<PAGE>
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT UNDER 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 EXCHANGE ACT
Commission file number 0-19567
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CARDIAC SCIENCE, INC.
--------------------------------------------------------------------------------
(Exact name of Small Business Issuer as specified in its charter)
DELAWARE 33-0465681
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(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
16931 MILLIKAN AVENUE, IRVINE, CALIFORNIA 92606
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(Address of principal executive offices)
Registrant's telephone number, including area code: (949) 587-0357
Check whether the issuer (1) 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.
Yes X No
--- ---
The number of shares of the Common Stock of the registrant outstanding as of
August 7, 2000 was 24,023,078.
<PAGE>
CARDIAC SCIENCE, INC.
INDEX TO FORM 10-Q
PART I. FINANCIAL INFORMATION
<TABLE>
<CAPTION>
PAGE NO.
--------
<S> <C>
Item 1. Financial Statements:
Consolidated Condensed Balance Sheets as of June 30, 2000 (Unaudited)
and December 31, 1999 3
Consolidated Condensed Statements of Operations (Unaudited) for the
three and six months ended June 30, 2000 and 1999 4
Consolidated Condensed Statements of Cash Flows (Unaudited) for the
six months ended June 30, 2000 and 1999 5
Consolidated Condensed Notes to Financial Statements (Unaudited) 6
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations 7
Item 3. Quantitative and Qualitative Disclosures About Market Risk 9
PART II. OTHER INFORMATION
Item 1. Legal Proceedings 10
Item 2. Changes in Securities and Use of Proceeds 10
Item 3. Defaults Upon Senior Securities 10
Item 4. Submission of Matters to a Vote of Security Holders 10
Item 5. Other Information 11
Item 6. Exhibits and Reports on Form 8-K 11
Signatures 12
</TABLE>
2
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CARDIAC SCIENCE, INC.
CONSOLIDATED CONDENSED BALANCE SHEETS
<TABLE>
<CAPTION>
(Unaudited)
June 30, December 31,
2000 1999
------------ ------------
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 9,103,336 $ 5,901,934
Accounts receivable 599,440 102,900
Inventory 2,403,996 438,592
Prepaid expenses 97,886 59,646
------------ ------------
Total current assets 12,204,658 6,503,072
Equipment, net 947,157 391,085
Other assets 175,366 150,178
------------ ------------
$ 13,327,181 $ 7,044,335
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses $ 4,682,299 $ 2,092,903
Current portion of capital lease obligation 45,286 25,717
------------ ------------
Total current liabilities 4,727,585 2,118,620
------------ ------------
Long term portion of capital lease obligation 173,813 103,507
------------ ------------
Stockholders' equity:
Preferred stock - $0.001 par value; 1,000,000 shares authorized, none
issued or outstanding -- --
Common stock - $ 0.001 par value; 20,000,000 shares authorized, 14,614,296
issued and outstanding at June 30, 2000 and 12,031,252
at December 31, 1999 14,615 12,031
Additional paid-in capital 32,865,464 23,748,322
Accumulated deficit (24,454,296) (18,938,145)
------------ ------------
Total stockholders' equity 8,425,783 4,822,208
------------ ------------
$ 13,327,181 $ 7,044,335
============ ============
</TABLE>
The accompanying notes are an integral part of the financial statements.
3
<PAGE>
CARDIAC SCIENCE, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
<TABLE>
<CAPTION>
Three months ended Six months ended
June 30, 2000 June 30, 1999 June 30, 2000 June 30, 1999
------------- ------------- ------------- -------------
<S> <C> <C> <C> <C>
Sales $ 924,962 $ -- $ 1,549,604 $ --
Cost of goods sold 817,833 -- 1,392,591 --
------------ ------------ ------------ ------------
Gross profit 107,129 -- 157,013 --
Operating expenses:
Research and development 1,285,857 1,072,282 2,423,881 1,669,310
Selling expenses 901,702 404,672 1,826,466 679,921
General and administrative 728,092 468,513 1,445,141 749,625
------------ ------------ ------------ ------------
Loss from operations (2,808,522) (1,945,467) (5,538,475) (3,098,856)
Interest income (expense), net 11,901 (460) 23,924 (3,632)
------------ ------------ ------------ ------------
Loss from operations before provision for
income taxes (2,796,621) (1,945,927) (5,514,551) (3,102,488)
Provision for income taxes -- -- 1,600 1,600
------------ ------------ ------------ ------------
Net loss $ (2,796,621) $ (1,945,927) $ (5,516,151) $ (3,104,088)
============ ============ ============ ============
Net loss per share (basic and diluted) $ (0.23) $ (0.24) $ (0.44) $ (0.40)
============ ============ ============ ============
Weighted average number of shares used in the
computation of net loss per share 12,379,059 8,198,222 12,437,491 7,671,205
============ ============ ============ ============
</TABLE>
The accompanying notes are an integral part of the financial statements.
