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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, 2003

 

¨   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

(State or other jurisdiction of incorporation or organization)

 

95-533362

(IRS Employer Identification No.)

6175 Nancy Ridge Drive, Suite 300, San Diego, California

(Address of principal executive offices)

 

92121

(Zip Code)

 

(858) 535-0202

(Registrant’s 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 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 x  No  ¨

 

As of July 10, 2003, 46,200,724 shares of common stock and no shares of preferred stock were outstanding.

 



Table of Contents

CARDIODYNAMICS INTERNATIONAL CORPORATION

 

FORM 10-Q

 

TABLE OF CONTENTS

 

          Page No.

PART I – FINANCIAL INFORMATION     
Item 1.    Financial Statements:     
     Balance Sheets (unaudited) at May 31, 2003 and November 30, 2002.    3
     Statements of Operations (unaudited) for the three and six months ended May 31, 2003 and 2002.    5
     Statements of Cash Flows (unaudited) for the six months ended May 31, 2003 and 2002    6
     Notes to Financial Statements (unaudited).    8
Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operation    12
Item 3.    Quantitative and Qualitative Disclosures about Market Risk    18
Item 4.    Controls and Procedures    18
PART II – OTHER INFORMATION     
Item 1.    Legal Proceedings    20
Item 2.    Changes in Securities    20
Item 3.    Defaults Upon Senior Securities    20
Item 4.    Submission of Matters to a Vote of Security Holders    20
Item 5.    Other Information    20
Item 6.    Exhibits and Reports on Form 8-K    20
     Signatures    21

 

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PART I – FINANCIAL INFORMATION

 

Item  1.    Financial   Statements

 

CARDIODYNAMICS INTERNATIONAL CORPORATION

 

Balance Sheets

(Unaudited, in thousands, except share data)

     May 31,
2003


   November 30,
2002


Assets

             

Current assets:

             

Cash and cash equivalents

   $ 7,179    $ 6,879

Accounts receivable, net of allowance for doubtful accounts of $2,230 in 2003 and $1,726 in 2002

     7,946      8,349

Inventory, net

     3,494      3,474

Current portion of long-term receivables

     2,487      2,522

Other current assets

     336      222
    

  

Total current assets

     21,442      21,446

Property and equipment, net

     539      414

Long-term receivables and note receivable, net

     1,785      1,654

Other assets

     52      52
    

  

Total assets

   $ 23,818    $ 23,566
    

  

Liabilities and Shareholders’ Equity

             

Current liabilities:

             

Accounts payable

   $ 1,111    $ 1,528

Accrued expenses

     111      173

Accrued salaries, wages and benefits

     1,147      1,195

Income taxes payable

     48     

Current portion of deferred service revenue

     247      285

Current portion of deferred rent

     16      16

Reserve for warranty repairs – current

     18      69

Current portion of capital lease obligations

     16      16
    

  

Total current liabilities

     2,714      3,282
    

  

Long-term portion of deferred service revenue

     133      166

Long-term portion of deferred rent

     101      106

Reserve for warranty repairs – long-term

     440      264

Long-term obligations under capital leases

     11      24
    

  

Total long-term liabilities

     685      560
    

  

Total liabilities

     3,399      3,842

 

Continued

 

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CARDIODYNAMICS INTERNATIONAL CORPORATION

 

Balance Sheets (Continued)

(Unaudited, in thousands, except share data)

 

     May 31,
2003


    November 30,
2002


 

Commitments and contingencies

   $ —       $ —    

Shareholders’ equity:

                

Preferred stock, 18,000,000 shares authorized, no shares issued or outstanding at May 31, 2003 or November 30, 2002

     —         —    

Common stock, no par value, 100,000,000 shares authorized, issued and outstanding 46,186,787 at May 31, 2003 and 46,171,584 shares at November 30, 2002

     49,832       49,774  

Accumulated other comprehensive income

     6       3  

Accumulated deficit

     (29,419 )     (30,053 )
    


 


Total shareholders’ equity

     20,419       19,724  
    


 


Total liabilities and shareholders’ equity

   $ 23,818     $ 23,566  
    


 


 

See accompanying notes to financial statements.

