<PAGE> 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON D.C. 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, 2000.
[ ] 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: 000-28372
CARDIAC PATHWAYS CORPORATION
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE 77-0278793
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification No.)
995 BENECIA AVENUE, SUNNYVALE, CA 94086
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (408) 737-0505
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 for such shorter period that the Registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. [X] Yes [ ] No
As of May 11, 2000 there were 2,078,236 shares of the Registrant's Common Stock
outstanding.
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CARDIAC PATHWAYS CORPORATION
INDEX
<TABLE>
<CAPTION>
PART I. FINANCIAL INFORMATION PAGE NO.
<S> <C> <C>
Item 1. Financial Statements and Notes (Unaudited)
Consolidated Balance Sheets as of March 31, 2000 and June 30, 1999 ...... 3
Consolidated Statements of Operations for the Three and Nine
Months Ended March 31, 2000 and 1999 .................................... 4
Consolidated Statements of Cash Flows for the Nine Months Ended
March 31, 2000 and 1999 ................................................. 5
Notes to Consolidated Financial Statements .............................. 6
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations ................................................... 9
Item 3. Quantitative and Qualitative Disclosures about Market Risk .............. 25
PART II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K ........................................ 26
SIGNATURES .......................................................................... 27
</TABLE>
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS AND NOTES
CARDIAC PATHWAYS CORPORATION
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
<TABLE>
<CAPTION>
March 31, June 30,
2000 1999 (1)
------------- -------------
ASSETS
<S> <C> <C>
Current assets:
Cash and cash equivalents $ 8,007,709 $ 2,339,660
Short-term investments 9,135,451 --
Accounts receivable, net of allowance for doubtful
accounts of $121,539 at March 31, 2000 and
$105,000 at June 30, 1999 729,823 898,296
Inventories 1,970,173 2,228,879
Prepaid expenses 180,101 338,479
Other current assets 402,804 76,720
------------- -------------
Total current assets 20,426,061 5,882,034
Property and equipment, net 3,205,628 2,891,818
Notes receivable from related parties 200,000 29,584
Intangible assets, net of accumulated amortization of
$266,667 at March 31, 2000 1,733,333 --
Deposits and other assets 86,137 102,406
------------- -------------
$ 25,651,159 $ 8,905,842
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities:
Accounts payable $ 687,524 $ 488,128
Accrued compensation and related benefits 1,179,870 835,277
Accrued clinical expenses 627,001 939,183
Other accrued expenses 896,123 738,831
Current obligations under capital leases 261,514 325,334
Short-term debt obligations -- 3,000,000
------------- -------------
Total current liabilities 3,652,032 6,326,753
Long-term obligations under capital leases 144,216 342,772
Deferred royalty income 2,405,862 2,630,862
Accrued series B preferred dividends 2,420,000 --
Commitments
Stockholders' equity:
Preferred stock, $.001 par value; 5,000,000 shares
authorized and 32,250 issued and outstanding at
March 31, 2000 and none issued and outstanding
at June 30, 1999; liquidation preference of
$32,910,000 at March 31, 2000 32 --
Common stock, $.001 par value; 30,000,000 shares
authorized; 2,058,257 shares issued and outstanding
at March 31, 2000 and 2,007,904 issued and
outstanding at June 30, 1999 2,058 2,008
Additional paid-in capital 109,666,279 80,152,542
Receivable from stockholders (321,667) (385,000)
Accumulated deficit (92,233,799) (79,983,404)
Deferred compensation (83,854) (180,691)
------------- -------------
Total stockholders' equity (deficit) 17,029,049 (394,545)
------------- -------------
$ 25,651,159 $ 8,905,842
============= =============
</TABLE>
(1) Derived from the Company's audited consolidated balance sheet as of June 30,
1999.
See notes to consolidated financial statements.
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CARDIAC PATHWAYS CORPORATION
CONSOLIDATED STATEMENT OF OPERATIONS
(UNAUDITED)
<TABLE>
<CAPTION>
Three months ended Nine months ended
March 31, March 31,
------------------------------- -------------------------------
2000 1999 2000 1999
------------ ------------ ------------ ------------
<S> <C> <C> <C> <C>
Net sales $ 1,511,061 $ 1,322,960 $ 4,755,163 $ 3,427,277
Cost of goods sold 1,904,341 991,119 4,831,829 3,111,677
------------ ------------ ------------ ------------
Gross margin (deficit) (393,280) 331,841 (76,666) 315,600
Operating expenses:
Research and development 1,712,946 3,069,920 5,365,297 9,783,331
Selling, general and administrative 3,642,402 1,596,064 7,336,959 4,669,302
------------ ------------ ------------ ------------
Total operating expenses 5,355,348 4,665,984 12,702,256 14,452,633
------------ ------------ ------------ ------------
Loss from operations (5,748,628) (4,334,143) (12,778,922) (14,137,033)
Other income (expense):
Interest income 282,907 140,785 800,502 652,594
Interest expense (11,170) (157,014) (58,866) (496,620)
Other, net (339,819) 11,822 (213,109) 31,854
------------ ------------ ------------ ------------
Total other income (expense), net (68,082) (4,407) 528,527 187,828
------------ ------------ ------------ ------------
Net loss (5,816,710) (4,338,550) (12,250,395) (13,949,205)
Preferred stock dividend 880,000 -- 2,420,000 --
Beneficial conversion feature related to the
issuance of the Series B preferred stock -- -- 960,000 --
------------ ------------ ------------ ------------
Net loss applicable to common stockholders $ (6,696,710) $ (4,338,550) $(15,630,395) $(13,949,205)
============ ============ ============ ============
Net loss per common share -
basic and diluted $ (3.29) $ (2.17) $ (7.74) $ (7.04)
============ ============ ============ ============
Shares used in computing net loss
per common share - basic and diluted 2,033,000 1,995,000 2,020,000 1,982,000
============ ============ ============ ============
</TABLE>
See notes to consolidated financial statements.
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CARDIAC PATHWAYS CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
<TABLE>
<CAPTION>
Nine months ended
March 31,
-------------------------------
2000 1999
------------ ------------
<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $(12,250,395) $(13,949,205)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization 1,284,114 949,959
Amortization of deferred royalty income (225,000) (225,000)
Amortization of deferred compensation 96,837 146,042
Issuance of nonqualified stock options for services -- 3,811
Changes in operating assets and liabilities:
Accounts receivable 168,473 (846,224)
Inventories 258,706 (384,809)
Prepaid expenses 158,378 20,252
Other current assets (326,085) 206,097
Accounts payable 199,396 (181,305)
Accrued compensation and related benefits 344,593 (2,269)
Accrued clinical expenses (312,182) (100,121)
Other accrued expenses 157,292 (129,028)
------------ ------------
Net cash used in operating activities (10,445,873) (14,491,800)
------------ ------------
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of short-term investments (11,135,451) (2,312,448)
Maturities and sales of short-term investments 2,000,000 18,352,904
Purchases of property and equipment, net (1,331,256) (1,695,752)
(Increase) decrease in notes receivable (170,416) 26,369
(Increase) in intangible assets (2,000,000) --
(Increase) decrease in deposits and other assets 16,269 164,533
------------ ------------
Net cash (used in) provided by investing activities (12,620,854) 14,535,606
------------ ------------
CASH FLOWS FROM FINANCING ACTIVITIES
Principal payments under capital lease obligations (262,376) (450,463)
Payment of short-term debt obligations (3,000,000) (6,300,000)
Decrease in notes receivable from stockholders 63,333 --
Proceeds from sale of preferred stock 31,750,000 --
Proceeds from sale of common stock 183,819 393,394
------------ ------------
Net cash provided by financing activities 28,734,776 (6,357,069)
------------ ------------
Net increase (decrease) in cash and cash equivalents 5,668,049 (6,313,263)
Cash and cash equivalents at beginning of period 2,339,660 7,268,877
------------ ------------
Cash and cash equivalents at end of period $ 8,007,709 $ 955,614
============ ============
</TABLE>
See notes to consolidated financial statements.
