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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 10-K/A
Amendment No. 2
[X]ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the fiscal year ended: December 31, 2000
Commission file number: 001-15051
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Careside, Inc.
(Exact name of registrant as specified in its charter)
Delaware 23-2863507
(State or other jurisdiction of (IRS Employer Identification No.)
incorporation or organization)
6100 Bristol Parkway, Culver City, CA 90230
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (310) 338-6767
Securities registered pursuant to Section 12(b) of the Act:
Common Stock, par value $.01 per share
And
Redeemable Common Stock Purchase Warrants
(Title of Class)
Securities registered pursuant to Section 12(g) of the Act:
None
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Indicate by check mark whether the Registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days. YES [X] No [_]
Indicate by check mark if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K is not contained herein and will not be contained, to
the best of registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K/A or any
amendment to this Form 10-K/A. [_]
On March 19, 2001, the aggregate market value of the Registrant's Common
Equity, par value $.01 per share, held by non-affiliates of the Registrant was
approximately $17 million, based upon the closing sale price reported for such
date on the American Stock Exchange. For purposes of this disclosure, shares
of Common Stock held by persons who hold more than 5% of the outstanding
shares of Common Stock and shares held by officers and directors of the
registrant have been excluded because such persons may be deemed to be
affiliates. This determination of affiliate status is not necessarily
conclusive for other purposes.
On March 19, 2001, 11,262,352 shares of the Registrant's Common Stock, par
value $.01 per share, were outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Registrant's Proxy Statement to be filed with the
Commission in connection with the Annual Meeting of Shareholders scheduled to
be held on May 24, 2001 are incorporated by reference into Part III of this
Form 10-K/A.
EXPLANATORY NOTE
This Form 10-K/A (Amendment No. 1) is being filed to amend Items 1, 8, 13
and 14 of the Annual Report on Form 10-K for the fiscal year ended December
31, 2000 (the "Original Form 10-K") which was filed on March 29, 2001.
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PART I
The Company's forward-looking statements in this Annual Report on Form 10-
K/A and those that may be made in the future by or on behalf of Careside,
Inc., including statements about the market and opportunity for the Company's
products, revenue growth and profitability potential, regulatory approvals,
competition, the ability to control expenses and international expansion, are
based on assumptions about many important factors. Several important factors
may cause the Company's actual results to differ materially from those
contemplated by these forward-looking statements. These factors include the
Company's limited operating history, and lack of profitability, its need for
additional financing, the acceptance of the Company's products by the medical
community, product development risks, the level of third party reimbursement
for medical tests, reliance on third party manufacturers, suppliers and
distributors, retention of key personnel, competitive risks, protection of the
Company's proprietary technology, and government regulation.
ITEM 1. BUSINESS
We have developed and 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 hematology tests. We plan to offer
immunochemistry tests for the Careside system later in 2001. Tests in these
five different test categories 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 five 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, the H-2000 and the Careside Connect. The Careside Analyzer 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
H-2000 is our hematology testing device. The Careside Connect is a data
interface, which will link the Analyzer with the H-2000 and any other testing
device. It also enables the electronic transmission of blood test results to
our customers' information systems. We released the Careside Connect for sale
in 2000.
The FDA has granted pre-market clearance for the Careside Analyzer and the
H-2000, and pre-market clearance or exemption for 41 blood tests performed by
the Analyzer and a 18-parameter hematology test for the H-2000, including
tests for professional laboratory use. We have received FDA approval for
point-of-care testing for the Careside Analyzer, thereby enabling non-
technical personnel with appropriate training to use it. Similar approvals
will be sought for the H-2000 in 2001.
Our concept and technology originated with SmithKline Beecham Clinical
Laboratories, Inc. (SBCL). In 1993, SBCL conducted extensive surveys of the
point-of-care market. As a result, in 1994, SBCL started our predecessor
business to develop the technology we use today. In November 1996, we acquired
the assets and contracts used in the predecessor business, including
intellectual property, equipment and other assets, 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 SBCL, including W. Vickery Stoughton, our Chief Executive Officer,
and Thomas H. Grove, Executive Vice President--Chief Technology Officer. Quest
Diagnostics Incorporated later acquired SBCL.
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
1
rhealthcare costs for physicians, providers and payers. 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,
reducing reliance on centralized testing services.
Careside's Technology and Products
We designed the Careside system as a platform for solving the limitations
of central blood testing laboratories and a means for healthcare providers not
currently conducting blood tests to start providing this service. The
advantages of our system can be summarized as follows:
. Cost-Effective Results--The Careside system is designed to provide test
results that are cost competitive with commercial laboratories.
. Rapid Test Results--The Careside system furnishes test results within
10-15 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 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 offers a broad menu of the
most commonly ordered blood tests, including critical care tests. The
Careside system is designed to perform hematology, chemistry,
electrochemistry, coagulation and immunochemistry tests. Our Careside
system has clearance or approval for 59 tests, including 18 hematology
tests. This, we believe, substantially exceeds the capabilities of any
point-of-care system currently on the market.
. 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 or with the
reagents in the H-2000. Data transfer is easily accomplished using the
Careside Connect product to connect data into local area networks or
through the Internet.
. 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 state-of-
the-art technology in larger testing devices utilized by centralized
laboratories.
. Embedded Quality Assurance and Quality Control--The Careside Analyzer
and the H-2000 have 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 telephone calls, and improve patient satisfaction and quality of
care. Healthcare providers can also increase their revenue by performing
and billing for tests themselves. Currently it is the laboratory, not
the physician, which gets paid for performing blood tests.
The disadvantages of our system stem from the fact that it is a new way of
providing laboratory testing services, so we cannot predict with certainty how
fast or whether the market will adopt it. As with any new technology, it
involves an expenditure of cash and some learning time by physicians and other
healthcare providers. Our system does not perform all in vitro tests. More
complex tests that are not supported by our decentralized testing system, such
as microbiology, genetic and other less common tests will still be referred to
commercial laboratories or to a core laboratory supporting multiple hospitals.
Centralized laboratories that continue to provide such complex testing should,
with routine tests handled elsewhere, be able to streamline procedures. We
think this will 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.
2
Product Development and Regulatory Status
Technology
Product Regulatory/Development Status Partner/Supplier
------- ----------------------------- ----------------
Careside Analyzer Cleared under Section 510(k) of the Food, Drug UMM Electronics, Inc.
and Cosmetic Act for use in licensed
laboratories and for Point-of Care (POC). The
Analyzer is offered for sale to customers.
Disposable Test Cartridges Chemistry, electrochemistry and coagulation Battelle
cartridges have been developed an are offered
for sale to customers. The immunochemistry test
cartridge is in development.
Cleared/Exempt for Planned 2001-2
Test Category Laboratory and POC Use Submissions
------------- ---------------------- --------------
Chemistry Glucose Lactate Fuji Photo Film Co., Ltd.
BUN (Urea Nitrogen) Direct LDL-cholesterol
Creatinine Direct HDL-cholesterol
BUN/Creatinine Ratio
Albumin
A/G Ratio (calc.)
Globulin (calc.)
Creatine Kinase
Creatine Kinase MB
% CKMB (calc.)
Total Cholesterol
HDL-Cholesterol*
LDL-Cholesterol (calc.)
Cholesterol/HDL Chol
Ratio
GGT
ALT
Cholinesterase*
Total Bilirubin
Phosphorus
Total Protein
Total Calcium
Uric Acid
Triglycerides
LDH
Bilirubin, Direct
Bilirubin, Indirect
(calc.)
Ammonia*
Carbon Dioxide, Total
Anion Gap (CO2+Echem)
Magnesium
Osmolality
Hemoglobin*
Hematocrit (calc.)
Alkaline Phosphatase
AST
ALT/AST Ratio
Amylase
Electrochemistry Chloride Ionized Calcium Fuji Photo Film Co., Ltd.
Potassium
Sodium
Coagulation PT* APTT Third Party Suppliers.
Fibrinogen
Thrombin Time
Immunochemistry Theophylline Third Party Suppliers.
Phenytoin
Digoxin
Phenobarbital
T4
T3 Uptake
Carbamazepine
-------
* Requires separate clearance or exemption for point-of-care.
3
Product Development and Regulatory Status
Technology
Hematology Status of Development Partner/Supplier
---------- --------------------- ----------------
Careside H-2000 FDA Cleared; offered for sale to customers Third Party Manufacturer
18 parameter, 3 part
differential
Hematology Tests
WBC All hematology tests have been FDA Aqua Solutions
RBC cleared under Section 510(k)
Platelet count
Lymphocyte
% Lymphocyte
Monocyte
% Monocyte
Granulocytes
% Granulocytes
Hematocrit
Hemoglobin
MCV
MCH
MCHC
RDW
MPV
PCT**
PDW**
--------
** For diagnostic use outside U.S., for quality control use within U.S.
Communication Product Status of Development Technology Partner
--------------------- --------------------- ------------------
Careside Connect Offered for sale to customers Third Party Manufacturer
provides an electronic
link between the
Careside Analyzer and
the Careside H-2000
testing device
The Careside System
The Careside system currently consists of two desktop testing instruments,
called the Careside Analyzer and the Careside H-2000, and patented disposable
test cartridges. The Careside Analyzer combines chemistry, electrochemistry,
coagulation and, in the future, immunochemistry testing in a single testing
instrument. Careside's H-2000 is a hematology testing device. We are not aware
of any point-of-care blood testing system on the market that has this combined
capability. We have also developed a data interface, called the Careside
Connect, which allows the electronic transmission of blood test results in a
standard data format.
The Careside Analyzer
The Careside Analyzer is approximately 14 inches tall by 12 inches wide and
11 inches deep and weighs about 24 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.
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-
4
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 and coagulation 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 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. The
Careside system is currently capable of conducting a maximum of eight tests
per patient 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.
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 as 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. Our data interface, called
the Careside Connect, allows the electronic transmission of blood test results
in a standard data format.
The Analyzer's Disposable Test Cartridges
Each test cartridge is designed to perform one test and may only be used
once. 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. 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 9 to 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
necessary, the
5
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. 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. 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 the colors of the reagent. Multiple reflectance measurements
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.
Electrochemistry Tests. Like chemistry tests, electrochemistry tests 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, which in this case is
whole blood, 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 an 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.
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. Generally, they are difficult to use, involve expense
instrumentation and costly reagents and have long assay times. We are in the
process of developing an immunochemistry test cartridge.
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 Analyzer and
on the test cartridge, generating a 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:
. Unique Cartridge Design. Specimen preparation, calibration and test
performance are incorporated in an inexpensive plastic cartridge. Where
necessary, the cartridge stores and measures 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.
6
. Ease of Sampling. Sampling is automatic and requires small volumes using
approximately 75 to 150 microliters (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 or 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 identify the type of
test contained in 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 is 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.
