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U.S. SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
x |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE |
SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended May
31, 2002
¨ |
|
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE |
SECURITIES EXCHANGE ACT OF 1934
For The Transition Period from
to
Commission File Number: 0-11868
CARDIODYNAMICS INTERNATIONAL CORPORATION
(Exact
name of registrant as specified in its charter)
California |
|
95-3533362 |
(State or other jurisdiction of
incorporation or organization) |
|
(IRS Employer Identification
No.) |
6175 Nancy Ridge Drive, Suite 300, San Diego, California |
|
92121 |
(Address of principal executive offices) |
|
(Zip Code) |
(858) 535-0202
(Registrants telephone number)
Indicate by check mark whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for
such shorter period that the registrant was required to fill such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
As of July 10, 2002, 46,144,712 shares of common stock and no shares of preferred stock were outstanding.
CARDIODYNAMICS INTERNATIONAL CORPORATION
FORM 10-Q
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Page No.
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PART IFINANCIAL INFORMATION |
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Item 1. |
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Financial Statements: |
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3 |
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5 |
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6 |
Item 2. |
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9 |
Item 3. |
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17 |
PART IIOTHER INFORMATION |
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Item 1. |
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17 |
Item 2. |
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17 |
Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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18 |
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19 |
2
PART IFINANCIAL INFORMATION
Item 1. Financial Statements
CARDIODYNAMICS INTERNATIONAL CORPORATION
BALANCE SHEETS
(In thousands, except share data)
ASSETS |
|
May 31, 2002
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November 30, 2001
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(Unaudited) |
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(Audited) |
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Current assets: |
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Cash and cash equivalents |
|
$ |
6,405 |
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$ |
6,394 |
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Accounts receivable, net of allowance for doubtful accounts of $1,613 in 2002 and $1,425 in 2001 |
|
|
6,814 |
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|
|
7,373 |
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Inventory, net |
|
|
3,541 |
|
|
|
2,821 |
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Current portion of long-term receivables |
|
|
2,086 |
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|
|
1,663 |
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Other current assets |
|
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455 |
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431 |
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Total current assets |
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19,301 |
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18,682 |
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Property and equipment, net |
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438 |
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|
490 |
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Long-term receivables and note receivable, net |
|
|
2,051 |
|
|
|
2,259 |
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Deposits |
|
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30 |
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|
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30 |
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Total assets |
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$ |
21,820 |
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|
$ |
21,461 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
|
$ |
1,450 |
|
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$ |
1,338 |
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Accrued expenses |
|
|
340 |
|
|
|
277 |
|
Accrued salaries, wages and benefits |
|
|
821 |
|
|
|
903 |
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Current maturities of long-term debt |
|
|
41 |
|
|
|
69 |
|
Deferred service revenue |
|
|
401 |
|
|
|
411 |
|
|
|
|
|
|
|
|
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Total current liabilities |
|
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3,053 |
|
|
|
2,998 |
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Long-term debt, less current maturities |
|
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27 |
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40 |
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Total liabilities |
|
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3,080 |
|
|
|
3,038 |
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Shareholders equity: |
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Preferred stock; no par value; 18,000,000 shares authorized; no shares issued or outstanding at May 31, 2002 or November
30, 2001 |
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Common stock; no par value; 100,000,000 shares authorized; issued and outstanding 46,142,712 shares at May 31, 2002 and
45,798,322 shares at November 30, 2001 |
|
|
49,686 |
|
|
|
48,786 |
|
Accumulated deficit |
|
|
(30,946 |
) |
|
|
(30,363 |
) |
|
|
|
|
|
|
|
|
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Total shareholders equity |
|
|
18,740 |
|
|
|
18,423 |
|
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|
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|
|
|
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Commitments and contingencies |
|
|
|
|
|
|
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Total liabilities and shareholders equity |
|
$ |
21,820 |
|
|
$ |
21,461 |
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|
|
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|
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See accompanying notes to financial
statements.