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CARDIAC PATHWAYS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2000
(UNAUDITED)
1. BASIS OF PRESENTATION
The accompanying unaudited consolidated financial statements have been
prepared in accordance with generally accepted accounting principles for interim
financial information and in accordance with the instructions to Form 10-Q and
Article 10 of Regulation S-X. Accordingly, they do not include all of the
financial information and footnotes required by generally accepted accounting
principles for complete financial statements. In the opinion of management, all
adjustments (consisting of normal recurring adjustments) considered necessary
for a fair presentation have been included.
The preparation of the financial statements in conformity with generally
accepted accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those estimates.
The operating results for the nine months ended March 31, 2000 are not
necessarily indicative of the results that may be expected for the fiscal year
ending June 30, 2000. The accompanying consolidated financial statements should
be read in conjunction with the audited consolidated financial statements and
notes thereto included in the Cardiac Pathways Corporation's (the "Company")
Annual Report on Form 10-K for the fiscal year ended June 30, 1999.
The Company has reclassified certain prior-year balances to conform with
current-year presentations.
2. PREFERRED STOCK FINANCING AND REVERSE STOCK SPLIT
In July 1999, the Company's stockholders authorized and the Company
completed a $32 million offering of Series B Preferred Stock at $1,000 per share
to a group of accredited investors and a 1-for-5 reverse stock split. In
connection with the Series B Preferred stock financing, the Company raised $31.5
million, net of issuance costs.
The March 31, 2000 balance sheet also reflects the discount or
beneficial conversion feature present in the convertible securities. The
discount was being recognized as a return to the preferred stockholders (similar
to a dividend) over the minimum period in which the preferred stockholders can
realize return, immediately for the Series B Preferred stockholders. The
discount has been accreted to additional paid in capital (accumulated deficit)
in the March 31, 2000 balance sheet. Each share of Series B Preferred Stock is
initially convertible into 200 shares of the Company's Common Stock. The Series
B Preferred Stock is entitled to a cumulative dividend of 11% of the purchase
price per share per year, and will have a liquidation preference in certain
circumstances equal to the initial purchase price plus accrued but unpaid
dividends. All share and per share amounts have been retroactively adjusted to
reflect the reverse stock split.
3. CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS
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The Company considers all highly liquid investments with an original
maturity of three months or less when purchased to be cash equivalents. All
other liquid investments are classified as short-term investments. At March 31,
2000, all short-term investments were classified as available-for-sale.
Available-for-sale securities are carried at fair market value with unrealized
gains and losses, net of tax, reported as a separate component of stockholders'
equity. To date, the Company has not experienced any significant unrealized
gains or losses on available-for-sale securities and, accordingly, no
adjustments have been made to stockholders' equity.
The following is a summary of available-for-sale securities at cost, which
approximates fair value:
<TABLE>
<CAPTION>
MARCH 31, JUNE 30,
DESCRIPTION 2000 1999
- ----------- ----------- ---------
<S> <C> <C>
Available for sale:
U.S. government agency $ 5,000,000 $--
U.S. corporate obligations 11,318,924 --
----------- ---
16,318,924 --
Amounts classified as cash equivalents 7,183,473 --
----------- ---
Amounts included in short-term investments $ 9,135,451 $--
=========== ===
</TABLE>
There were no material realized gains or losses for the nine-month
period ending March 31, 2000. The cost of securities sold is based on the
specific identification method.
4. CONSOLIDATED BALANCE SHEET COMPONENTS
Certain balance sheet components are as follows:
<TABLE>
<CAPTION>
MARCH 31, JUNE 30,
2000 1999
---------- ----------
<S> <C> <C>
Inventories:
Raw materials $1,510,124 $1,510,291
Work-in-process 192,832 174,016
Finished goods 267,217 544,572
---------- ----------
$1,970,173 $2,228,879
========== ==========
</TABLE>
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<TABLE>
<CAPTION>
MARCH 31, JUNE 30,
2000 1999
---------- ----------
<S> <C> <C>
Property and equipment:
Equipment $7,614,244 $6,836,137
Leasehold improvements 422,061 422,061
Equipment-in-process 971,753 622,384
---------- ----------
9,008,058 7,880,582
Less accumulated depreciation and
amortization 5,802,430 4,988,764
---------- ----------
$3,205,628 $2,891,818
========== ==========
</TABLE>
5. LICENSE AGREEMENT
In July 1999, the Company entered into an agreement with a Canadian
company to obtain an exclusive worldwide license to certain patents involving
the use of ultrasound technology. The terms of the agreement included payments
by the Company to the licensor of $1,000,000 each in August 1999 and January
2000.
6. STOCK PLANS
In July 1999, the Board of Directors of the Company approved an
amendment of the 1991 Stock Plan and 1996 Director Option Plan to increase the
number of shares reserved for issuance by 800,000 shares. This increase was
approved by the stockholders at the Special Meeting of Stockholders on July 20,
1999.
In November 1999, the Board of Directors of the Company approved the
amendment of the 1991 Stock Plan to increase the number of shares reserved for
issuance by 300,000 shares. This increase was approved by the stockholders at
the Annual Meeting of Stockholders on November 18, 1999.
In August 1998, the Board of Directors of the Company approved the
Company's 1998 Nonstatutory Stock Option Plan (the "Supplemental Plan"). The
Supplemental Plan provides for the issuance of nonstatutory options to
non-officer employees and consultants of the Company to acquire common stock of
the Company. The Supplemental Plan, as amended, provides for the granting of
options for up to 480,000 shares of common stock of the Company, that includes
400,000 shares of stock which were approved by the Company's Board of Directors
in July 1999.
7. RECEIVABLE FROM STOCKHOLDER
In March 1996, the Company entered into an employment agreement with an
officer of the Company pursuant to which it loaned $385,000 to the officer, the
proceeds of which were used to exercise a stock option granted to this officer
in January 1996. The stock exercised is pledged as collateral against the
receivable from the stockholder. In August 1998, the officer resigned from the
Company. In March 2000, a reserve against the receivable was recorded for the
amount of the difference between the $385,000 loaned and the fair value of the
pledged stock at March 31, 2000.
In May 1999, the Company entered into an employment agreement with an
officer of the Company pursuant to which the officer is entitled to a $250,000
loan from the Company at a 7% interest
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rate to purchase 250 shares of the Company's Series B Convertible Preferred
Stock. In March 2000, the loan was executed for the purchase of the stock.
8. RECENT PRONOUNCEMENTS
In June 1998, the FASB issued Statement of Financial Accounting
Standards No. 133 (FAS 133), "Accounting for Derivative Instruments and Hedging
Activities" which is required to be adopted in years beginning after June 15,
2000. The Company has not in the past and does not anticipate in the future
using derivative instruments, and the Company does not expect that the adoption
of FAS 133 will have a significant impact on its financial condition or results
of operations.
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following Management's Discussion and Analysis of Financial
Condition and Results of Operations contains forward-looking statements that
involve risks and uncertainties. The Company's actual results could differ
materially from those anticipated in these forward-looking statements as a
result of certain factors that include, but are not limited to, the risks
discussed in "Factors That May Impact Future Operations" as well as those
discussed in the following "Overview" section. These forward-looking statements
include the statement in the first paragraph of "Overview" relating to
expectations of operating losses, the statements in the second paragraph of
"Overview" relating to the range of clinical utility for the RPM Tracking System
and the potential reduction in procedure times, the statements in the forth
paragraph of "Overview" related to the manufacturing, marketing and distribution
of the Company's products, the statements in the last two sentences of "Cost of
Goods Sold" relating to the expectation for gross margins, the statements in the
last sentence of the "Factors that effect Future Operations" paragraph regarding
FAS 133, the statements in the last two sentences of the "Results of Operations"
paragraph regarding the Tracking System, the statement in the last sentence of
the last paragraph of "Liquidity and Capital Resources" regarding the Company's
expected liquidity needs and the statements regarding future capital
expenditures in the third and fourth paragraphs of "Liquidity and Capital
Resources."
