Nordicus Partners Corp - Quarter Report: 2006 December (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
10-Q
(Mark
One)
x |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For the quarterly period ended | December 31, 2006 |
or
o |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For the transition period from |
to
|
Commission File Number: | 0-28034 |
CardioTech
International, Inc.
|
(Exact
name of registrant as specified in its
charter)
|
Massachusetts
|
04-3186647
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
Employer Identification No.)
|
|
229
Andover Street, Wilmington,
Massachusetts
|
01887
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
(978) 657-0075 | ||
(Registrant’s telephone number, including area code) | ||
(Former name, former address and former fiscal year, if changed since last report) |
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days. Yes
x
No
q
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer, See definition of “accelerated
filer” and “large accelerated filer” in Rule 12b-2 of the Act, (Check
one):
q
Large
Accelerated Filer q
Accelerated Filer x
Non-Accelerated Filer
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes
q
No
x
As
of
February 9, 2007, 20,009,983 shares of the registrant’s Common Stock were
outstanding.
TABLE
OF CONTENTS
|
Page
|
||
PART
I.
|
FINANCIAL
INFORMATION
|
||
Item
1.
|
Condensed
Consolidated Financial Statements (unaudited)
|
||
Condensed
Consolidated Balance Sheets at December 31, 2006 and March 31,
2006
|
3
|
||
Condensed
Consolidated Statements of Operations for the three and nine
months
|
|||
ended
December 31, 2006 and 2005
|
4
|
||
Condensed
Consolidated Statements of Cash Flows for the nine months
ended
|
|||
December
31, 2006 and 2005
|
5
|
||
Notes
to Condensed Consolidated Financial Statements
|
6-14
|
||
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
15-25
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
25
|
|
Item
4.
|
Controls
and Procedures
|
25
|
|
PART
II.
|
OTHER
INFORMATION
|
||
Item
1.
|
Legal
Proceedings
|
26
|
|
Item
1A.
|
Risk
Factors
|
26
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
26
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
26
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
26
|
|
Item
5.
|
Other
Information
|
26
|
|
Item
6.
|
Exhibits
|
26
|
|
|
Signatures
|
27
|
-
2
-
ITEM
1. FINANCIAL
STATEMENTS
CardioTech
International, Inc.
|
|||||||
Condensed
Consolidated Balance Sheets
|
|||||||
(Unaudited
- in thousands, except share and per share
amounts)
|
|||||||
December
31,
|
March
31,
|
||||||
2006
|
2006
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
3,085
|
$
|
6,841
|
|||
Short-term
investment
|
1,012
|
-
|
|||||
Accounts
receivable-trade, net of allowance of $365 and
$572
as of December 31, 2006 and March 31, 2006, respectively
|
2,795
|
2,851
|
|||||
Accounts
receivable-other
|
288
|
265
|
|||||
Inventories
|
5,223
|
4,786
|
|||||
Prepaid
expenses and other current assets
|
242
|
210
|
|||||
Total
current assets
|
12,645
|
14,953
|
|||||
Property,
plant and equipment, net
|
4,232
|
4,059
|
|||||
Amortizable
intangible assets, net
|
496
|
584
|
|||||
Goodwill
|
487
|
487
|
|||||
Other
assets
|
122
|
130
|
|||||
Investment
in CorNova, Inc.
|
-
|
238
|
|||||
Total
assets
|
$
|
17,982
|
$
|
20,451
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
809
|
$
|
1,750
|
|||
Accrued
expenses
|
1,394
|
936
|
|||||
Deferred
revenue
|
414
|
132
|
|||||
Total
current liabilities
|
2,617
|
2,818
|
|||||
Deferred
rent
|
121
|
129
|
|||||
Stockholders'
equity:
|
|||||||
Preferred
stock; $.01 par value; 5,000,000 shares authorized;
500,000
shares issued and none outstanding as of
December
31, 2006 and March 31, 2006
|
-
|
-
|
|||||
Common
stock; $.01 par value; 50,000,000 shares authorized;
19,832,483
and 19,796,833 shares issued and outstanding as of
December
31, 2006 and March 31, 2006, respectively
|
198
|
198
|
|||||
Additional
paid-in capital
|
36,767
|
36,685
|
|||||
Accumulated
deficit
|
(21,721
|
)
|
(19,339
|
)
|
|||
Accumulated
other comprehensive loss
|
-
|
(40
|
)
|
||||
Total
stockholders' equity
|
15,244
|
17,504
|
|||||
Total
liabilities and stockholders' equity
|
$
|
17,982
|
$
|
20,451
|
The
accompanying notes are an integral part of these financial
statements.
