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, 1997.
____ 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)
North Carolina
56-1493744
(State or other jurisdiction of (IRS Employer
Incorporation or organization) Identification Number)
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 April 15, 1997
Common Stock, par value $.001 6,728,843
<PAGE>
CARDIOVASCULAR DIAGNOSTICS, INC.
INDEX TO FORM 10-Q
<TABLE>
<CAPTION>
<S> <C>
PAGE
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Consolidated Balance Sheets as of March 31, 1997 (unaudited)
and December 31, 1996 3
Consolidated Statements of Operations for the Three Months ended
March 31, 1997 and 1996 (unaudited) 4
Consolidated Statements of Cash Flows for the Three Months ended
March 31, 1997 and 1996 (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 2. Changes in Securities
Item 5. Other Information-Subsequent Events
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES 12
</TABLE>
<PAGE>
CARDIOVASCULAR DIAGNOSTICS, INC
Consolidated Balance Sheets
(in thousands, except per share data)
<TABLE>
<CAPTION>
March 31, March 31,
1997 1996
-------- ----------
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 3,456 $ 2,716
Short term investments, held to maturity 4,511 5,973
Accounts receivable 1,597 1,292
Inventories 1,923 2,019
Other current assets 233 198
-------- --------
Total current assets 11,720 12,198
Property and equipment, net 4,229 4,236
Intangible assets, net 1,676 1,700
Other assets 162 217
-------- --------
Total assets $ 17,787 $ 18,351
======== ========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 380 $ 377
Accrued expenses 204 220
Current portion of capital lease obligations 13 19
-------- --------
Total current liabilities 597 616
-------- --------
Long term debt 50 50
Capital lease obligations, less current portion 17 17
-------- --------
Total non-current liabilities 67 67
-------- --------
Total liabilities 664 683
-------- --------
Shareholders' equity:
Preferred stock, $.001 par value; authorized
1,000,000 shares--Series A participating preferred
stock, voting; designated 696,000 shares at
December 31, 1996; no shares issued or outstanding
at December 31, 1996
Common stock, $.001 par value; authorized 10,000,000
shares; 6,728,843 and 6,663,986 issued and
outstanding at March 31, 1997 and December 31,
1996, respectively 7 7
Additional paid-in capital 33,720 33,682
Cumulative translation adjustments (157) (48)
Accumulated deficit (16,417) (15,940)
Unearned compensation (30) (33)
-------- --------
Total shareholders' equity 17,123 17,668
-------- --------
Total liabilities and shareholders' equity $ 17,787 $ 18,351
======== ========
</TABLE>
The accompanying notes are an integral part of the
consolidated financial statements.
3
<PAGE>
CARDIOVASCULAR DIAGNOSTICS, INC
Consolidated Statements of Operations
(In thousands, except share data)
Three Months Ended
March 31, March 31,
1997 1996
-------- ----------
Net sales $ 2,284 $ 1,503
Cost of goods sold 1,523 1,188
-------- ----------
Gross profit 761 315
Operating expenses:
General and administrative 759 636
Sales and marketing 296 454
Research and development 524 511
------- ---------
Total operating expenses 1,579 1,601
Operating loss (818) (1,286)
Other income (expense):
Interest expense (1) (8)
Interest income 105 191
Grant/royalty - 10
Development income 250 -
------ --------
Total other income (expense) 354 193
------- --------
Net loss before taxes (464) (1,093)
Provision for income taxes (14) (19)
-------- --------
Net loss ($478) ($1,112)
========= ========
Loss per share (0.07) (0.17)
Average weighted shares outstanding 6,714,496 6,537,556
The accompanying notes are an integral part of the consolidated
financial statements.
4
<PAGE>
CARDIOVASCULAR DIAGNOSTICS, INC.
Consolidated Statements of Cash Flows
(In thousands)
<TABLE>
March 31, March 31,
1997 1996
-------- --------
<S> <C> <C>
Cash flows from operating activities:
Net loss ($ 478) ($ 1,112)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation 187 166
Amortization 41 39
Unrealized gain on investments -- 11
Change in assets and liabilities:
Receivables (305) (466)
Inventories 96 (48)
Other assets 6 (199)
Accounts payable and accrued expenses (13) (625)
-------- --------
Net cash used in operating activities (466) (2,234)
-------- --------
Cash flows from investing activities:
Payments for purchase of property and equipment (180) (327)
Costs incurred to obtain patents -- (3)
Purchase of investments (2,538) (10,699)
Investment maturities 4,000 0
-------- --------
Net cash provided by (used in) investing activities 1,282 (11,029)
-------- --------
Cash flows from financing activities:
Principal payments on long-term debt and capital
lease obligations (6) (703)
Net proceeds from issuance of stock 38 1,013
-------- --------
Net cash provided by financing activities 32 310
-------- --------
Effect of exchange rates on cash (108) 59
--------- --------
Net increase (decrease) in cash and cash equivalents 740 (12,894)
Cash and cash equivalents at beginning of period 2,716 16,237
-------- --------
Cash and cash equivalents at end of period $ 3,456 $ 3,343
======== ========
</TABLE>
The accompanying notes are an integral part of the consolidated
financial statements.