The H-2000 Hematology Testing Device
Hematology testing determines various attributes of a patient's blood, such
as how many platelets, monocytes or lymphocytes it has. In December 1999, we
acquired Texas International Laboratories (TIL) in an all-stock acquisition.
TIL had developed a new hematology analyzer, the Hematil-2000 which it
introduced in April 1999 as a high quality, low cost hematology analyzer that
was designed for both human and animal testing. When we acquired TIL, we
renamed the device the H-2000. Its hematology tests are equally applicable in
the veterinary and human markets.
The H-2000 weighs 37 lbs. and measures only slightly larger than a cubic
foot. It can provide 18 hematology diagnostic tests in approximately 2 minutes
from the time whole blood is drawn from a patient. The H-2000 uses fluid
reagents that can be purchased from us or other manufacturers. The
architecture is an open system that allows the H-2000 to operate with a number
of different reagent brands, giving it a high level of flexibility. The H-2000
is automatic and self-cleaning. It is designed to flag suspected abnormalities
in various cell populations.
The H-2000 is easy to operate. A few drops of blood are drawn into the H-
2000 through an aperture from either a normal test tube or a capillary tube
used in a finger prick. The blood is automatically distributed into counting
chambers. Reagents are mixed or used in counting chambers in combination with
both optical and electronic counting methods which perform up to four cross-
referenced measurements per sample, thereby ensuring accurate counts. The
reagents and cleaning fluids are flushed into a disposal bottle for standard
blood sample disposal.
The Careside Connect
We have partnered with Advanced Medical Information Technologies, Inc.,
also known as AdMIT, to develop a link between the Careside Analyzer and the
H-2000 and between the Careside system and other medical devices and
information systems. This cabled interface will enable users of the Careside
Analyzer to connect hematology devices (including the H-2000) 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. AdMIT is controlled by our Chief Information Officer, Dennis
Reiger. We will have exclusive rights to use the Careside Connect in the
point-of-care market for laboratory testing services.
7
In addition to linking the Careside Analyzer and the H-2000 or other
diagnostic testing devices, Careside Connect can 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.
The Laboratory Testing Market
General
The annual U.S. market for laboratory testing services is about $30 to $35
billion according to industry research. Clinical Laboratory Improvement
Amendments (CLIA) data and Washington G-2 reports, show that hospitals do 60-
65% of this testing, physician offices 7-8% and independent commercial labs
25-30%. The lab services market can be divided into three primary segments:
routine clinical testing (blood or urine testing), anatomic pathology (tissue)
and complex testing (DNA and genetic testing). All three comprise in vitro
testing, which means the testing is done on a sample outside the body. In vivo
testing is done in the body. Annual expenditures for routine in vitro testing
are over $25 billion in the U.S. and it is this segment that is served by the
Careside system. Routine in vitro tests are semi-automated on our system and
can be conducted by non-technical personnel. Therefore, our market opportunity
is virtually wherever blood is drawn from patients for standardized blood
tests. Based on industry data and estimates, we believe the worldwide market
for our blood tests is expected to be over $7 billion.
Most routine blood tests are sent to a central location, either a
commercial or hospital laboratory, for processing. Commercial laboratories
provide approximately 27% of all in vitro diagnostic testing services,
hospital laboratories provide approximately 63%, and the balance, about 10%,
is currently provided in physicians' offices.
Commercial Laboratories. Commercial laboratories have been the low cost
provider of in vitro 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.
Hospital Laboratories. 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.
8
Physicians' Offices. 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's Impact on Blood Testing
Managed care has put substantial pressure on healthcare providers to reduce
costs and to treat patients using clinical treatment protocols 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. On
the one hand, these pressures should increase testing volume. On the other
hand, managed care providers and other payers are becoming more stringent by
only reimbursing tests for which there is a clear medical need. Medicare and
other third party insurance reimbursement for diagnostic tests flow directly
to the laboratories performing the testing, not the healthcare professional
ordering the test, but the laboratories are responding with making only single
analyte and approved panel testing available to providers. 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 have decreased, requiring the healthcare provider
and the testing laboratory to be even more cost-effective. Designed with these
phenomena in mind, the Careside system performs single reagent testing and
offers packages of tests that are based on third-party payer approved panels.
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 enables 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 from use of our system.
Even with the focus on managed care, a very significant portion
(approximately 70%) of all testing is reimbursed on a fee for service basis.
Industry experts expect this number to increase further as commercial
laboratories renew managed care contracts. Previously, managed care companies
pushed for capitated testing services. Many commercial labs lost money on
these contracts, and, as the contracts come up for renewal, will push to
convert them to fee for service contracts, pay higher capitation amounts or
not renew them. We expect these factors to contribute significantly to making
the Careside system a desired alternative to central lab testing.
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.
Our key targeted market segments are as follows:
Physicians and Physician Groups. There are over 400,000 physicians and more
than 27,000 physician groups in the United States. 21,000 of these groups have
three to ten doctors and over 3,500 have more than 35 physicians. 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
9
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.
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.
Nursing Homes. There are approximately 15,000 nursing homes in the United
States comprising more than 1.6 million licensed beds. Occupancy rates average
over 90%. 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.
Home Care. In the 1990s, the number of home care agencies nearly doubled
and home care visits increased dramatically to over 300 million annually.
Industry experts expect the increase to continue. On average, 30% of home care
patients visited each week require laboratory testing. There are currently
over 20,000 home care agencies in the United States, with approximately 9,600
Medicare certified. Common laboratory tests ordered for home care 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. Home care agencies
would benefit from increased revenue opportunities and client service by using
the Careside system to conduct blood testing in their base offices.
Other Market Opportunities. Field military hospitals, ships, employee
health clinics, drop-in clinics, surgi-centers, dialysis units and other
alternate sites where blood is drawn and routine tests are ordered are all
potential customer opportunities for Careside.
Sales Strategy
Domestic
Careside has hired a small sales force to launch and train customers on its
products in the United States. We will supplement our domestic sales force
with distributors. Our sales force is compensated on a base plus commission
basis. The commission increases with volume sold. We sell to distributors at a
discounted purchase price. In 2001, we expect to have distribution partners in
the United States and in more than fifteen international countries for
distribution of the Careside system.
10
In the U.S., our focus is on selling decentralized lab operations and not
just testing devices. The Clinical Laboratory Improvement Amendments (CLIA)
require all providers who provide testing services to demonstrate quality
control (QC) and quality assurance (QA) processes that are standard to the
industry. Prior to CLIA, only commercial and hospital labs had demonstrated
these standards. CLIA added both cost and administrative difficulty to those
labs that did not meet these operating requirements. Our products are easy to
use and address the regulatory issues required by CLIA. They also greatly
lower the cost of QA/QC processes by automatically providing documentation
required by CLIA. We are selling a lab that can be operated at the point of
care and our sales force has been trained to prepare our customers to operate
a lab using our products. This means calibration of each test at the customer
site, initial documentation for QA/QC data files, and other preparation work
that is related to lab operations. We have trained our sales force with the
knowledge needed to sell and install cost-effective lab systems in our
customer sites. These sites include hospitals, large physician group
practices, managed care organizations, home care agencies and nursing homes,
either directly or through institutional pharmaceutical service organizations
which serve them.
We focused our domestic sales strategy at the end of 2000 on sales of
Analyzers and H-2000s in the human blood testing market. This represents a
shift away from international and veterinary sales for the H-2000.
International
International markets are not affected by the same regulatory requirements
as in the U.S. market. Because we have received FDA clearance and UL
certification for the Careside Analyzer, the Careside system is ready to be
sold in almost all international markets once the appropriate documentation
has been made available to country authorities. We are in discussions with
potential distributors for a number of foreign territories. Our strategy is to
pick distributors that are selling products into the health care market, but
not competitive products. Further, we are in discussions with country specific
distributors as opposed to distributors that are more international. Fuji
Photo Film Co., Ltd. has a right of first refusal to be our Analyzer
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.
Discussions are currently underway for distribution agreements in certain
European countries and in the Middle East and South Africa. In addition, the
acquisition of TIL has brought distribution opportunities with companies in
China, Mexico, Turkey, and certain South America countries. We are analyzing
the possibility of adding the entire Careside system to these distribution
agreements.
Distribution Partners
We supplement our own sales force with distribution agreements. In 2000, we
had sales through distributors in three different countries. All distributor
sales were on a discounted purchase price basis with no price protections or
rights of return. Each of our distributors can sell only in its own country
and is responsible for compliance with all local or import regulations. These
distributors are also responsible for customer support.
In 1997, we entered into a distribution arrangement with Smith Kline
Beecham Clinical Laboratories, Inc. (SBCL) which gave SBCL an exclusive right
to use and domestically distribute the Careside Analyzer within the commercial
laboratory industry and the non-exclusive rights to sell the Careside Analyzer
to hospitals and healthcare systems, other health care providers, managed care
organizations and insurers. In June 2000, after Quest Diagnostics, Inc.
purchased SBCL, Quest terminated this agreement.
Except for Fuji's right to distribute Analyzers in Japan on an exclusive
basis, none of our distribution agreements represents an exclusive arrangement
and all are terminable by us or the distributor upon giving appropriate
notice. The cancellation or termination of any one distribution agreement
would not be material to our future operations because we could use other
distributors in each of the countries where we currently use distributors.
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Sales
Careside Analyzers
In December 1999 through the beginning of 2000, we initiated a number of
Analyzer installations in pilot sites. These pilots involved assessing both
the economic opportunity provided to the customer from the use of the Careside
system, refining an instruction manual which is intended to provide customers
with the information they need to operate a lab using the Careside system,
reviewing user interface software and making changes, and working out bugs.
Careside also used this time to improve mechanical components and
manufacturing processes. One pilot was started at a small group practice that
had never run a lab. Another was with a larger group that has been operating a
lab prior to becoming a pilot site. Other pilots were initiated in a hospital
emergency room and in larger health care systems.
Careside sold four Analyzers during the first nine months of 2000. During
the second quarter of 2000, Careside was experiencing issues in both the
software and hardware of the Careside Analyzer that made it question the
reliability of the device in the field. It also experienced technical problems
with electrochemistry tests. As a result, Careside pulled back from the market
and corrected the issues that gave rise to the reliability concerns. Careside
did not lose any customers and it did not have to repurchase any devices as a
result of these technical difficulties. Rather, it worked with the customers
to ensure the reliability of the test results each customer received from its
Analyzer. We completed the revisions to the electrochemistry tests and
modifications to the Analyzer by November 2000. Devices in inventory were
corrected before being sold, placed in the field or becoming demonstration
units. As a result of these events, our backlog of Analyzer orders was
immaterial. After the re-launch of the Analyzer, three additional units were
sold in 2000.