3
CARDIODYNAMICS INTERNATIONAL CORPORATION
STATEMENTS OF OPERATIONS
(UnauditedIn
thousands, except share and per share data)
|
|
Three Months Ended May 31,
|
|
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Six Months Ended May 31,
|
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2002
|
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2001
|
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2002
|
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2001
|
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Net sales |
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$ |
5,623 |
|
|
$ |
4,480 |
|
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$ |
9,989 |
|
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$ |
8,445 |
|
Cost of sales |
|
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1,560 |
|
|
|
1,284 |
|
|
|
2,838 |
|
|
|
2,500 |
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Gross margin |
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4,063 |
|
|
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3,196 |
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|
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7,150 |
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5,945 |
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|
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Operating expenses: |
|
|
|
|
|
|
|
|
|
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|
|
|
|
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Research and development |
|
|
611 |
|
|
|
902 |
|
|
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1,253 |
|
|
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1,713 |
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Selling and marketing |
|
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3,049 |
|
|
|
2,470 |
|
|
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5,770 |
|
|
|
4,663 |
|
General and administrative |
|
|
422 |
|
|
|
396 |
|
|
|
861 |
|
|
|
846 |
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Total operating expenses |
|
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4,082 |
|
|
|
3,768 |
|
|
|
7,884 |
|
|
|
7,222 |
|
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|
|
|
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|
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|
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Loss from operations |
|
|
(19 |
) |
|
|
(572 |
) |
|
|
(734 |
) |
|
|
(1,277 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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Other income (expense): |
|
|
|
|
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|
|
|
|
|
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Interest income |
|
|
76 |
|
|
|
164 |
|
|
|
182 |
|
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|
355 |
|
Interest expense |
|
|
(3 |
) |
|
|
(16 |
) |
|
|
(6 |
) |
|
|
(29 |
) |
Other, net |
|
|
(6 |
) |
|
|
(6 |
) |
|
|
(24 |
) |
|
|
(12 |
) |
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Total other income |
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|
67 |
|
|
|
142 |
|
|
|
152 |
|
|
|
314 |
|
|
|
|
|
|
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|
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Income (loss) before income taxes |
|
|
48 |
|
|
|
(430 |
) |
|
|
(582 |
) |
|
|
(963 |
) |
Income taxes |
|
|
(1 |
) |
|
|
|
|
|
|
(1 |
) |
|
|
(1 |
) |
|
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|
|
|
|
|
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|
|
|
|
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Net income (loss) |
|
$ |
47 |
|
|
$ |
(430 |
) |
|
$ |
(583 |
) |
|
$ |
(964 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Net income (loss) per share, basic and diluted |
|
$ |
.00 |
|
|
$ |
(.01 |
) |
|
$ |
(.01 |
) |
|
$ |
(.02 |
) |
|
|
|
|
|
|
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Weighted-average number of common shares outstanding, basic |
|
|
46,113,799 |
|
|
|
45,524,882 |
|
|
|
46,024,279 |
|
|
|
45,522,310 |
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|
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|
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Weighted-average number of common shares outstanding, diluted |
|
|
47,433,448 |
|
|
|
45,524,882 |
|
|
|
46,024,279 |
|
|
|
45,522,310 |
|
|
|
|
|
|
|
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|
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See accompanying notes to financial statements.
4
CARDIODYNAMICS INTERNATIONAL CORPORATION
STATEMENTS OF CASH FLOWS
(UnauditedIn
thousands)
|
|
Six Months Ended May 31,
|
|
|
|
2002
|
|
|
2001
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(583 |
) |
|
$ |
(964 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
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Depreciation and amortization |
|
|
144 |
|
|
|
139 |
|
Provision for warranty repairs |
|
|
78 |
|
|
|
19 |
|
Provision for obsolete inventory |
|
|
56 |
|
|
|
48 |
|
(Reduction in) provision for demonstration inventory |
|
|
(16 |
) |
|
|
45 |
|
Provision for (reduction in) doubtful receivables |
|
|
188 |
|
|
|
(309 |
) |
Provision for (reduction in) doubtful long-term receivables |
|
|
25 |
|
|
|
(73 |
) |
Compensatory stock options granted |
|
|
36 |
|
|
|
31 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
371 |
|
|
|
(1,272 |
) |
Inventory |
|
|
(760 |
) |
|
|
(540 |
) |
Other current assets |
|
|
(240 |
) |
|
|
(837 |
) |
Long-term receivables and note receivable |
|
|
(24 |
) |
|
|
51 |
|
Accounts payable |
|
|
112 |
|
|
|
(461 |
) |
Accrued expenses |
|
|
(15 |
) |
|
|
(361 |
) |
Accrued salaries, wages and benefits |
|
|
(82 |
) |
|
|
(42 |
) |
Deferred service revenue |
|
|
(10 |
) |
|
|
244 |
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(720 |
) |
|
|
(4,282 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(92 |
) |
|
|
(91 |
) |
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(92 |
) |
|
|
(91 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Repayment of long-term debt |
|
|
(41 |
) |
|
|
(52 |
) |
Exercise of warrants and options |
|
|
883 |
|
|
|
55 |
|
Issuance of common stock, net |
|
|
(19 |
) |
|
|
(59 |
) |
|
|
|
|
|
|
|
|
|
Net cash provided (used in) by financing activities |
|
|
823 |
|
|
|
(56 |
) |
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
11 |
|
|
|
(4,429 |
) |
Cash and cash equivalents at beginning of period |
|
|
6,394 |
|
|
|
11,595 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
6,405 |
|
|
$ |
7,166 |
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial
statements.
