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 March 31, 2003
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 incorporation or organization) | (I.R.S. Employer Identification No.) |
104 Windsor Center Drive, East Windsor, NJ | 08520 | ||
(Address of Principle Executive Offices) | (Zip Code) |
(609) 443-9300
(Registrants
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_______ |
Indicate by check mark whether the Registrant is an accelerated filer (as defined in Rule 12b-2 of the Act) |
Yes _____ No____X__ |
The number of shares outstanding of each Issuer's classes of Common Stock as of the latest practicable date. |
Class | May 1, 2003 |
Common Stock, $0.15 par value | 20,137,342 |
i-STAT CORPORATION
TABLE OF CONTENTS
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
Consolidated Condensed Statements of Operations for thePART II OTHER INFORMATION
Item 4 - Submission of Matters to a Vote of Security Holders Item 6 - Exhibits and Reports on Form 8-K SIGNATURES CERTIFICATIONS2
Three Months Ended | |||||||||||
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March 31, |
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2003 |
2002 |
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Net revenues: | |||||||||||
Related party net revenues | $ | 12,971 | $ | 11,556 | |||||||
Third party net revenues | 2,237 | 2,669 | |||||||||
Other related party net revenues | 175 | 175 | |||||||||
Total net revenues | 15,383 | 14,400 | |||||||||
Cost of net revenues | 11,481 | 12,748 | |||||||||
Gross margin on total net revenues | 3,902 | 1,652 | |||||||||
Operating expenses: | |||||||||||
Research and development | 1,721 | 1,886 | |||||||||
Sales and marketing | 2,670 | 2,180 | |||||||||
General and administrative | 1,616 | 1,527 | |||||||||
Total operating expenses | 6,007 | 5,593 | |||||||||
Operating loss | (2,105 | ) | (3,941 | ) | |||||||
Other income, net | 1,542 | 189 | |||||||||
Net loss | (563 | ) | (3,752 | ) | |||||||
Accretion of Preferred Stock | (114 | ) | (112 | ) | |||||||
Dividends on Preferred Stock | (413 | ) | (549 | ) | |||||||
Net loss available to Common Stockholders | ($ 1,090 | ) | ($ 4,413 | ) | |||||||
Basic and diluted net loss per share | |||||||||||
available to Common Stockholders | ($ 0.05 | ) | ($ 0.22 | ) | |||||||
Shares used in computing basic and diluted net | |||||||||||
loss per share available to Common Stockholders | 20,117,110 | 19,980,887 | |||||||||
The accompanying notes are an integral part of these consolidated financial statements.
3
March 31, 2003 |
December 31, 2002 |
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Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 11,612 | $ | 27,059 | ||||
Martketable securities, current | 11,796 | | ||||||
Accounts receivable from related party, net | 5,990 | 7,070 | ||||||
Accounts receivable, net | 1,030 | 393 | ||||||
Inventories (Note 2) | 13,622 | 14,509 | ||||||
Prepaid expenses and other current assets | 1,210 | 2,089 | ||||||
Total current assets | 45,260 | 51,120 | ||||||
Martketable securities, long-term | 4,595 | | ||||||
Plant and equipment, net of accumulated depreciation of $39,299 as | ||||||||
of March 31, 2003 and $36,130 as of December 31, 2002 | 11,900 | 11,858 | ||||||
Other assets | 978 | 980 | ||||||
Total assets | $ | 62,733 | $ | 63,958 | ||||
Liabilities, Redeemable Preferred Stock and Stockholders' Deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,603 | $ | 2,927 | ||||
Accrued expenses | 3,879 | 4,860 | ||||||
Related party liability, current | 10,019 | 10,019 | ||||||
Deferred revenue, current | 120 | 30 | ||||||
Total current liabilities | 15,621 | 17,836 | ||||||
Deferred revenue, non-current | 1,900 | | ||||||
Related party liability, non-current (Note 11) | 47,000 | 47,000 | ||||||
Total liabilities | 64,521 | 64,836 | ||||||
Series D Redeemable Convertible Preferred Stock, liquidation value | ||||||||
$33,270 in 2003 and $32,617 in 2002 | 28,988 | 28,223 | ||||||
Stockholders' deficit: | ||||||||
Preferred Stock, $0.10 par value, shares authorized 7,000,000: | ||||||||
Series A Junior Participating Preferred Stock, $0.10 par | ||||||||
value, 1,500,000 shares authorized; none issued | | | ||||||
Series C Convertible Preferred Stock, 25,000 shares | ||||||||
authorized; none issued | | | ||||||
Common Stock, $0.15 par value, 50,000,000 shares authorized; | ||||||||
20,157,927 shares issued and 20,117,110 | ||||||||
shares outstanding as of March 31, 2003 and December 31, 2002 | 3,024 | 3,024 | ||||||
Treasury Stock, at cost, 40,817 shares | (750 | ) | (750 | ) | ||||
Additional paid-in capital | 252,006 | 252,771 | ||||||
Loan to officer, net | (12 | ) | (93 | ) | ||||
Accumulated deficit | (283,568 | ) | (283,005 | ) | ||||
Accumulated other comprehensive loss | (1,476 | ) | (1,048 | ) | ||||
Total stockholders' deficit | (30,776 | ) | (29,101 | ) | ||||
Total liabilities, redeemable preferred stock and stockholders' deficit | $ | 62,733 | $ | 63,958 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
4
Three Months Ended | |||||||||||
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March 31, |
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2003 |
2002 |
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Cash flows from operating activities: | |||||||||||
Net loss | ($563 | ) | ($3,752 | ) | |||||||
Adjustment to reconcile net loss to net cash | |||||||||||
provided by (used in) operating activities | (133 | ) | 736 | ||||||||
Change in assets and liabilities | 2,203 | 2,558 | |||||||||
Net cash provided by (used in) operating activities | 1,507 | (458 | ) | ||||||||
Cash flows from investing activities: | |||||||||||
Purchases of marketable securities | (16,391 | ) | | ||||||||
Purchases of equipment | (502 | ) | (858 | ) | |||||||
Other | (20 | ) | (21 | ) | |||||||
Net cash used in investing activities | (16,913 | ) | (879 | ) | |||||||
Cash flows from financing activities: | |||||||||||
Proceeds from stock options exercised | | 77 | |||||||||
Expenses related to private placement of Series D | |||||||||||
Redeemable Convertible Preferred Stock | |||||||||||
and Warrants | | (47 | ) | ||||||||
Net cash provided by financing activities | | 30 | |||||||||
Effect of currency exchange rate changes on cash | (41 | ) | (16 | ) | |||||||
Net decrease in cash and cash equivalents | (15,447 | ) | (1,323 | ) | |||||||
Cash and cash equivalents at beginning of period | 27,059 | 43,112 | |||||||||
Cash and cash equivalents at end of period | $ | 11,612 | $ | 41,789 | |||||||
The accompanying notes are an integral part of these consolidated financial statements.