5
<PAGE>
CARDIOVASCULAR DIAGNOSTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Note 1. Basis of Presentation
Cardiovascular Diagnostics, Inc. ("CVDI") is the parent company of Coeur
Laboratories, Inc. ("Coeur") and Cardiovascular Diagnostics Europe, BV ("CDE").
The "Company" refers to CVDI, Coeur and CDE. All CVDI financial reporting is
consolidated including the accounts of Coeur and CDE. All significant
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, 1996. 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, 1997 and has net operating loss carryforwards to offset any net income when
realized. Coeur made state income tax payments in the amount of $14,274, which
represents management's estimate of state income tax expense for the quarter
ended March 31, 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:
March 31, 1997 December 31, 1996
-------------- -----------------
Raw materials $1,609,934 $1,431,534
Finished goods 313,275 587,264
------------ -----------
$1,923,209 $2,018,798
Note 5. New Accounting Pronouncements
The Company will adopt Statement of Financial Accounting Standards (SFAS) No.
128, "Earnings Per Share", on December 31, 1997. SFAS No. 128 requires the
Company to change its method of computing, presenting and disclosing earnings
per share information. Upon adoption, all prior periods data presented will be
restated to conform to the provisions of SFAS No. 128.
6
<PAGE>
If the Company had adopted SFAS No. 128 for the period ended March 31, 1997, the
following computation would have been used to arrive at basic income per share
and diluted income per common share that would have been presented on the
consolidated statements of operations:
<TABLE>
<CAPTION>
THREE MONTHS ENDED
MARCH 31, MARCH 31,
1997 1996
------------------- -------------
<S> <C> <C>
Net loss ($ 477,631) ($1,112,839)
Weighted average number of
shares outstanding 6,714,496 6,537,556
----------- -----------
Loss per share ($ 0.07) ($ 0.17)
=========== ===========
Net loss ($ 477,631) ($1,112,839)
Weighted average shares:
Common shares outstanding 6,714,496 6,537,556
Dilutive effect stock options
& warrants -- --
----------- -----------
Total shares 6,714,496 6,537,556
Diluted loss per share ($ 0.07) ($ 0.17)
=========== ===========
</TABLE>
Note 6. Legal Proceedings
On March 20, 1997, CVDI filed a complaint in the United States District Court,
Eastern District of North Carolina, Western Division in Raleigh, North Carolina,
against Boehringer Mannheim Corporation ("BMC") located in Indiana. The suit
charges 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 has requested a
declaratory judgment that neither the products nor activities of CVDI infringe
U.S. Patents 5,164,598 or 5,300,779, purportedly owned by BMC.
On April 9, 1997 BMC answered the claims made by CVDI and submitted a
counterclaim against CVDI. The Company believes that the counterclaim
allegations are without merit and intends to defend itself against these
allegations vigorously.
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 actual results might differ
materially from those projected in the forward-looking statements. 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, including its Registration Statement on Form S-1,
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 subsidiaries, Coeur
Laboratories, Inc.("Coeur") and Cardiovascular Diagnostics Europe, BV ("CDE").
In May 1995, the Company began commercial marketing of its 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, 1997 were $2,284,000, an increase of
52% or $781,000, as compared to the same period in 1996. The increase in sales
were a direct result of increased TAS products sold to CVDI's North American
distributor, DADE International ("DADE"). Sales of Imaging Products for the
period ended March 31, 1997 were approximately $1,000,000 as compared to
approximately $1,112,000 for the period ended March 31, 1996.
Cost of goods sold increased $335,000 or 28% from March 31, 1996 to March 31,
1997, in correlation with the increased sales of TAS products. Accordingly,
gross profit increased to 33% from 21% for the three-month period ended March
31, 1997 as compared to the same period in 1996.
Total operating expenses decreased slightly, approximately $22,000, for the
quarter ended March 31, 1997 as compared to the same period in 1996. This
decrease was the overall effect of eliminating the direct sales force in late
1996 after the DADE North American distribution agreement was signed, partially
offset by the addition of administration and research and development staff and
increased rent for facility space.
General and administrative expenses increased $123,000 from March 31, 1996 to
March 31, 1997 due to increased staffing costs of approximately $97,000 and
additional facility space expenses of $25,000.
Sales and marketing expenses for the quarter ended March 31, 1997 were $296,000,
or 35%, less than the same period in 1996. This decrease was due to the
elimination of the direct sales force in late 1996.
Research and development expenses were $13,000 greater for the period ended
March 31, 1997 than for the same period in 1996. The Company expects research
and development expenses to increase during 1997 due to the clinical trials
planned for expanding the TAS test card menu.
Interest income decreased $85,000 for the three-month period ended March 31,
1997 from the three-month period ended March 31, 1996 due to decreased
investments as funds were used to support operations.
8
<PAGE>
Liquidity and Capital Resources
From December 31, 1996 to March 31, 1997, cash and cash equivalents and short
term investments decreased $722,000. A portion of this decrease was due to the
utilization of cash for operations of approximately $472,000 and capital
expenditures for property and equipment of $180,000.
