UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-QSB
(Mark One)
|X| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended: June 30, 2000
OR
|_| TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the transition period from __________ to __________
Commission File Number: 0-28260
EP MEDSYSTEMS, INC.
(Exact name of small business issuer as specified in its charter)
New Jersey 22-3212190
------------------------------------- ----------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
100 Stierli Court, Mount Arlington, New Jersey 07856
---------------------------------------------- -----
(Address of principal executive offices) (Zip Code)
(973) 398-2800
Issuer's telephone number
Check whether the issuer (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such
shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.|X| Yes |_|No
State the number of shares outstanding of each of the issuer's classes of common
equity, as of the latest practicable date:
Class Outstanding at July 20, 2000
----- ----------------------------
Common Stock, without par value 11,984,167 shares
Transitional Small Business Disclosure Format (check one): Yes |_| No |X|
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EP MEDSYSTEMS, INC. AND SUBSIDIARIES
FORM 10-QSB
CONTENTS
PART I -- Financial INFORMATION Page
--------
Item 1. Financial Statements
Consolidated Balance Sheet at June 30, 2000
(unaudited) 3
Consolidated Statements of Operations for three months
ended June 30, 2000 and 1999 (unaudited) 4
Consolidated Statements of Operations for six months 5
ended June 30, 2000 and 1999 (unaudited)
Consolidated Statements of Cash Flows for six months
ended June 30, 2000 and 1999(unaudited) 6
Notes to Consolidated Financial Statements (unaudited) 7-8
Item 2. Management's Discussion and Analysis or Plan of
Operation 9-12
PART II -- OTHER INFORMATION
Item 1. Legal Proceedings 13
Item 2. Changes in Securities 13
Item 3. Defaults Upon Senior Securities 13
Item 4. Submission of Matters to a Vote of Security Holders 13
Item 5. Other Information 13
Item 6. Exhibits and Reports on Form 8-K 14
Signatures and Exhibit Index 14
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EP MEDSYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEET
June 30,
2000
-----------------
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $ 1,673,488
Accounts receivable, net of allowances for
doubtful accounts of $94,022 2,289,159
Inventory, net 2,096,623
Prepaid expenses and other current assets 351,098
-----------------
Total current assets 6,410,368
Property and equipment, net 2,460,978
Intangible assets, net 508,580
Other assets 51,676
-----------------
Total assets $ 9,431,602
=================
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,464,084
Payables due to related parties 460,295
Accrued expenses 333,940
Deferred warranty revenue 225,423
Current portion of long-term debt 43,560
-----------------
Total current liabilities 2,527,302
Long-term debt, less current portion 449,999
-----------------
Total liabilities $ 2,977,301
-----------------
Commitments and contingencies
Shareholders' equity:
Preferred Stock, no par value, 5,000,000 shares
authorized, no shares issued and outstanding
Common stock, $.001 stated value, 25,000,000
shares authorized, 11,984,167 shares issued
and outstanding 11,984
Additional paid-in capital 26,265,995
Accumulated deficit (19,823,678)
-----------------
Total shareholders' equity 6,454,301
-----------------
Total liabilities and shareholders' equity $ 9,431,602
=================
The accompanying notes are an integral part of these statements.
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EP MEDSYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
For the Three Months Ended
June 30, June 30,
2000 1999
----------- -----------
Net sales $ 2,136,235 $ 2,421,601
Cost of products sold 1,062,164 1,071,901
----------- -----------
Gross profit 1,074,071 1,349,700
Operating costs and expenses:
Sales and marketing expenses 1,199,674 1,013,219
General and administrative expenses 693,070 607,102
Research and development expenses 735,874 608,110
----------- -----------
Loss from operations (1,554,547) (878,731)
Other income, net 7,709 21,642
----------- -----------
Net loss $ (1,546,838) $ (857,089)
=========== ===========
Basic and diluted loss per share $ (0.13) $ (0.09)
=========== ===========
Weighted average shares outstanding used
to compute basic and diluted loss per share 11,742,519 9,873,109
=========== ===========
The accompanying notes are an integral part of these statements.