5
(unaudited)
Basis of Presentation
The information presented as of March 31, 2003, and for the three months ended March 31, 2003 and 2002, is unaudited, but includes all adjustments (consisting of normal recurring accruals except for the inventory adjustment that was recorded in the first quarter of 2002, see Note 2) 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 December 31, 2002 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 consolidated condensed financial statements should be read in conjunction with the Companys audited financial statements for the year ended December 31, 2002, including the Notes thereto, which were included as part of the Companys Annual Report on Form 10-K, File No. 0-19841. |
Reclassification
Certain reclassifications have been made to 2002 amounts in order to conform them to the 2003 presentation. |
Marketable Securities
Marketable securities, current and long-term, consist of fixed-income investments in United States Treasury securities with a maturity of greater than three months from the date of purchase. The Company applies Statement of Financial Accounting Standards (SFAS) No. 115 Accounting for Certain Investments in Debt and Equity Securities to its investments in marketable securities. The Companys marketable securities are classified as held-to-maturity and are recorded at amortized cost. |
At March 31, 2003, marketable securities consisted of the following: |
Amortized Cost |
Market Value |
Unrealized Gain | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
(in thousands of dollars) | |||||||||||
U.S. Treasury securities - current | $ | 11,796 | $ | 11,799 | $ | 3 | |||||
U.S. Treasury securities - long-term | 4,595 | 4,600 | 5 | ||||||||
$ | 16,391 | $ | 16,399 | $ | 8 | ||||||
Basic and Diluted Loss per Share
Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of Common Shares outstanding for the period. Diluted loss per share 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 Company. The Company has not included potentially dilutive Common Shares in the diluted per-share computation for the periods presented, as the result is antidilutive due to the Companys net loss. |
Options to purchase 4,042,471 shares of common stock at $2.24 $32.58 per share, which expire on various dates from May 2003 to February 2013, were outstanding at March 31, 2003. In addition, warrants to purchase 1,875,357.5 shares of Common Stock at $8.00 per share were outstanding at March 31, 2003. The options and warrants were not included in the computation of diluted loss per share because the effect would be antidilutive (i.e., decrease the net loss per share) due to the Companys net loss. |
6
Comprehensive Income
SFAS No. 130, Reporting Comprehensive Income, requires certain items to be included in other comprehensive income. The only component of accumulated other comprehensive income (loss) for the Company is foreign currency translation adjustments resulting from the translation of the financial statements of the Companys Canadian subsidiary. |
Three Months |
Ended March 31, |
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---|---|---|---|---|---|---|---|---|---|---|---|
(In thousands of dollars) |
2003 |
2002 |
|||||||||
Net loss | ($563 | ) | ($3,752 | ) | |||||||
Other comprehensive income (loss): | |||||||||||
Foreign currency translation | (428) | 16 | |||||||||
Comprehensive loss | ($ 991 | ) | ($3,736 | ) | |||||||
Foreign Currency Translation/Transactions
In general, balance sheet amounts from the Companys Canadian subsidiary have been translated using exchange rates in effect at the balance sheet dates and the resulting translation adjustments have been included in the accumulated other comprehensive loss as a separate component of Consolidated Stockholders Deficit. The Statements of Operations from the Companys Canadian subsidiary have been translated using the average monthly exchange rates in effect during each period presented. |
Effective May 31, 2002, as a result of repayment of a portion of intercompany debt owed by the Companys Canadian subsidiary and that subsidiarys deemed ability and intent to repay the remaining intercompany debt, the Company is required to treat such intercompany debt as short-term in accordance with SFAS No. 52 Foreign Currency Translation. SFAS No. 52 requires the Company to record the impact of foreign currency gains and losses on short-term intercompany debt in the Companys results of operations. Foreign currency gains of approximately $1.4 million were recorded in other income, net for the three months ended March 31, 2003. These gains were primarily the result of the impact of the exchange rate between U.S. dollars and Canadian dollars on the debt owed by the Companys Canadian subsidiary to the Company. |
Stock Based Compensation
The Company applies the provisions of Accounting Principles Board Opinion No. 25 (APB 25) and related Interpretations in accounting for its stock based compensation plans. Accordingly, compensation expense has been recognized in the financial statements in respect to the above plans to the extent that the fair market value of the Companys common stock exceeds the exercise price of the stock option on the date of grant. During the three months ended March 31, 2003, there were no stock option grants with exercise prices below the fair market value of the Companys common stock on the date of grant. Had compensation costs for the above plans been determined based on the fair value at the grant dates for awards under those plans consistent with the method of SFAS No. 123, Accounting for Stock Based Compensation, the Companys net loss and net loss per share would have been increased to the pro forma amounts below: |
7
In thousands of dollars, except per share data |
March 31, |
|
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---|---|---|---|---|---|---|---|---|---|---|---|
2003 | 2002 | ||||||||||
Reported net loss available to Common Stockholders | ($1,090 | ) | ($4,413 | ) | |||||||
Proforma compensation expense under SFAS 123 | ($ 817 | ) | ($ 944 | ) | |||||||
Proforma net loss available to Common Stockholders | ($1,907 | ) | ($5,357 | ) | |||||||
Reported basic and diluted net loss per share | ($ 0.05 | ) | ($ 0.22 | ) | |||||||
Proforma basic and diluted net loss per share | ($ 0.09 | ) | ($ 0.27 | ) |
As options vest over a varying number of years, and awards are generally made each year, the proforma impacts shown here may not be representative of future pro forma expense amounts due to the annual grant of options by the Company. The proforma additional compensation expense of approximately $0.8 million and appproximately $0.9 million for the quarter ended March 31, 2003 and 2002, respectively, was calculated based on the fair value of each option grant using the Black-Scholes model with the following weighted average assumptions used for grants: |
