respect to all shares beneficially owned by them.
<TABLE>
<CAPTION>
(C) (D) (E)
(A) (B) Total Total Total
Shares of Shares Beneficial Ownership Percentage Percentage
Common Underlying (Column A plus Owned Before Owned After
Name of Beneficial Owner Stock Options/Warrants Column B) Offering Offering
- ------------------------ --------- ---------------- -------------------- ------------ -----------
<S> <C> <C> <C> <C> <C>
Kevin Kimberlin......... 765,891(1) 336,349(2) 1,102,240 20.3% 14.9%
c/o Spencer Trask
Securities
Incorporated
535 Madison Avenue,
18th Floor
New York, New York
10022
SmithKline Beecham
Corporation............ 229,808 559,402(3) 789,210 14.0% 10.3%
One Franklin Plaza
Philadelphia,
Pennsylvania 19101
W. Vickery Stoughton.... 285,005 152,693 437,698 8.4% 6.0%
c/o Careside, Inc.
6100 Bristol Parkway
Culver City, California
90230
Peter Friedli........... 373,521(4) 42,974(5) 416,495 8.1% 5.8%
c/o Friedli Corp.
Finance
Freigustrasse 5
8002 Zurich,
Switzerland
Dr. Thomas H. Grove..... 205,294 76,539 281,833 5.5% 3.9%
c/o Careside, Inc.
6100 Bristol Parkway
Culver City, California
90230
Philip B. Smith......... 94,315(6) 115,261(7) 209,576 4.0% 2.9%
James R. Koch........... -- 32,676 32,676 * *
William F. Flatley...... 15,470 6,490 21,962 * *
Anthony P. Brenner...... 9,615 7,644(8) 17,260 * *
Kenneth Kermes.......... 2,959 4,326 7,285 * *
Diana Mackie............ 4,438 -- 4,438 * *
C. Alan MacDonald....... -- 6,490 6,490 * *
All executive officers
and directors as a
group (9 persons)...... 617,096 402,119 1,019,218 18.6% 13.6%
</TABLE>
- --------
* Represents less than 1% of our outstanding shares of common stock.
(1) Includes 371,090 shares of common stock held by Oshkim Limited Partners,
L.P., and 339,041 shares of common stock held by Kevin Kimberlin Partners,
L.P., both of which are limited partnerships of which Mr. Kimberlin is the
general partner, and 55,760 shares of common stock held by Spencer Trask
Securities Incorporated of which Mr. Kimberlin is Chairman and exercises
voting control.
(2) Includes 20,517 shares of common stock issuable upon the exercise of
warrants held by Oshkim Limited Partners, L.P., and 38,095 shares of
common stock issuable upon the exercise of warrants held by Kevin
Kimberlin Partners, L.P. Also includes 277,737 shares of common stock
issuable upon the exercise of warrants owned by Spencer Trask Securities
Incorporated of which Mr. Kimberlin is Chairman and exercises voting
control. See "Certain Transactions--Financing Activities."
(3) Includes 325,828 shares of common stock underlying shares of Series A
Convertible Preferred Stock, and underlying warrants which will be
received if the Series A Convertible Preferred Stock is converted, owned
by S.R. One, Limited, an affiliate of SmithKline Beecham Corporation, as
of completion of the offering. Also includes 235,294 shares of common
stock issuable upon exercise of bridge loan warrants that will be owned by
S.R. One, Limited upon completion of the offering. S.R. One has agreed not
to exercise the bridge warrants until the earlier of six months after the
offering or December 17, 1999.
(4) Includes 373,521 shares of common stock owned by Venturetec, Inc., of
which Mr. Friedli is the controlling stockholder.
(5) Includes 9,320 shares of common stock issuable upon the exercise of
warrants owned by Pine Incorporated, a corporation owned and controlled by
Mr. Friedli.
(6) Includes 50,952 shares of common stock owned by Private Equity
Partnership, of which Mr. Smith is the general partner.
(7) Includes 108,771 shares of common stock issuable upon exercise of warrants
held by Private Equity Partnership.
(8) Includes 1,154 shares of common stock issuable upon the exercise of
options which were issued pursuant to a consulting agreement with an
affiliate of Mr. Brenner. See "Certain Transactions--Financing
Activities."
52
<PAGE>
CERTAIN TRANSACTIONS
SmithKline Beecham
In July 1996, we entered into a letter of intent with SmithKline Beecham
Corporation and SmithKline Beecham Diagnostics Systems Co., an affiliate of
SmithKline Beecham Corporation, with respect to their point-of-care development
program. Pursuant to that letter of intent, SmithKline Beecham Corporation
supported the point-of-care development program by funding $1.8 million of the
program's operating expenses for the transition period from July 1, 1996
through October 31, 1996. This funding has been reflected in the Statement of
Operations of the predecessor business for the ten months ended October 31,
1996. Pursuant to an asset purchase agreement, SmithKline Beecham Diagnostics
Systems Co. and SmithKline Beecham Clinical Laboratories, Inc., sold us certain
fixed and intangible assets used in connection with the point-of-care
development program. As consideration for the purchase of the assets, we issued
to SmithKline Beecham Diagnostics Systems Co. 5% of our total common stock
outstanding at that time. This stock was later transferred to SmithKline
Beecham Corporation. Ms. Mackie, Vice President for Strategy and Business
Development at SmithKline Beecham Healthcare Services, a division of SmithKline
Beecham Corporation, has served as one of our directors since February 1997 as
a representative of SmithKline Beecham Corporation. SmithKline Beecham
Corporation is one of our significant stockholders.
In addition to the operating funding provided during the transition period,
SmithKline Beecham Corporation made available to us a $1.0 million credit
facility at an interest rate of 8% per annum. We used the $1.0 million to fund
research and development and to establish our production facility by funding
capital purchases, rental payments for our facilities in Culver City,
California and operating expenses. In January 1997, the SmithKline Beecham
Corporation credit facility was converted into an additional 2% of our
outstanding common stock simultaneously with the initial closing of our 1997
private placement of common stock.
Simultaneously with the closing of the asset purchase, we entered into a
distribution and supply agreement with SmithKline Beecham Clinical
Laboratories, Inc. pursuant to which SBCL received exclusive distribution
rights to sell our products to segments of the commercial laboratory industry.
The exclusive distribution rights will extend to ten of the following
countries: United States, Great Britain, Mexico, Spain, South Africa,
Singapore, Malaysia, Indonesia, Australia, Chile, Argentina, France or Germany,
if SBCL or one of its affiliates owns, operates or manages a clinical
laboratory in such country on or before December 31, 2000. Whenever we obtain
the necessary approvals to market and sell our products in a listed country,
SBCL must submit purchase orders for the products within designated time
periods in order to preserve its exclusive rights in that country. Otherwise,
we will be free to sell our products in that country to the commercial
laboratory industry as well. Our ability to sell our products outside the
commercial laboratory industry is not limited by the contract with SBCL. SBCL
and its affiliates are not restricted from entering into similar commercial
distribution arrangements with other point-of-care diagnostic companies. In
consideration for this grant of exclusivity, SBCL will pay us an annual fee of
up to $100,000 commencing on the date of FDA approval of the CareSide Analyzer
and 25 designated tests. Subject to earlier termination, the distribution and
supply agreement will terminate five years from the date of such FDA approval.
Under the distribution and supply agreement, SBCL will, until December 31,
2000 or any earlier termination of the agreement, supply us with clinical
samples to enable us to validate tests for our research and development of
point-of-care products. We will bear the cost of retrieving the samples and
conducting our comparative validation tests. In addition, the distribution and
supply agreement obligates SBCL, upon FDA approval of the CareSide Analyzer and
30 designated tests, to purchase minimum numbers of CareSide Analyzers and test
cartridges from us for the first five years following such FDA approval. We
have agreed to supply SBCL with its requirements of CareSide Analyzers and
cartridges at our cost plus a reasonable margin. If we do not develop the
CareSide Analyzer and obtain FDA approval of 25 designated tests by
December 31, 2000, SBCL has the option to terminate the agreement or waive the
FDA approval requirement.
53
<PAGE>
Under our distribution and supply agreement with SBCL, all intellectual
property rights to patents, trademarks or otherwise which are associated with
the marketing and development of point-of-care products remain with us although
we share rights and responsibilities with SBCL in the protection of these
rights.
Financing Activities
On December 2, 1996, in connection with the establishment of a $1 million
working capital facility, we issued 557,601 shares of common stock to Exigent
Partners, L.P. for an aggregate purchase price of $98,995. The working capital
facility was arranged by Exigent Partners, L.P. to be provided to us in the
form of a $1.0 million irrevocable letter of credit from Citibank, N.A.,
secured by pledges of cash or cash equivalents by Exigent Partners, L.P. The
general partner of Exigent Partners, L.P. was Kevin Kimberlin, an affiliate of
Spencer Trask Securities Incorporated and one of our principal stockholders,
and the limited partners were Mr. Stoughton and Dr. Grove, two of our executive
officers and directors, and Mr. Smith, one of our directors. Of the 557,601
shares of common stock issued to Exigent Partners, L.P., Mr. Kimberlin took
beneficial ownership of 426,850 shares of common stock, and Mr. Stoughton and
Dr. Grove took beneficial ownership of 36,802 and 18,958 shares of common
stock, respectively. We repaid all funds drawn under the facility and the
letter of credit, both of which have since terminated. Exigent Partners, L.P.
was dissolved and each of its partners received a pro rata distribution of
shares of common stock. See "Principal Stockholders."
In 1997 and 1998, we undertook two private placements of our common stock,
both of which were completed through Spencer Trask Securities Incorporated.
Spencer Trask received approximately $2.5 million in commissions and expenses
from the private placements, which generated aggregate net proceeds to us of
$19.0 million. Affiliates of Spencer Trask, including its employees, received
warrants to purchase 384,615 shares of common stock at $5.20 per share in the
1997 private placement and warrants to purchase 340,237 shares of common stock
at $6.76 per share in the 1998 private placement. Warrants issued in connection
with both private placements will expire three years from the closing of the
offering.
As partial consideration for its services in the 1997 private placement,
Spencer Trask was granted a right of first refusal to act as underwriter or
agent for any proposed public offering or any private placement of our
securities. Spencer Trask was also granted the right to purchase securities in
any such offering in which purchasers in the 1997 private placement are
entitled to preemptive rights under the stockholders' agreement or in any sale
of common stock by the former partners of Exigent Partners, L.P. Spencer Trask
has waived all such rights in connection with the offering.
At the first closing of the 1997 private placement, we entered into an
investment banking agreement with Spencer Trask pursuant to which Spencer Trask
will receive a percentage, ranging from seven percent to two and one-half
percent, depending upon the size of the transaction involved, of the
consideration involved in any transaction we undertake with a person introduced
to us by Spencer Trask in the five years ending March 2002. The agreement also
provides for Spencer Trask, subject to certain terms and conditions, to act as
our exclusive representative in advising us with respect to executive
compensation benefits, insurance and retirement planning, providing us with
certain investment banking services and addressing our cash management needs.
Spencer Trask has waived all such rights relating to investment banking
services.
In connection with the 1997 and 1998 private placements, we entered into a
stockholders' agreement with each of our stockholders and warrantholders. The
stockholders' agreement included preemptive rights and provided for the
nomination and election of each of our current directors including Ms. Diana
Mackie, Vice President of a division of SmithKline Beecham Corporation. The
preemptive rights do not apply to shares issued in the offering. The
stockholders' agreement will terminate by its terms upon completion of the
offering. See "Management-- Agreement Relating to Election of Directors."
In December 1997, Cedar Capital Investors, an entity owned and controlled by
Anthony P. Brenner, one of our directors, provided certain financial consulting
services to us in connection with the 1998 private placement. In consideration
for providing such services, Cedar Capital Investors was reimbursed $6,651 for
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out-of-pocket expenses and received options to purchase 1,154 shares of common
stock at an exercise price of $.052 per share. These options remain exercisable
until August 8, 2007.