OVERVIEW
The Company, founded in April 1991, is currently shifting from a
broad-based research & development (R&D) and clinical development oriented
company to one focused on expansion of marketing, sales, customer support and
manufacturing capacity. The Company has experienced significant operating losses
since inception and as of March 31, 2000 had an accumulated deficit of
approximately $92.2 million. The Company has only recently seen increases in
revenues from sales in the Chilli cooled ablation catheters. Sales of the
Trio/Ensemble diagnostic catheters to international customers have remained
constant. The Mercator diagnostic mapping baskets and related equipment have
been discontinued in order for the Company to focus its resources on two
platforms; the Chilli cooled ablation catheter and the new Real Time Position
Management (RPM) Tracking System. The Company expects its operating losses to
continue through at least the end of calendar 2000, as it continues to expend
substantial funds to launch new products and ramp up manufacturing capacity.
The Company received FDA 510k clearance in March 2000 to begin marketing
the RPM Tracking System. This technology, developed by the Company, can be used
in many diagnostic electrophysiology procedures for real-time visualization of
catheters utilizing ultrasound technology. The RPM Tracking system is expected
to assist physicians in precisely manipulating catheters within the heart during
procedures, offering the potential for reductions in procedure times and
improved economic benefit to the hospital and physician.
Also this quarter, the Company has received FDA PMA (Pre-market
approval) clearance to market its new Chilli RPM cooled ablation catheters
incorporating the Company's RPM navigation technology. In addition, the Company
has received CE mark approval to market the RPM Tracking System, and reference
and ablation catheters incorporating RPM tracking technology in Europe.
Implementing a number of significant design improvements to Cardiac Pathways'
Chilli cooled ablation catheters, the new 7 French platform includes a
bi-directional steering capability and integrates the Company's ultrasound
transducer technology for dynamic real-time catheter navigation and
visualization. New models for the Chilli with and without the navigation
visualization technology were approved with the PMA.
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For the Company's products that have recently obtained FDA clearance or
approval, there can be no assurance that any such products will be successfully
commercialized or that the Company will achieve significant revenues from either
domestic or international sales. Although the FDA granted 510k clearance for the
RPM Tracking System and PMA approval for the Chilli Cooled Ablation catheters
with RPM tracking, the Company has limited experience in manufacturing,
marketing or selling these products in commercial quantities. In order to
successfully implement its business plan, the Company must manufacture and sell
the RPM and Chilli Cooled Ablation catheters in commercial quantities.
Furthermore, the Company will need to expend significant capital resources and
develop manufacturing expertise to establish large-scale manufacturing
capabilities. Manufacturers often encounter difficulties in scaling up
production of new products, including problems involving production yields,
quality control and assurance, component supply shortages, shortages of
qualified personnel, compliance with FDA regulations, and the need for further
FDA approval of new manufacturing processes. The Company intends to market its
products primarily through a direct sales force in the United States and
indirect sales channels internationally. Establishing a marketing and sales
capability sufficient to support sales in commercial quantities will require
significant management and financial resources. See "-- Factors That May Impact
Future Operations." The Company's Common Stock is currently listed for trading
on the Nasdaq Stock Market's National Market.
RESULTS OF OPERATIONS
Net Sales. The Company's net sales to date have resulted primarily from
sales of Chilli Cooled Ablation Catheters, Radii supraventricular tachycardia
mapping and ablation catheters and Trio/Ensemble diagnostic catheters. The
Company's net sales increased 14% to $1.5 million for the three months ended
March 31, 2000 compared to $1.3 million for the three months ended March 31,
1999. The increase in net sales for the three months ended March 31, 2000
compared to the same period a year ago was driven primarily by 48% growth in the
Chilli cooled ablation catheter and 36% growth in the Radii catheter product
line. For the nine months ended March 31, 2000, the Company had net sales of
$4.8 million compared to $3.4 million for the nine months ended March 31, 1999.
The increase in net sales for the nine months ended March 31, 2000 compared to
the same period in the prior year was primarily due to the growth of sales of
the Company's Chilli Cooled Ablation Catheter in the U.S. market and increased
sales of both Chilli and Radii catheters in Japan.
In December 1995, the Company received $3.0 million pursuant to a
royalty agreement with Arrow International Inc. ("Arrow"). This amount was
recorded as deferred royalty income and will be amortized to income for those
Trio/Ensemble catheters that Arrow manufactures and sells or ratably over the
period for which the related technology patents expire. A total of $225,000 of
royalty income related to the Arrow agreement has been recorded through March
31, 2000, of which $75,000 was recognized in the three months ended March 31,
2000.
Cost of Goods Sold. Cost of goods sold primarily includes raw materials
costs, catheter fabrication costs, and system assembly and test costs. Cost of
goods sold was $1.9 million for the three months ended March 31, 2000 and
resulted in a gross margin deficit of $393,000. In comparison, for the three
months ended March 31, 1999, cost of goods sold was $1.0 million and resulted in
a gross margin of $332,000. For the nine months ended March 31, 2000, the
Company had a gross margin deficit of $77,000, compared to a gross margin of
$316,000 for the nine months ended March 31, 1999. The decrease in the gross
margins for the three months ended March 31, 1999 compared to the same periods
in the prior fiscal year resulted from approximately $250,000 of costs
associated with discontinuing the Mercator Atrial Mapping Basket product line,
approximately $450,000 of costs associated with introduction of the RPM product
line and production increases for the Chilli product line. The Company
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expects that its gross margins will continue to be impacted by the cost of
bringing the RPM products on line. In the ensuing quarters, the Company expects
manufacturing process improvements and volume related costs improvements to have
positive effects on gross margins.
Research and Development. Research and development expenses include
costs associated with product research, clinical trials, prototype development,
design and testing, and costs associated with obtaining regulatory approvals.
Research and development expenses decreased 44% to $1.7 million for the three
months ended March 31, 2000 from $3.1 million for the three months ended March
31, 1999. Research and development expenses were $5.4 million for the nine
months ended March 31, 2000 compared to $9.8 million for the nine months ended
March 31, 1999. The decrease in research and development expenses was primarily
attributable to reducing the portfolio of engineering projects to concentrate on
RPM and Chilli/7 French catheter development initiatives.
Selling, General and Administrative. Selling, general and administrative
expenses include compensation and benefits for sales, marketing, senior
management and administrative personnel, various legal and professional fees
including those in connection with obtaining patent protection, and costs of
trade shows. Selling, general and administrative expenses increased to $3.6
million for the three months ended March 31, 2000 from $1.6 million for the
three months ended March 31, 1999. Selling, general, and administrative expenses
were $7.3 million for the nine months ended March 31, 2000, compared to $4.7
million for the nine months ended March 31, 1999. The three months ended March
31, 2000 included approximately $1.0 million of non-recurring expenditures
related to severance, recruiting, relocation, new product launch and settlement
of disputed fees with a professional search firm. The increase in selling,
general and administrative expenses resulted primarily from increased marketing
and sales infrastructure supporting the North America and European markets.
Other Income (Expense), Net. Other expenses, net were $68,000 for the
three months ended March 31, 2000 compared to $5,000 for the three months ended
March 31, 1999. Net other income was $529,000 for the nine months ended March
31, 2000, compared to $188,000 for the nine months ended March 31, 1999. The
period ended March 31, 2000 included a non-recurring $340,000 reserve against
loans to a former officer of the Company. Relative increases in net other income
for the nine months ended March 31, 2000 compared to the prior period was the
result of increased interest income on significantly higher cash, cash
equivalent and short-term investment balances.