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March 31, |
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2003 | 2002 | |||||||
Dividend yield | 0 | % | 0 | % | ||||
Expected volatility | 68 | .12% | 64 | .11% | ||||
Risk free interest rate | 2 | .90% | 4 | .30% | ||||
Expected option lives | 6 ye | ars | 6 ye | ars |
2. Inventories
Inventories consist of the following: |
(In thousands of dollars) | March 31, 2003 |
December 31, 2002 | ||||||
---|---|---|---|---|---|---|---|---|
Raw materials | $ | 3,408 | $ | 4,356 | ||||
Work-in-process | 4,668 | 3,920 | ||||||
Finished goods | 5,546 | 6,233 | ||||||
$ | 13,622 | $ | 14,509 | |||||
The Company and Abbott Laboratories (Abbott) are in disagreement over the amount of money Abbott is entitled to for the sharing of certain cartridge production cost savings resulting from increases in the volume of cartridges sold during the term of the Abbott Marketing and Distribution Agreement (the Abbott Distribution Agreement). This disputed item relates to different interpretations of certain terms of the Abbott Distribution Agreement. Additionally, the Company and Abbott are in disagreement over the amount of money the Company is entitled to for the development, production, maintenance and support of certain software products sold by Abbott during the term of the Abbott Distribution Agreement. If these disagreements are not resolved amicably, the Abbott Distribution Agreement states that they must be resolved through binding arbitration. Management of the Company believes that Abbotts position on both of these issues in dispute are without merit and that, in the event that these issues are resolved through arbitration, the Company will not incur any additional liability to Abbott. The disagreement regarding the sharing of certain cartridge production cost savings resulting from an increase in sales volume over the past several years is approximately $1.3 million at March 31, 2003, and if this matter is resolved in favor of Abbott, which management of the Company believes is unlikely, the Companys cost of goods sold would increase by up to the amount in dispute. The disagreement regarding payment for the development, production, maintenance, and support of certain software sold by Abbott over the past several years is approximately $0.8 million at March 31, 2003, and if this matter is resolved in favor of the Company, the Companys cost of goods sold would decrease by up to the amount in dispute. Such adjustment would be made when, and if, it is determined that an unfavorable outcome to the Company is probable, or, in the case of a payment of the disputed amounts by Abbott, when payment is received by the Company. |
8
On July 25, 2002, the Company announced its decision to allow the Abbott Distribution Agreement to expire effective December 31, 2003. As a result, the Company is obligated to make the following payments to Abbott on the dates noted: (a) on December 31, 2003, a $5.0 million one-time termination fee, (b) on December 31, 2003, approximately $5.0 million representing the unrecognized portion of a $25.0 million prepayment received from Abbott, (c) early in 2004, approximately $2.0 million to repurchase inventory and equipment from Abbott, and (d) on December 31, 2004, and on each December 31 thereafter through 2008, for a total of five unequal residual payments based upon Abbotts net sales of the Companys products during 2003, approximately $47.0 million in the aggregate. The Company recognized the $5.0 million one-time termination fee and the $47.0 million in estimated residual payments as expense in the third quarter of 2002. Since the Abbott residual payments are based on Abbotts actual net sales during 2003, the estimated liability for these residual payments may change as the actual net sales become known. There was no change to the estimate in the first quarter of 2003. These charges had a material impact on the Companys results of operations and these payments will have a material impact on the Companys future cash flows. |
The Company recorded approximately $12.9 million and approximately $11.6 million of net product sales to Abbott during the three months ended March 31, 2003 and 2002, respectively. Other related party revenues from Abbott were approximately $0.2 million in both of the three-month periods ended March 31, 2003 and 2002. The other related party revenues from Abbott consist of amounts reimbursed by Abbott for services performed by the Companys implementation coordinators. |
In January 2003, the Company and FUSO entered into a new Distribution Agreement (the FUSO Distribution Agreement). The FUSO Distribution Agreement extends FUSOs current non-exclusive distribution rights in Japan through December 31, 2003 and grants exclusive distribution rights in Japan from January 1, 2004 through December 31, 2008, subject to FUSO meeting certain sales milestones. During the first quarter of 2003, FUSO paid $2.0 million for marketing support throughout the exclusive term of the FUSO Distribution Agreement. The $2.0 million payment is included in cash and cash equivalents. The $2.0 million payment is refundable under certain circumstances until the exclusive term of the FUSO Distribution Agreement takes effect January 1, 2004. The $2.0 million payment will be recognized as revenue ratably over the five-year term of the FUSO Distribution Agreement. In addition, FUSO is expected to pay an additional $11.0 million in October 2003 as a prepayment that will be offset against future purchases of cartridges. |
Option Program Description
As incentives to Company personnel and others, the Board of Directors from time to time grants options to purchase shares of the Companys Common Stock. Most options are granted under the 1985 Stock Option Plan or Equity Incentive Plan (the Plans). Both Plans have been approved by the Companys stockholders. The maximum number of issuable shares of Common Stock under the Plans is 7,300,000 of which 1,574,781 are available for grant at March 31, 2003. Options under the 1985 Stock Option Plan can be granted until November 26, 2005, and options under the Equity Incentive Plan can be granted until March 31, 2008. The exercise price of an option is generally based upon the fair market value of the Companys Common Stock at the time of the grant, as determined by utilizing the closing price of the Companys Common Stock on the day prior to the date of grant. In general, the Company issues stock options that vest annually over a period of at least three years but not longer than five years. In addition, the Company has in the past, and may in the future, issue stock options with performance-based acceleration provisions. Acceleration of vesting can only occur if certain clearly defined and objective goals are met. These stock options with accelerated vesting are treated as fixed awards in accordance with APB 25 and Financial Accounting Standards Board Interpretation No. 44. Unexercised options issued under the Plans generally expire ten years from the date of grant or three months following termination of the optionees employment, whichever occurs first. |