H-2000s
We acquired the H-2000 from Texas International Laboratories, Inc. in
December 1999. In 2000, all of our H-2000 sales were into the veterinary
market. Approximately, 81% of these sales were sales into foreign countries.
64% of our international sales were to distributors in China. We do not expect
our H-2000 sales into the veterinary market to continue at the same levels due
to our 2001 focus on the human market. By focusing on the human market, we
expect our sales efforts for Analyzers to benefit our H-2000 sales as well,
because each device will be marketable to the same customers. The backlog of
our H-2000 sales was not material. It was also not material at the end of
1999.
Careside Connect
We had no sales of the Careside Connect in 2000 as it was under development
until early 2001.
Significant Customers
In 2000, the Company had sales to three customers that were individually
greater than 10 percent of net sales. Combined, these three customers amounted
to 38 percent of net sales and 25 percent of accounts receivable at December
31, 2000. The loss of any one of our customers would not be material to our
results of operations. We expect our future revenues to be derived
predominantly from the sale of Analyzers and cartridges in the U.S. markets.
Research and Development
In addition to our own research and development employees, we have entered
into a series of research and development agreements with third parties
relating to the Analyzer and its disposable test cartridges. 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.
12
We continue to pursue development work with other contract partners,
including further development of cartridge design with Battelle, coagulation
reagent technology with International Technidyne Corporation and software
development services of AdMIT for interfaces between the Careside Analyzer and
other medical devices and information systems.
Each of our ongoing development agreements provides for payment to our
development partners at market or below market rates. Each is terminable upon
notice to the other party and in the event of breach. We are not aware of any
intention of any of our contract partners to terminate their agreements with
us. In each case, we believe the cancellation of any one of our development
agreements would not be material to us.
Manufacturing and Supply
Analyzers
We have entered into an agreement with UMM Electronics, Inc. for the
manufacture of the Careside Analyzer at UMM Electronics' facility in
Indianapolis. The contract with UMM covers both development services and
manufacturing after development is completed. The development services
component of our UMM contract is almost complete. To date, UMM has
manufactured all of our Analyzers pursuant to this contract. The agreement
provides for pricing to be renegotiated annually, has a term of four years
from market introduction and is terminable by either party upon one year's
notice. We own or have the perpetual right to use all intellectual property
necessary to manufacture Analyzers in the event of termination of the UMM
contract.
Our inventories of Analyzers was sufficient in 2000 for internal validation
and sales to customers. In 2001, as sales are expected to increase, we expect
to start using software to track ordering and utilization patterns for
Analyzers and cartridges which will assist us in determining proper inventory
levels. Pending the data gathering, we are inventorying those Analyzers and
cartridges and components used to make cartridges which our management
estimates, based on their knowledge of the healthcare field, will be ordered
by providers.
Cartridges
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 has designed. 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 is subject to periodic FDA inspection
to determine whether our manufacturing processes comply with federal GMP
regulations for medical devices.
We assemble and package at our Culver City facility all cartridges used by
the Analyzer. 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 have purchased the equipment necessary for
this process. 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 has assisted 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 is 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 utilizes
proprietary process technology, designed by Battelle and owned by us, that is
scalable to meet increasing demand.
13
We outsource the manufacturing of the plastic components of our cartridges.
We use a third party to manufacture these components using injection molding
processes.
We have 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 30 chemistry tests. We have agreed to purchase our dry
chemistry reagents exclusively from Fuji. Fuji is also developing 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.
We purchase other chemistry, electrochemistry, coagulation and
immunochemistry reagents from International Technidyne Corporation and
Diagnostic Reagents, Inc. We pay for these on a per order basis in accordance
with pricing which is periodically revised by the supplier.
Providers will order test cartridges based on the tests they expect to
require for patient care. This will vary with the type of provider. At
present, we maintain inventories based on management's estimate of the tests
that providers will order. In 2001, we expect to start using software which
will capture provider's utilization patterns by type of provider. With this
data, we expect to be able to refine the level of inventories which we will
need to maintain.
H-2000s
Our hematology testing device, the H-2000, is manufactured by Ysebaert
pursuant to a contract which we assumed when we acquired Texas International
Laboratories, Inc. Typical of many contracts with European manufacturers, this
contract does not contain material terms other than pricing. We believe the
pricing available to us from Ysebaert to be competitive. Pricing is
periodically renegotiated with Ysebaert. We own or have the right to use all
intellectual property rights necessary to manufacture the H-2000 in the event
the Ysebaert contract is terminated.
The reagent solutions used with the H-2000 are currently supplied to us by
Aqua Solutions, Inc. We do not have commitments to purchase any minimum
quantities of solutions from them. Rather, we submit purchase orders on an as
needed basis.
We keep inventories of H-2000's and reagent solutions to support our sales
in hematology testing. Our inventories are maintained at levels which are
determined by our experience. In 2001, we expect to start using software which
captures data about order and utilization patterns among our hematology
customers. This data will help us to determine the inventory levels which we
will need to keep in the future.
Careside Connect
The Connect is a cabled interface that does not require any significant
manufacturing components as it is primarily software that interfaces between
the Analyzer and H-2000 or either of those devices and providers information
systems.
Competition
We 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
14
is not designed to provide the same range of tests, we believe that our
products 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.
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 and 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. 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 our system offers 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 which we
expect will be added later to our test menu.
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 products. To date,
we have filed nine patent applications on various components of
our technology with the U.S. Patent and Trademark Office. We have also sought
international patent protection with respect to certain of these U.S. patents
and patent applications. One patent was filed with International Technidyne
Corp. and covers a coagulation reagent that was discovered jointly. The other
eight patents cover the technology that is built into the Careside Analyzer
and the test cartridges. To date we have been issued three U.S. patents. These
patents as well as those still pending form a very strong portfolio that
protects our development investment. One patent issued covers our invention of
the spectrophotometric analytical cartridge, which allows our product to
perform light transmission based tests, such as coagulation and
immunochemistry in the Careside Analyzer. Another patent covers the
fundamental analytical reagent cartridge invention that underlies all of our
cartridge technology. A third patent covers our electrochemistry cartridge.
Four of the patent applications cover inventions that are components of the
Careside Analyzer, and one covers an additional discovery in another type of
cartridge.
Our agreements with UMM, 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.
15
In addition to patent protection, if any, we will rely upon trade secrets,
know-how and continuing technological innovation. All of our employees are
bound by confidentiality/non-disclosure policies or agreements. We have also
protected our name by trademarking "Careside" and the name "Careside
Analyzer."
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. FDA clearance must be obtained before making certain types of
product changes. The Careside Analyzer and tests have received marketing
clearance for point-of-care and physician office laboratory use.
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 41 tests, along with the 18-parameter
hematology test performed by the Careside H-2000, are already cleared or
exempt by the FDA have been classified in Class II. Certain future tests, such
as prostate specific antigen, are expected to require pre-market approval.
Only the H-2000 is used for in vitro animal testing. We are not required to be
licensed as a veterinarian and are not subjected to any additional regulation
by reason of our veterinary sales.
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.
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 and is registered with the FDA. The manufacture of
16
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 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. The H-2000 is being manufactured for Careside by Ysebaert in
France though Careside is the designated manufacturer under FDA regulation.
The Ysebaert facility is ISO 9002 certified.
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, in 2000, we obtained an Underwriters
Laboratories, or UL, listing for the instrument Careside Analyzer. UL has
reviewed 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).
The H-2000 is in the process of UL review. We expect to receive UL
certification for the H-2000 during 2001.
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 1988. 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.
Both the Careside Analyzer and the H-2000 were categorized as test systems of
moderate complexity. 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 are 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 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.
17
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
results 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 have purchased product liability
insurance in reasonable and customary amounts. 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 believe that our insurance coverage is 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
We had 64 employees as of December 31, 2000. Since our initial public
offering in June 1999, a number of senior managers have been added with
expertise in marketing and sales, information resources, materials management
and product development. In addition, the acquisition of TIL has enabled us to
move into the veterinary market with experienced management.
ITEM 8. FINANCIAL STATEMENTS
The Company's consolidated financial statements appear at pages F-1 through
F-20, as set forth in Item 14.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The information contained in the section titled "Certain Relationships and
Transactions" in the Proxy Statement, with respect to certain relationships
and related transactions, is incorporated herein by reference in response to
this Item 13. In addition, we continued in 2000 to utilize the software
development services of Advanced Medical Information Technologies, Inc., also
known as AdMit. AdMit is a company in which our Chief Information Officer,
Dennis Reiger, has an equity interest. We paid AdMit $276,000 in 2000. In
addition, we paid an entity owned in part by Mr. Reiger's brother
approximately $275,000 for programming services during 2000. These services
were at what we believed were below market rates for comparable services.
In June 2000, S.R. One, Limited agreed to extend the maturity date of the
note we owe them to November 2001. The original principal amount of the note
is $2 million. It is the remaining obligation we have from the loan S.R. One
made to us in December 1998, a third of which was converted to Series A
Preferred Stock, which
18
was in turn converted to common equity in July 2000. S.R. One has the option
to convert all or any portion of the remaining loan, plus accrued interest
thereon, into shares of Series A Convertible Preferred Stock. We also issued a
bridge warrant to S.R. One in connection with the bridge financing. The bridge
warrant is exercisable for 235,294 shares of common stock at an exercise price
of $6.37 and will expire on July 16, 2004. S.R. One is a venture capital
affiliate of GlaxoSmithKline, which owns more than 5% of our outstanding
common stock.
On November 29, 2000, December 21, 2000 and January 24, 2001, Careside
engaged in three closings of a private placement of common stock and warrants
to purchase common stock. Each purchaser in the private placement is an entity
controlled by Peter Friedli, who owns more than 5% of our outstanding common
stock.
On October 27, 2000, RoyCap, Inc. converted 20 shares of Series B
Convertible Preferred Stock at an exercise price of $2.2625 per share into
44,459 shares of Careside's common stock. On November 2, 2000, RoyCap
exercised a warrant to purchase 200 shares of Series B preferred. In addition,
on November 13, 2000, RoyCap converted 40 shares of Series B preferred at an
exercise price of $2.4063 per share into 83,800 shares of Careside's common
stock. RoyCap, Inc. is an investor that beneficially owns more than 5% of our
common stock.
19
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
(a)(1) Financial Statements
The financial statements listed in the accompanying Index to Consolidated
Financial Statements are filed as part of this Form 10--K/A, commencing on page
F-1.
(2) Financial Statement Schedules--none applicable
Other financial statement schedules are not included because they are not
required or the information is otherwise shown in the financial statements or
notes thereto.
(3) Exhibits
Exhibit
No. Description
------- -----------
2.1* Agreement and Plan of Merger dated as of December 7, 1999 by and among
Careside, Inc., Careside Hematology, Inc., Texas International
Laboratories, Inc., Yves LeBihan and Jean-Yves LeBihan.