5
CARDIODYNAMICS INTERNATIONAL CORPORATION
NOTES TO FINANCIAL STATEMENTS
(Unaudited)
Description of Business
CardioDynamics International Corporation (CardioDynamics, or The Company) is the innovator and market leader of a breakthrough technology called Impedance Cardiography (ICG). We
develop, manufacture, and market noninvasive heart-monitoring devices using our proprietary ICG technology, DISQ (Digital Impedance Signal Quantifier) technology, and ZMarc algorithm.
Unlike other cardiac function monitoring technologies, our monitors are noninvasive (without cutting into the
body). The Companys BioZ® Systems use a proprietary technology called impedance cardiography to
obtain data in a safe, efficient and cost-effective manner not previously available in the physicians office and many hospital settings. Just as Electrocardiography (ECG) noninvasively measures the hearts electrical characteristics, ICG
makes it possible to noninvasively measure the hearts mechanical characteristics. Our strategic partners include GE Medical Systems Information Technologies (GEMS-IT), Spacelabs Medical Systems, and Vasomedical.
Our proprietary, patented technology noninvasively monitors the hearts ability to deliver blood to the body and the amount of fluid
in the chest. Our products measure 12 hemodynamic (blood flow) parameters, the most significant of which is cardiac output, or the amount of blood pumped by the heart each minute. Our lead product, the BioZ.com®, has been cleared by the Federal Drug Administration (FDA) and carries the CE mark. We sell to US physicians and
hospitals through our own direct sales force and distribute our products to targeted international markets through a strategic alliance with GEMS-IT and a network of international distributors. In November 1998, Health Care Finance Administration
(HCFA), now known as the Center for Medicare & Medicaid Services (CMS), mandated Medicare reimbursement for our BioZ® procedures and in January 2001, implemented uniform reimbursement throughout the United States.
We were originally incorporated in California in June 1980 as Bomed Medical Manufacturing, Ltd. and in October 1993 changed our name to CardioDynamics International
Corporation.
Basis of Presentation
The information contained in this report is unaudited, but in our opinion reflects all adjustments necessary to make the financial position and results of operations for the interim periods a fair
statement of our operations and cash flows. All such adjustments are of a normal recurring nature. These statements should be read along with the Financial Statements and Notes that go along with our audited financial statements, as well as the
other financial information for the fiscal year ended November 30, 2001 as presented in our Annual Report on Form 10-K. Financial presentations for prior periods have been reclassified to conform to current year presentation. The results of
operations for the three and six months and cash flows for the six months ended May 31, 2002 are not necessarily indicative of the results that may be expected for the full fiscal year ending November 30, 2002.
6
CARDIODYNAMICS INTERNATIONAL CORPORATION
NOTES TO FINANCIAL STATEMENTS(Continued)
Inventory
Inventory consists of the following: (in thousands)
|
|
May 31, 2002
|
|
|
November 30, 2001
|
|
Electronic components and subassemblies |
|
$ |
1,591 |
|
|
$ |
1,657 |
|
Finished goods |
|
|
1,993 |
|
|
|
1,100 |
|
Demonstration units |
|
|
706 |
|
|
|
773 |
|
Less provision for obsolete inventory |
|
|
(628 |
) |
|
|
(572 |
) |
Less provision for demonstration inventory |
|
|
(121 |
) |
|
|
(137 |
) |
|
|
|
|
|
|
|
|
|
|
|
$ |
3,541 |
|
|
$ |
2,821 |
|
|
|
|
|
|
|
|
|
|
Long-Term Receivables and Note Receivable
In our third and fourth fiscal quarters of 2000, we offered no-interest financing of our BioZ® Systems with maturities ranging from 24 to 60 months. The long-term receivables are collateralized by the systems. In the first fiscal quarter
of 2001, we established a similar program through a third-party financing company to replace the internal financing program. We are now working with a core group of leasing companies to provide financing options to our customers. Under certain
circumstances we continue to provide in-house financing, although the contracts now typically include market rate interest provisions.
