<PAGE> 1
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2000
COMMISSION FILE NUMBER 0-19841
i-STAT CORPORATION
(Exact name of Registrant as specified in its charter)
DELAWARE 22-2542664
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
104 WINDSOR CENTER DRIVE, EAST WINDSOR, NJ 08520
(Address of principal executive offices) (Zip Code)
(609) 443-9300
(Registrant's telephone number, including area code)
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 [ ]
The number of shares outstanding of each of the Issuer's classes of Common Stock
as of the latest practicable date.
Class August 9, 2000
----- --------------
Common Stock, $ .15 par value 18,349,592
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i-STAT CORPORATION
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
NUMBER
<S> <C>
PART I FINANCIAL INFORMATION
Item 1 - Financial Statements
Consolidated Condensed Statements of Operations
for the three months and six months ended June 30, 2000 and 1999 .......... 3
Consolidated Condensed Balance Sheets
as of June 30, 2000 and December 31, 1999 ................................. 4
Consolidated Condensed Statements of Cash Flows
for the six months ended June 30, 2000 and 1999 ........................... 5
Notes to Consolidated Condensed Financial Statements .......................... 6 - 8
Item 2 - Management's Discussion and Analysis of Financial
Condition and Results of Operations ................................. 9 - 13
PART II OTHER INFORMATION
Item 1 - Legal Proceedings .................................................... 14
Item 4 - Submission of Matters to a Vote of Security Holders................... 15
Item 6 - Exhibits and Reports on Form 8-K ..................................... 16
SIGNATURES .............................................................................. 17
</TABLE>
2
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i-STAT CORPORATION
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS OF DOLLARS, EXCEPT SHARE AND PER SHARE DATA)
(unaudited)
<TABLE>
<CAPTION>
Three Months Ended Six Months Ended
June 30, June 30,
-------- --------
2000 1999 2000 1999
---- ---- ---- ----
<S> <C> <C> <C> <C>
Net revenues:
Related party sales............... $ 11,290 $ 8,853 $ 19,993 $ 16,909
Third party sales................. 2,564 1,912 4,070 3,653
Other related party revenues...... 955 661 1,900 1,201
------------- ------------- ------------- --------------
Total net revenues............ 14,809 11,426 25,963 21,763
Cost of sales.......................... 11,134 10,422 21,896 18,505
------------- ------------- ------------- --------------
Gross profit............. 3,675 1,004 4,067 3,258
------------- ------------- ------------- --------------
Operating expenses:
Research and development.......... 2,115 2,008 4,269 3,938
General and administrative........ 1,911 1,772 3,426 4,730
Sales and marketing............... 2,079 2,084 3,977 4,387
Litigation settlement............. 1,500 -- 1,500 --
------------- ------------- ------------- --------------
Total operating expenses...... 7,605 5,864 13,172 13,055
------------- ------------- ------------- --------------
Operating loss........... (3,930) (4,860) (9,105) (9,797)
-------------- -------------- -------------- ---------------
Other income (expense), net............ 439 368 945 814
------------- ------------- ------------- --------------
Net loss............................... $ (3,491) $ (4,492) $ (8,160) $ (8,983)
============== ============== ============== ==============
Basic and diluted net loss per share... $ (0.19) $ (0.26) $ (0.46) $ (0.51)
============== ============= ============== ===============
Shares used in computing basic and
diluted net loss per share........ 18,004,095 17,518,028 17,884,660 17,495,997
============= ============= ============= ==============
</TABLE>
The accompanying notes are an integral part of these consolidated condensed
financial statements.
3
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i-STAT CORPORATION
CONSOLIDATED CONDENSED BALANCE SHEETS
(IN THOUSANDS OF DOLLARS, EXCEPT SHARE AND PER SHARE DATA)
(unaudited)
<TABLE>
<CAPTION>
June 30, December 31,
2000 1999
---- ----
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents.......................................... $ 27,830 $ 25,575
Accounts receivable, net........................................... 989 413
Accounts receivable from related parties........................... 2,953 4,185
Inventories........................................................ 10,207 8,886
Prepaid expenses and other current assets.......................... 1,247 1,185
----------- -----------
Total current assets........................................... 43,226 40,244
Plant and equipment, net of accumulated depreciation of
$26,688 AND $24,761................................................ 16,593 15,936
Other assets............................................................ 1,903 1,944
----------- -----------
Total assets................................................... $ 61,722 $ 58,124
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable................................................... $ 2,590 $ 2,269
Accrued expenses................................................... 4,979 4,453
Deferred revenue (inclusive of related party deferred
revenue of $9,478 in 2000 and $1,545 in 1999).................. 9,498 1,564
----------- -----------
Total current liabilities...................................... 17,067 8,286
----------- -----------
Deferred revenue from related party, non-current................... 5,141 5,175
----------- -----------
Total liabilities.............................................. 22,208 13,461
----------- -----------
Stockholders' equity:
Preferred stock, $.10 par value, shares authorized 7,000,000:
Series A Junior Participating Preferred Stock, $.10 par value,
1,500,000 shares authorized; none issued....................... -- --
Series B Preferred Stock, $.10 par value, shares authorized, 2,138,702:
shares issued and outstanding -0- at June 30, 2000
and 2,138,702 at December 31, 1999............................. -- 214
Common Stock, $.15 par value, shares authorized 25,000,000:
shares issued and outstanding 18,314,925 at June 30, 2000
and 15,761,630 at December 31, 1999............................ 2,747 2,364
Treasury Stock, at cost, 40,817 shares at June 30, 2000 and
-0- shares at December 31, 1999................................ (750) --
Additional paid-in capital......................................... 237,939 234,487
Unearned compensation.............................................. (1,151) (1,547)
Loan to officer, net............................................... (825) (716)
Accumulated deficit................................................ (197,630) (189,470)
Accumulated other comprehensive loss related to
foreign currency translation................................... (816) (669)
----------- -----------
Total stockholders' equity..................................... 39,514 44,663
----------- -----------
Total liabilities and stockholders' equity..................... $ 61,722 $ 58,124
=========== ===========
</TABLE>
The accompanying notes are an integral part of these consolidated condensed
financial statements.
