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 March 31, 1998.
________ 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
0-26992
CARDIOVASCULAR DIAGNOSTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
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North Carolina 56-1493744
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(State or other jurisdiction of Incorporation or (IRS Employer Identification Number)
organization)
5301 Departure Drive
Raleigh, North Carolina 27616
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(Address of Principal Executive Office) (Zip Code)
Registrant's Telephone Number, Including Area Code 919-954-9871
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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 May 1, 1998
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Common Stock, par value $.001 6,793,079
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CARDIOVASCULAR DIAGNOSTICS, INC.
INDEX TO FORM 10-Q
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PART I. FINANCIAL INFORMATION PAGE
Item 1. Financial Statements
Consolidated Balance Sheets as of March 31, 1998 (unaudited)
and December 31, 1997 3
Consolidated Statements of Operations and Comprehensive Loss
for the Three Months ended March 31, 1998 and 1997 (unaudited) 4
Consolidated Statements of Cash Flows for the Three Months ended
March 31, 1998 and 1997 (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 10
Item 1. Legal Proceedings
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES 11
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CARDIOVASCULAR DIAGNOSTICS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
March 31, December 31,
1998 1997
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(Unaudited)
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ASSETS
Current assets:
Cash and cash equivalents $4,342 $5,885
Accounts receivable 1,881 1,888
Inventories 2,895 2,998
Other current assets 359 217
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Total current assets 9,477 10,988
Property and equipment, net 5,010 4,938
Intangible assets, net 1,518 1,568
Other assets 177 191
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Total assets $16,182 $17,685
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $472 $1,138
Accrued expenses 170 464
Current portion of long term debt and capital lease obligations 650 539
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Total current liabilities 1,292 2,141
Long term debt and capital lease obligations, less current portion 2,146 2,351
Total liabilities 3,438 4,492
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Shareholders' equity:
Preferred stock, $.001 par value; authorized 1,000,000 shares
no shares issued or outstanding at March 31, 1998
Common stock, $.001 par value; authorized 10,000,000 shares;
6,793,079 and 6,750,518 issued and outstanding at
March 31, 1998 and December 31, 1997, respectively. 7 7
Additional paid-in capital 33,896 33,827
Accumulated deficit (21,138) (20,619)
Unearned compensation (21) (22)
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Total shareholders' equity 12,744 13,193
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Total liabilities and shareholders' equity $16,182 $17,685
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Commitments and contingencies
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The accompanying notes are an integral part of the consolidated financial
statements.
3
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CARDIOVASCULAR DIAGNOSTICS, INC.
CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(In thousands, except share data)
Three Months Ended
March 31, March 31,
1998 1997
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Net sales $ 2,404 $2,284
Cost of goods sold 1,645 1,523
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Gross profit 759 761
Operating expenses:
General and administrative 764 759
Sales and marketing 228 296
Research and development 631 524
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Total operating expenses 1,623 1,579
Operating loss (864) (818)
Other income(expense):
Interest expense (76) (1)
Interest income 65 105
Grant/royalty income 7 0
Development income 375 250
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Total other income (expense) 371 354
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Net loss before income taxes (493) (464)
Provision for income taxes (26) (14)
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Net loss ($519) ($478)
Other comprehensive loss, net of tax:
Foreign currency translation adjustments - (108)
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Comprehensive loss ($519) ($586)
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Basic and diluted net loss per common share ($0.08) ($0.07)
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Average weighted shares outstanding 6,764,245 6,714,496
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The accompanying notes are an integral part of the consolidated financial
statements.
4
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CARDIOVASCULAR DIAGNOSTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(In thousands)
Three Months
Ended
March 31, March 31,
1998 1997
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Cash flows from operating activities:
Net loss ($519) ($478)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation 218 187
Amortization 65 41
Change in operating assets and liabilities:
Receivables 7 (305)
Inventories 103 96
Other assets (140) 6
Accounts payable and accrued expenses (960) (13)
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Net cash used in operating activities (1,226) (466)
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Cash flows from investing activities:
Payments for purchase of property and equipment (290) (180)
Costs incurred to obtain patents (2) -
Purchase of investments - (2,538)
Investment maturities - 4,000
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Net cash provided by (used in) investing activities (292) 1,282
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Cash flows from financing activities:
Principal payments on long-term debt and capital lease obligations (94) (6)
Net proceeds from issuance of common stock 69 38
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Net cash provided by (used in) financing activities (25) 32
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Effect of exchange rates on cash 0 (108)
Net increase (decrease) in cash and cash equivalents (1,543) 740
Cash and cash equivalents at beginning of period 5,885 2,716
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Cash and cash equivalents at end of period $4,342 $3,456
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The accompanying notes are an integral part of the consolidated financial
statements.