4
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CARDIAC SCIENCE, INC.
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
<TABLE>
<CAPTION>
Six months Six months
ended ended
June 30, 2000 June 30, 1999
------------- -------------
<S> <C> <C>
Cash flows from operating activities:
Net loss $(5,516,151) $(3,104,088)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 66,700 28,337
Compensation related to fair value of options granted to non-
employees 75,000 9,400
Expenses paid with common stock -- 218,295
Changes in operating assets and liabilities:
Accounts receivable (496,540) --
Inventory (1,965,404) --
Prepaid expenses (38,240) (5,700)
Other assets (25,188) --
Accounts payable and accrued expenses 1,802,496 (467,988)
----------- -----------
Net cash used in operating activities (6,097,327) (3,321,744)
----------- -----------
Cash flows from investing activities:
Purchase of equipment (532,897) (52,846)
----------- -----------
Net cash used in investing activities (532,897) (52,846)
----------- -----------
Cash flows from financing activities:
Payments on notes payable -- (162,502)
Proceeds from issuance of common stock 9,680,000 3,700,000
Proceeds from exercise of common stock warrants 137,981 350
Proceeds from exercise of common stock options 72,626 --
Costs of equity issuances (58,981) (245,740)
----------- -----------
Net cash provided by financing activities 9,831,626 3,292,108
----------- -----------
Net increase (decrease) in cash and cash equivalents 3,201,402 (82,482)
Cash and cash equivalents at beginning of period 5,901,934 1,247,602
----------- -----------
Cash and cash equivalents at end of period $ 9,103,336 $ 1,165,120
=========== ===========
</TABLE>
The accompanying notes are an integral part of the financial statements
5
<PAGE>
CARDIAC SCIENCE, INC.
CONSOLIDATED CONDENSED NOTES TO FINANCIAL STATEMENTS (UNAUDITED)
JUNE 30, 2000
1. ORGANIZATION AND CAPITALIZATION OF THE COMPANY
Cardiac Science, Inc. (the "Company") was incorporated on May 20, 1991 to
develop, manufacture and market software driven non-invasive (non-surgical)
Automatic External Cardioverter Defibrillator ("AECD") devices to treat persons
suffering from or at high risk of life-threatening arrhythmias. The Company has
developed proprietary tachyarrhythmia detection and discrimination software
technology -- RHYTHMx ECD(TM)-- designed to be incorporated into external
defibrillator and patient monitoring devices. RHYTHMx ECD enables these devices,
which are attached prophylactically to hospitalized patients who are determined
to be at temporary risk of cardiac arrest, to continuously monitor their heart
rhythms, accurately and instantly detect life-threatening ventricular
tachyarrhythmias and, when appropriate and without the aid of hospital staff,
automatically deliver potentially life saving defibrillation shocks within
seconds to convert a patient's heart back to its normal rhythm.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
In the opinion of the Company's management, the accompanying consolidated
condensed unaudited financial statements include all adjustments (which consist
only of normal recurring adjustments) necessary for a fair presentation of its
financial position at June 30, 2000 and results of operations and cash flows for
the periods presented. Although the Company believes that the disclosures in
these financial statements are adequate to make the information presented not
misleading, certain information and disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles
have been condensed or omitted and should be read in conjunction with the
Company's audited financial statements included in the Company's 1999 Annual
Report on Form 10-K. Results of operations for the six months ended June 30,
2000 are not necessarily indicative of results for the full year.
3. INVENTORY
Inventory, which consists of finished products and subassemblies, is stated
at the lower of cost (first-in, first-out) or market value. Inventory at June
30, 2000 and December 31, 1999 was comprised of finished goods.