9
General Option Information
The table below is a summary of stock option activity for the quarter ended March 31, 2003. |
|
Options |
Option Activity |
Weighted Average Exercise Price per Share |
Weighted Average Black-Scholes Value per Option |
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Outstanding at December 31, 2002 | 4,222,028 | $ | 9.18 | |||||||
Exercisable at December 31, 2002 | 1,592,672 | $ | 11.97 | |||||||
2003 Activity: | ||||||||||
Options granted | 241,739 | $ | 3.88 | $ | 2.45 | |||||
Options exercised | | | ||||||||
Options forfeited | (418,796 | ) | $ | 18.34 | ||||||
Options expired | (2,500 | ) | $ | 6.13 | ||||||
Outstanding at March 31, 2003 | 4,042,471 | $ | 7.91 | |||||||
Exercisable at March 31, 2003 | 1,820,454 | $ | 10.45 |
The weighted average remaining contractual lives of outstanding options at March 31, 2003 was approximately 7.46 years. |
The following table summarizes information about stock options outstanding at March 31, 2003. |
|
Options Outstanding |
Options Exercisable |
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Range of Exercise Price |
Number Outstanding at 3/31/03 |
Weighted Average Remaining Life (Years) |
Weighted Average Exercise Price |
Number Exercisable at 3/31/03 |
Weighted Average Exercise Price |
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In the Money Options (1): | |||||||||||||
$2.24$4.41 | 1,192,739 | 9.46 | $ | 3.10 | 0 | | |||||||
Out of the Money Options: | |||||||||||||
$5.08$6.44 | 1,184,537 | 7.49 | $ | 6.25 | 645,130 | $ | 6.19 | ||||||
$7.89$10.81 | 858,766 | 6.21 | $ | 9.44 | 562,586 | $ | 9.47 | ||||||
$11.81$17.96 | 600,901 | 5.69 | $ | 13.56 | 458,352 | $ | 13.50 | ||||||
$21.00$32.58 | 205,528 | 6.09 | $ | 22.45 | 154,386 | $ | 22.81 | ||||||
$2.24$32.58 | 4,042,471 | 7.46 | $ | 7.91 | 1,820,454 | $ | 10.45 | ||||||
(1) In-the-money options are those options with an exercise price less than the fair market value closing price of $5.07 at the end of the quarter.
10
Options Granted to Executive Officers
The following table details option grants to executive officers during the quarter ended March 31, 2003: |
Individual Grants
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Potential Realizable Value at Assumed Annual Rates of Stock Price Appreciation for Option Term ($) |
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Percent of Total Granted to Employees Year to Date (%) |
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Number of Securities Underlying Options Per Grant (#) |
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Exercise of Base Price ($/Share) |
Expiration Date |
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5% |
10% |
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William P. Moffitt | | | | | | | |||||||||||
Bruce F. Basarab | 6,219 | 2.57 | % | $ | 3.87/Share | 2/13/2013 | $ | 39,206 | $ | 62,431 | |||||||
Noah Kroloff | 6,468 | 2.68 | % | $ | 3.87/Share | 2/13/2013 | $ | 40,776 | $ | 64,931 | |||||||
Lorin J. Randall | 10,883 | 4.50 | % | $ | 3.87/Share | 2/13/2013 | $ | 68,609 | $ | 109,252 | |||||||
Michael Zelin | | | | | | |
The following table details option exercises during the quarter ended March 31, 2003 and remaining holdings of executive officers: |
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Number of Securities Underlying Unexercised Options at March 31, 2003 |
Values of Unexercised In-the-Money Options at March 31, 2003 |
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Shares Acquired on Exercise (#) |
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Name |
Value Realized ($) |
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Exercisable |
Unexercisable |
Exercisable |
Unexercisable |
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William P. Moffitt | | | 91,956 | 379,735 | | $ | 348,800 | ||||||
Bruce F. Basarab | | | | 126,219 | | $ | 279,863 | ||||||
Noah Kroloff | | | 142,605 | 85,778 | | $ | 116,762 | ||||||
Lorin J. Randall | | | | 95,883 | | $ | 143,860 | ||||||
Michael Zelin | | | 177,388 | 164,482 | | $ | 239,800 |
11
i-STAT Corporation (i-STAT or the Company), which was incorporated in Delaware in 1983, together with its wholly-owned subsidiaries, i-STAT Europe, i-STAT Canada Limited and i-STAT Limited, 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 Companys current products, known as the i-STAT® System, consist of portable, hand-held analyzers and single-use, disposable cartridges, the majority of which simultaneously perform different combinations of commonly ordered blood tests in approximately two to three minutes. Coagulation and immunoassay tests take longer than two to three minutes because of the nature of these tests. The i-STAT System requires the user to perform several simple steps, the results of which can be easily linked by infrared transmission to a health care providers information system. 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 users point-of-care testing program and to the users information systems for billing and archiving. The Company intends for the i-STAT System to become the standard of care for blood analysis at the point of patient care, enabling rapid clinical intervention, improved patient outcomes, and lower operational costs.
The i-STAT System currently performs blood tests for sodium, potassium, chloride, glucose, creatinine, urea nitrogen, hematocrit, ionized calcium, lactate, Celite® ACT (activated clotting time), Prothrombin time, arterial blood gases (pH, PCO2 and PO2), and bicarbonate, and derives certain other values, such as total carbon dioxide, base excess, anion gap, hemoglobin and O2 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. During the fourth quarter of 2002, the Company submitted a 510(k) filing with the Food and Drug Administration (the FDA) for a cartridge that performs the kaolin-based activated clotting time (kaolin ACT) test. Assuming timely regulatory approvals, the Company expects to begin commercial introduction of the kaolin ACT in 2003. The Company is also conducting clinical trials on its first immunoassay test, a test for troponin I, a cardiac marker capable of indicating the degree of heart muscle damage. The Company expects to file a 510(k) application with the FDA in the second quarter of 2003, and subject to regulatory approval, to begin commercial introduction of its troponin I test in the second half of 2003.
