e424b3
Filed Pursuant to Rule 424 (b) (3)
File No. 333-121625
CARDIOGENESIS CORPORATION
Prospectus Supplement No. 1 dated March 31, 2005
to the Prospectus dated January 14, 2005
On March 31, 2005, we filed with the Securities and Exchange Commission our Annual Report on
Form 10-K for the quarter and year ended December 31, 2004. The financial information and related
managements discussion and analysis of financial condition and results of operations attached
hereto supplement and supersede, in part, the information in the prospectus.
This prospectus supplement no. 1 should be read in conjunction with the prospectus, which is
required to be delivered with this prospectus supplement no.1.
Investing in our common stock involves a high degree of risk. See Risk Factors beginning on
page 2 of the prospectus for a discussion for the risks associated with our business.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus supplement no. 1 is
truthful or complete. Any representation to the contrary is a criminal offense.
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Item 6. |
Selected Consolidated Financial Data. |
The following selected consolidated statement of operations data
for fiscal years ended 2004, 2003 and 2002 and the consolidated
balance sheet data for 2004 and 2003 set forth below are derived
from our consolidated financial statements and are qualified by
reference to our consolidated financial statements included
herein.
The selected consolidated statement of operations data for
fiscal year ended 2001 and 2000 and the consolidated balance
sheet data for 2002, 2001 and 2000 have been derived from our
audited consolidated financial statements not included herein.
These historical results are not necessarily indicative of the
results of operations to be expected for any future period.
26
Selected Consolidated Financial Data
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Years Ended December 31, | |
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2004 | |
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2003 | |
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2002 | |
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2001 | |
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2000 | |
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| |
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(In thousands, except per share amounts) | |
Consolidated Statement of Operations Data:
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Net revenues
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$ |
15,454 |
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$ |
13,518 |
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$ |
13,048 |
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$ |
14,153 |
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$ |
22,210 |
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Cost of revenues
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|
2,193 |
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|
2,295 |
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2,935 |
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5,777 |
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10,055 |
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Gross profit
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13,261 |
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11,223 |
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10,113 |
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8,376 |
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12,155 |
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Operating expenses:
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Research and development
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1,442 |
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1,944 |
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657 |
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1,863 |
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5,065 |
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Sales, general and administrative
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11,322 |
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9,590 |
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12,297 |
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15,119 |
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22,009 |
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Restructuring and merger-related costs
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1,033 |
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Total operating expenses
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12,764 |
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11,534 |
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12,954 |
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18,015 |
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27,074 |
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Operating income (loss)
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497 |
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(311 |
) |
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(2,841 |
) |
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(9,639 |
) |
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(14,919 |
) |
Interest and other (expense) income, net
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(1,816 |
) |
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(37 |
) |
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2,311 |
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(608 |
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310 |
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Net loss
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$ |
(1,319 |
) |
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$ |
(348 |
) |
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$ |
(530 |
) |
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$ |
(10,247 |
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$ |
(14,609 |
) |
Net loss per share basic and diluted
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$ |
(0.03 |
) |
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$ |
(0.01 |
) |
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$ |
(0.01 |
) |
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$ |
(0.31 |
) |
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$ |
(0.48 |
) |
Shares used in per share calculation
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41,152 |
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37,303 |
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36,911 |
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33,311 |
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30,166 |
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Consolidated Balance Sheet Data:
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Cash, cash equivalents and marketable securities
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$ |
4,740 |
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$ |
1,013 |
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$ |
1,490 |
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$ |
2,629 |
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$ |
3,357 |
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Working capital
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6,994 |
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2,001 |
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1,614 |
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1,048 |
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4,662 |
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Total assets
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15,683 |
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6,460 |
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7,755 |
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11,309 |
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16,965 |
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Long-term debt, less current portion
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7,329 |
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6 |
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1 |
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32 |
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405 |
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Accumulated deficit
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(166,277 |
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(164,958 |
) |
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(164,610 |
) |
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(164,080 |
) |
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(153,833 |
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Total shareholders equity
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4,735 |
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3,820 |
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3,711 |
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3,582 |
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7,974 |
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Item 7. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations. |
This Managements Discussion and Analysis of Financial
Condition and Results of Operations contains descriptions of our
expectations regarding future trends affecting our business.
These forward-looking statements and other forward-looking
statements made elsewhere in this document are made in reliance
upon the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Please read the section below
titled Factors Affecting Future Results to review
conditions which we believe could cause actual results to differ
materially from those contemplated by the forward-looking
statements. Forward-looking statements are identified by words
such as believes, anticipates,
expects, intends, plans,
will, may and similar expressions. In
addition, any statements that refer to our plans, expectations,
strategies or other characterizations of future events or
circumstances are forward-looking statements. Our business may
have changed since the date hereof and we undertake no
obligation to update these forward looking statements.
The following discussion should be read in conjunction with
financial statements and notes thereto included in this Annual
Report on Form 10-K.
Overview
Cardiogenesis Corporation, formerly known as Eclipse Surgical
Technologies, Inc., incorporated in California in 1989, designs,
develops and distributes laser-based surgical products and
disposable fiber-optic
27
accessories for the treatment of advanced cardiovascular disease
through transmyocardial revascularization (TMR) and
percutaneous myocardial channeling (PMC). PMC was
formerly referred to as percutaneous myocardial
revascularization (PMR). The new name PMC more
literally depicts the immediate physiologic tissue effect of the
Cardiogenesis PMC system to ablate precise, partial thickness
channels into the heart muscle from the inside of the left
ventricle.
In February 1999, we received final approval from the FDA for
our TMR products for certain indications, and we are permitted
to sell those products in the U.S. on a commercial basis.
We have also received the European Conforming Mark (CE
Mark) allowing the commercial sale of our TMR laser
systems and our PMC catheter system to customers in the European
Community. Effective July 1999, the Centers for Medicare and
Medicaid Services (CMS) began providing Medicare
coverage for TMR. As a result, hospitals and physicians are now
eligible to receive Medicare reimbursement for TMR equipment and
procedures performed on Medicare recipients.
We have completed pivotal clinical trials involving PMC, and
study results were submitted to the FDA in a Pre Market Approval
(PMA application) in December 1999 along with
subsequent amendments. In July 2001, the FDA Advisory Panel
recommended against approval of PMC for public sale and use in
the United States. In February 2003, the FDA granted an
independent panel review of our pending PMA application for PMC
by the Medical Devices Dispute Resolution Panel
(MDDRP). In July 2003, the FDA agreed to review
additional data in support of our PMA supplement for PMC under
the structure of an interactive review process between us and
the FDA review team The independent panel review by the MDDRP
was cancelled in lieu of the interactive review, but the FDA has
agreed to reschedule the MDDRP hearing in the future, if the
dispute cannot be resolved. In August 2004, we met with the FDA
and agreed on the steps needed to design and initiate a new
clinical trial to confirm the safety and efficacy of PMC. In
January 2005, we again met with the agency and agreed on major
trial parameters. We are working closely with the FDA in
finalizing the clinical trial protocol to be formally agreed
upon. Once the agreement is achieved and the related costs are
clearly understood, we expect to move forward, either on our own
or with a corporate partner in the interventional cardiology
arena. There can be no assurance, however, that we will receive
a favorable determination from the FDA.
As of December 31, 2004, we had an accumulated deficit of
$166,277,000. We may continue to incur operating losses. The
timing and amounts of our expenditures will depend upon a number
of factors, including the efforts required to develop our sales
and marketing organization, the timing of market acceptance of
our products and the status and timing of regulatory approvals.
Results of Operations
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Year Ended December 31, 2004 Compared to Year Ended
December 31, 2003 |
We generate our revenues primarily through the sale of our TMR
laser base units and related handpieces, and related services.
Net revenues of $15,454,000 for the year ended December 31,
2004 increased $1,936,000, or 14%, when compared to net revenues
of $13,518,000 for the year ended December 31, 2003. The
increase in net revenues was primarily due to an increase in
domestic handpiece and laser revenues of $1,113,000 and
$692,000, respectively, as well as an increase in international
handpiece and laser sales of $3,000 and $65,000, respectively.
In addition, service and other revenue of $1,034,000 increased
by $63,000 for the year ended December 31, 2004 when
compared to $971,000 for the year ended December 31, 2003.
The increase in handpiece revenue is primarily related to a
higher average per unit selling price and a higher quantity sold
in 2004 as compared to 2003. In the year ended December 31,
2004, domestic handpiece revenue consisted of $2,214,000 in
sales to customers operating under our loaned laser program, of
which $699,000 was attributed to premiums associated with such
sales. In the year ended December 31, 2003, domestic
handpiece revenue consisted of $2,649,000 in sales of product to
customers operating under our loaned laser program, of which
$781,000 was attributed to premiums associated with such sales.
In the years
28
ended December 31, 2004 and 2003, sales of product to
customers not operating under our loaned laser program were
$7,936,000 and $6,387,000, respectively.
For the year ended December 31, 2004, domestic laser sales
increased by $692,000 compared to the year ended
December 31, 2003 primarily from a moderate increase in the
conversion of loaned lasers to outright sales. International
sales, accounting for approximately 3% of total sales for the
year ended December 31, 2004, increased $67,000 from the
prior year when international sales also accounted for 3% of
total sales. The increase in international sales occurred
primarily as a result of a higher average selling price of
lasers sold abroad.
Gross profit increased to 86% of net revenues for the year ended
December 31, 2004 as compared to 83% of net revenues for
the year ended December 31, 2003. Gross profit in absolute
dollars increased by $2,038,000 to $13,261,000 for the year
ended December 31, 2004, as compared to $11,223,000 for the
year ended December 31, 2003. The increase in gross profit
as a percent of sales, and in absolute terms, resulted from an
increase in margins due to a more favorable product mix as
higher-margin laser sales accounted for a greater portion of
revenues than in prior periods. In addition, margins on
disposable handpieces increased due to improvements in
manufacturing which resulted in higher yields.
Research and development expenditures of $1,442,000 decreased
$502,000 or 26% for the year ended December 31, 2004 when
compared to $1,944,000 for the year ended December 31,
2003. The decrease resulted from decreases in the costs
associated with our efforts to obtain FDA clearance for PMC.
Such costs were $1.4 million in 2003 compared to $288,000
in 2004 , with the decrease being partially offset by increased
spending on research and development activity for our minimally
invasive TMR platform in 2004.
For the years ended December 31, 2004 and 2003, research
and development expense included a credit of $152,000 and
$601,000, respectively, due to the reversal each year of amounts
recorded in accrued liabilities in prior years for estimated
clinical trial obligations subsequently determined no to be
needed.
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Sales, General and Administrative |
Sales, general and administrative expenditures of $11,322,000
increased $1,732,000 or 18% for the year ended December 31,
2004 when compared to $9,590,000 for the year ended
December 31, 2003. The increase in expenses resulted
primarily from an increase in employee expenses of $1,504,000
primarily related to an increase in our sales force, as well as
higher sales commissions paid out associated with an increase in
sales revenue. Additionally, advertising and marketing, and
training and clinical research expense increased $202,000 and
$214,000 respectively, due to the promotion of new products.
This was offset by a decrease in facilities and office expense
of $137,000 related to operational cost reduction efforts.
