<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 September 30, 1996
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the Transition period from ________ to _______
Commission File Number: 0-28424
CARDIOGENESIS CORPORATION
(Exact name of registrant as specified in its charter)
<TABLE>
<S> <C>
Delaware 77-0352469
____________________________________ ________________________________________
(State or other jurisdiction of (I.R.S. employer
incorporation or organization) identification No.)
</TABLE>
540 OAKMEAD PARKWAY
SUNNYVALE, CALIFORNIA 94086
(Address of principal executive offices, including zip code)
(408) 328-8500
(Registrant's telephone number, including area code)
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.
Yes [X] No [ ]
The number of shares of Common Stock outstanding as of October 31, 1996 was
11,948,037.
- 1 -
<PAGE> 2
CARDIOGENESIS CORPORATION
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
<S> <C> <C>
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
Condensed Balance Sheets as of September 30, 1996 and December 31, 1995 3
Condensed Statements of Operations for the three months 4
and nine months ended September 30, 1996 and 1995
Condensed Statements of Cash Flows for the nine months 5
ended September 30, 1996 and 1995
Notes to Condensed Financial Statements 6
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION 7
AND RESULTS OF OPERATIONS
PART II. OTHER INFORMATION
ITEM 1. LITIGATION 11
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K 11
SIGNATURE 12
INDEX TO EXHIBITS 13
</TABLE>
-2-
<PAGE> 3
CARDIOGENESIS CORPORATION
Condensed Balance Sheets
(in thousands)
<TABLE>
<CAPTION>
December 31 September 30
----------- ------------
1995 1996
----------- ------------
ASSETS (unaudited)
<S> <C> <C>
Current assets:
Cash and cash equivalents $ 4,150 $ 5,638
Available-for-sale securities 9,886 55,589
Accounts receivable 870 1,748
Inventories 625 1,124
Other current assets 325 842
-------- ----------
Total current assets 15,856 64,941
Long term assets 367 1,493
-------- ----------
Total assets $ 16,223 $ 66,434
======== ==========
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' (DEFICIT) EQUITY
Current liabilities:
Accounts payable and accrued expenses $ 794 $ 2,043
Deferred revenue 870 --
-------- ----------
Total liabilities 1,664 2,043
Redeemable convertible preferred stock 22,390 --
Stockholders' (deficit) equity: (7,831) 64,391
-------- ----------
Total liabilities, redeemable convertible preferred stock,
and stockholders' (deficit) equity $ 16,223 $ 66,434
======== ==========
</TABLE>
The accompanying notes are an integral part of these financial statements.
-3-
<PAGE> 4
CARDIOGENESIS CORPORATION
Condensed Statements of Operations
(in thousands, except per share data)
(unaudited)
<TABLE>
<CAPTION>
Three Months Ended September 30 Nine Months Ended September 30
------------------------------- ------------------------------
1995 1996 1995 1996
-------------- --------------- -------------- --------------
<S> <C> <C> <C> <C>
Sales $ -- $ 1,119 $ -- $ 2,968
Cost of sales -- 826 -- 2,032
------- -------- ------- -------
Gross profit -- 293 -- 936
------- -------- ------- -------
Operating expenses:
Research and development 798 1,730 1,962 4,991
General and administrative 317 707 836 1,699
Sales and marketing 117 617 188 1,337
------- -------- ------- -------
Operating expenses 1,232 3,054 2,986 8,027
------- -------- ------- -------
Operating loss (1,232) (2,761) (2,986) (7,091)
Interest income (expense) (12) 868 108 1,437
------- -------- ------- -------
Net loss $(1,244) $ (1,893) $(2,878) $(5,654)
======= ======== ======= =======
Net loss per share $ (0.29) $ (0.16) $ (0.68) $ (0.70)
======= ======== ======= =======
Shares used in computing net
loss per share 4,229 11,937 4,229 8,082
======= ======== ======= =======
</TABLE>
The accompanying notes are an integral part of these financial statements.