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EP MEDSYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
For the Six Months Ended
June 30, June 30,
2000 1999
----------- -----------
Net sales $ 5,039,218 $ 4,956,011
Cost of products sold 2,396,546 2,265,066
----------- -----------
Gross profit 2,642,672 2,690,945
Operating costs and expenses:
Sales and marketing expenses 2,440,264 2,083,765
General and administrative expenses 1,304,923 1,204,683
Research and development expenses 1,313,268 1,052,847
----------- -----------
Loss from operations (2,415,783) (1,650,350)
Other income, net 234,110 49,190
----------- -----------
Net loss $ (2,181,673) $ (1,601,160)
=========== ===========
Basic and diluted loss per share $ (0.19) $ (0.16)
=========== ===========
Weighted average shares outstanding used
to compute basic and diluted loss per share 11,561,726 9,872,765
=========== ===========
The accompanying notes are an integral part of these statements.
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EP MEDSYSTEMS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
<TABLE>
<CAPTION>
For the Six Months Ended
June 30, June 30,
2000 1999
------------- ------------
<S> <C> <C>
Cash flows from operating activities:
Net loss $ (2,181,673) $ (1,601,160)
Adjustments to reconcile net loss to net cash
Used in operating activities:
Depreciation and amortization 370,212 141,560
Changes in assets and liabilities:
Decrease (increase) in accounts receivable 644,804 (531,712)
Increase in inventories (208,520) (417,040)
(Increase) decrease in prepaid and other current assets (97,189) 61,259
Increase in other assets (28,753) (12,851)
Increase in payables due to related parties 130,383 315,726
Increase in accounts payable 468,810 396,226
Decrease in accrued expenses, deferred
revenue and customer deposits (277,714) (205,983)
------------- ------------
Net cash (used in) operating activities $ (1,179,640) $ (1,853,975)
------------- ------------
Cash flows from investing activities:
Proceeds from maturity of investments -- 729,351
Capital expenditures (741,446) (667,983)
------------- ------------
Net cash (used in) investing activities $ (741,446) $ 61,368
------------- ------------
Cash flows from financing activities:
Proceeds from exercise of warrants 718,375 --
Proceeds from exercise of stock options 887,971 6,000
Net (payments) borrowings under note payable (18,503) 513,722
------------- ------------
Net cash provided by financing activities $ 1,587,843 $ 519,722
------------- ------------
Net (decrease) in cash and cash equivalents (333,243) (1,272,885)
Cash and cash equivalents, beginning of period 2,006,731 2,332,931
------------- ------------
Cash and cash equivalents, end of period $ 1,673,488 $ 1,060,046
============= ============
</TABLE>
The accompanying notes are an integral part of these statements.
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EP MEDSYSTEMS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
Note 1. Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared
in accordance with generally accepted accounting principles for interim
financial information and in accordance with the instructions to Form 10-QSB.
Accordingly, they do not include all of the financial information and footnotes
required by generally accepted accounting principles for complete financial
statements. In the opinion of management, all adjustments (including normal
recurring adjustments) considered necessary for a fair presentation have been
included.
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and accompanying notes.
Actual results could differ from those estimates.
The results of operations for the respective interim periods are not necessarily
indicative of the results to be expected for the full year. The accompanying
unaudited consolidated financial statements should be read in conjunction with
the audited consolidated financial statements and the notes thereto included in
the Company's Form 10-KSB for the year ended December 31, 1999 filed with the
Securities and Exchange Commission.
