SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
[X] Quarterly report pursuant to Section 13 or 15 (d) of the Securities
Exchange Act of 1934. For the quarterly period ended September 30, 1999.
[ ] Transition Report Pursuant to Section 13 or 15 (d) of the Securities
Exchange Act of 1934. For the transition period from
_________ to ___________.
Commission File Number
0-25133
PHARMANETICS, INC.
(Exact Name of Registrant as Specified in its Charter)
North Carolina 56-2098302
(State or other jurisdiction of (IRS Employer Identification Number
Incorporation or organization)
5301 Departure Drive
Raleigh, North Carolina 27616
(Address of Principal Executive Office) (Zip Code)
Registrant's Telephone Number, Including Area Code 919-954-9871
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or 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. YES [X] NO [ ]
Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date.
Class Outstanding as of November 4, 1999
Common Stock, par value $.001 7,478,648
<PAGE>
PHARMANETICS, INC.
INDEX TO FORM 10-Q
PAGE
PART I. FINANCIAL INFORMATION ----
Item 1. Financial Statements
Consolidated Balance Sheets as of September 30, 1999
(unaudited) and December 31, 1998 3
Consolidated Statements of Operations for the Three Months
and Nine Months ended September 30, 1999 and 1998
(unaudited) 4
Consolidated Statements of Cash Flows for the Nine Months
ended September 30, 1999 and 1998 (unaudited) 5
Notes to Unaudited Consolidated Financial Statements 6
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations 8
PART II. OTHER INFORMATION
Item 6. Index to Exhibits 11
SIGNATURES 12
EXHIBIT 13
2
<PAGE>
PHARMANETICS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
<TABLE>
<CAPTION>
SEPTEMBER 30, DECEMBER 31,
1999 1998
----- ----
(UNAUDITED)
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $3,589 $3,998
Investments, held-to-maturity 3,243 3,703
Accounts receivable, net 751 2,069
Inventories 1,486 2,397
Oher current assets 225 299
------- ------
Total current assets 9,294 12,466
Property and equipment, net 3,210 4,543
Patents and intellectual property, net 595 1,547
Other assets, net 247 137
------- ------
Total assets $13,346 $18,693
======== =======
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $172 $429
Accrued expenses 283 169
Current portion of long-term debt
and capital lease obligations 765 725
----- -----
Total current liabilities 1,220 1,323
Long-term debt and capital lease obligations,
less current portion 1,073 1,626
------- ------
Total liabilities 2,293 2,949
------- ------
Commitments and contingencies
Shareholders' equity:
Preferred stock, $.001 par value; authorized
1,000,000 shares--no shares issued or
outstanding at September 30, 1999 or
December 31, 1998 - -
Common stock, $.001 par value; authorized
10,000,000 shares; 7,478,648 and 7,452,781
issued and outstanding at September 30, 1999
and December 31, 1998, respectively 7 7
Additional paid-in capital 40,080 40,010
Accumulated deficit (29,031) (24,262)
Unearned compensation (3) (11)
------- ------
Total shareholders' equity 11,053 15,744
------- ------
Total liabilities and
shareholders' equity $13,346 $18,693
======= =======
The accompanying notes are an integral part of the consolidated financial statements.
</TABLE>
3
<PAGE>
PHARMANETICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(IN THOUSANDS, EXCEPT SHARE DATA)
<TABLE>
<CAPTION>
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30 SEPTEMBER 30 SEPTEMBER 30 SEPTEMBER 30
1999 1998 1999 1998
---- ---- ---- ----
<S> <C> <C> <C> <C>
Net sales $ 745 $ 1,223 $ 2,882 $ 3,256
Cost of goods sold 764 737 2,358 2,144
---- ---- ----- -----
Gross profit (19) 486 524 1,112
---- ---- ----- -----
Operating expenses:
General and administrative 635 691 1,992 2,118
Sales and marketing 181 157 545 542
Research and development 664 682 2,008 1,870
------ ---- ----- -----
Total operating expenses 1,480 1,530 4,545 4,530
------ ----- ----- -----
Operating loss (1,499) (1,044) (4,021) (3,418)
-------- ------- ------ ------
Other income (expense)
Interest expense (75) (99) (244) (279)
Interest income 75 54 191 143
Grant/royalty income - 101 13 153
Development income 100 - 100 375
----- ---- ---- ----
Total other income (expense) 100 56 60 392
----- ---- ---- ----
Net and comprehensive loss from continuing
operations (1,399) (988) (3,961) (3,026)
Discontinued operations:
Income from operations of Coeur
Laboratories, Inc. (net of income taxes) - 43 18 557
Loss on disposal of Coeur Laboratories, Inc.