-4-
<PAGE> 5
CARDIOGENESIS CORPORATION
Condensed Statements of Cash Flows
(in thousands)
(unaudited)
<TABLE>
<CAPTION>
Nine Months Ended September 30
------------------------------
1995 1996
----------- ---------------
<S> <C> <C>
Cash from operating activities:
Net loss $(2,878) $ (5,654)
Adjustments to reconcile net loss to
net cash used in operating activities:
Depreciation and amortization 86 259
Amortization of deferred compensation -- 702
Disposal of property and equipment -- 7
Changes in assets and liabilities:
Accounts receivable -- (878)
Inventories -- (499)
Prepaids and other (4) (517)
Accounts payable and other 199 50
Accrued expenses 49 972
Accrued compensation 19 227
Deferred revenue -- (870)
------- ---------
Net cash used in operating activities (2,529) (6,201)
------- ---------
Cash flows from investing activities:
Purchase of available-for-sale securities (1,814) (109,928)
Maturities of available-for-sale securities 5,335 64,225
Acquisition of property and equipment (668) (1,398)
Other assets 19 6
------- ---------
Net cash provided by (used in)
investing activities 2,872 (47,095)
------- ---------
Cash flows from financing activities:
Proceeds from issuance of Common Stock, net -- 54,784
------- ---------
Net cash provided by financing activities -- 54,784
------- ---------
Net increase in cash and cash equivalents 343 1,488
Cash and cash equivalents, beginning of period 1,802 4,150
------- ---------
Cash and cash equivalents, end of period $ 2,145 $ 5,638
======= =========
</TABLE>
The accompanying notes are an integral part of these financial statements.
-5-
<PAGE> 6
CARDIOGENESIS CORPORATION
NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 1 - INTERIM CONDENSED FINANCIAL STATEMENTS
These interim condensed financial statements are unaudited, but have
been prepared in accordance with generally accepted accounting principles for
interim information and with the instructions to Form 10-Q. In the opinion of
management, all adjustments (consisting of normal recurring accruals) considered
necessary for a fair presentation of financial position, results of operations
and cash flows at the dates and for the periods presented have been included.
The interim financial information herein is not necessarily indicative of
results for any future period. The interim condensed financial statements should
be read in conjunction with the audited financial statements and the notes
thereto for the fiscal year ended December 31, 1995 included in the Company's
Registration Statement on Form SB-2 (Reg. St. No. 333-3752-LA), declared
effective by the Securities and Exchange Commission on May 21, 1996.
NOTE 2 - INVENTORIES
Inventories (in thousands) consisted of the following:
<TABLE>
<CAPTION>
DECEMBER 31 SEPTEMBER 30
1995 1996
--------------------------
(unaudited)
<S> <C> <C>
Raw materials $ 73 $ 82
Finished goods 552 1,042
---- ------
$625 $1,124
==== ======
</TABLE>
NOTE 3 - INITIAL PUBLIC OFFERING
In May 1996, the Company completed its initial public offering. The
Company sold 3,000,000 shares of Common Stock at a price to the public of $20.00
per share, resulting in net proceeds to the Company (after deducting
underwriting discounts and commissions and offering expenses) of approximately
$54.8 million.
NOTE 4 - NET LOSS PER SHARE
Net loss per share is computed using the weighted average number of
shares of Common Stock outstanding. Common equivalent shares from stock options
and Preferred Stock are excluded from the computation as their effect is
antidilutive, except that, pursuant to the Securities and Exchange Commission
Staff Accounting Bulletins, Common and Common equivalent shares issued at prices
below the public offering price during the 12 months immediately preceding the
effective date have been included in the calculation as if they were outstanding
for all periods presented (using the treasury stock method).
NOTE 5 - LITIGATION
On September 11, 1996, the Company filed an action for declaratory
relief against PLC Systems, Inc. of Canada and its wholly-owned American
subsidiary, PLC Medical Systems, Inc., (collectively, "PLC"), seeking a judgment
that PLC's United States patent No. 5,125,926 to a certain heart-synchronized
pulsed laser system is invalid and unenforceable. In the suit, filed in the
United States District Court for the Northern District of California, the
Company also requested the Court to enter judgment that the Company's
Transmyocardial Revascularization (TMR) systems do not infringe the PLC patent.
In October 1996, PLC responded to the complaint. In its response, PLC took the
position that its patent has been infringed by the Company, but made no further
claims.
