Exhibit 99
[LOGO] EPMediSystems
For Further Information Contact:
NASDAQ: EPMD Joseph M. Turner, CFO
FOR RELEASE NOVEMBER 15, 2000 (973) 398-2800
EP MEDSYSTEMS REPORTS THIRD QUARTER RESULTS
AND CONSUMMATES A $3.2 MILLION FINANCING WITH MEDTRONIC
MOUNT ARLINGTON, N.J. (November 15, 2000) -- EP MedSystems, Inc. (NASDAQ: EPMD)
today announced results for the nine months ended September 30, 2000. Net sales
were $7,756,310 as compared to $7,792,278 in 1999. The basic and diluted loss
per share for the nine months ended September 30, 2000 was $0.27 per share as
compared to $0.25 for the same period in 1999.
Net sales for the third quarter ended September 30, 2000 were $2,717,092 as
compared to $2,836,267 for the comparable period in 1999. The net loss for the
quarter was $976,873 as compared to $841,944 for the same period in 1999. The
basic and diluted loss per share for the quarter was $0.08 in both 2000 and
1999. The increase in the operating loss was primarily attributable to exchange
rate fluctuations, costs relating to the completion of the ALERT(R) clinical
trial, development costs related to the new Ultrasound catheter imaging system
and additional investment in the Company's sales and clinical team.
This week, EP MedSystems, Inc. entered into a debt financing for up to $3.2
million with Medtronic, Inc. The financing is in the form of a secured
promissory note bearing interest at two percent above the prime rate, is
repayable in three years and is secured by a pledge of stock owned by EPMD's
Chairman in another company. EP MedSystems, Inc. received $1.6 million at
closing and funding of the remaining portion of the loan will occur on or about
December 31, 2000, subject to certain conditions. Medtronic, Inc., with annual
sales in excess of $5 billion, is the world's leading medical technology
company.
Mr. David A. Jenkins, EP MedSystem's Chairman and CEO, commented, "We are
pleased to have concluded this arrangement of financing. It is intended to
bridge the short period of time until our key disposable products receive
approval. The debt structure allows us to have the cash without dilution to
current shareholders. All of us at EPMD are looking forward to the U.S. approval
of our disposable products, and their expected contribution to growth."
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Mr. Jenkins, stated further, "With the anticipated ALERT(R) U.S. market release,
we will begin our transition from sales generated primarily from capital
equipment to more predictable sales generated largely from disposable catheter
products. We achieved significant milestones in the nine months of 2000
including the completion of the U.S. ALERT(R) clinical trial and submitting its
Pre-Market Approval ("PMA") to the United States Food and Drug Administration
(the "FDA") in September 2000.
During the nine months of this year, EPMD achieved a number of significant
milestones, including:
o FDA grant of expedited review of the ALERT(R) System upon acceptance of
the Pre Market Approval application.
o Completion of the ALERT(R)U.S. clinical trial.
o Submission of the ALERT(R) PMA application with the FDA in September 2000.
o Positive results of the ALERT(R) clinical trial showing success in 81% of
the ALERT(R) patients versus success in 74% of the external cardioversion
patients.
o Introduction of Windows for Workmate.
o Receipt of CE Mark for the ALERT(R) Companion II, our touchscreen
defibrillation system.
o The finalization of a joint agreement with Witt Biomedical Corp. to
develop and market a combination cardiology workstation which is expected
to provide hemodynamic and electrophysiological monitoring in the newest
Windows(TM) operating system.
EP MedSystems develops and markets cardiac electrophysiology ("EP") products
used to diagnose and treat certain cardiac disorders. The Company's EP product
line includes the EP WorkMate(R) Computerized Electrophysiology Workstation, the
EP-3(TM) Computerized Electrophysiology Stimulator and EP catheters. The
ALERT(R) catheter is proprietary and used in tandem with the ALERT(R) Companion
to deliver a bi-phasic low energy waveform used to convert atrial fibrillation
to a normal synus rhythm. EPMD estimates that there are approximately 2 million
people in the U.S. with atrial fibrillation; a disease associated with reduced
cardiac output, congestive heart failure, and stroke. For more information visit
our Website at www.epmedsystems. com.