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Non-Operating Expense (Income) |
Total non-operating expense of $1,816,000 increased $1,779,000
or 4808% for the year ended December 31, 2004 when compared
to $37,000 for the year ended December 31, 2003. This
increase is primarily due to non-operating, non-cash charges
recorded in 2004 in relation to the Secured Convertible Term
Note (Note) issued in October 2004. These
non-operating, non-cash charges resulted from mark to market
charges on derivatives and warrants and interest and debt
issuance costs associated with the Note. Since the fair value of
the warrants and derivatives is tied in large part to our stock
price, in the future, if our stock price increases between
reporting periods, the warrants and derivatives become more
valuable. As such, there is no
29
way to forecast what the non-operating, non-cash charges will be
in the future or what the future impact will be on our financial
statements.
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2004 | |
|
2003 | |
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| |
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Years Ended December 31, | |
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| |
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Change | |
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| |
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) In thousands | |
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($ | |
Interest expense Secured Convertible Term Note
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|
$ |
77 |
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|
$ |
|
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$ |
77 |
|
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|
100 |
% |
Interest expense other
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|
58 |
|
|
|
44 |
|
|
|
14 |
|
|
|
32 |
% |
Non-cash interest expense Change in derivative
value
|
|
|
1,263 |
|
|
|
|
|
|
|
1,263 |
|
|
|
100 |
% |
Non-cash interest expense Accretion of discount
on Note
|
|
|
141 |
|
|
|
|
|
|
|
141 |
|
|
|
100 |
% |
Non-cash interest expense Amortization of debt
issuance costs relating to the Note
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|
35 |
|
|
|
|
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|
35 |
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|
100 |
% |
Other non-cash expense- Change in fair value of warrants
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|
|
290 |
|
|
|
|
|
|
|
290 |
|
|
|
100 |
% |
Interest income
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|
|
(48 |
) |
|
|
(7 |
) |
|
|
(41 |
) |
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|
586 |
% |
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Total interest expense, net
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|
$ |
1,816 |
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|
$ |
37 |
|
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$ |
1,779 |
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Year Ended December 31, 2003 Compared to Year Ended
December 31, 2002 |
We generate our revenues primarily through the sale of our TMR
laser base units and related handpieces, and related services .
Net revenues of $13,518,000 for the year ended December 31,
2003 increased $470,000, or 4%, when compared to net revenues of
$13,048,000 for the year ended December 31, 2002. The
increase in net revenues was due to an increase in domestic
handpiece and laser revenues of $268,000 and $286,000,
respectively, offset by a decrease in international handpiece
and laser sales of $9,000 and $69,000, respectively.
The increase in handpiece revenue is primarily related to a
higher average per unit selling price in 2003 as compared to
2002. In an effort to accelerate market adoption of the TMR
procedure, we developed a program pursuant to which we loan
lasers to hospitals in return for the hospital purchasing a
minimum number of handpieces at a premium over the list price.
In the year ended December 31, 2003, domestic handpiece
revenue consisted of $2,649,000 in sales to customers operating
under our loaned laser program, of which $781,000 was attributed
to premiums associated with such sales. In the year ended
December 31, 2002, domestic handpiece revenue consisted of
$2,832,000 in sales of product to customers operating under our
loaned laser program, of which $756,000 was attributed to
premiums associated with such sales. In the years ended
December 31, 2003 and 2002, sales of product to customers
not operating under our loaned laser program were $6,387,000 and
$5,937,000, respectively.
For the year ended December 31, 2003, domestic laser sales
increased by $286,000 compared to the year ended
December 31, 2002 primarily from a moderate increase in the
conversion of loaned lasers to outright sales. International
sales, accounting for approximately 3% of total sales for the
year ended December 31, 2003, decreased $78,000 from the
prior year when international sales accounted for 4% of total
sales. The decrease in international sales occurred primarily as
a result of fewer handpiece sales resulting from decreased sales
and marketing efforts in the international market compared to
2002. Service and other revenue of $971,000 slightly decreased
by $6,000 for the year ended December 31, 2003 when
compared to $977,000 for the year ended December 31, 2002.
Gross profit increased to 83% of net revenues for the year ended
December 31, 2003 as compared to 78% of net revenues for
the year ended December 31, 2002. Gross profit in absolute
dollars increased by $1,110,000 to $11,223,000 for the year
ended December 31, 2003, as compared to $10,113,000 for the
year ended December 31, 2002. The increase in gross profit
as a percent of sales, and in absolute terms, resulted from
improved margins on lasers sold. These margins improved
primarily due to sales of lasers originally placed
30
under our laser loan program that were converted to outright
sales. In addition, margins on disposable handpieces increased
due to improvements in manufacturing which resulted in higher
yields.
Research and development expenditures of $1,944,000 increased
$1,287,000 or 196% for the year ended December 31, 2003
when compared to $657,000 for the year ended December 31,
2002. The increase in overall research and development expense
resulted primarily from an increase in costs for outside
services of $463,000 related to the PMC approval process. For
the year ended December 31, 2003, a reduction of $601,000
was recorded on accrued liabilities recorded in prior years for
estimated clinical trial obligations. This reduction of accrued
liabilities decreased $828,000 for the year ended
December 31, 2002 and contributed to the overall increase
in research and development expenditures.
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Sales, General and Administrative |
Sales, general and administrative expenditures of $9,590,000
decreased $2,707,000 or 22% for the year ended December 31,
2003 when compared to $12,297,000 for the year ended
December 31, 2002. The decrease in expenses resulted
primarily from a decrease in employee expenses of $1,077,000
primarily related to reductions in our workforce. Additionally,
outside services, advertising and marketing, training and
clinical research, and facilities and office expense decreased
$564,000, $396,000, $152,000, $118,000, respectively, due to
overall cost cutting efforts.
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Interest and Other Income (Expense), Net |
Interest and other income (expense), net is comprised of
interest income, interest expense and our former ownership
interest in Microheart, Inc., a privately-held company
(Microheart).
Interest income of $7,000 decreased $32,000 or 82% for the year
ended December 31, 2003 when compared to $39,000 for the
year ended December 31, 2002. This decrease was due to
lower interest rates and lower investments in cash equivalents.
Interest expense of $44,000 increased $31,000 or 238% for the
year ended December 31, 2003 when compared to $13,000 for
the year ended December 31, 2002. This increase is
primarily due to a higher level of financing for equipment under
capital lease and amortization of debt issue costs.
A gain on the sale of an investee of $2,285,000 for the year
ended December 31, 2002 resulted from the sale of our
ownership interest in Microheart in April 2002.
Liquidity and Capital Resources
Cash and cash equivalents were $4,740,000 at December 31,
2004 compared to $1,013,000 at December 31, 2003, an
increase of $3,727,000. Net cash used in operating activities
was $967,000 for the twelve months ended December 31, 2004
primarily due to increased accounts receivable balances from
increased sales. Cash and cash equivalents were $1,013,000 at
December 31, 2003 compared to $1,490,000 at
December 31, 2002, a decrease of $477,000. We used $680,000
of cash for operating activities in the twelve months ended
December 31, 2003 primarily to pay down accounts payable
and accrued liabilities. During the year ended December 31,
2002, we incurred operating losses of $2,841,000, which, when
coupled with the payment of current liabilities partially offset
by non-cash operating expenses, resulted in the use of
$3,196,000 to support operating activities.
Cash used in investing activities during the twelve months ended
December 31, 2004 was $401,000 related to the acquisition
of property and equipment. Cash used in investing activities
during the twelve months ended December 31, 2003 was
$80,000 and was attributed to the acquisition of property and
equipment. Cash provided by investing activities during the
twelve months ended December 31, 2002 was $2,223,000
primarily consisting of the net proceeds obtained from the sale
of our ownership interest in Microheart.
31
Cash provided by financing activities during the twelve months
ended December 31, 2004 was $5,095,000 due primarily to
proceeds from the sale of common stock to private entities and
the proceeds from the Secured Convertible Term Note agreement
with Laurus Funds. In January 2004, we sold
3,100,000 shares of common stock to private investors for a
total price of $2,700,000. We also issued a warrant to
purchase 3,100,000 additional shares of common stock at a
price of $1.37 per share. The warrant is immediately
exercisable and has a term of five years.
In October 2004, we completed a financing transaction with
Laurus Master Fund, Ltd, a Cayman Islands corporation
(Laurus), pursuant to which we issued a Secured
Convertible Term Note in the aggregate principal amount of
$6.0 million and a warrant to purchase an aggregate of
2,640,000 shares of our common stock at a price of
$0.50 per share to Laurus in a private offering. Net
proceeds to us from the financing, after payment of fees and
expenses to Laurus and its affiliates, were $5,752,500. Of this
amount, we received $2,875,250 shown in net cash provided by
financing activities and $2,877,250 which was deposited in a
restricted cash account and is shown in the Supplemental
schedule of non-cash investing and financing activities. Funds
deposited in the restricted cash account will only be released
to us, if at all, upon satisfaction of certain conditions, such
as: 1) voluntary conversion of the restricted funds by
Laurus, and 2) conversion rights of the restricted funds by
us subject to certain stock price levels and trading volume
limitations.
The Note matures in October 2007, absent earlier redemption by
us or earlier conversion by Laurus. Annual interest on the Note
is equal to the prime rate published in The Wall
Street Journal from time to time, plus two percent (2.0%),
provided that such annual rate of interest may not be less than
six and one-half percent (6.5%), subject to certain downward
adjustments resulting from certain increases in the market price
of our common stock. Interest on the Note is payable monthly in
arrears on the first day of each month during the term of the
Note, commencing November 2004. In addition, commencing May
2005, we are required to make monthly principal payments of
$100,000 per month. To the extent that funds are released
from the restricted cash account prior to repayment in full of
the unrestricted portion of the Note proceeds, the monthly
payment amount may be increased by an amount equal to the amount
released from the restricted cash account divided by the
remaining number of monthly principal payments due on or prior
to the maturity date. The Note is convertible into shares of our
common stock at the option of Laurus and, in certain
circumstances, at our option.
The $6,000,000 Note includes embedded derivative financial
instruments. In conjunction with the Note, we issued a warrant
to purchase 2,640,000 shares of common stock. The
accounting treatment of the derivatives and warrant requires
that we record the derivatives and warrant at their relative
fair value as of the inception date of the agreement, and at
fair value as of each subsequent balance sheet date. Any change
in fair value will be recorded as non-operating, non-cash income
or expense at each reporting date. If the fair value of the
derivatives and warrant is higher at the subsequent balance
sheet date, we will record a non-operating, non-cash charge. If
the fair value of the derivatives and warrant is lower at the
subsequent balance sheet date, we will record non-operating,
non-cash income. As of December 31, 2004, the derivatives
were valued at $2,337,777. Conversion related derivatives were
valued using the Binomial Option Pricing Model with the
following assumptions: dividend yield of 0%; annual volatility
of 70.5%; and risk free interest rate of 3.25% as well as
probability analysis related to trading volume restrictions. The
remaining derivatives were valued using discounted cash flows
and probability analysis. The warrant was valued at $766,020 at
December 31, 2004 using the Binomial Option Pricing model
with the following assumptions: dividend yield of 0%; annual
volatility of 70.5%; risk-free interest rate of 3.94%; and
exercise factor of 2. Both the derivatives and warrant were
classified as long-term liabilities.