Net Loss. The Company recorded a net loss of $5.8 million for the three
months ended March 31, 2000 compared to the net loss of $4.3 million for the
three months ended March 31, 1999. Net loss applicable to common stockholders
for the three months ended March 31, 2000 was $6.7 million or $3.29 per share,
compared to the net loss of $4.3 million or $2.17 per share for the three months
ended March 31, 1999. The net loss was $12.3 million for the nine months ended
March 31, 2000 with a net loss applicable to common stockholders of $15.6
million or $7.74 per share, compared to a net loss of $13.9 million or $7.04 per
share for the nine months ended March 31, 1999.
Impact of Adoption of New Accounting Standards. In June 1998, the FASB
issued Statement of Financial Accounting Standards No. 133 (FAS 133),
"Accounting for Derivative Instruments and Hedging Activities" which is required
to be adopted in years beginning after June 15, 2000. The Company has not in the
past and does not anticipate in the future using derivative instruments, and the
Company does not expect that the adoption of FAS 133 will have a significant
impact on its financial condition or results of operations.
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LIQUIDITY AND CAPITAL RESOURCES
Since inception, the Company has financed its operations through a
combination of private placements of equity securities yielding $65.0 million,
equipment lease financing arrangements yielding $4.0 million and a prepaid
royalty arrangement yielding $3.0 million. In addition, the Company closed its
initial public offering in June 1996 and raised net proceeds of $43.1 million
and since July 1999 it raised net proceeds of $31.8 million in its Series B
Convertible Preferred Stock financing. As of March 31, 2000, the Company had
$17.1 million in cash, cash equivalents and short-term investments. Based on its
present plans, the Company believes its working capital, operating cash flow and
other potential financing activities will be adequate to finance the liquidity
needs of the Company during the next 12 months. Other potential financing
activities include, but are not limited to, subscribing the remaining authorized
Series B Preferred Stock, a secondary offering and/or technology licenses.
Net cash used in operating activities was approximately $10.4 million
and approximately $14.5 million for the nine months ended March 31, 2000 and
1999, respectively. For each of these periods, the net cash used in operating
activities resulted primarily from net losses. Net cash of approximately $12.6
million was used in investing activities for the nine months ended March 31,
2000 compared to approximately $14.5 million used in investing activities for
the nine months ended March 31, 1999. Net cash used and provided by investing
activities resulted primarily from purchases, maturities and sales of short-term
investments, offset in part by purchases of equipment and licenses.
As of March 31, 2000, the Company had capital equipment of approximately
$9.0 million, less accumulated depreciation and amortization of approximately
$5.8 million, to support its clinical, development, manufacturing and
administrative activities. The Company had financed approximately $4.0 million
from capital lease obligations through March 31, 2000. The Company expects
capital expenditures to increase over the next several years as it acquires
equipment to support manufacturing operations.
The Company's future liquidity and capital requirements will depend upon
numerous factors, including the progress of the Company's product development
efforts, the progress of the Company's clinical trials, actions relating to
regulatory matters, the costs and timing of expansion of the Company's product
development, manufacturing, marketing and sales activities, the extent to which
the Company's products gain market acceptance, and competitive developments. In
order to successfully manufacture its products in commercial quantities and
market and sell its FDA-cleared products, the Company may be required to raise
additional funds.
FACTORS THAT MAY IMPACT FUTURE OPERATIONS
Limited Operating History; History of Losses and Expectation of Future
Losses
The Company was founded in 1991 and to date has engaged primarily in
researching, developing, testing and obtaining regulatory clearances for its
products. The Company has experienced significant operating losses since
inception. As of March 31, 2000, the Company had an accumulated deficit of $92.2
million. To date, the Company has generated only limited revenues from sales of
its products and expects its operating losses to continue through at least the
end of calendar 2000 as it continues to expend funds to conduct its research and
development activities, establish commercial-scale manufacturing capabilities
and expand its sales and marketing activities. There can be no assurance that
any of the Company's products for diagnosis and treatment of ventricular
tachycardia and other arrhythmias will be successfully commercialized or that
the Company will achieve significant revenues from either international or
domestic sales. In addition, there can be no assurance that the Company will
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achieve or sustain profitability in the future or meet the expectations of
securities industry analysts. The Company's results of operations may fluctuate
significantly from quarter to quarter or year to year and will depend on
numerous factors, including actions relating to regulatory matters, progress of
clinical trials, the extent to which the Company's products gain market
acceptance, the scale-up of manufacturing abilities and the expansion of sales
and marketing activities and competition.
Clinical Trials
There can be no assurance that the Company's current or future products
will prove to be safe and effective in clinical trials under applicable United
States or international regulatory guidelines or that additional modifications
to the Company's products will not be necessary. Furthermore, there can be no
assurance that the Company will be successful in completing development of the
Tracking System products. With respect to the Chilli Cooled Ablation System,
because ablation treatment of cardiac arrhythmias is a relatively new and, to
date untested treatment, the long-term effects of radiofrequency ablation on
patients are unknown. As a result, the long-term success of ablation therapy in
treating ventricular tachycardia and other tachyarrhythmias will not be known
for several years.
On February 2, 1999, the Company obtained PMA approval for the Chilli
Cooled Ablation Catheter and the Radiofrequency Generator and Integrated Fluid
Pump, the products that together form the Company's Cooled Ablation System. On
March 11, 1999, the Company suspended and later terminated a clinical trial for
the Local Sector Mapping Basket, a variation of the Mercator Mapping Basket. On
January 27, 1999, the Company received 510(k) clearance for the Mercator Atrial
Mapping Basket sizes 70cc and 100cc and the Arrhythmia Mapping System, the
products that together form the Company's Arrhythmia Mapping System for
diagnostic mapping of the right atrium. The Company discontinued a clinical
trial for a second version of the Nexus Linear Lesion Catheter for the treatment
of atrial flutter in February 1999 and atrial fibrillation in July 1999.
Development and trial activity for the Nexus product line has been suspended by
the Company.
Cooled Ablation System for Ventricular Tachycardia. The Company obtained
PMA approval for the Chilli Cooled Ablation Catheter and Radiofrequency
Generator and Fluid Pump on February 2, 1999. The PMA application required the
Company to perform a post market study. During September 1999, the Company
submitted a PMA supplement requesting the addition of tracking technology, new
curve sizes and bi-directional deflection to the Chilli catheter. The Company
received PMA clearance from the FDA for its new Chilli cooled ablation
catheters, which incorporates Real-time Position Management navigation
technology in March 2000.
Tracking System. In August 1999, the Company submitted a
510(k)application requesting clearance of the Tracking System. In March 2000,
the Company received 510 (k) approval for its Real-time Position Management
tracking system. In April 2000, the Company received CE mark certification,
which grants the Company approval to market the RPM tracking system, including
the Chilli cooled ablation catheters, in Europe. This system is comprised of the
Arrhythmia Mapping Computer, the Signal Acquisition Module, the Position
Acquisition Module, and two reference diagnostic catheters. The Tracking System
is designed to enable the real-time tracking of catheter position information
minimizing the use of fluoroscopy. The Company believes this new technology will
enhance the performance of diagnostic electrophysiology studies. Furthermore,
the Company believes the combination of the Chilli catheter with the Tracking
System will enhance the performance of radiofrequency ablation procedures.
Mercator High Density Array Catheter for the Right Atrium. In June 1997,
the Company received IDE approval by the FDA to conduct a clinical trial of the
Mercator Atrial Mapping Basket for the right
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atrium and the Arrhythmia Mapping System for complex atrial tachyarrhythmias.