Note 2. Inventories
Inventories at June 30, 2000 consist of the following:
Raw materials $ 1,245,310
Work in process 125,732
Finished goods 725,581
-----------
$ 2,096,623
===========
Note 3. Note payable
In March 1999, the Company entered into a $500,000 Term Loan Agreement with a
bank, maturing December 31, 2004. The purpose of the term loan was to fund the
purchase of 7,500 square feet of manufacturing and warehouse space at its West
Berlin, NJ facility and make necessary building improvements. Interest is
payable monthly in arrears at either Prime plus 3/4% or LIBOR plus 3 1/4%, at
the Company's option. Principal is payable commencing January 2000 in 48 equal
monthly installments under a 15 year amortization schedule with a balloon
payment due in December 2004.
In addition, in March 1999, the Company entered into a $2 million Revolving
Credit Facility expiring March 31, 2001. The proceeds of the revolver are
intended to fund working capital purposes. Borrowings bear interest at either
the bank's Prime Rate plus
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1/2% or LIBOR plus 3%, at the Company's option. A facility fee is payable
quarterly on the average unused commitment at a rate of 3/4%. No amounts were
outstanding under the facility as of June 30, 2000. In August 2000, the Company
drew down $746,000 under the facility.
Under the Term Loan Agreement and the Revolving Credit Facility documentation,
the Company is required to maintain certain financial ratios and meet certain
net worth and indebtedness tests. The debt is collateralized by a first priority
lien on all corporate assets. The loan documentation also prohibits the Company
from incurring certain additional indebtedness, limits investments, advances or
loans and restricts substantial asset sales, capital expenditures and cash
dividends.
Note 4. Common Stock and Liquidity
In February 2000, the Company received $718,000 related to the exercise of
warrants that were issued in conjunction with the Company's private placement in
September 1999. Investors included in the exercise were two of its institutional
shareholders and two members of its board of directors. Common stock of 205,250
shares was issued in conjunction with the exercise of the warrants. In addition,
the exercise price of the remaining unexercised warrants to purchase 362,250
shares of common stock was increased from $3.50 to $7.50 per share.
The Company has used the net proceeds from the exercise of warrants for working
capital purposes. Management believes that its current liquidity position will
be sufficient to meet the needs of the Company until at least March 31, 2001. In
the event the Company cannot raise capital funds after March 31, 2001, the
Company believes that it can reduce non-core-related expenditures, which will
allow it to continue its operations for sometime thereafter. However, that
continuation may not be possible should circumstances outside the Company's
control (including, for example, changes in general economic conditions or other
matters, which adversely affect the Company's business) significantly interfere
with the Company's business.
Note 5. Other Income
In March 2000, the Company sold its New Jersey cumulative 1998 net operating
loss for one of its statutory subsidiaries for approximately $217,000. This
amount is included in other income.
Note 6. Industry Segment and Geographic Information
The Company manages its business on the basis of one reportable segment, the
manufacture and sale of cardiac electrophysiology products. The Company's chief
operating decision-makers use consolidated results to make operating and
strategic decisions.
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The following table sets forth product sales by geographic segment for the six
months ended June 30,
2000 1999
--------------- ---------------
United States $ 2,452,000 $ 2,946,000
Europe/Middle East 1,315,000 907,000
Asia and Pacific Rim 1,272,000 1,103,000
--------------- ---------------
$ 5,039,000 $ 4,956,000
=============== ===============
Sales of the Company's cardiac electrophysiology devices and related catheters
aggregated $4,308,000 and $731,000, respectively, for the six months ended June
30, 2000 and $4,332,000 and $624,000, respectively, for the comparable period in
1999. The Company's long-lived assets are located in the U.S.
Item 2. Management's Discussion and Analysis or Plan of Operation
Overview
EP MedSystems, Inc. was formed in January 1993 and operates in a single industry
segment. The Company develops, manufactures, markets and sells a line of
products for the cardiac electrophysiology market used to diagnose, monitor and
treat irregular heartbeats known as arrhythmias. Since inception, the Company
has acquired technology, has developed new products and has begun marketing
various electrophysiology products. The Company's current products include the
EP-WorkMate(R) electrophysiology workstation, the EP-3(TM) Stimulator,
diagnostic electrophysiology catheters and internal cardioversion catheters.