4
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i-STAT CORPORATION
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(IN THOUSANDS OF DOLLARS)
(unaudited)
<TABLE>
<CAPTION>
Six Months Ended
June 30,
--------
2000 1999
---- ----
<S> <C> <C>
Cash flows from operating activities:
Net loss............................................................. $ (8,160) $ (8,983)
Adjustments to reconcile net loss to net cash provided by
(used in) operating activities.................................... (70) 1,996
Change in assets and liabilities..................................... 10,982 732
----------- -------------
Net cash provided by (used in) operating activities............... 2,752 (6,255)
----------- -------------
Cash flows from investing activities:
Purchase of equipment................................................ (3,021) (3,704)
Other................................................................ (111) (161)
----------- -------------
Net cash used in investing activities............................. (3,132) (3,865)
----------- -------------
Cash flows from financing activities:
Proceeds from issuance of common stock............................... 3,488 205
Purchase of treasury stock........................................... (750) --
Loan to officer...................................................... (257) (716)
---------- -------------
Net cash provided by (used in) financing activities............... 2,481 (511)
----------- ------------
Effect of currency exchange rate changes on cash..................... 154 (45)
----------- ------------
Net increase (decrease) in cash and cash equivalents................. 2,255 (10,676)
Cash and cash equivalents at beginning of period..................... 25,575 38,390
----------- -------------
Cash and cash equivalents at end of period........................... $ 27,830 $ 27,714
=========== =============
</TABLE>
The accompanying notes are an integral part of these consolidated condensed
financial statements.
5
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i-STAT CORPORATION
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(unaudited)
1. GENERAL
Basis of Presentation
The information presented as of June 30, 2000 and 1999, and for the
periods then ended, is unaudited, but includes all adjustments
(consisting only of normal recurring accruals) which the management of
i-STAT Corporation (the "Company") believes to be necessary for the
fair presentation of results for the periods presented. The results for
the interim periods are not necessarily indicative of results to be
expected for the year. The year end consolidated condensed balance
sheet data was derived from the audited financial statements, but does
not include all disclosures required by generally accepted accounting
principles. These condensed financial statements should be read in
conjunction with the Company's audited financial statements for the
year ended December 31, 1999, including the Notes thereto, which were
included as part of the Company's Annual Report on Form 10-K, File No.
0-19841.
Basic and Diluted Loss per Share
Basic and diluted net loss per share is calculated using the weighted
average number of common shares and preferred shares outstanding for
all periods presented. Series B preferred shares have been included in
the calculations since their date of issuance and through conversion in
March 2000, as they are convertible into common shares on a 1:1 basis
and have substantially the same characteristics as common stock. Basic
EPS excludes dilution and is computed by dividing income available to
common stockholders by the weighted-average number of common shares
outstanding for the period. Diluted EPS reflects the potential dilution
that could occur if securities or other contracts to issue common stock
were exercised or converted into common stock or resulted in the
issuance of common stock that then shared in the earnings of the
entity. The Company has not included potential common shares in the
diluted per-share computation, as the result is antidilutive.
Options to purchase 2,829,156 shares of common stock at $1.50 - $32.58
per share, which expire on various dates from November 2000 to June
2010, were outstanding at June 30, 2000. These shares were not included
in the computation of diluted EPS because the effect would be
antidilutive due to the net loss.
Comprehensive Income
<TABLE>
<CAPTION>
Three Months Ended Six Months Ended
June 30, June 30,
2000 1999 2000 1999
(in thousands of dollars)
<S> <C> <C> <C> <C>
Net loss ........................... $ (3,491) $ (4,492) $ (8,160) $ (8,983)
Other comprehensive income (loss):
Foreign currency translation ... (167) 204 (147) 427
---------- ----------- ----------- ----------
Comprehensive loss ................. $ (3,658) $ (4,288) $ (8,307) $ (8,556)
========== ========== ========== ==========
</TABLE>
Recently Issued Accounting Pronouncements:
In June 1998, the FASB issued SFAS No. 133, "Accounting for Derivative
Instruments and Hedging Activities". SFAS No. 133 is effective for all
fiscal quarters of all fiscal years beginning after June 15, 2000
(January 1, 2001 for the Company). SFAS No. 133 requires that all
derivative instruments be recorded on the balance sheet at their fair
value. Changes in the fair value of derivatives are recorded each
period in current earnings or other comprehensive income, depending on
whether a derivative is designated as part of a hedge transaction and,
if it is, the type of hedge transaction. The Company presently does not
have any derivative instruments or hedging activities and,
consequently, SFAS No. 133 is not expected to have a material impact on
the Company's results of operations, financial position or cash flows.
In December 1999, the Securities and Exchange Commission ("SEC")
issued Staff Accounting Bulletin No. 101 ("SAB 101") which addresses
the staff's views on the application of U.S. generally accepted
accounting principles for revenue recognition. The Company will be
required to adopt the guidance of this bulletin no later than the
fourth quarter of 2000. The Company does not expect SAB 101 to have a
material impact on its financial condition or results of operations.
6
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i-STAT CORPORATION
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(unaudited)
(continued)
Reclassification:
Certain reclassifications have been made to 1999 amounts to conform
them to the 2000 presentations.