-6-
<PAGE> 7
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATION
This Form 10-Q contains forward-looking statements within the meaning
of Section 21E of the Securities Exchange Act of 1934, as amended. These
forward-looking statements involve a number of risks and uncertainties,
including: acceptance of transmyocardial revascularization ("TMR") as a safe and
efficacious treatment for coronary artery disease; results of the Company's
ongoing clinical trials of its intraoperative TMR ("ITMR"(TM)) System and any
future clinical trials of the Company's TMR Systems; approval by the Food and
Drug Administration ("FDA") of the Company's ITMR System for further clinical
trials and of its thoracoscopic TMR ("TTMR"(TM)) System and percutaneous
myocardial revascularization ("PMR"(TM)) System for initial clinical trials; the
ability to respond to rapid and significant technological change; the ability to
comply with regulatory requirements in foreign countries; the ability to obtain
patent protection for its products and processes, to preserve its trade secrets
and proprietary technology and to operate without infringing upon the patents or
proprietary rights of third parties; the ability to compete successfully against
other producers of TMR systems, including PLC Systems, Inc., Eclipse Surgical
Technologies, Inc., and United States Surgical Corporation, and against others
that provide therapies that may treat the medical indications that may be
treatable with TMR; the ability to obtain third-party reimbursement for use of
the Company's TMR System; continuing, timely availability of components used in
the Company's TMR Systems, including the Holmium:YAG (Ho:YAG) laser and the
electrocardiogram (ECG) monitor; the ability to retain and attract in the future
key scientific, technical, marketing, sales, managerial and finance personnel;
the ability to increase production of the Company's TMR Systems and to comply
with good manufacturing practices and other manufacturing regulations; the
ability to establish a sales and marketing organization and establish
relationships with distributors internationally; the ability to minimize
exposure to product liability risks or product recalls and the sufficiency of
the Company's insurance coverage; and other factors described throughout this
Form 10-Q, and in the Company's Registration Statement on Form SB-2 (File No.
333-3752-LA) declared effective by the Securities and Exchange Commission on May
21, 1996, particularly the section entitled "RISK FACTORS."
The actual results that the Company achieves may differ materially from
any forward-looking statements due to such risks and uncertainties. The Company
has identified by an asterisk (*) various sentences within this Form 10-Q which
contain such forward-looking statements, and words such as "believes",
"anticipates", "expects", "intends" and similar expressions are intended to
identify forward-looking statements, but are not the exclusive means of
identifying such statements. The Company undertakes no obligation to revise any
forward-looking statements in order to reflect events or circumstances that may
arise after the date of this report. Readers are urged to carefully review and
consider the various disclosures made by the Company in this report and in the
Company's other reports filed with the Securities and Exchange Commission that
attempt to advise interested parties of the risks and factors that may affect
the Company's business.
OVERVIEW
Since its inception, the Company has been primarily engaged in the
design and development of its TMR Systems. The Company has a limited history of
operations and has experienced significant operating losses since inception.
*Operating losses are expected to continue at least through 1997 as the Company
continues to perform research and development, to fund clinical trials in
support of regulatory and reimbursement approvals, and to expand its marketing,
sales, and operational activities.
*The research, manufacture, sale, and distribution of medical devices
such as the Company's TMR Systems are subject to numerous regulations imposed by
governmental authorities, principally the FDA and corresponding state and
foreign agencies. *The regulatory process is lengthy, expensive, and uncertain.
FDA approval of a Pre Market Approval ("PMA") application is required before any
TMR System can be marketed in the United States. *Securing FDA approvals and
clearances will require submission to the FDA of extensive clinical data and
technical information that has not yet been developed or obtained.
-7-
<PAGE> 8
To date, the Company has shipped and recognized revenue on a limited
number of ITMR Systems for clinical trials, both in Europe and the United
States, and for commercial use in Europe. The Company recognizes revenues upon
shipment of its products to customers and fulfillment of acceptance terms, if
any, and when no significant contractual obligations remain outstanding.
Deferred revenue consisted of shipments made which were subject to limited
rights of return primarily associated with finalizing terms of definitive
distributor agreements.
In July 1996, the Company received the European CE mark approval for
commercialization of its ITMR products, which is required for the Company to
begin marketing its ITMR products in European Union States. The CE mark is
awarded to companies whose products meet the essential requirements of the
European Medical Device Directive and provides the regulatory approval necessary
for commercialization. In October 1996, the Company commercially launched its
ITMR System in Europe during the European Association of Cardio-Thoracic Surgery
conference in Prague, Czech Republic. *The Company anticipates most of its
revenues from product sales over the next several years will be derived from
international sales through distributors, primarily in Europe. *Any such
international sales will be subject to a number of risks, including
reimbursement approval, foreign currency fluctuations, economic or political
instability, foreign tax laws, shipping delays, various tariffs and trade
regulations and restrictions and foreign medical regulations, any of which could
have a significant impact on the Company's ability to deliver products on a
competitive and timely basis
The Company is also currently conducting two multi-center, prospective,
randomized studies of the ITMR System, one in "no-option" patients with ITMR as
the stand alone procedure and the other a study of the ITMR system as an adjunct
to first coronary artery bypass. A total of up to 650 patients at up to 45
clinical trial sites are approved to be included in these two protocols.