4. SUBSEQUENT EVENTS
On July 1, 2000 the Company acquired Cadent Medical Corporation ("Cadent"),
a privately-held company that has developed a cell phone size defibrillator
designed to be worn by mobile cardiac patients. As consideration the Cadent
shareholders received an aggregate of 4.5 million shares of restricted common
stock of the Company. This business combination will be accounted for by the
purchase method of accounting. No adjustments have been included in these
consolidated financial statements for this transaction.
For the period of July 1, 2000 through August 4, 2000 the Company sold
approximately 4.73 million shares of common stock for an aggregate purchase
price of approximately $21.3 million to a group of US, Australian and Swiss
institutional and private investors.
On July 1, 2000 the Company purchased all rights in and to U.S. Patent
number 4,576,170 from Lindell Bradley, M.D. and Thang-Quang Nguyen in exchange
for 165,000 shares of restricted common stock of the Company. This patent was
previously under exclusive license to the Company.
6
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
GENERAL
The following discussion should be read in conjunction with the
consolidated financial statements and notes thereto set forth elsewhere in this
Quarterly Report on Form 10-Q.
Cardiac arrest is the single largest cause of death in the United States
and Europe. Our mission is to increase the survival rate of cardiac arrest
victims and create a new standard of care through the development and
commercialization of our proprietary technology.
We have developed proprietary tachyarrhythmia detection and discrimination
software technology -- RHYTHMx ECD(TM)-- designed to be incorporated into
external defibrillator and patient monitoring devices. RHYTHMx ECD enables these
devices, which are attached prophylactically to hospitalized patients who are
determined to be at temporary risk of cardiac arrest, to
- continuously monitor their heart rhythms
- accurately and instantly detect life-threatening ventricular
tachyarrhythmias, and
- when appropriate and without the aid of hospital staff, automatically
deliver potentially life saving defibrillation shocks within seconds
to convert a patient's heart back to its normal rhythm.
We commenced operations in May 1991. Our operations consisted primarily of
research and development activities and clinical FDA testing until our
acquisition of Diagnostic Monitoring in April 1997. Diagnostic Monitoring
manufactured PC-based Holter Electrocardiogram systems and Ambulatory Holter
recorders and distributed these products in over 40 countries. We sold
substantially all of the assets of Diagnostic Monitoring on December 31, 1998.
We have three products, two of which are still under development, that
utilize our proprietary technology. Our initial product, the Powerheart(R), is a
fully automatic external bedside defibrillator-monitor designed for bedside
in-hospital use. The Powerheart attaches prophylactically to "at-risk" cardiac
patients for the purpose of providing fully automatic detection and treatment of
life-threatening heart rhythms (ventricular tachyarrhythmias) that lead to
cardiac arrest.
In December 1998, we entered into a five-year exclusive distribution and
licensing agreement with the world leader in external defibrillation, Medtronic
Physio-Control, a subsidiary of Medtronic, Inc. Medtronic Physio-Control will
market the Powerheart in the U.S., Canada and selected European countries, and
also has been licensed to integrate RHYTHMx ECD into Medtronic's LIFEPAK(R) line
of in-hospital external defibrillators. We have signed distribution agreements
to date covering 30 other international markets giving us representation in over
40 countries.
We received 510(k) clearance from the U.S. Food and Drug Administration for
the clinical version of the Powerheart in October 1997. We received European
regulatory clearance for Powerheart in late 1999 and we made our first
commercial shipment in December 1999. We subsequently received 510(k) clearance
from the FDA for the commercial version of the Powerheart in January 2000.
Shipments of Powerhearts to Medtronic Physio-Control, as well as our
international distributors, began in the first quarter of 2000.
In September 1998, we entered into a development and manufacturing
agreement with Zevex International, Inc. ("Zevex"), a contract medical device
manufacturer, to manufacture the commercial version
7
<PAGE>
of the Powerheart. Effective July 1, 2000 we have mutually agreed with Zevex to
terminate this relationship and we will begin manufacturing the Powerheart at
our site in Irvine, California. In anticipation of this change, Zevex has
provided us with additional inventory of Powerhearts at June 30, 2000 to enable
us to effect a smooth transition to manufacturing.