Long-term receivables and note consist of the following: (in thousands)
|
|
May 31, 2002
|
|
|
November 30, 2001
|
|
Long-term receivables, net of deferred interest |
|
$ |
4,311 |
|
|
$ |
4,086 |
|
Secured note receivable |
|
|
364 |
|
|
|
349 |
|
Less allowance for doubtful long-term receivables |
|
|
(538 |
) |
|
|
(513 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
4,137 |
|
|
|
3,922 |
|
Less current portion of long-term receivables |
|
|
(2,086 |
) |
|
|
(1,663 |
) |
|
|
|
|
|
|
|
|
|
|
|
$ |
2,051 |
|
|
$ |
2,259 |
|
|
|
|
|
|
|
|
|
|
7
CARDIODYNAMICS INTERNATIONAL CORPORATION
NOTES TO FINANCIAL STATEMENTS(Continued)
Net Income (Loss) Per Share
Net income (loss) per share is computed by dividing the net income (loss) by the weighted-average number of common shares outstanding during the period. Diluted income
(loss) per share is calculated by including the additional shares of common stock issuable upon exercise of outstanding options and warrants in the weighted-average share calculation. The following table lists the options and warrants, each
convertible into one share of common stock, which were not included in the diluted earnings per share calculation as their effect was antidilutive.
|
|
Three Months Ended May
31,
|
|
Six Months Ended May
31,
|
|
|
2002
|
|
2001
|
|
2002
|
|
2001
|
Stock options |
|
1,454,358 |
|
3,954,805 |
|
4,002,705 |
|
3,954,805 |
Warrants |
|
2,000,000 |
|
2,472,170 |
|
2,379,536 |
|
2,472,170 |
|
|
|
|
|
|
|
|
|
Total |
|
3,454,358 |
|
6,426,975 |
|
6,382,241 |
|
6,426,975 |
|
|
|
|
|
|
|
|
|
8
Item 2. Managements Discussion and Analysis of Financial
Condition and Results of Operations
FORWARD LOOKING STATEMENTS: NO ASSURANCES INTENDED
This Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of
1933 and Section 21E of the Securities Exchange Act of 1934. These statements include statements regarding our plans, goals, strategies, intent, beliefs or current expectations. These statements are expressed in good faith and we believe, had a
reasonable basis when expressed, but there can be no assurance that these expectations will be achieved or accomplished. Sentences in this document containing verbs such as plan, intend, anticipate,
target, estimate, expect, etc., and/or future-tense or conditional constructions (will, may, could, should, etc.) constitute forward-looking statements that involve
risks and uncertainties. Items contemplating, or making assumptions about, actual or potential future sales, market size, collaborations, trends or operating results also constitute such forward-looking statements.
Although forward-looking statements in this Report reflect the good faith judgment of management, such statements can only be based on
facts and factors currently known by management. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in, or
anticipated by the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes, include without limitation, those discussed in our Annual Report on Form 10-K for the year ended November 30, 2001.
Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Report. We undertake no obligation to revise or update any forward-looking statements in order to reflect any event or
circumstance that may arise after the date of this Report. Readers are urged to carefully review and consider the various disclosures made by us in our 10-K for the year ended November 30, 2001, which attempt to advise interested parties of the
risks and factors that may affect the our business, financial condition, results of operations and cash flows.
The following discussion should be read along with the Financial Statements and Notes to our audited financial statements, as well as the other financial information for the fiscal year ended November 30, 2001.
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OVERVIEW
Cardiovascular disease is the number one killer of men and women in the United States and in 31 of the 35 countries reporting mortality statistics. Over 60,000,000 Americans have some form of cardiovascular disease, which includes,
high blood pressure, congestive heart failure, congenital heart defects, hardening of the arteries, stroke and other diseases of the circulatory system. Our proprietary ICG technology provides medical professionals in the hospital and
physicians office with noninvasive access to the objective patient data they need to effectively assess, diagnose and treat congestive heart failure and hypertension, and to evaluate emergency, pacemaker and dialysis patients.
Currently, the primary method used to measure hemodynamic parameters is pulmonary artery catheterization (PAC). The invasive
PAC procedure requires hospitalization and involves an incision into the patients neck or groin region and the insertion of a catheter (plastic tube) through the heart directly into the pulmonary artery. Complications associated with this
procedure occur in as many as one in four reported cases and include irregular heartbeats, infection, pulmonary artery rupture and death.
Because of the high risk of complications, physicians generally prescribe PAC only for critically ill patients. In the non-sterile environment of a physicians office or outpatient clinic, PAC is simply unavailable. As
a result, in the great majority of situations, the physician seeking to diagnose cardiovascular disease must indirectly assess the patients hemodynamic status by measuring blood pressure, checking the pulse, looking at neck veins and employing
subjective examination techniques that are prone to human error. A compelling need exists for objective, noninvasive measurement tools, such as our BioZ® systems.