In July 1998, in connection with the relocation of James R. Koch, our Chief
Financial Officer, Treasurer and Executive Vice President, as well as one of
our directors, from Texas to the Los Angeles area in August 1998, we provided a
bridge loan to Mr. Koch, pursuant to a promissory note executed in our favor by
Mr. Koch, in the aggregate principal amount of $125,000. The bridge loan, which
was subject to an interest rate of 7.5% per annum, was paid in full by Mr. Koch
on September 21, 1998. As of that date, an aggregate of $125,911 in principal
and interest was owing under the promissory note.
In December 1998, we entered into a bridge financing with S.R. One, Limited,
a business trust controlled by SmithKline Beecham Corporation. For
consideration of $3.0 million cash, we issued S.R. One a $3.0 million note
payable bearing interest at 8%. In April 1999, S.R. One agreed to convert $1
million of the $3 million loan, together with accrued interest on the $1
million, upon consummation of the offering, into shares of Series A Convertible
Preferred Stock. The conversion price will be $6.375, which is 85% of the
initial public offering price per unit. The number of shares of our Series A
Convertible Preferred Stock issued to S.R. One upon the conversion of the loan
will depend upon when the offering is completed. If the offering closes on June
21, 1999, S.R. One will receive 162,914 shares of Series A Convertible
Preferred Stock. Each share of Series A Convertible Preferred Stock will in
turn be convertible, at the option of the holder, six months after the offering
into units, comprised of one share of our common stock and one warrant to
purchase an additional share of our common stock. All accrued and unpaid
dividends with respect to shares of Series A Convertible Preferred Stock that
are converted by S.R. One will be converted into units at the initial public
offering price per unit. The exercise price and other terms of the warrant
received on the conversion of the Series A Convertible Preferred Stock will be
the same as the warrants included in units sold in the offering. The remaining
$2 million of the loan matures in December 1999. The annual interest rate on
the remaining $2 million will increase to 10% on July 1, 1999. If the remainder
of the bridge loan is not repaid by December 1, 1999, S.R. One will have the
option to convert all or any portion of the remaining loan, plus accrued
interest thereon, into shares of Series A Convertible Preferred Stock. This
Series A Convertible Preferred Stock will be issued to S.R. One on the same
basis as the Series A Convertible Preferred Stock that is issued to S.R. One as
part of the $1 million conversion at the completion of the offering.
In connection with the bridge financing, we issued a warrant to S.R. One
which entitled it to purchase that number of shares of common stock equal to
$750,000 divided by 85% of the initial public offering price per share of
common stock. The number of warrants doubled if the bridge loan was not repaid
by June 30, 1999. As part of the conversion of a portion of the bridge
financing into shares of Series A Convertible Preferred Stock, the bridge
warrant will be modified such that it will be exercisable in all events for the
number of shares of common stock which is equal to $1,500,000 divided by
$6.375, which is 85% of the initial public offering price per unit in the
offering. S.R. One has agreed that it will not exercise the bridge warrant
until the earlier of December 17, 1999 or six months after the offering is
completed.
We consider the terms of all of the above-referenced transactions to be at
arm's length and reasonably equivalent to terms it could have obtained through
negotiations with unaffiliated third parties under similar economic conditions.
Any transactions undertaken in the future, including loans, we enter into with
any of our officers, directors and principal stockholders or their affiliates,
will be approved by a majority of the entire Board of Directors, and will be on
terms no less favorable to us than could be obtained from unaffiliated third
parties. See "Description of Capital Stock--Takeover Protection and Certain
Charter and By-Law Provisions."
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DESCRIPTION OF CAPITAL STOCK
Upon completion of the offering, our authorized capital stock will consist of
(1) 50,000,000 shares of common stock, $.01 par value per share, and (2)
5,000,000 shares of preferred stock, $.01 par value per share, of which there
will be 7,084,340 shares of common stock and 162,914 shares of Series A
Convertible Preferred Stock outstanding, if the offering closes on June 21,
1999, assuming no exercise of the underwriters' over-allotment option. The
following description of our capital stock is a summary and is qualified in its
entirety by the provisions of our Amended and Restated Certificate of
Incorporation and Amended (including the Certificate of Designations for our
Series A Convertible Preferred Stock) and Restated By-Laws, copies of which
have been filed as exhibits to the registration statement of which this
prospectus forms a part.
Units
Each unit consists of one share of common stock and one warrant to purchase
an additional share of common stock. The units will automatically separate 30
days from the date of this prospectus, after which the common stock and
warrants in the units will trade separately.
Common Stock
The issued and outstanding shares of common stock being offered hereby will
be, when sold and issued in accordance herewith, validly issued, fully paid and
non-assessable. Each holder of shares of common stock will be entitled to one
vote for each share held of record and may not cumulate votes for election of
directors. The shares will not be entitled to preemptive rights under
applicable law and will not be subject to redemption or assessment. Subject to
the rights and preferences of the holders of any preferred stock outstanding in
the future, upon our liquidation, dissolution or winding-up, the holders of
shares of common stock will be entitled to receive, pro rata, our assets which
are legally available for distribution to stockholders. In addition, subject to
the rights and preferences of the holders of any preferred stock outstanding in
the future, the holders of shares of common stock will be entitled to share
ratably in dividends as, if and when declared by our Board of Directors. We do
not anticipate that any dividends will be paid in the foreseeable future. As of
June 15, 1999, there were 433 holders of common stock.
Series A Convertible Preferred Stock
The Series A Convertible Preferred Stock will have a stated value equal to
$7.50 per share. If the offering closes on June 21, 1999, the number of shares
of Series A Convertible Preferred Stock outstanding will be 162,914. The Series
A Convertible Preferred Stock will be preferred over common stock in dividends
and will have a liquidation preference over common stock equal to the stated
value of the Series A Convertible Preferred Stock, plus all accrued and unpaid
dividends on the Series A Convertible Preferred Stock. Each share of Series A
Convertible Preferred Stock will have one vote on all matters to be voted on by
the holders of the common stock and will vote with the holders of the common
stock as one voting group. The Series A Convertible Preferred Stock has the
right to vote as a separate class pursuant to applicable law and on any action
limiting the preferences or rights of the Series A Convertible Preferred Stock,
reclassifying the common stock or any other capital stock ranking junior to the
Series A Convertible Preferred Stock into any class of security ranking senior
to or the same as the Series A Convertible Preferred Stock, or increasing the
authorized number of shares of Series A Convertible Preferred Stock. The Series
A Convertible Preferred Stock will bear a cumulative dividend, which shall
accrue if not declared by the Board of Directors, at an annual rate of 10% of
stated value.
Each share of Series A Convertible Preferred Stock will be convertible at the
option of the holder six months after the offering into one unit comprised of
one share of common stock and a warrant to purchase one additional share of
common stock. All accrued and unpaid dividends with respect to shares of Series
A Convertible Preferred Stock that are converted will be converted into units
at the initial offering price per unit. The terms and conditions of the
warrants received on conversion of Series A Convertible Preferred Stock,
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including its exercise price, will be identical to the terms and conditions of
the warrants included in the units sold in the offering.
We will have the right to redeem the Series A Convertible Preferred Stock at
any time for a per share amount equal to the sum of $7.50, any accrued and
unpaid dividends and the greater of $0.05 or the excess of the average five day
closing price of a share of common stock over the exercise price of the warrant
issuable upon conversion of the Series A Convertible Preferred Stock.
Undesignated Preferred Stock
In addition to the common stock and the Series A Convertible Preferred Stock,
we are, without further action by stockholders, also authorized to issue up to
4,837,086 shares of preferred stock. Our Board of Directors may determine the
timing, series, designation, and number of shares of preferred stock to be
issued, as well as the rights, preferences, and limitations of such shares,
including those relating to voting power, redemption, conversion, dividend
rights, and liquidation. The issuance of preferred stock could adversely affect
the voting power of the holders of common stock or have the effect of
deterring, delaying or preventing any attempt by a person, entity or group to
obtain control of us. We have no current plans to issue any shares of preferred
stock.
Unit Warrants
Each warrant comprising part of the units sold in the offering will entitle
the holder to purchase one share of common stock at an exercise price of $9.00.
We may reduce the exercise price of the warrants for a period of at least 20
days. We must give holders of warrants at least 15 days' notice of such
decrease, which notice may be in the form of a press release. The warrants will
generally be exercisable at any time commencing 30 days after the date of this
prospectus until the fifth anniversary of the date of this prospectus, unless
earlier redeemed. The warrants are redeemable by us, in whole or in part pro
rata from all warrant holders, at a price of $0.05 per warrant, upon 30 days'
prior written notice, if the closing price defined in the warrant agreement,
which we describe below, per share of common stock for the ten consecutive
trading days immediately preceding the date of notice of redemption equals or
exceeds $14.00. We may not redeem any warrants until six months after the date
of this prospectus. We may give more than one notice of redemption. If given,
notices of redemption are required to be mailed by registered or certified mail
to record holders of warrants. If we give notice of our intention to redeem, a
holder will have the choice either to sell or exercise his or her warrants
before the date specified in the redemption notice or to accept the redemption
price. After the redemption date, there can be no exercise of the warrants that
were the subject of the redemption.
Upon the completion of the offering, an additional 200,000 warrants will be
issued to the representatives of the underwriters entitling them to receive,
upon due exercise and payment of $9.00 as the exercise price, 200,000 units
having the same terms as the units sold in the offering. The representatives'
warrants will expire five years from the effective date of the offering and
will be exercisable commencing one year after the effective date of the
offering. See "Underwriting."
The warrants will be issued in registered form under a warrant agreement
between us and American Stock Transfer & Trust Company, as warrant agent. The
shares of common stock underlying the warrants, when issued upon exercise of a
warrant, will be fully paid and nonassessable. We will pay any transfer tax
incurred as a result of the issuance of common stock to the holder upon its
exercise.
The warrants contain provisions that protect the holders against dilution by
adjustment of the exercise price. These adjustments will occur in the event of
a merger, consolidation, sale or conveyance of all of the capital stock or
substantially all of the assets of Careside, stock split or reverse stock
split, stock dividend, capital reorganization or reclassification of our common
stock. We have the option to issue fractional shares or cash for fractional
shares upon the exercise of a warrant. The holder of a warrant will not, by
reason of owning a warrant, possess any rights as our shareholder until he or
she exercises the warrant.
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A warrant may be exercised upon surrender of the warrant certificate on or
before the expiration or redemption date of the warrant at the offices of the
warrant agent, with the form of "Election to Purchase" on the reverse side of
the warrant certificate completed and executed as indicated, accompanied by
payment of the exercise price (by certified or bank check payable to the order
of Careside, Inc.) for the number of shares with respect to which the warrant
is being exercised.
For a holder to exercise the warrants, there must be a current registration
statement in effect with the Securities and Exchange Commission and
qualification in effect under applicable state securities laws (or applicable
exemptions from state qualification requirements) with respect to the issuance
of common stock or other securities underlying the warrants. We have agreed to
use all commercially reasonable efforts to cause the registration statement, of
which this prospectus forms a part, to remain effective in anticipation of and
before the exercise of the warrants and take such other actions under the laws
of various states as may be required to cause the sale of common stock or other
securities upon exercise of warrants to be lawful. We will not be required to
honor the exercise of warrants if, in the opinion of our Board of Directors,
with the advice of counsel, the sale of securities upon exercise would be
unlawful. If the securities underlying the warrants are not registered under a
current effective registration statement or qualified under applicable state
securities laws and securities of the same class are listed on a securities
exchange or there are at least two independent market makers for the securities
of the same class, we may elect to redeem warrants submitted for exercise
instead of obtaining registration and qualification. If we elect to redeem the
warrants instead of obtaining registration, the redemption price of the
warrants would be equal to the difference between the aggregate low asked price
or closing price of the securities underlying the warrants and the exercise
price of the warrants.
The foregoing discussion of material terms and provisions of the warrants is
qualified in its entirety by reference to the detailed provisions of the
warrant agreement, the form of which has been filed as an exhibit to the
registration statement of which this prospectus is a part.
