Exhibit 99.1
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COMPANY CONTACT: | | INVESTOR CONTACTS: | | MEDIA CONTACTS: |
Cardima, Inc. | | Investor Relations Group | | Investor Relations Group |
Barry D. Michaels | | Gino De Jesus | | Janet Vasquez |
Interim Chief Financial Officer | | John Nesbett | | Dian Griesel, Ph.D. |
(510) 354-0300 | | (212) 825-3210 | | (212) 825-3210 |
www.cardima.com | | | | |
FOR IMMEDIATE RELEASE
CARDIMA ANNOUNCES THIRD QUARTER 2004 FINANCIAL RESULTS
FREMONT, Calif. (November 15, 2004) –Cardima®, Inc. (Nasdaq SC: CRDM), developer of the REVELATION® Tx, REVELATION® T-Flex and REVELATION® Helix microcatheter systems for the treatment of atrial fibrillation (AF), today reported financial results for the third quarter ended September 30, 2004.
Net sales for the third quarter ended September 30, 2004 were $569,000, a 1% increase from the same period in 2003. United States derived net sales increased 29% to $282,000 in the third quarter of 2004, compared with $219,000 in the same period of 2003. European derived net sales decreased 49% to $63,000 from $123,000 for the third quarters of 2004 and 2003 respectively. Asian market net sales increased 2% or $5,000 to $224,000 in the third quarter of 2004 from $219,000 for the same period in 2003.
Net loss for the third quarter of 2004 decreased 28%, or $1,038,000, to $2,704,000, or $0.03 per share, compared with $3,742,000, or $0.05 per share, for the third quarter of 2003. The improvement was the result of management actions to reduce operating expenses, which decreased by 12 percent to $2,386,000 for the third quarter of 2004 from $2,701,000 for the same period in 2003. Selling, general and administrative expenses decreased by 15%, or $233,000, to $1,370,000 from $1,603,000 for the third quarters of 2004 and 2003, respectively. Research and development expenses decreased 7% to $1,016,000 in the third quarter of 2004 from $1,098,000 for the third quarter of 2003. Shares used in calculating the net loss per share increased to 84.7 million shares outstanding from 70.1 million shares due to the issuance of shares in connection with private placements since the third quarter of 2003 and the exercise of warrants following a redemption call issued in late 2003.
Cardima has scheduled an investor conference call regarding this announcement to be held today, beginning at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time). To participate in the live call via telephone, please call (800) 901-5226 (domestic) or
(617) 786-4513 (international) and use participant passcode #37746810. Individuals interested in listening to the conference call via the Internet may do so by visiting the investor relations section of the Company’s Web site atwww.cardima.com. A telephonic replay of this call will be available for 14 days starting from 3:30 PM Pacific Time on Monday, November 15, 2004 through 8:59 PM Pacific Time on Monday, November 29, 2004. Please call (888) 286-8010 (domestic) or (617) 801-6888 (international) and use the participant passcode #79218277. The live webcast will be archived on Cardima’s website for one year.
About Cardima
Cardima, Inc. has developed the REVELATION® Tx, REVELATION T-Flex and REVELATION Helix linear ablation microcatheters, the NAVIPORT deflectable guiding catheters, and the INTELLITEMP energy management system for the minimally invasive treatment of atrial fibrillation (AF). The REVELATION Helix was developed for the treatment of AF originating in the pulmonary veins of the heart. The REVELATION Tx, REVELATION T-Flex and REVELATION Helix systems and the INTELLITEMP have received CE Mark approval in Europe. The Company has also developed a Surgical Ablation System, which targets market application by cardiac surgeons to ablate cardiac tissue during heart surgery using radio frequency (RF) energy.
Except for the historical information contained herein, the matters discussed in this press release, including potential future events relating to the listing of the Company’s common stock on Nasdaq, the Company’s belief about its pre-market approval application, or PMA, for the REVELATION® Tx, the performance and utility of its products and the prospects for entering into a strategic transaction for its Surgical Ablation System, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by such forward-looking statements. Potential risks and uncertainties include the risk that the Company will not be able to maintain listing of its common stock on Nasdaq; the risk that the Company will not be able to raise additional capital when needed to continue operations; the risk that the Company will be unable to obtain U.S. FDA approval for the Company’s PMA for the REVELATION® Tx linear ablation microcatheter system, including uncertainties associated with its ability to revise the study design and collect data acceptable to the FDA; the risk that the approval process for the REVELATION Tx or any other product, including additional clinical trials, will require substantial unanticipated expenses and management attention; the limited number of cases employing the Company’s products and the limited amount follow-up information involving these cases; uncertainties associated with the Company’s ability to secure distribution partners; the possibility of business disruption or unanticipated expenses due to the Company’s staffing reduction and financing efforts; and uncertainties associated with its ability to conduct successful clinical trials, obtain and maintain regulatory approvals, gain acceptance for the Company’s products from the marketplace or successfully manufacture, market, sell and distribute its products. Additional risks are set forth in the Company’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2004 and June 30, 2004 and Annual Report on Form 10-K for the year ended December 31, 2003. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events or changes in the Company’s plans or expectations.
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(Financial Tables Follow)
Cardima, Inc.
Statements of Operations
(Unaudited)
In thousands, except per share amounts
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| | | Three months ended
September 30,
| | | Nine months ended
September 30,
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| | | 2004
| | | 2003
| | | 2004
| | | 2003
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Net sales | | $ | 569 | | | $ | 561 | | | $ | 1,783 | | | $ | 1,690 | |
Cost of goods sold | | | 893 | | | | 709 | | | | 2,121 | | | | 2,347 | |
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Gross margin | | | (324 | ) | | | (148 | ) | | | (338 | ) | | | (657 | ) |
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Operating expenses: | | | | | | | | | | | | | | | | |
Research and development | | | 1,016 | | | | 1,098 | | | | 3,208 | | | | 3,811 | |
Selling, general and administrative | | | 1,370 | | | | 1,603 | | | | 4,145 | | | | 5,296 | |
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Total operating expenses | | | 2,386 | | | | 2,701 | | | | 7,353 | | | | 9,107 | |
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Operating loss | | | (2,710 | ) | | | (2,849 | ) | | | (7,691 | ) | | | (9,764 | ) |
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Interest and other income, net | | | 9 | | | | 15 | | | | — | | | | 48 | |
Other non-cash expense | | | — | | | | (904 | ) | | | (33 | ) | | | (904 | ) |
Interest expense | | | (3 | ) | | | (4 | ) | | | (11 | ) | | | (10 | ) |
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Net loss | | $ | (2,704 | ) | | $ | (3,742 | ) | | $ | (7,735 | ) | | $ | (10,630 | ) |
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Basic and diluted net loss per share | | $ | (0.03 | ) | | $ | (0.05 | ) | | $ | (0.09 | ) | | $ | (0.18 | ) |
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Weighted average shares used in computing basic and diluted net loss per share | | | 84,684 | | | | 70,071 | | | | 83,785 | | | | 59,391 | |
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Selected Balance Sheet Data
(Unaudited)
In Thousands
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| | | September 30,
2004
(Unaudited)
| | December 31,
2003*
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Cash, cash equivalents and short term investments | | $ | 2,081 | | $ | 6,446 |
Working capital | | | 1,525 | | | 5,209 |
Total assets | | | 4,734 | | | 9,310 |
Total liabilities | | | 2,288 | | | 3,010 |
Stockholders’ equity | | | 2,446 | | | 6,300 |
| * | Derived from audited financial statements included in the Company’s Annual report on Form 10-K |
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