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 FUSO Pharmaceutical Industries, Ltd. (FUSO), in Europe through Hewlett-Packard Company and in Mexico, South America, China, Australia, and certain other Asian and Pacific Rim countries, through selected distribution channels. Since November 1998, Abbott Laboratories (Abbott) has become, subject to certain pre-existing rights of the Companys other international distributors, the exclusive worldwide distributor of the Companys existing products and any new products the Company may develop for use in the professionally attended human healthcare delivery market during the term of the Abbott Marketing and Distribution Agreement (the Abbott Distribution Agreement). The majority of the Companys net revenues are currently derived from Abbott.
On July 25, 2002, the Company announced its decision to allow the Abbott Distribution Agreement to expire effective December 31, 2003. As a result, the Company is obligated to make the following payments to Abbott on the dates noted: (a) on December 31, 2003, a $5.0 million one-time termination fee, (b) on December 31, 2003, approximately $5.0 million representing the unrecognized portion of a $25.0 million prepayment received from Abbott, (c) early in 2004, approximately $2.0 million to repurchase inventory and equipment from Abbott, and (d) on December 31, 2004, and on each December 31 thereafter through 2008, for a total of five unequal residual payments based upon Abbotts net sales of the Companys products during 2003, approximately $47.0 million in the aggregate. The Company recognized the $5.0 million one-time termination fee and the $47.0 million in estimated residual payments as expense in the third quarter of 2002. Since the Abbott residual payments are based on Abbotts actual net sales during 2003, the estimated liability for these residual payments may change as the actual net sales become known. There was no change to the estimate in the first quarter of 2003. These charges had a material impact on the Companys results of operations and these payments will have a material impact on the Companys future cash flows. The Company anticipates that the profit margins presently being earned by Abbott as a result of the sale of the Companys products will be earned by the Company commencing January 1, 2004, and will provide the Company with the sufficient cash to fund these payments to Abbott. The Company has begun to take actions to assume primary responsibility for the marketing and sale of its products, effective January 1, 2004. These actions have included hiring additional sales personnel, a vice president of medical affairs, a director of marketing, a general manager in Europe and an executive vice president of commercial operations. The Company anticipates further additions of sales and marketing personnel during 2003. In April 2003, the Company created i-STAT Ltd., a wholly-owned subisidiary located in England, that will facilitate direct sales to customers in certain countries in Europe starting in 2004. The Company will incur additional costs and may recognize lower unit sales than anticipated as a result of resuming direct distribution of its products, the combination of which may adversely impact the Companys future results of operations and cash flows.
12
In January 2003, the Company and FUSO entered into a new Distribution Agreement (the FUSO Distribution Agreement). The FUSO Distribution Agreement extends FUSOs current non-exclusive distribution rights in Japan through December 31, 2003 and grants exclusive distribution rights in Japan from January 1, 2004 through December 31, 2008, subject to FUSO meeting certain sales milestones. During the first quarter of 2003, FUSO paid $2.0 million for marketing support throughout the exclusive term of the FUSO Distribution Agreement. The $2.0 million payment is included in cash and cash equivalents. The $2.0 million payment is refundable under certain circumstances until the exclusive term of the FUSO Distribution Agreement takes effect January 1, 2004. The $2.0 million payment will be recognized as revenue ratably over the five-year term of the FUSO Distribution Agreement. In addition, FUSO is expected to pay an additional $11.0 million in October 2003 as a prepayment that will be offset against future purchases of cartridges.
Three Months Ended March 31, 2003
The Company generated total net revenues of approximately $15.4 million and approximately $14.4 million for the three months ended March 31, 2003 and 2002, respectively, including international net revenues (as a percentage of total net revenues) of approximately $4.1 million (26.9%) and approximately $4.0 million (27.8%), respectively. Total net revenues from Abbott represented approximately 85.0% and 81.5% of the Companys worldwide total net revenues for the three months ended March 31, 2003 and 2002, respectively.
The approximately $1.0 million, or 6.8%, increase in total net revenues was primarily due to increased sales volume of the Companys cartridges, reflecting higher cartridge consumption by existing hospital customers and the addition of new hospital customers. Worldwide cartridge shipments increased by 28.6% to 3,459,075 units in the three months ended March 31, 2003, from 2,688,825 units in the three months ended March 31, 2002. The increase in worldwide cartridge volume was partially offset by a decrease in worldwide average selling prices per cartridge, which decreased from approximately $3.47 in the first quarter of 2002 to $3.24 in the first quarter of 2003. The decrease in worldwide average selling prices per cartridge is primarily a result of the pricing arrangements under the Abbott Distribution Agreement, which produce lower average selling prices as volume increases. Analyzer revenue decreased $0.4 million, or 14.1%, as analyzer sales volume declined from 1,175 units in the three months ended March 31, 2002 to 936 units in the three months ended March 31, 2003. The decline was primarily evident in the domestic market and is attributable to a greater volume of customers upgrading to newer versions of the analyzer in the first quarter of 2002. Other related party revenues were approximately $0.2 million in each of the three-month periods ended March 31, 2003 and March 31, 2002. The other related party revenues from Abbott consist of amounts reimbursed by Abbott for services performed by the Companys implementation coordinators.
13
As a result of the expiration of the Abbott Distribution Agreement, effective December 31, 2003, the Company expects a material increase in net revenues resulting from the increase in the average sales price it will recognize as a result of selling the Companys products directly to end-user customers and distributors. Currently, the Companys average sales price is lower than the end-user average sales price or average sales price to sub-distributors due to distribution discounts taken by Abbott.
The gross margin on total net revenues was $3.9 million and $1.7 million in the three months ended March 31, 2003 and 2002, respectively. Gross margin percentage on sales of products and services, which excludes other net revenues such as royalties and reimbursements of sales and marketing expenses, was 25.7% and 11.7% in the three months ended March 31, 2003 and 2002, respectively. Gross margin percentage on the sale of products generally improves with increased production and shipment volume of the Companys cartridges and as a result of overhead absorption and improvements in manufacturing productivity and yields. Gross margin percentage improved in the first quarter of 2003 compared to the first quarter of 2002 primarily because of a charge of approximately $1.6 million (11.2%) recorded in the first quarter of 2002 for the write-off of certain cartridges in inventory and the replacement of certain cartridges in the field that exhibited a higher than usual quality check rejection rate.