3.1** Amended and Restated Certificate of Incorporation of Careside, Inc.
3.2** Certificate of Designations of Series A Convertible Preferred Stock
3.3** Amended and Restated Bylaws of Careside, Inc.
3.4+ Certificate of Designations of Series B Convertible Preferred Stock
4.1*** Specimen Stock Certificate
4.1a** Specimen Warrant Certificate
4.1b** Specimen Unit Certificate
4.2*** Placement Agent Warrant Agreement dated as of January 31, 1997 by and
between Careside, Inc. and Spencer Trask Securities Incorporated
(including Form of Warrant)
4.3*** Placement Agent Warrant Agreement dated as of March 6, 1998 by and
between Careside, Inc. and Spencer Trask Securities Incorporated
(including Form of Warrant)
4.4*** Securities Purchase Agreement dated as of December 17, 1998 by and
between S.R. One, Limited and Careside, Inc. (including Form of Note)
(as amended)
4.5*** Warrant Issued to S.R. One, Limited on December 17, 1998
4.6** Warrant Agreement dated June 21, 2000, by and between Careside, Inc.
and Paulson Investment Company, Inc.
4.7** Warrant Agreement dated June 21, 2000, by and between Careside, Inc.
and American Stock Transfer & Trust Company, as Warrant Agent
4.8** Warrant issued to S.R. One, Limited dated June 21, 1999
4.9** New Note issued to S.R. One, Limited dated as of June 21, 1999
4.11*** Securities Purchase and Subscription Agreement dated as of March 8,
2000 by and between Careside, Inc. and Purchasers
4.12*** Warrant Agreement dated as of March 8, 2000 by and between Careside,
Inc. and H. C. Wainwright & Co., Inc. (including Warrant certificate)
4.13*** Contingent Warrant Agreement dated as of March 8, 2000 by and between
Careside, Inc. and Purchasers (including Form of Warrant)
4.14+ Securities Purchase Agreement dated as of September 13, 2000 by and
between RoyCap, Inc. and Careside, Inc.
20
Exhibit
No. Description
------- -----------
4.15+ Series B Convertible Preferred Warrant issued to RoyCap, Inc. on
September 13, 2000
4.16+ Warrant Agreement by and between RoyCap, Inc. and Careside, Inc.
dated as of September 13, 2000 (including Warrant Certificate)
4.17+ Common Stock Purchase issued to RoyCap, Inc. on September 13, 2000
4.18+ Warrant Agreement By and between Brighton Capital, Ltd. and Careside,
Inc. dated as of September 13, 2000 (including Warrant Certificate)
10.1*** Registration Rights Agreement dated as of November 7, 1996 by and
among SmithKline Beecham Diagnostic Systems Co., SmithKline Beecham
Corporation and Careside, Inc.
10.2*** Registration Rights Agreement dated as of December 4, 1996 by and
among Careside, Inc., Exigent Partners, L.P., W. Vickery Stoughton,
Thomas H. Grove, Kenneth B. Asarch, William S. Knight, Donald S.
Wong, Ashok K. Sawhney and Philip B. Smith
10.3*** Amendment No. 1 to Registration Rights Agreement dated as of January
31, 1997 by and among Careside, Inc. Exigent Partners, L.P., W.
Vickery Stoughton, Thomas H. Grove, Kenneth B. Asarch, William S.
Knight, Donald S. Wong, Ashok K. Sawhney and Philip B. Smith
10.4*** Registration Rights Agreement dated as of December 4, 1996 by and
between Careside, Inc. and Spencer Trask Securities Incorporated
10.5*** Registration Rights Agreement dated as of January 31, 1997 by and
among Careside, Inc. and the Investors signatory thereto
10.6*** Stockholders Agreement dated as of December 4, 1996 by and among the
Careside, Inc., SmithKline Beecham Corporation, SmithKline Beecham
Diagnostic Systems Co., Spencer Trask Securities Incorporated,
Exigent Partners, L.P., W. Vickery Stoughton, Thomas H. Grove,
Kenneth B. Asarch, William S. Knight, Donald S. Wong, Ashok K.
Sawhney, Philip B. Smith and each Investor signatory thereto
10.7**** Registration Rights Agreement dated as of December 7, 1999 by and
between Careside, Inc. and Yves LeBihan and Jean-Yves LeBihan.
10.8+ Registration Rights Agreement dated as of September 13, 2000, by and
between RoyCap, Inc., Brighton Capital, Inc. and Careside, Inc.
10.9*** Registration Rights Agreement dated as of March 6, 1998 by and among
Careside, Inc. and the Investors signatory thereto
10.10*** Registration Rights Agreement dated as of March 6, 1998 by and
between Careside, Inc. and Spencer Trask Securities Incorporated
10.11*** Registration Rights Agreement dated as of December 17, 1998 by and
between Careside, Inc. and S.R. One, Limited
10.12*** 1996 Key Executive Stock Option Plan, as amended and restated
10.13*** 1998 Incentive and Non-Qualified Stock Option Plan
10.14*** 1998 Director Stock Option Plan
10.15*** Standard Industrial/Commercial Single-Tenant Lease-NET dated as of
October 14, 1996, by and between Fox Hills Business Park, a
California limited partnership and Careside, Inc.
10.16*** Agreement dated as of August 31, 1996, by and between Fuji Photo Film
Co., Ltd. and Careside, Inc.
10.18*** Product Development and Supply Agreement dated as of July 18, 1997,
by and between Careside, Inc. and UMM Electronics, Inc.
21
Exhibit
No. Description
------- -----------
10.20*** Agreement No. CPO32284 Cost Type executed December 5 and 17, 1996 by
and between Battelle Memorial Institute and Careside, Inc.
10.21*** Joint Research & Development Agreement dated as of October 28, 1996
by and between Careside, Inc. and International Technidyne
Corporation
10.22*** Employment Agreement dated as of March 3, 1997 between Careside, Inc.
and W. Vickery Stoughton
10.23*** Employment Agreement dated as of March 3, 1997 between Careside, Inc.
and Thomas H. Grove
10.24*** Employment Agreement dated as of July 30, 1998 between Careside, Inc.
and James R. Koch
10.37** Securities Conversion Agreement dated as of June 14, 1999 between
S.R. One, Limited and Careside, Inc.
10.38** Form of Amended and Restated Registration Rights Agreement dated as
of June 21, 1999 between S.R. One, Limited and Careside, Inc.
23.1 Consent of Arthur Andersen LLP.
--------
* Incorporated herein by reference to Careside's current report on Form 8-K
filed on December 22, 1999.
** Incorporated herein by reference to Careside's Quarterly Report on Form
10-Q for the quarterly period ended June 30, 1999 filed on August 13,
1999.
*** Incorporated herein by reference to the Registration Statement on Form S-
1 of Careside, Inc., as amended. Registration No. 333-69207.
**** Incorporated herein by reference to Careside's Annual Report on Form 10-K
filed on March 31, 2000.
+ Incorporated herein by reference to the Registration Statement on Form S-
3 of Careside, Inc. filed on September 27, 2000. Registration No. 333-
46746.
(b) Reports on Form 8-K.
A report on Form 8-K was filed on December 7, 1999 reporting the Company's
acquisition of Texas International Laboratories, Inc. on December 7, 1999. An
amendment to that 8-K was filed on February 22, 2000, reporting Item 7
Financial Information.
A report on Form 8-K was filed on January 28, 2000 reporting that the
Company issued a press release announcing a proposed equity private placement.
A report on Form 8-K was filed on April 20, 2000 reporting that the Company
issued press releases announcing that it had completed the equity private
placement previously discussed on January 28, 2000.
22
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this Annual Report to be
signed on its behalf by the undersigned, thereunto duly authorized, in Culver
City, California, on the 12th day of September, 2001.
CARESIDE, INC.
/s/ W. Vickery Stoughton
By: _________________________________
W. Vickery Stoughton
Chairman of the Board of
Directors and Chief Executive
Officer
23
REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS
To the Shareholders of Careside, Inc.:
We have audited the accompanying consolidated balance sheets of Careside,
Inc. (a Delaware corporation) as of December 31, 1999 and 2000, and the
related consolidated statements of operations, stockholders' equity and cash
flows for each of the three years in the period ended December 31, 2000. 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 auditing standards generally
accepted in the United States. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on
a test basis, evidence supporting the amounts and disclosures in the financial
statements. 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 consolidated financial statements referred to above
present fairly, in all material respects, the financial position of Careside,
Inc. as of December 31, 1999 and 2000, and the results of its operations and
its cash flows for each of the three years in the period ended December 31,
2000, in conformity with accounting principles generally accepted in the
United States.
The accompanying consolidated financial statements have been prepared
assuming that the Company will continue as a going concern. As discussed in
Note 1 to the consolidated financial statements, the Company has suffered
recurring losses from operations and has accumulated a significant deficit
that 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
Los Angeles, California
March 23, 2001
F-1
CARESIDE, INC.
CONSOLIDATED BALANCE SHEETS--DECEMBER 31, 1999 AND 2000
1999 2000
------------ ------------
ASSETS
------
Current Assets:
Cash and cash equivalents........................ $ 4,905,440 $ 1,789,259
Accounts receivable, net of allowance of $0 in
1999 and $53,670 in 2000........................ 78,046 104,132
Inventory........................................ 548,623 2,698,351
Prepaid expenses and other....................... 102,615 173,520
------------ ------------
Total current assets........................... 5,634,724 4,765,262
------------ ------------
Property and Equipment, net of accumulated
depreciation of $1,846,275 in 1999 and $4,212,593
in 2000........................................... 5,939,186 5,643,028
Deferred Offering Costs............................ 2,318 --
Deposits and Other................................. 15,000 23,974
Goodwill, net of accumulated amortization of
$36,577 in 1999, and $566,276 in 2000............. 2,798,170 2,231,221
------------ ------------
$ 14,389,398 $ 12,663,485
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
------------------------------------
Current Liabilties:
Current portion of long-term debt................ $ 2,316,192 $ 2,519,946
Current portion of obligation under capital
lease........................................... 11,006 12,650
Accounts payable................................. 844,904 1,456,652
Accrued expenses................................. 886,260 420,504
Accrued interest................................. 156,493 333,918
------------ ------------
Total current liabilties....................... 4,214,855 4,743,670
------------ ------------
Long-Term Debt, net of current portion............. 1,059,876 1,192,418
------------ ------------
Obligation Under Capital Lease, net of current
portion........................................... 35,835 23,185
------------ ------------
Manditorily Redeemable Series B Convertible
Preferred Stock 0 and 290 shares issued and
outstanding at December 31, 1999 and 2000,
respectively...................................... -- 1,054,030
Stockholders' Equity:
Preferred stock, $.01 par value: 5,000,000 shares
authorized--Series A Convertible Preferred
162,914 and 0 shares issued and outstanding at
December 31, 1999 and 2000, respectively........ 1,629 --
Common stock, $.01 par value:
50,000,000 shares authorized--7,609,581 and
10,590,191 shares issued and outstanding at
December 31, 1999 and 2000, respectively........ 76,095 105,901
Additional paid-in capital....................... 37,496,984 50,743,642
Accumulated Deficit.............................. (28,495,876) (45,199,361)
------------ ------------
Total stockholders' equity..................... 9,078,832 5,650,182
------------ ------------
$ 14,389,398 $ 12,663,485
============ ============
The accompanying notes are an integral part of these consolidated statements.