Cash provided by financing activities during the twelve months
ended December 31, 2003 was $283,000 primarily due to
proceeds from employee stock option exercises and common stock
purchased under the Employee Stock Purchase Plan. Cash used in
financing activities during the twelve months ended
December 31, 2002 was $254,000 resulting from payments on
short term borrowings of $825,000. This was offset by net
proceeds of $486,000 obtained from the sale of our common stock
to the State of Wisconsin Investment Board in April 2002 and
proceeds of $85,000 received from the sale of stock under the
Employee Stock Purchase Plan.
32
We have incurred significant losses for the last several years
and at December 31, 2004 we had an accumulated deficit of
$166,277,000. Our ability to maintain current operations is
dependent upon maintaining our sales at least at the same levels
achieved this year.
We also plan to continue our cost containment efforts by
focusing on sales, general and administrative expenses. We have
significantly reduced our cost of revenues, primarily due to the
outsourcing of a significant portion of our manufacturing which
allows us to purchase products at lower costs. To reduce
operating expenses, we have focused our efforts on reducing
headcount and overall expenses in functions that are not
essential to core and critical activities.
Currently, our primary goal is to maintain profitability at the
operating level. Our actions have been guided by this
initiative, and the resulting cost containment measures have
helped to conserve our cash. Our focus is upon core and critical
activities, thus operating expenses that are nonessential to our
core operations have been eliminated.
We believe our cash balance as of December 31, 2004 will be
sufficient to meet our capital, debt and operating requirements
through the next 12 months. We believe that if revenues
from sales or new funds from debt or equity instruments are
insufficient to maintain the current expenditure rate, it will
be necessary to significantly reduce our operations until an
appropriate solution is implemented.
We will have a continuing need for new infusions of cash if we
incur losses in the future. We plan to increase our sales
through increased direct sales and marketing efforts on existing
products and achieving regulatory approval for other products.
If our direct sales and marketing efforts are unsuccessful or we
are unable to achieve regulatory approval for our products, we
will be unable to significantly increase our revenues. We
believe that if we are unable to generate sufficient funds from
sales or from debt or equity issuances to maintain our current
expenditure rate, it will be necessary to significantly reduce
our operations. We may be required to seek additional sources of
financing, which could include short-term debt, long-term debt
or equity. There is a risk that we may be unsuccessful in
obtaining such financing and that we will not have sufficient
cash to fund our operations.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Less than | |
|
1-3 | |
|
3-5 | |
|
More than |
Contractual Obligations |
|
Total | |
|
1 Year | |
|
Years | |
|
Years | |
|
5 Years |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(In thousands) |
Secured Convertible Term Note, net of restricted cash
|
|
$ |
3,000 |
|
|
$ |
800 |
|
|
$ |
2,200 |
|
|
|
|
|
|
|
|
|
Secured Convertible Term Note Interest(1)
|
|
$ |
203 |
|
|
$ |
54 |
|
|
$ |
149 |
|
|
|
|
|
|
|
|
|
Capital Lease Obligations
|
|
$ |
23 |
|
|
$ |
5 |
|
|
$ |
12 |
|
|
$ |
6 |
|
|
|
|
|
Operating Leases
|
|
$ |
686 |
|
|
$ |
366 |
|
|
$ |
320 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
3,912 |
|
|
$ |
1,225 |
|
|
$ |
2,681 |
|
|
$ |
6 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Assumes 6.75% effective interest rate. |
Critical Accounting Policies and Estimates
The preparation of financial statements in conformity with
generally accepted accounting principles requires our management
to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements
and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those
estimates.
The following presents a summary of our critical accounting
policies and estimates, defined as those policies and estimates
we believe are: (i) the most important to the portrayal of
our financial condition and results of operations, and
(ii) that require our most difficult, subjective or complex
judgments, often as a result of the need to make estimates about
the effects of matters that are inherently uncertain. Our most
significant estimates relate to the determination of the
allowance for bad debt, inventory reserves, valuation allowance
33
relating to deferred tax asset, warranty reserve, the assessment
of future cash flows in evaluating intangible assets for
impairment and assumptions used in fair value determination of
warrants and derivatives.
We recognize revenue on product sales upon receipt of a purchase
order upon shipment of the products when the price is fixed or
determinable and when collection of sales proceeds is reasonably
assured. Where purchase orders allow customers an acceptance
period or other contingencies, revenue is recognized upon the
earlier of acceptance or removal of the contingency.
Revenues from sales to distributors and agents are recognized
upon shipment when there is evidence that an arrangement exists,
delivery has occurred under the Companys standard FOB
shipping point terms, the sales price is fixed or determinable
and the ability to collect sales proceeds is reasonably assured.
The contracts regarding these sales do not include any rights of
return or price protection clauses.
We frequently loan lasers to hospitals in return for the
hospital purchasing a minimum number of handpieces at a premium
over the list price. The loaned lasers are depreciated to cost
of revenues over a useful life of 24 months. The revenue on
the handpieces is recognized upon shipment at an amount equal to
the list price. The premium over the list price represents
revenue related to the use of the laser unit and is recognized
ratably, generally over the 24-month useful life of the placed
lasers.
Revenues from service contracts, rentals, and per procedure fees
are recognized upon performance or over the terms of the
contract as appropriate.
Accounts receivable consist of trade receivables recorded upon
recognition of revenue for product sales, reduced by reserves
for the estimated amount deemed uncollectible due to bad debt.
The allowance for doubtful accounts is our best estimate of the
amount of probable credit losses in our existing accounts
receivable. We review the allowance for doubtful accounts
quarterly with the corresponding provision included in general
and administrative expenses. Past due balances over 90 days
and over a specified amount are reviewed individually for
collectibility. All other balances are reviewed on a pooled
basis by type of receivable. Account balances are charged off
against the allowance when we feel it is probable the receivable
will not be recovered. We do not have any off-balance-sheet
credit exposure related to our customers.
Inventories are stated at the lower of cost (principally
standard cost, which approximates actual cost on a first-in,
first-out basis) or market value. We regularly monitor potential
excess, or obsolete, inventory by analyzing the usage for parts
on hand and comparing the market value to cost. When necessary,
we reduce the carrying amount of our inventory to its market
value.
|
|
|
Valuation of Long-lived Assets: |
We assess potential impairment of our finite lived, intangible
assets and other long-lived assets when there is evidence that
recent events or changes in circumstances indicate that their
carrying value may not be recoverable. Reviews are performed to
determine whether the carrying value of assets is impaired based
on comparison to the undiscounted estimated future cash flows.
If the comparison indicates that there is impairment, the
impaired asset is written down to fair value, which is typically
calculated using discounted estimated future cash flows. The
amount of impairment would be recognized as the excess of the
assets carrying value over its fair value. Events or changes in
circumstances which may cause impairment include: significant
changes in the manner of use of the acquired asset, negative
industry or economic trends, and underperformance relative to
historic or projected future operating results.
34
We account for income taxes using the liability method under
which deferred tax assets or liabilities are calculated at the
balance sheet date using current tax laws and rates in effect
for the year in which the differences are expected to affect
taxable income. Valuation allowances are established, when
necessary, to reduce deferred tax assets to the amounts expected
to be realized.
35
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of
Cardiogenesis Corporation
In our opinion, the accompanying consolidated financial
statements listed in the index appearing under
Item 15(a)(1) present fairly, in all material respects, the
financial position of Cardiogenesis Corporation and its
subsidiaries (the Company) at December 31, 2004
and December 31, 2003, and the results of their operations
and their cash flows for each of the three years in the period
ended December 31, 2004 in conformity with accounting
principles generally accepted in the United States of America.
In addition, in our opinion, the financial statement schedule
listed in the index appearing under Item 15(a)(2) presents
fairly, in all material respects, the information set forth
therein when read in conjunction with the related consolidated
financial statements. These financial statements and the
financial statement schedule are the responsibility of the
Companys management; our responsibility is to express an
opinion on these financial statements and the financial
statement schedule based on our audits. We conducted our audits
of these statements in accordance with the Standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles
used and significant estimates made by management, and
evaluating the overall financial statement presentation. We
believe that our audits provide a reasonable basis for our
opinion.
|
|
|
PricewaterhouseCoopers LLP |
Orange County, California
March 16, 2005
43
CARDIOGENESIS CORPORATION
CONSOLIDATED BALANCE SHEETS
December 31, 2004 and 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
(In thousands) | |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
4,740 |
|
|
$ |
1,013 |
|
|
Accounts receivable, net
|
|
|
3,578 |
|
|
|
1,830 |
|
|
Inventories, net
|
|
|
1,782 |
|
|
|
1,339 |
|
|
Prepaids and other current assets
|
|
|
513 |
|
|
|
453 |
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
10,613 |
|
|
|
4,635 |
|
Property and equipment, net
|
|
|
601 |
|
|
|
408 |
|
Restricted cash
|
|
|
2,884 |
|
|
|
|
|
Other assets
|
|
|
1,585 |
|
|
|
1,417 |
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
15,683 |
|
|
$ |
6,460 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
893 |
|
|
$ |
876 |
|
|
Accrued liabilities
|
|
|
1,263 |
|
|
|
1,159 |
|
|
Customer deposits
|
|
|
|
|
|
|
25 |
|
|
Deferred revenue
|
|
|
658 |
|
|
|
573 |
|
|
Current portion of capital lease obligation
|
|
|
5 |
|
|
|
1 |
|
|
Current portion of Secured Convertible Term Note
|
|
|
800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
3,619 |
|
|
|
2,634 |
|
Capital lease obligation, less current portion
|
|
|
18 |
|
|
|
6 |
|
Other long-term liability
|
|
|
496 |
|
|
|
|
|
Secured Convertible Term Note and related obligations
|
|
|
6,815 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
10,948 |
|
|
|
2,640 |
|
|
|
|
|
|
|
|
Commitments and contingencies (Note 8)
|
|
|
|
|
|
|
|
|
|
Shareholders equity:
|
|
|
|
|
|
|
|
|
|
Preferred stock:
|
|
|
|
|
|
|
|
|
|
|
no par value; 5,000 shares authorized; none issued and
outstanding;
|
|
|
|
|
|
|
|
|
|
Common stock:
|
|
|
|
|
|
|
|
|
|
|
no par value; 75,000 shares authorized; 41,500 and
37,859 shares issued and outstanding at December 31,
2004 and 2003, respectively
|
|
|
171,012 |
|
|
|
168,778 |
|
|
Accumulated deficit
|
|
|
(166,277 |
) |
|
|
(164,958 |
) |
|
|
|
|
|
|
|
|
|
Total shareholders equity
|
|
|
4,735 |
|
|
|
