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)
Registrants 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 Registrants Common Stock outstanding.
TABLE OF CONTENTS
PART I. Financial Information
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 | |||
2
PART I.
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 Companys 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
3
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
4
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 | ||||
5
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 Companys 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. MANAGEMENTS 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.
6
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
7
assumptions can materially affect the fair value estimate, in managements 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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