 

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CARDIODYNAMICS INTERNATIONAL CORPORATION

 

Statements of Operations

(Unaudited – In thousands, except per share data)

 

    

Three Months Ended

May 31,


   

Six Months Ended

May 31,


 
     2003

    2002

    2003

    2002

 

Net sales

   $ 7,285     $ 5,623     $ 13,670     $ 9,989  

Cost of sales

     1,672       1,560       3,304       2,838  
    


 


 


 


Gross margin

     5,613       4,063       10,366       7,151  
    


 


 


 


Operating expenses:

                                

Research and development

     784       611       1,520       1,253  

Selling and marketing

     3,870       3,049       7,351       5,770  

General and administrative

     479       422       978       861  
    


 


 


 


Total operating expenses

     5,133       4,082       9,849       7,884  
    


 


 


 


Income (loss) from operations

     480       (19 )     517       (733 )
    


 


 


 


Other income (expense):

                                

Interest income

     82       76       175       182  

Interest expense

     (5 )     (3 )     (10 )     (6 )

Other, net

     —         (6 )     —         (25 )
    


 


 


 


Total other income

     77       67       165       151  
    


 


 


 


Income (loss) before provision for income taxes

     557       48       682       (582 )

Provision for income taxes

     (39 )     (1 )     (48 )     (1 )
    


 


 


 


Net income (loss)

   $ 518     $ 47     $ 634     $ (583 )
    


 


 


 


Net income (loss) per common share, basic and diluted

   $ .01     $ .00     $ .01     $ (.01 )
    


 


 


 


Weighted-average number of shares used in per share calculation:

                                

Basic

     46,187       46,114       46,184       46,024  
    


 


 


 


Diluted

     47,104       47,433       47,176       46,024  
    


 


 


 


 

See accompanying notes to financial statements.

 

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CARDIODYNAMICS INTERNATIONAL CORPORATION

 

Statements of Cash Flows

(Unaudited – In thousands)

 

    

Six Months Ended

May 31,


 
     2003

    2002

 

Cash flows from operating activities:

                

Net income (loss)

   $ 634     $ (583 )

Adjustments to reconcile net income (loss) to net cash provided by (used) in operating activities:

                

Depreciation and amortization

     147       144  

Provision for obsolete inventory

     15       56  

Provision for warranty repairs

     125       78  

Provision for (reduction in) demonstration inventory

     8       (16 )

Provision for doubtful receivables

     504       188  

Provision for doubtful long-term receivables

     13       25  

Compensatory stock options granted

     19       36  

Other non-cash items

     3       —    

Changes in operating assets and liabilities:

                

Accounts receivable

     (101 )     371  

Inventory

     (43 )     (760 )

Other current assets

     (114 )     (240 )

Long-term receivables and note receivable

     (109 )     (24 )

Accounts payable

     (417 )     112  

Accrued expenses

     (62 )     (15 )

Accrued salaries, wages and benefits

     (48 )     (82 )

Income taxes payable

     48       —    

Deferred rent

     (5 )     —    

Deferred service revenue

     (71 )     (10 )
    


 


Net cash provided by (used in) operating activities

     546       (720 )
    


 


Cash flows from investing activities:

                

Purchases of property and equipment

     (272 )     (92 )
    


 


Net cash used in investing activities

     (272 )     (92 )
    


 


 

Continued

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes to financial statements.

 

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CARDIODYNAMICS INTERNATIONAL CORPORATION

 

Statements of Cash Flows (Continued)

(Unaudited – In thousands)

 

     Six Months Ended
May 31,


 
     2003

    2002

 

Cash flows from financing activities:

                

Repayment of capital lease obligations and long-term debt

   $ (13 )   $ (41 )

Exercise of options and warrants

     25       883  

Issuance of common stock, net

     14       (19 )
    


 


Net cash provided by financing activities

     26       823  
    


 


Net increase in cash and cash equivalents

     300       11  

Cash and cash equivalents at beginning of period

     6,879       6,394  
    


 


Cash and cash equivalents at end of period

   $ 7,179     $ 6,405  
    


 


Supplemental disclosures of cash flow:

                

Cash paid for interest

   $ 10     $ 18  
    


 


Cash paid for income taxes

   $ —       $ 1  
    


 


 

See accompanying notes to financial statements.