2. INVENTORIES
Inventories consist of the following:
<TABLE>
<CAPTION>
June 30, 2000 December 31, 1999
(In thousands of dollars)
<S> <C> <C>
Raw materials $ 4,947 $ 3,402
Work in process 3,388 2,764
Finished goods 1,872 2,720
---------- ---------
$ 10,207 $ 8,886
========== =========
</TABLE>
3. COMMITMENTS AND CONTINGENCIES
The Company is a defendant in a case entitled Nova Biomedical
Corporation, Plaintiff v. i-STAT Corporation, Defendant. The Complaint,
which was filed in the United States District Court for the District of
Massachusetts on June 27, 1995, alleges infringement by i-STAT of
Nova's U.S. Patent No. 4,686,479. In February 1998, the Court entered
summary judgment in favor of the Company on the issue of patent
infringement. The plaintiff appealed the dismissal to the Federal
Circuit which affirmed two of the grounds of the dismissal (proper
interpretation of the patent and the fact that the Company does not
literally infringe), but remanded the case back to the District Court
with instructions to reconsider whether the Company's device is the
equivalent of the patented device and therefore infringes under the
"doctrine of equivalents." The Company has submitted to the Court a
motion for summary judgment in its favor on the "doctrine of
equivalents," and oral argument on this motion has been set for August
2000. Should the plaintiff prevail on this issue, it could have a
material and adverse impact on the financial position, results of
operations and cash flows of the Company.
The Company was a defendant in a class action complaint entitled Susan
Kaufman, on behalf of herself and all others similarly situated,
Plaintiff, v. i-STAT Corporation, William P. Moffitt, Lionel M.
Sterling, Imants R. Lauks and Matthias Plum, Jr. The class action was
brought by Susan Kaufman on her behalf and on behalf of all purchasers
of the Company's Common Stock between May 9, 1995 and March 19, 1996.
The complaint, which was filed in the Superior Court of New Jersey in
Mercer County on June 19, 1996, alleged New Jersey common law fraud and
negligent misrepresentation, and is predicated on a "fraud on the
market" theory in connection with certain sales of i-STAT stock by the
Company's chief executive officer, chief technology officer and two
outside directors during a nine-month period. The plaintiff sought
unspecified compensatory damages, interest and payment of all costs and
expenses incurred in connection with the class action. On April 28,
1998, the Court entered summary judgment in favor of all the
defendants. The plaintiff appealed and on August 10, 1999, the
Appellate Division of the Superior Court filed an opinion sustaining
the trial court's determination as to the negligent misrepresentation
claims but reversing as to the common law fraud claims. The Company
appealed the reversal and, on July 27, 2000, the Supreme Court of the
State of New Jersey reversed the decision of the Appellate Division and
reinstated the decision of the Superior Court dismissing the
plaintiff's action. In doing so, the Supreme Court ruled that New
Jersey does not recognize a class action lawsuit predicated on the
"fraud on the market" theory in connection with the purchase or sale of
securities. As a result of this ruling, the Company, which has always
viewed the complaint as being entirely without merit, believes that no
action which is based on the same alleged facts would be sustained
against the Company or any of the named defendants in either state or
Federal courts.
The Company was a defendant in a case entitled Customedix Corporation,
Plaintiff v. i-STAT Corporation, Defendant. The complaint, which was
filed in the United States District Court for the District of
Connecticut on December 26, 1996, alleged infringement by i-STAT of
Customedix's U.S. Patent No. 4,342,964. The plaintiff sought injunctive
relief and an accounting for i-STAT'S profits and the damages to
Customedix from such alleged infringement.
7
<PAGE> 8
i-STAT CORPORATION
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(unaudited)
(continued)
Although the Company was prepared to contest the case vigorously, did
not believe that it had infringed the Customedix patent and had
obtained an opinion from recognized patent counsel to the effect that
no infringement had occurred, management concluded that the
uncertainty inherent in any litigation as well as the drain on
management's time and the Company's resources merited an amicable
resolution of this lawsuit. Accordingly, on June 14, 2000, the
Company entered into a settlement agreement under which the Company
paid the plaintiff $1.5 million and the plaintiff agreed to
permanently withdraw the complaint and to release the Company from any
and all claims of whatsoever nature that the plaintiff may have had
against the Company, whether under the referenced Patent or otherwise.
4. RELATED PARTY TRANSACTIONS
In January 2000, the Company received from Abbott Laboratories
("Abbott") the third installment of prepayments for guaranteed future
incremental cartridge sales (as defined in the Distribution Agreement
with Abbott), in the amount of $10.8 million. This amount, and the
second installment of $4.0 million which was received in January 1999,
are carried on the consolidated condensed balance sheet as deferred
revenue, current, net of amortization of such prepayments to income as
incremental cartridge sales are generated. The first installment of
$5.0 million is carried on the consolidated condensed balance sheet as
deferred revenue, non-current, and will be amortized to income after
the other installments have been fully amortized to income.
The Company generated $11,290,000 and $8,040,000 of net sales from
Abbott for the three months ended June 30, 2000 and 1999, respectively,
and $19,854,000 and $15,221,000 for the six months ended June 30, 2000
and 1999, respectively. Other related party revenues from Abbott
comprise approximately $955,000 and $661,000 for the three months ended
June 30, 2000 and 1999, respectively, and $1,900,000 and $1,201,000 for
the six months ended June 30, 2000 and 1999, respectively, to fund
certain research and development and marketing expenses. At June 30,
2000, the company had $2,953,000 of accounts receivable due from
Abbott. In addition, the company had $9,478,000 and $1,545,000 of
deferred revenue, current, and $5,141,000 and $5,175,000 of deferred
revenue, non-current, from Abbott at June 30, 2000, respectively, and
December 31, 1999, respectively.
On March 16, 2000, Agilent Technologies, Inc., a subsidiary of
Hewlett-Packard Company, converted its holding of 2,138,702 shares of
Series B Preferred Stock into 2,138,702 shares of Common Stock, and
sold its holding and is no longer a related party.