-
3
-
CardioTech
International, Inc.
|
|||||||
Condensed
Consolidated Statements of Operations
|
|||||||
(Unaudited
- in thousands, except per share
amounts)
|
For
The Three Months Ended
December
31,
|
For
The Nine Months Ended
December
31,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Revenues:
|
|||||||||||||
Product
sales
|
$
|
5,049
|
$
|
5,240
|
$
|
14,723
|
$
|
16,452
|
|||||
Royalties
|
365
|
229
|
943
|
692
|
|||||||||
5,414
|
5,469
|
15,666
|
17,144
|
||||||||||
Cost
of sales
|
3,992
|
4,463
|
11,704
|
13,346
|
|||||||||
Gross
margin
|
1,422
|
1,006
|
3,962
|
3,798
|
|||||||||
Operating
expenses:
|
|||||||||||||
Research
and development, regulatory and engineering
|
426
|
358
|
1,170
|
1,061
|
|||||||||
Selling,
general and administrative
|
1,990
|
1,482
|
5,223
|
4,430
|
|||||||||
2,416
|
1,840
|
6,393
|
5,491
|
||||||||||
Loss
from operations
|
(994
|
)
|
(834
|
)
|
(2,431
|
)
|
(1,693
|
)
|
|||||
Interest
and other income:
|
|||||||||||||
Interest
income
|
44
|
9
|
103
|
31
|
|||||||||
Other
income
|
124
|
-
|
224
|
68
|
|||||||||
Interest
and other income, net
|
168
|
9
|
327
|
99
|
|||||||||
Equity
in net loss of CorNova, Inc.
|
-
|
(133
|
)
|
(278
|
)
|
(216
|
)
|
||||||
Net
loss
|
$
|
(826
|
)
|
$
|
(958
|
)
|
$
|
(2,382
|
)
|
$
|
(1,810
|
)
|
|
Net
loss per common share, basic and diluted
|
$
|
(0.04
|
)
|
$
|
(0.05
|
)
|
$
|
(0.12
|
)
|
$
|
(0.09
|
)
|
|
Shares
used in computing net loss per common
share,
basic and diluted
|
19,832
|
19,499
|
19,826
|
19,369
|
The accompanying notes are an integral part of these financial statements.
-
4
-
CardioTech
International, Inc.
|
|||
Condensed
Consolidated Statements of Cash Flows
|
|||
(Unaudited
- in thousands)
|
For
The Nine Months Ended
December
31,
|
|||||||
2006
|
2005
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(2,382
|
)
|
$
|
(1,810
|
)
|
|
Adjustments
to reconcile net loss to net cash flows:
|
|||||||
Depreciation
and amortization
|
603
|
752
|
|||||
Equity
in net loss of CorNova, Inc.
|
278
|
216
|
|||||
Provision
for doubtful accounts
|
83
|
133
|
|||||
Share-based
compensation
|
21
|
5
|
|||||
Deferred
rent
|
(8
|
)
|
(39
|
)
|
|||
Changes
in assets and liabilities:
|
|||||||
Accounts
receivable-trade, net
|
(27
|
)
|
109
|
||||
Accounts
receivable-other
|
(23
|
)
|
(38
|
)
|
|||
Inventories
|
(437
|
)
|
(618
|
)
|
|||
Prepaid
expenses and other current assets
|
(32
|
)
|
(35
|
)
|
|||
Accounts
payable
|
(941
|
)
|
(88
|
)
|
|||
Accrued
expenses
|
458
|
16
|
|||||
Deferred
revenue
|
282
|
(78
|
)
|
||||
Net
cash flows used in operating activities
|
(2,125
|
)
|
(1,475
|
)
|
|||
Cash
flows from investing activities:
|
|||||||
Purchase
of property, plant and equipment
|
(687
|
)
|
(342
|
)
|
|||
Purchase
of short-term investment
|
(1,012
|
)
|
-
|
||||
Decrease
in other assets
|
8
|
15
|
|||||
Net
cash flows used in investing activities
|
(1,691
|
)
|
(327
|
)
|
|||
Cash
flows from financing activities:
|
|||||||
Net
proceeds from issuance of common stock
|
61
|
616
|
|||||
Purchase
of common stock
|
(1
|
)
|
(8
|
)
|
|||
Net
cash flows provided by financing activities
|
60
|
608
|
|||||
Net
change in cash and cash equivalents
|
(3,756
|
)
|
(1,194
|
)
|
|||
Cash
and cash equivalents at beginning of period
|
6,841
|
7,469
|
|||||
Cash
and cash equivalents at end of period
|
$
|
3,085
|
$
|
6,275
|
|||
Supplemental
Disclosure of Cash Flow Information:
|
|||||||
Interest
received
|
$
|
103
|
$
|
31
|
|||
Interest
paid
|
$
|
2
|
$
|
-
|
|||
Taxes
paid
|
$
|
2
|
$
|
4
|
The
accompanying notes are an integral part of these
financial statements.