3,820 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity
|
|
$ |
15,683 |
|
|
$ |
6,460 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements
44
CARDIOGENESIS CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
For the Years Ended December 31, 2004, 2003 and 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands, except per share | |
|
|
amounts) | |
Net revenues
|
|
$ |
15,454 |
|
|
$ |
13,518 |
|
|
$ |
13,048 |
|
Cost of revenues
|
|
|
2,193 |
|
|
|
2,295 |
|
|
|
2,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
13,261 |
|
|
|
11,223 |
|
|
|
10,113 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,442 |
|
|
|
1,944 |
|
|
|
657 |
|
|
Sales, general and administrative
|
|
|
11,322 |
|
|
|
9,590 |
|
|
|
12,297 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
12,764 |
|
|
|
11,534 |
|
|
|
12,954 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss)
|
|
|
497 |
|
|
|
(311 |
) |
|
|
(2,841 |
) |
Interest expense
|
|
|
(135 |
) |
|
|
(44 |
) |
|
|
(13 |
) |
Interest income
|
|
|
48 |
|
|
|
7 |
|
|
|
39 |
|
Non-cash interest expense
|
|
|
(1,439 |
) |
|
|
|
|
|
|
|
|
Other non-cash expense
|
|
|
(290 |
) |
|
|
|
|
|
|
|
|
Gain on sale of investee
|
|
|
|
|
|
|
|
|
|
|
2,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(1,319 |
) |
|
|
(348 |
) |
|
|
(530 |
) |
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
$ |
(1,319 |
) |
|
$ |
(348 |
) |
|
$ |
(442 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$ |
(0.03 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding
|
|
|
41,152 |
|
|
|
37,303 |
|
|
|
36,911 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements
45
CARDIOGENESIS CORPORATION
CONSOLIDATED STATEMENTS OF SHAREHOLDERS EQUITY
For the Years Ended December 31, 2004, 2003 and 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
|
|
|
|
Other | |
|
|
|
|
|
|
Common Stock | |
|
Comprehensive | |
|
|
|
|
|
|
| |
|
Income | |
|
Accumulated | |
|
|
|
|
Shares | |
|
Amount | |
|
(Loss) | |
|
Deficit | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Balances, December 31, 2001
|
|
|
36,507 |
|
|
$ |
167,750 |
|
|
$ |
(88 |
) |
|
$ |
(164,080 |
) |
|
$ |
3,582 |
|
|
Issuance of common stock pursuant to stock purchased under the
Employee Stock Purchase Plan
|
|
|
114 |
|
|
|
85 |
|
|
|
|
|
|
|
|
|
|
|
85 |
|
|
Issuance of common stock for cash
|
|
|
500 |
|
|
|
486 |
|
|
|
|
|
|
|
|
|
|
|
486 |
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
88 |
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(530 |
) |
|
|
(530 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances, December 31, 2002
|
|
|
37,121 |
|
|
|
168,321 |
|
|
|
|
|
|
|
(164,610 |
) |
|
|
3,711 |
|
|
Issuance of common stock pursuant to exercise of options
|
|
|
607 |
|
|
|
294 |
|
|
|
|
|
|
|
|
|
|
|
294 |
|
|
Issuance of common stock pursuant to stock purchased under the
Employee Stock Purchase Plan
|
|
|
131 |
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
Issuance of common stock purchase warrants
|
|
|
|
|
|
|
75 |
|
|
|
|
|
|
|
|
|
|
|
75 |
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(348 |
) |
|
|
(348 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances, December 31, 2003
|
|
|
37,859 |
|
|
|
168,778 |
|
|
|
|
|
|
|
(164,958 |
) |
|
|
3,820 |
|
Issuance of common stock pursuant to exercise of options
|
|
|
317 |
|
|
|
184 |
|
|
|
|
|
|
|
|
|
|
|
184 |
|
Issuance of common stock pursuant to stock purchased under the
Employee Stock Purchase Plan
|
|
|
184 |
|
|
|
87 |
|
|
|
|
|
|
|
|
|
|
|
87 |
|
Issuance of common stock for cash
|
|
|
3,140 |
|
|
|
2,304 |
|
|
|
|
|
|
|
|
|
|
|
2,304 |
|
Reclassification of stock purchase warrants to long-term
liabilities
|
|
|
|
|
|
|
(341 |
) |
|
|
|
|
|
|
|
|
|
|
(341 |
) |
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,319 |
) |
|
|
(1,319 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances, December 31, 2004
|
|
|
41,500 |
|
|
$ |
171,012 |
|
|
$ |
|
|
|
$ |
(166,277 |
) |
|
$ |
4,735 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements
46
CARDIOGENESIS CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Years Ended December 31, 2004, 2003 and 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(1,319 |
) |
|
$ |
(348 |
) |
|
$ |
(530 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative and warrant fair value adjustments
|
|
|
1,553 |
|
|
|
|
|
|
|
|
|
|
|
Accretion related to discount on notes payable
|
|
|
141 |
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
228 |
|
|
|
261 |
|
|
|
308 |
|
|
|
Gain from sale of equity investee
|
|
|
|
|
|
|
|
|
|
|
(2,285 |
) |
|
|
Provision for doubtful accounts
|
|
|
19 |
|
|
|
26 |
|
|
|
335 |
|
|
|
Inventory reserves
|
|
|
32 |
|
|
|
198 |
|
|
|
854 |
|
|
|
Interest expense accrued on note payable
|
|
|
77 |
|
|
|
|
|
|
|
|
|
|
|
Amortization of other assets
|
|
|
195 |
|
|
|
195 |
|
|
|
194 |
|
|
|
Amortization of debt issuance costs
|
|
|
66 |
|
|
|
44 |
|
|
|
|
|
|
|
Loss on disposal of property and equipment
|
|
|
|
|
|
|
|
|
|
|
28 |
|
|
|
Reduction of clinical trial accrual
|
|
|
(152 |
) |
|
|
(601 |
) |
|
|
(1,282 |
) |
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(1,767 |
) |
|
|
105 |
|
|
|
34 |
|
|
|
|
Inventories
|
|
|
(475 |
) |
|
|
95 |
|
|
|
729 |
|
|
|
|
Prepaids and other current assets
|
|
|
259 |
|
|
|
202 |
|
|
|
619 |
|
|
|
|
Other assets
|
|
|
(157 |
) |
|
|
(103 |
) |
|
|
|
|
|
|
|
Accounts payable
|
|
|
17 |
|
|
|
(365 |
) |
|
|
(307 |
) |
|
|
|
Accrued liabilities
|
|
|
256 |
|
|
|
(316 |
) |
|
|
(1,084 |
) |
|
|
|
Current portion of long term liabilities
|
|
|
|
|
|
|
|
|
|
|
(495 |
) |
|
|
|
Customer deposits
|
|
|
(25 |
) |
|
|
(25 |
) |
|
|
(4 |
) |
|
|
|
Deferred revenue
|
|
|
85 |
|
|
|
(48 |
) |
|
|
(310 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(967 |
) |
|
|
(680 |
) |
|
|
(3,196 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of equity in investee
|
|
|
|
|
|
|
|
|
|
|
2,285 |
|
|
Acquisition of property and equipment
|
|
|
(401 |
) |
|
|
(80 |
) |
|
|
(62 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities
|
|
|
(401 |
) |
|
|
(80 |
) |
|
|
2,223 |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of common stock from exercise of
options and from stock purchased under the Employee Stock
Purchase Plan
|
|
|
271 |
|
|
|
307 |
|
|
|
85 |
|
|
Net proceeds from sale of common stock to private entities
|
|
|
2,304 |
|
|
|
|
|
|
|
486 |
|
|
Payments on short term borrowings
|
|
|
(351 |
) |
|
|
|
|
|
|
(794 |
) |
|
Net proceeds from issuance of long-term debt
|
|
|
2,875 |
|
|
|
|
|
|
|
|
|
|
Repayments of capital lease obligations
|
|
|
(4 |
) |
|
|
(24 |
) |
|
|
(31 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities
|
|
|
5,095 |
|
|
|
283 |
|
|
|
(254 |
) |
|
|
|
|
Effect of exchange rates on cash and cash equivalents
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
3,727 |
|
|
|
(477 |
) |
|
|
(1,139 |
) |
Cash and cash equivalents at beginning of year
|
|
|
1,013 |
|
|
|
1,490 |
|
|
|
2,629 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year
|
|
$ |
4,740 |
|
|
$ |
1,013 |
|
|
$ |
1,490 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$ |
10 |
|
|
$ |
19 |
|
|
$ |
13 |
|
|
|
|
|
|
|
|
|
|
|
|
Taxes paid
|
|
$ |
41 |
|
|
$ |
23 |
|
|
$ |
60 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of noncash investing and financing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock purchase warrants
|
|
$ |
|
|
|
$ |
75 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Legally restricted proceeds from issuance of long-term debt
|
|
$ |
2,877 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements
47
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Nature
of Operations:
Cardiogenesis Corporation (Cardiogenesis or the
Company), formerly known as Eclipse Surgical
Technologies, Inc., was founded in 1989 to develop, manufacture
and market surgical lasers and accessories for the treatment of
disease. Currently, Cardiogenesis emphasis is on the
development and manufacture of products used for transmyocardial
revascularization (TMR) and percutaneous myocardial
channeling (PMC), which are cardiovascular
procedures. PMC was formerly referred to as percutaneous
myocardial revascularization (PMR). The new name PMC
more literally depicts the immediate physiologic tissue effect
of the Cardiogenesis PMC system to ablate precise, partial
thickness channels into the heart muscle from the inside of the
left ventricle.
Cardiogenesis markets its products for sale primarily in the
U.S., Europe and Asia. Cardiogenesis operates in a single
segment.
These financial statements contemplate the realization of assets
and the satisfaction of liabilities in the normal course of
business. Cardiogenesis has sustained significant operating
losses for the last several years and may continue to incur
losses through 2005. Management believes its cash and cash
equivalents balance as of December 31, 2004 is sufficient
to meet the Companys capital and operating requirements
for the next 12 months.
Cardiogenesis may require additional financing in the future.
There can be no assurance that Cardiogenesis will be able to
obtain additional debt or equity financing, if and when needed,
on terms acceptable to the Company. Any additional equity or
debt financing may involve substantial dilution to
Cardiogenesis stockholders, restrictive covenants or high
interest costs. The failure to raise needed funds on
sufficiently favorable terms could have a material adverse
effect on the execution of the Companys business plan,
operating results or financial condition. Cardiogenesis
long term liquidity also depends upon its ability to increase
revenues from the sale of its products and achieve
profitability. The failure to achieve these goals could have a
material adverse effect on the execution of the Companys
business plan, operating results or financial condition.
2. Summary of Significant
Accounting Policies:
The preparation of financial statements in conformity with
generally accepted accounting principles requires management to
make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting
period. Actual results could differ from those estimates.
|
|
|
Cash and Cash Equivalents: |
All highly liquid instruments purchased with a maturity of three
months or less at the time of purchase are considered cash
equivalents.
Accounts receivable consist of trade receivables recorded upon
recognition of revenue for product sales, reduced by reserves
for the estimated amount deemed uncollectible due to bad debt.
The allowance for doubtful accounts is the Companys best
estimate of the amount of probable credit losses in its existing
accounts receivable. The Company reviews the allowance for
doubtful accounts quarterly with the corresponding provision
included in general and administrative expenses. Past due
balances over 90 days and over a specified amount are
reviewed individually for collectibility. All other balances are
reviewed on a pooled basis
48
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
by type of receivable. Account balances are charged off against
the allowance when the Company feels it is probable the
receivable will not be recovered. The Company does not have any
off-balance-sheet credit exposure related to its customers.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at | |
|
|
|
|
|
Balance at | |
|
|
Beginning | |
|
|
|
|
|
End of | |
|
|
of Period | |
|
Additions (1) | |
|
Deductions (2) | |
|
Period | |
|
|
| |
|
| |
|
| |
|
| |
Allowance for doubtful accounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts
|
|
$ |
1,354 |
|
|
$ |
335 |
|
|
$ |
1,240 |
|
|
$ |
449 |
|
Year ended December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts
|
|
$ |
449 |
|
|
$ |
26 |
|
|
$ |
449 |
|
|
$ |
26 |
|
Year ended December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts
|
|
$ |
26 |
|
|
$ |
19 |
|
|
$ |
34 |
|
|
$ |
11 |
|
|
|
(1) |
Charged to costs and expenses. |
|
(2) |
Amounts written off against the reserve. |
Inventories are stated at the lower of cost (principally
standard cost, which approximates actual cost on a first-in,
first-out basis) or market value. The Company regularly monitors
potential excess, or obsolete, inventory by analyzing the usage
for parts on hand and comparing the market value to cost. When
necessary, the Company reduces the carrying amount of inventory
to its market value.