During ICG monitoring using our BioZ® systems, an undetectable electrical signal is sent through our proprietary sensors on the patients neck and chest. Our sophisticated DISQ technology and ZMARC algorithm analyze and record significant hemodynamic parameters. Based on this data, a physician can quickly and safely identify underlying cardiovascular disorder, assess and diagnose, customize and target treatment,
monitor the effectiveness of prescribed medications and more accurately identify potential complications.
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Our objective is to establish the BioZ® product line as a standard of care in cardiovascular medicine. Key elements of our corporate strategy include:
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accelerate market penetration through our direct sales force; |
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broaden our distribution channels through strategic relationships; |
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secure additional recurring revenue through enhanced proprietary sensors; |
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maintain market leadership through product improvements and extensions; |
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target new market opportunities through technology development; and |
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develop ICG products for home healthcare. |
Our objective will be achieved if and when noninvasive cardiac output, our primary measurement, becomes the Sixth Vital Sign, as oxygen saturation became the fifth vital sign in the mid-1980s. We intend to position ICG technology as a key diagnostic and
monitoring tool in assessing and treating congestive heart failure, hypertension, pacemaker, emergency, critically ill, surgical, high-risk obstetric, dialysis, cardiac rehabilitation, immune suppressed and home healthcare patients.
RESULTS OF OPERATIONS (Quarters referred to herein are fiscal quarters ended May 31)
RevenuesNet sales for the second fiscal quarter of 2002 were $5,623,000, an increase of 26% over the same three-month period
of fiscal 2001 in which net sales were $4,480,000 and our 16th consecutive quarter of year-over-year quarterly revenue growth. Year to date sales were $9,989,000, as compared to $8,445,000 during the first six months of fiscal 2001. The increase in
sales during the three and six month periods ended May 31, 2002, when compared to the same periods last year, can be attributed to several factors including a higher per-unit average sales price, increased recurring revenue and an increase in the
number of sales force personnel. In the first half of last year, GEMS-IT purchased $1,690,000 of product from us as part of their fiscal 2001 annual purchase commitment, while in the first half of fiscal 2002, they did not purchase any products from
us for sale in the United States because of their existing inventory levels. GEMS-IT has however purchased 18 BioZ Systems for overseas distribution so far this year. We shipped 157 BioZ Systems during the quarter, up from 131 in the same quarter
last year and bringing the year to date number of systems shipped to 282. Our installed base of stand-alone systems has increased by 46% from one year ago to over 1,900 systems being used in over 1,300 customer sites.
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Sales by our domestic direct sales force, who target physician offices and US
hospitals, increased 53% in the second quarter of 2002 over the second quarter of 2001, primarily as a result of a 24% higher average unit sales price and a 15% increase direct sales personnel. The average price per unit sold by our direct sales
force has continued to increase for several reasons, including greater awareness and acceptance of ICG technology, uniform nationwide Medicare reimbursement, inclusion of additional options, warranty and accessories in the Bioz.com system price, and
the absence of competitive products or cost-effective alternative technologies. We have continued to expand the number of field sales associates and ended the second quarter with 41 domestic sales representatives and 11 clinical sales specialists.
Our BioZtect sensor and cable system has a
proprietary interface to ensure that customers exclusively use the BioZtect with our BioZ systems.
Each time our BioZ products are used, disposable sets of four dual sensors are required. Recurring sensor revenue increased 51% in the second quarter of 2002 to $701,000 (12% of sales), from $463,000 (10% of sales) in the same quarter of 2001. The
BioZtect sensors for our ICG Module have a list price of $19.95 and sensors for our stand-alone systems have a list price of $9.95 per application, however customers can obtain significant sensor
pricing discounts though our auto-ship sensor program in exchange for minimum monthly sensor purchase commitments. We are focused on increasing the average usage per customer and have made this one of the goals for our clinical application
specialists. As the installed base of BioZ equipment grows, we expect the revenue generated by our disposable sensors to continue to increase.
Gross MarginWe generated $4,063,000 of gross margin in the quarter, up 27% over the same quarter last year in which our gross margin was $3,196,000. As a percentage of sales, our gross
margin was 72% in the second quarter, up from 71% in the same quarter last year. In the first half of fiscal 2002, our gross margin percentage was 72% of sales, up from 70% of sales in the same six-month period last year. Late in the fourth quarter
of fiscal 2001, we commenced shipments of our new, re-engineered BioZ.com which has a manufactured cost that is approximately 30% lower than the previous generation BioZ.com system. This direct material cost reduction, along with a higher sales
volume and higher average sales price per unit accounted for the second quarter increase in gross margin. The improved gross margin was offset somewhat in both the first and second quarters of fiscal 2002 by certain research, development and
clinical expenses related to the manufacturing solution for the 43 second generation BioZ systems that we voluntarily retrieved from customer sites during the first quarter.