The Company has identified the diagnosis and treatment of atrial fibrillation as
a primary focus for its ongoing development efforts. Atrial fibrillation is the
most commonly sustained abnormal heart rhythm, estimated to afflict over
2,000,000 people in the United States with an estimated 345,000 new cases being
diagnosed each year. Although not immediately life threatening, atrial
fibrillation has been linked to a diminished lifestyle and to a significantly
increased risk of stroke. In patients over the age of 65, atrial fibrillation is
reported to quadruple the risk of stroke. In this regard, the Company has
developed a new product for internal cardioversion of atrial fibrillation known
as the ALERT(R) System, which uses a patented electrode catheter and the
Companion energy source to deliver measured, variable, low energy electrical
impulses directly to the inside of the heart in order to convert atrial
fibrillation to a normal heart rhythm.
The ALERT(R) System is not approved for sale in the United States, but the
Company has completed clinical trials relative to its application for an
Investigational Device Exemption ("IDE") submitted to the United States Food and
Drug Administration (the "FDA"). The Company's initial Pre Market Approval
("PMA") application, filed in November 1999, contained clinical results covering
78 patients. The FDA requested additional information, including increasing
patient enrollment to 150 patients. Upon
9
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addressing the FDA's additional requests, the Company was advised by the FDA
that expedited review would be granted for the ALERT(R) System. Expedited
review, in general, means that the FDA would be expected to give the ALERT(R)
System PMA application priority over all other regular PMA applications. The
purpose of this expedited review process is to afford the U.S. public the
benefit of new medical technology as soon as possible, while assuring that
safety and effectiveness is still obtained. No other legally marketed
therapeutic device, which uses low atrial defibrillation thresholds, like the
ALERT(R) System is currently available for sale in the U.S. Approval to market
and sell the ALERT(R) System in the U.S. may take until the first quarter of
2001, if approved at all. However, the Company is approved to market and sell
the ALERT(R) System with the CE Mark in the European Community.
In addition, the Company has developed an intracardiac ultrasound product line
including the ViewMate(TM) ultrasound imaging console and a deflectable
intracardiac imaging catheter. These products are designed to improve a
physician's ability to visualize the inside chambers of the heart, including the
internal anatomy of the heart. The Company believes that the ViewMate(TM) System
may play an important role as an imaging tool in conjunction with new and
effective treatment of complex cardiac arrhythmias, including ventricular
tachyarrhythmias ("VT") and atrial fibrillation ("AF"). The Company's ultrasound
products are not approved for sale and the Company does not anticipate receiving
approval to sell these products until the first half of 2001, if approved at
all.
Forward-Looking Statements
This report contains certain statements of a forward-looking nature relating to
such matters as anticipated financial and operational performance, business
prospects, technological developments, results of clinical trials, new products,
research and development activities and similar matters. These statements are
based on information currently available to management and on management's
beliefs and assumptions. When used in this document the words "anticipate",
"designed to", "estimate", "believe", "plans", and similar expressions are
intended to identify forward-looking statements but these are not the exclusive
means of identifying such statements. Such statements are only predictions and
are subject to risks and uncertainties and actual events or results may differ
materially from those anticipated, estimated, or projected due to a number of
factors. In evaluating such statements, specific consideration should be given
to the various factors effecting the industry and economy generally, as well as
those identified in this report and in the Company's other reports filed with
the Securities and Exchange Commission, which could cause actual results to
differ materially from those indicated by such forward-looking statements.
RESULTS OF OPERATIONS
Net sales were $5,039,218 in the first half of 2000 (an increase of $83,207 or
2%) as compared to $4,956,011 for the prior period in 1999. The majority of the
increase in revenue in the first six months of 2000 resulted from increased
worldwide sales of the EP WorkMate(R), which represented a substantial
percentage of sales during the first half of
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2000. The Company also realized increased sales of certain of its catheter
products during the period.