 

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CARDIODYNAMICS INTERNATIONAL CORPORATION

 

Notes to Financial Statements

(Unaudited)

 

1. Description of Business

 

CardioDynamics International Corporation (“CardioDynamics”) is the innovator and market leader of a breakthrough technology called Impedance Cardiography (ICG). We develop, manufacture, and market noninvasive heart-monitoring devices using proprietary BioZ® ICG technology, with DISQ® (Digital Impedance Signal Quantifier) technology, AERIS (Adaptive Extraction & Recognition of Impedance Signals) processing and the Z MARC® Algorithm.

 

Unlike other traditional cardiac function monitoring technologies, our monitors are noninvasive (without cutting into the body). Our BioZ® ICG systems obtain data in a safe, efficient and cost-effective manner not previously available in the physician’s office and many hospital settings. Just as Electrocardiography (ECG) noninvasively monitors the heart’s electrical characteristics, ICG makes it possible to noninvasively assess the heart’s mechanical characteristics. Our technology noninvasively monitors the heart’s ability to deliver blood to the body and the amount of fluid in the chest. Our products provide 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 products, the BioZ® ICG Monitor and the BioZ® ICG Module for GEMS-IT Patient Monitoring Systems have been cleared by the Food and Drug Administration (FDA) and carry the CE mark.

 

Our strategic partners include GE Medical Systems Information Technologies (GEMS-IT), Philips Medical Systems, Spacelabs Medical Systems, Vasomedical and SunTech Medical Instruments, Inc.

 

We were originally incorporated in California in June 1980 and changed our name to CardioDynamics International Corporation in 1993.

 

a. 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 presentation of our operations and cash flows. All such adjustments are of a normal recurring nature. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission. These statements should be read along with the Financial Statements and Notes that go along with our audited financial statements, as well as other financial information for the fiscal year ended November 30, 2002 as presented in our Annual Report on Form 10-K. Financial presentations for prior periods have been reclassified to conform to current period presentation. The results of operations for the three and six months ended May 31, 2003 and cash flows for the six months ended May 31, 2003 are not necessarily indicative of the results that may be expected for the full fiscal year ending November 30, 2003.

 

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CARDIODYNAMICS INTERNATIONAL CORPORATION

 

Notes to Financial Statements

(Unaudited)

 

b. Stock Options

 

In December 2002, the FASB issued SFAS No. 148, Accounting for Stock-Based Compensation – Transition and Disclosure, an amendment of FASB Statement No. 123. SFAS No. 148 amends SFAS No. 123, Accounting for Stock-Based Compensation by providing alternative methods of transition for a voluntary change to the fair value method of accounting for stock based employee compensation. In addition, SFAS No. 148 amends the disclosure requirements of SFAS No. 123 to require prominent stock option disclosures in both annual and interim financial statements. The disclosure requirements are effective for financial statements of interim and annual periods ended after December 15, 2002.

 

At May 31, 2003, we have one stock-based employee compensation plan. We apply APB Opinion No. 25 in accounting for our Plan. Stock-based employee compensation costs are not reflected in net income when the options are granted under the plan and have an exercise price equal to or greater than the market value of the underlying common stock on the date of the grant. No compensation cost has been recognized in the financial statements for the stock options issued to employees since they were all issued at fair market value on the date of grant.

 

The following table illustrates the effect on net income (loss) and net income (loss) per common share as if we had applied the fair value recognition provisions of SFAS No. 123 to stock based employee compensation:

 

    

(in thousands,

except per share data)


 
    

Three Months

Ended

May 31,


   

Six Months

Ended

May 31,


 
     2003

   2002

    2003

    2002

 

Net income (loss), as reported

   $ 518    $ 47     $ 634     $ (583 )

Pro forma net income (loss)

     188      (207 )     (13 )     (1,019 )

Net income (loss) per common share, basic and diluted, as reported

     .01      .00       .01       (.01 )

Pro forma net income (loss) per common share, basic and diluted

     .00      (.00 )     (.00 )     (.02 )

 

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CARDIODYNAMICS INTERNATIONAL CORPORATION

 

Notes to Financial Statements

(Unaudited)

 

2.   Inventory

 

Inventory consist of the following (in thousands):

 

     May 31,
2003


    November 30,
2002


 

Electronic components and subassemblies

   $ 1,744     $ 1,549  

Finished goods

     1,218       1,416  

Demonstration units

     818       772  

Less provision for obsolete inventory

     (144 )     (129 )

Less provision for demonstration inventory

     (142 )     (134 )
    