The Company submitted a 510(k) application for clearance of the Mercator Atrial
Mapping Basket in July 1998 and received clearance in January 1999 for two of
the three basket sizes (70 and 100cc). The Mercator product line has been
discontinued by the Company.
No Existing Market
The Company's Arrhythmia Mapping System received 510(k) clearance from
the FDA in August 1997 for basic diagnostic electrophysiology studies. In
September 1997, the Company began marketing the system commercially in the
United States. In February 1999, the Company received approval from the FDA of
its PMA application to commercially release its Chilli Cooled Ablation Catheter.
The Company received PMA clearance from the FDA for its new Chilli cooled
ablation catheters, which incorporate Real-time Position Management navigation
technology, in March 2000. Also in March 2000, the Company received 510 (k)
approval for its Real-time Position Management tracking system. In April 2000,
the Company received CE mark certification, which grants the Company approval to
market the RPM tracking system, including the Chilli cooled ablation catheters,
in Europe. However, there can be no assurance that these products will gain any
significant degree of market acceptance among physicians, patients, and health
care payors. The Company believes that physicians' acceptance of procedures
using the Company's RPM tracking system will be essential for market acceptance
of such system. Even though the clinical efficacy of the system has been
established, electrophysiologists, cardiologists and other physicians may elect
not to recommend the use of the RPM tracking system for any number of reasons.
There can be no assurance that this system will be successfully commercialized
in the United States or in international markets where it has not yet received
approval. The Company believes that, as with any novel medical technology, there
will be a significant learning process involved for physicians to become
proficient. Broad use of the system will require training of
electrophysiologists, and the time required to complete such training could
adversely affect market acceptance. Failure of the product to achieve
significant market acceptance would have a material adverse effect on the
Company's business, financial condition and results of operations. If the RPM
tracking system achieves market acceptance, and the Company is unable to
manufacture sufficient quantities of such product to satisfy customer demand,
the Company's business, financial condition and results of operations would be
materially adversely affected.
Marketing and Distribution
The Company currently has only a limited sales and marketing
organization. For products that have received FDA clearances or approvals, the
Company markets primarily through a direct sales force in the United States. The
Company's Vice President of Sales and Marketing manages distributor
relationships outside North America. In addition, the Company intends to
leverage its existing field clinical specialists' technical expertise to support
the revenue producing installations. There can be no assurance that
electrophysiologists will accept the Company's products or systems on a
commercial basis. Failure of such products or systems to gain market acceptance
would have a material adverse effect upon the Company's business, financial
condition and results of operations.
Establishing a marketing and sales capability sufficient to support
sales of the Company's products in commercial quantities will require
substantial efforts and require significant management and financial resources.
There can be no assurance the Company will be able to build a marketing staff or
sales force, that the establishment of such a marketing staff or sales force
will be cost effective or that the Company's sales and marketing efforts will be
successful. As the Company obtains the necessary regulatory approvals for its
ventricular tachycardia products in international markets, it expects to
establish a sales
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and marketing capability in those markets primarily through distributors. There
can be no assurance that the Company will be able to enter into agreements with
desired distributors on a timely basis or at all, or that such distributors will
devote adequate resources to selling the Company's products. Failure to
establish appropriate distribution relationships could have a material adverse
effect upon the Company's business, financial condition and results of
operations. The Company currently sells its products through distributors in
certain international markets. All sales of the Company's products to date have
been denominated in U.S. dollars. The end-user price is determined by the
distributor and varies from country to country. Changes in overseas economic
conditions, currency exchange rates, foreign tax laws, or tariffs or other trade
regulations could have a material adverse effect on the Company's ability to
market its products internationally and therefore on its business, financial
condition and results of operations.
Major Distributor; Dependence on Japan Lifeline
The Company currently relies upon international distributors of
specialty cardiovascular products to market and sell its products. A large
percentage of the Company's revenues are derived from sales to its Japanese
distributor, Japan Lifeline. During fiscal 1999, 1998 and 1997 Japan Lifeline
accounted for 52%, 80% and 66%, respectively, of the Company's net sales. In
fiscal 2000, the Company anticipates that Japan Lifeline will continue to
account for a significant percentage of the Company's net sales. The Company
also relies on its European distributors for a significant portion of its
revenues. If the Company's sales to any of its international distributors
decline, the Company would experience a material decline in revenues. Even if
the Company is successful in selling its products through new international
distributors, the rate of growth of the Company's net sales could be materially
and adversely effected if its current international distributors do not continue
to sell a substantial number of the Company's products. If the Company's sales
to its current international distributors decline, the Company cannot be certain
that it will be able to attract additional distributors that can market its
products effectively or can provide timely and cost-effective customer support
and service. None of the Company's international distributors are obligated to
sell the Company's products after its agreement with the Company has expired.
Further, the Company cannot be certain that its current international
distributors will continue to represent its products or that they will continue
to devote a sufficient amount of effort and resources to selling the Company's
products.
Strategic Relationships
The Company intends to pursue strategic relationships with corporations
and research institutions with respect to the research, development,
international regulatory approval, manufacturing and marketing of certain of its
products. There can be no assurance that the Company will be successful in
establishing or maintaining any such relationships or that any such relationship
will be successful.
Manufacturing
Components and raw materials are purchased from various qualified
suppliers and subjected to stringent quality specifications. The Company
conducts quality audits of suppliers and is establishing a vendor certification
program. A number of components for the Company's products are provided by sole
source suppliers. For certain of these components, there are relatively few
alternative sources of supply, and establishing additional or replacement
vendors for such components could not be accomplished quickly. The Company plans
to qualify additional suppliers if and as future production volumes increase.
Because of the long lead time for some components that are currently available
from a single source, a vendor's inability to supply such components in a timely
manner could have a material adverse effect on the Company's ability to
manufacture the mapping basket, mapping equipment and ablation equipment
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<PAGE> 17
and therefore on its business, financial condition and ability to market its
products as currently contemplated.
The Company has limited experience manufacturing its products in the
volumes that will be necessary for the Company to achieve significant commercial
sales, and there can be no assurance that reliable, high volume manufacturing
capacity can be established or maintained at commercially reasonable costs. The
Company needs to expend significant capital resources and develop manufacturing
expertise to establish large scale manufacturing capabilities. Manufacturers
often encounter difficulties in scaling up production of new products, including
problems involving production yields, quality control and assurance, component
supply shortages, shortages of qualified personnel, compliance with FDA
regulations, and the need for further FDA approval of new manufacturing
processes. In addition, the Company believes that substantial cost reductions in
its manufacturing operations will be required for it to commercialize its
catheters and systems on a profitable basis. Any inability of the Company to
establish and maintain large scale manufacturing capabilities would have a
material adverse effect on the Company's business, financial condition and
results of operations.
The Company's manufacturing facilities are subject to periodic
inspection by regulatory authorities, and its operations must undergo QSR
compliance inspections conducted by the FDA. The Company is required to comply
with QSR in order to produce products for sale in the United States and with
ISO 9001/EN46001 standards in order to produce products for sale in Europe. In
December 1997, the Company received ISO 9001/EN46001 certification from its
European Notified Body. Any failure of the Company to comply with QSR or
ISO 9001/EN46001 standards may result in the Company being required to take
corrective actions, such as modification of its policies and procedures. The
State of California also requires that the Company obtain a license to
manufacture medical devices which was granted in February 1998. If the Company
is unable to maintain such a license, it would be unable to manufacture or ship
any product, and such inability would have a material adverse effect on the
Company's business, financial condition and results of operations.
