EP MedSystems Reports Third Quarter and Nine Month Results.WEST BERLIN, N.J. -- EP MedSystems, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : EPMD EPMD Erick and Parrish Making Dollars (rap group) EPMD Electric Plant Monitoring Device EPMD Enlisted Personnel Management Director/Directorate ), a market leader in electrophysiology electrophysiology /elec·tro·phys·i·ol·o·gy/ (-fiz?e-ol´ah-je) 1. the study of the mechanisms of production of electrical phenomena, particularly in the nervous system, and their consequences in the living organism. 2. products used to diagnose and treat certain types of cardiac rhythm Noun 1. cardiac rhythm - the rhythm of a beating heart heart rhythm regular recurrence, rhythm - recurring at regular intervals atrioventricular nodal rhythm, nodal rhythm - the normal cardiac rhythm when the heart is controlled by the disorders, today announced financial results for the three and nine months ended September 30, 2005. For the nine months ended September 30, 2005, revenues were $12,501,000, an increase of 12% from the $11,149,000 reported in the same period last year. The gross margin for the nine months ended September 30, 2005 increased to 63%, compared to 58% for the comparable period of 2004. The net loss for the nine months ended September 30, 2005 was $4,422,000 or ($0.17) per basic and diluted share, compared to $3,924,000 or ($0.17) per basic and diluted share in the prior year. The Company's administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. were higher in the nine months as a result of higher legal fees and other costs associated with the Administrative Subpoena subpoena (səpē`nə) [Lat.,=under penalty], in law, an order to a witness to appear before a court. A subpoena ad testificandum [Lat. received by the Company during the second quarter, the SEC inquiry and the related investigations of sales of the Company's products into Iran and Syria, which are more fully described in the Company's Quarterly Report filed on Form 10-Q Form 10-Q See 10-Q. . Revenues for the quarter were $4,270,000, a decrease of 9% from the $4,677,000 reported for the three months ended September 30, 2004. The gross margin for the three months ended September 30, 2005 increased to 63%, compared to 60% for the comparable period in 2004. The net loss for the quarter was $1,849,000, compared to the $710,000 reported in 2004. The basic and diluted loss per share for the three months ended September 30, 2005 was ($0.07), which compared to ($0.03) for the comparable period in 2004. The Company finished the quarter with cash and cash equivalents of $6,607,000. The Company also announced that 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. has requested additional clinical data to support 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. (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 ) supplement filing to market the ALERT(R) CS/RA dual-purpose catheter system. The Company is in the process of evaluating our response to the FDA requests. The product line is currently available for sale in Europe. David Jenkins David Jenkins may refer to:
Corporate Conference Call EP MedSystems' management will host a conference call today, November 10, 2005, at 4:30 p.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT (1:30 p.m. PDT PDT abbr. Pacific Daylight Time PDT Pacific Daylight Time PDT n abbr (US) (= Pacific Daylight Time) → hora de verano del Pacífico PDT ) to review the second quarter financial results and other corporate events. David Jenkins, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. will host the call and take part in a Q & A session. The call can be accessed by dialing 866-249-5225 and giving the company name, "EP MedSystems". Participants are asked to call the number approximately 10 minutes before the conference call begins. A replay of the conference call will be available two hours after the call for the following five days by dialing 800-405-2236 and entering the following pass code: 11044541#. The call can also be accessed live on the web at www.epmedsystems.com in the investor relations Investor relations The process by which the corporation communicates with its investors. area of the site or by going to http://www.mkr-group.com. About EP MedSystems: EP MedSystems develops and markets cardiac electrophysiology Cardiac electrophysiology is the science of the mechanisms, functions, and performance of the electrical activities of specific regions of the heart. This term is usually used in describing studies of such phenomena by invasive (intracardiac) recording of spontaneous activity as ("EP") products used to diagnose and treat