 


     $ 3,494       3,474  
    


 


 

3.   Property and Equipment

 

Property and equipment consist of the following (in thousands):

 

     May 31,
2003


    November 30,
2002


 

Office furniture and equipment

   $ 243     211  

Manufacturing, lab equipment and fixtures

     292     277  

Sales equipment and exhibit booth

     48     43  

Computer software and equipment

     935     715  

Leasehold improvements

     117     117  
    


 

       1,635     1,363  

Less accumulated depreciation and amortization

     (1,096 )   (949 )
    


 

     $ 539     414  
    


 

 

4.   Long-Term Receivables and Note Receivable

 

In the third and fourth fiscal quarters of 2000, we offered no-interest financing for our BioZ® ICG systems with maturities ranging from 24 to 60 months. The long-term receivables resulting from this financing program are collateralized by the respective systems. In the first fiscal quarter of 2001, we established a similar program through third-party financing companies to replace the internal equipment-financing program. Under certain circumstances, we may continue to provide in-house financing to our customers, although the contracts now typically include market rate interest provisions. Revenue is recorded on these contracts at the time of shipment, when title transfers, and there is no right of return. Interest income is recognized over the term of the contract.

 

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CARDIODYNAMICS INTERNATIONAL CORPORATION

 

Notes to Financial Statements

(Unaudited)

 

4.   Long-Term Receivables and Note Receivable – (Continued)

 

Long-term receivables and note receivable consist of the following (in thousands):

 

     May 31,
2003


    November 30,
2002


 

Long-term receivables, net of deferred interest

   $ 4,458     $ 4,349  

Secured note receivable

     394       394  

Less allowance for doubtful long-term receivables

     (580 )     (567 )
    


 


       4,272       4,176  

Less current portion of long-term receivables

     (2,487 )     (2,522 )
    


 


     $ 1,785     $ 1,654  
    


 


 

5.   Net Income (Loss) Per Common Share

 

Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted-average number of common shares outstanding during the period. Diluted net income 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 dilutive equity instruments, each convertible into one share of common stock (in thousands):

 

     May 31,

     2003

   2002

Stock options

   4,812    4,003

Warrants

   2,359    2,379
    
  

Total

   7,171    6,382
    
  

 

    

Three Months Ended

May 31,


  

Six Months Ended

May 31,


     2003

   2002

   2003

   2002

Weighted-average number of shares used in basic per share calculation

   46,187    46,114    46,184    46,024
    
  
  
  

Effect of dilutive securities:

                   

Stock options

   917    1,266    992    —  

Warrants

   —      53    —      —  
    
  
  
  

Dilutive potential shares outstanding

   917    1,319    992    —  
    
  
  
  

Weighted-average number of shares used in diluted per share calculation

   47,104    47,433    47,176    46,024
    
  
  
  

 

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CARDIODYNAMICS INTERNATIONAL CORPORATION

 

Item 2.   Management’s 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. This filing includes statements regarding our plans, goals, strategies, intent, beliefs or current expectations. These statements are expressed in good faith and based upon a reasonable basis when made, 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,” and the like, 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, collaborations, trends or operating results, potential market size, growth and penetration rates, also constitute such forward-looking statements.

 

Although forward-looking statements in this Report on Form 10-Q 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, 2002. 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 Annual Report on Form 10-K for the year ended November 30, 2002, which attempt to advise interested parties of the risks and factors that may affect the our business, financial condition, results of operation and cash flows.

 

The following discussion should be read along with the Financial Statements and Notes to our audited financial statements for the fiscal year ended November 30, 2002, as well as the other interim unaudited financial information for the current fiscal year.

 

OVERVIEW

 

CardioDynamics 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, patented ICG technology.

 

Our ICG technology non-invasively monitors the heart’s ability to deliver blood to the body and the amount of fluid in the chest. Our products provide 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 BioZ® ICG Monitors have been cleared by the Federal Drug Administration (FDA) and carry the CE mark.

 

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We sell to physicians and hospitals in the United States through our own direct sales force and distribute our products to domestic hospitals and targeted international markets through a strategic alliance with GE Medical Systems Information Technologies (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 national uniform pricing throughout the United States. To date, we have sold over 2,600 ICG systems to physician offices and hospital sites throughout the world.