For the life of the warrants, the holders have the opportunity to profit from
a rise in the market price of the common stock without assuming the risk of
ownership of the shares of common stock underlying the warrants. The warrant
holders may be expected to exercise their warrants at a time when we would, in
all likelihood, be able to obtain any needed capital by an offering of common
stock on terms more favorable than those provided for by the warrants.
Furthermore, the terms on which we could obtain additional capital during the
life of the warrants may be adversely affected by the existence of the
warrants.
Prior Warrants
As of June 15, 1999, we had outstanding exercisable warrants to purchase
384,615 shares of common stock at $5.20 per share. These warrants were issued
in connection with the 1997 private placement and will expire three years after
the completion of the offering. In addition, as of June 15, 1999, we had
outstanding exercisable warrants to purchase 340,237 shares of common stock at
$6.76 per share. These warrants were issued in connection with the 1998 private
placement and will expire three years from the closing of the offering.
Further, we issued a bridge warrant to S.R. One, Limited in connection with the
bridge financing. The bridge warrant will become exercisable on the earlier of
December 17, 1999 or six months after the completion of the offering for
235,294 shares of common stock, which is equal to $1,500,000 divided by 85% of
the initial public offering price per unit in the offering. The bridge warrant
has an exercise price of $6.375, which is 85% of the initial public offering
price per unit. The bridge warrant will expire four years after completion of
the offering.
Registration Rights
Granted in Private Placements
We granted investors in the 1997 and 1998 private placements of common stock
demand and incidental registration rights. These include the right of the
holders of a majority of the registrable shares to demand registration of their
shares and the right of these investors to include their shares in other
registrations of our equity securities, other than in connection with issuances
under our benefit and other employee plans. We
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granted similar rights with respect to the shares underlying the warrants
issued to Spencer Trask Securities Incorporated in connection with the 1997 and
1998 private placements. In addition, we agreed to effect a registration under
the Securities Act for the resale of the common stock purchased by investors in
the 1997 private placement automatically within 180 days after the date of this
prospectus. We also agreed to effect a registration for the resale of the
common stock purchased by investors in the 1998 private placement automatically
within 360 days after the date of this prospectus. This automatic registration
may be delayed by Spencer Trask together with the underwriters of this
offering. If we fail to register the common stock underlying the shares in
accordance with the terms of the agreements with the investors in the 1997 and
1998 private placements, we must either repurchase the shares at the fair
market value or give investors the ability to elect a majority of our Board of
Directors in order to provide liquidity. Pursuant to powers of attorney granted
by many investors, and amendments and waivers to the registration agreements,
our obligation to effect such registrations has been deferred until one year
after the date of this prospectus.
Granted to SmithKline
We have also granted demand and incidental registration rights to SmithKline
Beecham Corporation for the registration under the Securities Act of the resale
of any or all of the common stock held by it at any time after the date of this
prospectus. SmithKline has agreed not to make a demand for registration for a
period of at least one year after the offering. If we register an issuance of
our equity securities, other than shares issuable under employee or other
benefit plans, SmithKline may request that its shares be included in the
registration.
Granted to Management and Exigent Partners, L.P.
Additionally, Messrs. Stoughton and Smith, Drs. Grove and Asarch and three of
our employees and the former partners of Exigent Partners, L.P. have also been
granted demand and incidental registration rights with respect to their common
stock. The holders of a majority of all registrable securities owned by these
stockholders may demand on two occasions registration for the resale of any or
all of their shares. If we register an issuance of our equity securities, other
than shares issuable under our employee or other benefit plans, these holders
may request to include their shares in the registration.
Granted to S.R. One
In December 1998 in connection with the bridge financing and in April 1999 in
connection with the conversion of a portion of the bridge loan into Series A
Convertible Preferred Stock, we granted demand and incidental registration
rights to S.R. One, Limited. S.R. One may demand that its shares of common
stock purchased upon exercise of the bridge warrant, or the common stock and
warrants issued on conversion of the Series A Convertible Preferred Stock, be
registered under the Securities Act. S.R. One may make such demand anytime
after six months and before three years after this offering. S.R. One has the
same incidental registration rights as SmithKline, described above.
Granted to Representative
Pursuant to a warrant agreement that we have entered into with Paulson
Investment Company, Inc., on behalf of each of the representatives of the
underwriters, we have agreed to maintain an effective registration statement
with respect to the issuance of the common stock and warrants included in the
units issued to our underwriters' representatives, if necessary, to allow their
public resale without restriction, at all times during the period in which the
representatives' warrants are exercisable, beginning one year after the
effective date of the offering. The representatives' warrants, as well as the
shares of common stock and warrants included in the units issuable upon
exercise of the representatives' warrants, are being registered on the
registration statement of which this prospectus is a part. We will cause the
registration statement to remain effective until the earlier of the time that
all of the representatives' warrants have been exercised and the date which is
five years after the effective date of the offering. All expenses incurred in
connection with the registration of the shares of common stock and warrants
included in the units issuable upon the exercise of the representatives'
warrants will be borne by us. Under the warrant agreement, the parties will
also be bound by standard indemnification and contribution provisions with
respect to the registration of the warrant shares issuable upon the exercise of
the representatives' warrants.
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General
As of June 15, 1999, there were 5,084,340 shares of common stock subject to
registration rights. We will pay for all expenses incurred in connection with
these registrations, other than underwriting discounts and commissions. The
registration agreements also provide for customary indemnification and
contribution provisions involving the participants in any registration effected
pursuant thereto. The foregoing is only a summary of certain of the terms and
conditions of the registration rights agreements involving such parties. Copies
of the actual agreements have been filed with the Securities and Exchange
Commission as exhibits to the registration statement of which this prospectus
is a part.
Certain Federal Income Tax Considerations
The following discussion sets forth the material federal income tax
consequences, under current law, relating to the purchase and sale of the units
and the underlying common stock and warrants. The discussion is a summary and
does not purport to deal with all aspects of federal taxation that may be
applicable to an investor, nor does it consider specific facts and
circumstances that may be relevant to a particular investor's tax position.
Some holders, such as dealers in securities, insurance companies, tax exempt
organizations, foreign persons and those holding common stock or warrants as
part of a straddle or hedge transaction, may be subject to special rules that
are not addressed in this discussion. This discussion is based only on current
provisions of the Internal Revenue Code of 1986, as amended, and on
administrative and judicial interpretations as of the date hereof, all of which
are subject to change. You should consult your own tax advisor as to the
specific tax consequences to you of this offering, including the applicability
of federal, state, local and foreign tax laws.
Allocation of Purchase Price
Each unit as a whole will have a tax basis equal to the cost of the unit. The
measure of income or loss from some of the transactions described below depends
on the tax basis in each of the warrant and the common stock comprising the
unit. We have allocated the purchase price between the warrant and the common
stock so that the tax basis for the warrant will be $0.05 and the tax basis for
the common stock will be equal to $7.45. If you disagree with the allocation,
please see your tax advisor for advice on how to notify the Internal Revenue
Service that you disagree with the allocation and claim a different basis.
Exercise or Sale of Warrants
No gain or loss will be recognized by a holder of a warrant on the purchase
of shares of common stock for cash on an exercise of a warrant, except that
gain will be recognized to the extent cash is received in lieu of fractional
shares. The tax basis of common stock received upon exercise of a warrant will
equal the sum of the holder's tax basis for the exercised warrant and the
exercise price. The holding period of the common stock acquired will begin on
the date the warrant is exercised and the common stock is purchased. It does
not include the period during which the warrant was held.
Gain or loss from the sale or other disposition of a warrant will be capital
gain or loss to its holder if the common stock to which the warrant relates
would have been a capital asset in the hands of such holder. This capital gain
or loss will be long-term capital gain or loss if the holder has held the
warrant for more than one year at the time of the sale, disposition or lapse.
On the redemption of a warrant by us, the holder generally will realize capital
gain or loss. Individuals generally have a maximum federal income tax of 20% on
long term capital gains. The deduction of capital losses is subject to
limitations.
Sale of Common Stock
A holder's sale of common stock which is not in connection with a tax free
reorganization of Careside will result in the recognition of gain or loss to
the holder in an amount equal to the difference between the amount realized and
such holder's tax basis in the common stock. If the common stock constitutes a
capital asset in the hands of the holder, gain or loss upon the sale of the
common stock will be characterized as long-
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term or short-term capital gain or loss, depending on whether the common stock
has been held for more than one year. Individuals generally have a maximum
federal income tax of 20% on long term capital gains. The deductions of capital
losses is subject to limitations.
Expiration of Warrants Without Exercise
If a holder of a warrant allows it to expire without exercise, the expiration
will be treated as a sale or exchange of the warrant on the expiration date.
The holder will have a loss equal to the amount of such holder's tax basis in
the lapsed warrant. If the warrant constitutes a capital asset in the hands of
the holder, the loss will be characterized as long-term or short-term capital
loss, depending on whether the warrant was held for more than one year. The
deduction of capital losses is subject to limitations.
Takeover Protection and Certain Charter and By-Law Provisions
Certain provisions of the Delaware General Corporation Law (the "DGCL"), our
Amended and Restated Certificate of Incorporation (the "Charter") our Amended
and Restated By-Laws (the "By-Laws") and our stock option plans may have an
anti-takeover effect and may delay, deter or prevent a tender offer, proxy
contest or other takeover attempt. This may be true even in circumstances where
a takeover attempt might result in payment of a premium over market price for
shares held by stockholders.
Following the completion of the offering, we will become subject to Section
203 of the DGCL. Section 203 prohibits, subject to certain exceptions, a
Delaware corporation from engaging in any business combination with any
interested stockholder for a period of three years following the date that such
stockholder became an interested stockholder. A business combination includes
mergers, asset sales and other transactions that may result in a financial
benefit to stockholders. A person will be deemed an interested stockholder
triggering this protection if the person together with any affiliates or
associates of such person, beneficially owns, directly or indirectly, 15% or
more of our outstanding voting stock. There are three exceptions to these
provisions. First, if our Board of Directors gives prior approval to either the
business combination or the transaction which resulted in the stockholder
becoming an interested stockholder then the restrictions do not apply. Second,
the restrictions will not apply if, upon the consummation of the transaction
which resulted in the stockholder becoming an interested stockholder, the
interested stockholder owns at least 85% of our outstanding voting stock.
Finally, the restrictions will not apply if, at the time of or following the
consummation of the transaction in which the stockholder became an interested
stockholder, our Board of Directors approves the business combination and
stockholders holding at least 66 2/3% of our outstanding voting stock not owned
by the interested stockholder authorize the business combination.
Upon completion of the offering, our Board of Directors will be divided into
three classes of directors each containing, as nearly as possible, an equal
number of directors. Directors within each class will serve three-year terms.
Approximately one-third of the directors will sit for election at each annual
meeting of our stockholders. All directors elected to our classified Board of
Directors serve until the election and qualification of their successors or
their earlier resignation or removal. The Board of Directors may create new
directorships and fill such positions so created. In addition, the Board of
Directors or its remaining members, even though less than a quorum may fill
vacancies on the Board of Directors occurring for any reason until the next
annual election of directors. Members of the Board of Directors may only be
removed for cause. These provisions may have the effect of deterring or
delaying any attempt by any group to obtain control of us by a proxy contest.
For example, a third party would be required to have its nominees elected at
two separate annual meetings in order to elect a majority of the members of the
Board of Directors.
We may issue 4,837,086 shares of undesignated preferred stock. Under certain
circumstances, the issuance of preferred stock could be utilized as a method of
discouraging, delaying or preventing a change in control of our stock.
Our Charter provides that any action required or permitted to be taken by our
stockholders may be effected only at an annual or special meeting of
stockholders. Such action will not be permitted to be taken by
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written consent in lieu of a meeting. Our Charter and the By-Laws also provide
that special meetings of stockholders may only be called by a majority of our
Board of Directors, our Chairman or our Chief Executive Officer. Stockholders
will not be permitted to call a special meeting or to require that our Board of
Directors call a special meeting of stockholders.