-
5
-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1.
|
|
Description
of Business
|
CardioTech
International, Inc. (including its wholly-owned subsidiaries, collectively
“CardioTech” or the “Company”) is a medical device company that designs,
develops, manufactures and sells materials and innovative products for the
treatment of cardiovascular, orthopedic, oncology and other diseases. The
Company’s subsidiaries and divisions are Gish Biomedical, Inc. (“Gish”) and
Catheters and Disposables Technology, Inc. ("CDT"), and its biomaterials
division. The Company operates in one segment, medical device manufacturing
and
sales.
The
Company is using its proprietary technology to develop and manufacture the
CardioPassTM
synthetic coronary artery bypass grafts (“SynCAB”) made of
ChronoFlexTM.
If
successfully developed, the Company believes that the CardioPass graft may
be
used initially to provide an alternative to patients with insufficient or
inadequate native vessels for use in SynCAB surgery as a result of repeat
procedures, trauma, disease or other factors. Gish manufactures single use
cardiopulmonary bypass products that have a disposable component. CDT is an
original equipment manufacturer and supplier of private-label advanced
disposable medical devices from concept to finished, packaged and sterilized
products. The biomaterials division develops, manufactures and sells ChronoFlex,
a family of polyurethanes that have been demonstrated to be biocompatible and
non-toxic. CardioTech has partnered to develop a drug-eluting stent. The Company
owns approximately 31% of the issued and outstanding shares of common stock
of
CorNova, Inc. (“CorNova”), a
privately held, development stage company focused on the development of a
next-generation drug-eluting stent. Assuming the conversion to common stock
of
all of CorNova’s issued and outstanding shares of preferred stock, the Company’s
shares of CorNova common stock would represent approximately 17% of the issued
and outstanding equity of CorNova (See Note 14).
These
condensed consolidated financial statements include the accounts of the Company
and its wholly-owned subsidiaries. All significant intercompany balances and
transactions have been eliminated. The Company’s investment in CorNova is
accounted for using the equity method of accounting in accordance with APB
Opinion No. 18, “The
Equity Method of Accounting for Investments in Common Stock.”
The
Company’s corporate headquarters are located in Wilmington, Massachusetts, with
manufacturing operations in California and Minnesota.
2.
|
|
Interim
Financial Statements
|
The
condensed consolidated financial information for the three and nine months
ended
December 31, 2006 and 2005 is unaudited but includes all adjustments (consisting
only of normal recurring adjustments) that the Company considers necessary
for a
fair presentation of the financial position at such date and of the operating
results and cash flows for the period. The results of operations for the three
and nine months ended December 31, 2006 and 2005 are not necessarily indicative
of results that may be expected for the entire year. The information contained
in this Form 10-Q should be read in conjunction with the Company’s audited
financial statements, included in its Annual Report on Form 10-K as of and
for
the year ended March 31, 2006 and its Quarterly Reports on Form 10-Q as of
and
for the quarters ended June 30, 2006 and September 30, 2006 filed with the
Securities and Exchange Commission.
The
balance sheet at March 31, 2006 has been derived from our audited consolidated
financial statements at that date but does not include all of the information
and footnotes required by generally accepted accounting principles for complete
financial statements.
3.
|
|
Cash,
Cash Equivalents and Short-term
Investment
|
The
Company considers all highly liquid investments with original maturity less
than
90 days from the date of purchase as cash equivalents. The Company’s cash
equivalents consist principally of money market accounts. As of December 31,
2006, the Company’s only short-term investment was composed of a certificate of
deposit having a maturity date of February 28, 2007.
4.
|
|
Revenue
Recognition
|
The
Company recognizes revenue in accordance with Staff Accounting Bulletin (“SAB”)
No. 104, “Revenue Recognition in Financial Statements.” The Company recognizes
revenue from product sales upon shipment, provided that a purchase order has
been received or a contract has been executed, there are no uncertainties
regarding customer acceptance, the sales price is fixed or determinable and
collection is deemed probable. If uncertainties regarding customer acceptance
exist, the Company recognizes revenue when those uncertainties are resolved
and
title has been transferred to the customer. Amounts collected or billed prior
to
satisfying the above revenue recognition criteria are recorded as deferred
revenue. The Company also receives license and royalty fees for the use of
its
proprietary biomaterials. CardioTech recognizes these fees as revenue in
accordance with the terms of the contracts. Contracted product design and
development projects
are recognized on a time and materials basis as services are
performed.