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EP MEDSYSTEMS, INC.
SELECTED FINANCIAL DATA
(Unaudited)
<TABLE>
<CAPTION>
Three Months Ended Nine Months Ended
September 30, September 30,
---------------------------- ---------------------------
Income Statement Data 2000 1999 2000 1999
------------ ------------ ------------ -----------
<S> <C> <C> <C> <C>
Net Sales $ 2,717,092 $ 2,836,267 $ 7,756,310 $ 7,792,278
Cost of products sold 1,213,981 1,215,711 3,610,527 3,480,777
------------ ------------ ------------ -----------
Gross Profit 1,503,111 1,620,556 4,145,783 4,311,501
Operating expenses
Sales and marketing 1,147,978 1,034,065 3,636,928 3,228,309
General and administrative 723,361 797,772 2,028,283 1,817,623
Research and development 600,278 625,606 1,864,861 1,752,808
------------ ------------ ------------ -----------
Loss from operations (968,505) (836,887) 3,384,288 (2,487,237)
Other (expense) income, net (8,368) (5,057) 225,742 44,133
------------ ------------ ------------ -----------
Net Loss $ (976,873) $ (841,944) $ (3,158,546) $(2,443,104))
============ ============ ============ ===========
Basic and diluted loss per share $ (.08) $ (.08) $ (.27) $ (.25)
============ ============ ============ ===========
Weighted Average
Shares Outstanding 11,988,808 10,233,189 11,705,126 9,958,053
============ ============ ============ ===========
</TABLE>
At September 30, At December 31,
Balance Sheet Data 2000 1999
------------ --------------
Cash and cash equivalents $1,236,000 $2,007,000
Working capital 2,771,000 4,876,000
Total assets 9,009,000 9,663,000
Total liabilities 3,509,000 2,674,000
Shareholder's equity 5,501,000 6,989,000
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This Release contains certain statements of a forward-looking nature relating to
future events or the future financial performance of the Company. When used by
EPMD, the words or phrases "believes," "anticipates," "expects," "intends,"
"will likely result," "estimates," "projects" or similar expressions are
intended to identify such forward-looking statements, but are not the exclusive
means of identifying such statements. 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 results discussed
in the forward-looking statements. Factors that could cause or contribute to
such differences include, but are not limited to, the Company's history of
losses and uncertainty of profitability; risks regarding demand for new and
existing products, particularly the EP WorkMate(R) and the ALERT(R) System; the
success of new product development efforts; clinical results of the ALERT(R)
System; the uncertainty as to whether the Company's products will receive
approval for sale in the United States and in the event that they do receive
approval, the risk that there will not be third party reimbursement available;
the Company's highly competitive industry and rapid technological change within
the industry and the fact that the industry is dominated by large companies with
much greater resources than the Company; the reliance on key personnel; the
uncertainty of patent or proprietary technology protection, particularly with
respect to the ALERT(R) System; as well other factors discussed in the Company's
Annual Report on Form 10-KSB for the fiscal year ended December 31, 1999 and
Quarterly report on Form 10-QSB for the quarter ended March 31, 2000 filed with
the SEC.
The Company cautions investors and others to review the cautionary statements
set forth in this Release and in the Company's reports filed with the Securities
and Exchange Commission and cautions that other factors may prove to be
important in affecting the Company's business and results of operations. Readers
are cautioned not to place undue reliance on these forward-looking statements,
INCLUDING ANY DISCUSSION REGARDING THE INCREASE OF FUTURE REVENUES OF THE
COMPANY, which speak only as of the date of this report. The Company 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 anticipated
events.
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