F-2
CARESIDE, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Year Ended December 31,
---------------------------------------
1998 1999 2000
----------- ------------ ------------
Net Sales............................ $ -- $ 60,956 $ 741,039
Cost of Sales........................ -- 30,566 1,001,097
----------- ------------ ------------
Gross Profit (Loss).............. -- 30,390 (260,058)
Operating Expenses:
Research and development--
products.......................... 8,297,974 8,252,081 9,073,391
Research and development--
software.......................... -- 313,400 898,256
Selling and marketing.............. 249,000 1,204,548 3,657,072
General and administrative......... 601,129 1,134,900 2,124,264
Goodwill amortization.............. -- 36,577 566,949
----------- ------------ ------------
Operating Loss................... (9,148,103) (10,911,116) (16,579,990)
Other income(expense):
Interest Income.................... 234,089 291,008 371,781
Interest Expense................... (22,275) (970,525) (495,276)
----------- ------------ ------------
Net Loss......................... (8,936,289) (11,590,633) (16,703,485)
Preferred stock dividends on Series A
& B................................. -- (55,201) (68,684)
Accreted dividend on Series B........ -- -- (83,028)
Beneficial conversion feature on
Series B............................ -- -- (84,044)
----------- ------------ ------------
Net loss available to common
stockholders........................ $(8,936,289) $(11,645,834) $(16,939,241)
----------- ------------ ------------
Basic and Diluted Net Loss per Common
Share............................... $ (1.93) $ (1.88) $ (1.92)
Shares used in Computing Basic and
Diluted Net Loss per Common Share... 4,629,916 6,210,496 8,800,171
----------- ------------ ------------
The accompanying notes are an integral part of these consolidated statements.
F-3
CARESIDE, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
Common Stock Preferred Stock Additional Total
------------------- ----------------- Paid-in Accumulated Stockholders'
Shares Amount Shares Amount Capital Deficit Equity
---------- -------- -------- ------- ----------- ------------ -------------
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......... 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
Issuance of warrants in
conjunction 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
Shares issued in
connection with initial
public offering, net... 2,000,000 20,000 -- -- 12,340,788 -- 12,360,788
Issuance of Series A
Preferred stock in
exchange for bridge
debt................... -- -- 162,914 1,629 1,036,946 -- 1,038,575
Issuance of warrant with
bridge conversion...... -- -- -- -- 289,801 -- 289,801
Accrued Series A
Preferred dividend..... -- -- -- -- (55,201) -- (55,201)
Shares issued in
connection with
acquisition of Texas
International
Laboratories, Inc. .... 521,739 5,217 -- -- 2,864,348 -- 2,869,565
Shares issued in
connection with ESPP... 3,502 35 -- -- 16,757 -- 16,792
Net loss................ -- -- -- -- -- (11,590,633) (11,590,633)
---------- -------- -------- ------- ----------- ------------ ------------
Balance, December 31,
1999................... 7,609,581 76,095 162,914 1,629 37,496,984 (28,495,876) 9,078,832
Shares issued in
connection with private
placements, net........ 2,510,570 25,105 -- -- 12,603,565 -- 12,628,670
Shares issued in
connection with
exercise of stock
options................ 1,154 12 -- -- 48 -- 60
Accrued Series A
Preferred dividend..... -- -- -- -- (51,787) -- (51,787)
Accrued Series B
Preferred dividend..... -- -- -- -- (16,897) -- (16,897)
Accreted Series B
Preferred dividend..... -- -- -- -- (83,028) -- (83,028)
Shares issued in
connection with ESPP... 30,454 305 -- -- 102,963 -- 103,268
Conversion of Series A
Preferred and accrued
and unpaid dividends... 179,696 1,797 (162,914) (1,629) 106,820 -- 106,988
Issuance of warrants in
connection with Series
B Preferred Stock...... -- -- -- -- 530,986 -- 530,986
Shares issued in
connection with the
conversion of the
Series B Preferred..... 128,259 1,283 -- -- 53,992 -- 55,275
Shares issued in
connection with
cashless exercise of
stock warrant.......... 385 4 -- -- (4) -- --
Shares issued in
connection with
exercise of contingent
stock warrants......... 130,092 1,300 -- -- -- -- 1,300
Net loss................ -- -- -- -- -- (16,703,485) (16,703,485)
---------- -------- -------- ------- ----------- ------------ ------------
Balance, December 31,
2000................... 10,590,191 $105,901 -- $ -- $50,743,642 $(45,199,361) $ 5,650,182
========== ======== ======== ======= =========== ============ ============
The accompanying notes are an integral part of these consolidated statements.
F-4
CARESIDE, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Year Ended December 31,
---------------------------------------
1998 1999 2000
----------- ------------ ------------
Operating Activities:
Net loss............................ $(8,936,289) $(11,590,633) $(16,703,485)
Adjustments to reconcile net loss to
net cash used in operating
activities:
Depreciation and amortization..... 367,231 1,357,488 2,933,268
Amortization of debt discount..... 20,960 309,154 --
Noncash interest expense.......... -- 289,801 --
Changes in operating assets and
liabilties:
Accounts receivable............... -- (73,446) (26,086)
Inventory......................... -- (472,123) (2,149,728)
Prepaid expenses and other........ (25,118) (20,442) (70,905)
Deposits and other................ 80,067 2,700 (8,974)
Accounts payable.................. 876,904 (72,942) 611,748
Accrued expenses.................. (49,192) 670,621 (425,220)
Accrued interest.................. -- 195,068 177,425
----------- ------------ ------------
Net cash used in operating
activities..................... (7,665,437) (9,404,754) (15,661,957)
----------- ------------ ------------
Investing Activities:
Purchases of property and
equipment.......................... (2,005,463) (3,820,634) (2,070,160)
Cash acquired in purchase of Texas
International Laboratories, Inc.... -- 118 --
----------- ------------ ------------
Net cash used in investing
activities..................... (2,005,463) (3,820,516) (2,070,160)
----------- ------------ ------------
Financing Activities:
Proceeds from borrowings under long-
term debt.......................... 2,541,084 2,058,831 795,456
Payments on long-term debt.......... -- (223,847) (459,160)
Payments on capital lease
obligation......................... -- (6,139) (11,006)
Deferred offering costs............. (498,443) (2,318) 2,318
Net Proceeds from the issuance of
preferred and common stock......... 10,317,713 12,377,580 14,288,328
----------- ------------ ------------
Net cash provided by financing
activities..................... 12,360,354 14,204,107 14,615,936
Net Increase (Decrease) in Cash and
Cash Equivalents..................... 2,689,454 978,837 (3,116,181)
Cash and Cash Equivalents, beginning
of period............................ 1,237,149 3,926,603 4,905,440
----------- ------------ ------------
Cash and Cash Equivalents, end of
period............................... $ 3,926,603 $ 4,905,440 $ 1,789,259
=========== ============ ============
The accompanying notes are an integral part of these consolidated statements.
F-5
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Careside
Background
Careside, Inc. ("Careside" or "the Company") 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 is a compact portable device with
related disposables that performs chemistry, electrochemistry, immunochemistry
and coagulation testing.
In December 1999, Careside completed an acquisition of Texas Instrument
Laboratories, Inc. ("TIL") and merged TIL into a newly formed, wholly-owned
subsidiary, Careside Hematology. TIL manufactured hematology products used
primarily in veterinary applications.
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. In the fourth
quarter of 2000, Careside had substantially completed the initial development
efforts of the Company's core product and began generating sales and
increasing its focus on marketing efforts. In 1998, 1999 and for the nine
months ended September 30, 2000, Careside was considered a development stage
enterprise. Since its inception, Careside has generated minimal revenues and
incurred significant losses. Careside anticipates incurring additional losses
over at least the next year, and such losses are expected to increase as
Careside expands its marketing activities. The accompanying consolidated
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 consolidated financial statements
for the year ended December 31, 2000, the Company incurred a net loss of
$16,703,485, has used cash for operating activities of $15,661,957 and has an
accumulated a deficit of $45,199,361. These factors raise substantial doubt
about the ability of the Company to continue as a going concern. Additional
financing will be needed by Careside to fund its operations. In addition, 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. The Company's failure
to raise capital on acceptable terms could have a material adverse effect on
its business, financial condition or results of operations. There can be no
assurance that Careside's future product enhancements will receive regulatory
clearance, that the Company will be able to obtain additional financing, be
profitable in the marketplace, or will be able to repay its current debt
obligations.
2. Summary of Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include the accounts of Careside and
Careside Hematology. Intercompany accounts and transactions are eliminated in
consolidation.
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,
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.
F-6
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
Cash and Cash Equivalents
All highly liquid investments with an original maturity of three months or
less are presented as cash equivalents in the accompanying consolidated
financial statements.
Inventory
Inventories are stated at the lower of cost or market with cost determined
on a first-in, first-out basis, and are summarized as follows:
December 31,
-------------------
1999 2000
-------- ----------
Raw materials........................................... $369,937 $1,163,593
Work in process......................................... 48,620 126,111
Finished goods.......................................... 130,066 2,036,265
Reserve for excess and obsolescence..................... -- (627,618)
-------- ----------
$548,623 $2,698,351
======== ==========
Allowance for Doubtful Accounts
Allowances for doubtful accounts are estimates and are established based on
the specific circumstances of each customer.
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. The Company uses
lives of two to nine years for laboratory equipment and manufacturing
equipment and three to ten years for office equipment. Leasehold improvements
generally are amortized over the remaining life of the lease.
Goodwill
Goodwill represents the excess of the purchase price and related costs over
the value assigned to the tangible net assets of TIL. Goodwill is being
amortized on a straight line basis over five years. Periodically, the Company
reviews the recoverability of goodwill. The measurement of possible impairment
is based primarily on the ability to recover the balance of goodwill from
expected future operating cash flows on an undiscounted basis. In management's
opinion, no impairment exists at December 31, 2000.