-
6
-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Generally,
the customer specifies the delivery method and is responsible for delivery
costs. However, in certain situations, the customer specifies the delivery
method and requests the Company pay the delivery costs and then invoice the
delivery costs to the customer or include an estimate of the delivery costs
in
the price of the product. Delivery costs billed to customers for the three
months ended December 31, 2006 and 2005 totaled $92,000 and $100,000,
respectively. Delivery costs billed to customers for the nine months ended
December 31, 2006 and 2005 totaled $275,000 and $307,000, respectively. Delivery
costs billed to customers have been recorded as revenue.
5.
|
|
Stock
Based
Compensation
|
In
December 2004, the Financial Accounting Standards Board (“FASB”) issued SFAS No.
123R, Share-Based
Payment—An Amendment of FASB Statements No. 123 and 95
(“SFAS
No. 123R”), which requires all companies to measure compensation cost for all
share-based payments, including employee stock options, at fair value.
Generally, the approach in SFAS No. 123R is similar to the approach described
in
SFAS No. 123, Accounting
for Stock-Based Compensation
(“SFAS
No.123”). However, SFAS No. 123R requires all share-based payments to employees,
including grants of employee stock options, to be recognized in the financial
statements based on their fair value over the requisite service period. Pro
forma disclosure is no longer an alternative. In March 2005, the SEC issued
Staff Accounting Bulletin (“SAB”) No. 107 (“SAB No. 107”), which expressed the
views of the SEC regarding the interaction between SFAS No. 123R and certain
rules and regulations of the SEC. SAB No. 107 provides guidance related to
the
valuation of share-based payment arrangements for public companies, including
assumptions such as expected volatility and expected term.
Prior
to
April 1, 2006, the Company applied the pro forma disclosure requirements under
SFAS No. 123 and accounted for its stock-based employee compensation plans
using
the intrinsic value method under the recognition and measurement provisions
of
Accounting Principles Board Opinion No. 25, Accounting
for Stock Issued to Employees
and
related interpretations.
Effective
April 1, 2006, the Company adopted the fair value recognition provisions of
SFAS
No. 123R, using the modified prospective transition method. Under this
transition method, compensation cost recognized in the statement of operations
for the three and nine months ended December 31, 2006 includes: (a) compensation
cost for all share-based payments granted prior to, but not yet vested as of
April 1, 2006, based on the grant-date fair value estimated in accordance with
the original provisions of SFAS No. 123; and (b) compensation cost for all
share-based payments granted, modified or settled subsequent to April 1, 2006,
based on the grant date fair value estimated in accordance with the provisions
of SFAS 123R. In accordance with the modified prospective transition method,
results for prior periods have not been restated.
For
the
three and nine month periods ended December 31, 2006, the Company recorded
share-based compensation expense of approximately $13,000 and $21,000,
respectively. For the three and nine month periods ended December 31, 2005,
the
Company recorded share-based compensation expense for options that vested of
approximately $5,000 and $5,000, respectively.
The
following table illustrates the effect on net loss and net loss per share if
the
Company had applied the fair value recognition provisions of SFAS No. 123 to
options granted for the three and nine months ended December 31, 2005. Since
stock-based compensation expense for the three and nine months ended December
31, 2006 was calculated under the provisions of SFAS No. 123R, there is no
disclosure of pro forma net loss and net loss per share for that period. For
purposes of the pro forma disclosure for the three and nine months ended
December 31, 2005 set forth in the table below, the value of the options is
estimated using a Black-Scholes option pricing model.
-
7
-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Had
compensation cost for the Company’s stock option grants been determined
consistent with SFAS 123, the Company’s net loss and net loss per share would
approximate the pro forma amounts below for the three and nine months ended
December 31, 2005:
(in
thousands, except per share data)
|
Three
Months
Ended
December 31, 2005
|
Nine
Months
Ended
December 31, 2005
|
|||||
Net
loss, as reported
|
$
|
(958
|
)
|
$
|
(1,810
|
)
|
|
Less:
Stock-based employee compensation expense determined
under
fair value based method for all employee awards
|
(443
|
)
|
(604
|
)
|
|||
Pro
forma, net loss
|
$
|
(1,401
|
)
|
$
|
(2,414
|
)
|
|
Basic
and diluted loss per share:
|
|||||||
As
reported
|
$
|
(0.05
|
)
|
$
|
(0.09
|
)
|
|
Pro
forma
|
$
|
(0.07
|
)
|
$
|
(0.12
|
)
|
On
July
8, 2004, the Board of Directors of the Company accelerated the vesting of all
outstanding options, such that at July 8, 2004, all outstanding options were
fully vested. The Company accelerated the vesting of the options to avoid
compensation expense associated with the adoption of SFAS 123R. This action
resulted in the immediate vesting of options to purchase 922,503 shares of
the
Company’s common stock.