(including income taxes of $14) - - (826) -
----- ---- ---- ----
Net and comprehensive loss ($1,399) ($945) ($4,769) ($2,469)
======== ====== ======== ========
Basic and diluted net loss per common share:
From continuing operations ($0.19) ($0.14) ($0.53) ($0.44)
======== ======= ======== ========
From discontinued operations $ - $0.01 ($0.11) $0.08
======== ======= ======== ========
Basic and diluted net loss per common share ($0.19) ($0.13) ($0.64) ($0.36)
======== ======= ======== ========
Average weighted shares outstanding 7,477,452 7,010,706 7,466,217 6,859,330
========== ========== ========== ==========
The accompanying notes are an integral part of the consolidated financial statements.
</TABLE>
4
<PAGE>
PHARMANETICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(In thousands)
<TABLE>
<CAPTION>
NINE MONTHS ENDED
September 30 September 30
1999 1998
---- -----
<S> <C> <C>
Cash flows from operating activities:
Net loss ($4,769) ($2,469)
Adjustments to reconcile net loss to net cash
used in operating activities:
Stock-based compensation: general and administrative 51 76
Gain on sale of assets (161) -
Depreciation 669 667
Amortization of intangible and other assets 191 218
Write-off of goodwill 809 -
Amortization of discount on investment (40) (9)
Provision for inventory obsolescence 50 100
Change in assets and liabilities:
Accounts receivable 1,278 (138)
Inventories 150 483
Other assets (122) ( 99)
Accounts payable and accrued expenses 106 (714)
---- ---
Net cash used in operating activities (1,788) (1,885)
------ ------
Cash flows from investing activities:
Payments for purchase of property and equipment (190) (433)
Costs incurred to obtain patents and intangibles (58) (214)
Proceeds from maturities of investments 3,750 -
Purchases of investments (3,250) (2,429)
Proceeds from sale of segment 1,661 -
------- ------
Net cash provided by (used in) investing activities 1,913 (3,076)
------- ------
Cash flows from financing activities:
Principal payments on long-term debt and capital lease
obligations (553) (385)
Net proceeds from issuance of stock 19 6,094
------- ------
Net cash provided by (used in) financing activities (534) 5,709
------- -----
Net increase (decrease) in cash and cash equivalents (409) 748
Cash and cash equivalents at beginning of period 3,998 5,885
------- -----
Cash and cash equivalents at end of period $3,589 $6,633
====== ======
</TABLE>
5
<PAGE>
PHARMANETICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Note 1. Organization and Basis of Presentation
PharmaNetics, Inc. (the "Company") is a holding company incorporated in July
1998 as the parent company of Cardiovascular Diagnostics, Inc. ("CVDI"). CVDI
was incorporated in November 1985 and develops, manufactures and markets rapid
turnaround, point-of-care diagnostic tests to assess blood clot formation and
dissolution. CVDI develops tests based on its proprietary, dry chemistry
diagnostic test system, known as the Thrombolytic Assessment System ("TAS"), to
provide rapid and accurate evaluation of hemostasis at the point of patient
care. Until June 15, 1999 Coeur Laboratories ("Coeur"), which manufactures and
sells disposable power injection syringes, was a wholly-owned subsidiary of
CVDI. On that date, substantially all of the operating assets and liabilities of
Coeur were sold to Coeur Acquisition L.L.C., a private investment firm backed by
Bison Investments of Tampa, Florida. The consolidated financial statements
include the accounts of the Company and its wholly-owned subsidiaries, including
Coeur through June 15, 1999. All intercompany activity has been eliminated. The
consolidated financial statements included herein as of any date other than
December 31 have been prepared by the Company without audit, pursuant to the
rules and regulations of the Securities and Exchange Commission. Financial
information as of December 31 has been derived from the audited financial
statements of the Company, but does not include all disclosures required by
generally accepted accounting principles. In the opinion of management, the
accompanying unaudited consolidated financial statements include all adjustments
(consisting only of normal recurring adjustments) necessary to present fairly
the consolidated financial position, results of operations and cash flows of the
Company. For further information regarding the Company's accounting policies,
refer to the Consolidated Financial Statements and related notes included in the
Company's Annual Report on Form 10-K for the year ended December 31, 1998.
Results for the interim period are not necessarily indicative of the results for
any other interim period or for the full fiscal year.
Note 2. Income Taxes
The Company has no federal income tax provision or benefit, because the Company
did not realize net income for the quarter ended September 30, 1999 and has net
operating loss carryforwards to offset any net income when realized. Income tax
expense recognized represents Coeur's state income tax expense.