The level of sales for the remaining six months of 2000 will depend primarily on
sales of the EP WorkMate(R) and diagnostic catheters and the ability of the
Company's direct sales force and network of international independent
distributors to effectively market and sell the Company's existing products. The
ALERT(R) System is not approved for sale in the United States, but the Company
has completed clinical trials relative to its application for an Investigational
Device Exemption ("IDE") submitted to the United States Food and Drug
Administration (the "FDA"). The Company's initial Pre Market Approval ("PMA")
application, filed in November 1999, contained clinical results covering 78
patients. The FDA requested additional information, including increasing patient
enrollment to 150 patients. Upon addressing the FDA's additional requests, the
Company was advised by the FDA that expedited review would be granted for the
ALERT(R) System. Approval to market and sell the ALERT(R) System in the U.S. may
take until the second quarter of 2001, if approved at all. However, the Company
is approved to market and sell the ALERT(R) System with the CE Mark in the
European Community. While, the Company expects the ALERT(R) System to contribute
a greater proportion of revenues in 2001 and beyond, the Company cannot
accurately predict the sales level of the ALERT(R) System in Europe for the
remaining six months in 2000 at this time, or when it will be available, if at
all, in the United States.
Cost of products sold were $2,396,546 for the six months ended June 30, 2000 (an
increase of $131,480 or 6%) as compared to $2,265,066 for the same period in
1999. Gross profit on sales for the six months ended June 30, 2000 was
$2,642,672 (or 52% as a percentage of sales), as compared with $2,690,945 (or
54% as a percentage of product sales) for the comparable period in 1999. The
Company realized a decrease in gross profit on sales during this period
primarily due to the decrease in domestic sales of the EP WorkMate(R), which
currently yield a higher gross profit than international sales of the EP
WorkMate(R). The Company hopes to improve its overall gross profit percentage as
sales of the ALERT(R) System and other catheter products increase, which should
offset the fixed costs, associated with maintaining a catheter manufacturing
operation.
Sales and marketing expenses were $2,440,264 in the first six months of 2000 (an
increase of $356,499 or 17%) over $2,083,765 in the first half of 1999. The
increase during this period was primarily due to the expenses associated with
increase in personnel, travel, trade show related expenses, and product
promotional expenses in support of the Company's sales efforts. The
international distribution network is currently supported by a team of direct
international sales and marketing professionals, international field clinical
engineers and administrative support personnel.
General and administrative expenses were $1,304,923 for six the months ended
June 30, 2000 (an increase of $100,240 or 8%) as compared to $1,204,683 for the
same period in 1999. The increase during this period was due to administrative
costs necessary to support the increased operations worldwide. It is anticipated
that these expenses will decline as a percentage of revenues as incremental
sales are generated.
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Research and development expenses were $1,313,268 for the first half of 2000 (an
increase of 260,421 or 25%) as compared to $1,052,847 for the same period of
1999. During this period, the Company incurred research and development expenses
primarily associated with the clinical trials for the ALERT(R) System,
development costs and costs of preparing regulatory submissions for the new
ultrasound imaging product line, as well as costs associated with several new
products under development. In addition, the Company has ongoing development
efforts on existing products, including the EP WorkMate(R) and the EP-3(TM)
Stimulator. The Company expects that research and development expenses are
likely to increase in future periods, in part due to ongoing expenses related to
the ALERT(R) System clinical trials, new product development activities and
regulatory applications aimed at gaining approval to sell other new products.
The net loss for the six months ended June 30, 2000 was $2,181,673 as compared
to a net loss of $1,601,160 during the comparable period in 1999. The basic and
diluted loss per share for the six months ended June 30, 2000 was $0.19 per
share versus $0.16 per share in 1999.
Liquidity and Capital Resources
Since inception, the Company's expenses have exceeded its sales, resulting in an
accumulated deficit of approximately $19,824,000 at June 30, 2000.