Long-Lived Assets
The Company reviews its long-lived assets (including goodwill) for
impairment whenever events or changes in circumstances indicate that the
carrying amount of an asset or a group of assets may not be recoverable. If an
asset is determined to be impaired, the loss is measured as the amount by
which the carrying amount of the asset exceeds fair value. If an evaluation is
required, the estimated future undiscounted cash flows associated with the
asset would be compared to the asset's carrying amount to determine if a
write-down to market value or discounted cash flow value is required. The
Company has not recorded an impairment loss in any period presented.
F-7
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
Fair Value of Financial Instruments
Cash equivalents are reflected in the accompanying consolidated 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 based on borrowing rates currently available to the Company for
loans with similar terms and maturities.
Revenue Recognition
The Company applies the provisions of Staff Accounting Bulletin No. 101
(SAB 101) when recognizing revenue. SAB 101 states that the revenue generally
is realized or realizable and earned when all of the following criteria are
met: a) persuasive evidence of an arrangement exists, b) delivery has occurred
or the services have been rendered, c) the seller's price to the buyer is
fixed or determinable and d) collectibility is reasonably assured.
The Company recognizes revenue from the sale of analyzers upon customer
acceptance. The Company recognizes revenue on the sale of test cartridges,
supplies and hematology solutions once shipment has occurred and all of the
conditions of SAB 101 have been met.
The Company's distributors do not have rights of return or cancellation and
price protection provisions. Revenue from distributors that does not meet all
of the requirements of SAB 101 are deferred and recognized upon the sale of
the product to the end user.
The Company has entered into sales agreements with leasing companies
whereby the Company sells its products directly to the leasing company, who
then leases the products to the end user. Sales to the leasing company are on
a non-recourse basis and are recognized at the later date of shipment or
customer acceptance, when applicable.
Warranty
The Company outsources the manufacture of its Analyzer to a third party who
warrantees the Analyzers for 30 months from the date of shipment to the
Company. Careside offers a 24 month warranty to the customer. Procedures have
been put in place to assure no system will be shipped with less than a
remaining 24 month warranty. As such, no provision for warranty has been
recorded for the years ended December 31, 1998, 1999 and 2000.
Research and Development
Research and development costs are charged to expense as incurred. The
company uses both internal and external resources to produce and develop
software to run its hardware products. Costs to develop this software are
accounted for in accordance with Statement of Financial Accounting Standards
(SFAS) No. 86, "Accounting for the Costs of Computer Software to be Sold,
Leased, or Otherwise Marketed," which requires the Company to capitalize
software development costs when "technological feasibility" of the product has
been established and future revenues assure recovery of the capitalized
amounts. Because of the relatively short time period between "technological
feasibility" and product release, the Company has not capitalized any software
development costs as of December 31, 1999 or December 31, 2000.
Income Taxes
The Company 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
F-8
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
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
The Company applies Accounting Principles Board ("APB") Opinion No. 25,
"Accounting for Stock Issued to Employees," in accounting for its stock
options. The Company 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 11).
Net Loss Per Common Share
The Company has presented net loss per common share pursuant to SFAS No.
128, "Earnings per Share." Basic loss per common 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 common share has not been presented since the impact on loss per share
using the treasury stock method is anti-dilutive due to the Company'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 initial public offering which took place in June 1999. All references in
the accompanying consolidated financial statements to the number of shares and
per share amounts have been retroactively restated to reflect the reverse
stock split.
Reclassifications
Certain prior year amounts have been reclassified to conform to the current
year presentation.
Recently Issued Pronouncements
In June 1999, the FASB issued SFAS No. 133 "Accounting for Derivative
Instruments and Hedging Activities". SFAS No. 133 establishes accounting and
reporting standards for derivative instruments, including certain derivative
instruments embedded in other contracts, and for hedging activities. SFAS No.
133, as amended by SFAS No. 137, is effective for all fiscal quarters of
fiscal years beginning after June 15, 2000. The Company does not believe that
implementation of SFAS No. 133 and SFAS No. 137 will have a material impact.
3. Concentration of Risk
In 2000, the Company had sales to three customers that were individually
greater than 10 percent of net sales. Combined, these three customers amounted
to 38 percent of net sales and 25 percent of accounts receivable at December
31, 2000. The Company's geographic sales data is as follows:
1999 2000
------- --------
Domestic................................................. $ 5,067 $281,823
Asia Pacific............................................. 48,355 428,436
Europe................................................... -- 18,580
Latin America............................................ 7,534 12,200
------- --------
$60,956 $741,039
======= ========
F-9
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
4. Property and Equipment
December 31,
------------------------
1999 2000
----------- -----------
Laboratory equipment.............................. $ 3,865,507 $ 4,607,144
Manufacturing equipment........................... 3,233,301 4,357,105
Computer and office equipment..................... 315,414 513,258
Leasehold improvements............................ 371,239 378,114
----------- -----------
7,785,461 9,855,621
Less--Accumulated depreciation and amortization... (1,846,275) (4,212,593)
----------- -----------
$ 5,939,186 $ 5,643,028
=========== ===========
At December 31, 2000, Careside had analyzers with a cost of $1,056,000 and
a net book value of $425,400 included in laboratory equipment and computer and
office equipment. These analyzers are used for testing purposes, as design
reference units, in research and development activities and for sales and
marketing demonstrations.
Depreciation and amortization expense for the years ended December 31,
1998, 1999 and 2000, was $367,231, $1,357,488 and $2,933,268, respectively.
5. Income Taxes
Deferred income tax assets or liabilities are computed based on the
temporary differences between the financial statement and income tax bases of
assets and liabilities using the enacted marginal income tax rate in effect
for the year in which the differences are expected to reverse. Realization of
the net deferred tax assets is dependent on generating sufficient taxable
income during the periods in which temporary differences will reverse. The
amount of the net deferred tax assets considered realizable, however, could be
adjusted in the near term if estimates of future taxable income during the
reversal periods are revised. Deferred income tax expenses or credits are
based on the changes in the deferred income tax assets or liabilities from
period to period. At December 31, 2000, the Company had net operating loss
carryforwards for federal income tax purposes of approximately $33,634,347. In
addition, the Company has federal research and development credit
carryforwards of approximately $1,047,937. The net operating loss
carryforwards expire beginning in 2011 through 2020. The research and
development credit carryforward expire in 2012 through 2021. The credits and
carryforwards 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 interests. The Company
experienced such changes in ownership upon the closing of its 1997 and 2000
private placements. The Company does not believe these changes in ownership
will have a material impact on its ability to utilize its net operating loss
and tax credit carryforwards. There can be no assurance that ownership changes
in future periods will not significantly limit the Company's ability to use
existing or future net operating loss or tax credit carryforwards.
F-10
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
The components of the deferred income tax assets are as follows:
December 31,
--------------------------
1999 2000
------------ ------------
Net operating loss carryforwards................ $ 7,612,306 $ 14,408,954
Research and development credit carryforwards... 1,115,120 1,403,593
Capitalized research and development............ 2,152,254 1,840,084
Start-up costs.................................. 1,570,460 1,358,515
Accruals........................................ 18,569 124,389
Depreciation and amortization................... 783,964 1,219,365
Deferred rent................................... 31,365 53,619
Inventory reserve............................... -- 304,389
State tax benefit............................... (319,686) (343,803)
Valuation allowance............................. (12,964,352) (20,369,105)
------------ ------------
$ -- $ --
============ ============
Due to the uncertainty surrounding the realization of the deferred tax
asset, the Company has provided a valuation allowance against the entire
asset.
6. Common Stock 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 $8.7 million, 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. The
estimated fair value of these warrants, computed using the Black-Scholes
option pricing model, was $763,527. This amount was offset against the
proceeds and credited to additional paid-in capital. These warrants are
currently exercisable and expire seven years from the date of issuance.
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 $10.2 million. 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. The estimated fair value of these warrants, computed using the Black-
Scholes option pricing model, was $827,178. This amount was offset against the
proceeds and credited to additional paid-in capital. These warrants are
currently exercisable and expire seven years from the date of issuance. 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. The estimated
fair value of these warrants using the Black-Scholes option pricing model, was
$7,762 and was offset against the proceeds and credited to additional paid-in
capital.
In June 1999, Careside completed an initial public offering of its common
stock. The offering totaled 2,000,000 shares of common stock and 2,000,000
tradable warrants exercisable into one share of common stock each. The
combined share and warrant were sold at a price of $7.50 per unit. The
warrants are currently exercisable at a price of $9.00 per share and expire on
the earlier of five years from the date of issuance or if they are called.
They are callable at $0.05 per warrant upon 30 days written notice if the
common stock trades for ten consecutive days at a price equal to or exceeding
$14.00 per share.
In March 2000, the Company sold 1,184,091 shares of common stock in a
private placement for $8.77 per share resulting in net proceeds of $9,544,488,
net of $840,000 of cash offering costs. The $8.77 per share was at
F-11
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
a discount of 20 percent from the average closing price for the twenty days
prior to the initial closing date of the sales. The placement agent received
warrants to purchase 101,305 shares of Careside's common stock at $8.77 per
share. In connection with the sale, the Company issued the investors and the
placement agent contingent warrants for nominal value exercisable into 154,246
shares of the Company's common stock at an exercise price of $0.01 per share.
The contingent warrants were exercisable upon certain conditions and expired
on December 15, 2000. During the third quarter, the conditions triggering the
exercisabiltiy of these contingent warrants were met. A total of 130,092
warrants were exercised and converted to 130,092 shares of common stock and
the remainder expired. The estimated fair value of the 101,305 and the 154,246
warrants, computed using the Black-Scholes option pricing model were $971,804
and $1,996,697 respectively. These amounts were offset against the proceeds of
the offering and credited to additional paid-in capital.
In November and December 2000, the Company sold 1,326,479 shares of common
stock to an existing investor for an average price of $2.56 per share, at 90
percent of fair market value, resulting in net proceeds of $3,084,203, net of
$313,624 of cash offering costs. In conjunction with the placement, warrants
to purchase an aggregate of 66,324 shares of common stock were issued with an
average exercise price of $2.56. The estimated fair value of these warrants,
computed using the Black-Scholes option pricing model was $101,638. This
amount was offset against the proceeds and credited to additional paid-in
capital.
7. Preferred Stock
In June 1999, the Company exchanged $1,038,575 of bridge financing and
unpaid interest (see Note 9) for 162,914 shares of Series A Convertible
Preferred Stock. In July 2000, this Preferred Stock in the amount of 162,914
and its accrued, unpaid dividends in the amount of 16,782 shares were
converted into a unit consisting of 179,696 shares of common stock and a
warrant to purchased 179,696 additional shares of common stock at $9.00 per
share.
During 2000, the Company sold 150 shares of Series B Convertible Preferred
Stock to an investor for net proceeds of $615,030, net of expenses of
$134,970. In connection with this sale, the Company issued a warrant to the
investor to purchase 200 additional shares of Series B Preferred Stock at an
exercise price of $5,000 per share. This warrant was exercised in November
2000 resulting in gross proceeds of $1,000,000.