5. RESTRICTED STOCK
On February 5, 1999, the board of directors awarded 310,000 shares of
restricted Common Stock to four executive officers of the Company. The
restricted Common Stock had a fair value at the date of grant of
approximately $2,751,250. One executive officer was awarded 250,000
shares of restricted Common Stock, 50,000 shares of which immediately
vested on February 5, 1999, and the remaining 200,000 shares cliff vest
on February 5, 2002. The 60,000 shares awarded to the other three
executive officers vest over a three year period.
In connection with the award of 250,000 shares to one executive
officer, on June 30, 1999, the Company loaned the executive officer
approximately $716,000 to pay withholding taxes. The promissory note
for the withholding tax amount carries an interest rate of 5.37%,
payable annually, and the principal amount of the loan is repayable
three years from the date of the execution of a second promissory note
for the remaining taxes of approximately $257,000 which were loaned on
April 13, 2000 at an interest rate of 6.36%. One third of the principal
amount of these loans will be forgiven on each anniversary date of the
loan for the remaining taxes if the executive officer remains in the
employment of the Company. The Company will also make a "tax gross-up"
payment to the executive officer in connection with any taxes that may
be due as a result of the forgiveness of these loans.
Compensation expenses in the amount of approximately $297,000 and
$215,000 were recorded in connection with these awards, the loan
forgiveness and the associated tax gross-up payment during the three
months ended June 30, 2000 and 1999, respectively, and $568,000 and
$802,000 during the six months ended June 30, 2000 and 1999,
respectively.
8
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i-STAT CORPORATION
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
GENERAL
The Company was incorporated in Delaware in 1983 and develops,
manufactures and markets medical diagnostic products for blood analysis that
provide health care professionals with immediate and accurate critical,
diagnostic information at the point of patient care. The Company's current
products, known as the i-STAT(R) System, consist of portable, hand-held
analyzers and single-use disposable cartridges, each of which simultaneously
performs different combinations of commonly ordered blood tests in approximately
two minutes. The i-STAT System also includes peripheral components that enable
the results of tests to be transmitted by infrared means to both a proprietary
information system for managing the user's point-of-care testing program and to
the user's information systems for billing and archiving.
The i-STAT System currently performs blood tests for sodium,
potassium, chloride, glucose, creatinine, urea nitrogen, hematocrit, ionized
calcium, lactate, Celite(R) Act (activated clotting time), arterial blood gases,
and bicarbonate, and derives certain other values, such as total carbon dioxide,
base excess, anion gap, hemoglobin and O(2) saturation, by calculation from the
tests performed. The Company continues to engage in research and development in
order to improve its existing products and develop new products based on the
i-STAT System technology. The Company currently is developing three additional
tests for the measurement of coagulation: kaolin ACT, partial thromboplastin
time ("aPTT"), and prothrombin time ("PT"). The Company is also studying the
development of cardiac marker tests. The Company also is in the process of
developing an analyzer and associated peripheral equipment which, in addition to
having the measurement capabilities currently possessed by the i-STAT System,
will incorporate the glucose measurement capabilities of an Abbott Laboratories
("Abbott") product.
Prior to November 1, 1998, the Company marketed and distributed its
products in the United States and Canada principally through its own direct
sales and marketing organization, in Japan through Japanese marketing partners,
in Europe through Hewlett-Packard Company ("HP") and in Mexico, South America,
China, Australia, and certain other Asian and Pacific Rim countries, through
selected distribution channels. Pursuant to a technology collaboration between
the Company and HP, in November 1997 HP commenced selling a patient monitoring
system which integrates all of the blood diagnostics capabilities of the i-STAT
System. On September 2, 1998, the Company entered into a long-term sales,
marketing and research alliance with Abbott which, among other things, has
altered significantly the manner in which the Company markets and sells its
products worldwide. The majority of the Company's revenues are now derived from
Abbott. Please see "Long-Term Sales and Marketing Alliance with Abbott
Laboratories" under item 7 of the Company's Annual Report on Form 10-K for the
year ended December 31, 1999 for a description of the Company's agreements with
Abbott. Copies of such agreements were filed with the Securities and Exchange
Commission as exhibits to the Company's Quarterly Report on Form 10-Q for the
quarterly period ended June 30, 1998.
RESULTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 2000
The Company generated revenues of approximately $14.8 million and $11.4
million for the three months ended June 30, 2000 and 1999, respectively,
including international revenues (as a percentage of total revenues) of $4.0
million (27.3%) and $2.9 million (25.4%), respectively. Revenues from Abbott
represented approximately 82.7% And 76.1% Of the Company's worldwide revenues
for the three months ended June 30, 2000 and 1999, respectively.
The $3.4 million (29.6%) increase in revenues was primarily due to
increased shipment volumes of the Company's cartridges, reflecting higher
cartridge consumption by existing hospital customers and the addition of new
hospital customers in the United States and internationally, and the shipment of
cartridge backorders from the first quarter of 2000. Worldwide cartridge
shipments increased 33.9% to 2,587,525 units in the three months ended June 30,
2000, from 1,932,800 units in the three months ended June 30, 1999. Revenues
from the increased cartridge shipments were offset by lower worldwide average
selling prices per cartridge, which declined from approximately $4.04 to $3.96
per cartridge in the same periods. Cartridge average selling prices are expected
to continue to decline because of the product transfer pricing arrangements
applicable under the strategic alliance between the Company and Abbott. The
increase in revenues also reflects an increase in shipment volumes of the
Company's analyzers and peripheral equipment, and an increase of approximately
$0.3 million in reimbursements from Abbott to fund certain research and
development and marketing expenses (the "Abbott Reimbursements"). The Abbott
Reimbursements are shown as "Other related party revenues" on the consolidated
condensed statements of operations.