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Research and DevelopmentOur research and development costs for the
second quarter of fiscal 2002 decreased approximately 32% to $611,000, from $902,000 during the second quarter of fiscal 2001. Expenditures for research and development for the first six months of fiscal 2002 have also decreased, from $1,713,000, to
$1,253,000. The decrease can be attributed to less reliance on outside consultants for engineering services that our in-house engineers now provide and the allocation to cost of goods sold of a portion of our research and development expenses that
were devoted to the development of a manufacturing solution for the 43 second generation BioZ systems that we voluntarily retrieved from customer sites. Even though overall research and development expenses decreased as compared with the same
quarter last year, our investment in clinical studies increased during the quarter primarily as a result of our sponsorship of two clinical studies, PREDICT, which began in late 2000 and is scheduled to complete its first phase in late 2002, and
ESCAPE-BIG, which began in mid 2001 and is scheduled to be completed in the early part of fiscal 2003. The larger of the two studies, PREDICT, has 21 research sites participating with over 200 patients currently enrolled.
On March 22, 2002 we announced an agreement between our company and Medtronic, Inc. the worlds leading medical technology company.
The agreement provides for the evaluation of clinical utility of our proprietary IGC technology in optimizing the programming of Medtronics implantable device for Cardiac Resynchronization Therapy (CRT). The agreement also addresses the
potential integration of the BioZ ICG Module with Medtronic instrumentation on terms that would be negotiated in the future, if such integration were to take place.
Selling and MarketingSelling and marketing expenses for the second fiscal quarter of 2002 increased $579,000, or 23% over the second quarter of 2001 with
expenses of $3,049,000 and $2,470,000, respectively. For the first six months of fiscal 2002 selling and marketing expenses were $5,770,000 as compared to $4,663,000 for the same six-month period last year. The increase was primarily due to the
addition of sales and marketing personnel. At the end of May 2002, we had a total of 73 sales and marketing personnel, up from 63 at the end of May 2001, including 45 territory managers, 12 marketing and support employees, 11 clinical sales
specialists and 5 international distribution managers.
General and AdministrativeOur general and
administrative cost were $422,000 in the second quarter fiscal 2002, compared to $396,000 for second quarter of fiscal 2001. We continue to focus on ongoing cost containment in all areas of our business with additional emphasis in the areas that are
not directly related to sales growth. Year-to-date general and administrative costs were $861,000 as compared to $846,000 for the same period last year. As a percentage of sales, general and administrative expenses in the first six months of 2002
were reduced to 9% from 10% in the first half of 2001.
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Interest Income and ExpenseWe earned $76,000 of interest income in
the second quarter of fiscal 2002, down from $164,000 in the second quarter of fiscal 2001. For the six months ended May 31, 2002 interest income was $182,000 as compared to $355,000 for the first six months of fiscal 2001. The decrease is primarily
due to fewer funds available for investment throughout the period and lower rates of interest earned on invested funds. We incurred interest expense of $3,000 during the second quarter of fiscal 2002, down from the $16,000 we recorded during the
same period last year. For the six months ended May 31, 2002 we incurred interest expense of $6,000 as compared to $29,000 of interest expense recorded during the same six-month period last year. Interest expense is primarily related to capital
leases, several of which have recently come to the end of their terms.
Net LossNet income for the
second quarter of fiscal 2002 was $47,000 or $.00 per common share, compared with a net loss of $430,000, or ($.01) per common share for the second quarter of fiscal 2001. The net income earned during the second fiscal quarter of 2002 reduced our
year to date net loss of $583,000, or ($.01) per common share. In the first half of fiscal 2001, our net loss was $964,000 or ($.02) per common share. The average number of common shares outstanding during the first six months of fiscal 2002,
increased by 1% over last year primarily due to the exercise of stock options and warrants during the past year.
LIQUIDITY AND
CAPITAL RESOURCES
Net cash used in operating activities for the six months ended May 31, 2002 was $720,000,
compared with $4.3 million used in the first six months of fiscal 2001. During the six months ended May 31, 2002, increased purchases of inventory, short-term customer financing and the net loss from operations were the main uses of cash in
operating activities. Increases in accounts receivable, long-term receivables and inventory, driven by higher sales levels, comprised the majority of the operating cash used in the first half of fiscal of 2001.
