Cardima Announces Third Quarter Financial Results.Business Editors FREMONT Fremont (frē`mŏnt). 1 City (1990 pop. 173,339), Alameda co., W Calif., on San Francisco Bay; inc. 1956. Long an agricultural center, with champagne vineyards founded (1870) by Leland Stanford, it still ships fruits and vegetables. , Calif.--(BUSINESS WIRE)--Oct. 24, 2002 Cardima(R), Inc. (Nasdaq: 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 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 September: see month. 30, 2002. The Company reported a net loss of $3,358,000, or $0.07 per share, for the third quarter of 2002, compared with a net loss of $3,090,000, or $0.09 per share, for the third quarter of 2001. The net loss for the first nine months of 2002 was $9,096,000, or $0.21 per share, compared with $5,724,000, or $0.20 per share, which included a $4 million gain on the sale of certain patents reported in the first quarter of 2001. Revenues for the third quarter of 2002 were $444,000, compared with $465,000 for the third quarter of 2001, a decrease of 4.5%. For the nine-month period ended September 30, 2002, revenues were $1,633,000, compared with $1,477,000 for the same nine-month period in 2001, representing an increase of 11%. The overall increase in sales for the nine-month period in 2002 is attributed to the initial launch of therapeutic products in Europe during the first quarter and continued growth in Asian markets. 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 third quarter of 2002 increased 4%, to $2,744,000, compared with $2,629,000 for the third quarter of 2001. Selling, general and administrative expenses for the third quarter of 2002 increased by less than 0.5%, or $6,000, to $1,544,000, compared with $1,538,000 for the same period of 2001. Research, development, clinical and regulatory expenses for the third quarter of 2002 were $1,200,000, compared with $1,091,000 for the third quarter of 2001, an increase of 10%. Mr. Gabriel Vegh, Chief Executive Officer of Cardima, said, "During this quarter, we achieved a major milestone by submitting the REVELATION Tx pre-market Pre-Market Trading done before the regular market opens. Notes: Participation by market makers and ECNs is voluntary, so in pre-market there may be less liquidity than during normal hours of trading. 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 ) application to the Food and Drug Administration (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. ). Our regulatory and clinical team worked very hard to make this submission on schedule and I am very proud of their efforts. We are working with the FDA to schedule a panel meeting to review our PMA application as soon as possible." The PMA submission, which is an important step for Cardima in gaining U.S. approval for the REVELATION Tx 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. to treat paroxysmal paroxysmal (per´ adj recurring in paroxysms. AF, is targeted for approval in the first quarter of 2003. The REVELATION Tx is the first 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. catheter-based treatment for AF to complete a multi-center clinical trial and be submitted in a PMA to the FDA. 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 (888) 212-9184 for domestic callers, or (706) 643-0144 for international callers. A telephone replay will be available until 11:59 p.m. Eastern Time October 26, 2002 by dialing (800) 642-1687 for domestic callers, or (706) 645-9291 for international callers, and using the passcode 6257691. Individuals interested in listening to the conference call via the Internet Internet Publicly accessible computer network connecting many smaller networks from around the world. It grew out of a U.S. Defense Department program called ARPANET (Advanced Research Projects Agency Network), established in 1969 with connections between computers at the may do so by visiting the Company's Web site at www.cardima.com. A replay will be available on the Web site for 90 days. Cardima, Inc. developed the REVELATION(R) Tx linear ablation ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. microcatheter system as a minimally invasive, single-use product that has the potential for curing AF. The REVELATION(R) Tx linear ablation microcatheter system is believed by the Company to be the first device that has completed a multi-center clinical trial and submitted a pre-market approval (PMA) application to treat AF to the U.S. Food and Drug Administration (FDA). Cardima submitted the PMA to the FDA on September 20, 2002. Clinical trial data from the REVELATION(R) Tx microcatheter demonstrated safety and promising efficacy. Approval of the REVELATION Tx will mark a major milestone in the Company's mission to get better devices in the hands of the medical community that provide a potential cure for AF. 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 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.
Cardima, Inc.
Statements of Operations
In thousands, except per share amounts
Three months ended Nine months ended
September 30, September 30,
2002 2001 2002 2001
Revenues $ 444 $ 465 $ 1,633 $ 1,477
Cost of goods sold 1,074 949 2,667 2,868
Gross margin (630) (484) (1,034) (1,391)
Operating expenses:
Research and
development 1,200 1,091 3,246 3,738
Selling, general and
administrative 1,544 1,538 4,865 4,639
Total operating
expenses 2,744 2,629 8,111 8,377
Operating loss (3,374) (3,113) (9,145) (9,768)
Interest and other
income 18 37 65 93
Interest expense (2) (14) (16) (49)
Gain on sale of
intellectual property -- -- -- 4,000
Net loss $ (3,358) $ (3,090) $ (9,096) $ (5,724)
Net loss per share $ (0.07) $ (0.09) $ (0.21) $ (0.20)
Shares used in computing
net loss per share 47,072 34,641 44,139 28,469
Selected Balance Sheet Data
(Unaudited)
September 30,
2002 December 31,
(Unaudited) 2001(a)
Cash, cash equivalents and
short term investments $ 2,887 $ 7,542
Working capital 2,354 6,756
Total assets 6,858 11,818
Total liabilities 2,729 3,061
Stockholders' equity 4,129 8,757
(a) Derived from audited financial statements
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