The second product, currently under development, is a fully automatic
defibrillator module that is designed for integration into third party
manufactured bedside patient monitoring systems. Functionally, this module is
designed to extend patient monitoring systems beyond diagnostics to provide
patients who suffer life-threatening tachyarrhythmias with the added protection
of automatic therapy delivery without the aid of hospital staff. The third
product, also under development, is a small, wearable, "cell phone sized" fully
automatic defibrillator that is designed to be worn by patients who are
ambulatory in either a hospital or home environment.
We have been issued one patent and we have acquired one additional patent.
In addition, we have six patents pending and we intend to file additional
patents relating to our proprietary technology.
RESULTS OF OPERATIONS
Sales were $924,962 and $1,549,604 respectively, for the three and six
months ended June 30, 2000, as compared to no sales for the three and six months
ended June 30, 1999. Sales consisted primarily of Powerheart units to both
Medtronic Physio-Control and our international distributors.
Cost of sales were $817,833 and $1,392,591 respectively, for the three and
six months ended June 30, 2000, as compared to no cost of sales for the three
and six months ended June 30, 1999. This amount was attributable primarily to
the sale of Powerhearts.
Research and development expenses increased to $1,285,857 and $2,423,881,
respectively, for the three and six months ended June 30, 2000, from $1,072,282
and $1,669,310, respectively, for the three and six months ended June 30, 1999.
Increases in research and development expenses included increases in personnel
costs and related fringes and costs associated with independent engineering
contractors.
Selling expenses increased to $901,702 and $1,826,466, respectively, for
the three and six months ended June 30, 2000, from $404,672 and $679,921,
respectively, for the three and six months ended June 30, 1999. The increase was
a result of marketing expenses related to the Powerheart including costs
associated with the development of marketing literature and the addition of
personnel and related fringes.
General and administrative expenses increased to $728,092 and $1,445,141,
respectively, for the three and six months ended June 30, 2000, from $468,513
and $749,625, respectively, for the three and six months ended June 30, 1999.
The increase in expenses for the quarter and six months ended June 30, 2000 as
compared to the same periods in 1999 included personnel costs and related
fringes, consulting and professional fees.
Interest income, net, increased to $11,901 and $23,924 for the three month
and year to date period ended June 30, 2000 as compared to interest expense net
of $460 and $3,632, respectively, for the same periods in the prior year due to
the reduction of the bank line of credit and investment of the proceeds from
private placements.
8
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LIQUIDITY AND CAPITAL RESOURCES
At June 30, 2000, we had cash and cash equivalents of $9,103,336 and
working capital of $7,477,073 as compared to cash and cash equivalents of
$5,901,934 and working capital of $4,384,452 at December 31, 1999. From
inception, our sources of funding for operations were derived from equity
placements aggregating approximately $31 million. We have incurred losses of
$24,454,296 since inception, and we expect to incur substantial additional
operating losses as a result of expenditures related to marketing and sales
efforts, research and product development activities. The timing and amounts of
these expenditures will depend upon many factors, some of which are beyond our
control, such as the requirements for and time required to obtain approval of
510(k) applications or other regulatory approvals, the progress of research and
development programs, and market acceptance of our products.
Successful completion of our development program for our products and
transition to attain profitable operations is dependent upon achieving a level
of revenues adequate to support the required cost structure.
We anticipate that the current cash balance and the approximately $21.3
million raised in July and August 2000 (see footnote 4 to the consolidated
condensed financial statements) will be sufficient to meet our cash
requirements for at least the next eighteen months. From time to time, we may
also consider the acquisitions of, or evaluate investments in, certain
products and businesses complementary to our business. Any such acquisitions
or investments may require additional capital resources. There can be no
assurance that such additional resources will be available on terms
satisfactory to us, or at all, or that any financing transaction will not be
dilutive to current stockholders.
FORWARD LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains certain forward-looking
statements within the meaning of Section 21E of the Securities Exchange Act of
1934, including statements regarding:
- products under development;
- technological and competitive advantages;
- future cash requirements and the adequacy of cash on hand;
- our ability to improve patient care, increase survival rates, decrease
recovery time, lessen patient debilitation, and reduce patient care
costs and
- strategic alliances.