For the first six months of fiscal 2002, $823,000 of cash was provided from financing activities, primarily as a result of the exercise of
stock options and warrants during the period. For the first six months of fiscal 2001, $56,000 of cash was used in financing activities, primarily for the repayment of long-term debt and for the costs associated with the issuance of common stock.
In January 1999, we established a secured revolving credit line with Imperial Bank, now Comerica Bank. The credit
line provides for borrowings at the banks prime rate. All the assets of the Company collateralize the credit line. In June of 2001 the line of credit was renewed and increased to $4,000,000 and has been extended through September 2002. Under
the terms of the agreement, we are required to maintain minimum ratios of current assets to liabilities and not to exceed certain loss levels. At May 31, 2002 there was no outstanding borrowing under the line of credit.
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We have operating loss carryforwards of
approximately $28,000,000 for federal income tax purposes. The Tax Reform Act of 1986 contains provisions which limit the federal net operating loss carryforwards that can be used in any given year in the event of specified occurrences, including
significant ownership changes. If these specified events occur we may lose some or all of the tax benefits of these carryforwards. A valuation allowance has been recognized for the full amount of the deferred tax asset created by these
carryforwards.
Since May 1999, we have raised approximately $24 million through various private placements of
common stock to institutional and accredited investors. To date, these financings, together with the line of credit and various loans, have provided the capital required to fund initial commercialization of our BioZ products. In the near term, we intend to use our cash on hand and line of credit to fund ongoing research and
development efforts, expansion of our direct sales force and international sales presence, capital expenditures and to meet our working capital requirements.
Our long-term liquidity will depend on our ability to further commercialize the BioZ and other diagnostic products and to raise additional funds through
public or private financing, bank loans, collaborative relationships or other arrangements. We can give no assurance that such additional funding will be available on terms attractive to us, or at all.
RECENT ACCOUNTING DEVELOPMENTS
In July 2001, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards (SFAS) 141, Business Combinations, and 142, Goodwill and Other Intangible Assets, which supersedes
Accounting Principles Board Opinion 17, Intangible Assets. SFAS 141 requires that all business combinations be accounted for under the purchase method. The statement further requires separate recognition of intangible assets that meet one of
the two criteria, as defined in the statement. This statement applies to all business combinations initiated after June 30, 2001. Under SFAS 142, goodwill and intangible assets with indefinite lives are no longer amortized but are tested at least
annually for impairment. Separable intangible assets with defined lives will continue to be amortized over their useful lives. The provisions of SFAS 142 will apply to goodwill and intangible assets acquired before and after the statements
effective date, fiscal years beginning after December 15, 2001 or the beginning of the Companys fiscal year 2003. It is not anticipated that the adoption of the provisions of SFAS 141 and 142 will have a material impact on our results of
operations or financial position.
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In August 2001, the Financial Accounting Standards Board issued SFAS 143,
Accounting for Asset Retirement Obligations, which addresses financial accounting and reporting for obligations associated with the retirement of tangible long-lived assets and the associated asset retirement costs. The standard applies to
legal obligations associated with the retirement of long-lived assets that result from the acquisition, construction, development and (or) normal use of the asset. SFAS 143 requires that the fair value of a liability for an asset retirement
obligation be recognized in the period in which it is incurred if a reasonable estimate of fair value can be made. The fair value of the liability is added to the carrying amount of the associated asset and this additional carrying amount is
depreciated over the life of the asset. The liability is accreted at the end of each period through charges to operating expense. If the obligation is settled for other than the carrying amount of the liability, the Company will recognize a gain or
loss on settlement. We are required to adopt the provisions of Statement No. 143 for the quarter ending February 28, 2003. It is not anticipated the adoption of SFAS 143 will have a material effect on our results of operations or financial position.
In October 2001, the FASB issued Statement of Financial Accounting Standards No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets (Statement No. 144), which addresses financial accounting and reporting for the impairment or disposal of long-lived assets. While Statement No. 144 supersedes Statement of Financial Accounting
Standards No. 121, Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of (Statement No. 121), it retains many of the fundamental provisions of Statement No. 121, including the recognition and
measurement of the impairment of long-lived assets to be held and used, and the measurement of long-lived assets to be disposed of by sale. Statement No. 144 also supersedes the accounting and reporting provisions of Accounting Principles Board
Opinion No. 30, Reporting the Results of OperationsReporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions (Opinion No. 30), for the disposal of a
segment of a business. However, it retains the requirement in Opinion No. 30 to report separately discontinued operations and extends that reporting to a component of an entity that either has been disposed of (by sale, abandonment, or in a
distribution to owners) or is classified as held for sale. Statement No. 144 is effective for fiscal years beginning after December 15, 2001. It is not anticipated that the financial impact of this statement will have a material effect on our
results of operations or financial position.