The Company is completing pre-clinical studies on its Percutaneous
Myocardial Revascularization (PMR) System and has initiated human clinical
studies in Europe. The Company has not initiated clinical testing of its
thoracoscopic TMR System. *The Company does not believe it will be able to
complete clinical trials of, obtain regulatory approval for, and begin
commercial sales of its TMR systems in the United States for several years, if
ever.
*There can be no assurance that the Company's research and development
efforts will be successful. *Given that clinical testing is incomplete, there
can be no assurance that any of the Company's TMR Systems will be shown to be
safe or effective. *Accordingly, the Company is unable to predict the likelihood
that its products will be approved for marketing by the FDA or, with the
exception of the existing European CE mark for the Company's ITMR products, any
other foreign government agency, and there can be no assurance that such
approvals will be obtained or that any of the TMR Systems or any other product
development by the Company will be successfully introduced or achieve any
significant degree of market acceptance. *There can be no assurance that the
Company will ever achieve either significant revenues from sales of any of its
TMR Systems or ever achieve or sustain profitability.
*Results of the Company's operations have varied and are expected to
fluctuate significantly from quarter to quarter depending on numerous factors,
including: (1) demand for the Company's products, new product introductions by
the Company or its competitors or transitions to new products; (2) the timing of
orders and shipments; (3) the mix of sales between distributors and the
Company's potential direct sales force; (4) competition, including pricing
pressures; (5) the timing of regulatory and third-party reimbursement approvals;
(6) expansion of the Company's manufacturing capacity and the Company's ability
to manufacture its products efficiently; (7) the timing of research and
development expenses, including clinical trial-related expenditures; and (8)
seasonal factors affecting the number of procedures performed.
On September 11, 1996, the Company filed an action for declaratory
relief against PLC Systems, Inc. of Canada and its wholly-owned American
subsidiary, PLC Medical Systems, Inc., (collectively, "PLC"), seeking a judgment
that PLC's United States patent No. 5,125,926 to a certain heart-synchronized
pulsed laser system is invalid and unenforceable. In the suit, filed in the
United States District Court for the Northern District of California, the
Company also requested the Court to enter judgment that the Company's
Transmyocardial Revascularization (TMR) systems do not infringe the PLC patent.
In October 1996, PLC responded to the
-8-
<PAGE> 9
complaint. In its response, PLC took the position that its patent has been
infringed by the Company, but made no further claims.
Also in September 1996, the Company incorporated a wholly owned
subsidiary in the Netherlands in Europe. The office, located in Amsterdam, was
established to provide sales support to the European distributors.
RESULTS OF OPERATIONS
Sales. Sales of the Company's ITMR System for use in clinical trials
and commercial use in Europe were $1.1 million and $3.0 million for the three
months and nine months ended September 30, 1996, respectively. The revenue
resulted from the continuing efforts to establish clinical sites at medical
centers and hospitals in the US and from sales to international distributors. No
sales were recorded during 1995.
Cost of Sales. Cost of sales consists of direct and indirect costs of
providing the ITMR System to customers. Cost of sales were $826,000, or 74% of
sales, and $2.0 million, or 68% of sales, for the three months and nine months
ended September 30, 1996, respectively. The increase in cost of sales resulted
from growth in the Company's manufacturing and quality departments in
preparation for the October 1996 commercialization of the ITMR System in Europe.
In addition, due to the allocation of costs over a greater number of units sold
for the nine months ended September 30, 1996, cost of sales as a percentage of
sales decreased to 68% from 74%. *The acceptance of the Company's products in
Europe is subject to a number of risks, including the willingness of the medical
community to adopt TMR, and TMR's safety and efficacy as a treatment for
coronary artery disease, compliance with regulatory requirements, and various
other factors referenced above.
Research and Development Expenses. Research and development expenses
increased 154% to $5.0 million for the nine months ended September 30, 1996 from
$2.0 million for the nine months ended September 30, 1995 and 117% to $1.7
million from $798,000 for the three months ended September 30, 1996 and 1995,
respectively. These increases were primarily a result of the Company's
initiation of three clinical protocols of the ITMR System. The first clinical
trial began in late 1995. *The Company expects research and development expenses
to substantially increase in the future as the Company continues the
multi-center, prospective, randomized clinical trials of its ITMR System in
"no-option" patients as a stand alone procedure and as an adjunct to first
coronary artery bypass, and as the Company prepares to initiate clinical trials
of the PMR and TTMR Systems. *There can be no assurance that the TTMR or PMR
systems will be approved for clinical trials or that any of the Company's TMR
Systems will prove to be safe or effective.