Note 3. Cash Equivalents
The Company considers all highly liquid investments with a maturity of three
months or less at the date of purchase to be cash equivalents.
Note 4. Inventory
Inventories consisted of the following:
September 30, 1999 December 31, 1998
------------------- -------------------
Raw materials $1,254,000 $1,860,000
Finished goods 232,000 537,000
---------- ----------
$1,486,000 $2,397,000
Note 5. Loss Per Common Share
In accordance with Statement of Financial Accounting Standards ("SFAS") No. 128,
"Earnings Per Share" ("EPS"), the Company is required to present both basic and
diluted EPS on the face of the Statement of Operations. Basic EPS excludes
dilution and is computed by dividing income (loss) available to common
shareholders by the weighted average number of common shares outstanding for the
period. Diluted EPS is the same as basic EPS for the Company's three and
nine-month periods ended September 30, 1999 and 1998, because, for loss periods,
potential common shares (such as options) are not included in computing diluted
EPS since the effect would be antidilutive.
6
<PAGE>
Note 6. Distribution Agreement
In August 1998, the Company signed a five-year distribution agreement with
Chiron Diagonstics ("Chiron"), now a part of Bayer Diagnostics ("Bayer"). Bayer
will distribute the Company's PT, aPTT, HMT and LHMT test carts in North
American and certain South American, European and Asian countries, subject to
minimum annual sales. At the time the distribution agreement was signed, the
Company received an equity investment of $6 million from Chiron.
Note 7. Discontinued Operations.
On June 15, 1999 the Company sold substantially all of the operating assets and
liabilities of Coeur to Coeur Acquisition L.L.C, a private investment firm
backed by Bison Investments of Tampa, Florida. The Company retained Coeur's
cash, receivables and certain other assets. The loss on disposal of the segment
was approximately $826,000, which was primarily due to the write-off of goodwill
related to Coeur. State income taxes applicable to the results of the
discontinued operations was approximately $17,000 and $67,000 for the nine
months ended September 30, 1999 and 1998, respectively and approximately $0 and
$14,000 for the three months ended September 30, 1999, and 1998, respectively.
Revenues applicable to the discontinued operations were approximately $1,801,000
and $3,542,000 for the nine months ended September 30, 1999 and 1998,
respectively and approximately $0 and $979,000 for the nine months ended
September 30, 1999 and 1998, respectively.
7
<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
INTRODUCTION
This Management's Discussion and Analysis of Financial Condition and Results of
Operations contains forward-looking statements. The Company's actual results
might differ materially from those projected in the forward-looking statements
due to any number of factors, including those set forth below under "--Factors
That May Affect Future Results". Additional information concerning factors that
could cause actual results to materially differ from those in the
forward-looking statements is contained in the Company's other SEC filings,
copies of which are available upon request from the Company.
The following discussion should be read in connection with the unaudited
Consolidated Financial Statements and Notes thereto appearing elsewhere in this
report. Unless the context indicates otherwise, all references to the Company
include PharmaNetics, Inc., its subsidiary Cardiovascular Diagnostics, Inc.
("CVDI") and Coeur Laboratories, Inc.("Coeur"), a wholly-owned subsidiary of
CVDI until June 15, 1999.
CVDI develops, markets and manufactures a Thrombolytic Assessment System
("TAS"), consisting of a compact, portable analyzer and disposable test cards
which are inserted into the analyzer to perform a variety of hemostasis tests.
In 1996, CVDI signed development and distribution agreements with Dade
International, Inc. ("Dade") and Avecor Cardiovascular to distribute its
products. In August 1998, CVDI signed a global distribution agreement with
Chiron Diagnostics, which is now a part of the diagnostics division of the Bayer
Corporation, to distribute CVDI's PT, aPTT, HMT, and LHMT test cards in North
America and certain South American, European and Asian countries. At that time,
the Company received an equity investment of $6 million from Chiron. This
distribution agreement has or will replace the distribution agreements which
existed prior to such date. In connection with CVDI's termination of the
distribution agreement with Dade, the Company agreed to continue to supply test
cards to Dade's existing customers for three years.
