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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 June 30, 2004

 

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.    x  Yes    ¨  No

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Securities Exchange Act of 1934).    ¨  Yes    x  No

 

As of July 31, 2004, there were 84,624,207 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)   3
    Condensed Balance Sheets as of June 30, 2004 and December 31, 2003   3
    Condensed Statements of Operations for the Three and Six Months Ended June 30, 2004 and 2003   4
    Condensed Statement of Cash Flows for the Six Months Ended June 30, 2004 and 2003   5
    Notes to Condensed Financial Statements   6

Item 2.

  Management’s Discussion and Analysis of Financial Condition and Results of Operations   12
    Factors Affecting Future Results   19

Item 3.

  Quantitative and Qualitative Disclosure About Market Risk   39

Item 4.

  Controls and Procedures   39

 

PART II. Other Information

 

Description


  Page

Item 1.

  Legal Proceedings   40

Item 2.

  Changes in Securities and Use of Proceeds   40

Item 3.

  Default Upon Senior Securities   40

Item 4.

  Submission of Matters to a Vote of Security Holders   41

Item 5.

  Other Information   41

Item 6.

  Exhibits and Reports on Form 8-K   41
Signatures   43

 

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Table of Contents

PART I.

 

Item 1. Financial Statements

 

CARDIMA, INC.

CONDENSED BALANCE SHEETS

(In thousands, except share amounts)

 

     June 30,
2004
(Unaudited)


   

December 31,

2003

(1)


 

ASSETS

                

Current assets:

                

Cash and cash equivalents

   $ 4,570     $ 6,446  

Accounts receivable, net of $87 allowances for doubtful accounts at June 30, 2004 and December 31, 2003

     391       299  

Inventories

     1,073       991  

Prepaid expenses

     475       325  

Other current assets

     10       31  
    


 


Total current assets

     6,519       8,092  

Property and equipment, net

     464       554  

Notes receivable from officers

     569       626  

Other assets

     38       38  
    


 


     $ 7,590     $ 9,310  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY

                

Current liabilities:

                

Accounts payable

   $ 1,156     $ 910  

Accrued compensation

     817       869  

Warrant liability

     —         658  

Other current liabilities

     271       279  

Credit obligation

     101       125  

Capital lease obligation - current portion

     41       42  
    


 


Total current liabilities

     2,386       2,883  

Deferred rent

     46       45  

Capital lease obligation - noncurrent portion

     63       82  
    


 


Total liabilities

     2,495       3,010  
    


 


Commitments and contingencies

                

Stockholders’ equity:

                

Common stock, $0.001 par value; 150,000,000 shares authorized, 84,624,207 shares issued and outstanding at June 30, 2004; 125,000,000 shares authorized, 80,333,798 issued and outstanding as of December 31, 2003; at amount paid in

     113,814       109,988  

Accumulated deficit

     (108,719 )     (103,688 )
    


 


Total stockholders’ equity

     5,095       6,300  
    


 


     $ 7,590     $ 9,310  
    


 



(1) The balance sheet as of December 31, 2003 was derived from the audited financial statements included in the Company’s 2003 Annual Report on Form 10-K filed with the Securities and Exchange Commission but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.

 

See accompanying notes to condensed financial statements

 

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CARDIMA, INC.

CONDENSED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

     Three months ended
June 30,


    Six months ended
June 30,


 
     2004

    2003

    2004

    2003

 

Net sales

   $ 578     $ 491     $ 1,214     $ 1,129  

Cost of goods sold

     510       677       1,228       1,638  
    


 


 


 


Gross margin

     68       (186 )     (14 )     (509 )

Operating expenses:

                                

Research and development

     1,204       1,639       2192       2,713  

Selling, general and administrative

     1,548       1,859       2775       3,693  
    


 


 


 


Total operating expenses

     2,752       3,498       4,967       6,406  
    


 


 


 


Operating loss

     (2,684 )     (3,684 )     (4,981 )     (6,915 )

Interest and other income (expense)

     15       21       (9 )     33  

Other non-cash expense

     —         —         (33 )     —    

Interest expense

     (4 )     (4 )     (8 )     (6 )
    


 


 


 


Net loss

   $ (2,673 )   $ (3,667 )   $ (5,031 )   $ (6,888 )
    


 


 


 


Basic and diluted net loss per share

   $ (0.03 )   $ (0.06 )   $ (0.06 )   $ (0.12 )
    


 


 


 


Shares used in computing basic and diluted net loss per share

     84,624       62,391       84,624       57,611  
    


 


 


 


 

See accompanying notes to financial statements

 

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CARDIMA, INC.

STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

     Six months ended
June 30,


 
     2004

    2003

 

CASH FLOWS FROM OPERATING ACTIVITIES

                

Net loss

   $ (5,031 )   $ (6,888 )

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

                

Depreciation and amortization

     131       384  

Other non-cash expense related to warrants

     33       —    

Non-cash stock-based compensation

     60       —    

Loss on disposal of assets

     2       9  

Non-cash interest (income) charge on notes receivable from officers

     57       (15 )

Changes in operating assets and liabilities:

                

Accounts receivable, net

     (92 )     102  

Inventories, net

     (82 )     17  

Prepaid expenses

     (150 )     128  

Other current assets

     21       100  

Accounts payable

     246       (995 )

Accrued compensation

     (52 )     (260 )

Other current liabilities

     (8 )     (4 )

Deferred rent

     1       23  
    


 


Net cash used in operating activities

     (4,864 )     (7,399 )