5
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CARDIOVASCULAR DIAGNOSTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Note 1. Organization and Basis of Presentation
Cardiovascular Diagnostics, Inc. (the "Company") develops, manufactures and
markets a proprietary cardiovascular diagnostic test system that provides rapid
and accurate evaluation of hemostasis at the point of patient care. The
Company's wholly owned subsidiary, Coeur Laboratories Inc., ("Coeur"),
manufactures and sells disposable power injection syringes and manifolds. The
consolidated financial statements include the accounts of the Company and the
wholly owned subsidiary. 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, 1997.
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 Paid
No federal income tax provision or benefit has been provided for income tax
purposes, as the Company has not realized net income for the quarter ended March
31, 1998 and has net operating loss carryforwards to offset any net income when
realized. Income tax expense recognized represents management's estimate of
Coeur's state income tax expense for the quarters ended March 31, 1998 and
1997.
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 (in thousands):
March 31, 1998 December 31, 1997
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Raw materials $2,239 $2,122
Finished goods 656 876
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$2,895 $2,998
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Note 5. Development Income
During the quarters ended March 31, 1998 and 1997, the Company recognized
$375,000 and $250,000 of development income upon meeting milestones as part of
collaboration agreements.
Note 6. Loss Per Common Share
On December 31, 1997, the Company adopted Statement of Financial Accounting
Standards ("SFAS") No. 128, "Earnings Per Share". In accordance with SFAS No.
128, the Company has replaced the presentation of primary earnings per share
("EPS") with a presentation of basic EPS and has presented both basic and
diluted EPS on the face of the Statements of Operations. Basic EPS excludes
dilution and is computed by dividing income available to common shareholders by
the weighted average number of common shares outstanding for the period. Diluted
EPS is computed by dividing income available to common shareholders by the
weighted average number of common shares plus potentially dilutive shares such
as options. Diluted EPS is
6
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the same as basic EPS because, for loss periods, potential common shares (such
as options) are not included in computing diluted EPS since the effect would be
antidilutive.
Note 7. New Accounting Pronouncements
The Company has adopted SFAS No. 130 "Reporting Comprehensive Income" beginning
January 1, 1998. SFAS No. 130 requires the Company to display an amount
representing total comprehensive income (loss) for all periods presented. The
Company has elected to display this information in the Statements of Operations.
All prior period data has been restated to conform to the
provisions of this statement.
The Company will adopt SFAS No. 131 "Disclosures about Segments of an Enterprise
and Related Information" as of December 31, 1998. SFAS No. 131 requires the
Company to report selected information about operating segments beginning with
its 1998 year end financial report issued to shareholders. It also establishes
standards for related disclosures about products and services, geographic areas
and major customers. The Company does not believe the adoption of this new
pronouncement will have a significant impact on the financial statements.
Note 8. Legal Proceedings
As reported in its filings on Form 10-K for the period ended December 31, 1997,
in March 1997, the Company filed suit in the U. S. District Court, Eastern
District of North Carolina, against Boehringer Mannheim Corporation ("BMC")
located in Indiana. The suit charged BMC with misappropriation of CVDI's trade
secrets by improper disclosure, breach of contract, breach of fiduciary duty,
unfair and deceptive trade practices, and constructive fraud. In addition, CVDI
requested a declaratory judgment that neither the products nor activities of
CVDI infringe U.S. Patents purportedly owned by BMC. On April 9, 1997 BMC
answered the claims made by CVDI and submitted a counterclaim against CVDI. Each
party filed a motion for judgment on the pleading with respect to all claims
asserted by the other party. On November 10, 1997, the Court issued a Judgement
and Order granting CVDI's motion for judgment on the pleadings, holding that
CVDI has a license, until June 21, 1999, or until the last of the patents
expire, to the patents at issue. It dismissed all other claims of the parties.
Both parties have appealed and are awaiting the Court's decision. It is
management's opinion that the disposition of this matter will not have a
material adverse impact on the consolidated financial position, results of
operations or liquidity of the Company.
7
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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 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 conjunction 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 Cardiovascular Diagnostics, Inc. ("CVDI") and its subsidiary, Coeur
Laboratories, Inc.("Coeur").
The Company 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.
Coeur currently manufactures and sells a line of disposable syringes used in
angiography injectors, as well as a line of angiographic procedure kit manifolds
(collectively, "Imaging Products").