Patent and patent related expenditures are expensed as general
and administrative expenses as incurred.
In conjunction with the Secured Convertible Term Note,
$2,877,250 of the amounts received by the Company was deposited
in a restricted cash account. As of December 31, 2004, the
Company has received $7,000 of interest income related to this
balance, which is also restricted. Funds deposited in the
restricted cash account will only be released to the Company, if
at all, upon satisfaction of certain conditions, such as:
1) voluntary conversion of the restricted funds by Laurus,
and 2) conversion rights of the restricted funds by
Cardiogenesis subject to certain stock price requirements and
trading volume limitations. See Note 7.
Property and equipment are stated at cost and depreciated on a
straight-line basis over their estimated useful lives of two to
seven years. Assets acquired under capital leases are amortized
over the shorter of their estimated useful lives or the term of
the related lease (generally three to five years). Amortization
of leasehold improvements is based on the straight-line method
over the shorter of the estimated useful life or the lease term.
|
|
|
Accounting for the Impairment or Disposal of Long-Lived
Assets: |
The Company assesses potential impairment of finite lived,
intangible assets and other long-lived assets when there is
evidence that recent events or changes in circumstances indicate
that their carrying value may not be recoverable. Reviews are
performed to determine whether the carrying value of assets is
impaired based
49
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
on comparison to the undiscounted estimated future cash flows.
If the comparison indicates that there is impairment, the
impaired asset is written down to fair value, which is typically
calculated using discounted estimated future cash flows. The
amount of impairment would be recognized as the excess of the
assets carrying value over its fair value. Events or
changes in circumstances which may cause impairment include:
significant changes in the manner of use of the acquired asset,
negative industry or economic trends, and underperformance
relative to historic or projected future operating results.
|
|
|
Fair Value of Other Financial Instruments: |
The Companys financial instruments consist primarily of
cash equivalents, accounts receivables, trade accounts payable,
accrued liabilities and the Secured Convertible Term Note and
related embedded derivatives. The carrying amounts of certain of
Cardiogenesis financial instruments including cash
equivalents, accounts receivable, accounts payable, and accrued
liabilities approximate fair value due to their short
maturities. The fair value of the embedded derivatives related
to the Secured Convertible Term Note and related obligations was
determined using the Binomial Option Pricing Model.
|
|
|
Derivative financial instruments |
The Companys derivative financial instruments consist of
embedded derivatives related to the $6,000,000 Secured
Convertible Term Note (Note). These embedded
derivatives include certain conversion features and variable
interest features. The accounting treatment of derivatives
requires that the Company record the derivatives at their
relative fair values as of the inception date of the agreement,
and at fair value as of each subsequent balance sheet date. Any
change in fair value will be recorded as non-operating, non-cash
income or expense at each reporting date. If the fair value of
the derivatives is higher at the subsequent balance sheet date,
the Company will record a non-operating, non-cash charge. If the
fair value of the derivatives is lower at the subsequent balance
sheet date, the Company will record non-operating, non-cash
income. As of December 31, 2004, the derivatives were
valued at $2,337,777. Conversion related derivatives were valued
using the Binomial Option Pricing Model with the following
assumptions: dividend yield of 0%; annual volatility of 70.5%;
and risk free interest rate of 3.25% as well as probablility
analysis related to trading volume restrictions. The remaining
derivatives were valued using discounted cash flows and
probability analysis. The derivatives are classified as
long-term liabilities. See Note 7.
Cardiogenesis recognizes revenue on product sales upon receipt
of a purchase order, shipment of the products, the price is
fixed or determinable and collection of sales proceeds is
reasonably assured. Where purchase orders allow customers an
acceptance period or other contingencies, revenue is recognized
upon the earlier of acceptance or removal of the contingency.
Revenues from sales to distributors and agents are recognized
upon shipment when there is evidence that an arrangement exists,
delivery has occurred under the Companys standard FOB
shipping point terms, the sales price is fixed or determinable
and the ability to collect sales proceeds is reasonably assured.
The contracts regarding these sales do not include any rights of
return or price protection clauses.
Cardiogenesis frequently loans lasers to hospitals in return for
the hospital purchasing a minimum number of handpieces at a
premium over the list price. The loaned lasers are depreciated
to cost of revenues over a useful life of 24 months. The
revenue on the handpieces is recognized upon shipment at an
amount equal to the list price. The premium over the list price
represents revenue related to the use of the laser unit and is
recognized ratably, generally over the 24-month useful life of
the placed lasers.
Revenues from service contracts, rentals, and per procedure fees
are recognized upon performance or over the terms of the
contract as appropriate.
50
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
Shipping and Handling Costs and Revenues: |
All shipping and handling costs are expensed as incurred and are
recorded as a component of cost of sales. Amounts billed to
customers for shipping and handling are included as a component
of revenue.
|
|
|
Research and Development: |
Research and development costs are charged to operations as
incurred.
Cardiogenesis laser products are generally sold with a one
year warranty. Cardiogenesis provides for estimated future costs
of repair or replacement which are reflected in accrued
liabilities in the accompanying financial statements.
Cardiogenesis expenses all advertising as incurred.
Cardiogenesis advertising expenses were $573,000, $80,000
and $221,000 for 2004, 2003, and 2002, respectively. Advertising
expenses include fees for website design and hosting, reprints
from medical journals, promotional materials and sales sheets.
Cardiogenesis accounts for income taxes using the liability
method under which deferred tax assets or liabilities are
calculated at the balance sheet date using current tax laws and
rates in effect for the year in which the differences are
expected to affect taxable income. Valuation allowances are
established, when necessary, to reduce deferred tax assets to
the amounts expected to be realized.
|
|
|
Foreign Currency Translation: |
In 2002, there were translation adjustments recorded in
Cardiogenesis financial statements attributed to an
international subsidiary, a foreign sales corporation
(FSC). The FSC used its local currency as its
functional currency. Assets and liabilities were translated at
exchange rates in effect at the balance sheet date and income
and expense accounts at average exchange rates during the year.
Resulting translation adjustments were recorded in accumulated
other comprehensive income (loss) in shareholders equity.
In 2003, the Company decided to discontinue this FSC and at
December 31, 2003 and 2004 the only remaining asset is a
nominal cash balance.
|
|
|
Stock-Based Compensation: |
Cardiogenesis accounts for its stock-based compensation in
accordance with Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees
(APB 25). Cardiogenesis has elected to adopt
the disclosure only provisions of Statement of Financial
Accounting Standards No. 123, Accounting for
Stock-Based Compensation (SFAS 123),
which requires pro forma disclosures in the financial statements
as if the measurement provisions of SFAS 123 had been
adopted. In addition, the Company has made the appropriate
disclosures as required under the Statement of Financial
Accounting Standards No. 148, Accounting for
Stock-Based Compensation Transition and
Disclosure.
Had compensation cost for the Stock Option Plan, the
Directors Stock Option Plan and the ESPP been determined
based on the fair value of the options at the grant date for
awards consistent with the provisions of
51
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
SFAS 123, Cardiogenesis net loss and net loss per
share would have increased to the pro forma amounts indicated
below (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Net loss as reported
|
|
$ |
(1,319 |
) |
|
$ |
(348 |
) |
|
$ |
(530 |
) |
Stock-based employee compensation, net of related tax effects
|
|
$ |
(482 |
) |
|
$ |
(1,135 |
) |
|
$ |
(1,404 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma net loss
|
|
$ |
(1,801 |
) |
|
$ |
(1,483 |
) |
|
$ |
(1,934 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share as reported
|
|
$ |
(0.03 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
Pro forma basic and diluted net loss per share
|
|
$ |
(0.04 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.05 |
) |
Weighted average basic and diluted shares outstanding
|
|
|
41,152 |
|
|
|
37,303 |
|
|
|
36,911 |
|
The above pro-forma disclosures are not necessarily
representative of the effects on reported net income or loss for
future years. The aggregate fair value and weighted average fair
value per share of options granted in the years ended
December 31, 2004, 2003 and 2002 were $593,000, $651,000,
and $646,000, and $0.63, $0.33, and $0.58, respectively. The
fair value of each option grant is estimated on the date of
grant using the Black-Scholes option pricing model with the
following weighted-average assumptions for grants in 2004, 2003
and 2002:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Expected life of option
|
|
|
7 years |
|
|
|
7 years |
|
|
|
7 years |
|
Risk-free interest rate
|
|
|
3.7 |
% |
|
|
3.68 |
% |
|
|
4.04 |
% |
Expected dividends
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected volatility
|
|
|
79 |
% |
|
|
151 |
% |
|
|
75 |
% |
The aggregate fair value and weighted average fair value per
share of purchase rights under the ESPP in fiscal years 2004,
2003 and 2002 were $45,000, $55,000 and $56,000, and $0.34,
$0.43 and $0.59, respectively. The fair value for the purchase
rights under the ESPP is estimated using the Black-Scholes
option pricing model, with the following assumptions for the
rights granted in 2004, 2003 and 2002:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Expected life
|
|
|
0.5 years |
|
|
|
0.5 years |
|
|
|
0.5 years |
|
Risk-free interest rate
|
|
|
3.7 |
% |
|
|
3.68 |
% |
|
|
4.04 |
% |
Expected dividends
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected volatility
|
|
|
79 |
% |
|
|
151 |
% |
|
|
75 |
% |
Cardiogenesis accounts for non-employee stock-based awards, in
which goods or services are the consideration received for the
stock options issued, in accordance with the provisions of
SFAS No. 123 and related interpretations. Compensation
expense for non-employee stock-based awards is recognized in
accordance with FASB Interpretation 28, Accounting
for Stock Appreciation Rights and Other Variable Stock Options
or Award Plans, an Interpretation of APB Opinions No. 15,
and 25 (FIN 28). Under SFAS No. 123 and
FIN 28, the Company records compensation expense based on
the then-current fair values of the stock options at each
financial date. Compensation recorded during the service period
is adjusted in subsequent periods for changes in the stock
options fair value.
52
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Basic earnings per share (EPS) is computed by
dividing the net loss by the weighted average number of common
shares outstanding for the period. Diluted EPS is computed
giving effect to all dilutive potential common shares that were
outstanding during the period. Dilutive potential common shares
consist of incremental shares issuable upon the exercise of
stock options, warrants and convertible notes payable using the
treasury stock method.