 

Our products help physicians assess, diagnose, and treat cardiovascular disease, which is the number one killer of adults in the United States. According to the American Heart Association (AHA), approximately one in five Americans has some form of cardiovascular disease. The AHA estimated that over $329 billion was spent in the United States during 2002 as a result of cardiovascular disease and stroke. This figure includes both the direct costs associated with physicians and other professionals, hospital and nursing home services and medication and the indirect costs associated with lost productivity resulting from morbidity and mortality.

 

Electrocardiogram (ECG) is a widely used noninvasive assessment of the electrical characteristics of the heart. Our ICG technology non-invasively quantifies the mechanical functioning of the heart. Conditions that can interfere with the proper mechanical functioning of the heart include hypertension, congestive heart failure, pulmonary disease, high-risk pregnancy and kidney dysfunction. Our technology complements ECG and supplements information obtained through the five vital signs – heart rate, respiration rate, body temperature, blood pressure and oxygen saturation – quickly, safely and cost effectively. Our customers have suggested noninvasive cardiac output to be the “Sixth Vital Sign.”

 

Currently, the primary method used to assess hemodynamic parameters is pulmonary artery catheterization (PAC). The invasive PAC procedure requires hospitalization and involves an incision into the patient’s neck or groin region and the insertion of a catheter (plastic tube) into 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 physician’s 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 patient’s 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® ICG systems.

 

During ICG monitoring using our BioZ® ICG systems, an undetectable electrical signal is sent through our proprietary sensors on the patient’s neck and chest. Our sophisticated DISQ® (Digital Impedance Signal Quantifier) technology, AERIS (Adaptive Extraction & Recognition of Impedance Signals) processing and Z MARC® 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 our BioZ® ICG technology as a standard of care in cardiovascular medicine. Key elements of our strategy include efforts to:

 

accelerate market penetration through expansion of our direct sales force and distribution network;

 

leverage sales force investment by offering select, complimentary products;

 

broaden our distribution channels through strategic relationships;

 

grow and protect recurring revenue through increased use of our proprietary disposable sensors;

 

maintain market leadership through continuous innovation, product improvements and extensions; and

 

target new market opportunities through technology and application development.

 

RESULTS OF OPERATIONS (Quarters referred to herein are fiscal quarters ended May 31)

 

Net Sales – Net sales for the second quarter of 2003 were $7,285,000, an increase of 30% over the same three-month period of 2002 in which net sales were $5,623,000. During the first six months of fiscal 2003, net sales were $13,670,000, up 37% from $9,989,000 in the first half of fiscal 2002. The increase in net sales in the second quarter can be attributed to a 21% increase in the number of BioZ Systems sold and a 71% increase in disposable sensor revenue. We sold 183 BioZ Systems and placed nine fee-per-use rentals during our second quarter, up from 151 sold and eight fee-per use rentals in the same quarter last year.

 

Sales by our domestic direct sales force, which targets physician offices and hospitals, increased 34% in the second quarter of 2003 over the second quarter in 2002, representing 95% of our overall sales for the quarter. We experienced a 25% increase in unit productivity by our direct sales force compared with the same quarter last year, partly driven by lower sales force turnover and the sales support of our clinical application specialists. These specialists assist in three primary areas: pre-sales activities including demonstrations, post sales activities such as initial set-up and training for physician and staff, and ongoing customer support to maintain customer satisfaction and increase recurring sales of our proprietary disposable sensors.

 

Each time our BioZ® products are used, disposable sets of four BioZtect® sensors are required. This recurring sensor revenue increased 71% in the second quarter of 2003 to $1,198,000 accounting for 16% of sales, up from $701,000 or 12% of sales in the same quarter of 2002. The growth was primarily driven by a 58% increase in the number of units in the active installed base along with a 21% increase in the average use per BioZ system in the installed base. Sensor sales for the first six months of fiscal 2003 were $2,175,000, an increase of 74% over sensors sold during the same period last year of $1,248,000. The BioZtect® sensors for our ICG Module have a list price of $19.95 and we recently increased the list price for our BioZ sensors from $9.95 to $10.95 per application; however, domestic outpatient customers can obtain significant sensor pricing discounts through our discount sensor program in exchange for minimum monthly sensor purchase commitments. At the end of the second quarter of 2003, approximately 46% of our active customer base was participating in the discount sensor program. As the installed base of BioZ® equipment grows, we expect the revenue generated by our disposable BioZtect® sensors to continue to increase.