Patents and Proprietary Rights
The Company's success will depend in part on its ability to obtain
patent and copyright protection for its products and processes, to preserve its
trade secrets and to operate without infringing or violating the proprietary
rights of third parties. The Company's strategy is to actively pursue patent
protection in the United States and foreign jurisdictions for technology that it
believes to be proprietary and that offers a potential competitive advantage for
its products. The Company holds issued and allowed patents covering a number of
fundamental aspects of the Company's Ventricular Tachycardia Ablation System,
Arrhythmia Mapping Systems and Atrial Fibrillation Ablation System. The patent
positions of medical device companies, including those of the Company, are
uncertain and involve complex and evolving legal and factual questions. The
coverage sought in a patent application either can be denied or significantly
reduced before or after the patent is issued. Consequently, there can be no
assurance that any patents from pending patent applications or from any future
patent application will be issued, that the scope of any patent protection will
exclude competitors or provide competitive advantages to the Company, that any
of the Company's patents will be held valid if subsequently challenged or that
others will not claim rights in or ownership of the patents and other
proprietary rights held by the Company. In addition, there can be no assurance
that competitors, many of which have substantial resources and have made
substantial investments in competing technologies, will not seek to apply for
and obtain patents that will prevent, limit or interfere with the Company's
ability to make, modify, use or sell its products either in the United States or
in international markets. Litigation or regulatory proceedings, which could
result in substantial cost and uncertainty to the Company, may also be necessary
to enforce patent or other intellectual property rights of the Company or to
determine the scope and validity of other parties'
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proprietary rights. There can be no assurance that the Company will have the
financial resources to defend its patents from infringement or claims of
invalidity.
In addition to patents, the Company relies on trade secrets and
proprietary know how to compete, which it seeks to protect, in part, through
appropriate confidentiality and proprietary information agreements. These
agreements generally provide that all confidential information developed or made
known to individuals by the Company during the course of the relationship with
the Company is to be kept confidential and not disclosed to third parties,
except in specific circumstances. The agreements also generally provide that all
inventions conceived by the individual in the course of rendering service to the
Company shall be the exclusive property of the Company. There can be no
assurance that proprietary information or confidentiality agreements with
employees, consultants and others will not be breached, that the Company will
have adequate remedies for any breach, or that the Company's trade secrets will
not otherwise become known to or independently developed by competitors.
The medical device industry has been characterized by extensive
litigation regarding patents and other intellectual property rights, and
companies in the medical device industry have employed intellectual property
litigation to gain a competitive advantage. There can be no assurance that the
Company will not become subject to patent infringement claims or litigation in a
court of law, or interference proceedings declared by the United States Patent
and Trademark Office ("USPTO") to determine the priority of inventions or an
opposition to a patent grant in a foreign jurisdiction. The defense and
prosecution of intellectual property suits, USPTO interference or opposition
proceedings and related legal and administrative proceedings are both costly and
time-consuming. Any litigation, opposition or interference proceedings will
result in substantial expense to the Company and significant diversion of effort
by the Company's technical and management personnel. An adverse determination in
litigation or interference proceedings to which the Company may become a party
could subject the Company to significant liabilities to third parties, require
disputed rights to be licensed from third parties or require the Company to
cease using such technology. Although patent and intellectual property disputes
in the medical device area have often been settled through licensing or similar
arrangements, costs associated with such arrangements may be substantial and
could include ongoing royalties. Furthermore, there can be no assurance that
necessary licenses from others would be available to the Company on satisfactory
terms, if at all. Adverse determinations in a judicial or administrative
proceeding or failure to obtain necessary licenses could prevent the Company
from manufacturing and selling its products, which would have a material adverse
effect on the Company's business, financial condition and results of operations.
The Company is aware of certain patents owned or licensed by others and relating
to cardiac catheters and cardiac monitoring. Certain enhancements of the
Company's products are still in the design and pre-clinical testing phase.
Depending on the ultimate design specifications and results of pre-clinical
testing of these enhancements, there can be no assurance that the Company would
be able to obtain a license to such parties' patents or that a court would find
that such patents are either not infringed by the Company's enhancements or that
the Company's patents are invalid. Further, there can be no assurance that
owners or licensees of these patents will not attempt to enforce their patent
rights against the Company in a patent infringement suit or other legal
proceeding, regardless of the likely outcome of such suit or proceeding.
Competition
At present, the Company considers its primary competition to be
companies involved in current, more established therapies for the treatment of
ventricular tachycardia and atrial fibrillation, including drugs, external
electrical cardioversion and defibrillation, implantable defibrillators,
ablation accompanied by pacemaker implantation and open-heart surgery. In
addition, several competitors are also developing new approaches and new
products for the treatment and mapping of ventricular tachycardia and other
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arrythmias, including ablation systems using ultrasound, microwave, laser and
cryoablation technologies and mapping systems using contact mapping,
single-point spatial mapping and non-contact, multisite electrical mapping
technologies. Many of the Company's competitors have an established presence in
the field of interventional cardiology and electrophysiology, including Boston
Scientific Corporation, C.R. Bard, Inc., Johnson and Johnson through its Cordis
Division, St. Jude Medical and Medtronic, Inc. Many competitors have
substantially greater financial and other resources than the Company, including
larger research and development staffs, more experience, capabilities in
conducting research and development activities, testing products in clinical
trials, obtaining regulatory approvals and manufacturing, marketing and
distributing products. There can be no assurance that the Company will succeed
in developing and marketing technologies and products that are more clinically
efficacious and cost effective than the more established treatments or the new
approaches and products developed and marketed by its competitors. Furthermore,
there can be no assurance that the Company will succeed in developing new
technologies and products that are available prior to its competitors' products.
The failure of the Company to demonstrate the efficacy and cost effective
advantages of its products over those of its competitors or the failure to
develop new technologies and products before its competitors, could have a
material adverse effect on the Company's business, financial condition and
results of operations.
The Company believes that the primary competitive factors in the market
for cardiac ablation and mapping devices are safety, efficacy, ease of use and
price. In addition, the length of time required for products to be developed and
to receive regulatory and, in some cases, third party payor reimbursement
approval are important competitive factors. The medical device industry is
characterized by rapid and significant technological change. Accordingly, the
Company's success will depend in part on its ability to respond quickly to
medical and technological changes through the development and introduction of
new products. Product development involves a high degree of risk and there can
be no assurance that the Company's new product development efforts will result
in any commercially successful products. The Company believes it competes
favorably with respect to these factors, although there is no assurance that it
will be able to continue to do so.
Government Regulation
United States
The design, pre-clinical and clinical testing, manufacture, labeling,
sale, distribution and promotion of the Company's products are subject to
regulation by numerous governmental authorities, principally the FDA and
corresponding state and foreign regulatory agencies. Noncompliance with
applicable requirements can result in, among other things, fines, injunctions,
civil penalties, recall or seizure of products, total or partial suspension of
production, failure of the government to grant premarket clearance or premarket
approval for devices, withdrawal of marketing authorization, a recommendation by
the FDA that the Company not be permitted to enter into government contracts
and/or criminal prosecution. The FDA also has the authority to request repair,
replacement or refund of the cost of any device manufactured or distributed by
the Company.
Before a new device can be introduced into the market, a manufacturer
must generally obtain marketing clearance through a premarket notification under
Section 510(k) of the FDC Act or an approval of a PMA application under
Section 515 of the FDC Act. Commercial distribution of a device for which a
510(k) clearance is required can begin only after the FDA issues an order
finding the device to be "substantially equivalent" to a predicate device. If
the Company cannot establish that a proposed device is substantially equivalent
to a legally marketed predicate device, the Company must seek premarket approval
of the proposed device from the FDA through the submission of a PMA application.