The sale of Series B Convertible Preferred Stock also included the
placement of callable two year warrants for up to 4,000,000 shares of common
stock at an exercise price of $14.00; however if the warrant is exercised in
response to a Company call, then the exercise price will be the lesser of
$14.00 per share or 95% of the average closing price of the stock for the two
day period immediately after the date of the notice of the call from the
Company.
The sale also included a warrant to the placement agent to purchase 25,000
shares of common stock at an exercise price of $5.63 per share, or 120% of the
closing price on the date prior to the sale. The warrant expires on September
13, 2005.
The placement agent for the Series B Convertible Preferred Stock received a
warrant to purchase 50,000 shares of common stock at an exercise price of
$5.63 per share. The warrant expires on September 13, 2005.
The Series B Convertible Preferred Stock has a stated value equal to $5,000
per share and is entitled to an annual five percent (5%) dividend payable, as
declared by the board of directors, payable in cash, additional shares of
Series B Preferred, or any combination of the two. Accrued and unpaid
dividends were $66,451 at December 31, 2000. The Series B Preferred has a
liquidation preference over the Common Stock, but ranks junior to the Series A
Convertible Preferred Stock with respect to rights on liquidation, dissolution
or winding
F-12
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
up. The liquidation preference is equal to the stated value of the Series B
Preferred Stock, plus all accrued and unpaid dividends. The Series B 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 B Preferred
Stock, reclassifying the Common Stock or any other capital stock ranking
junior to the Series B Preferred Stock into any class of security ranking
senior to or the same as the Series B Preferred Stock, or increasing the
authorized number of shares of Series B Preferred Stock.
Each share of Series B Preferred Stock is convertible at the option of the
holder at any time before September 13, 2002 into a number of shares of Common
Stock equal to the stated value of $5,000 (plus all accrued and unpaid
dividends thereon) divided by the lower of (a) the average of the lowest ten
closing sales prices within the last thirty days prior to the date the holder
delivers a notice exercising his or her right to convert and (b) $5.48. In
October and November 2000, 60 shares of Series B Preferred Stock, plus accrued
and unpaid dividends totaling $2,233 were converted to 128,259 shares of
common stock. The holder may only convert a number of shares of Series B
Preferred Stock such that the aggregate number of shares of Common Stock
issued to the holder after such conversion of the Series B Preferred Stock and
as a result of all prior conversions of Series B Preferred Stock, do not, when
aggregated with the number of shares of Common Stock previously issued, or
then issuable pursuant to an exercise notice received, upon exercise of the
warrant to purchase up to 4,000,000 shares of common stock discussed above,
exceed 1,797,631 shares of Common Stock (which number will be adjusted for
stock splits and similar events) in violation of Section 713 of the Listing
Standards of the American Stock Exchange, unless and until the shareholders of
Careside have approved such aggregate issuance of Common Shares in excess of
1,797,631.
The Company has the right to redeem the Series B Preferred Stock, pro rata
among all the holders of the Series B Preferred Stock, at any time upon notice
to the shareholders for a per share amount equal to $5,750 plus all accrued
and unpaid dividends per share redeemed. The shareholders must be given a
minimum of thirty days notice before the date of redemption. During that
period, the holders may elect to convert such holder's Series B Preferred
stock into Common Shares equal to the Series B Stated Value of $5,000 plus all
accrued and unpaid dividends, divided by the lower of (a) the average of the
lowest ten closing sales prices within the last thirty days prior to the date
of notice and (b) $5.475.
At September 13, 2002, any shares of Series B Preferred Stock not converted
to common stock must be purchased by the Company at stated value, plus any
accrued and unpaid dividends. Due to this mandatory redemption feature, the
Series B Preferred Stock is classified as mezzanine financing.
At the date of sale, the conversion feature for the 150 shares was
beneficial to the investor because if it was exercised, it could have resulted
in proceeds to the investor in excess of the original purchase price of the
150 shares allocated to the Series B Preferred Stock after allocations to
warrants. The beneficial conversion feature was recorded as an $84,044 non-
cash charge against the preferred proceeds. This non-cash charge was recorded
as a dividend to preferred stockholders in the computation of earnings per
share.
The estimated relative fair value of the warrants to purchase 200 shares of
Series B Preferred Stock, up to 4,000,000 shares of common stock, 25,000
shares of common stock and 50,000 shares of common stock was $12,626,
$495,601, $9,327 and $13,362 respectively. These amounts were offset against
the net proceeds of sale and resulted in an allocation of the remaining net
proceeds of $84,044 to the Series B Preferred. Since the Series B Preferred is
mandatorily redeemable at the option of the holder, the carrying value of
shares not converted to common stock must be accreted as a non-cash dividend
to preferred stockholders up to the redemption value of $5,000 per share on a
straight line basis through September 13, 2002. The non-cash accreted dividend
recorded through December 31, 2000 was $83,028.
F-13
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
8. Purchase of Texas Instrument Laboratories, Inc.
In December 1999, Careside acquired all of the outstanding common stock of
TIL in exchange for 521,739 shares of Careside's common stock. TIL was then
merged into Careside's newly formed, wholly-owned subsidiary, Careside
Hematology. The transaction was accounted for using the purchase method of
accounting. Careside acquired substantially all assets of TIL for $2,869,565,
which represented the market value of the 521,739 shares of common stock on
the date of acquisition. The excess of the purchase price over the book value
of TIL was recorded as goodwill in the amount of $2,834,747. Goodwill will be
amortized over a five-year period. Amortization expense was $36,577 in 1999
and $566,949 in 2000.
The following unaudited proforma results of operations for the years ended
December 31, 1998 and 1999 have been prepared as if the acquisition of TIL
occurred on January 1, 1998:
Years Ended December 31,
-------------------------
1998 1999
----------- ------------
(unaudited)
Revenue........................................... $ 285,856 $ 321,823
Net loss.......................................... (9,532,870) (12,103,215)
Net loss available to common stockholders......... (9,532,870) (12,158,416)
Basic and diluted loss per common share........... (1.85) (1.81)
9. Related Party Transactions
In December 1998, Careside entered into an agreement with an affiliate of
SmithKline for up to $3,000,000 of bridge financing. In 1999, $1,000,000 of
this debt, plus $38,575 of accrued and unpaid interest was converted to Series
A Preferred Stock (see Note 7).
In 1999, the Careside entered into an agreement with Advanced Medical
Information Technologies, Inc. (AdMIT) to develop software and hardware.
During 1999, Careside paid AdMIT $300,000 which was included in research and
development--software expense. In November 1999, one of the owners of AdMIT
was hired by Careside to be its Senior Vice President and Chief Information
Officer. In May 2000, the Company amended its agreement with AdMIT to commit
to an additional expenditure of $300,000, of which $200,000 has been incurred
and expensed in 2000. In connection with the amendment, the Company also
received a 15 percent ownership interest in AdMIT. This investment is carried
at no value due to uncertainty regarding the long-term realizability of the
investment. In addition to commitments under this agreement, Careside made
additional payments of $76,000 to AdMIT in 2000 for additional research and
development expenditures. In addition during 2000, payments of $275,000 for
software programming were made to a consulting firm where the CIO's brother is
one of the partners. These payments totaling $275,000 were for contract
programming and were invoiced at rates which management believes are below
market cost from similar competitive service providers.
F-14
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
10. Debt
Long-term debt consists of the following:
December 31,
------------------------
1999 2000
----------- -----------
Note payable, interest at 10%, due on November 30,
2001................................................ $ 2,000,000 $ 2,000,000
Equipment loan due to finance company, interest at
14%, due in monthly, installments of principal and
interest of $26,837, with a final payment of
$133,490 in December 2002........................... 854,286 638,945
Equipment loan due to finance company, interest at
15%, due in monthly installments of principal and
interest of $14,347, with a final payment of $69,854
in September 2003................................... 521,782 421,929
Equipment loan due to finance company, interest at
15%, due in monthly installments of principal and
interest of $20,696, with a final payment of $99,432
in January 2004..................................... -- 651,490
----------- -----------
3,376,068 3,712,364
Less--Current Portion................................ (2,316,192) (2,519,946)
----------- -----------
$ 1,059,876 $ 1,192,418
=========== ===========
In December 1998, Careside entered into a $2,500,000 facility with an
equipment financing company. Borrowings under the facility are evidenced as
separate loans and are secured by specific equipment assets. Each equipment
loan has a 48-month term and bears interest at approximately 14% and 15% per
year. As of December 31, 2000, approximately $2.4 million of the facility had
been drawn under this facility to finance equipment purchases. Careside
recorded interest expense of $0, $155,369 and $283,579 in 1998, 1999 and 2000,
respectively related to these borrowings.
In December 1998, Careside entered into an agreement with an affiliate of
SmithKline (S.R. One, Limited) for up to $3,000,000 of bridge financing, of
which $1,500,000 was drawn on December 28, 1998 and the remaining $1,500,000
was drawn on January 31, 1999. The extended maturity date is June 30, 2001.
Careside issued a warrant (the "Bridge Warrant") in connection with the bridge
financing. The Bridge Warrant was originally exercisable into that number of
shares of common stock which is equal to $750,000 divided by 85% of the
initial public offering price per share. The Bridge Warrant has an exercise
price of $6.375 per share. The Bridge Warrant became exercisable in December
1999 and expires on June 16, 2004. Using the Black-Scholes pricing 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 was amortized over the estimated term of the note as additional interest
expense. In June 1999, $1,000,000 of the bridge financing plus $38,575 of
unpaid interest was converted to Series A Convertible Preferred Stock (see
Note 7). In connection with the conversion, the Bridge Warrant was modified
such that it will be exercisable into that number of shares of common stock
which is equal to $1,500,000 divided by 85% of the Offering price per share.
Using the Black-Scholes pricing model, the estimated fair value of the
increase in shares under the Bridge Warrant modification was calculated at
$289,801 and was recorded as interest expense in 1999, with a corresponding
increase in stockholders' equity. In November 2000, the bridge note expiration
date was extended to June 30, 2001. In conjunction with the extension, the
bridge warrant expiration date was extended to June 16, 2004. Using the Black-
Scholes pricing model the estimated fair value of the bridge warrant
modification was calculated to be $172,138 and will be recorded as non-cash
interest expense over the extended period of the loan. S. R. One has 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 would be issued to S.R. One on the same
basis as the Series A Convertible Preferred Stock that was issued to S. R. One
in connection with the $1 million conversion discussed above.