Results of Operations
Net sales for the quarter ended March 31, 1998 were $2,404,000, an increase of
$120,000 compared to the same period in 1997. The 1998 quarter included initial
sales of $675,000 to Knoll AG as part of a $2.1 million order received during
the quarter. The 1997 quarter included the initial shipments of TAS products to
CVDI's North American distributor, DADE Behring ("DADE"). Cost of goods sold
increased $122,000 between the March 31, 1998 and March 31, 1997 quarters. The
resulting 32% gross profit for the first quarter of 1998 was a slight decrease
from the 33% gross profit percentage for the three-month period ended March 31,
1997.
Total operating expenses for the quarter ended March 31, 1998 were $1,623,000, a
$44,000 increase from the first quarter of 1997. General and administrative
expenses were essentially unchanged from the March 31, 1997 quarter to the March
31, 1998 quarter. Sales and marketing expenses decreased $68,000 from the March
31, 1997 quarter to the March 31, 1998 quarter due to fewer personnel in 1998
and reduced travel costs associated with fewer personnel. Research and
development expenses for the quarter ended March 31, 1998 were $631,000 compared
to $524,000 for the quarter ended March 31, 1997. The increase was due to higher
costs for personnel, supplies and validation processes related to on-going
development projects as well as projects for which 510(k)'s were submitted to
the FDA during the quarter.
Interest expense for the quarter ended March 31, 1998 was $76,000, an increase
of $75,000 from the prior year period. The increase was related to long-term
debt obtained by the Company in December 1997. Interest income decreased
$41,000 for the three-month period ended March 31, 1998 compared to the same
period in 1997 due to decreased investments as funds were used to support
operations.
Development income for the quarter ended March 31, 1998 increased to $375,000
compared to $250,000 for the quarter ended March 31, 1997. The income recognized
in each of these quarters relates to collaborations entered into by the Company
for which milestones were achieved in the respective quarter.
For the three months ended March 31, 1997, comprehensive income consists of
foreign currency translation adjustments related to a foreign subsidiary.
Operations of this subsidiary were ceased during the year ended December 31,
1997.
Liquidity and Capital Resources
From December 31, 1997 to March 31, 1998, cash and cash equivalents decreased
$1,543,000. This decrease was mainly due to the utilization of cash for
operations, capital expenditures of $290,000 and repayment of long-term debt of
$94,000.
The Company expects to incur additional operating losses during 1998. The
Company's working capital requirements will depend on many factors, primarily
the volume of subsequent orders of TAS products from the distributors. In
addition, the Company expects to incur costs associated with clinical trials for
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. In addition, the Company may consider a joint venture
or the sale of manufacturing rights to complete the commercialization of its
routine anticoagulant monitoring tests. Management believes that its existing
capital resources and the cash flows from operations will be adequate to satisfy
its planned capital requirements through 1998.
8
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Factors The 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 or announcements concerning
public companies. Such broad fluctuations may adversely affect the market price
of the Company's common stock. Securities of issuers having relative 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.
9
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Part II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
27.1 Financial Data Schedule
(b) No reports on Form 8-K were filed during the period.
10
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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.
CARDIOVASCULAR DIAGNOSTICS, INC.
Date: May 14, 1998 By: /s/ Paul Storey
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Paul Storey
Treasurer
(Principal Financial and Accounting Officer)
11
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<FISCAL-YEAR-END> DEC-31-1998
<PERIOD-START> JAN-01-1998
<PERIOD-END> MAR-31-1998
<CASH> 4,342
<SECURITIES> 0
<RECEIVABLES> 1,896
<ALLOWANCES> (15)
<INVENTORY> 2,895
<CURRENT-ASSETS> 359
<PP&E> 8,697
<DEPRECIATION> (3,687)
<TOTAL-ASSETS> 16,182
<CURRENT-LIABILITIES> 1,292
<BONDS> 0
0
0
<COMMON> 7
<OTHER-SE> 12,737
<TOTAL-LIABILITY-AND-EQUITY> 16,182
<SALES> 2,404
<TOTAL-REVENUES> 2,404
<CGS> (1,645)
<TOTAL-COSTS> (1,645)
<OTHER-EXPENSES> (1,623)
<LOSS-PROVISION> (11)
<INTEREST-EXPENSE> (76)
<INCOME-PRETAX> (493)
<INCOME-TAX> (26)
<INCOME-CONTINUING> (519)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (519)
<EPS-PRIMARY> (0.08)
<EPS-DILUTED> (0.08)
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