9
<PAGE> 10
i-STAT CORPORATION
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(continued)
Gross profit (as a percentage of sales) increased by approximately $2.7
million to $3.7 million (24.8%) in the quarter ended June 30, 2000, compared
with a gross profit of $1.0 million (8.8%) in the quarter ended June 30, 1999.
Gross profit in the prior year quarter included a charge of approximately $1.7
million resulting from temporary production losses associated with one of the
newer manufacturing processes. The improvement in gross profit was primarily due
to increased production volume of the Company's cartridges, which caused fixed
manufacturing costs to be spread over a larger number of product units, and an
increase of approximately $0.3 million in Abbott Reimbursements. The increase in
gross profit was partially offset by lower average selling prices per cartridge
and lower average selling prices for analyzers, in each case because of the
transfer pricing arrangements between the Company and Abbott.
The Company incurred research and development costs (as a percentage of
sales) of approximately $2.1 million (14.3%) and $2.0 million (17.6%) for the
three months ended June 30, 2000 and 1999, respectively, consisting of costs
associated with the personnel, material, equipment and facilities necessary for
conducting new product development. The Company's current research and
development program includes the development of tests for coagulation, one of
which, Celite(R) ACT (activated clotting time), received Food and Drug
Administration clearance to market in early 2000. The company currently is
developing three additional tests for the measurement of coagulation: kaolin
ACT, partial thromboplastin time ("aPTT"), and prothrombin time ("PT"). The
Company also is studying the development of cardiac marker tests, and other
tests to measure enzymes and other analytes. The Company also is in the process
of developing an analyzer and associated peripheral equipment which, in addition
to having the measurement capabilities currently possessed by the i-STAT System,
will incorporate the glucose measurement capabilities of an Abbott product.
Consequently, research and development expenditures are expected to increase
over the next three years. The amount and timing of such increase will depend
upon numerous factors including the level of activity at any point in time, the
success of the Company's development programs and its financial resources. Some
portion of these expenditures may be funded by Abbott. Revenues and gross profit
in the three months ended June 30, 2000 and 1999, include approximately $0.8
million and $0.5 million, respectively, of such funding.
The Company incurred general and administrative expenses (as a
percentage of sales) of approximately $1.9 million (12.9%) and $1.7 million
(15.5%) for the three months ended June 30, 2000 and 1999, respectively. General
and administrative expenses consisted primarily of salaries and benefits of
personnel, office costs, legal and other professional fees and other costs
necessary to support the Company's infrastructure.
The Company incurred sales and marketing expenses (as a percentage of
sales) of approximately $2.1 million (14.4%) and $2.1 million (18.2%) for the
three months ended June 30, 2000 and 1999, respectively, consisting primarily of
salaries, benefits, travel, and other expenditures for sales representatives,
implementation coordinators, international marketing support, order entry,
distribution, technical services, clinical affairs, product literature, market
research, and other sales infrastructure costs. A portion of the costs of the
implementation coordinators is reimbursed by Abbott, and revenues and gross
profit in the three months ended June 30, 2000 and 1999, include approximately
$0.2 million and $0.2 million, respectively, of such reimbursement.
The Company incurred litigation settlement costs of $1.5 million in the
three months ended June 30, 2000 in settlement of the patent infringement
litigation with Customedix Corporation.
Other income, net, of approximately $0.4 million and $0.4 million for
the three months ended June 30, 2000 and 1999, respectively, primarily reflects
interest income earned on cash and cash equivalents balances.
Net loss for the three months ended June 30, 2000 was approximately
$3.5 million, or 19 cents per share, compared with a net loss of approximately
$4.5 million, or 26 cents per share, for the second quarter of 1999. The
weighted average number of shares used in computing basic and diluted net loss
per share was approximately 18.004 million and 17.518 million in the 2000 and
1999 periods, respectively.
10
<PAGE> 11
i-STAT CORPORATION
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(continued)
SIX MONTHS ENDED JUNE 30, 2000
The Company generated revenues of approximately $26.0 million and $21.8
million for the six months ended June 30, 2000 and 1999, respectively, including
international revenues (as a percentage of total revenues) of $6.9 million
(26.5%) and $5.2 million (23.7%), respectively. Revenues from Abbott represented
approximately 83.8% and 75.4% of the Company's worldwide revenues for the six
months ended June 30, 2000 and 1999, respectively. The $4.2 million (19.3%)
increase in revenues was primarily due to increased shipment volume of the
Company's cartridges, reflecting higher cartridge consumption by existing
hospital customers and the addition of new hospital customers in the United
States and internationally. Worldwide cartridge shipments increased 27.3% to
4,652,400 units in the six months ended June 30, 2000, from 3,654,900 units in
the six months ended June 30, 1999. Revenues from the increased cartridge
shipments were partially offset by lower worldwide average selling prices per
cartridge, which declined from approximately $4.12 to $3.68 per cartridge in the
same periods. Cartridge average selling prices are expected to continue to
decline because of the product transfer pricing arrangements between the Company
and Abbott. The increase in revenues also reflects an increase in shipment
volumes of the Company's analyzers and peripheral equipment, and an increase of
approximately $0.7 million in Abbott Reimbursements.
Gross profit (as a percentage of sales) increased by approximately $0.8
million to $4.1 million (15.6%) in the six months ended June 30, 2000, compared
with a gross profit of $3.3 million (15.0%) in the six months ended June 30,
1999. Gross profit in the prior year included a charge of approximately $1.7
million resulting from temporary production losses associated with one of the
newer manufacturing processes in the second quarter of 1999. Gross profit in the
first half of 2000 was negatively impacted by manufacturing process problems
caused by defective tape from a tape supplier that resulted in high scrap levels
and a reduced level of production during the first quarter of 2000. The
improvement in gross profit was primarily due to increased production volume of
the Company's cartridges, which caused fixed manufacturing costs to be spread
over a larger number of product units, and an increase of approximately $0.7
million in Abbott Reimbursements. The increase in gross profit was partially
offset by lower average selling prices per cartridge and lower average selling
prices for analyzers, in each case because of the transfer pricing arrangements
between the Company and Abbott.