During February 2000, the Company received $718,000 related to the exercise of
warrants that were issued in conjunction with the private placement in September
1999. Investors included in the exercise were two of the Company's institutional
shareholders and two members of its board of directors. Common stock of 205,250
shares was issued in conjunction with the exercise of the warrants. In addition,
the exercise price of the remaining unexercised warrants to purchase 362,250
shares of common stock was increased from $3.50 to $7.50 per share.
The Company has used the net proceeds from the exercise of warrants for working
capital purposes. Management believes that its current liquidity position will
be sufficient to meet the needs of the Company until at least March 31, 2001. In
the event the Company cannot raise capital funds after March 31, 2001, the
Company believes that it can reduce non-core-related expenditures, which will
allow it to continue its operations for sometime thereafter. However, that
continuation may not be possible should circumstances outside the Company's
control (including, for example, changes in general economic conditions or other
matters which could adversely affect the Company's business) significantly
interfere with the Company's business.
The Company has a $2 million Revolving Credit Facility expiring March 31, 2001.
The proceeds of the revolver are intended to fund working capital purposes. No
amounts were outstanding under the facility as of June 30, 2000. In August 2000,
the Company drew down $746,000 under the facility.
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Net cash used in operating activities for the six months ended June 30, 2000
decreased $674,00 as compared to 1999. The net use of cash in operations for the
six months ended June 30, 2000 was primarily due to the Company's loss from
operations. Payables to related parties increased $130,000. Payments to related
parties are made on terms similar to those of other suppliers.
Capital expenditures were $741,000 during the six months ended June 30, 2000 as
compared to $668,000 for the same period in 1999. Capital expenditures for the
six months ended June 30, 2000 resulted from building infrastructure
improvements to the Company's manufacturing facility.
As of the date of this Quarterly Report on Form 10-QSB, the Company does not
have any other material commitments for capital expenditures. However, the
Company expects to purchase capital equipment and to expand its manufacturing
and assembly capabilities as it continues to grow. The Company leases office and
manufacturing space and certain office equipment under operating leases.
The Company expects its operating losses to continue in the near future as it
continues to expend substantial funds for research and development, clinical
trials in support of regulatory approvals, increased manufacturing capacity and
expansion of sales and marketing activities. The amount and timing of future
losses will be dependent upon, among other things, increased sales of the
Company's existing products, clinical approval and market acceptance of the
ALERT(R) System and developmental, regulatory and market success of new products
under development. There can be no assurance that any of the Company's
development projects will be successful or that if development is successful,
that the products will generate any sales. Based upon its current plans and
projections, the Company believes that its existing capital resources will be
sufficient to meet its anticipated operational needs at least until March 2001.
Impact of the Year 2000
As of the date of this filing the Company has not experienced any disturbances
or interruption in its ability to transact business with its suppliers or
customers as a result of the year 2000 transition. The Company, however,
continues to monitor its systems, suppliers, and customers for any unanticipated
issues that have yet to surface.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
There were no material developments in legal proceedings disclosed by the
Company in previous reports.
Item 2. Changes in Securities
None.
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Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
The following exhibits will be filed as part of this Form
10-QSB:
Exhibit 27 Financial Data Schedule (SEC filing only)
(b) Reports on Form 8-K
None.
SIGNATURES
In accordance with the requirements of the Exchange Act, the Registrant caused
this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
EP MEDSYSTEMS, INC.
--------------------
(Registrant)
Date: August 11, 2000 By: /s/ David A. Jenkins
--------------- --------------------
David A. Jenkins
President and Chief Executive Officer
Date: August 11, 2000 By: /s/ Joseph M. Turner
--------------- --------------------
Joseph M. Turner
Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
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EXHIBIT INDEX
Exhibit
Number Description of Exhibit
-------------- -----------------------------------------------
Exhibit 27 Financial Data Schedule
(SEC filing only)
15