F-15
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
Future maturities of debt at December 31, 2000 are as follows:
2001............................................................ $2,519,946
2002............................................................ 709,306
2003............................................................ 384,973
2004............................................................ 98,139
----------
$3,712,364
==========
11. Stock Options and Warrants
Stock Options
Careside has adopted various stock option plans, which provide for the
granting of options to purchase up to 1,201,923 shares of common stock to
directors, officers, consultants and employees of the Company. At December 31,
2000 603,260 shares were available for future grant under the plans. 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. Generally,
options are not granted at prices below the fair market value at the date of
grant. Each option expires on such date as the Board of Directors may
determine. Generally options vest from 3 to 5 years.
The table below summarizes the option activity for 1998, 1999, and 2000:
Weighted Exercisable
Weighted Average Fair Weighted
Number Average Value of Average
of Exercise Options Granted Number Exercise
Shares Price During the Year Exercisable Price
------- -------- --------------- ----------- -----------
Outstanding at December
31, 1997............... 317,163 $5.49 23,051 $5.28
======= =====
Granted............... 111,950 6.76 $1.83
=====
Exercised............. (17,715) 6.76
Cancelled............. (673) 5.20
------- -----
Outstanding at December
31, 1998............... 410,725 5.78 198,343 $5.08
======= =====
Granted............... 95,017 6.17 $2.82
=====
Exercised............. -- --
Cancelled............. (8,365) 6.07
------- -----
Outstanding at December
31, 1999............... 497,377 5.85 390,278 $5.76
======= =====
Granted............... 148,500 8.62 $5.10
=====
Exercised............. (1,154) 0.05
Cancelled............. (64,929) 7.42
------- -----
Outstanding at December
31, 2000............... 579,794 $6.40 479,857 $6.05
======= ===== ======= =====
The table below summarizes information about options outstanding at
December 31, 2000:
Weighted Weighted
Number Average Average Number
Outstanding at Remaining Exercise Price Exercisable at
Range of December 31, Contractual of Options December 31,
Exercise Prices 2000 Life Outstanding 2000
--------------- -------------- ----------- -------------- --------------
$5.00-6.00......... 341,252 6.7 years $5.42 335,511
$6.69-10.00........ 238,542 7.2 years $7.79 144,346
------- --------- ----- -------
$5.00-10.00........ 579,794 6.9 years $6.40 479,857
======= ========= ===== =======
F-16
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
As permitted by SFAS No. 123 "Accounting for Stock-Based Compensation," the
Company continues to apply the accounting rules of APB No. 25 governing the
recognition of compensation expense for employee stock options. Such
accounting rules measure compensation expense on the first date at which both
the exercise price and the number of shares are known. Expense is only
recognized in circumstances where the exercise price is less than the fair
market value at the measurement date. No such expense has been recorded in the
accompanying consolidated statements of operations. In 1998 Careside issued
1,154 options to a consultant. Compensation expense recorded for these options
was immaterial.
Under the requirements of SFAS No. 123 pro forma disclosure of compensation
expense using the fair value method is required to be disclosed if the Company
applies APB No. 25. Pro forma compensation has been computed by estimating the
fair value of options at the date of grant using the Black-Scholes option
pricing model.
The following assumptions were used in estimating the fair value of
options:
1998 1999 2000
--------- ---------- ----------
Weighted average risk-free interest
rate.................................. 5.56% 5.92% 6.50%
Weighted average expected life......... 7.0 years 4.17 years 4.00 years
Weighted average volatility............ 0% 60% 72.5%
Dividend yield......................... 0% 0% 0%
Had the compensation cost of these options been recorded for the years
ended December 31, 1998, 1999 and 2000, the Company's net loss would have been
as follows:
1998 1999 2000
----------- ------------ ------------
Net Loss:
As reported.......................... (8,936,289) (11,645,834) (16,939,241)
Pro forma............................ (9,279,356) (12,055,116) (17,388,486)
Loss per share:
As reported.......................... $ (1.93) $ (1.88) $ (1.92)
Pro forma............................ $ (2.00) $ (1.94) $ (1.98)
Stock Warrants
The following table summarizes outstanding warrants at December 31, 2000
issued in connection with private equity financings and the initial public
offering (the Offering):
Outstanding Exercise Issuance Expiration
Type of Warrants Warrants Price Date Date
---------------- ----------- -------- -------------- --------------
Common Stock................. 384,615 $ 5.20 February 1997 February 2004
Common Stock................. 339,312 6.76 June 1998 June 2005
Common Stock................. 235,294 6.38 December 1998 June 2004
Units........................ 200,000 9.00 June 1999 June 2004
Common Stock................. 101,305 8.77 March 2000 March 2005
Common Stock................. 179,626 9.00 July 2000 June 2004
Common Stock................. 25,000 5.63 September 2000 September 2005
Common Stock................. 50,000 5.63 September 2000 September 2005
Common Stock................. 4,000,000 14.00 September 2000 September 2002
Common Stock................. 66,324 2.56 November and November and
December 2000 December 2004
---------
5,581,476
=========
F-17
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
The warrants to purchase 200,000 units were granted to the underwriters of
the Offering. Each warrant carries an exercise price of $9.00 and allows the
purchase of one share of common stock and a tradable warrant identical to
those sold in the Offering. The warrants are exercisable for a four year
period beginning on the first anniversary of the Offering. (See Notes 6 and 7
for discussion of warrants issued in 2000.)
12. Statements of Cash Flows
The Company prepares its statements of cash flows using the indirect method
as defined under SFAS No. 95. The Company considers all highly liquid
investments with an original maturity of three months or less to be cash
equivalents. Supplemental cash flows disclosures are as follows:
1998 1999 2000
----- -------- --------
Cash paid for interest.............................. $ -- $157,653 $317,851
Cash paid for income taxes.......................... -- -- --
Non-cash Investing and Financing Activities:
1998 1999 2000
----- ---------- --------
Conversion of bridge financing to Series A
Preferred Stock................................. $ -- $1,038,575 $ --
Acquisition of equipment under capital lease..... -- 52,980 --
Accrued dividends on Series A Preferred stock.... -- 55,201 51,787
Accrued dividends on Series B Preferred stock.... -- -- 16,897
Accreted dividends on Series B Preferred stock... -- -- 83,028
Beneficial conversion feature on Series B
Preferred stock................................. -- -- 84,044
Conversion of Series A Preferred stock and unpaid
dividends....................................... -- -- 106,988
Conversion of Series B Preferred stock........... -- -- 55,275
Cashless exercise of common stock warrant........ -- -- 4
In connection with the Company's initial public offering, $498,433 of
previously unpaid deferred offering costs were offset against accounts payable
in 1999.
In connection with the acquisition of TIL in December 1999, the Company
recorded the following non-cash amounts which have been excluded from the
consolidated statement of cash flows:
Additional paid-in capital..................................... $2,869,565
Goodwill....................................................... 2,834,747
Net assets acquired............................................ 34,818
13. Commitments
Leases
The Company leases office and laboratory facilities under non-cancelable
operating leases expiring from August 2000 to April 2007. Rent expense for the
years ended 1998, 1999 and 2000 was $156,756, $174,497 and $323,168,
respectively.
Included in property and equipment is approximately $52,980 of equipment,
at acquisition cost, which is leased under a noncancellable lease accounted
for as a capital lease expiring in June 2003. Accumulated depreciation in 1999
and 2000 related to equipment under capital leases was $4,415 and $21,287,
respectively.
F-18
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
At December 31, 2000, the future minimum annual rental payments under lease
agreements are as follows:
Capital Operating
Leases Leases Total
-------- ---------- ----------
December 31:
2001......................................... 16,875 339,259 356,134
2002......................................... 16,875 363,615 380,490
2003......................................... 9,020 373,229 382,249
2004......................................... -- 386,107 386,107
2005......................................... -- 400,008 400,008
Thereafter................................... -- 326,983 326,983
-------- ---------- ----------
42,770 $2,189,201 $2,231,971
========== ==========
Less--Amount representing interest at
approximately 14 percent.................... (6,935)
--------
Present value of minimum lease payments...... 35,835
--------
Less--Current portion........................ (12,650)
--------
$ 23,185
========
Collaborative Arrangements
Careside has utilized strategic partners with specific design and
technology expertise 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 Hematology, Inc. has an agreement with
Ysebaert, Inc., the manufacturer of the H-2000. The Company has minimum
purchase requirements, as defined in the agreements, with two of its
suppliers. Purchase commitment levels were not met for the year ended December
31, 2000. These suppliers have agreed not to enforce the fiscal 2000
requirements.
The Company purchases its dry film based chemistry reagents solely from
Fuji Photo Film Co., Ltd. In addition, UMM Electronics, Inc. is the sole
designer and manufacturer of the Careside Analyzer. The loss of these
suppliers could impact the Company's ability to obtain and produce these items
in the short-term. However, the Company believes that acceptable alternative
suppliers are available.
Employment Agreements
In 1997 and 1998 the Company entered into three-year renewable employment
agreements with three of its executive officers that provide for aggregate
annual compensation of approximately $660,000.
14. Profit Sharing Plan
The Company 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 percent of their compensation to the plan.
The Company matches 50 percent of the employee's contribution up to 4 percent
of an employee's compensation. Contributions under the Plan were, $34,657,
$47,195 and $72,913 for the years ended 1998, 1999 and 2000, respectively.
F-19
CARESIDE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
15. Employee Stock Purchase Plan
In 1999, the Company's shareholders approved the Employee Stock Purchase
Plan ("ESPP"), under which 150,000 shares of the Company's common stock could
be sold to employees. Each quarter, an eligible U.S. employee may elect to
withhold up to 15 percent of his or her salary to purchase shares of the
Company's stock at a price equal to 85 percent of the fair value of the stock
as of the first day of the quarter, or the last day of the quarter. The ESPP
will terminate at the earlier of the date that all 150,000 shares have been
sold or the date as of which the Board of Directors chooses to terminate the
plan as provided in the plan provision. In 1999, 3,502 shares of the Company's
stock were sold under the ESPP for $16,792. During 2000, 30,454 shares of the
Company's stock were sold under the ESPP for $103,268 and at December 31,
2000, 116,044 shares remained available for sale.
16. Subsequent Events
In January 2001, the Company granted 401,500 options to its employees under
the 1996 and 1998 stock option Plans with a weighted average exercise price of
$2.69 per share. There were an additional 37,500 options granted to non-
employee directors under the 1998 Director Stock Option Plan with a weighted
average exercise price of $2.69 per share.
In January 2001, the Company sold 416,472 shares of common stock in a
private placement for $2.25 per share (at 90 percent of the closing price on
that date) resulting in proceeds of $857,411, net of $79,650 of offering
costs. In connection with the sale, the Company issued a warrant exercisable
into 20,824 shares of the Company's common stock at an exercise price of $2.25
per share. The estimated fair value of the warrant using the Black-Scholes
option pricing model was $31,220 and was offset against the proceeds of the
sale.
F-20