The Company incurred research and development costs (as a percentage of total net revenues) of approximately $1.7 million (11.2%) and approximately $1.9 million (13.1%) for the three months ended March 31, 2003 and 2002, respectively. Research and development expenses consist of costs associated with the personnel, material, equipment and facilities necessary for conducting new product development.
The Company incurred sales and marketing expenses (as a percentage of total net revenues) of approximately $2.7 million (17.4%) and approximately $2.2 million (15.1%) for the three months ended March 31, 2003 and 2002, respectively. Sales and marketing expenses consist primarily of salaries, commissions, benefits, travel, business development and similar expenditures for sales representatives, implementation coordinators and international marketing support, as well as order entry, product distribution, technical services, clinical affairs, product literature, market research, and other sales infrastructure costs. The increase in sales and marketing expenses is attributable to the actions taken to assume primary responsibility for the marketing and sale of its products, effective January 1, 2004. These actions have included hiring additional sales personnel, a vice president of medical affairs, an executive vice president of commercial operations, a director of marketing and a general manager in Europe. The Company anticipates further additions of sales and marketing personnel during 2003. The Company will incur additional costs and may recognize lower unit sales than anticipated as a result of resuming direct distribution of its products, the combination of which may adversely impact the Companys future results of operations and cash flows. A portion of the costs of implementation coordinators is reimbursed by Abbott, and as a result, approximately $0.2 million of reimbursement is included in total net revenues in each of the three month periods ended March 31, 2003 and 2002.
The Company incurred general and administrative expenses (as a percentage of total net revenues) of approximately $1.6 million (10.5%) and approximately $1.5 million (10.6%) for the three months ended March 31, 2003 and 2002, respectively. General and administrative expenses consist primarily of salaries and benefits of personnel, office costs, legal and other professional fees and other costs necessary to support the Companys infrastructure. The Company expects that general and administrative costs will remain relatively consistent with recent levels, subject to normal quarterly fluctuations, despite the actions taken to terminate the Abbott Distribution Agreement and assume the primary responsibility for the marketing and sale of its products.
Other income, net, of $1.5 million and $0.2 million for the three months ended March 31, 2003 and 2002, respectively, primarily reflects interest income earned on cash and cash equivalents, marketable securities, and for 2003, the net impact of certain foreign currency gains and losses. Effective May 31, 2002, as a result of repayment of a portion of intercompany debt owed by the Companys Canadian subsidiary and that subsidiarys deemed ability and intent to repay the remaining intercompany debt, the Company is required to treat such intercompany debt as short-term in accordance with Statement of Financial Accounting Standards (SFAS) No. 52 Foreign Currency Translation. SFAS No. 52 requires the Company to record the impact of foreign currency gains and losses on short-term intercompany debt in the Companys results of operations. Foreign currency gains of $1.4 million were recorded for the three months ended March 31, 2003. These gains were the result of the impact of the exchange rate between U.S. dollars and Canadian dollars on the debt owed by i-STAT Corporations Canadian subsidiary to i-STAT Corporation. The amount of the gains and losses could continue to be material in the event of significant changes in the exchange rate between U.S. dollars and Canadian dollars.
14
The Company recorded accretion of Preferred Stock of approximately $0.1 million in each of the three months ended March 31, 2003 and 2002. The accretion of Preferred Stock relates to the issuance by the Company of Series D Redeemable Convertible Preferred Stock (the Series D Stock) in December of 2001. The accretion recorded by the Company reflects amortization of the difference between the carrying value and the redemption value of such stock. The Series D Stock is being accreted over a period of ten years.
The Series D Stock carries a dividend of 8%, which is either accrued or paid in cash quarterly, at the option of the Company. The dividend on the Series D Stock was recorded at its fair value of approximately $0.4 million and $0.5 million in the three months ended March 31, 2003 and 2002, respectively. The dividend was not paid in cash and approximately $0.7 million and $0.6 million were accrued and added to the liquidation preference of the Series D Stock in the three months ended March 31, 2003 and 2002, respectively.
Net loss available to Common Stockholders for the three months ended March 31, 2003 was approximately $1.1 million, or 5 cents per basic and diluted share, compared with a net loss of approximately $4.4 million, or 22 cents per basic and diluted share, for the first quarter of 2002. The principal factors contributing to the decrease of approximately $3.3 million in the net loss available to Common Stockholders were the write-off of certain cartridges in inventory and the replacement of certain cartridges in the field that exhibited a higher than usual quality check rejection rate in the amount of approximately $1.6 million in the first quarter of 2002, the exchange rate gains of $1.4 million related to the inter-company debt owed by the Companys Canadian subsidiary and the increase in total net revenues. The weighted average number of shares used in computing basic and diluted net loss per share was approximately 20.117 million and 19.981 million in the 2003 and 2002 periods, respectively.
Liquidity and Capital Resources
At March 31, 2003, the Company had cash, cash equivalents and total marketable securities of approximately $28.0 million, an increase of approximately $0.9 million from the December 31, 2002 balance of approximately $27.1 million. The increase primarily reflects the receipt of $2.0 million from FUSO for marketing support throughout the five-year exclusive term of the FUSO Distribution Agreement. The $2.0 million is included in cash and cash equivalents and is refundable under certain circumstances until the exclusive term of the FUSO Distribution Agreement takes effect January 1, 2004. This increase was partially offset by purchases of equipment that totaled approximately $0.5 million in the first quarter of 2003. Working capital decreased by approximately $3.6 million from approximately $33.3 million to approximately $29.7 million during the same period because of the purchase of $4.6 million of long-term marketable securities.