The Company incurred research and development costs (as a percentage of
sales) of approximately $4.3 million (16.4%) and $4.0 million (18.1%) for the
six months ended June 30, 2000 and 1999, respectively, consisting of costs
associated with the personnel, material, equipment and facilities necessary for
conducting new product development. The Company's current research and
development program includes the development of tests for coagulation, one of
which, Celite(R) ACT (activated clotting time), received Food and Drug
Administration clearance to market in early 2000. The Company currently is
developing three additional tests for the measurement of coagulation: kaolin
ACT, partial thromboplastin time ("aPTT"), and prothrombin time ("PT"). The
Company also is studying the development of cardiac marker tests, and other
tests to measure enzymes and other analytes. The Company is also in the process
of developing an analyzer and associated peripheral equipment, which, in
addition to having the measurement capabilities currently possessed by the
i-STAT System, will incorporate the glucose measurement capabilities of an
Abbott product. Consequently, research and development expenditures are expected
to increase over the next three years. The amount and timing of such increase
will depend upon numerous factors including the level of activity at any point
in time, the success of the Company's development programs and its financial
resources. Some portion of these expenditures may be funded by Abbott. Revenues
and gross profit in the six months ended June 30, 2000 and 1999 include
approximately $1.6 million and $0.9 million, respectively, of such funding.
The Company incurred general and administrative expenses (as a
percentage of sales) of approximately $3.4 million (13.2%) and $4.7 million
(21.7%) for the six months ended June 30, 2000 and 1999, respectively. General
and administrative expenses consisted primarily of salaries and benefits of
personnel, office costs, legal and other professional fees and other costs
necessary to support the Company's infrastructure. The decrease of approximately
$1.3 million primarily reflects fees in the 1999 period for special consulting
services to assist in the development of manufacturing strategies and capacity
plans, and to identify business development opportunities.
The Company incurred sales and marketing expenses (as a percentage of
sales) of approximately $4.0 million (15.3%) and $4.4 million (20.2%) for the
six months ended June 30, 2000 and 1999, respectively, consisting primarily of
salaries, benefits, travel, and other expenditures for sales representatives,
implementation coordinators, international marketing support, order entry,
distribution, technical services, product literature, market research, clinical
studies and other sales infrastructure costs. The dollar decrease from period to
period is primarily attributable to cost reductions following the assumption by
Abbott
11
<PAGE> 12
i-STAT CORPORATION
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(continued)
of principal responsibility for the marketing and sales of the i-STAT System. A
portion of the costs of the implementation coordinators are reimbursed by
Abbott, and revenues and gross profit in the six months ended June 30, 2000 and
1999, include approximately $0.3 million and $0.3 million of such reimbursement,
respectively.
The Company incurred litigation settlement costs of $1.5 million in the
three months ended June 30, 2000 in settlement of the patent infringement
litigation with Customedix Corporation.
Other income, net, of approximately $0.9 million and $0.8 million for
each of the six months ended June 30, 2000 and June 30, 1999, primarily reflects
interest income earned on cash and cash equivalents balances.
Net loss for the six months ended June 30, 2000 decreased 9.1% to
approximately $8.2 million, or 46 cents per share, compared with a net loss of
approximately $9.0 million, or 51 cents per share, for the six months ended June
30, 1999. The weighted average number of shares used in computing basic and
diluted net loss per share was approximately 17.885 million and 17.496 million
in the 2000 and 1999 periods, respectively.
LIQUIDITY AND CAPITAL RESOURCES
At June 30, 2000, the Company had cash and cash equivalents of
approximately $27.8 million, an increase of approximately $2.2 million from the
December 31, 1999 balance of approximately $25.6 million. The increase primarily
reflects the receipt of $10.8 million from Abbott in January 2000, representing
the third installment of prepayments for guaranteed future incremental cartridge
sales (as defined in the Distribution Agreement with Abbott), and the receipt of
approximately $2.7 million from the proceeds of stock option exercises,
partially offset by approximately $8.0 million of cash used in operating
activities, and equipment purchases of approximately $3.0 million. Working
capital decreased by approximately $5.9 million from $32.0 million to $26.1
million during the same period. Changes in working capital during the six months
ended June 30, 2000, primarily reflect the increase in cash and cash
equivalents, an increase of approximately $1.3 million in inventories, a
decrease of approximately $0.7 million in accounts receivable, and an increase
of approximately $0.8 million in accounts payable and accrued expenses. Changes
in working capital also include an increase of approximately $7.9 million in
deferred revenue, which reflects the receipt of the $10.8 million prepayment
from Abbott, partially offset by the amortization of such prepayments to income
as incremental cartridge sales (as defined in the Distribution Agreement with
Abbott) are generated. The Company expects its existing funds to continue to
decline until its revenues are sufficient to support its growth, but, together
with payments due from Abbott in respect of guaranteed future incremental
cartridge sales, to be sufficient to meet its obligations and its liquidity and
capital requirements for the near term. The Company regularly monitors capital
raising alternatives in order to take advantage of opportunities to supplement
its current working capital upon favorable terms, including joint ventures,
strategic corporate partnerships or other alliances and the sale of equity
and/or debt securities. The Company's need, if any, to raise additional funds to
meet its working capital and capital requirements will depend upon numerous
factors, including the results of its marketing and sales activities, its new
product development efforts, manufacturing efficiencies and competitive
conditions.
