Cardima Announces First Quarter Financial Results.Business Editors & Health/Medical Writers FREMONT, Calif.--(BW HealthWire)--April 25, 2002 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) ): Quarterly Highlights Include: -- 103% Increase in International Sales Led by the REVELATION Helix in Europe and Strong Diagnostic Product Sales in Japan -- REVELATION Tx Clinical Trial in the U.S. on Track Cardima(R), Inc. (Nasdaq SC:CRDM), developer of the REVELATION(TM) Tx and REVELATION(TM) 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 first quarter ended March 31, 2002. Revenues for the first quarter of 2002 increased to $766,000, compared to $539,000 for the first quarter of 2001, an increase of 42%. The increase is primarily due to a 103% increase in international sales, from $286,000 in Q1 2001 to $582,000 in Q1 2002, led by initial therapeutic product sales of the REVELATION Helix in Europe and strong diagnostic product sales in Japan. Revenues for the first quarter represent a 73% increase over Q4 2001 revenues of $442,000. 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. for the first quarter of 2002 decreased to $2,466,000 compared to $2,866,000 for the first quarter of 2001, a decrease of 14%. Selling, marketing, general and administrative expenses for the first quarter of 2002 increased by $124,000 due to a $165,000 increase in selling expenses as a result of the ramp up Ramp Up To increase a company's operations in anticipation of increased demand. Notes: A company might 'ramp up' operations if they just signed a contract creating substantially more demand for their product. See also: Demand, Economies of Scale of sales efforts to support the REVELATION Helix launch in Europe, which was offset by a decrease in marketing and general and administrative expenses of $41,000. Research and development expenses for the first quarter of 2002 were $833,000 compared to $1,357,000 for the first quarter of 2001, a decrease of 39%, due to the Company's continued focus and redirection Diverting data from their normal destination to another; for example, to a disk file instead of the printer, or to a server's disk instead of the local disk. See virtual directory, symbolic link, shortcut, redirector and DOS redirection. 1. of resources to projects and clinical trials relating directly to treating atrial fibrillation. The Company reported an operating loss operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. of $2,590,000 for the first quarter of 2002, compared to an operating loss of $3,301,000, for the first quarter of 2001. The net loss for the first quarter of 2002 was $2,570,000, or $0.06 per share, compared to net income of $692,000, or $0.03 per share, for the first quarter of 2001, which included a $4 million gain from the sale of certain patents reported in the first quarter of 2001. At March 31, 2002, the Company had cash and cash equivalents of approximately $4 million. Commenting on the first quarter of 2002, Mr. Gabriel Vegh, Chief Executive Officer of Cardima, Inc., said, "We are optimistic op·ti·mist n. 1. One who usually expects a favorable outcome. 2. A believer in philosophical optimism. op about the initial sales of the REVELATION Helix in Europe and pleased with the strong diagnostic product sales in Japan. In the U.S., excellent progress was made toward bringing the REVELATION Tx clinical trial to its conclusion later this year. The pre-market approval (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 ) submission is planned for Q3 of 2002. We are looking forward to the year end when we believe our first therapeutic catheter catheter /cath·e·ter/ (kath´e-ter) 1. a tubular, flexible surgical instrument that is inserted into a cavity of the body to withdraw or introduce fluid. 2. urethral c. will be approved in the U.S.," added Mr. Vegh. Cardima has scheduled an investor conference call regarding this announcement to be held today, beginning at 4:30 p.m. Eastern Time. To participate in the live call via telephone, please call 800/366-7417. A telephone replay will be available until 11:59 p.m. Eastern Time April 27, 2002 by dialing 800/405-2236 pass code 464411. Individuals interested in listening to the conference call via the Internet may do so by visiting the Company's website at www.cardima.com. A replay will be available on the website for 90 days. Cardima, Inc. developed the linear ablation ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. REVELATION Tx system for treating atrial fibrillation. Since atrial fibrillation afflicts an estimated 2 million people in the 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. and approximately 4.5 million people worldwide, the Company believes it is a potential $6 billion market that is poorly served by current treatment alternatives. The REVELATION Tx microcatheter system is a 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. , single-use system with the potential of curing atrial fibrillation, and is believed by the Company to be at least two years ahead of other development-stage ablation therapies ablation therapy See Ablation–cardiology. in the approval process. Phase I and II data with the REVELATION Tx microcatheter system have demonstrated safety and promising efficacy. The Company is targeting 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 REVELATION Tx by the end of calendar year 2002. The Company's REVELATION Helix received CE mark approval in December 2001 with initial market launch in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community in the first quarter of 2002. Except for the historical information contained herein, the matters discussed in this press release 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 in such forward-looking statements. Potential risks and uncertainties include the Company's ability to raise additional capital, conduct successful clinical trials, obtain regulatory approvals and gain acceptance from the marketplace for its products. Additional risks are set forth in the Company's 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, 2001 filed with the Securities and Exchange Commission on April 1, 2002. 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 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.
Cardima, Inc.
Statements of Operations
In thousands, except per share amounts
Three months ended
March 31,
2002 2001
(Unaudited) (Unaudited)
Revenues $766 $539
Cost of goods sold 890 974
Gross margin (124) (435)
Operating expenses:
Research and development 833 1,357
Sales, general and administrative 1,633 1,509
Total operating expenses 2,466 2,866
Operating loss (2,590) (3,301)
Interest and other income 28 12
Interest expense (8) (19)
Gain on sale of intellectual property - 4,000
Net income/loss $(2,570) $692
Net income/(loss) per share $(0.06) $0.03
Shares used in calculating
net income/(loss) per share 42,641 21,620
Selected Balance Sheet Data
In thousands
March 31, December 31,
2002 2001(a)
(Unaudited)
Cash, cash equivalents and
short-term investments $4,011 $7,542
Working capital 4,077 6,756
Total assets 8,574 11,818
Total liabilities 2,443 3,061
Stockholders' equity 6,132 8,757
(a) Derived from audited financial statements
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