CASH FLOWS FROM INVESTING ACTIVITIES

                

Capital expenditures

     (43 )     (43 )
    


 


Net cash used in investing activities

     (43 )     (43 )

CASH FLOWS FROM FINANCING ACTIVITIES

                

Principal payments under leases and credit obligations

     (45 )     15  

Payments of issuance costs

     (70 )     —    

Net proceeds from sale of common stock

     3,146       6,207  
    


 


Net cash provided by financing activities

     3,031       6,222  
    


 


NET DECREASE IN CASH AND CASH EQUIVALENTS

     (1,876 )     (1,220 )

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

   $ 6,446     $ 3,385  
    


 


CASH AND CASH EQUIVALENTS, END OF PERIOD

   $ 4,570     $ 2,165  
    


 


 

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CARDIMA, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

June 30, 2004

(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 and six month periods ended June 30, 2004 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2004 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, 2003. The accompanying balance sheet at December 31, 2003 has been derived from those audited financial statements.

 

Certain reclassifications have been made to prior year amounts to conform to the current year presentation. These reclassifications had no effect on prior reported results of operations or retained earnings.

 

2. MANAGEMENT’S PLANS

 

As of June 30, 2004 Cardima, Inc. had approximately $4,570,000 in cash and cash equivalents, working capital of $4,133,000 and an accumulated deficit of $108,719,000. Management expects to continue to incur additional losses in the foreseeable future as the Company works towards regulatory approval and commercialization of the REVELATION® Tx in the United States, commercialization of the Cardima Surgical Ablation System and the commercialization of the REVELATION® Helix in Europe. Our management currently estimates that our cash balances as of June 30, 2004 will be sufficient to fund planned expenditures into the fourth quarter of 2004, but this cannot be predicted with certainty. Although our management recognizes the need to raise funds in the near future, there can be no assurance that we will be successful in consummating any fundraising transaction, or, if we do consummate such a transaction, that its terms and conditions will not be unfavorable to us. Any failure by us to obtain additional funding will have a material adverse effect upon us. Our independent auditors have stated that there is substantial doubt as to our ability to continue as a going concern.

 

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Cardima, Inc., continues to pursue regulatory approvals and distribution relationships in significant market opportunities worldwide. We currently have distribution agreements for various products covering eight countries with an emphasis on Europe and the Pacific Rim, and we are currently seeking a distributor or distributors for our Surgical Ablation System, which received United States Food and Drug Administration 510(k) clearance in 2003. We have arranged for warehousing capacity in Europe to support both distribution and direct customer sales. Securing FDA approval of the REVELATION® Tx remains one of our primary goals. On May 28, 2004 we received a letter, dated May 21, 2004, from the FDA, stating that our PMA for the REVELATION Tx linear ablation microcatheter system was not approvable based on the requirements of applicable regulations. We will continue to pursue regulatory approvals in the U.S. and in other markets which we believe have both the clinical potential and adequate medical support structure to accept a developing technology application. We cannot assure you that we will be able to obtain or maintain any necessary regulatory approvals or that, if such regulatory approvals are obtained, that we will be able to successfully market our products, or that we will be able to establish a successful distribution channel for our Surgical Ablation System.

 

3. STOCK-BASED COMPENSATION

 

We have elected to follow Accounting Principles Board Opinion No. (“APB”) 25, “Accounting for Stock Issued to Employees” and related interpretations in accounting for our employee stock options, including Financial Accounting Standard Board Interpretation (“FIN”) 44, “Accounting for Certain Transactions Involving Stock Compensation.”

 

Compensation expense is based on the difference, if any, between the fair value of our common stock and the exercise price of the option or share right on the measurement date, which is typically the grant date. This amount is recordable as “Deferred stock compensation” in the Balance Sheets and amortized as a charge to operations over the vesting period of the applicable options or share rights. In accordance with Statement of Financial Accounting Standards (“SFAS”) No. 123, “Accounting for Stock-Based Compensation,” as amended by SFAS 148, “Accounting for Stock-Based Compensation – Transition and Disclosure,” we have provided below the pro forma disclosures of the effect on net loss and loss per share as if SFAS 123 had been applied in measuring compensation expense for all periods presented.

 

The following information regarding pro forma net loss and net loss per share has been determined as if we had accounted for our employee stock options and employee stock plan under the fair value method prescribed by SFAS 123. The resulting effect on net loss and net loss per share pursuant to SFAS 123 is not likely to be representative of the effects on net loss and loss per share pursuant to SFAS 123 in future periods, due to subsequent periods including additional grants and periods of vesting.

 

The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. Because our employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input

 

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assumptions can materially affect the fair value estimate, in management’s opinion the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options.

 

For purposes of disclosures pursuant to SFAS 123 as amended by FAS 148, the estimated fair value of options is amortized to expense over the options’ vesting period.

 

The following table illustrates the effect on reported net loss per share if we had applied the fair value recognition provisions of SFAS 123 to stock-based employee compensation (in thousands, except per share amounts):

 

     Three Months
Ended June 30,


   

Six Months

Ended June 30,


 
     2004

    2003

    2004

    2003

 

Net loss applicable to common shareholders - as reported

   $ (2,673 )   (3,667 )   (5,031 )   (6,888 )

Add:

Stock-based employee compensation expense included in reported net income

     2     —       94     —    

Deduct:

Total stock-based employee compensation expense determined under fair value based method for all awards

     (446 )   (561 )   (730 )   (796 )
    


 

 

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