Cardima Announces Third Quarter Financial Results.Business Editors FREMONT, Calif.--(BUSINESS WIRE)--Nov. 13, 2003 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) ) Quarterly Highlights Include: -- Receives approval and launches REVELATION(R) Helix STX STX - Start Of Text microcatheter in Europe -- First commercial use of REVELATION(R) Helix STX 2.5 in Europe -- U.S. market launch of surgical ablation ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. system and first commercial procedure performed at Lenox Hill Lenox Hill is a neighborhood on Manhattan's Upper East Side. It forms the lower section of the Upper East Side, closest to Midtown. While it is agreed that the neighborhood ranges from 77th Street to 60th Street, its eastern border is disputed. -- Private placement raises gross proceeds of $7.4 million Cardima(R), Inc. (Nasdaq:CRDM), 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, 2003. 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 quarter ended September 30, 2003 increased overall by 26% to $561,000 from $444,000 for the same period in 2002. This increase was distributed throughout all regions with a 32% increase in the European region, a 29% increase in domestic sales and a 27% increase in sales in the Asian region, when comparing third quarter 2003 revenues with third quarter 2002 revenues. For the nine-month period ended September 30, 2003, revenues increased 4% to $1,690,000 compared with $1,633,000 for the same nine-month period in 2002. Net loss for the third quarter of 2003 decreased to $2,658,000, or $0.04 per share compared with $3,358,000, or $0.07 per share, for the second quarter of 2002. The decrease in net loss was due to the 26% increase in revenue as well as a 19% decrease in research and development expenses and an 8% decrease in sales, general and administrative expenses. For the nine-month period ended September 30, 2003, net loss increased 5% to $9,546,000 from $9,096,000 for the same nine-month period in 2002. This 5% increase in net loss correlates directly to the 5% increase in research and development expenses and the 5% increase in sales, general and administrative expenses, offset by the 3% increase in revenue and the 3% increase in cost of goods sold Cost of goods sold The total cost of buying raw materials, and paying for all the factors that go into producing finished goods. cost of goods sold , when comparing the nine-month period of 2003 with the nine-month period of 2002. Shares used in calculating the net loss per share increased to 70.1 million shares outstanding from 47.1 million shares due to the issuance of shares in connection with private placements since the third quarter of 2002. "This quarter, Cardima was able to achieve several significant milestones. We are pleased that in August, 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 at Lenox Hill Hospital Lenox Hill Hospital, on Manhattan's Upper East Side, is a 652-bed, acute care hospital and a major teaching affiliate of NYU Medical Center. Founded in 1857 as the German Dispensary, today's 10-building Lenox Hill Hospital complex has occupied its present site since 1868 when it were the first to use our Surgical Ablation System," said Gabriel Vegh, Chief Executive Officer of Cardima. "The doctors have been key in acknowledging to the cardiac surgery Cardiac surgery is surgery on the heart and/or great vessels performed by a cardiac surgeon. Frequently, it is done to treat complications of ischemic heart disease (for example, coronary artery bypass grafting), correct congenital heart disease, or treat valvular heart disease community that the Cardima system is a viable alternative to existing surgical tools to the treatment of AF." Dr. Vegh continues, "We continued working with the 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. in order to find common ground on which to obtain approval of our REVELATION Tx(R) technology. The 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 approval remains to be our primary goal." 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 800-915-4836 (domestic) or 973-317-5319 (international). A telephone replay will be available until midnight Eastern Time November 27, 2003 by dialing 800-428-6051 (domestic) and 973-709-2089 (international) and entering passcode 311864. 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 replay will be available on the Web site for one year. Cardima, Inc. developed the REVELATION(R) Tx linear ablation microcatheter system as 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 product that may have the potential for curing AF. Cardima submitted the PMA to the FDA on September 20, 2002 and was granted expedited review status on November 5, 2002. On May 29, 2003, the Company met with the Circulatory Systems circulatory system, group of organs that transport blood and the substances it carries to and from all parts of the body. The circulatory system can be considered as composed of two parts: the systemic circulation, which serves the body as a whole except for the Device Panel, who recommended that the U.S. Food and Drug Administration not approve our premarket approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device. application for the REVELATION(R) Tx. The Circulatory Systems Device Panel commented favorably fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. on the safety and need for this type of device. However, the Panel felt that efficacy data was not sufficiently clear and supportive for the approval. We continue to focus our resources primarily on gaining FDA approval for our submitted REVELATION(R) Tx microcatheter system PMA. We have submitted preliminary information and have had ongoing communications with officials from the FDA to discuss, in further detail, those issues necessary for approval. 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, whether the Company's pre-market approval application for the REVELATION(R) Tx or any other product will be approved by the FDA, whether the Company will be able to conduct successful clinical trials, obtain regulatory approvals, gain acceptance for its products from the marketplace and whether the Company will be able to successfully market, sell and derive significant revenue from its products, including REVELATION(R) Tx. 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, 2002, filed with the Securities and Exchange Commission on March 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 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. (Financial Tables Follow)
Cardima, Inc.
Statements of Operations
In thousands, except per share amounts
Three months ended Nine months ended
September 30, September 30,
------------------ -----------------
2003 2002 2003 2002
--------- -------- -------- --------
Revenues $561 $444 $1,690 $1,633
Operating expenses:
Cost of Goods Sold 840 1,074 2,746 2,667
Research and development 967 1,200 3,412 3,246
Selling, general and
administrative 1,423 1,544 5,116 4,865
--------- -------- -------- --------
Total operating expenses 3,230 3,818 11,274 10,778
--------- -------- -------- --------
Operating loss (2,669) (3,374) (9,584) (9,145)
Interest and other income 15 19 48 66
Interest expense (4) (3) (10) (17)
Gain on sale of intellectual
property -- -- --- ---
--------- -------- -------- --------
Net loss $(2,658) $(3,358) $(9,546) $(9,096)
========= ======== ======== ========
Net loss per share $(0.04) $(0.07) $(0.16) $(0.21)
========= ======== ======== ========
Shares used in computing net loss
per share 70,071 47,072 59,391 44,139
========= ======== ======== ========
Selected Balance Sheet Data
(Unaudited)
Sept. 30,
2003 Dec. 31,
(Unaudited) 2002*
----------- ---------
Cash, cash equivalents and short term investments $ 6,296 $ 3,385
Working capital 5,850 1,866
Total assets 9,605 7,265
Total liabilities 2,586 3,715
Stockholders' equity 7,019 3,550
* Derived from audited financial statements
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