On March 16, 2000, Agilent Technologies, Inc., a subsidiary of HP,
converted its holding of 2,138,702 shares of Series B Preferred Stock into
2,138,702 shares of Common Stock, and sold its holding and is no longer a
related party.
The impact of inflation on the Company's business has been minimal and
is expected to be minimal for the near-term.
RECENT ACCOUNTING PRONOUNCEMENTS
In June 1998, the Financial Accounting Standards Board ("FASB") issued
SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities".
SFAS No. 133 as amended, is effective for all fiscal quarters of all fiscal
years beginning after June 15, 2000 (January 1, 2001 for the Company). SFAS No.
133 requires that all derivative instruments be recorded on the balance sheet at
their fair value. Changes in the fair value of derivatives are recorded each
period in current earnings or other comprehensive income, depending on whether a
derivative is designated as part of a hedge transaction and, if it is, the type
of hedge transaction. The Company presently does not have any derivative
instruments or hedging activities and, consequently, SFAS No. 133 is not
expected to have a material impact on the Company's consolidated results of
operations, financial position or cash flows.
In December 1999, the Securities and Exchange Commission ("SEC")
issued Staff Accounting Bulletin No. 101 ("SAB 101") which addresses the
staff's views on the application of U.S. generally accepted accounting
principles for revenue recognition. The Company will be required to adopt the
guidance of this bulletin no later than the fourth quarter of 2000. The Company
does not expect SAB 101 to have a material impact on its financial condition or
results of operations.
12
<PAGE> 13
i-STAT CORPORATION
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(continued)
SPECIAL NOTE ON FORWARD-LOOKING STATEMENTS
CERTAIN STATEMENTS IN THIS "MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS," RELATE TO FUTURE EVENTS AND
EXPECTATIONS AND AS SUCH CONSTITUTE "FORWARD-LOOKING STATEMENTS," WITHIN THE
MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. THE WORDS
"BELIEVES," "ANTICIPATES," "PLANS," "EXPECTS," AND SIMILAR EXPRESSIONS ARE
INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. SUCH FORWARD-LOOKING STATEMENTS
INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES, AND OTHER FACTORS WHICH MAY
CAUSE THE ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS OF THE COMPANY TO BE
MATERIALLY DIFFERENT FROM ANY FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS
EXPRESSED OR IMPLIED BY SUCH FORWARD-LOOKING STATEMENTS AND TO VARY
SIGNIFICANTLY FROM REPORTING PERIOD TO REPORTING PERIOD. SUCH FACTORS INCLUDE,
AMONG OTHERS, COMPETITION FROM EXISTING MANUFACTURERS AND MARKETERS OF BLOOD
ANALYSIS PRODUCTS WHO HAVE GREATER RESOURCES THAN THE COMPANY, ECONOMIC
CONDITIONS AFFECTING THE COMPANY'S TARGET MARKETS, THE UNCERTAINTY OF NEW
PRODUCT DEVELOPMENT INITIATIVES, THE ABILITY TO ATTRACT AND RETAIN KEY
SCIENTIFIC, TECHNOLOGICAL AND MANAGEMENT PERSONNEL, DEPENDENCE UPON LIMITED
SOURCES FOR PRODUCT MANUFACTURING COMPONENTS, UPON A SINGLE MANUFACTURING
FACILITY AND UPON INNOVATIVE AND HIGHLY TECHNICAL MANUFACTURING TECHNIQUES,
MARKET RESISTANCE TO NEW PRODUCTS AND POINT OF CARE BLOOD DIAGNOSIS,
INCONSISTENCY IN CUSTOMER ORDER PATTERNS, DOMESTIC AND INTERNATIONAL REGULATORY
CONSTRAINTS, UNCERTAINTIES OF INTERNATIONAL TRADE, PENDING AND POTENTIAL
DISPUTES CONCERNING OWNERSHIP OF INTELLECTUAL PROPERTY, AVAILABILITY OF CAPITAL
UPON FAVORABLE TERMS AND DEPENDENCE UPON AND CONTRACTUAL RELATIONSHIPS WITH
STRATEGIC PARTNERS, PARTICULARLY ABBOTT LABORATORIES. SEE ADDITIONAL DISCUSSION
UNDER "FACTORS THAT MAY AFFECT FUTURE RESULTS" IN THE COMPANY'S ANNUAL REPORT ON
FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 1999, AND OTHER FACTORS DETAILED FROM
TIME TO TIME IN THE COMPANY'S OTHER FILINGS WITH THE SECURITIES AND EXCHANGE
COMMISSION.
13
<PAGE> 14
i-STAT CORPORATION
PART II -- OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
The Company is a defendant in a case entitled Nova Biomedical
Corporation, Plaintiff v. i-STAT Corporation, Defendant. The Complaint, which
was filed in the United States District Court for the District of Massachusetts
on June 27, 1995, alleges infringement by i-STAT of Nova's U.S. Patent No.
4,686,479. In February 1998, the Court entered summary judgment in favor of the
Company on the issue of patent infringement. The plaintiff appealed the
dismissal to the Federal Circuit which affirmed two of the grounds of the
dismissal (proper interpretation of the patent and the fact that the Company
does not literally infringe), but remanded the case back to the District Court
with instructions to reconsider whether the Company's device is the equivalent
of the patented device and therefore infringes under the "doctrine of
equivalents." The Company has submitted to the Court a motion for summary
judgment in its favor on the "doctrine of equivalents," and oral argument on
this motion has been set for August 2000. Should the plaintiff prevail on this
issue, it could have a material and adverse impact on the financial position,
results of operations and cash flows of the Company.