General and Administrative Expenses. General and administrative
expenses increased 100% to $1.7 million for the nine months ended September 30,
1996 from $836,000 for the same period in 1995 and increased 123% to $707,000
from $317,000 for the three months ended September 30, 1996 and 1995,
respectively. These increases from 1995 were primarily a result of increased
general and administrative personnel and expenses in support of a higher level
of operations and in support of obligations from being a public company. *Future
increases in general and administrative expenses are dependent on the factors
discussed above and there can be no assurance that any such increases will
occur.
Sales and Marketing Expenses. Sales and marketing expenses increased
611% to $1.3 million for the nine months ended September 30, 1996 from $188,000
for the same period in 1995 and 427% to $617,000 from $117,000 for the three
months ended September 30, 1996 and 1995, respectively. These increases were
primarily a result of hiring sales and marketing personnel, expenses incurred
for contractor services, and in the third quarter of 1996, the Company's
European launch of its ITMR System. *As the Company prepares for marketing
approval in the United States and supports product commercialization
internationally, the Company anticipates the number of sales and marketing
personnel will increase significantly, resulting in higher sales and marketing
expenses. *However, the process of obtaining regulatory approvals is lengthy,
expensive and uncertain, and, as discussed above, such approval and
commercialization processes are subject to various risks.
Interest Income. Interest income increased to $1.4 million for the nine
months ended September 30, 1996 from $108,000 for the same period in 1995. For
the three months ended September 30, 1996, the Company recorded
-9-
<PAGE> 10
interest income of $868,000 versus net interest expense of $12,000 during the
same period in 1995. The increases in interest income were primarily due to the
completion of the Company's initial public offering resulting in larger cash,
cash equivalents, and available-for-sale securities balances. *The effect of
interest income is expected to lessen through 1997 as the Company's cash balance
is depleted to fund operating expenses.
LIQUIDITY AND CAPITAL RESOURCES
The Company has funded its operations since inception primarily through
the private and public sale of capital stock and interest income on proceeds
from such financings. From its inception through September 30, 1996, the Company
had raised approximately $76 million, net of issuance costs, through the sale of
its capital stock.
Cash used in the Company's operating activities was $6.2 million and
$2.5 million for the nine months ended September 30, 1996 and 1995,
respectively. The increases in cash used in the Company's operations were
primarily a result of higher research and development, sales and marketing, and
administrative activities resulting in higher net losses, and to increases in
accounts receivable and inventories associated with initial sales of the
Company's ITMR Systems. The Company's capital expenditures were $1.4 million and
$668,000 for the nine months ended September 30, 1996 and 1995, respectively.
The increase was primarily due to the costs of acquiring capital equipment to
support growth in the number of its employees and relocating the Company's
facility to Sunnyvale, California in May 1996. *The Company expects capital
expenditures to increase primarily in connection with the international
commercialization of its ITMR System, discussed above, and general increases in
business operations.
At September 30, 1996, the Company had cash, cash equivalents, and
available-for-sale securities of $61.2 million. *The Company plans to finance
its operations and capital needs principally from cash, cash equivalents,
available-for-sale securities, and interest thereon and believes these funds
will be sufficient to fund its operations at least through 1997. *However, the
Company's future liquidity and capital requirements will depend upon numerous
factors, including the progress of the Company's clinical research and product
development programs; the receipt of and the time required to obtain regulatory
clearances and approvals; the resources required to gain reimbursement
approvals; the resources the Company devotes to the development, manufacture and
marketing of its products; the resources required to hire and develop a direct
sales force, develop the network of distributors internationally, and to expand
manufacturing capacity; facilities requirements; market acceptance and demand
for its products; and the resources required to defend potential third-party
patent infringement claims; and other factors. *The timing and amount of such
capital requirements cannot be accurately predicted. *Consequently, although the
Company believes that its cash, cash equivalents and available-for-sale
securities will provide adequate funding for its operations and capital
requirements through at least 1997, the Company may be required to raise
additional funds through public or private debt or equity financings,
collaborative relationships, bank facilities or other arrangements. *There can
be no assurance that the Company will not require additional funding sooner than
it anticipates or that such additional funding, if needed, will be available on
terms attractive to the Company, or at all. *Any additional equity financing may
be dilutive to stockholders, and debt financing, if available, may involve
imposition of restrictive covenants upon the company.