Our Charter provides that any director or the entire Board of Directors may
be removed only for cause and only upon the affirmative vote of holders of 80%
or more of the outstanding shares of our capital stock. Further, our Charter
provides that the amendment of this provision for removing directors for cause
may only be amended by the affirmative vote of at least 75% of the voting power
of all the then outstanding shares of our capital stock voting together as a
single class.
Our By-Laws establish an advance notice procedure for nomination, other than
by or at the direction of our Board of Directors, of candidates for election as
directors. Advance notice procedures also exist for other stockholder proposals
to be considered at annual or special meetings of stockholders. In general, we
must receive notice of intent to nominate a director or raise business at an
annual meeting not less than 60 nor more than 90 days prior to the scheduled
annual meeting. In the case of a special meeting called for the purpose of
electing directors, such notice of intent must be received not later than the
close of business on the fifth day following the day on which notice of the
date of the meeting was mailed. Such notice of intent must contain certain
specified information concerning the person to be nominated or the mater to be
brought before the meeting.
In addition, our By-Laws allow our Board of Directors to increase the number
of directors from time to time although a decrease in the number of directors
may not have the effect of shortening the term of any incumbent director. Our
By-Laws also grant the Board of Directors the authority to fill any vacancies
on the Board of Directors, including vacancies resulting from an increase in
the number of directors. Our Charter states that our By-Laws may be amended by
the stockholders only by the vote of not less than 80% of the outstanding
shares of stock entitled to vote upon the election of directors.
The provisions of the Charter and the By-Laws summarized in the preceding
paragraphs may have the effect of delaying, deferring or preventing a non-
negotiated merger or other business combination involving us. These provisions
are intended to encourage any person interested in acquiring us to negotiate
with and obtain the approval of our Board of Directors in connection with the
transaction. Certain of these provisions may, however, discourage our future
acquisition in a transaction not approved by our Board of Directors in which
stockholders might receive an attractive value for their shares or that a
substantial number or even a majority of our stockholders might believe to be
in their best interest. As a result, stockholders who desire to participate in
such a transaction may not have the opportunity to do so. Such provisions could
also discourage bids for our common stock at a premium, as well as create a
depressive effect on the market price of our common stock. See "Risk Factors--
Statute, Charter and By-laws May Delay or Prevent Acquisition of Careside."
Our stock option plans, in certain circumstances, allow our Board of
Directors or a committee thereof to accelerate the vesting or exercise date of
any options granted thereunder. The ability to accelerate the vesting or
exercise date of options could be utilized as a method of discouraging,
delaying or preventing a change in control of our stock. See "Management--Stock
Option Plans."
Transfer Agent and Registrar
The transfer agent and registrar and warrant agent for our units, common
stock and warrants is American Stock Transfer & Trust Company, New York, New
York.
62
<PAGE>
SHARES ELIGIBLE FOR FUTURE SALE
Upon completion of the offering, we expect to have 7,084,340 shares of common
stock outstanding, assuming no exercise of outstanding options or warrants, or
7,384,340 shares if the underwriters' over-allotment is exercised in full. Of
these shares, the 2,000,000 shares of common stock, and the shares of common
stock issued upon exercise of the warrants, issued as part of the units sold in
the offering will be freely tradeable without restrictions or further
registration under the Securities Act, except that any shares purchased by our
"affiliates", as that term is defined under the Securities Act, may generally
only be sold in compliance with the limitations of Rule 144 under the
Securities Act. All of the remaining outstanding shares of common stock are
restricted securities within the meaning of Rule 144 and may not be sold in the
absence of registration under the Securities Act unless an exemption from
registration is available, including the exemption from registration offered by
Rule 144.
Holders of more than 95% of our restricted shares of common stock, other than
those beneficially owned by S.R. One, Limited, have agreed (the "Lock-Up
Agreements") not to sell or otherwise dispose of any of their shares of common
stock for a period of one year after completion of the offering, without the
prior written consent of Paulson Investment Company, Inc. and Millennium
Financial Group, Inc., subject to certain limited exceptions. S.R. One has a
six month lock-up period. After the expiration of these lock-up periods, or
earlier with the prior written consent of Paulson and Millennium, 5,084,340
shares of the common stock may be sold in the public market pursuant to Rule
144.
In general, under Rule 144, as currently in effect, beginning 90 days after
the date of this prospectus, a person who has beneficially owned restricted
shares for at least one year, including a person who may be deemed to be our
affiliate, may sell within any three-month period a number of shares of common
stock that does not exceed a maximum number of shares. This maximum is equal to
the greater of 1% of the then outstanding shares of our common stock or the
average weekly trading volume in the common stock during the four calendar
weeks immediately preceding the sale. Sales under Rule 144 are also subject to
restrictions relating to manner of sale, notice and availability of current
public information about us. In addition, under Rule 144(k) of the Securities
Act, a person who is not our affiliate, has not been an affiliate of ours
within three months prior to the sale and has beneficially owned shares for at
least two years, would be entitled to sell such shares immediately without
regard to volume limitations, manner of sale provisions, notice or other
requirements of Rule 144.
Beginning 90 days after the date of this prospectus, certain shares issued or
issuable upon the exercise of options granted by us prior to the date of this
prospectus will also be eligible, subject to the lock-up periods, for sale in
the public market pursuant to Rule 701 under the Securities Act. Pursuant to
Rule 701, persons who purchase shares upon exercise of options granted under a
written compensatory plan or contract may sell such shares in reliance on Rule
144 without having to comply with the holding period requirements of Rule 144,
and in the case of non-affiliates, without having to comply with the public
information, volume limitation or notice provisions of Rule 144. As of June 15,
1999, we have options outstanding to purchase 422,403 shares of common stock
which have not been exercised and which become exercisable at various times in
the future. Any shares issued upon the exercise of these options will be
eligible for sale pursuant to Rule 701.
We intend to file a Form S-8 registration statement under the Securities Act
approximately 180 days after the closing of the offering to register up to an
aggregate of 1,334,208 shares of common stock reserved for issuance under our
stock option plans and the employee stock purchase plan. See "Management--Stock
Option Plans" and "--Employee Stock Purchase Plan." Accordingly, shares
registered under such registration statement will, subject to Rule 144 volume
limitations applicable to affiliates, be available for sale in the open market,
unless such options are subject to vesting restrictions or the Lock-Up
Agreements. As of June 15, 1999, options to purchase 422,403 shares of common
stock were outstanding. An additional 911,805 shares of common stock remained
available for future grants under our 1996 and 1998 stock option plans and
issuance under the employee stock purchase plan.
63
<PAGE>
We previously issued warrants to purchase an aggregate of 724,852 shares of
common stock at exercise prices ranging $5.20 to $6.76 per share to Spencer
Trask Securities Incorporated. These warrants are exercisable until three years
after completion of the offering. The bridge warrant issued to S.R. One,
Limited will become exercisable on the earlier of December 17, 1999 or six
months after completion of the offering to purchase a number of shares of
common stock equal to $1,500,000 divided by $6.375, which is 85% of the initial
public offering price per unit. The bridge warrant has an exercise price of 85%
of the initial public offering price per unit and will expire on the earlier of
December 17, 2005 or four years after the completion of the offering. The
holders of the warrants and the bridge warrant are entitled to certain
registration rights with respect to the shares issuable upon exercise of such
warrants. These shares may be sold without restriction in the public market
upon registration, and with respect to more than 95% of these shares, after the
lock-up period expires.
The shares of Series A Convertible Preferred Stock issued to S.R. One upon
completion of this offering as part of the conversion of the bridge financing,
together with accrued and unpaid dividends thereon, are convertible at the
option of the holder six months after this offering into a unit comprised of
one share of common stock and a warrant to purchase one additional share of
common stock. The warrant will have the same terms as the warrants issued as
part of the units sold in this offering. The holder of the Series A Convertible
Preferred Stock is entitled to certain registration rights with respect to the
shares of common stock, and the shares of common stock issuable upon exercise
of the warrants, included in the units received upon conversion of the Series A
Convertible Preferred Stock.
In connection with the offering, the Company has agreed to issue to the
representatives of the underwriters warrants to purchase 200,000 units. This
number is equal to 10% of the number of units being offered by this prospectus,
excluding over-allotment shares. The representatives' warrants will be
exercisable into units at any time during the four-year period commencing one
year after the effective date of the offering. The common stock and warrants
issued to the representatives upon exercise of these warrants will be freely
tradable.
Prior to the offering, there has been no market for our common stock and
there can be no assurance that a significant public market for the common stock
will develop or be sustained after the offering. Future sales of substantial
amounts of common stock, including shares issued upon exercise of outstanding
options and warrants in the public market after the offering, or the perception
that such sales may occur, could adversely affect market prices prevailing from
time to time and could impair our ability to raise capital through the sale of
our securities.
64
<PAGE>
UNDERWRITING
The underwriters named below, for whom Paulson Investment Company, Inc.,
Millennium Financial Group, Inc. and marion bass securities corporation are
acting as the representatives, have severally agreed, subject to the terms and
conditions contained in an underwriting agreement, to purchase from us, and we
have agreed to sell to each underwriter, the aggregate number of units
indicated below opposite the name of such underwriter at the initial public
offering price less the underwriting discount set forth below and on the cover
page of this prospectus:
<TABLE>
<CAPTION>
Number of
Units
Name of Underwriter Purchased
- ------------------- ---------
<S> <C>
Paulson Investment Company, Inc....................................... 1,595,000
marion bass securities corporation.................................... 300,000
Kashner Davidson Securities Corporation............................... 40,000
Redwine & Co., Inc.................................................... 30,000
American Fronteer Financial Corporation............................... 25,000
Millenium Financial Group, Inc........................................ 10,000
TOTAL............................................................... 2,000,000
=========
</TABLE>
The underwriting agreement provides that the obligations of the underwriters
are subject to certain conditions and that the underwriters are committed to
purchase all of the units, other than those covered by the over-allotment
option described below, if any are purchased. The underwriting agreement also
provides that we will indemnify the underwriters against certain liabilities,
including liabilities under the Securities Act, and will contribute to payments
which the underwriters may be required to make in respect thereof.
The representatives have advised us that the underwriters propose to offer
the units directly to the public initially at the public offering price set
forth on the cover page of this prospectus and to certain dealers, who may
include the underwriters, at such public offering price less a selling
concession not to exceed $0.30 per unit. The underwriters may allow, and such
dealers may reallow, a concession of not more than $0.10 per unit to certain
other dealers. After the offering, the offering price, the concession to
certain dealers and other selling terms may be changed by the representatives
of the underwriters. The representatives have informed us that they do not
expect the underwriters to confirm sales of units on a discretionary basis.
We have granted to the underwriters an option, exercisable not later than 45
days after the date of this prospectus, to purchase up to a maximum of 300,000
additional units solely to cover over-allotments, if any, at the initial public
offering price less the underwriting discount set forth herein. If the
underwriters exercise the over-allotment option, each underwriter will be
committed to purchase a proportionate number of the additional units based on
its relative proportion of units to be purchased by it shown in the preceding
table.
Without the prior written consent of Paulson Investment Company, Inc. and
Millennium Financial Group, Inc., holders of more than 95% of our shares of
common stock, certain option and warrant holders, including our officers and
directors, and we, are not permitted to offer, pledge, sell, contract to sell
or otherwise transfer or dispose of, directly or indirectly, our securities
until after at least one year (six months in the case of S.R. One, Limited)
after the closing of the offering. Such prohibition does not apply to our grant
of options under our stock option plans, our issuance of warrants to the
representatives, our issuance of our units upon exercise of the over-allotment
option, our issuance of common stock upon the exercise of the warrants
contained in the units, or our issuance of common stock pursuant to conversion
of our Series A Convertible Preferred Stock or upon exercise of the bridge loan
warrants held by S.R. One or other outstanding warrants.
The following table sets forth the amount of the underwriting discount and
the nature of the compensation to be paid to the underwriters for each unit and
in total. Such amounts are shown assuming both no exercise and full exercise of
the underwriters' over-allotment option.