Given the consolidating hospital market and pricing pressures, the Company's
strategy has evolved towards becoming more focused on the development of
specialty tests for drugs, some with narrow ranges between over- and
under-dosage. The Company believes that rapid diagnostic capabilities improve
patient care and turnover, and that there is a market trend to obtain diagnostic
information faster in order to effect therapy sooner. The Company also believes
that these trends should allow the Company to obtain higher pricing for these
specialty tests. As a result, the Company has exhibited the flexibility of the
TAS platform and the potential to expand its menu of specialty tests by signing
collaboration agreements with pharmaceutical companies to monitor the effects of
new drugs that are in clinical trials. The Company believes that these and other
collaborations for specialty tests will also further demand for analyzers and
routine anticoagulant tests. The Company believes it is well positioned in its
development efforts to expand its menu of tests to monitor developmental drugs
where rapid therapeutic intervention is needed.
On June 15, 1999, the Company sold substantially all of the operating assets and
liabilities of its Coeur Laboratories, Inc. subsidiary. All prior period
financial information has been restated to present the results of operations of
Coeur as a discontinued segment.
RESULTS OF OPERATIONS
THREE MONTHS ENDED SEPTEMBER 30, 1999 VS SEPTEMBER 30, 1998
Net sales for the quarter ended September 30, 1999 were $745,000 compared to
$1,223,000 in the same period in 1998. Revenues flutuate depending on the timing
of collaborative partners' clinical trials. In the 1998 third quarter, the
Company sold analyzers to Knoll AG totaling $675,000 as part of their clinical
trials. The decreased analyzer revenue from Knoll was partially offset by
increased analyzer sales to Bayer.
Cost of goods sold for the quarter ended September 30, 1999 was $764,000
compared to $737,000 in the comparable period in 1998. The negative gross profit
for the 1999 period was mainly due to fixed manufacturing costs not covered by
low unit volumes of cards and analyzers sold during the quarter. The Company
expects its gross profit to improve in the future due to anticipated higher
volumes of cards and analyzers sold by Bayer and from anticipated higher average
sale prices of cards that are sold to collaborative partners. Higher gross
profits in the 1998 third quarter were due to higher volume and higher average
sale prices of analyzers.
Total operating expenses for the quarter ended September 30, 1999 were
$1,480,000, a 3% decrease from the third quarter of 1998. General and
administrative expenses decreased slightly but were partially offset by higher
sales and marketing expenses. Research and development expenses decreased
slightly. Research and development expenses fluctuate depending on the timing of
field and clinical trials.
8
<PAGE>
Other income (expense) for the quarter ended September 30, 1999, which is
composed of interest income, interest expense, royalty income and development
income, was a net income of $100,000 compared to a net income of $56,000 in the
quarter ended September 30, 1998. Grant income was higher for the 1998 third
quarter due to an NIH grant that was in process during that quarter. We
recognized development income in the 1999 third quarter upon achievement of a
milestone under a collaboration with a pharmaceutical partner.
NINE MONTHS ENDED SEPTEMBER 30, 1999 VS SEPTEMBER 30, 1998
Net sales for the nine months ended September 30, 1999 were $2,882,000, a
decrease compared to $3,256,000 for the same period in 1998. The decrease was
due to lower revenues from analyzer sales because the 1998 period included
approximately $1.3 million in sales to Knoll in conjunction with a collaborative
agreement. This decrease was partially offset by revenues from cards and
controls for the nine months ended September 30, 1999, which increased
approximately 34% compared to the same period in 1998.
Cost of goods sold for the nine months ended September 30, 1999 was $2,358,000
compared to $2,144,000 for the same period in 1998. This increase was mainly due
to higher overhead expenses during the 1999 period. The gross profit percentage
decreased compared to the prior year due to the higher expenses and lower
average sale prices for cards and analyzers in the nine months of 1999 compared
to 1998.
Total operating expenses of $4,545,000 for the nine months ended September 30,
1999 represents a slight increase compared to the same period in 1998. Decreases
in general and administrative expenses were offset by increased research and
development expenses due to higher personnel expenses.
Other income (expense) for the nine months ended September 30, 1999 decreased
$332,000. This is primarily the result of lower grant revenue in 1999 due to the
ending of an NIH grant in the third quarter of 1998 and lower development income
recorded by the Company in the nine months ended September 30, 1999. The Company
achieved several milestones in 1998 in connection with collaborations with Knoll
and Dade International.