No
compensation cost was recognized because of the acceleration, however, should
an
optionee realize a benefit from the acceleration that they would not have
otherwise been eligible for, then the Company would recognize compensation
expense. The compensation expense would be determined by the difference between
the closing stock price at July 8, 2004 of $3.92 and the option exercise price,
multiplied by the number of shares on which the optionee obtained a benefit
from
the accelerated vesting. At July 8, 2004 the total potential compensation
expense was $149,000. There was no compensation cost related to the acceleration
of vesting of stock options recorded for the three and nine months ended
December 31, 2006 and 2005. At December 31, 2006, there is no remaining
unrecognized compensation cost from the acceleration.
The
Black-Scholes option valuation model was developed for use in estimating the
fair value of traded options, which have no vesting restrictions and are fully
transferable. In addition, option valuation models require the input of highly
subjective assumptions including the expected stock price volatility. Because
the Company’s employee stock options have characteristics significantly
different from those of traded options, and because changes in the subjective
input assumptions can materially affect the fair value estimate, in management’s
opinion, the existing models do not necessarily provide a reliable single
measure of the fair value of its employee stock options.
The
fair
value of options granted during the three and nine months ended December 31,
2006 and 2005 is estimated on the date of grant using the Black-Scholes option
pricing model with the following weighted average assumptions:
Three
Months Ended
December
31,
|
Nine
Months Ended
Deember
31,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Dividend
yield
|
None
|
None
|
None
|
None
|
|||||||||
Expected
volatility
|
103.00
|
80.00
|
103.00
|
80.00
|
|||||||||
Risk-free
interest rate
|
4.67%
|
|
4.48%
|
|
4.68%
|
|
4.50%
|
|
|||||
Expected
life
|
6.5
years
|
10
years
|
6.5
years
|
10
years
|
Dividend
yield
- The
Company has never declared or paid any cash dividends on any of its capital
stock and does not expect to do so in the foreseeable future. Accordingly,
the
Company uses an expected dividend yield of zero to calculate the grant-date
fair
value of a stock option.
Expected
volatility
- The
expected volatility is a measure of the amount by which the Company’s stock
price is expected to fluctuate during the expected term of options granted.
The
Company determines the expected volatility solely based upon the historical
volatility of the Company’s common stock over a period commensurate with the
option’s expected term. The Company does not believe that the future volatility
of its common stock over an option’s expected term is likely to differ
significantly from the past.
-
8
-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Risk-free
interest rate
- The
risk-free interest rate is the implied yield available on U.S. Treasury
zero-coupon issues with a remaining term equal to the option’s expected term on
the grant date.
Expected
life
- For
option grants subsequent to the adoption of SFAS 123R, the expected life of
stock options granted is based on the simplified method prescribed under SAB
107, “Share-Based Payment.” Accordingly, the expected term is presumed to be the
midpoint between the vesting date and the end of the contractual
term.
The
Company recognizes compensation expense on a straight-line basis over the
requisite service period based upon options that are ultimately expected to
vest, and accordingly, such compensation expense has been adjusted by an amount
of estimated forfeitures. Forfeitures represent only the unvested portion of
a
surrendered option. SFAS No. 123R requires forfeitures to be estimated at the
time of grant and revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. Prior to the adoption of SFAS No.
123R,
the Company accounted for forfeitures upon occurrence as permitted under SFAS
No. 123. However, the estimation of forfeitures requires significant judgment,
and to the extent actual results or updated estimates differ from the Company’s
current estimates, such amounts will be recorded as a cumulative adjustment
in
the period estimates are revised. As of December 31, 2006, there are unvested
options for approximately 161,877 shares and the Company believes that there
is
no risk of forfeiture. The limited number of unvested options are held by
employees and a member of the Company’s Board of Directors and the Company
expects these options to fully vest, therefore a forfeiture rate of zero has
been assumed. The weighted average fair value of stock options granted during
the three months ended December 31, 2006 and 2005 was $1.73 and $2.35 per share,
respectively. The weighted average fair value of stock options granted during
the nine months ended December 31, 2006 and 2005 was $1.76 and $2.29 per share,
respectively.