65
<PAGE>
<TABLE>
<CAPTION>
Compensation to be paid to Underwriters
---------------------------------------------------------------
No Exercise of Over- Full Exercise of Over-
Allotment Option Allotment Option
------------------------------- -------------------------------
Per Unit Total Per Share Total
-------------- ---------------- -------------- ----------------
<S> <C> <C> <C> <C>
Underwriting Discount...
Representative's
Warrants(1)............ 1/10th Warrant 200,000 Warrants 1/10th Warrant 200,000 Warrants
Non-accountable Expense
Allowance(2)........... N/A $281,250 N/A $323,438
</TABLE>
- --------
(1) In connection with the offering, we have agreed to issue warrants to the
representatives of the underwriters to purchase a number of units equal to
ten percent (10%) of the number of units being offered hereby, excluding
over-allotment shares. The representatives' warrants will be exercisable
into units during the four-year period beginning on the first anniversary
of the effective date of the offering, at an exercise price equal to one
hundred twenty percent (120%) of the initial public offering price per unit
set forth on the cover page of this prospectus. The representatives'
warrants are restricted from sale, transfer, assignment or hypothecation
for a period of one year from the effective date of the offering except to
officers and partners of the representatives of the underwriters. See
"Description of Capital Stock--Registration Rights." To the extent that the
representatives of the underwriters realize any gain from the resale of the
shares issuable upon the exercise of such warrants, such gain may be deemed
additional underwriting compensation.
(2) We have also agreed to pay the representatives of the underwriters a non-
accountable expense allowance equal to 1.5% of the gross proceeds of the
offering. In addition, we have agreed to pay up to $54,350 of the
underwriters' counsel's fees and expenses for their services to the
underwriters in connection with the offering during the period through
March 31, 1999.
The following table sets forth an itemization of all expenses we will pay in
connection with the issuance and distribution of the securities being
registered. Except for the SEC Registration Fee, the American Stock Exchange
Listing Fee and the NASD Fee, the amounts listed below are estimates.
<TABLE>
<CAPTION>
Nature of Expense Amount
- ----------------- ----------
<S> <C>
SEC Registration Fee................................................ $ 13,116
American Stock Exchange Listing Fee................................. 50,000
NASD Fee............................................................ 6,790
Printing and engraving fees......................................... 300,000
Registrant's counsel fees and expenses.............................. 500,000
Accounting fees and expenses........................................ 200,000
Underwriters' Expenses.............................................. 281,250
Blue Sky expenses and NASD counsel fees............................. 56,000
Transfer agent and registrar fees................................... 8,000
Other Offering Expenses............................................. 107,000
Miscellaneous....................................................... 77,844
----------
TOTAL............................................................. $1,600,000
==========
</TABLE>
Prior to the offering, there has been no public market for our units, shares
of common stock or warrants. The initial public offering price of the units and
the exercise price and other terms of the warrants underlying the units, as
well as the exercise price of the representatives' warrants, were determined
through arm's length negotiations between us and the representatives of the
underwriters, and do not necessarily bear any relationship to our assets, book
value, financial condition, or other established criteria of value. In
determining such prices and terms, consideration was given to prevailing market
conditions, the prospects for the business and industry in which we compete, an
assessment of our management, our capital structure, our past and present
operations, and our prospects for future earnings. The initial public offering
price of the units and the
66
<PAGE>
exercise price of the warrants should not be considered to be indicative of our
actual value. There can be no assurance that an active trading market will
develop for our units, shares of common stock or warrants or that the aggregate
prices at which our units, common stock and warrants will sell in the public
market after the offering will be higher than the price at which the units will
be sold in the offering.
In connection with the offering, certain underwriters and selling group
members and their respective affiliates may engage in transactions that
stabilize, maintain or otherwise affect the market price of our units, common
stock and/or warrants. Such transactions may include stabilization transactions
effected in accordance with Regulation M of the Securities Exchange Act of
1934, pursuant to which such persons may bid for or purchase units, common
stock and/or warrants for the purpose of pegging, fixing or maintaining the
price of our units, common stock and/or warrants at a level that is higher than
the market would dictate in the absence of such transactions.
The underwriters may also create a short position for the account of the
underwriters by selling more units in connection with the offering than they
are committed to purchase from the company, and in such case may purchase
units, common stock or warrants in the open market following the completion of
the offering to cover all or a portion of such short position. The underwriters
may also cover all or a portion of such short position, up to 300,000 units, by
exercising the over-allotment option described herein.
In addition, the representatives of the underwriters may also impose a
"penalty bid" under contractual arrangements with the underwriters whereby the
representatives may reclaim from an underwriter, or dealer participating in the
offering, for the account of other underwriters, the selling concession with
respect to units that are distributed in the offering but subsequently
purchased for the account of the underwriters in the open market.
In general, any of the transactions described above may result in the
maintenance of the price of our units, common stock or warrants at a level
above that which might otherwise prevail in the absence of such transactions.
We and the underwriters make no representation or prediction as to the
direction or magnitude of any effect that such transactions may have on the
price of our units, common stock or warrants. In addition, we and the
underwriters make no representation that the representatives of the
underwriters or the underwriters, as the case may be, will engage in such
transactions or that such transactions, once commenced, will not be
discontinued without notice.
Millennium Financial Group, Inc. was organized in June 1996. Since such date,
Millennium has been engaged primarily in the institutional brokerage business
and has participated as an underwriter or a member of the selling group in
seven public offerings. Millennium acted as a co-managing underwriter in four
of those offerings and has participated in a total of ten private offerings.
The offering contemplated hereby will be the fifth public offering co-managed
by Millennium.
Spencer Trask Securities Incorporated is not participating as an underwriter
or member of the selling group in the offering. Fahnestock & Co. Inc.
originally acted as lead underwriter in connection with this offering. In April
1999, Fahnestock withdrew from participation in the offering. Paulson
Investment Company, Inc. subsequently became lead underwriter. As a result of
Fahnestock's earlier involvement, we paid Fahnestock $60,000 to cover its out-
of-pocket expenses.
LEGAL MATTERS
The validity of units offered hereby will be passed upon for us by Pepper
Hamilton LLP. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., Boston,
Massachusetts has acted as counsel for the underwriters in connection with the
offering.
67
<PAGE>
EXPERTS
The audited financial statements included in this prospectus and elsewhere in
the registration statement have been audited by Arthur Andersen LLP,
independent public accountants, as indicated in their reports with respect
thereto, and are included herein in reliance upon the authority of that firm as
experts in giving their reports. Reference is made to their report contained
elsewhere in this prospectus on us which contains an explanatory paragraph
regarding our ability to continue as a going concern.
The statements in this prospectus under the captions "Risk Factors -- Our
Proprietary Technology is a Crucial Part of Our Business -- We Do Not Have Any
Patents on Our Proprietary Technology," "Risk Factors-- Our Proprietary
Technology is a Crucial Part of Our Business -- Our Technology May Infringe on
the Proprietary Rights of Third Parties" and "Business -- Patents and
Proprietary Rights" relating to patent matters have been reviewed and approved
by Oppenheimer Wolff & Donnelly LLP, Los Angeles, California, patent counsel to
Careside, as experts on such matters, and are included herein in reliance upon
that review and approval.
WHERE YOU CAN GET MORE INFORMATION
Our fiscal year ends on December 31. We will file annual, quarterly and
current reports, proxy statements and other information with the Securities and
Exchange Commission. You may read and copy any reports, statements or other
information on file at the SEC's public reference room in Washington, D.C. You
can request copies of those documents, upon payment of a duplicating fee, by
writing to the SEC.
We have filed a registration statement on Form S-1 with the SEC. This
prospectus, which forms a part of the registration statement, does not contain
all of the information included in the registration statement. Certain
information is omitted. You should refer to the registration statement and its
exhibits. With respect to references made in this prospectus to any contract or
other document relating to us, such references are not necessarily complete.
You should refer to the exhibits attached to the registration statement for
copies of the actual contract or document. You may review a copy of the
registration statement at the SEC's public reference room in Washington, D.C.,
and at the SEC's regional offices in Chicago, Illinois and New York, New York.
Please call the SEC at 1-800-SEC-0330 for further information on the operation
of the public reference rooms. Our SEC filings, including the registration
statement, can also be reviewed by accessing the SEC's Internet site at
http://www.sec.gov.
68
<PAGE>
CARESIDE, INC.
INDEX TO FINANCIAL STATEMENTS
<TABLE>
<CAPTION>
Page
----
<S> <C>
CARESIDE, INC.:
Report of Independent Public Accountants................................. F-2
Balance Sheets........................................................... F-3
Statements of Operations................................................. F-4
Statements of Stockholders' Equity (Deficit)............................. F-5
Statements of Cash Flows................................................. F-6
Notes to Financial Statements............................................ F-7
PREDECESSOR BUSINESS:
Report of Independent Public Accountants................................. F-14
Statement of Operations.................................................. F-15
Notes to Statement of Operations......................................... F-16
</TABLE>
F-1
<PAGE>
REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS
To Careside, Inc.:
We have audited the accompanying balance sheets of Careside, Inc. (a Delaware
corporation in the development stage) as of December 31, 1997 and 1998, and the
related statements of operations, stockholders' equity (deficit) and cash flows
for the period from inception (July 10, 1996) to December 31, 1996, the years
ended December 31, 1997 and 1998, and the period from inception (July 10, 1996)
to December 31, 1998. 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 in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of
material misstatement. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a reasonable basis
for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Careside, Inc. as of December
31, 1997 and 1998, and the results of its operations and its cash flows for the
period from inception (July 10, 1996) to December 31, 1996, the years ended
December 31, 1997 and 1998, and the period from inception (July 10, 1996) to
December 31, 1998, in conformity with generally accepted accounting principles.
The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. As discussed in Note 1 to the
financial statements, the Company will require significant funding to continue
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 1. The financial statements do not include any adjustments relating to
the recoverability and classification of asset carrying amounts or the amount
and classification of liabilities that might result should the Company be
unable to continue as a going concern.
ARTHUR ANDERSEN LLP
Philadelphia, Pa.,
January 20, 1999 (except for the
recapitalization discussed in Note 2,
as to which the date is June 15, 1999)
F-2
<PAGE>
CARESIDE, INC.
(a development-stage company)
BALANCE SHEETS
<TABLE>
<CAPTION>
December 31,
------------------------- March 31,
1997 1998 1999
----------- ------------ -----------
(unaudited)
<S> <C> <C> <C>
ASSETS
CURRENT ASSETS:
Cash and cash equivalents............ $ 1,237,149 $ 3,926,603 $ 2,051,786
Prepaid expenses and other........... 226,580 251,698 83,447
----------- ------------ -----------
Total current assets............... 1,463,729 4,178,301 2,135,233
PROPERTY AND EQUIPMENT, net............ 1,578,727 3,216,959 4,206,992
DEFERRED OFFERING COSTS................ -- 498,443 888,828
DEPOSITS............................... 97,767 17,700 17,700
----------- ------------ -----------
$ 3,140,223 $ 7,911,403 $ 7,248,753
=========== ============ ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Current portion of long-term debt.... $ -- $ 186,998 $ 3,193,671
Accounts payable..................... 492,985 1,369,889 1,923,874
Accrued expenses..................... 209,631 160,439 184,648
----------- ------------ -----------
Total current liabilities.......... 702,616 1,717,326 5,302,193
----------- ------------ -----------
LONG-TERM DEBT......................... -- 2,044,932 803,092
----------- ------------ -----------
COMMITMENTS (Note 9)
STOCKHOLDERS' EQUITY:
Preferred stock, $.01 par value,
5,000,000 shares authorized, none
issued.............................. -- -- --
Common stock, $.01 par value,
50,000,000 shares authorized,
3,365,400, 5,084,340 and 5,084,340
shares issued and outstanding....... 33,654 50,843 50,843
Additional paid-in capital........... 10,372,907 21,003,545 21,003,545
Deficit accumulated during
development stage................... (7,968,954) (16,905,243) (19,910,920)
----------- ------------ -----------
Total stockholders' equity......... 2,437,607 4,149,145 1,143,468
----------- ------------ -----------
$ 3,140,223 $ 7,911,403 $ 7,248,753
=========== ============ ===========
</TABLE>
The accompanying notes are an integral part of these statements.