The Company was a defendant in a class action complaint entitled
Susan Kaufman, on behalf of herself and all others similarly situated,
Plaintiff, v. i-STAT Corporation, William P. Moffitt, Lionel M. Sterling, Imants
R. Lauks and Matthias Plum, Jr. The class action was brought by Susan Kaufman on
her behalf and on behalf of all purchasers of the Company's Common Stock between
May 9, 1995 and March 19, 1996. The complaint, which was filed in the Superior
Court of New Jersey in Mercer County on June 19, 1996, alleged New Jersey common
law fraud and negligent misrepresentation, and is predicated on a "fraud on the
market" theory in connection with certain sales of i-STAT stock by the Company's
chief executive officer, chief technology officer and two outside directors
during a nine-month period. The plaintiff sought unspecified compensatory
damages, interest and payment of all costs and expenses incurred in connection
with the class action. On April 28, 1998, the Superior Court entered summary
judgment in favor of all the defendants. The plaintiff appealed and on August
10, 1999, the Appellate Division of the Superior Court filed an opinion
sustaining the trial court's determination as to the negligent misrepresentation
claims but reversing as to the common law fraud claims. The Company appealed the
reversal and, on July 27, 2000, the Supreme Court of the State of New Jersey
reversed the decision of the Appellate Division and reinstated the decision of
the Superior Court dismissing the plaintiff's action. In doing so, the Supreme
Court ruled that New Jersey does not recognize a class action lawsuit predicated
on the "fraud on the market" theory in connection with the purchase or sale of
securities. As a result of this ruling, the Company, which has always viewed the
complaint as being entirely without merit, believes that no action which is
based on the same alleged facts would be sustained against the Company or any of
the named defendants in either state or Federal courts.
The Company was a defendant in a case entitled Customedix
Corporation, Plaintiff v. i-STAT Corporation, Defendant. The complaint, which
was filed in the United States District Court for the District of Connecticut on
December 26, 1996, alleged infringement by i-STAT of Customedix's U.S. Patent
No. 4,342,964. The plaintiff sought injunctive relief and an accounting for
i-STAT's profits and the damages to Customedix from such alleged infringement.
Although the Company was prepared to contest the case vigorously, did not
believe that it had infringed the Customedix patent and had obtained an opinion
from recognized patent counsel to the effect that no infringement had occurred,
management concluded that the uncertainty inherent in any litigation as well
as the drain on management's time and the Company's resources merited an
amicable resolution of this lawsuit. Accordingly, on June 14, 2000, the Company
entered into a settlement agreement under which the Company paid the plaintiff
$1.5 million and the plaintiff agreed to permanently withdraw the complaint and
to release the Company from any and all claims of whatsoever nature that the
plaintiff may have had against the Company, whether under the referenced Patent
or otherwise.
14
<PAGE> 15
i-STAT CORPORATION
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The company held its Annual Meeting of Stockholders on May 24, 2000, at which
time two matters were submitted to a vote of stockholders. A description of the
matters voted upon and a voting tabulation for each matter is as follows:
I. Election of five members to the Board of Directors, each to
serve until the next Annual Meeting.
<TABLE>
<CAPTION>
NUMBER OF VOTES
-------------------------------------------------------------------
Name of Nominee For Against/Withheld Abstentions Broker Non-Votes
--------------- --- ---------------- ----------- ----------------
<S> <C> <C> <C> <C>
J. Robert Buchanan, M.D. 16,622,489 33,002 N/A N/A
Stephen D. Chubb 16,619,589 35,902 N/A N/A
William P. Moffitt 16,622,623 32,868 N/A N/A
Lionel N. Sterling 16,622,889 32,602 N/A N/A
Anne VanLent 16,618,589 36,902 N/A N/A
</TABLE>
II. Ratification of the appointment of PricewaterhouseCoopers LLP,
as independent accountants to audit the Company's books and
accounts for the year 2000.
<TABLE>
<CAPTION>
NUMBER OF VOTES
-------------------------------------------------------------------
For Against/Withheld Abstentions Broker Non-Votes
--- ---------------- ----------- ----------------
<S> <C> <C> <C>
16,617,701 25,028 12,762 N/A
</TABLE>
15
<PAGE> 16
EXHIBIT INDEX
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
3.1 Restated Certificate of Incorporation (Form S-8/S-3
Registration Statement, File No. 33-48889)*
3.2 By-Laws (Form 10-K for fiscal year ended December 31, 1996)*
3.3 Certificate of Designation, Preferences and Rights of Series A
Preferred Stock (Form 8-K, dated July 10, 1995 and amended on
September 11, 1995)*
3.4 Certificate of Designation, Preferences and Rights of Series B
Preferred Stock (Form 8-K, dated July 10, 1995 and amended on
September 11, 1995)*
4.1 Stockholder Protection Agreement, dated as of June 26, 1995,
between Registrant and First Fidelity Bank, National
Association (Form 8-K, dated July 10, 1995 and amended on
September 11, 1995)*
27 Financial Data Schedule
* These items are hereby incorporated by reference from the
exhibits of the filing or report indicated (except where
noted, Commission File No. 0-19841) and are hereby made a part
of this Report.
(b) Reports on Form 8-K
During the quarter for which this Report on Form 10-Q is
filed, no reports on Form 8-K were filed.
16
<PAGE> 17
i-STAT CORPORATION
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
DATE: August 14, 2000
i-STAT CORPORATION
(Registrant)
BY: /s/ William P. Moffitt
William P. Moffitt
President and Chief
Executive Officer
(Principal Executive Officer)
BY: /s/ Roger J. Mason
Roger J. Mason
Vice President of Finance,
Treasurer and Chief
Financial Officer
(Principal Financial Officer and
Accounting Officer)
17
<PAGE> 18
EXHIBIT INDEX
EXHIBIT NO.
-----------
27 Financial Data Schedule