 

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International sales were $268,000 in the second quarter of 2003, compared with $382,000 in the second quarter of 2002. In the first half of fiscal 2003, international sales were $767,000, a decrease of 2% over international sales of $785,000 in the same six months last year.

 

Revenue derived from extended service contracts, spare parts, accessories and non-warranty repairs for the second quarter of 2003 was $246,000, up from $221,000 for the three months ended May 31, 2002 and $377,000 versus $354,000 in the first half of 2003 and 2002, respectively. Prior to 2001, our systems included a 13-month warranty, however, since then our new BioZ® Systems come with a standard five-year warranty. As a result, we do not anticipate that this revenue stream will grow significantly in the near term.

 

Gross Margin – We generated $5,613,000 of gross margin in the second quarter, up 38% over the same quarter last year in which our gross margin was $4,063,000. As a percentage of sales, our gross margin was 77% in the second quarter, up from 72% in the same quarter last year. In the first half of fiscal 2003, our gross margin percentage was 76% of sales, up from 72% of sales in the same six-month period last year. The increase in gross margin is largely the result of improved manufacturing efficiencies, a decrease in our sensor costs, higher net revenue per unit due to modified leasing company incentive programs and a reduction in the number of demo systems sold at a lower list price.

 

Research and Development – Our investment in research, product development and clinical studies increased 28% in the second quarter of 2003 to $784,000, from $611,000 in the second quarter of 2002. For the first six months of fiscal 2003 expenditures for research and development increased to $1,520,000 from $1,253,000 during the first six months of fiscal 2002. The majority of the increase can be attributed to the hiring of additional engineering and research personnel providing us with the capacity to focus increased attention on the development of new products and product enhancements.

 

We entered into a co-development and OEM agreement with Philips Medical Systems in the third quarter of 2002 under which we will develop and manufacture a proprietary ICG module for integration into the Philips 12-lead electrocardiography (ECG) products, providing a combined ECG/ICG monitor. We are expecting this product to be released in the second half of 2004. Under the terms of the agreement, the co-developed products will be sold by both companies. We do not anticipate that this development and OEM agreement will require significant additional development resources, nor do we expect to derive additional revenue from the co-developed product in 2003.

 

Spending on clinical studies during the first six months of fiscal 2003, decreased approximately $156,000 compared to the same six-month period last year now that Phase I data collection of the PREDICT study has been completed and we are in the process of compiling and analyzing the data. Data collection for the ESCAPE-BIG study, which began in mid 2001, is targeted to be completed and move into the analysis phase by the end of this year.

 

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Selling and Marketing – Selling and marketing expenses for the second quarter of 2003 were $3,870,000, up 27% over the second quarter of 2002 at $3,049,000. For the six months ended May 31, 2003, selling and marketing expenses were $7,351,000 compared to $5,770,000 for the same six-month period last year. The expense growth was primarily due to higher commission expense on increased sales by our direct sales force and additional allowance for doubtful accounts resulting from higher accounts receivable balances. Selling and marketing expenses for the first half of fiscal 2003 were 54% of sales, down from 58% in the same period last year. This improvement is primarily due to the increased productivity of our domestic sales force. We now have a total of 66 field sales personnel, up 8% over last year at this same time. We plan to increase the number of field sales personnel by approximately 10% to 15% by the end of this year.

 

General and Administrative – Our general and administrative expenses were $479,000 in the second quarter 2003, compared with $422,000 in second quarter of 2002. For the six months ended May 31, 2003 general and administrative costs were $978,000, compared to $861,000 in the first six months of fiscal 2002. As a percentage of sales, general and administrative expenses for the six months of fiscal 2003 were 7%, down from 9% in the same period last year. This decrease is largely a result of our ongoing focus on administrative cost containment and continued sales growth.

 

Other Income and Expense – We earned $82,000 of interest income in the second quarter of 2003, up from $76,000 earned in the second quarter of 2002. The increase is primarily due to an increase in the funds available for investment and an increase in the interest received on our internally financed leases. Year to date interest income is slightly down at $175,000, as compared to $182,000 during 2002. The year to date decrease is primarily due to lower interest rates earned on our invested funds. Interest expense for the six months ended May 31, 2003 was $10,000, compared to $6,000 for the same six-month period last year and is primarily related to capital leases.