F-3
<PAGE>
CARESIDE, INC.
(a development-stage company)
STATEMENTS OF OPERATIONS
<TABLE>
<CAPTION>
For the Period For the Period For the Period
From From From
Inception For the Year Inception Inception
(July 10, 1996) Ended For the Three Months (July 10, 1996) (July 10, 1996)
Through December 31, Ended March 31, Through Through
December 31, ------------------------ ------------------------ December 31, March 31,
1996 1997 1998 1998 1999 1998 1999
--------------- ----------- ----------- ----------- ----------- --------------- ---------------
(unaudited) (unaudited)
<S> <C> <C> <C> <C> <C> <C> <C>
OPERATING EXPENSES:
Research and
development......... $ 1,561,847 $ 5,895,465 $ 8,297,974 $ 1,541,119 $ 2,076,046 $ 15,755,286 $ 17,831,332
General and
administrative...... 55,515 640,574 850,129 196,595 569,907 1,546,218 2,116,125
----------- ----------- ----------- ----------- ----------- ------------ ------------
Operating loss....... (1,617,362) (6,536,039) (9,148,103) (1,737,714) (2,645,953) (17,301,504) (19,947,457)
INTEREST INCOME....... -- 213,585 234,089 17,857 42,054 447,674 489,728
INTEREST EXPENSE...... (20,809) (8,329) (22,275) -- (401,778) (51,413) (453,191)
----------- ----------- ----------- ----------- ----------- ------------ ------------
NET LOSS.............. $(1,638,171) $(6,330,783) $(8,936,289) $(1,719,857) $(3,005,677) $(16,905,243) $(19,910,920)
=========== =========== =========== =========== =========== ============ ============
BASIC NET LOSS PER
SHARE................ $ (2.25) $ (2.04) $ (1.93) $ (0.49) $ (0.59)
=========== =========== =========== =========== ===========
SHARES USED IN
COMPUTING BASIC NET
LOSS PER SHARE 728,465 3,098,980 4,629,916 3,521,808 5,084,340
=========== =========== =========== =========== ===========
</TABLE>
The accompanying notes are an integral part of these statements.
F-4
<PAGE>
CARESIDE, INC.
(a development-stage company)
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)
<TABLE>
<CAPTION>
Deficit
Accumulated
Common Stock Additional Stock During Total
----------------- Paid-in Subscription Development Stockholders'
Shares Amount Capital Receivable Stage Equity (Deficit)
--------- ------- ----------- ------------ ------------ ----------------
<S> <C> <C> <C> <C> <C> <C>
BALANCE, JULY 10, 1996
(inception)............ -- $ -- $ -- $ -- $ -- $ --
Shares issued to
founders and
management............ 659,344 6,593 (6,593) -- -- --
Shares issued to
SmithKline Beecham
Corporation in
connection with asset
purchase.............. 34,702 347 571,006 -- -- 571,353
Sale of shares to
Exigent Partners,
L.P................... 557,601 5,576 93,419 (98,995) -- --
Shares issued to
investment banker in
connection with equity
financing............. 30,173 302 (302) -- -- --
Shares issued to
SmithKline Beecham
Corporation pursuant
to antidilution
agreement............. 30,935 310 (310) -- -- --
Net loss............... -- -- -- -- (1,638,171) (1,638,171)
--------- ------- ----------- ------- ------------ -----------
BALANCE, DECEMBER 31,
1996................... 1,312,755 13,128 657,220 (98,995) (1,638,171) (1,066,818)
Shares issued in
connection with
private placement, net
of expenses of
$1,291,772 1,923,090 19,231 8,688,998 -- -- 8,708,229
Shares issued to
SmithKline Beecham
Corporation upon
conversion of note
payable............... 129,555 1,295 1,026,689 -- -- 1,027,984
Payment of stock
subscription.......... -- -- -- 98,995 -- 98,995
Net loss............... -- -- -- -- (6,330,783) (6,330,783)
--------- ------- ----------- ------- ------------ -----------
BALANCE, DECEMBER 31,
1997................... 3,365,400 33,654 10,372,907 -- (7,968,954) 2,437,607
Shares issued in
connection with
private placement, net
of expenses of
$1,302,029............ 1,701,225 17,012 10,180,959 -- -- 10,197,971
Shares issued in
connection with
exercise of stock
options............... 17,715 177 119,565 -- -- 119,742
Value of warrants
issued in connection
with bridge
financing............. -- -- 330,114 -- -- 330,114
Net loss............... -- -- -- -- (8,936,289) (8,936,289)
--------- ------- ----------- ------- ------------ -----------
BALANCE, DECEMBER 31,
1998 .................. 5,084,340 50,843 21,003,545 -- (16,905,243) 4,149,145
Net loss (unaudited)... -- -- -- -- (3,005,677) (3,005,677)
--------- ------- ----------- ------- ------------ -----------
BALANCE, MARCH 31, 1999
(unaudited)............ 5,084,340 $50,843 $21,003,545 $ -- $(19,910,920) $ 1,143,468
========= ======= =========== ======= ============ ===========
</TABLE>
The accompanying notes are an integral part of these statements.
F-5
<PAGE>
CARESIDE, INC.
(a development-stage company)
STATEMENTS OF CASH FLOWS
<TABLE>
<CAPTION>
For the Period For the Period For the Period
From From From
Inception Inception Inception
(July 10, 1996) For the Year Ended For the Three Months (July 10, 1996) (July 10, 1996)
Through December 31, Ended March 31, Through Through
December 31, ------------------------ ------------------------ December 31, March 31,
1996 1997 1998 1998 1999 1998 1999
--------------- ----------- ----------- ----------- ----------- --------------- ---------------
(unaudited) (unaudited)
<S> <C> <C> <C> <C> <C> <C> <C>
OPERATING ACTIVITIES:
Net loss............. $(1,638,171) $(6,330,783) $(8,936,289) $(1,719,857) $(3,005,677) $(16,905,243) $(19,910,920)
Adjustments to
reconcile net loss
to net cash used in
operating
activities--
Depreciation......... 12,275 145,858 367,231 43,965 234,761 525,364 760,125
Imputed interest on
note payable........ -- 8,329 -- -- -- 8,329 8,329
Amortization of debt
discount............ -- -- 20,960 -- 309,154 20,960 330,114
Changes in assets and
liabilities--
Decrease (increase)
in prepaid expenses
and other........... (15,840) (210,740) (25,118) 12,164 168,251 (251,698) (83,447)
Decrease (increase)
in deposits......... (102,700) 19,933 80,067 (968) -- (2,700) (2,700)
Increase in accounts
payable............. 284,079 208,906 876,904 327,583 553,985 1,369,889 1,923,874
Increase (decrease)
in accrued
expenses............ 575,301 (346,014) (49,192) (110,483) 24,209 180,095 204,304
----------- ----------- ----------- ----------- ----------- ------------ ------------
Net cash used in
operating
activities......... (885,056) (6,504,511) (7,665,437) (1,447,596) (1,715,317) (15,055,004) (16,770,321)
----------- ----------- ----------- ----------- ----------- ------------ ------------
INVESTING ACTIVITIES:
Purchases of property
and equipment....... (344,733) (888,510) (2,005,463) (299,976) (1,224,794) (3,238,706) (4,463,500)
----------- ----------- ----------- ----------- ----------- ------------ ------------
FINANCING ACTIVITIES:
Net borrowings
(repayments) on line
of credit........... 400,000 (400,000) -- -- -- -- --
Proceeds from the
issuance of notes... 1,000,000 -- 2,541,084 -- 1,500,000 3,541,084 5,041,084
Deferred offering
costs............... (191,906) -- (498,443) -- (390,385) (690,349) (1,080,734)
Proceeds from the
issuance of Common
stock............... -- 8,900,134 10,317,713 7,159,321 -- 19,217,847 19,217,847
Payments on note
payable............. -- -- -- -- (44,321) -- (44,,321)
Payment of stock
subscription........ -- 98,995 -- -- -- 98,995 98,995
Cash received from
SmithKline Beecham
Corporation in
connection with
asset purchase...... 52,736 -- -- -- -- 52,736 52,736
----------- ----------- ----------- ----------- ----------- ------------ ------------
Net cash provided by
financing
activities......... 1,260,830 8,599,129 12,360,354 7,159,321 1,065,294 22,220,313 23,285,607
----------- ----------- ----------- ----------- ----------- ------------ ------------
NET INCREASE
(DECREASE) IN CASH
AND CASH
EQUIVALENTS.......... 31,041 1,206,108 2,689,454 5,411,749 (1,874,817) 3,926,603 2,051,786
CASH AND CASH
EQUIVALENTS,
BEGINNING OF PERIOD.. -- 31,041 1,237,149 1,237,149 3,926,603 -- --
----------- ----------- ----------- ----------- ----------- ------------ ------------
CASH AND CASH
EQUIVALENTS, END OF
PERIOD............... $ 31,041 $ 1,237,149 $ 3,926,603 $ 6,648,898 $ 2,051,786 $ 3,926,603 $ 2,051,786
=========== =========== =========== =========== =========== ============ ============
</TABLE>
The accompanying notes are an integral part of these statements.
F-6
<PAGE>
CARESIDE, INC.
(a development-stage company)
NOTES TO FINANCIAL STATEMENTS
1. CARESIDE:
Background
Careside, Inc., formerly Exigent Diagnostics, Inc., is focused on designing
products intended to perform routine diagnostic blood tests in doctors'
offices, hospital rooms, patient homes or anywhere a patient is receiving
medical attention. Careside's first product in development is a compact
portable device with related disposables that performs chemistry,
electrochemistry, immunochemistry and coagulation testing.
Development-Stage Risks and Liquidity
Careside was incorporated in July 1996 to acquire an ongoing, point-of-care
("POC") testing, development-stage product from SmithKline Beecham Corporation
and its affiliates ("SmithKline") and to complete the development of and to
manufacture, market and distribute POC diagnostic products. Since its
inception, Careside has generated no revenues and incurred significant losses.
Careside anticipates incurring additional losses over at least the next several
years, and such losses are expected to increase as Careside expands its
research and development activities. Substantial financing will be needed by
Careside to fund its operations and to commercially develop its products. The
ability of Careside to commercialize its products will depend on, among other
things, the relative cost to the customer of Careside's products compared to
alternative products, its ability to obtain necessary regulatory approvals and
to manufacture the products in accordance with Good Manufacturing Practices,
and its ability to market and distribute its products. There can be no
assurance that Careside's research and development efforts will be successful
or that any products developed by Careside will receive regulatory clearance or
be profitable in the marketplace.
The accompanying financial statements have been prepared in conformity with
principles of accounting applicable to a going concern. These principles
contemplate the realization of assets and the satisfaction of liabilities in
the normal course of business. As shown in the accompanying financial
statements, Careside incurred a net loss of $8,936,289 and used cash for
operating activities of $7,665,437 for the year ended December 31, 1998.
Management believes that Careside's existing sources of liquidity together with
the proceeds to be received from its initial public offering (the "Offering")
contemplated in this prospectus will be sufficient to fund its planned
operations into 2000. There can be no assurance that the Offering will be
successful.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
Interim Financial Statements
The financial statements as of March 31, 1999 and for the three months ended
March 31, 1998 and 1999 are unaudited and, in the opinion of management,
include all adjustments (consisting only of normal and recurring adjustments)
necessary for a fair presentation of results for these interim periods. The
results of operations for the three months ended March 31, 1999 are not
necessarily indicative of the results expected for the entire year.
Use of Estimates
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make 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 expenses during the reporting period. Actual results
could differ from those estimates.
Cash and Cash Equivalents
Careside considers all highly liquid investments consisting of purchases with
an original maturity of three months or less to be cash equivalents.