Accounts receivable increased 65% or $585,000 from December 31, 1996 to March
31, 1997 due to the increase in TAS sales for the first quarter in 1997.
The Company expects to incur additional operating losses during 1997. 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.
Management believes that its existing capital resources and the cash flows from
operations will be adequate to satisfy its planned capital requirements through
at least 1998.
Factors That May Affect Future Results
A number of uncertainties exist that may affect the Company's future operating
results and stock price, including managed care, FDA regulations, and other
regulatory guidelines affecting the Company. 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 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.
Closure of the European Office
On March 31, 1997, CVDI closed the office located in the Netherlands. The
distribution agreements remain in place through CVDI and inventory will continue
to be shipped to the distributors through the bonded warehouse in the
Netherlands. Sales orders from European distributors will be processed through
the office in Raleigh, North Carolina, but the inventory will shipped to the
distributors from the Netherlands. CVDI believes that this change will improve
the support to the distributors and reduce the operating expenses associated
with European sales.
9
<PAGE>
Part II. OTHER INFORMATION
Item 1. Legal Proceedings
On March 20, 1997, CVDI filed a complaint in the United States District Court,
Eastern District of North Carolina, Western Division in Raleigh, North Carolina,
against Boehringer Mannheim Corporation ("BMC") located in Indiana. The suit
charges 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 has requested a
declaratory judgment that neither the products nor activities of CVDI infringe
U.S. Patents 5,164,598 or 5,300,779, purportedly owned by BMC.
On April 9, 1997 BMC answered the claims made by CVDI and submitted a
counterclaim against CVDI. The Company believes that the counterclaim
allegations are without merit and intends to defend itself against these
allegations vigorously.
Item 2. Changes in Securities
(a) No material modifications
(b) No material limitations or qualifications
(c) During the three months ended March 31, 1997, the Company issued the
following unregistered securities:
From January 1, 1997 through March 31, 1997, the Company issued options
to purchase an aggregate of 80,000 shares of Common Stock to employees
of the Company.
Item 5. Other Information-Subsequent Events
On April 8, 1997 CVDI signed a distribution agreement with AVECOR
Cardiovascular, Inc. ("AVECOR") to sell in the United States and Canada certain
heparin monitoring test cards in the surgical and critical care areas of
hospitals. CVDI currently has a Heparin Monitoring Test ("HMT") and will have a
Heparin Management Panel of tests ("HMP") as an alternative to the Activated
Clotting Time test ("ACT").
10
<PAGE>
On April 25, 1997 CVDI signed a collaboration agreement with Eli Lilly and
Company ("Lilly") to develop a test to monitor a therapeutic anticoagulant for
the treatment of sepsis. CVDI's goal is to submit a 510k application to the FDA
by the end of January 1998. Lilly is already in Phase II clinical trials at 40
hospital sites. Upon the conclusion of the Phase II and development of the test
card by CVDI, Lilly will being the Phase III clinical trials. Lilly will
purchase test cards and analyzers from CVDI to support the Phase III clinical
trials.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
11.1 Statement regarding computation of income (loss) per share
27.1 Financial Data Schedule
(b) No reports on Form 8-K were filed during the period.
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.
CARDIOVASCULAR DIAGNOSTICS, INC.
Date: May 15, 1997 By: /s/ B. Denise Hobbs
-------------------
B. Denise Hobbs
Treasurer
(Principal Financial and Accounting Officer)
12
<PAGE>
EXHIBIT 11.1
CARDIOVASCULAR DIAGNOSTICS, INC
Computations of Earnings Per Share
(Dollars and shares per thousand, except per share data)
(Unaudited)
Three Months Ended
March 31, March 31,
1997 1966
------- -------
Net Loss ($478) ($1,113)
====== ========
Weighted average number of shares outstanding 6,714 6,538
====== ========
Loss per share ($0.07) ($0.17)
======== ========
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1997
<PERIOD-START> JAN-01-1997
<PERIOD-END> MAR-31-1997
<CASH> 3,456
<SECURITIES> 4,511
<RECEIVABLES> 1,622
<ALLOWANCES> (25)
<INVENTORY> 1,923
<CURRENT-ASSETS> 233
<PP&E> 7,299
<DEPRECIATION> (3,070)
<TOTAL-ASSETS> 17,787
<CURRENT-LIABILITIES> 597
<BONDS> 0
0
0
<COMMON> 7
<OTHER-SE> 17,116
<TOTAL-LIABILITY-AND-EQUITY> 17,787
<SALES> 2,284
<TOTAL-REVENUES> 2,284
<CGS> 1,523
<TOTAL-COSTS> 1,523
<OTHER-EXPENSES> (1,579)
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> (1)
<INCOME-PRETAX> (464)
<INCOME-TAX> (14)
<INCOME-CONTINUING> (478)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (478)
<EPS-PRIMARY> (0.07)
<EPS-DILUTED> (0.07)
</TABLE>