The Company expects its existing cash, cash equivalents and total marketable securities to be sufficient to meet its short-term obligations, liquidity and capital requirements. In addition, the Company expects its existing cash, cash equivalents and total marketable securities and cash expected to be generated from future operations, including an $11.0 payment due from FUSO under the new FUSO Distribution Agreement and the increased cash flows from selling its products direct to end-users (the profit margins presently being earned by Abbott as a result of the sale of the Companys products will be earned by the Company commencing January 1, 2004), to be sufficient to meet all of its obligations and capital requirements for the foreseeable future, including those payment obligations resulting from the termination of the Abbott Distribution Agreement. However, numerous factors may change this expectation, including the results of its sales and marketing activities, the success of its new product development efforts, manufacturing difficulties, manufacturing efficiencies, the results of dispute resolution proceedings, competitive conditions, long-term strategic decisions, and other factors listed under Factors That May Affect Future Results in the Companys 2002 Annual Report on Form 10-K on file with the Securities and Exchange Commission. 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.
15
International sales are invoiced in U.S. dollars, however, the payment received from international partners, primarily Abbott, are subject to changes in the value of the U.S. dollar relative to local currencies. The price paid by customers to our international partners is set in local foreign currencies. Therefore, when the value of foreign currencies changes with respect to the U.S. dollar, the price paid by our partners to us changes. Price reductions are limited, however, by guaranteed U.S. dollar minimum prices established for each cartridge.
The Companys cartridge manufacturing is conducted through a wholly-owned subsidiary in Canada. Most manufacturing labor and overhead costs of this subsidiary are incurred in Canadian dollars, while some raw material purchases are made in U.S. dollars. The Companys Canadian operation is primarily funded by payments in U.S. dollars made by the Company for cartridges purchased for resale to its customers. Since most of the cartridge manufacturing expenses are incurred in Canadian dollars, the cost of products sold and therefore, the Companys consolidated results of operations and cash flows can be impacted by a change in exchange rates between the Canadian dollar and the U.S. dollar.
The impact of inflation on the Companys business has been minimal and is expected to be minimal for the near-term.
Contingencies
The Company and Abbott are in disagreement over the amount of money Abbott is entitled to for the sharing of certain cartridge production cost savings resulting from increases in the volume of cartridges sold during the term of the Abbott Distribution Agreement. This disputed item relates to different interpretations of certain terms of the Abbott Distribution Agreement. Additionally, the Company and Abbott are in disagreement over the amount of money the Company is entitled to for the development, production, maintenance and support of certain software products sold by Abbott during the term of the Abbott Distribution Agreement. If these disagreements are not resolved amicably, the Abbott Distribution Agreement states that they must be resolved through binding arbitration. Management of the Company believes that Abbotts position on both of these issues in dispute are without merit and that, in the event that these issues are resolved through arbitration, the Company will not incur any additional liability to Abbott. The disagreement regarding the sharing of certain cartridge production cost savings resulting from an increase in sales volume over the past several years is approximately $1.3 million at March 31, 2003, and if this matter is resolved in favor of Abbott, which management of the Company believes is unlikely, the Companys cost of goods sold would increase by up to the amount in dispute. The disagreement regarding payment for the development, production, maintenance, and support of certain software sold by Abbott over the past several years is approximately $0.8 million at March 31, 2003, and if this matter is resolved in favor of the Company, the Companys cost of goods sold would decrease by up to the amount in dispute. Such adjustment would be made when, and if, it is determined that an unfavorable outcome to the Company is probable, or, in the case of a payment of the disputed amounts by Abbott, when payment is received by the Company.
16
Special Note on Forward-Looking Statements
CERTAIN STATEMENTS IN THIS MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS, MAY 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 AND GEOPOLITICAL CONDITIONS AFFECTING THE COMPANYS TARGET MARKETS, ACTS OF TERRORISM, 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. IN ADDITION, THE COMPANYS DECISION TO END ITS ALLIANCE WITH ABBOTT LABORATORIES AND RESUME DIRECT DISTRIBUTION OF ITS PRODUCTS INVOLVES ADDITIONAL RISKS AND UNCERTAINTIES THAT ARE DIFFICULT TO QUANTIFY AT THIS TIME. FOR EXAMPLE, THE COMPANY MAY INCUR COSTS OR RECOGNIZE REVENUES IN CONNECTION WITH RESUMING DIRECT DISTRIBUTION THAT ARE GREATER OR LESSER, RESPECTIVELY, THAN ANTICIPATED. SEE ADDITIONAL DISCUSSION UNDER FACTORS THAT MAY AFFECT FUTURE RESULTS IN THE COMPANYS ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2002, AND OTHER FACTORS DETAILED FROM TIME TO TIME IN THE COMPANYS OTHER FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION.
The Chief Executive Officer and Chief Financial Officer of the Company (its principal officer and principal financial officer, respectively) have concluded, based on their evaluation as of a date within 90 days prior to filing this Report, that the Companys disclosure controls and procedures are effective to ensure that information required to be disclosed by the Company in the reports filed or submitted by it under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commissions rules and forms, and include controls and procedures designed to ensure that information required to be disclosed by the Company in such reports is accumulated and communicated to the companys management, including the Chief Executive Officer and Chief Financial Officer, as appropriate and allow timely decisions regarding required disclosure.
There were no significant changes in the Companys internal controls or in other factors that could significantly affect these controls subsequent to the date of this evaluation.
17
The company held its Annual Meeting of Stockholders on April 30, 2003, 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 six members to the Board of Directors, each to serve until the next Annual Meeting.
Number of Votes | |||||||||
---|---|---|---|---|---|---|---|---|---|
Name of Nominee | For | Against/Withheld | Abstentions | Broker Non-Votes | |||||
J. Robert Buchanan, M.D | 18,259,992 | 50,680 | N/A | N/A | |||||
Sam H. Eletr, Ph.D | 18,282,292 | 28,380 | N/A | N/A | |||||
Daniel R. Frank | 18,276,791 | 33,881 | N/A | N/A | |||||
William P. Moffitt | 18,237,130 | 73,542 | N/A | N/A | |||||
Lionel N. Sterling | 18,257,492 | 53,180 | N/A | N/A | |||||
Anne M. VanLent | 18,257,612 | 53,060 | N/A | N/A |
II. Ratification
of the appointment of PricewaterhouseCoopers LLP, as independent accountants to
audit the Company's 2003 financial
statements.