These forward-looking statements are based on current expectations that
involve numerous risks and uncertainties, including those risks and
uncertainties discussed in this Form 10-Q and in our Annual Report on Form 10-K
for the year ended December 31, 1999. Assumptions relating to the foregoing
involve judgments with respect to, among other things, future economic,
competitive, and market conditions and future business decisions, all of which
are difficult or impossible to predict accurately and many of which are beyond
our control. Although we believe that our assumptions underlying the
forward-looking statements are reasonable, any of the assumptions could prove
inaccurate and, therefore, we cannot assure you that the results discussed or
implied in such forward-looking statements will prove to be accurate. In light
of the significant uncertainties inherent in such forward-looking statements,
the inclusion of such statements should not be regarded as a representation by
us or any other person that our objectives and plans will be achieved. Words
such as "believes," "anticipates," "expects," "intends," "may," and similar
expressions are intended to identify forward-looking statements, but are not the
exclusive means of identifying such statements. We undertake no obligation to
revise any of these forward-looking statements.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
9
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CARDIAC SCIENCE, INC.
PART II. OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
None.
Item 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
During the three-month period ending June 30, 2000, we sold 2,151,111
shares of our common stock for an aggregate purchase price of $9,680,000
to foreign investors in an offshore transaction pursuant to Regulation S
promulgated under the Securities Act of 1933. In connection with the
offering, we are obligated to pay a finder a fee equal to 8.5 percent of
the gross proceeds of the sale, payable in cash or common stock.
During the three-month period ending June 30, 2000, we sold an aggregate
of 107,500 shares of common stock through the exercise of warrants for
an aggregate purchase price of $1,228. The shares were sold pursuant to
Section 4(2) of the Securities Act of 1933.
Item 3. DEFAULTS UPON SENIOR SECURITIES
None.
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On May 19, 2000 we held an Annual Meeting of Stockholders in Irvine,
California. The stockholders voted on four matters.
The following votes were cast for the nominees for election of
directors, and all such nominees were elected.
<TABLE>
<CAPTION>
Votes For Votes Against Votes Abstain
<S> <C> <C> <C>
Raymond Cohen 9,302,350 0 8,659
Paul Quadros 9,302,350 0 8,659
Peter Crosby 9,302,263 0 8,746
Howard Evers 9,302,263 0 8,746
</TABLE>
The following votes were cast to amend the Company's restated
certificate of incorporation, as amended, to increase the authorized
shares of common stock.
9,090,012 votes for the ratification and approval
89,737 votes against the ratification and approval
131,260 votes abstained from voting
The following votes were cast for the ratification and approval of the
amendment to the Company's 1997 Stock Option/Stock Issuance Plan to
increase the number of shares reserved for issuance under the plan:
10
<PAGE>
7,045,673 votes for the ratification and approval
81,697 votes against the ratification and approval
2,183,639 votes abstained from voting
The votes cast on the ratification of the selection of
PricewaterhouseCoopers LLP as independent accountants for the Company
for the year ending December 31, 2000 were as follows:
9,305,136 votes for the ratification and appointment
4,250 votes against the ratification and appointment
1,623 votes abstained from voting
Item 5. OTHER INFORMATION
None.
Item 6. EXHIBITS AND REPORTS ON FORM 8-K
a) Exhibits:
10.1 Assignment of Patent dated July 1, 2000 by Lindell
Bradley, M.D., and Thang-Quang Nguyen in favor of
Cardiac Science, Inc.
10.2 Patent Acquisition Agreement dated July 1, 2000 by
and among Lindell Bradley, M.D. and Thang-Quang
Nguyen together with Cardiac Science, Inc.
27.1 Financial Data Schedule.
b) Reports on Form 8-K:
None.
11
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SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant
caused this report to be signed on its behalf by the undersigned, hereunto duly
authorized.
CARDIAC SCIENCE, INC.
Date: August 11, 2000 /s/ Brett L. Scott
---------------- --------------------------
Brett L. Scott
(Authorized Officer and Principal
Financial Officer)
12
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Index to Exhibits
10.1 Assignment of Patent dated July 1, 2000 by Lindell Bradley,
M.D., and Thang-Quang Nguyen in favor of Cardiac Science,
Inc.
10.2 Patent Acquisition Agreement dated July 1, 2000 by and among
Lindell Bradley, M.D. and Thang-Quang Nguyen together with
Cardiac Science, Inc.
27.1 Financial Data Schedule.
13