CardioTech’s
1996 Employee, Director and Consultants Stock Option Plan (the “1996 Plan”) was
approved by CardioTech’s Board of Directors and Stockholders in March 1996. A
total of 7,000,000 shares have been reserved for issuance under the 1996 Plan.
Under the terms of the 1996 Plan the exercise price of Incentive Stock Options
issued under the Plan must be equal to the fair market value of the common
stock
at the date of grant. In the event that Non Qualified Options are granted under
the 1996 Plan, the exercise price may be less than the fair market value of
the
common stock at the time of the grant (but not less than par value). In October
2003, the Company’s shareholders approved the CardioTech International, Inc.
2003 Stock Option Plan (the “2003 Plan” and, together with the 1996 Plan, the
“Plans”), which authorizes the issuance of 3,000,000 shares of common stock with
terms similar to the 1996 Plan. Substantially all of the stock options granted
pursuant to the 1996 Plan provide for the acceleration of the vesting of the
shares of common stock subject to such options in connection with certain
changes in control of the Company. A similar provision is not included the
2003
Plan. In most cases, options granted under the Plans expire ten years from
the
grant date. Under Forms S-8 filed by the Company on June 12, 1996 and June
27,
2003, there are a total of 7,489,920 shares of common stock registered for
issuance pursuant to the 1996 Plan. Under a Form S-8 filed by the Company on
July 23, 2004, there are a total of 3,000,000 shares of common stock registered
for issuance pursuant to the 2003 Plan. As of December 31, 2006, no options
remain available for future grant under the 1996 Plan and 1,590,399 shares
remain available for future grant under the 2003 Plan.
-
9
-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Information
regarding option activity for the nine months ended December 31, 2006 under
the
Plan is summarized below:
Options
Outstanding
|
|
Weighted
Average Exercise Price per Share
|
|
Weighted
Average Remaining Contractual Term in Years
|
|
Aggregate
Intrinsic Value
|
|||||||
Options
outstanding as of April 1, 2006
|
6,210,880
|
$
|
2.21
|
6.50
|
|||||||||
Granted
|
210,418
|
1.76
|
|||||||||||
Exercised
|
(36,250
|
)
|
1.70
|
||||||||||
Cancelled
|
(410,451
|
)
|
3.45
|
||||||||||
Forfeited
|
(424,412
|
)
|
1.94
|
||||||||||
Options
outstanding as of December 31, 2006
|
5,550,185
|
$
|
2.12
|
6.25
|
$
|
2,367,860
|
|||||||
Options
exercisable as of December 31, 2006
|
5,388,308
|
$
|
2.13
|
6.15
|
$
|
2,330,235
|
The
aggregate intrinsic value in the table above represents the total pre-tax
intrinsic value (the difference between the closing price of the common stock
on
December 29, 2006 of $1.95 and the exercise price of each in-the-money option)
that would have been received by the option holders had all option holders
exercised their options on December 31, 2006. Total intrinsic value of stock
options exercised under the Plan for the three and nine months ended December
31, 2006 was $0 and $33,000, respectively.
6.
|
|
Comprehensive
Income or
Loss
|
SFAS
No.
130, “Reporting
Comprehensive Income,”
establishes standards for the reporting and displaying of comprehensive income
or loss and its components in the consolidated financial statements.
Comprehensive income (loss) is the Company’s total of net income (loss) and all
other non-owner changes in equity including such items as unrealized holding
gains (losses) on securities classified as available-for-sale by CorNova,
foreign currency translation adjustments and minimum pension liability
adjustments. During the three and nine months ended December 31, 2006 and 2005,
the Company’s only item of other comprehensive income or loss was its equity in
unrecognized holding losses on securities classified as available for sale
recorded by CorNova.
Three
Months Ended
|
Nine
Months Ended
|
||||||||||||
December
31,
|
December
31,
|
||||||||||||
(In
thousands)
|
2006
|
|
2005
|
|
2006
|
|
2005
|
||||||
Net
loss
|
$
|
(826
|
)
|
$
|
(958
|
)
|
$
|
(2,382
|
)
|
$
|
(1,810
|
)
|
|
Other
comprehensive income (loss)
|
-
|
(58
|
)
|
(40
|
)
|
84
|
|||||||
Comprehensive
loss
|
$
|
(826
|
)
|
$
|
(1,016
|
)
|
$
|
(2,422
|
)
|
$
|
(1,726
|
)
|
7.
|
|
Related
Person
Transactions
|
The
Company has an investment in CorNova, Inc., of which Dr. Eric Ryan is Chairman,
CEO and a major shareholder. The Company, on July 15, 2004, entered into a
two-year consulting agreement with Dr. Ryan, which provides for a range of
payments, in either cash or common stock, for the achievement of certain
milestones related to the manufacturing, commencement of European clinical
trials and the receipt of a restricted CE mark of the Company’s CardioPass
SynCAB. There were no expenses related to this agreement recognized for the
three and nine months ended December 31, 2006. There was $38,000 in expenses
related to this agreement recognized in the three and nine months ended December
31, 2005. This agreement expired as of July 15, 2006.