 

Net Income (Loss) – Net income in the second quarter of fiscal 2003 was $518,000 or $0.01 per common share, bringing our net income in the first half of 2003 to $634,000 or $0.01 per common share. In fiscal 2002 we had net income in the second quarter of $47,000, or $0.00 per common share, reducing our first half of 2002 net loss to $583,000 or ($0.01) per common share.

 

LIQUIDITY AND CAPITAL RESOURCES

 

Net cash provided by operating activities for the first six months of 2003 was $546,000, compared with a use of $720,000 in the first six months of fiscal 2002. The improvement in operating cash flow resulted from the net income earned along with non-cash provisions for depreciation, warranty repairs and doubtful receivables, partly offset by a reduction in accounts payable.

 

For the first six months of fiscal 2003, $272,000 was invested in property and equipment compared with $92,000 during the same time period last year. Much of the increased investment in fiscal 2003 is for a new computer information system that we are currently in the process of implementing. We expect to convert to the new system early in our fourth quarter of 2003.

 

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For the first six months of fiscal 2003, $26,000 of cash was provided by financing activities, compared with $823,000 provided during the same six-month period of 2002. The cash provided by financing activities in both periods was primarily the result of the exercise of stock options and warrants.

 

We have a secured revolving credit line with Comerica Bank that provides for borrowings up to $4,000,000 at the bank’s prime rate through September 2003. All the assets of the Company collateralize the credit line. 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, 2003, there were no outstanding borrowings under the line of credit and it is not anticipated that borrowings will be necessary during the balance of this fiscal year.

 

We have operating loss carryforwards of approximately $24 million for federal income tax purposes. The Tax Reform Act of 1986 contains provisions that 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. As a result of the California state budget shortfall, California has suspended the use of net operating loss carryforwards in 2003 and 2004, which will require us to pay franchise tax on any income earned in California in those years.

 

Since May 1999, we have raised approximately $24 million through various private placements of common stock to accredited and institutional 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 availability under our line of credit to fund ongoing research and development efforts, expansion of our field sales force, 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.

 

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.

 

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CARDIODYNAMICS INTERNATIONAL CORPORATION

 

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 our entire portfolio of cash equivalents in commercial paper, certificates of deposit, money market and mutual 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.

 

Item 4.   Controls and Procedures

 

Our management, including our Chief Executive Officer (CEO) and Chief Financial Officer (CFO), does not expect that our disclosure controls or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

The CEO/CFO evaluation of our disclosure controls and our internal controls included a review of the controls’ objectives and design, the controls’ implementation by CardioDynamics and the effect of the controls on the information generated for use in this Quarterly Report. In the course of the controls evaluation, we sought to identify data errors, controls failures or acts of fraud and to confirm that appropriate corrective action, including process improvements, were being undertaken.

 

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This type of evaluation will be done on a quarterly basis so that the conclusions concerning controls effectiveness can be reported in our Quarterly Reports on Form 10-Q and Annual Report on Form 10-K. The overall goals of these various evaluation activities are to monitor our disclosure controls and our internal controls and to make modifications as necessary; our intent in this regard is that the disclosure controls and the internal controls will be maintained as dynamic systems that change (including with improvements and corrections) as conditions warrant.

 

Among other matters, we sought in our evaluation to determine whether there were any “significant deficiencies” or “material weaknesses” in the company’s internal controls, or whether the company had identified any acts of fraud involving personnel who have a significant role in the Company’s internal controls. This information was important both for the controls evaluation generally and because Items 5 and 6 in the Section 302 Certifications of the CEO and CFO require that the CEO and CFO disclose that information to our Board’s Audit Committee and to our independent accountants and to report on related matters in this section of the Report.

 

Our review of our internal controls was made within the context of the relevant professional auditing standards defining “internal controls,” “significant deficiencies,” and “material weaknesses.” “Internal controls” are processes designed to provide reasonable assurance that our transactions are properly authorized, our assets are safeguarded against unauthorized or improper use, and our transactions are properly recorded and reported, all to permit the preparation of our financial statements in conformity with generally accepted accounting principles. “Significant deficiencies” are referred to as “reportable conditions,” or control issues that could have a significant adverse effect on the ability to record, process, summarize and report financial data in the financial statements. A “material weakness” is a particularly serious reportable condition where the internal control does not reduce to a relatively low level the risk that misstatements caused by error or fraud may occur in amounts that would be material in relation to the financial statements and not be detected within a timely period by employees in the normal course of performing their assigned functions. As part of our internal controls procedures, we also address other, less significant control matters that we or our auditors identify, and we determine what revision or improvement to make, if any, in accordance with our on-going procedures.