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The Company will be required to make a new 510(k) submission for any
device that is cleared through the 510(k) process if the Company modifies or
enhances the device in a manner that could significantly affect safety or
effectiveness, or if those changes constitute a major modification in the
intended use of the device. If the Company cannot establish that a proposed
device is substantially equivalent to a legally marketed predicate device, the
Company must seek premarket approval of the proposed device from the FDA through
the submission of a PMA application. There can be no assurance that the FDA will
act favorably or quickly on any of the Company's PMA applications. Significant
difficulties and costs may be encountered by the Company in its efforts to
obtain FDA clearance that could delay or preclude the Company from selling its
products in the United States. Furthermore, there can be no assurance that the
FDA will not request additional data or require that the Company conduct further
clinical studies, causing the Company to incur substantial cost and delay. In
addition, there can be no assurance that the FDA will not impose strict labeling
requirements, onerous operator training requirements or other requirements as a
condition of its PMA approval, any of which could limit the Company's ability to
market its systems. Labeling and promotional activities are subject to scrutiny
by the FDA and, in certain circumstances, by the Federal Trade Commission
("FTC"). FDA enforcement policy strictly prohibits the marketing of FDA cleared
or approved medical devices for unapproved uses. Further, if a company wishes to
modify a product after FDA approval of a PMA, including changes in indications
or other modifications that could affect safety or efficacy, additional
clearances or approvals will be required from the FDA. Failure to receive or
delays in receipt of FDA clearances or approvals, including the need for
additional clinical trials or data as a prerequisite to clearance or approval,
or any FDA conditions that limit the ability of the Company to market its
systems, could have a material adverse effect on the Company's business,
financial condition and results of operations.
International
The European Union has promulgated rules which require that medical
products distributed after June 14, 1998 bear the CE mark, an international
symbol of adherence to quality assurance standards and compliance with
applicable European medical device directives. Quality system certification is
one of the CE mark requirements. The Company has received ISO 9001/EN46001
certification by its European Notified Body, one of the CE mark certification
prerequisites, for its manufacturing facility in Sunnyvale, California.
Furthermore, in January 1998, the Company received the right to affix the CE
mark to its Arrhythmia Mapping System and Chilli Cooled Ablation System. In
April 1998, the Company received the right to affix the CE mark to its Radii
catheters. In July 1998, the Company received the right to affix the CE mark to
its Trio/Ensemble catheters. In April 2000, the Company received CE mark
certification for the RPM tracking system, and for its Chilli cooled ablation
catheters incorporating Real-time Position Management navigation technology.
While the Company intends to satisfy the requisite policies and procedures that
will permit it to receive the CE Mark Certification for other products, there
can be no assurance that the Company will be successful in meeting the European
certification requirements and failure to receive the right to affix the CE mark
will prohibit the Company from selling these and other products in member
countries of the European Union.
The time required to obtain approval for sale in foreign countries may
be longer or shorter than that required for FDA approval, and the requirements
may differ. Export sales of medical devices that have not received FDA marketing
authorization are subject to FDA export requirements. In accordance with the FDA
Export Reform & Enforcement Act of 1996, such devices may be exported to any
country provided that the device meets a number of criteria including marketing
authorization in one of the "Tier I" countries identified in that Act. If the
device has no marketing authorization in a Tier I country, and is intended for
marketing, it may be necessary to obtain approval from the FDA to export the
device. In order to obtain export approval, the Company may be required to
provide the FDA with documentation from the medical device regulatory authority
of the country in which the study is to be conducted or the
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purchaser is located, stating that the device has the approval of the country.
In addition, the FDA must find that the exportation of the device is not
contrary to the public health and safety of the country in order for the Company
to obtain the permit. The Company currently has marketing authorization in one
or more Tier I countries for all its clinically used products. The Company is in
the process of obtaining the necessary marketing approvals or conducting
clinical trials in the United Kingdom, Germany, France, Canada, Japan and
several other countries in Europe and Asia.
Third-Party Reimbursement and Uncertainty Related to Health Care Reform
In the United States, health care providers, including hospitals and
physicians, that purchase medical products for treatment of their patients,
generally rely on third party payors, principally federal Medicare, state
Medicaid and private health insurance plans, to reimburse all or a part of the
costs and fees associated with the procedures performed using these products.
The Company's success will be dependent upon, among other things, the ability of
health care providers to obtain satisfactory reimbursement from third party
payors for medical procedures in which the Company's products are used. Third
party payors may deny reimbursement if they determine that a prescribed device
has not received appropriate regulatory clearances or approvals, is not used in
accordance with cost-effective treatment methods as determined by the payor, or
is experimental, unnecessary or inappropriate. Third party reimbursement is
generally provided on the basis of the procedure's DRG code is established by
the HCFA. The failure of the procedures in which the Company's products are used
or an insufficient level of reimbursements for such procedures would have a
material adverse effect on the Company's business, financial condition and
results of operations. In addition, medical equipment reimbursements have been
mandated by statute to be reduced in the past, and there can be no assurance
that any such reimbursements with respect to the Company's products will be
adequate or provided at all. Failure by hospitals and other users of the
Company's products to obtain reimbursement from third party payors, or changes
in government and private third party payors' policies toward reimbursement for
procedures employing the Company's products, would have a material adverse
effect on the Company's business, financial condition and results of operations.
Moreover, the Company is unable to predict what additional legislation or
regulation, if any, relating to the health care industry or third party coverage
and reimbursement may be enacted in the future, or what effect such legislation
or regulation would have on the Company.
Reimbursement systems in international markets vary significantly by
country and by region within some countries, and reimbursement approvals must be
obtained on a country by country basis. Many international markets have
government managed health care systems that control reimbursement for new
products and procedures. In most markets, there are private insurance systems as
well as government managed systems. Market acceptance of the Company's products
will depend on the availability and level of reimbursement in international
markets targeted by the Company. There can be no assurance that the Company will
obtain reimbursement in any country within a particular time, for a particular
amount, or at all.
Regardless of the type of reimbursement system, the Company believes
that physician advocacy of the Company's products will be required to obtain
reimbursement. The Company believes that less invasive procedures generally
provide less costly overall therapies as compared to conventional drug, surgery
and other treatments. In addition, the Company believes that treatment with the
Company's products will be more efficacious than currently available therapies.
The Company anticipates that hospital administrators and physicians would
justify the use of the Company's products by the attendant cost savings and
clinical benefits that the Company believes would be derived from the use of its
products. However, there can be no assurance that this will be the case. There
can be no assurance that reimbursement for the Company's products will be
available in the United States or in international markets under either
government or
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private reimbursement systems, or that physicians will support and advocate
reimbursement procedures using the Company's products.
Product Liability and Insurance
The development, manufacture and sale of medical products entail
significant risk of product liability claims and product failure claims. The
Company has only limited commercial sales to date and does not yet have, and
will not have for a number of years, sufficient clinical data to allow the
Company to measure the risk of such claims with respect to its products. The
Company faces an inherent business risk of financial exposure to product
liability claims in the event that the use of its products results in personal
injury or death. The Company also faces the possibility that defects in the
design or manufacture of the Company's products might necessitate a product
recall. There can be no assurance that the Company will not experience losses
due to product liability claims or recalls in the future. In addition, the
Company will require increased product liability coverage if any of its
potential products are successfully commercialized. Such insurance is expensive,
difficult to obtain and may not be available in the future on acceptable terms,
or at all. Any claims against the Company regardless of their merit or eventual
outcome could have a material adverse effect upon the Company's business,
financial condition and results of operations.
Employees
The Company's ability to operate successfully depends in significant
part upon the continued service of certain key scientific, technical, clinical,
regulatory and managerial personnel, and its continuing ability to attract and
retain additional highly qualified scientific, technical, regulatory and
managerial personnel. Competition for such personnel is intense, and there can
be no assurance that the Company can retain such personnel or that it can
attract or retain other highly qualified scientific, technical, clinical,
regulatory and managerial personnel in the future, including key sales and
marketing personnel. The loss of key personnel or the inability to hire and
retain qualified personnel could have a material adverse effect upon the
Company's business, financial condition and results of operations.