For | Against/Withheld | Abstentions | Broker Non-Votes | ||||||
18,271,030 | 27,050 | 12,592 | N/A |
18
(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)* |
3.5 | Certificate of Designation, Preferences and Rights of Series C Preferred Stock (Form 10-Q for the quarterly period ended September 30, 2002)* |
3.6 | Certificate of Amendment to the Restated Certificate of Incorporation (Form 10-Q for the quarterly period ended September 30, 2002)* |
3.7 | Certificate of Designation, Preferences and Rights of Series D Preferred Stock (Form 10-K for fiscal year ended December 31, 2002.)* |
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)* |
10.1 | Employment Agreement, dated April 1, 2003, between the Registrant and Michael P. Zelin |
99.1 | Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.** |
99.2 | Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.** |
* | 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. |
** | Pursuant to Commission Release No. 33-8212, this certification will be treated as accompanying this report on Form 10-Q and not filed as part of such report for the purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of Section 18 of the Exchange Act and this certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference. |
(b) Reports on Form 8-K
On February 3, 2003, the Company filed a current Report on Form 8-K attaching a press release pertaining to the signing of a new distribution agreement with Fuso Pharmaceutical Industries, Ltd. which extended Fusos distribution rights for the i-STAT® System in Japan. |
On February 24, 2003, the Company filed a current Report on Form 8-K attaching a press release that disclosed its financial results for the fourth quarter and full year 2002. |
On March 24, 2003, the Company filed a current Report on Form 8-K furnishing sworn statements of the Chief Executive Officer and Chief Financial Officer pursuant to Commission Order No. 4-460, and the statements of the Chief Executive Officer and Chief Financial Officer required under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
On April 24, 2003, the Company filed a current Report on Form 8-K attaching a press release that disclosed its financial results for the first quarter of 2003. |
19
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: May 8, 2003
i-STAT Corporation
(Registrant)
BY: /s/William P.
Moffitt
William P. Moffitt
President and Chief Executive Officer
(Principal Executive
Officer)
BY: /s/Lorin J. Randall
Lorin J. Randall
Senior Vice President of Finance,
Treasurer and Chief Financial Officer
Principal Financial Officer and
Accounting Officer
20
CERTIFICATION
I, William P. Moffitt, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of i-STAT Corporation; |
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operation and cash flows of i-STAT Corporation as of, and for, the periods presented in this quarterly report; |
4. | i-STAT Corporations other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for i-STAT Corporation and we have: |
a) | designed such disclosure controls and procedures to ensure that material information relating to i-STAT Corporation, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; |
b) | evaluated the effectiveness of i-STAT Corporations disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report; and |
c) | presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation; |
5. | i-STAT Corporations other certifying officers and I have disclosed, based on our most recent evaluation, to i-STAT Corporations auditors and the audit committee of i-STAT Corporations board of directors (or persons performing the equivalent function): |
a) | all significant deficiencies in the design or operation of internal controls which could adversely affect i-STAT Corporations ability to record, process, summarize and report financial data and have identified for i-STAT Corporations auditors any material weaknesses in internal controls; and |
b) | any fraud, whether or not material, that involves management or other employees who have a significant role in i-STAT Corporations internal controls; and |
6. | i-STAT Corporations other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. |
DATE: May 8, 2003
/s/ William P. Moffitt
William
P. Moffitt
President and Chief Executive Officer(Principal
Executive Officer)
21
CERTIFICATION
I, Lorin J. Randall, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of i-STAT Corporation; |
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operation and cash flows of i-STAT Corporation as of, and for, the periods presented in this quaterly report; |
4. | i-STAT Corporations other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for i-STAT Corporation and we have: |
a) | designed such disclosure controls and procedures to ensure that material information relating to i-STAT Corporation, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; |
b) | evaluated the effectiveness of i-STAT Corporations disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report; and |
c) | presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation; |
5. | i-STAT Corporations other certifying officers and I have disclosed, based on our most recent evaluation, to i-STAT Corporations auditors and the audit committee of i-STAT Corporations board of directors (or persons performing the equivalent function): |
a) | all significant deficiencies in the design or operation of internal controls which could adversely affect i-STAT Corporations ability to record, process, summarize and report financial data and have identified for i-STAT Corporations auditors any material weaknesses in internal controls; and |
b) | any fraud, whether or not material, that involves management or other employees who have a significant role in i-STAT Corporations internal controls; and |
6. | i-STAT Corporations other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. |
DATE: May 8, 2003
/s/ Lorin J. Randall
Lorin J.
Randall
Senior Vice President of Finance,Treasurer
and Chief Financial Officer
(Principal
Financial Officer and Accounting Officer)
22
EXHIBIT 99.1
CERTIFICATION PURSUANT
TO
18 U.S.C. SECTION 1350, AS
ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
William P. Moffitt, as President and Chief Executive Officer of i-STAT Corporation (the Company), certifies, pursuant to 18 U.S.C. (S)1350, as adopted pursuant to (S)906 of the Sarbanes-Oxley Act of 2002, that:
(1) the Companys Report on Form 10-Q for the quarter ended March 31, 2003 as filed with the Securities and Exchange Commission on the date hereof (the Report) fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
/s/ William P. Moffitt
_________________
William P. Moffitt
President and Chief
Executive Officer
May 8, 2003
(A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to i-STAT Corporation and will be retained by i-STAT Corporation and furnished to the Securities and Exchange Commission or its staff upon request.)
23
EXHIBIT 99.2
CERTIFICATION PURSUANT
TO
18 U.S.C. SECTION 1350, AS
ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
Lorin J. Randall, as Senior Vice President of Finance, Treasurer and Chief Financial Officer of i-STAT Corporation (the Company), certifies, pursuant to 18 U.S.C. (S)1350, as adopted pursuant to (S)906 of the Sarbanes-Oxley Act of 2002, that:
(1) the Companys Report on Form 10-Q for the quarter ended March 31, 2003 as filed with the Securities and Exchange Commission on the date hereof (the Report) fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
/s/ Lorin J. Randall
_________________
Lorin J. Randall
Senior Vice President
of Finance,
Treasurer and
Chief Financial Officer
May 8, 2003
(A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to i-STAT Corporation and will be retained by i-STAT Corporation and furnished to the Securities and Exchange Commission or its staff upon request.)
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