In April 2002, the FASB issued Statement No. 145, Rescission of
FASB Statements No. 4,44 and 64, Amendment of FASB Statement No. 13, and Technical Corrections. Statement 145 updates, clarifies and simplifies existing accounting pronouncements including: rescinding Statement No. 4, which required all gains
and losses from extinguishment of debt to be aggregated and, if material, classified as an extraordinary item, net of related income tax effect and amending Statement No. 13 to require that certain lease modifications that have economic effects
similar to sale-leaseback transactions be accounted for in the same manner as sale-leaseback transactions. Statement 145 is effective for fiscal years beginning after May 15, 2002, which early adoption of the provisions related to the rescission of
Statement No. 4 encouraged. We do not expect the adoption of this statement to have a material impact on our results of operations or financial position.
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OTHER ITEMS
The Company is not a party to off-balance sheet arrangements, does not engage in trading activities involving non-exchange traded contracts, and is not a party to any
transaction with persons or activities that derive benefits, except as disclosed herein, from their non-independent relationships with the Company.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
INTEREST RATE SENSITIVITY
The primary objective of our investment activities is to
preserve principal, while at the same time, maximize the income we receive from our investments without significantly increasing risk. In the normal course of business, we employ established policies and procedures to manage our exposure to changes
in the fair value of our investments. Under our current policies, we do not use interest rate derivative instruments to manage exposure to interest rate changes. We attempt to ensure the safety and preservation of our invested principal funds by
limiting default risks, market risk and reinvestment risk. We mitigate default risk by investing in investment grade securities. Some of the securities that we have invested in may be subject to market risk. This means that a change in prevailing
interest rates may cause the principal amount of the investment to fluctuate. For example, if we hold a security that was issued with a fixed rate equal to the then-prevailing interest rate and the prevailing interest rate later rises, the fair
value of our investment will decline. To minimize this risk, we maintain substantially all of our portfolio of cash equivalents in commercial paper, certificates of deposit and money market funds. Our interest income is sensitive to changes in the
general level of U.S. interest rates, however, due to the nature of our short-term investments, we have concluded that there is no material market risk exposure.
PART IIOTHER INFORMATION
Item 1. Legal
Proceedings
None.
Item 2. Changes in Securities
None.
Item 3. Defaults Upon Senior Securities
None.
Item
4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
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Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits:
Exhibit
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Title
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10.1 |
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Service Agreement among Rivertek Medical Systems, Inc., Dennis G. Hepp and the Company, dated January 1,
2002. |
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10.2 |
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Amendment to lease agreement between CRV Partners, L.P., and CardioDynamics International Corporation, dated March
21, 2002. |
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10.3 |
* |
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Addendum to OEM Development and Purchase Agreement between CardioDynamics International Corporation and GE Marquette
Medical Systems, Inc., dated April 24, 2002. |
* |
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Confidential treatment has been requested as to certain portions of this Exhibit pursuant to Rule 406 promulgated under the Securities Act. Such portions have
been omitted and filed separately with the Securities and Exchange Commission. |
(b) Reports on Form 8-K:
None.
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CARDIODYNAMICS INTERNATIONAL CORPORATION
This Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E
of the Securities Exchange Act of 1934. These statements include statements regarding our plans, goals, strategies, intent, beliefs or current expectations. These statements are expressed in good faith and we believe had a reasonable basis when
expressed, but there can be no assurance that these expectations will be achieved or accomplished. Sentences in this document containing verbs such as plan, intend, anticipate, target,
estimate, expect, etc., and/or future-tense or conditional constructions (will, may, could, should, etc.) constitute forward-looking statements that involve risks and
uncertainties. Items contemplating, or making assumptions about, actual or potential future sales, market size, collaborations, trends or operating results also constitute such forward-looking statements. These statements are only predictions and
actual results could differ materially. Certain factors that might cause such a difference as well as other risks are detailed in the Companys annual report on Form 10-K for the fiscal year ended November 30, 2001 and any later filed SEC
reports. Any forward-looking statement speaks only as of the date we made the statement, and we do not undertake to update the disclosures contained in this document or reflect events or circumstances that occur subsequently or the occurrence of
unanticipated events.
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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By: |
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/s/ MICHAEL K.
PERRY
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Michael K. Perry Chief
Executive Officer (Principal Executive Officer) |
Date: July 15, 2002
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By: |
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/s/ STEPHEN P. LOOMIS
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Stephen P. Loomis Vice
President, Finance, Chief Financial Officer (Principal Financial and Accounting Officer) |
Date: July 15, 2002
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