RECENT ACCOUNTING PRONOUNCEMENTS
During October 1995, the Financial Accounting Standards Board issued
Statement No. 123 ("SFAS No. 123"), "Accounting of Stock-Based Compensation,"
which establishes a fair value method of accounting for stock-based compensation
plans, and requires additional disclosures for those companies that elect not to
adopt the new method of accounting. The Company has elected not to adopt the new
method of accounting as contained in the statement and will include additional
disclosures in the financial statements for the year ending December 31, 1996.
-10-
<PAGE> 11
PART II. OTHER INFORMATION
ITEM 1. LITIGATION
On September 11, 1996, the Company filed an action for declaratory
relief against PLC Systems, Inc. of Canada and its wholly-owned American
subsidiary, PLC Medical Systems, Inc., (collectively, "PLC"), seeking a judgment
that PLC's United States patent No. 5,125,926 to a certain heart-synchronized
pulsed laser system is invalid and unenforceable. In the suit, filed in the
United States District Court for the Northern District of California, the
Company also requested the Court to enter judgment that the Company's
Transmyocardial Revascularization (TMR) systems do not infringe the PLC patent.
In October 1996, PLC responded to the complaint. In its response, PLC took the
position that its patent has been infringed by the Company, but made no further
claims.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
Number Description
- ------ -----------
11.01 Statement Regarding Computation of Net Loss Per Share
27.01 Financial Data Schedules
(b) Reports on Form 8-K
none
-11-
<PAGE> 12
SIGNATURE
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.
CARDIOGENESIS CORPORATION
(Registrant)
Date: November 13, 1996 By: /s/ Richard P. Powers
_____________________________________________
Richard P. Powers
Chief Financial Officer, Vice President of
Finance and Administration, and Secretary
(Duly Authorized Officer, Principal Financial
Officer, and Principal Accounting Officer)
-12-
<PAGE> 13
INDEX TO EXHIBITS
EXHIBIT
11.01 Statement Regarding Computation of Net Loss Per Share
27.01 Financial Data Schedules
-13-
<PAGE> 1
EXHIBIT 11.01
CARDIOGENESIS CORPORATION
COMPUTATION OF NET LOSS PER SHARE(1)
(in thousands, except per share data)
(unaudited)
<TABLE>
<CAPTION>
Three Months Ended September 30 Nine Months Ended September 30
------------------------------- ------------------------------
1995 1996 1995 1996
------------- --------------- --------------- -------------
<S> <C> <C> <C> <C>
Weighted average common shares outstanding
for the period -- 7,708 -- 3,853
Common equivalent shares pursuant to Staff
Accounting Bulletin No. 83 4,229 4,229 4,229 4,229
------- -------- ------- -------
Shares used in per share calculation 4,229 11,937 4,229 8,082
======= ======== ======= =======
Net loss $(1,244) $ (1,893) $(2,878) $(5,654)
======= ======== ======= =======
Net loss per share $ (0.29) $ (0.16) $ (0.68) $ (0.70)
======= ======== ======= =======
</TABLE>
- ----------
(1) There is no difference between primary and fully diluted net loss per
share for all periods presented.
-14-
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM (A) THE
COMPANY'S FINANCIAL STATEMENTS FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND
IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH (B) FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
<CURRENCY> U.S. DOLLARS
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> DEC-31-1996
<PERIOD-START> JAN-01-1996
<PERIOD-END> SEP-30-1996
<EXCHANGE-RATE> 1
<CASH> 5,638
<SECURITIES> 55,589
<RECEIVABLES> 1,748
<ALLOWANCES> 0
<INVENTORY> 1,124
<CURRENT-ASSETS> 64,941
<PP&E> 1,493
<DEPRECIATION> 0
<TOTAL-ASSETS> 66,434
<CURRENT-LIABILITIES> 2,043
<BONDS> 0
0
0
<COMMON> 64,391
<OTHER-SE> 0
<TOTAL-LIABILITY-AND-EQUITY> 66,434
<SALES> 2,968
<TOTAL-REVENUES> 2,968
<CGS> 2,032
<TOTAL-COSTS> 2,032
<OTHER-EXPENSES> 8,027
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> (1,437)
<INCOME-PRETAX> (5,654)
<INCOME-TAX> 0
<INCOME-CONTINUING> (5,654)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
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<NET-INCOME> (5,654)
<EPS-PRIMARY> (.70)
<EPS-DILUTED> (.70)
</TABLE>