 

Our CEO and CFO have, within 90 days of the date of this report, reviewed our process of gathering, analyzing and disclosing information that is required to be disclosed in our periodic reports (and information that, while not required to be disclosed, may bear upon the decision of management as to what information is required to be disclosed) under the Exchange Act of 1934, including information pertaining to the condition of, and material developments with respect to, our business, operations and finances. Based on this evaluation, our CEO and CFO have concluded that our process provides for timely collection and evaluation of information that may need to be disclosed to investors.

 

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CARDIODYNAMICS INTERNATIONAL CORPORATION

 

        
PART II – OTHER 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.

Item 6.      Exhibits and Reports on Form 8-K
(a )   

Exhibits:

Exhibit

    

Title


10.1

 

   Amendment to 1995 Stock Option/Stock Issuance Plan dated October 17, 2002.

99.1

 

   Certification of CEO pursuant Section 906 of the Sarbanes-Oxley Act of 2002.

99.2

 

   Certification of CFO pursuant Section 906 of the Sarbanes-Oxley Act of 2002.

(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. This filing includes 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 Company’s annual report on Form 10-K for the fiscal year ended November 30, 2002 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.

 

         

Date: July 14, 2003

      By:  

/s/    MICHAEL K. PERRY        


               

Michael K. Perry

Chief Executive Officer (Principal Executive Officer)

         

Date: July 14, 2003

      By:  

/s/    STEPHEN P. LOOMIS         


               

Stephen P. Loomis

Vice President, Finance, Chief Financial Officer

(Principal Financial and Accounting Officer)

 

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CERTIFICATIONS

 

I, Michael K. Perry, Chief Executive Officer of CardioDynamics International Corporation, certify that:

 

  1.   I have reviewed this Quarterly Report on Form 10-Q of CardioDynamics International Corporation (the “Registrant”);

 

  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 operations and cash flows of the Registrant as of, and for, the periods presented in this quarterly report;

 

  4.   The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the Registrant and we have;

 

  a)   designed such disclosure controls and procedures to ensure that material information relating to the Registrant is made known to us, particularly during the period in which the periodic report is being prepared;

 

  b)   evaluated the effectiveness of the Registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the “Evaluation Date”);

 

  c)   presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on the required evaluation as of the Evaluation Date;

 

  5.   The Registrant’s other certifying officer and I have disclosed based on our most recent evaluation, to the Registrant’s auditors and to the audit committee of the Registrant’s 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 the Registrant’s ability to record, process, summarize and report financial data and have identified for the Registrant’s 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 the Registrant’s internal controls; and

 

  6.   The Registrant’s other certifying officer 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.

 

By:

 

/s/    MICHAEL K. PERRY        


    Chief Executive Officer

Date: July 14, 2003

 

 

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CERTIFICATIONS

 

I, Stephen P. Loomis, Chief Financial Officer of CardioDynamics International Corporation, certify that:

 

  1.   I have reviewed this Quarterly Report on Form 10-Q of CardioDynamics International Corporation (the “Registrant”);

 

  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 operations and cash flows of the Registrant as of, and for, the periods presented in this quarterly report.;

 

  4.   The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the Registrant and we have;

 

  a)   designed such disclosure controls and procedures to ensure that material information relating to the Registrant is made known to us, particularly during the period in which the periodic report is being prepared;

 

  b)   evaluated the effectiveness of the Registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the “Evaluation Date”);

 

  c)   presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on the required evaluation as of the Evaluation Date;

 

  5.   The Registrant’s other certifying officer and I have disclosed based on our most recent evaluation, to the Registrant’s auditors and to the audit committee of the Registrant’s 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 the Registrant’s ability to record, process, summarize and report financial data and have identified for the Registrant’s 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 the Registrant’s internal controls; and

 

  6.   The Registrant’s other certifying officer 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.

 

By:

 

/s/    STEPHEN P. LOOMIS         


    Chief Financial Officer

Date: July 14, 2003

 

 

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