certain cardiac rhythm disorders. The Company's EP product line includes the EP-WorkMate(R) Electrophysiology Workstation with RPM(TM) Real-time Position Management(TM) navigation technology, the EP-4(TM) Computerized Cardiac Stimulator, fixed and 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 diagnostic electrophysiology catheters and related disposable supplies, the ALERT(R) System and ALERT family of internal cardioversion Cardioversion Definition Cardioversion refers to the process of restoring the heart's normal rhythm by applying a controlled electric shock to the exterior of the chest. catheters, and the ViewMate(R) intracardiac intracardiac /in·tra·car·di·ac/ (-kahr´de-ak) within the heart. in·tra·car·di·ac adj. Within the heart. intracardiac within the heart. ultrasound catheter imaging system. For more information, visit our Website at www.epmedsystems.com. Forward Looking Statements: This Release may contain certain statements of a forward-looking nature relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc future events or the future financial performance of the Company. 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. include information concerning our possible or assumed future results of operations and statements preceded by, followed by or including the words "believes", "expects", "anticipates", "intends", "plans", "estimates", "see opportunities" or similar expressions. Such forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. Such forward-looking statements are only predictions and are subject to risks and uncertainties that could cause actual results or events to differ materially and adversely from the events discussed in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, EP MedSystems' history of losses, uncertainty of market acceptance of our products and level of sales, uncertainty of future profitability and future liquidity needs, possible costs, fines or penalties that may be incurred in connection with government inquiries and investigations and risks regarding regulatory approvals and demand for new and existing products, as stated in the Company's Annual Report filed on Form 10-KSB and quarterly reports filed on Form 10-Q and 10-QSB. EP MedSystems cautions investors and others to review the cautionary statements set forth in this press release and in EP MedSystems' reports filed with the Securities and Exchange Commission and cautions that other factors may prove to be important in affecting the EP MedSystems' business and results of operations. Readers are cautioned not to place undue reliance on this press release and other forward-looking statements, which speak only as of the date of this release. EP MedSystems undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date of this report or to reflect the occurrence of unanticipated events. Other highlights reported for the quarter and nine months include:
Three Months Ended Nine Months Ended
September 30, September 30,
Income Statement ------------------------- -------------------------
Data 2005 2004 2005 2004
------------ ------------ ------------ ------------
Net Sales $4,270,000 $4,677,000 $12,501,000 $11,149,000
Cost of products
sold 1,592,000 1,876,000 4,619,000 4,665,000
------------ ------------ ------------ ------------
Gross Profit 2,678,000 2,801,000 7,882,000 6,484,000
Operating expenses
Sales and
marketing 2,110,000 2,156,000 6,413,000 5,857,000
General and
administrative 1,811,000 716,000 4,072,000 2,277,000
Research and
development 588,000 531,000 1,760,000 1,769,000
------------ ------------ ------------ ------------
Total Operating
Expenses 4,509,000 3,403,000 12,245,000 9,903,000
------------ ------------ ------------ ------------
Loss from
operations (1,831,000) (602,000) (4,363,000) (3,419,000)
------------ ------------ ------------ ------------
Interest expense,
net (18,000) (108,000) (59,000) (505,000)
------------ ------------ ------------ ------------
Net Loss $(1,849,000) $(710,000) $(4,422,000) $(3,924,000)
============ ============ ============ ============
Basic and diluted
loss per share $(0.07) $(0.03) $(0.17) $(0.17)
============ ============ ============ ============
Weighted Average
Shares Outstanding 25,847,567 23,511,520 25,755,732 23,387,478
============ ============ ============ ============
Balance Sheet Data At September 30, At September 30,
2005 2004
---------------- ----------------
Cash and cash equivalents $6,607,000 $5,783,000
Working capital 7,117,000 8,448,000
Total assets 17,148,000 15,300,000
Total liabilities 7,679,000 6,454,000
Shareholder's equity 9,469,000 8,846,000
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