F-7
<PAGE>
Property and Equipment
Property and equipment are stated at cost. Property and equipment capitalized
under capital leases are recorded at the present value of the minimum lease
payments due over the lease term. Depreciation and amortization are provided
using the straight-line method over the estimated useful lives of the related
assets or the lease term, whichever is shorter. Careside uses lives of three to
five years for research and manufacturing equipment and five to seven years for
office equipment.
Fair Value of Financial Instruments
Cash and cash equivalents, prepaid expenses and other current assets,
accounts payable and accrued expenses are reflected in the accompanying
financial statements at fair value due to the short-term nature of those
instruments. The carrying amount of long-term debt approximates fair value on
the balance sheet dates.
Research and Development
Research and development costs are charged to expense as incurred.
Income Taxes
Careside follows Statement of Financial Accounting Standards ("SFAS") No.
109, "Accounting for Income Taxes." Under SFAS No. 109, the liability method is
used in accounting for income taxes. Under this method, deferred tax assets and
liabilities are determined based on differences between the financial reporting
and tax bases of assets and liabilities and are measured using enacted tax
rates that are expected to be in effect when the differences reverse.
Accounting for Stock-Based Compensation
Careside applies Accounting Principles Board ("APB") Opinion No. 25,
"Accounting for Stock Issued to Employees," in accounting for its stock
options. Careside follows the disclosure requirements of SFAS No. 123,
"Accounting for Stock-Based Compensation," which permits pro forma disclosure
of the net loss using a fair value-based method of accounting for employee
stock option plans (see Note 8).
Net Loss Per Common Share
Careside has presented net loss per share pursuant to SFAS No. 128, "Earnings
per Share," and the Securities and Exchange Commission Staff Accounting
Bulletin No. 98. Net loss per share is computed using the weighted average
number of common and dilutive common equivalent shares outstanding during the
period.
Basic loss per share was computed by dividing net loss applicable to common
shareholders by the weighted average number of shares of Common stock
outstanding during the period. Dilutive loss per share has not been presented,
since the impact on loss per share using the treasury stock method is anti-
dilutive due to Careside's losses.
Recapitalization
In February 1999, Careside's stockholders approved a 1-for-5.2 reverse stock
split of Careside's Common stock to be effective upon consummation of the
offering. All references in the accompanying financial statements to the number
of shares and per share amounts have been retroactively restated to reflect the
reverse stock split.
Recently Issued Pronouncements
In June 1997, the Financial Accounting Standards Board ("FASB") issued SFAS
No. 130, "Reporting Comprehensive Income." This statement requires companies to
classify items of other comprehensive income
F-8
<PAGE>
separately from retained earnings and additional paid-in capital in the
stockholders' equity section of the balance sheet. SFAS No. 130 is effective
for financial statements issued for fiscal years beginning after December 15,
1997. Management believes that SFAS No. 130 will not have a material adverse
effect on Careside's financial statements.
In June 1997, the FASB issued SFAS No. 131, "Disclosure about Segments of an
Enterprise and Related Information." This statement establishes additional
standards for segment reporting in the financial statements and is effective
for fiscal years beginning after December 15, 1997. Management is currently
evaluating the need to make additional disclosures under SFAS No. 131. However,
this statement will not have any effect on Careside's reported financial
position or results of operations.
3. PROPERTY AND EQUIPMENT:
<TABLE>
<CAPTION>
December 31,
---------------------- March 31,
1997 1998 1999
---------- ---------- ----------
<S> <C> <C> <C>
Laboratory equipment.................. $1,280,663 $3,264,286 $4,475,181
Leasehold improvements................ 371,239 371,239 371,239
Computer and office equipment......... 84,958 106,798 120,697
---------- ---------- ----------
1,736,860 3,742,323 4,967,117
Less-Accumulated depreciation and
amortization......................... (158,133) (525,364) (760,125)
---------- ---------- ----------
$1,578,727 $3,216,959 $4,206,992
========== ========== ==========
</TABLE>
Depreciation and amortization expense for the period from inception (July 10,
1996) through December 31, 1996, the years ended 1997 and 1998, the three
months ended March 31, 1998 and 1999, the period from inception (July 10, 1996)
through December 31, 1998 and the period from inception (July 10, 1996) through
March 31, 1999 was $12,275, $145,858, $367,231, $43,965, $234,761, $525,364 and
$760,125, respectively.
4. INCOME TAXES:
At December 31, 1998, Careside had net operating loss carryforwards for
federal income tax purposes of approximately $2,148,000. In addition, Careside
has federal research and development credit carryforwards of approximately
$225,000. The net operating loss and credit carryforwards begin to expire in
2011 and are subject to review and possible adjustment by the Internal Revenue
Service. The Tax Reform Act of 1986 contains provisions that may limit the net
operating loss carryforwards available to be used in any given year in the
event of significant changes in ownership interest.
The approximate income tax effect of each type of temporary difference and
carryforward is as follows:
<TABLE>
<CAPTION>
December 31,
----------------------
1997 1998
---------- ----------
<S> <C> <C>
Net operating loss carryforwards........................ $ 233,188 $ 730,438
Research and development credit carryforwards........... 128,623 224,775
Capitalized research and development.................... 2,219,926 4,395,926
Start-up costs.......................................... 185,906 419,936
Nondeductible accruals.................................. 8,779 6,663
Nondeductible depreciation and amortization............. 53,765 178,623
Valuation allowance..................................... (2,830,187) (5,956,361)
---------- ----------
$ -- $ --
========== ==========
</TABLE>
Due to the uncertainty surrounding the realization of the deferred tax asset,
Careside has provided a full valuation allowance against this asset.
F-9
<PAGE>
5. COMMON STOCK PRIVATE PLACEMENTS:
In March 1997, Careside completed a private placement (the "1997 Private
Placement") of 1,923,090 shares of its Common stock at $5.20 per share. The
1997 Private Placement raised approximately $8,800,000, net of the placement
agent's commission and offering costs. In connection with the 1997 Private
Placement, the placement agent and its affiliates received warrants to purchase
384,615 shares of Careside's Common stock at $5.20 per share. These warrants
are currently exercisable and expire on the later of seven years from the date
of issuance or three years from the closing the Offering.
In June 1998, Careside completed a private placement (the "1998 Private
Placement") of 1,701,225 shares of its Common stock at $6.76 per share, which
generated net proceeds of approximately $10,200,000. In connection with the
1998 Private Placement, the placement agent and its affiliates received
warrants to purchase 340,237 shares of Careside's Common stock at $6.76 per
share. These warrants are currently exercisable and expire on the later of
seven years from the date of issuance or three years from the closing of the
Offering. In connection with providing financial consulting services for the
1998 Private Placement, Careside granted an option to purchase 1,154 shares of
Common stock at $.05 per share to an entity owned by a director of Careside.
6. TRANSACTIONS WITH SMITHKLINE:
On November 7, 1996, Careside and SmithKline entered into an Asset Purchase
Agreement (the "Agreement") under which Careside acquired certain assets and
intangible property related to SmithKline's POC business in exchange for a 5%
equity interest in Careside. In connection with the Agreement, SmithKline
loaned Careside $1,000,000, which was converted into an additional 2% equity
interest in Careside upon the closing of the 1997 Private Placement (see Note
5). The Agreement provided for certain antidilution protection, which required
Careside to issue additional shares of Common stock to SmithKline such that it
maintained its 7% ownership interest, until a defined equity financing was
completed. Upon the closing of the 1997 Private Placement, the antidilution
protection lapsed and SmithKline owned 195,192 shares, representing 5.8% of the
then outstanding Common stock. The tangible property received in connection
with the Agreement was as follows:
<TABLE>
<S> <C>
Cash........................................................... $ 52,736
Property and equipment......................................... 503,617
Deposit........................................................ 15,000
--------
$571,353
========
</TABLE>
In December 1998, Careside entered into an agreement with an affiliate of
SmithKline for up to $3,000,000 of bridge financing (see Note 7).
7. DEBT:
<TABLE>
<CAPTION>
December 31,
------------------
1997 1998
------- ----------
<S> <C> <C>
Note payable, interest at 8%, $1,500,000 due on January
31, 2000,
net of unamortized discount of $309,154................ $ -- $1,190,846
Equipment loan due to finance company, interest at 14%,
due in 47
remaining monthly installments of principal and
interest
of $26,836, with a final payment of $133,489 in
December 2002.......................................... -- 1,041,084
------- ----------
2,231,930
Less--Current portion................................... -- (186,998)
------- ----------
Long-term debt.......................................... $ -- $2,044,932
======= ==========
</TABLE>
In connection with the Agreement (see Note 6), Careside borrowed $1,000,000
from SmithKline. In connection with closing the 1997 Private Placement (see
Note 5), 129,555 shares of Common stock were issued to SmithKline upon the
conversion of the $1,000,000 note plus accrued interest of $27,985.
F-10
<PAGE>
In December 1996, Careside established a $1,000,000 line of credit facility
with a bank collateralized by a standby letter of credit guaranteed by Exigent
Partners, L.P. ("Exigent Partners"), whose partners are the founders of
Careside and an affiliate of the private placement agent. In consideration for
the establishment of the standby letter of credit, Exigent Partners was issued
557,601 shares of Common stock at $0.18 per share. The balance outstanding
under the line at December 31, 1996 was $400,000, with interest at 9.25% per
year. The line was repaid in connection with the 1997 Private Placement.
In December 1998, Careside entered into a $2,500,000 facility with an
equipment lease financing company. Borrowings under the facility will be
evidenced as separate loans and will be secured by specific equipment assets.
Each equipment loan will have a 48-month term and bears interest at
approximately 14% per year, adjusted for an index rate based on 48-month U.S.
Treasury Notes at the time of borrowing.
In December 1998, Careside entered into an agreement with an affiliate of
SmithKline for up to $3,000,000 of bridge financing, of which $1,500,000 was
drawn on December 28, 1998. The remaining $1,500,000 may be drawn, at
Careside's option, prior to January 31, 1999. The outstanding principal under
the bridge financing matures upon the earliest of the completion of the
Offering, a private equity financing of at least $8,000,000 or January 31,
2000. Careside issued a warrant (the "Bridge Warrant") in connection with the
bridge financing. The Bridge Warrant is exercisable into that number of shares
of Common stock which is equal to $750,000 divided by 85% of the Offering price
per share. The Bridge Warrant has an exercise price equal to 85% of the
Offering price. If the Offering does not occur, the Bridge Warrant is
exercisable into 103,022 shares of Common stock at an exercise price of $7.28
per share. If the outstanding principal under the bridge financing is not
repaid by June 30, 1999, the Bridge Warrant becomes exercisable for twice as
many shares of Common stock. The Bridge Warrant becomes exercisable on the
earlier of December 1999 or six months after the completion of the Offering and
expires on the earlier of December 2005 or four years after the completion of
the Offering. Using the Black-Scholes model, the estimated fair value of the
Bridge Warrant was calculated at $330,114 and was recorded as a reduction in
the carrying amount of the bridge note, with a corresponding increase in
stockholders' equity. The discount on the bridge note is being amortized over
the estimated term of the note as additional interest expense.
Future maturities of debt at December 31, 1998 are as follows:
<TABLE>
<S> <C>
1999......................................................... $ 186,998
2000......................................................... 1,715,141
2001......................................................... 247,520
2002......................................................... 391,425
----------
2,541,084
Less--Unamortized discount................................... (309,154)
----------
$2,231,930
==========
</TABLE>
Careside borrowed the remaining $1,500,000 under the Bridge Financing in
January 1999.
8. STOCK OPTIONS AND WARRANTS:
Stock Options
Careside has adopted the 1996 Incentive and Non-Qualified Stock Option Plan
and the 1996 Key Executive Stock Option Plan (together, the "Plans"), which
provide for the granting of options to purchase up to 576,923 shares of Common
stock to directors, officers, consultants and employees of Careside. The number
of options to be granted and the option prices are determined by the Board of
Directors in accordance with the terms of the Plans. Each option expires on
such date as the Board of Directors may determine.
