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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

 


 

FORM 10-Q

 

  x   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.  

 

       For the quarterly period ended March 31, 2003

 

OR

 

  ¨   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.  

 

       For the transition period from                      to                     .

 

 

Commission File Number: 0-22419

 


 

CARDIMA, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

     

94-3177883

(State or Other Jurisdiction

of Incorporation or Organization)

     

(I.R.S. Employer

Identification No.)

 

47266 Benicia Street

Fremont, CA 94538-7330

(Address of Principal Executive Offices) (Zip Code)

 

Registrant’s telephone number, including area code: (510) 354-0300

 


 

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) had 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 Exchange Act).     Yes  ¨  No  x

 

As of May 12, 2003, there were 62,931,248 shares of Registrant’s Common Stock outstanding.

 



Table of Contents

 

CARDIMA, INC.

 

TABLE OF CONTENTS

 

PART I.    Financial Information

 

    

Description


  

Page


Item 1.

  

Financial Statements (unaudited)

  

1

    

Condensed Balance Sheets for the Three Months Ended March 31, 2003 and 2002

  

1

    

Condensed Statements of Operations for the Three Months Ended March 31, 2003 and 2002

  

2

    

Condensed Statements of Cash Flows for the Three Months Ended March 31, 2003 and 2002

  

3

    

Notes to Condensed Financial Statements

  

4

    Item 2.

  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

  

9

    

Factors Affecting Future Results

  

15

Item 3.

  

Quantitative and Qualitative Disclosure About Market Risk

  

29

Item 4.

  

Controls and Procedures

  

29

PART II.     Other Information

    
    

Description


  

Page


Item 2.

  

Changes in Securities and Use of Proceeds

  

29

    Item 6.

  

Exhibits and Reports on Form 8-K

  

30

     Signatures

  

31

     Certifications

  

32


Table of Contents

 

PART I.

 

Item 1.    Financial Statements

 

CARDIMA, INC.

CONDENSED BALANCE SHEETS

(In thousands, except share and per share amounts)

 

ASSETS

  

March 31,

2003

(Unaudited)


    

December 31,

2002

(1)


 

Current assets:

                 

Cash and cash equivalents

  

$

2,827

 

  

$

3,385

 

Accounts receivable, net of allowances for doubtful accounts of $80 at March 31, 2003 and $79 at December 31, 2002

  

 

420

 

  

 

318

 

Inventories

  

 

1,061

 

  

 

1,226

 

Other current assets

  

 

427

 

  

 

622

 

    


  


Total current assets

  

 

4,735

 

  

 

5,551

 

Property and equipment, net

  

 

891

 

  

 

1,030

 

Notes receivable from officers

  

 

603

 

  

 

595

 

Other assets

  

 

89

 

  

 

89

 

    


  


    

$

6,318

 

  

$

7,265

 

    


  


LIABILITIES AND STOCKHOLDERS’ EQUITY

                 

Current liabilities:

                 

Accounts payable

  

$

1,191

 

  

$

2,029

 

Accrued compensation

  

 

1,099

 

  

 

1,238

 

Other current liabilities

  

 

617

 

  

 

276

 

Capital lease obligation—current portion

  

 

43

 

  

 

142

 

    


  


Total current liabilities

  

 

2,950

 

  

 

3,685

 

Deferred rent

  

 

16

 

  

 

4

 

Capital lease obligation—noncurrent portion

  

 

98

 

  

 

26

 

Commitments

                 

Stockholders’ equity:

                 

Common stock, $0.001 par value; 100,000,000 shares authorized, 58,472,803 shares issued and outstanding at March 31, 2003; 54,394,264 as of December 31, 2002; at amount paid in

  

 

96,928

 

  

 

94,003

 

Accumulated deficit

  

 

(93,674

)

  

 

(90,453

)

    


  


Total stockholders’ equity

  

 

3,254

 

  

 

3,550

 

    


  


    

$

6,318

 

  

$

7,265

 

    


  



(1)   The balance sheet as of December 31, 2002 was derived from the audited financial statements included in the Company’s 2002 Annual Report on Form 10-K filed with the Securities and Exchange Commission.

 

See accompanying notes to condensed financial statements

 

1


Table of Contents

 

CARDIMA, INC.

CONDENSED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

    

Three months ended

March 31,


 
    

2003


    

2002


 

Net sales

  

$

638

 

  

$

766

 

Cost of goods sold

  

 

1,085

 

  

 

890

 

    


  


Gross margin

  

 

(447

)

  

 

(124

)

Operating expenses:

                 

Research and development

  

 

950

 

  

 

833

 

Selling, general and administrative

  

 

1,834

 

  

 

1,633

 

    


  


Total operating expenses

  

 

2,784

 

  

 

2,466

 

    


  


Operating loss

  

 

(3,231

)

  

 

(2,590

)

Interest and other income

  

 

12

 

  

 

28

 

Interest expense

  

 

(2

)

  

 

(8

)

    


  


Net loss

  

$

(3,221

)

  

$

(2,570

)

    


  


Basic and diluted net loss per share

  

$

(0.06

)

  

$

(0.06

)

    


  


Shares used in computing basic and diluted net loss per share

  

 

55,344

 

  

 

42,641

 

    


  


 

See accompanying notes to financial statements

 

2


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CARDIMA, INC.

STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

    

Three months ended

March 31,


 
    

2003


    

2002


 

CASH FLOWS FROM OPERATING ACTIVITIES

                 

Net loss

  

$

(3,221

)

  

$

(2,570

)

Adjustments to reconcile net loss to net cash provided by operations:

                 

Depreciation and amortization

  

 

220

 

  

 

247

 

Reversal of stock-based compensation

  

 

—  

 

  

 

(122

)

Loss on disposal of assets

  

 

7

 

  

 

6

 

Non-cash interest income on notes receivable from officers

  

 

(8

)

  

 

(7

)

Changes in operating assets and liabilities:

                 

Accounts receivable

  

 

(102

)

  

 

(230

)

Inventories

  

 

165

 

  

 

(21

)

Other current assets

  

 

153

 

  

 

3

 

Other assets

  

 

42

 

  

 

105

 

Accounts payable

  

 

(838

)

  

 

(229

)

Accrued employee compensation

  

 

(139

)

  

 

(274

)

Other current liabilities

  

 

341

 

  

 

4

 

Deferred rent

  

 

12

 

  

 

(6

)

    


  


Net cash used in operating activities

  

 

(3,368

)

  

 

(3,094

)

CASH FLOWS FROM INVESTING ACTIVITIES

                 

Capital expenditures

  

 

(88

)

  

 

(390

)

    


  


Net cash used in investing activities

  

 

(88

)

  

 

(390

)

CASH FLOWS FROM FINANCING ACTIVITIES

                 

Principal payments under capital leases

  

 

(27

)

  

 

(114

)

Net proceeds from sale of common stock

  

 

2,925

 

  

 

67

 

    


  


Net cash provided by (used in) financing activities

  

 

2,898

 

  

 

(47

)

    


  


NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

  

$

(558

)

  

 

(3,531

)

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

  

$

3,385

 

  

$

7,542

 

    


  


CASH AND CASH EQUIVALENTS END OF PERIOD

  

$

2,827

 

  

$

4,011

 

    


  


 

3


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CARDIMA, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

March 31, 2003

(Unaudited)

 

1.    BASIS OF PRESENTATION

 

The accompanying unaudited condensed financial statements have been prepared by the Company according to the rules and regulations of the Securities and Exchange Commission for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the financial information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation have been included.

 

The operating results for the three month period ended March 31, 2003 are not necessarily indicative of the results that may be expected for the entire fiscal year ending December 31, 2003 or for future operating results. The accompanying financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2002. The accompanying balance sheet at December 31, 2002 has been derived from these audited financial statements.

 

2.    MANAGEMENT’S PLANS

 

As of March 31, 2003, the Company had approximately $2,827,000 in cash and cash equivalents, working capital of $1,785,000 and an accumulated deficit of $93,673,000. Management expects to continue to incur additional losses in the foreseeable future as the Company completes its key clinical trial in the United States, commercialization of the REVELATION® Tx in the United States and the commercialization of the REVELATION® Helix in Europe. Management believes that the Company’s cash balances will be sufficient to fund planned expenditures through September 30, 2003. Although management recognizes the need to raise funds in the near future, there can be no assurance that the Company will be successful in consummating any such transaction, or, if such a transaction is consummated, that the terms and conditions of such financing will not be unfavorable to us. Any failure by management to obtain additional funding will have a material effect upon us and will likely result in our inability to continue as a going concern.

 

The Company continues to initiate relationships with new distributors worldwide. As of March 31, 2003, the Company had distributors in place in eight countries that provide service and sales support in twelve countries, consultants and sales agents in place in two countries that provide service and sales support in five countries and a European distribution center in place which provides service and sales support to an additional nine European countries. The Company is currently seeking regulatory approval of all its therapeutic products in China, but cannot predict if its products will ultimately be approved for sale in that region. In addition, the Company cannot predict whether or not it will be successful in marketing and selling its diagnostic and therapeutic products in China and other Asian countries. Recent foreign regulatory approval developments affecting the Company’s product registrations include the

 

4


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acceptance by Turkey of the CE Mark already in place in Europe for the Company’s diagnostic and therapeutic products and the ratification of an agreement between the EU and Switzerland, granting approval to market and sell CE Mark products in that country.

 

3.    PRIVATE PLACEMENTS

 

On December 31, 2002 and January 22, 2003, we sold by means of a private placement an aggregate of 5,333,319 shares of our common stock at a price per share of $0.74955 for an aggregate net proceeds of approximately $3.5 million. In addition, we issued to the investors warrants to purchase 2,400,000 shares of our common stock at an exercise price of $0.8245 per share. The warrants became exercisable on March 1, 2003 and March 23, 2003, respectively, and will be reduced on a share-for-share basis to the extent that an investor sells our common stock or other securities during the sixty (60) day period between each of the closings and March 1, 2003 and March 23, 2003, respectively. The warrants allow for a “cashless exercise” whereby the exercising party may use shares issuable upon exercise of the warrant in payment of the exercise price. We may not redeem the warrants and the warrants are subject to a mandatory exchange or termination in the case of certain reorganizations, mergers, or divestitures. We paid to the party which acted as finder in connection with this private placement a fee of $25,000 in cash plus 66,667 shares of our common stock upon execution of a letter agreement. Upon the closing of the transactions, we also paid to the finder a total of $300,000 in cash and issued to the finder warrants to purchase 533,331 shares of our common stock at an exercise price of $0.82