Cardima Announces Third Quarter 2004 Financial Results.FREMONT, Calif. -- Cardima(R), Inc. (Nasdaq SC: CRDM CRDM Control Rod Drive Mechanism CRDM Centre for Rapid Design and Manufacture (Buckinghamshire Chilterns University) CRDM Cumann Rince Dea Mheasa (Irish dancing organisation) ), developer of the REVELATION(R) Tx, REVELATION(R) T-Flex and REVELATION(R) Helix microcatheter systems for the treatment of atrial fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. (AF), today reported financial results for the third quarter ended September 30, 2004. Net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight for the third quarter ended September 30, 2004 were $569,000, a 1% increase from the same period in 2003. United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. 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 Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. , 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 Investor relations The process by which the corporation communicates with its investors. section of the Company's Web site at www.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(R) Tx, REVELATION T-Flex and REVELATION Helix linear ablation ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. microcatheters, the NAVIPORT deflectable de·flect intr. & tr.v. de·flect·ed, de·flect·ing, de·flects To turn aside or cause to turn aside; bend or deviate. [Latin d guiding catheters, and the INTELLITEMP energy management system for the minimally invasive invasive /in·va·sive/ (-siv) 1. having the quality of invasiveness. 2. involving puncture of the skin or insertion of an instrument or foreign material into the body; said of diagnostic techniques. treatment of atrial fibrillation (AF). The REVELATION Helix was developed for the treatment of AF originating in the pulmonary veins pulmonary vein n. A vein that carries oxygenated blood from the lungs to the left atrium of the heart. 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 A cardiac surgeon is a surgeon who performs cardiac surgery - operative procedures on the heart and great vessels. Training In the United States and Canada, a cardiac surgery residency typically comprises anywhere from six to nine years (or longer) of training to become to ablate ab·late v. To remove or destroy the function of. ablate to remove, especially by cutting. ablate verb To remove; excise 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 relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the listing of the Company's common stock on Nasdaq, the Company's belief about its pre-market approval application, or PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy , for the REVELATION(R) 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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval for the Company's PMA for the REVELATION(R) 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 disruption /dis·rup·tion/ (dis-rup´shun) a morphologic defect resulting from the extrinsic breakdown of, or interference with, a developmental process. 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 Form 10-Q See 10-Q. for the quarters ended March 31, 2004 and June 30, 2004 and Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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 CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or after the date hereof here·of adv. Of this. hereof Adverb Formal or law of or concerning this Adv. 1. hereof - of or concerning this; "the twigs hereof are physic" , or to reflect the occurrence of unanticipated events or changes in the Company's plans or expectations.
Cardima, Inc.
Statements of Operations
(Unaudited)
In thousands, except per share amounts
Three months ended Nine months ended
September 30, September 30,
--------------------------------------------------- ------------------
2004 2003 2004 2003
-------- -------- ------- ----------
Net sales $569 $561 $1,783 $1,690
Cost of goods sold 893 709 2,121 2,347
-------- -------- ------- ----------
Gross margin (324) (148) (338) (657)
-------- -------- ------- ----------
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
-------- -------- ------- ----------
Total operating expenses 2,386 2,701 7,353 9,107
-------- -------- ------- ----------
Operating loss (2,710) (2,849) (7,691) (9,764)
Interest and other income, net 9 15 - 48
Other non-cash expense - (904) (33) (904)
Interest expense (3) (4) (11) (10)
-------- -------- ------- ----------
Net loss $(2,704)$(3,742) $(7,735) $(10,630)
======== ======== ======= ==========
Basic and diluted net loss per
share $(0.03) $(0.05) $(0.09) $(0.18)
======== ======== ======= ==========
Weighted average shares used in
computing basic and diluted net
loss per share 84,684 70,071 83,785 59,391
======== ======== ======= ==========
Selected Balance Sheet Data
(Unaudited)
In Thousands
September 30, December 31,
2004 2003*
(Unaudited)
------------------- -------------
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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