The
Company provides research and development services to CorNova in connection
with
the development of the drug-eluting stent. During the three and nine months
ended December 31, 2005, the Company recognized $12,000 in connection with
these
services. As of December 31, 2006, there were no accounts receivable or payables
outstanding related to CorNova.
-
10
-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
8.
|
|
Inventories
|
Inventories
consist of the
following:
(in
thousands)
|
December
31,
2006
|
March
31,
2006
|
|||||
Raw
materials
|
$
|
2,530
|
$
|
2,143
|
|||
Work
in progress
|
1,145
|
1,033
|
|||||
Finished
goods
|
1,548
|
1,610
|
|||||
Total
inventories
|
$
|
5,223
|
$
|
4,786
|
9.
|
|
Property,
Plant and
Equipment
|
Property,
plant and equipment consists of the following:
(in
thousands)
|
December
31,
2006
|
|
March
31,
2006
|
||||
Land
|
$
|
500
|
$
|
500
|
|||
Building
|
2,153
|
2,053
|
|||||
Machinery,
equipment and tooling
|
2,956
|
2,473
|
|||||
Furniture,
fixtures and office equipment
|
748
|
651
|
|||||
Leasehold
improvements
|
1,343
|
1,336
|
|||||
7,700
|
7,013
|
||||||
Less:
accumulated depreciation and amortization
|
(3,468
|
)
|
(2,954
|
)
|
|||
$
|
4,232
|
$
|
4,059
|
LeMaitre
Vascular Products, Inc., a third party contractor, has manufactured coronary
grafts for our limited use. In October 2006, the Company purchased proprietary
equipment for $350,000 in cash which is designed for the future manufacture
of
its CardioPass grafts, as well as for the development of additional medical
devices. Under the terms of the agreement, the seller of the equipment has
rights to a 5% royalty on future net commercial sales of CardioPass
grafts.
For
the
three months ended December 31, 2006 and 2005, depreciation expense was $185,000
and $200,000, respectively. For the nine months ended December 31, 2006 and
2005, depreciation expense was $514,000 and $608,000, respectively.
10. |
Earnings
Per Share
|
The
Company follows SFAS No. 128, “Earnings
Per Share,”
where
basic earnings per share is computed by dividing net income (loss) by the
weighted average number of common shares outstanding during the period. Diluted
earnings per share are based upon the weighted average number of common shares
outstanding during the period plus additional weighted average common equivalent
shares outstanding during the period. Common equivalent shares result from
the
assumed exercise of outstanding stock options and warrants.
Options
and warrants totaling 6,430,916 shares of common stock, that were outstanding
as
of December 31, 2006, were excluded from the calculation of diluted earnings
per
share because the effect would be antidilutive.
Options
and warrants totaling 7,258,040 shares of common stock, that were outstanding
as
of December 31, 2005, were excluded from the calculation of diluted earnings
per
share because the effect would be antidilutive. (Note 12).
11. |
Enterprise
and Related Geographic
Information
|
The
Company acquired Gish Biomedical, Inc. effective April 7, 2003 and subsequent
to
that date, the Company has managed its business on the basis of one reportable
operating segment, Medical Device Manufacturing and Sales, in accordance with
the qualitative and quantitative criteria established by SFAS 131, “Disclosures
About Segments of an Enterprise and Related Information.”
Sales
to
foreign customers (primarily Europe and Asia) aggregated approximately
$982,000
and $709,000 for the three months ended December 31, 2006 and 2005,
respectively, and $2,754,000 and $2,482,000 for the nine months ended December
31, 2006 and 2005, respectively.
The
Company has no long-lived assets outside the United States.
-
11
-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Revenues
for the presented periods are as follows:
Three
Months Ended
December
31,
|
Nine
Months Ended
December
31,
|
||||||||||||
(in
thousands)
|
2006
|
|
2005
|
|
2006
|
|
2005
|
||||||
Medical
devices
|
$
|
4,887
|
$
|
4,958
|
$
|
14,247
|
$
|
15,550
|
|||||
Contracted
product design and development
|
162
|
282
|
476
|
902
|
|||||||||
Royalties
|
365
|
229
|
943
|
692
|
|||||||||
$
|
5,414
|
$
|
5,469
|
$
|
15,666
|
$
|
17,144
|
12. |
Stockholders’
Equity
|
During
the three months ended December 31, 2006 and 2005, the Company issued 0 and
45,000 shares of common stock, respectively, as a result of the exercise of
options by employees, generating cash proceeds of $0 and $84,000, respectively.