In addition, in order to manufacture and market its products in
commercial quantities, the Company believes that it will be required to expand
its operations, particularly in the areas of research and development,
manufacturing and sales and marketing. The Company hired a new Chief Executive
Officer in May 1999. The Company also hired a new Chief Financial Officer, a new
Vice President of Operations and a new Vice President of Sales in January 2000.
There can be no assurance that these newly hired officers of the Company will be
able to operate effectively with that portion of the management team that was
retained. Further, there can be no assurance that the Company's officers and
Sales and Marketing personnel will be able to build a successful sales force or
that they will be able to operate effectively with the existing management team.
As the Company expands its operations in these areas, such expansion will likely
result in new and increased responsibilities for management personnel and place
significant strain upon the Company's management, operating and financial
systems and resources. To accommodate any such growth and compete effectively,
the Company will be required to implement and improve information systems,
procedures, and controls, and to expand, train, motivate and manage its work
force. Any failure to implement and improve the Company's operational, financial
and management systems or, to expand, train, motivate or manage employees as
required by future growth, if any, could have a material adverse effect on the
Company's business, financial condition and results of operations.
22
<PAGE> 23
Year 2000 Compliance
As of the date of this filing, the Company has not incurred any
significant business disruptions as a result of Year 2000 issues. However, while
no such occurrence has developed as of the date of this filing to the Company's
knowledge, Year 2000 issues that may arise related to material third parties may
not be apparent immediately and therefore, there is no assurance that the
Company will not be affected by future disruptions. The Company will continue to
monitor the issue vigilantly and work to remediate any issues that may arise. We
do not anticipate incurring material expenses or experiencing any material
disruptions as a result of any Year 2000 issues.
Issuance of Preferred Stock Could Delay or Prevent Corporate Takeover
The Board of Directors has the authority to issue up to 5,000,000 shares
of undesignated Preferred Stock and to determine the rights, preferences,
privileges and restrictions of such shares without any further vote or action by
the stockholders. To date, the Board of Directors has designated 30,000 shares
as Series A Participating Preferred Stock in connection with the Company's
Stockholder Rights Plan. The issuance of Preferred Stock under certain
circumstances could have the effect of delaying or preventing a change in
control of the Company or otherwise adversely affecting the rights of the
holders of Common Stock or Series B Preferred Stock.
On April 22, 1997, pursuant to a Preferred Shares Rights Agreements (the
"Rights Agreement") between the Company and Norwest Bank Minnesota, N.A. (the
"Rights Agent"), the Company's Board of Directors declared a dividend of one
right to purchase 1/1000 a share of the Company's Series A Participating
Preferred Stock ("Series A Preferred") for each outstanding share of Common
Stock and Series B Preferred Stock (on an as converted basis) of the Company (a
"Right"). Each Right entitles the registered holder to purchase from the Company
1/1000 a share of Series A Preferred at an exercise price of $125 (the "Purchase
Price"), subject to adjustment. The Rights approved by the Board are designed to
protect and maximize the value of the outstanding equity interests in the
Company in the event of an unsolicited attempt by an acquirer to take over the
Company, in a manner or on terms not approved by the Board of Directors. The
Rights have been declared by the Board in order to deter coercive tactics,
including a gradual accumulation of shares in the open market of a 15% or
greater position to be followed by a merger or a partial or two tier tender
offer that does not treat all stockholders equally. The Rights should not
interfere with any merger or business combination approved by the Board of
Directors. However, the Rights may have the effect of rendering more difficult
or discouraging an acquisition of the Company deemed undesirable by the Board of
Directors. The Rights may cause substantial dilution to a person or group that
attempts to acquire the Company on terms or in a manner not approved by the
Company's Board of Directors, except pursuant to an offer conditioned upon the
negation, purchase or redemption of the Rights.
Potential Volatility of Stock Price
The market price of shares of Common Stock, like that of the common
stock of many medical products and high technology companies, has in the past
been, and is likely in the future to continue to be highly volatile. Factors
such as fluctuations in the Company's operating results, proportion of ownership
between common stockholders and preferred series B stockholders, announcements
of technological innovations or new commercial products by the Company or
competitors, government regulation, changes in the current structure of the
health care financing and payment systems, developments in or disputes regarding
patent or other proprietary rights, release of reports by securities analysts,
change in securities analysts recommendations, economic and other external
factors and general market conditions may have a significant effect on the
market price of the Common Stock. Also, at some future time, the
23
<PAGE> 24
Company's revenues and results of operations may be below the expectations of
securities analysts or investors, resulting in significant fluctuations in the
market price of the Company's Common Stock. Moreover, the stock market has from
time to time experienced extreme price and volume fluctuations which have
particularly affected the market prices for medical products and high technology
companies and which have often been unrelated to the operating performance of
such companies. These broad market fluctuations, as well as general economic,
political and market conditions, may adversely affect the market price of the
Company's Common Stock. In the past, following periods of volatility in the
market price of a company's stock, securities class action litigation has
occurred against the issuing company. There can be no assurance that such
litigation will not occur in the future with respect to the Company. Such
litigation could result in substantial costs and a diversion of management's
attention and resources, which could have a material adverse effect on the
Company's business, operating results and financial condition. Any adverse
determination in such litigation could also subject the Company to significant
liabilities.
Absence of Dividends
The Company has not paid any cash dividends since inception and does not
anticipate paying cash dividends in the foreseeable future.
24
<PAGE> 25
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There have been no material changes to the Company's disclosures about
market risk from those set forth in the Company's Annual Report on Form 10-K for
the year ended June 30, 1999.
25
<PAGE> 26
CARDIAC PATHWAYS CORPORATION
PART II. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) The exhibits listed on the accompanying Exhibit Index are filed as a
part hereof.
(b) No reports on Form 8-K have been filed for the quarter ended March
31, 2000.
26
<PAGE> 27
CARDIAC PATHWAYS CORPORATION
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.
DATE: MAY 11, 2000 CARDIAC PATHWAYS CORPORATION
/S/ THOMAS M. PRESCOTT
-------------------------------------
THOMAS M. PRESCOTT
PRESIDENT AND CHIEF EXECUTIVE OFFICER
/S/ ELDON M. BULLINGTON
-------------------------------------
ELDON M. BULLINGTON
VICE PRESIDENT OF FINANCE AND
CHIEF FINANCIAL OFFICER
27
<PAGE> 28
CARDIAC PATHWAYS CORPORATION
INDEX TO EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT NO. EXHIBIT DESCRIPTION PAGE NO.
- ----------- ------------------- --------
<S> <C> <C>
27.1 Financial Data Schedule 28
</TABLE>
28
<TABLE> <S> <C>
<ARTICLE> 5
<MULTIPLIER> 1,000
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> JUN-30-2000
<PERIOD-START> JUL-01-1999
<PERIOD-END> MAR-31-2000
<CASH> 8,008
<SECURITIES> 9,135
<RECEIVABLES> 730
<ALLOWANCES> 122
<INVENTORY> 1,970
<CURRENT-ASSETS> 20,426
<PP&E> 9,008
<DEPRECIATION> 5,802
<TOTAL-ASSETS> 25,651
<CURRENT-LIABILITIES> 3,652
<BONDS> 0
0
0
<COMMON> 2
<OTHER-SE> 17,029
<TOTAL-LIABILITY-AND-EQUITY> 25,651
<SALES> 4,755
<TOTAL-REVENUES> 4,755
<CGS> 4,832
<TOTAL-COSTS> 4,832
<OTHER-EXPENSES> 12,702
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 59
<INCOME-PRETAX> (15,630)
<INCOME-TAX> 0
<INCOME-CONTINUING> (15,630)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (15,630)
<EPS-BASIC> (7.74)
<EPS-DILUTED> (7.74)
</TABLE>