Options to purchase 4,177,000, 4,070,000, and
3,477,000 shares of common stock were outstanding at
December 31, 2004, 2003 and 2002, respectively. The range
of per share exercise prices for these options was
$0.32-$12.6875 for 2004, 2003 and 2002. Warrants to
purchase 75,000 shares of common stock at
$1.63 per share were outstanding as of December 31,
2004 and 2003. Warrants to purchase 275,000 shares of
common stock at prices ranging from $.35 to $.44 per share
were outstanding as of December 31, 2004 and 2003. Warrants
to purchase 3,100,000 and 2,640,000 shares of common
stock at $1.37 and $0.50, respectively, per share were also
outstanding at December 31, 2004. A $6,000,000 convertible
note payable, convertible at $0.50 per share subject to
certain downward adjustments due to decreases in the
Companys stock price, was outstanding at December 31,
2004. None of the options, warrants or convertible notes were
included in the calculation of diluted EPS because their
inclusion would have been anti-dilutive.
|
|
|
Recently Issued Accounting Standards: |
In September 2004, the Emerging Issues Task Force finalized its
consensus on EITF Issue No. 04-8, The Effect of
Contingently Convertible Debt on Diluted Earnings Per
Share (EITF 04-8). EITF 04-8 addresses when the
dilutive effect of contingently convertible debt with a market
price trigger should be included in diluted earnings per share
(EPS). Under EITF 04-8, the market price contingency should
be ignored and these securities should be treated as
non-contingent, convertible securities and always included in
the diluted EPS computation unless their inclusion would be
anti-dilutive. EITF 04-8 requires these securities be
included in diluted EPS using either the if-converted method or
the net share settlement method, depending on the conversion
terms of the security. EITF 04-8 is effective for all
periods ending after December 15, 2004 and is to be applied
by retrospectively restating previously reported EPS. The
adoption of EITF 04-8 will have an effect on the
Companys diluted EPS computation if, in future periods,
the inclusion of contingently convertible debt becomes dilutive.
In November 2004, the FASB issued SFAS No. 151,
Inventory Costs An Amendment of ARB
No. 43, Chapter 4 (SFAS No. 151).
SFAS No. 151 amends the guidance in ARB No. 43,
Chapter 4, Inventory Pricing, to clarify the
accounting for abnormal amounts of idle facility expense,
freight, handling costs, and wasted material (spoilage). Among
other provisions, the new rule requires that items such as idle
facility expense, excessive spoilage, double freight, and
rehandling costs be recognized as current-period charges
regardless of whether they meet the criterion of so
abnormal as stated in ARB No. 43. Additionally,
SFAS No. 151 requires that the allocation of fixed
production overheads to the costs of conversion be based on the
normal capacity of the production facilities.
SFAS No. 151 is effective for inventory costs incurred
during fiscal years beginning after June 15, 2005. The
Company is currently evaluating the effect that the adoption of
SFAS No. 151 will have on its consolidated results of
operations and financial position, but does not expect the
adoption of this Statement to have a material impact.
In December 2004, the FASB issued SFAS No. 123
(revised 2004), Share-Based Payment
(SFAS No. 123R), which replaces SFAS No. 123
and supercedes APB Opinion No. 25. SFAS No. 123R
addresses the accounting for transactions in which an enterprise
receives employee services in exchange for (a) equity
instruments of the enterprise or (b) liabilities that are
based on the fair value of the enterprises equity
instruments or that may be settled by the issuance of such
equity instruments. SFAS No. 123R requires all
share-based payments to employees, including grants of employee
stock options and restrictive stock grants and units, to be
recognized as a compensation cost based on their fair values.
The pro forma disclosures
53
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
previously permitted under SFAS No. 123 no longer will
be an alternative to financial statement recognition. The
Company is required to adopt SFAS No. 123R no later
than July 1, 2005. Under SFAS No. 123R, the
Company must determine the appropriate fair value model to be
used for valuing share-based payments, the amortization method
for compensation cost and the transition method to be used at
the date of adoption. The transition methods include prospective
and retroactive adoption options. Under the retroactive option,
prior periods may be restated either as of the beginning of the
year of adoption or for all periods presented. The prospective
method requires that compensation expense be recorded for all
unvested stock options and restricted stock at the beginning of
the first quarter of adoption of SFAS No. 123R, while
the retroactive methods would record compensation expense for
all unvested stock options and restricted stock beginning with
the first period restated. The Company is currently assessing
the impact that adoption of this Standard will have on its
consolidated result of operations, financial position and cash
flows. However, the Company believes that adoption of this
standard will result in a charge to reported earnings.
Inventories consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Raw materials
|
|
$ |
1,085 |
|
|
$ |
1,042 |
|
Work in process
|
|
|
210 |
|
|
|
159 |
|
Finished goods
|
|
|
889 |
|
|
|
511 |
|
|
|
|
|
|
|
|
|
|
|
2,184 |
|
|
|
1,712 |
|
Less reserves
|
|
|
(402 |
) |
|
|
(373 |
) |
|
|
|
|
|
|
|
|
|
$ |
1,782 |
|
|
$ |
1,339 |
|
|
|
|
|
|
|
|
|
|
4. |
Property and Equipment: |
Property and equipment consists of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Computers and equipment
|
|
$ |
3,031 |
|
|
$ |
2,732 |
|
Manufacturing and demonstration equipment
|
|
|
2,240 |
|
|
|
2,181 |
|
Leasehold improvements
|
|
|
193 |
|
|
|
193 |
|
|
|
|
|
|
|
|
|
|
|
5,464 |
|
|
|
5,106 |
|
Less accumulated depreciation and amortization
|
|
|
(4,863 |
) |
|
|
(4,698 |
) |
|
|
|
|
|
|
|
|
|
$ |
601 |
|
|
$ |
408 |
|
|
|
|
|
|
|
|
Equipment under capital lease of $28,000, net of accumulated
amortization of $7,000 at December 31, 2004, is included in
computers and equipment.
54
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Other assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Debt issuance costs
|
|
$ |
381 |
|
|
$ |
|
|
Licensing fee for PMC, net
|
|
|
1,119 |
|
|
|
1,314 |
|
Rental security deposit
|
|
|
85 |
|
|
|
103 |
|
|
|
|
|
|
|
|
|
|
$ |
1,585 |
|
|
$ |
1,417 |
|
|
|
|
|
|
|
|
On January 5, 1999, Cardiogenesis entered into an Agreement
(the PLC agreement) with PLC Medical Systems, Inc.
(PLC), which granted Cardiogenesis a non-exclusive
worldwide use of certain PLC patents. In return, Cardiogenesis
agreed to pay PLC a fee totaling $2,500,000 over an
approximately forty-month period. The present value of these
payments of $2,300,000 was recorded as a prepaid asset, included
in other assets, and is being amortized over the life of the
underlying patents. The Company has included the related
amortization expense in sales, general and administrative
expenses in the accompanying Consolidated Statements of
Operations. The Company has recorded related accumulated
amortization of $1,168,000 and $973,000 as of December 31,
2004 and 2003, respectively. The patent is being amortized
straight-line at a rate of approximately $195,000 per year
through 2010.
The patents covered in the PLC agreement are valuable to the
Companys Percutaneous Myocardial Channeling
(PMC) product line. The PMC product line is not
approved for sale in the United States but is sold
internationally. If PMC product sales are not substantial and
consistent in the future, the Company may suffer an impairment
of the assets value on the balance sheet.
In association with the October 2004 financing transaction
discussed in Note 7, the Company capitalized debt issuance
costs of $417,000. The costs are classified in other assets. The
costs are being amortized over the life of the note using the
effective interest method. In 2004, the total amortization
expense related to the debt issuance costs was $35,000 and is
included in non-cash interest expense on the accompanying 2004
Consolidated Statement of Operations.
Accrued liabilities consists of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Accrued research support
|
|
$ |
|
|
|
$ |
152 |
|
Accrued accounts payable and related expenses
|
|
|
200 |
|
|
|
327 |
|
Accrued vacation
|
|
|
206 |
|
|
|
203 |
|
Accrued commissions
|
|
|
602 |
|
|
|
234 |
|
Accrued other
|
|
|
255 |
|
|
|
243 |
|
|
|
|
|
|
|
|
|
|
$ |
1,263 |
|
|
$ |
1,159 |
|
|
|
|
|
|
|
|
|
|
7. |
Long-term Liabilities: |
In October 2004, the Company completed a financing transaction
with Laurus Master Fund, Ltd, a Cayman Islands corporation
(Laurus), pursuant to which the Company issued a
Secured Convertible Term Note (the Note) in the
aggregate principal amount of $6.0 million and a warrant to
purchase an aggregate
55
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
of 2,640,000 shares of the Companys common stock to Laurus
in a private offering. Net proceeds to the Company from the
financing, after payment of fees and expenses to Laurus, were
$5,752,500, $2,875,250 of which was received by the Company and
$2,877,250 of which was deposited in a restricted cash account.
Additional debt issuance costs of $170,000 were incurred in
conjunction with the transaction and are included in accrued
liabilities on the accompanying balance sheet. Funds deposited
in the restricted cash account will only be released to the
Company, if at all, upon satisfaction of certain conditions,
such as: 1) voluntary conversion of the restricted funds by
Laurus, and 2) conversion rights of the restricted funds by
Cardiogenesis subject to certain stock price levels and trading
volume limitations.
The Note matures in October 2007, absent earlier redemption by
the Company or earlier conversion by Laurus. The Note is
convertible into shares of the Companys common stock at
the option of Laurus and, in certain circumstances, at the
Companys option and subject to certain trading volume
limitations and certain limitations on Laurus ownership
percentage. The Laurus financing documents restrict the Company
from obtaining additional debt financing, subject to certain
specified exceptions. In addition, subject to certain
exceptions, the Company has granted to Laurus a right of first
refusal to provide additional financing in the event that the
Company proposes to engage in additional debt financing or to
sell any equity securities. The Note is collateralized by all of
the Companys assets.
Under certain rare circumstances, the Note agreement could
result in conversion of the Companys common stock at
conversion prices that are low enough that the shares required
would be in excess of the shares currently authorized by the
Company. Although it is unlikely, if the Company was in a
situation where the current shares authorized were not
sufficient to cover the conversion amount, a cash payment would
be required. Since there is a possibility that a cash payment
would be required, certain features of the Note as well as other
equity related instruments have been recorded as liabilities on
the Companys balance sheet.
The $6,000,000 Note includes certain features that are
considered embedded derivative financial instruments, such as a
variety of conversion options, a variable interest rate feature,
events of default and a variable liquidated damages clause.
These features are described below, as follows:
|
|
|
|
|
The Note is convertible at the holders option at any time
at the fixed conversion price of $.50 per share. This conversion
feature has been identified as an embedded derivative and has
been bifurcated and recorded on the Companys balance sheet
at its fair value; |
|
|
|
Beginning May 2005, the Company is required to make monthly
principal payments of $100,000 per month. The monthly payment as
well as related accrued interest must be converted to common
stock at the fixed conversion price of $.50 if the fair value of
the Companys common stock is greater than $0.55 per share
for the 5 days preceding the payment due date. This
conversion feature has been identified as an embedded derivative
and has been bifurcated and recorded on the Companys
balance sheet at its fair value; |
|
|
|
Restricted cash must be converted at a fixed conversion price of
$.50 per share if the fair value of the Companys common
stock is greater than 125%, 150% or 175% (each threshold must
meet higher trading volume limits) of the initial fixed
conversion price of $.50 per share. This conversion feature has
been identified as an embedded derivative and has been
bifurcated and recorded on the Companys balance sheet at
its fair value; |
|
|
|
Annual interest on the Note is equal to the prime
rate published in The Wall Street Journal from time to
time, plus two percent (2.0%), provided that such annual rate of
interest may not be less than six and one-half percent (6.5%).