DISCONTINUED OPERATIONS
On June 15, 1999, the Company sold substantially all of the operating assets and
liabilities of its Coeur Laboratories, Inc. subsidiary. The loss on disposal of
the segment was approximately $826,000, primarily due to the write-off of
goodwill related to Coeur. The income from operations for the six-month period
ended June 30, 1999 of this discontinued segment decreased approximately
$496,000 compared to the same period in 1998 due to lower sales volume combined
with higher production costs. The higher production costs resulted chiefly from
operating inefficiencies, such as rework of products, due to issues with several
suppliers during the period. Operating expenses of the discontinued segment for
the six months ended June 30, 1999 were essentially unchanged from the same
period in 1998
LIQUIDITY AND CAPITAL RESOURCES
At September 30, 1999, the Company had cash and cash equivalents and short-term
investments of $6.8 million and working capital of $8.1 million, as compared to
$7.7 million and $11.1 million, respectively, at December 31, 1998. During the
nine months ended September 30, 1999, the Company used cash in operating
activities of $1.8 million. The use of cash was primarily due to funding the net
operating loss of the Company. Net cash provided by investing activities during
the nine months ended September 30, 1999 was $1.9 million, resulting mainly from
the maturity of short-term investments and the proceeds from the sale of Coeur.
Net cash used in financing activities was due to paydown of the Company's
long-term debt.
The Company expects to incur additional operating losses during the remainder of
1999 and 2000. The Company's working capital requirements will depend on many
factors, primarily the volume of future orders of TAS products from the
Company's distributors, primarily Bayer. In addition, the Company expects to
incur costs associated with clinical trials for development of new test cards.
The Company may acquire other products, technologies or businesses that
complement the Company's existing and planned products, although the Company
currently has no understanding, commitment or agreement with respect to any such
acquisitions. Management believes that its existing capital resources and cash
flows from operations, including projected cash flows from its distribution
agreement with Bayer, will be adequate to satisfy its planned capital
requirements through 1999. To enhance liquidity, the Company plans to consider
external sources of financing as needed, including equity financings such as
private placement, a follow-on public offering of common stock or additional
equity infusions from collaborative partners.
9
<PAGE>
YEAR 2000
Computers, software and microprocessors that use only two digits to identify a
year in a date field may be unable to process accurately certain date-based
information at or after the year 2000. This is commonly referred to as the "Year
2000 issue". The Company is addressing the issue in several ways. First, the
Company has established a team to monitor product compliance and believes that
all Company products are Year 2000 compliant. Secondly, the Company has sought
Year 2000 compliance certification from its major suppliers and vendors related
to their products and internal business applications. Finally, the Company has
established a team to coordinate Year 2000 compliance related to internal
systems.
Many of the Company's systems use vendor-provided software and Year 2000
compliance will be achieved through vendor-provided upgrades. For other internal
systems, testing will be completed internally to ensure Year 2000 compliance.
Currently, the Company has completed its assessment and testing of Year 2000
compliance with respect to 100% of its own products, 100% of its own internal
systems and 100% of its vendor-provided systems and applications. The Company
believes that the cost of its Year 2000 compliance program, which solely relates
to internal personnel time, was approximately $50,000 through September 30,
1999. The Company does not believe that its business will be materially
adversely affected by the Year 2000 issue. However, the Company continues to
bear risk related to the Year 2000 and could be materially adversely affected if
significant customers or suppliers fail to address the issue. In a worst case
scenario, the Company could be forced to spend significant resources and funds
to find alternative suppliers or providers of systems and applications used by
the Company.
FACTORS THAT MAY AFFECT FUTURE RESULTS
A number of uncertainties exist that may affect the Company's future operating
results and stock price, including: risks associated with development of new
tests, particularly specialty tests that rely on development, regulatory
approval, commercialization and market acceptance of collaborators' new drugs;
market acceptance of TAS; the Company's continuing losses and the resulting
potential need for additional capital in the future; managed care and continuing
market consolidation, which may result in price pressure, particularly on
routine tests; and FDA regulations and other regulatory guidelines affecting the
Company and/or its collaborators. The market price of the common stock could be
subject to significant fluctuations in response to variations in the Company's
quarterly operating results as well as other factors which may be unrelated to
the Company's performance. The stock market in recent years has experienced
extreme price and volume fluctuations that often have been unrelated or
disproportionate to the operating performance of and announcements concerning
public companies. Such broad fluctuations may adversely affect the market price
of the Company's common stock. Securities of issuers having relatively limited
capitalization or securities recently issued in an initial public offering are
particularly susceptible to volatility based on short-term trading strategies of
certain investors.
10
<PAGE>
Part II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
27.1 Financial Data Schedule
(b) Reports on Form 8-k
None
11
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
PHARMANETICS, INC.
Date: November 12, 1999 By: /s/ Paul Storey
-------------------
Paul Storey
Treasurer
(Principal Financial and
Accounting Officer)
12
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<NAME> PharmaNetics, Inc.
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<CASH> 3,589
<SECURITIES> 3,243
<RECEIVABLES> 805
<ALLOWANCES> (54)
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