F-11
<PAGE>
For purposes of SFAS No. 123 disclosure requirements, the fair value of each
option grant is estimated on the date of grant using the Black-Scholes option-
pricing model using the following assumptions for options granted during 1997
and 1998: weighted average risk-free interest rate of 6.41% and 5.56%; expected
weighted average life of 6.7 and 7.0 years; dividend yield of zero; and
volatility of zero. The weighted average fair value of each option granted
during 1997 and 1998 was $1.72 and $2.20, respectively. Had the compensation
cost of these options been recorded for the year ended December 31, 1997 and
1998, the Company's net loss would have increased by approximately $28,000 and
$316,000, respectively.
Information with respect to options under the Plans is as follows:
<TABLE>
<CAPTION>
Options Outstanding
------------------------------
Available Price Aggregate
for Grant Shares Per Share Price
--------- ------- ---------- ----------
<S> <C> <C> <C> <C>
Balance, inception (July
10, 1996)................ -- -- $ -- $ --
Authorized.............. 576,923 -- -- --
-------- ------- ---------- ----------
Balance, December 31,
1996..................... 576,923 -- -- --
Granted................. (317,163) 317,163 .05--7.44 1,741,122
-------- ------- ---------- ----------
Balance, December 31,
1997..................... 259,760 317,163 .05--7.44 1,741,122
Granted................. (111,950) 111,950 6.76--7.28 762,782
Cancelled............... 673 (673) 5.20 (3,500)
Exercised............... -- (17,715) 6.76 (119,753)
-------- ------- ---------- ----------
Balance, December 31,
1998..................... 148,483 410,725 .05--7.28 2,380,651
Granted................. (1,202) 1,202 8.00 9,616
Cancelled............... 339 (339) 6.76 (2,292)
-------- ------- ---------- ----------
Balance, March 31, 1999... 147,620 411,588 $.05--8.00 $2,387,975
======== ======= ========== ==========
</TABLE>
As of March 31, 1999, 198,343 options were exercisable at prices ranging from
$.05 to $7.28 per share, with a weighted average exercise price of $5.70 per
share. At March 31, 1999, the aggregate exercise price of these options was
$1,129,802.
Stock Warrants
The following table summarizes outstanding warrants at March 31, 1999:
<TABLE>
<CAPTION>
Type of Outstanding Exercise
Warrants Warrants Price Issuance Date
-------- ----------- -------- -------------
<S> <C> <C> <C>
Common stock 384,615 $5.20 February 1997
Common stock 340,237 $6.76 April 1998
-------
724,852
=======
</TABLE>
The warrants issued in March 1997 and June 1998 are currently exercisable and
expire on the later of seven years from the date of issuance or three years
from the closing of the Offering. In addition to the above warrants, the
Company issued a Bridge Warrant in connection with the issuance of debt (See
Note 7). The Bridge Warrant becomes exercisable on the earlier of December 1999
or six months after the completion of the Offering and expires on the earlier
of December 2005 or four years after the completion of the Offering.
F-12
<PAGE>
9. COMMITMENTS:
Leases
Careside leases an office and laboratory facility under a noncancelable
operating lease. Rent expense for the period from inception (July 10, 1996)
through December 31, 1996, the years ended 1997 and 1998, the three months
ended March 31, 1998 and 1999, the period from inception (July 10, 1996)
through December 31, 1998 and the period from inception (July 10, 1996) through
March 31, 1999 was $26,126, $156,756, $156,756, $39,189, $39,189, $339,638 and
$378,827, respectively. Future minimum rental payments under these leases at
December 31, 1998 are as follows:
<TABLE>
<S> <C>
1999............................................................ 167,440
2000............................................................ 177,040
2001............................................................ 152,200
--------
$496,680
========
</TABLE>
Collaborative Arrangements
Careside has utilized strategic partners with specific design expertise and
state-of-the-art technology in order to develop the Careside system rapidly and
on a cost-effective basis. Careside has agreements with (i) Fuji Photo Film
Co., Ltd. for the supply of its dry film based chemistry reagents,(ii)
International Technidyne Corporation for the joint development of coagulation
reagents, (iii) UMM Electronics, Inc. to design and manufacture the CareSide
Analyzer and (iv) Advanced Medical Information Technologies, Inc. to develop
software to link the Careside system and other medical devices, including the
hematology device. In addition, Careside contracted with Hauser, Inc. for the
design of the Careside system and with Battelle Memorial Institute for the
design of the system's disposable test cartridges and their automated assembly
manufacturing system. Careside's agreements with its strategic partners do not
obligate Careside to any minimum purchase commitments.
Employment Agreements
Careside has entered into three-year renewable employment agreements with
three of its executive officers that provide for aggregate annual compensation
of approximately $539,000.
10.RETIREMENT PLAN:
Careside maintains a 401(k) profit sharing plan on behalf of its employees.
Participation in the plan is voluntary and eligible employees, as defined, may
contribute up to 15% of their compensation to the plan. Careside matches 50% of
the employee's contribution up to 4% of an employee's compensation. Careside's
contributions were zero, $32,315, $34,657, $9,490, $13,849, $66,972 and $80,821
for the period from inception (July 10, 1996) through December 31, 1996, the
years ended 1997 and 1998, the three months ended March 31, 1998 and 1999, the
period from inception (July 10, 1996) through December 31, 1998 and the period
from inception (July 10, 1996) through March 31, 1999, respectively.
F-13
<PAGE>
REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS
To Careside, Inc:
We have audited the accompanying statement of operations for the ten months
ended October 31, 1996 of the Predecessor Business (see Note 1). This financial
statement is the responsibility of the Company's management. Our responsibility
is to express an opinion on this financial statement based on our audit.
We conducted our audit in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of
material misstatement. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audit provides a reasonable basis
for our opinion.
The statement of operations has been prepared for the purpose of complying
with the rules and regulations of the Securities and Exchange Commission (for
inclusion in the Form S-1 filing of Careside, Inc.) as described in Note 1 and
is not intended to be a complete presentation of the financial results of the
Predecessor Business.
In our opinion, the statement of operations referred to above presents
fairly, in all material respects, the results of operations of the Predecessor
Business for the ten months ended October 31, 1996, in conformity with
generally accepted accounting principles.
ARTHUR ANDERSEN LLP
Philadelphia, Pa.,
October 16, 1998
F-14
<PAGE>
PREDECESSOR BUSINESS (NOTE 1)
STATEMENT OF OPERATIONS
<TABLE>
<CAPTION>
Ten Months
Ended
October 31,
1996
-----------
<S> <C>
OPERATING EXPENSES:
Research and development........................................ $ 3,054,503
General and administrative...................................... 224,399
-----------
NET LOSS.......................................................... $(3,278,902)
===========
</TABLE>
The accompanying notes are an integral part of this statement.
F-15
<PAGE>
PREDECESSOR BUSINESS
NOTES TO STATEMENT OF OPERATIONS
1. BASIS OF PRESENTATION:
Careside, Inc. was incorporated in Delaware on July 12, 1996, and had no
operations until the purchase of certain assets from SmithKline Beecham
Corporation ("SmithKline") on November 7, 1996. The assets were acquired in
exchange for an equity interest in Careside. The assets acquired are referred
to as the "Predecessor Business." In connection with Careside's initial public
offering as contemplated in this Prospectus, the accompanying financial
statement has been prepared to comply with the rules and regulations of the
Securities and Exchange Commission.
The statement of operations represents the research and development and
related general and administrative expenses incurred by the Predecessor
Business in connection with the technology and know-how acquired by Careside.
The development of the technology related to the Predecessor Business commenced
in 1994.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
Use of Estimates
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make 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 expenses during the reporting period. Actual results
could differ from those estimates.
Research and Development
Research and development costs are charged to expense as incurred.
Transactions with SmithKline
For the ten months ended October 31, 1996, SmithKline allocated corporate
overhead to the Predecessor Business of $55,118 for employee benefits and other
corporate services. These allocations were based on actual payroll expense
incurred by the Predecessor Business and the estimated cost of services
provided by SmithKline. Management believes the method of allocation of such
expenses is reasonable and that the Predecessor Business would not have
incurred any other material costs if it had operated on a stand alone basis. In
addition, SmithKline funded approximately $7,450,000 of operating losses and
capital expenditures since the commencement of the Predecessor Business for
which no interest charge has been reflected in the statement of operations.
Cash Flow Information
For the ten months ended October 31, 1996, cash used in operations was
$3,233,423 and purchases of property and equipment were $242,507.
F-16
<PAGE>
[Inside Back Cover]
ROUTINE BLOOD ANALYSIS PROCEDURE
<TABLE>
<CAPTION>
THE TRADITIONAL WAY [Careside Logo] THE CARESIDE SOLUTION
<S> <C> <C> <C> <C>
[Drawings of At hospital or 1. [Photos of Draw blood. Place a
Traditional 1 commercial lab, Cartridge and Blood few drops of whole
Blood Testing caregiver or Test] blood into the
Procedures] phlebotomist draws blood cartridge sample well.
sample.
Technicians properly
2 package and store blood
sample for transport.
Hospitals hand-carry 2. [Photos of Using the touch-screen
multiple samples to the CareSide Analyzer or keyboard, input
3 clinical lab. Commercial and Test Menu] demographic
laboratories receive information and select
samples via ground tests to be performed.
and/or air courier. Insert appropriate
cartridges and press
start.
4 Lab technicians receive
and log the samples.
5 Samples are then 3. [Photos of Test 10 to 15 minutes
separated for different Results and Test later, CareSide
testing stations. Analysis] Analyzer(TM) provides
test results via print
card, screen and/or
electronic data
transfer. Caregiver
can immediately review
data with patient.
Technicians centrifuge
6 the samples to separate
whole blood into serum
and plasma.
Skilled technologists
7 prepare various large,
high-volume analyzers
for batch processing and
run the tests.
Skilled technologists CareSide Analyzer(TM): 10 to 15 Minutes
8 review results to assure
that they pass quality Hospital lab: Typically 4 to 6 Hours
control checks.
Commercial lab: Typically 24 Hours
Data is transferred to
9 laboratory information
systems and into QA/QC
records.
10 Data is disseminated to
the caregivers.
Caregiver reviews the
11 data and reconciles it
with patient charts.
Caregiver calls patient
12 to report results and to
order additional therapy
or schedule follow-up
visit if required.
</TABLE>
<PAGE>
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We have not authorized any dealer, salesperson or other person to give any
information or represent anything not contained in this prospectus. You must
not rely on any unauthorized information. This prospectus does not offer to
sell or buy any units in any jurisdiction where it is unlawful. The
information in this prospectus is current as of June 16, 1999.
----------------
TABLE OF CONTENTS
<TABLE>
<CAPTION>
Page
----
<S> <C>
Prospectus Summary....................................................... 3
Risk Factors............................................................. 7
Special Note Regarding Forward-Looking Statements........................ 14
Use of Proceeds.......................................................... 15
Dividend Policy.......................................................... 15
Capitalization........................................................... 16
Dilution................................................................. 17
Selected Financial Data.................................................. 18
Management's Discussion and Analysis of Financial Condition and Results
of Operations........................................................... 19
Business................................................................. 24
Management............................................................... 44
Principal Stockholders................................................... 52
Certain Transactions..................................................... 53
Description of Capital Stock............................................. 56
Shares Eligible for Future Sale.......................................... 63
Underwriting............................................................. 65
Legal Matters............................................................ 67
Experts.................................................................. 68
Where You Can Get More Information....................................... 68
Index to Financial Statements............................................ F-1
</TABLE>
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Until July 11, 1999 (25 days after the date of this prospectus), all dealers
that buy, sell or trade these securities, whether or not participating in this
offering, may be required to deliver a prospectus. This is in addition to the
dealers' obligation to deliver a prospectus when acting as underwriters and
with respect to their unsold allotments or subscriptions.
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[LOGO OF CARESIDE]
2,000,000 Units
Each Unit Consists of One Share of Common Stock and One Redeemable Common
Stock Purchase Warrant
----------------
PROSPECTUS
----------------
Paulson Investment Company, Inc.
Millennium Financial Group, Inc.
marion bass securities corporation
June 16, 1999
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