For every 25% increase in the Companys common stock fair
value above $.50 per share, the interest rate will be reduced by
2%. The interest rate may never be reduced below 0%. Interest on
the Note is payable monthly in arrears on the first day of each
month during the term of the Note, beginning November 2004. The
potential interest rate reduction due to future |
56
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
|
|
possible increases in the Companys stock price has been
identified as an embedded derivative and has been bifurcated and
recorded on the Companys balance sheet at its fair value; |
|
|
|
The Note agreement includes a liquidated damages provision based
on any failure to meet registration requirements for shares
issuable under the conversion of the note or exercise of the
warrants by February 2005. This liquidated damages feature
represents an embedded derivative. However, based on the de
minimus value associated with this feature, no value has been
assigned at issuance and at December 31, 2004; |
|
|
|
The Note agreement contains certain events of default including
delinquency, bankruptcy, change in control and stop trade or
trade suspension. In the event of default, Laurus has the right
to call the debt at a 30% premium, increase the note rate to the
stated rate, increase the note rate by an additional 12%,
foreclose on the collateral, and/or seek other remedies.
Laurus right to increase the interest rate on the debt in
the event of default represents an embedded derivative. However,
based on the de minimus value associated with this feature, no
value has been assigned at issuance and at December 31,
2004. |
In conjunction with the Note, the Company issued a warrant to
purchase 2,640,000 shares of common stock. The accounting
treatment of the derivatives and warrant requires that the
Company record the derivatives and the warrant at their relative
fair value as of the inception date of the agreement, and at
fair value as of each subsequent balance sheet date. Any change
in fair value will be recorded as non-operating, non-cash income
or expense at each reporting date. If the fair value of the
derivatives and warrants is higher at the subsequent balance
sheet date, the Company will record a non-operating, non-cash
charge. If the fair value of the derivatives and warrants is
lower at the subsequent balance sheet date, the Company will
record non-operating, non-cash income. As of December 31,
2004, the derivatives were valued at $2,338,000. Conversion
related derivatives were valued using the Binomial Option
Pricing Model with the following assumptions: dividend yield of
0%; annual volatility of 70.5%; and risk free interest rate of
3.25% as well as probablility analysis related to trading volume
restrictions. The remaining derivatives were valued using
discounted cash flows and probability analysis. Warrants were
valued at $766,000 at December 31, 2004 using the Binomial
Option Pricing model with the following assumptions: dividend
yield of 0%; annual volatility of 70.5%; risk-free interest rate
of 3.94%; and exercise factor of 2. Both the derivatives and
warrants were classified as long-term liabilities.
The initial relative fair value assigned to the embedded
derivative was $1,075,000 and the initial relative fair value
assigned to the warrant was $631,000, both of which were
recorded as discounts to the Note and are being amortized to
interest expense over the expected term of the debt, using the
effective interest method. At December 31, 2004, the
unamortized discount on the Note was $1,565,000. The effective
interest rate on the Note for the period ended December 31,
2004 was 152%.
Future principal obligations, net of restricted cash, due under
the note are as follows:
|
|
|
|
|
2005
|
|
$ |
800,000 |
|
2006
|
|
|
1,200,000 |
|
2007
|
|
|
1,000,000 |
|
|
|
|
|
Total
|
|
$ |
3,000,000 |
|
|
|
|
|
The market price of the Companys common stock
significantly impacts the extent to which the Company is
permitted to convert the unrestricted and restricted portions of
the Laurus debt into shares of the Companys common stock.
The lower the market price of the Companys common stock as
of the respective times of conversion, the more shares the
Company will need to issue to Laurus to convert the principal
and interest payments then due on the unrestricted portion of
the debt. If the market price of the Companys common stock
falls below certain thresholds, the Company will be unable to
convert any such repayments of
57
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
principal and interest into equity, and the Company will be
forced to make such repayments in cash. The Companys
operations could be materially adversely impacted if the Company
is forced to make repeated cash payments on the unrestricted
portion of the Laurus debt.
Further, prior to the full repayment of the unrestricted portion
of the Laurus debt, the Company will only be able to require
conversions of the $3,000,000 restricted cash amount to the
extent the market price of the Companys common stock
exceeds certain levels. To the extent that the market price of
the Companys common stock does not reach such specified
levels, the Company will be not be entitled to take possession
of any of the restricted cash during the term of the Laurus
note. The restricted portion of the debt will continue to accrue
interest during the entire period that the Company is unable to
require conversion. In addition, to the extent that conversions
of the restricted portion of the debt are not effected during
the term of the Note, the Company has only a limited ability to
convert a specified amount of the restricted debt (subject to
meeting certain minimum market price thresholds and volume
requirements), and the Company will be required to repay the
remaining restricted principal and interest in cash. The cash
required to pay such principal amounts payable would come from
the restricted cash and any such interest amounts payable would
most likely be paid from available cash, which may not be
sufficient to repay the amounts due.
|
|
8. |
Commitments and Contingencies: |
Cardiogenesis has entered into an operating lease for an office
facility with terms extending through October 2006. The minimum
future rental payments are as follows (in thousands):
|
|
|
|
|
Year Ending December 31, |
|
|
|
|
|
2005
|
|
$ |
350 |
|
2006
|
|
|
306 |
|
|
|
|
|
|
|
$ |
656 |
|
|
|
|
|
Rent expense was approximately $359,000, $547,000 and $504,000
for the years ended December 31, 2004, 2003 and 2002,
respectively.
In November 2003, the Companys employment relationship
with Darrell Eckstein, Cardiogenesis former President,
Chief Operating Officer, Acting Chief Financial Officer, Chief
Accounting Officer, Treasurer and Secretary was terminated. In
connection with his departure, Mr. Eckstein has made
certain breach of contract claims arising out of his employment
agreement with the Company, as well as certain tort claims and
is seeking unspecified monetary damages. Pursuant to the terms
of Mr. Eckstein s employment agreement, the matter has been
submitted to binding arbitration. The Company believes
Mr. Ecksteins claims are without merit and is
vigorously defending against these claims. However, if
Mr. Eckstein were to prevail on some or all of his claims,
the Company cannot give any assurances that such claims would
not have a material adverse effect on the Company s financial
condition, results of operations or cash flows. Because of the
preliminary stage of this case, an estimate of potential
damages, if any, would be premature and speculative. As a
result, the Company has not made any such estimate. Any legal
costs in connection with this case are being expensed as
incurred and are included in selling, general and administrative
on the accompanying Statement of Operations.
|
|
|
Issuances of Common Stock: |
In April 2002, the Company sold 500,000 shares, of common
stock at a purchase price of $1.00 per share to a
governmental entity. Certain bylaws were amended as a condition
of these sales.
58
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In January 2004, Cardiogenesis sold approximately
3,100,000 shares of common stock to private investors for a
total price of $2,700,000.
During the year ended December 31, 2001, the Company issued
warrants to purchase 75,000 shares of common stock at
a price of $1.63 per share in connection with a facilities
lease agreement executed in 2001. The warrants were fair valued
at $94,000 using the Black-Scholes pricing model and are being
amortized over the five-year lease term. For the years ended
December 31, 2004, 2003 and 2002, the Company recorded
amortization charges to rent expense of $19,000 per year in
connection with these warrants. The warrants expire in May 2006
and were outstanding at December 31, 2004.
During the year ended December 31, 2003, the Company issued
five-year warrants to purchase 275,000 shares of
common stock at exercise prices ranging from $.35 to
$.44 per share in connection with a credit facility that
was executed in March 2003 and canceled in March 2004. The
warrants were fair valued at $75,000 using the Black-Scholes
pricing model. For the years ended December 31, 2004 and
2003, the Company recorded amortization of $31,000 and $44,000,
respectively, in connection with these warrants. The warrants
were fully amortized in 2004 when the credit facility was
cancelled. The warrants expire in March 2008 and were
outstanding at December 31, 2004.
In January 2004, in conjunction with a private equity offering,
Cardiogenesis issued a warrant to purchase approximately
3,100,000 shares of common stock at a price of
$1.37 per share. The warrants are immediately exercisable
and have a term of five years.
In October 2004, Cardiogenesis issued a warrant to purchase an
aggregate of 2,640,000 shares of the Companys common
stock at a price of $0.50 per share, with a term of
7 years, to Laurus Master Fund in connection with the
secured convertible note agreement. (See Note 7).
During the years ended December 31, 2004, 2003 and 2002, no
warrants were exercised.
|
|
|
Options Granted to Consultants: |
At December 31, 2004, 2003, 2002, options for consultants
to purchase a total of 70,000, 57,000, and 47,000 shares of
common stock, respectively, at exercise prices ranging from $.78
to $1.40 per share were outstanding. The terms under which
stock options are exercised are the same as Cardiogenesis
Stock Option Plan which is described below. Substantially all of
these options were exercisable at the date of grant. These
options are included in the Stock Option Plan disclosures below.
The Companys articles of incorporation authorize the board
of directors, subject to any limitations prescribed by law, to
issue shares of preferred stock in one or more series without
shareholder approval. On August 17, 2001 the Company
adopted a shareholder rights plan, as amended, and under the
rights plan, the board of directors declared a dividend
distribution of one right for each outstanding share of common
stock to shareholders of record at the close of business on
August 30, 2001. Pursuant to the Rights Agreement, in the
event (a) any person or group acquires 15% or more of the
Companys then outstanding shares of voting stock (or 21%
or more of the Companys then outstanding shares of voting
stock in the case of State of Wisconsin Investment Board),
(b) a tender offer or exchange offer is commenced that
would result in a person or group acquiring 15% or more of the
Companys then outstanding voting stock, (c) the
Company is acquired in a merger or other business combination in
which the Company is not the surviving corporation or
(d) 50% or more of the Companys consolidated assets
or earning power are sold, then the holders of the
Companys common stock are entitled to exercise the rights
under the Rights Plan, which include, based on the type of event
which has occurred, (i) rights to purchase preferred shares
from the Company, (ii) rights to purchase
59
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
common shares from the Company having a value twice that of the
underlying exercise price, and (iii) rights to acquire
common stock of the surviving corporation or purchaser having a
market value of twice that of the exercise price. The rights
expire on August 17, 2011, and may be redeemed prior
thereto at $.001 per right under certain circumstances.
Cardiogenesis maintains a Stock Option Plan, which includes the
Employee Program under which incentive and nonstatutory options
may be granted to employees and the Consultants Program, under
which nonstatutory options may be granted to consultants of the
Company. As of December 31, 2004, Cardiogenesis had
reserved a total of 10,100,000 shares of common stock for
issuance under this plan. Under the plan, options may be granted
at not less than fair market value, as determined by the Board
of Directors. Options generally vest over a period of three
years and expire ten years from date of grant. No shares of
common stock issued under the plan are subject to repurchase.
|
|
|
Directors Stock Option Plan: |
Cardiogenesis maintains a Directors Stock Option Plan
which provides for the grant of nonstatutory options to
directors who are not officers or employees of the Company. As
of December 31, 2004, Cardiogenesis had reserved
875,000 shares of common stock for issuance under this
plan. Under this plan, options are granted at the trading price
of the common stock at the date of grant. Options generally vest
over twelve to thirty-six months and expire ten years from date
of grant. No shares of common stock issued under the plan are
subject to repurchase.
|
|
|
Employee Stock Purchase Plan: |
Cardiogenesis maintains an Employee Stock Purchase Plan
(ESPP), under which 1,178,400 shares of common
stock have been reserved for issuance. Cardiogenesis adopted the
ESPP in April 1996. The purpose of the ESPP is to provide
eligible employees of Cardiogenesis with a means of acquiring
common stock of Cardiogenesis through payroll deductions.
Eligible employees are permitted to purchase common stock at 85%
of the fair market value through payroll deductions of up to 15%
of an employees compensation, subject to certain
limitations. During fiscal years 2004, 2003 and 2002,
approximately 184,000, 131,000 and 114,000 shares,
respectively, were sold through the ESPP.
60
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Option activity under the Stock Option Plan and the Directors
Stock Option Plan is as follows (in thousands, except per
share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options | |
|
|
|
|
| |
|
|
|
|
|
|
Weighted | |
|
|
Shares | |
|
|
|
Average | |
|
|
Available | |
|
Number | |
|
Price per | |
|
|
for Grant | |
|
of Shares | |
|
Share | |
|
|
| |
|
| |
|
| |
Balance, December 31, 2001
|
|
|
510 |
|
|
|
2,787 |
|
|
$ |
2.42 |
|
|
Additional shares reserved
|
|
|
1,500 |
|
|
|
|
|
|
|
|
|
|
Options granted
|
|
|
(1,105 |
) |
|
|
1,105 |
|
|
$ |
0.82 |
|
|
Options forfeited
|
|
|
415 |
|
|
|
(415 |
) |
|
$ |
3.86 |
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2002
|
|
|
1,320 |
|
|
|
3,477 |
|
|
$ |
1.74 |
|
|
Additional shares reserved
|
|
|
1,500 |
|
|
|
|
|
|
|
|
|
|
Options granted
|
|
|
(2,034 |
) |
|
|
2,034 |
|
|
$ |
0.52 |
|
|
Options forfeited
|
|
|
834 |
|
|
|
(834 |
) |
|
$ |
1.46 |
|
|
Options exercised
|
|
|
|
|
|
|
(607 |
) |
|
$ |
0.48 |
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2003
|
|
|
1,620 |
|
|
|
4,070 |
|
|
$ |
1.37 |
|
|
Additional shares reserved
|
|
|
1,800 |
|
|
|
|
|
|
|
|
|
|
Options granted
|
|
|
(941 |
) |
|
|
941 |
|
|
$ |
.87 |
|
|
Options forfeited
|
|
|
487 |
|
|
|
(487 |
) |
|
$ |
1.72 |
|
|
Options expired
|
|
|
30 |
|
|
|
(30 |
) |
|
$ |
1.44 |
|
|
Options exercised
|
|
|
|
|
|
|
(317 |
) |
|
$ |
.58 |
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2004
|
|
|
2,996 |
|
|
|
4,177 |
|
|
$ |
1.28 |
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes information about the
Companys stock options outstanding and exercisable under
the Stock Option Plan and the Directors Stock Option Plan
at December 31, 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding | |
|
Options Exercisable | |
|
|
| |
|
| |
|
|
|
|
Weighted | |
|
|
|
|
|
|
|
|
Average | |
|
Weighted | |
|
|
|
Weighted | |
|
|
|
|
Remaining | |
|
Average | |
|
|
|
Average | |
|
|
Number | |
|
Contractual Life | |
|
Exercise | |
|
Number | |
|
Exercise | |
Exercise Prices |
|
Outstanding | |
|
(In Years) | |
|
Price | |
|
Exercisable | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
|
|
|
|
|
(In thousands) | |
|
|
$0.32 - $ 0.37
|
|
|
694 |
|
|
|
8.72 |
|
|
$ |
0.35 |
|
|
|
684 |
|
|
$ |
0.35 |
|
$0.43 - $ 0.54
|
|
|
55 |
|
|
|
9.75 |
|
|
$ |
0.49 |
|
|
|
16 |
|
|
$ |
0.51 |
|
$0.56 - $ 0.83
|
|
|
993 |
|
|
|
8.48 |
|
|
$ |
0.73 |
|
|
|
583 |
|
|
$ |
0.73 |
|
$0.84 - $ 0.91
|
|
|
307 |
|
|
|
7.67 |
|
|
$ |
0.87 |
|
|
|
303 |
|
|
$ |
0.87 |
|
$1.01 - $ 1.16
|
|
|
771 |
|
|
|
8.28 |
|
|
$ |
1.10 |
|
|
|
480 |
|
|
$ |
1.10 |
|
$1.17 - $ 1.40
|
|
|
376 |
|
|
|
7.98 |
|
|
$ |
1.30 |
|
|
|
360 |
|
|
$ |
1.30 |
|
$1.67 - $ 1.75
|
|
|
714 |
|
|
|
4.17 |
|
|
$ |
1.70 |
|
|
|
714 |
|
|
$ |
1.70 |
|
$2.57 - $ 6.06
|
|
|
147 |
|
|
|
5.74 |
|
|
$ |
3.88 |
|
|
|
147 |
|
|
$ |
3.88 |
|
$6.38 - $12.69
|
|
|
120 |
|
|
|
3.42 |
|
|
$ |
8.81 |
|
|
|
120 |
|
|
$ |
8.81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,177 |
|
|
|
7.54 |
|
|
$ |
1.28 |
|
|
|
3,407 |
|
|
$ |
1.38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Companys stock options exercisable under the Stock
Option Plan and the Directors Stock Option Plan at
December 31, 2004 and 2003 were 3,407,000 and
3,335,000 shares, respectively.
61
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
10. |
Employee Retirement Plan: |
Cardiogenesis maintains a 401(k) plan for its employees. The
plan allows eligible employees to defer up to 15% of their
earnings, not to exceed the statutory amount per year on a
pretax basis through contributions to the plan. The plan
provides for employer contributions at the discretion of the
Board of Directors. For the years ended December 31, 2004,
2003 and 2002, $115,000, $85,000 and $93,000 of employer
contributions were made to the plan, respectively.
The Company operates in one segment. The principal markets for
the Companys products are in the United States.
International sales occur in Europe, Canada and Asia and
amounted to $483,000, $415,000 and $494,000 for the years ended
December 31, 2004, 2003 and 2002, respectively. The
international sales represent 3%, 3% and 4% of total sales for
the years ended December 31, 2004, 2003 and 2002,
respectively. The majority of international sales are
denominated in Euros.
Significant components of Cardiogenesis deferred tax
assets are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31 | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Net operating losses
|
|
$ |
53,751 |
|
|
$ |
54,420 |
|
Credits
|
|
|
3,627 |
|
|
|
3,750 |
|
Research and development
|
|
|
748 |
|
|
|
525 |
|
Reserves
|
|
|
355 |
|
|
|
321 |
|
Accrued liabilities
|
|
|
1,099 |
|
|
|
511 |
|
Depreciation/ Amortization
|
|
|
195 |
|
|
|
109 |
|
|
|
|
|
|
|
|
Net deferred tax asset
|
|
|
59,775 |
|
|
|
59,636 |
|
Less valuation allowance
|
|
|
(59,775 |
) |
|
|
(59,636 |
) |
|
|
|
|
|
|
|
Net deferred tax assets
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
The Company has established a valuation allowance to the extent
of its deferred tax assets because it was determined by
management that it was more likely than not at the balance sheet
date that such deferred tax assets would not be realized. At
such time as it is determined that it is more likely than not
that the deferred tax assets are realizable, the valuation
allowance will be reduced.
As of December 31, 2004, the Company had federal and state
net operating loss carryforwards of approximately $150,640,000
and $43,424,000, respectively, to offset future taxable income.
In addition, the Company had federal and state credit
carryforwards of approximately $2,512,000 and $968,000 available
to offset future tax liabilities. The Companys net
operating loss carryforwards, as well as federal credit
carryforwards, will expire at various dates beginning in 2008
through 2024, if not utilized. Research and experimentation
credits carry forward indefinitely for state purposes. The
Company also has a manufacturers investment credit for state
purposes of approximately $147,000.
The Internal Revenue Code limits the use of net operating loss
and tax credit carryforwards in certain situations where changes
occur in the stock ownership of a company. The Company believes
that the sale of common stock in its initial public offering and
the merger with Cardiogenesis resulted in changes in ownership
which could restrict the utilization of the carryforwards.
Income tax expense for each of the three years ended
December 31, 2004 was $800 per year.
62
CARDIOGENESIS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
13. |
Risks and Concentrations: |
Cardiogenesis sells its products primarily to hospitals and
other healthcare providers in North America, Europe and Asia.
Cardiogenesis performs ongoing credit evaluations of its
customers and generally does not require collateral. Although
Cardiogenesis maintains allowances for potential credit losses
that it believes to be adequate, a payment default on a
significant sale could materially and adversely affect its
operating results and financial condition. At December 31,
2004, three customers individually accounted for 11%, 12%, and
15% of gross accounts receivable. For the years ended
December 31, 2004, 2003 and 2002, no customer individually
accounted for 10% or more of net revenues.
At December 31, 2004 and 2003, the Company had amounts on
deposit with financial institutions in excess of the federally
insured limits of $100,000.
Certain components of laser units and fiber-optic handpieces are
generally acquired from multiple sources. Other laser and
fiber-optic components and subassemblies are purchased from
single sources. Although the Company has identified alternative
vendors, the qualification of additional or replacement vendors
for certain components or services is a lengthy process. Any
significant supply interruption would have a material adverse
effect on the Companys ability to manufacture its products
and, therefore, would harm its business. The Company intends to
continue to qualify multiple sources for components that are
presently single sourced.
From January 1, 2005 through March 11, 2005, Laurus
elected to convert an aggregate of $355,140 of principal and
interest under the Note into an aggregate of 710,281 shares
of Cardiogenesis common stock at a conversion price of
$.50 per share. See Note 7. Of this amount, $275,000 in
principal was converted into shares of common stock and a
corresponding amount was released from restricted cash as
available for use by the Company in the first quarter of 2005.
63
CARDIOGENESIS CORPORATION
SCHEDULE II VALUATION AND QUALIFYING
ACCOUNTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at | |
|
|
|
|
|
Balance at | |
|
|
Beginning | |
|
|
|
|
|
End of | |
|
|
of Period | |
|
Additions(1) | |
|
Deductions(2) | |
|
Period | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Inventory reserve:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory reserve
|
|
$ |
1,246 |
|
|
$ |
854 |
|
|
$ |
1,739 |
|
|
$ |
361 |
|
Year ended December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory reserve
|
|
$ |
361 |
|
|
$ |
198 |
|
|
$ |
186 |
|
|
$ |
373 |
|
Year ended December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory reserve
|
|
$ |
373 |
|
|
$ |
32 |
|
|
$ |
3 |
|
|
$ |
402 |
|
Valuation allowance relating to deferred tax asset:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Valuation allowance
|
|
$ |
63,931 |
|
|
$ |
|
|
|
$ |
1,471 |
|
|
$ |
62,460 |
|
Year ended December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Valuation allowance
|
|
$ |
62,460 |
|
|
$ |
|
|
|
$ |
2,824 |
|
|
$ |
59,636 |
|
Year ended December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Valuation allowance
|
|
$ |
59,636 |
|
|
$ |
139 |
|
|
|
|
|
|
$ |
59,775 |
|
|
|
(1) |
Charged to costs and expenses. |
|
(2) |
Amounts written off against the reserve. |
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED
FROM THE YEARS ENDED DECEMBER 31, 2004, 2003 AND 2002 AND
IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL
STATEMENTS.
64