During the nine months ended December 31, 2006 and 2005, the Company issued
36,250 and 278,804 shares of common stock, respectively, as a result of the
exercise of options by employees, generating cash proceeds of $62,000 and
$616,000, respectively.
During
the three months ended December 31, 2006 and 2005, the Company repurchased
0 and
1,500 shares of its common stock, respectively, at a cost of $0 and $2,800,
respectively. During the nine months ended December 31, 2006 and 2005, the
Company repurchased 600 and 3,300 shares of its common stock, respectively,
at a
cost of $1,500 and $6,200, respectively.
On
December 22, 2004, the Company issued 1,139,586 shares of its common stock
at
$2.40 per share in connection with a private placement receiving $2,735,000
in
gross proceeds, less placement agent fees and related transaction costs of
approximately $314,000. In connection with the transaction, the investors had
rights to purchase up to 1,139,586 shares of common stock at a price of $2.40
per share, which were exercisable for a period commencing December 22, 2004
and
ending on July 27, 2005. Effective July 28, 2005 these additional investment
rights were unexercised and expired.
13. |
Income
Taxes
|
The
Company uses the liability method of accounting for income taxes as set forth
in
SFAS No. 109, “Accounting
for Income Taxes.”
Under
this method, deferred taxes are determined based on the difference between
the
financial statement and tax bases of assets and liabilities using enacted tax
rates in effect in the years in which the differences are expected to reverse.
Deferred tax assets are recognized and measured based on the likelihood of
realization of the related tax benefit in the future.
For
the
three and nine months ended December 31, 2006 and 2005, the Company provided
for
no income taxes, other than state income taxes, as the Company has significant
net loss carryforwards.
14. |
Investment
in CorNova
|
An
Exchange and Venture Agreement (the “Agreement”) was entered into on March 5,
2004 by and among CardioTech, Implant Sciences Corporation, and CorNova, Inc.
(“CorNova”).
CorNova is a privately-held, development stage company, incorporated as a
Delaware corporation on October 10, 2003. CorNova’s focus is the development of
interventional
catheters and stent systems .
On
March 5, 2004, CardioTech and Implant each agreed to transfer to CorNova 12,931
shares and 10,344 shares of their common stock (collectively, the “Contributory
Shares”), respectively, in exchange for 1,500,000 shares, each, of CorNova’s
common stock. The number of Contributory Shares issued reflects the fair market
value of CardioTech’s and Implant’s common stock as of November 18, 2003, for an
aggregate value of $75,000 each. As of November 18, 2003, this also resulted
in
CardioTech and Implant each receiving approximately thirty-one percent (31%)
of
the issued and outstanding common equity of CorNova.
-
12
-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Upon
the
event of CorNova securing additional financing in the minimum amount of
$1,000,000 and up to a maximum amount of $3,000,000 (the “Series A Financing”),
CardioTech and Implant were each required to issue additional shares of their
common stock (the “Investment Shares”), where the number of Investment Shares to
be issued was equal to twenty-five percent (25%), of the gross proceeds of
the
Series A Financing divided by the respective five (5) day average of the closing
prices of the common stock of CardioTech and Implant as published in the Wall
Street Journal on the dates immediately preceding the closing of the Series
A
Financing. CorNova, Inc. completed its Series A Financing transaction on
February 4, 2005. At that time, the Company became obligated to contribute
shares of its common stock equal to $750,000. The number of shares was
determined to be 308,642. Simultaneous with the issuance and exchange of the
Investment Shares, as set forth in the Agreement, CardioTech granted to CorNova
an exclusive license for the technology consisting of ChronoFlex DES polymer
or
any poly (carbonate) urethane containing derivative thereof for use on
drug-eluting stents (collectively the “Technology”) In January 2006, CorNova
sold 198,000 shares of CardioTech common stock that it owned .
The
Company has no additional obligation to contribute assets or additional common
stock nor to assume any liabilities or to fund any losses that CorNova may
incur. In addition to the issuance of its common stock at the completion of
a
Series A Financing, CardioTech granted to CorNova an exclusive license for
the
technology consisting of ChronoFlex DES polymer, or any poly (carbonate)
urethane containing derivative thereof tailored to the drug(s) specified by
CorNova, for use on drug-eluting stents.
Both
the
Contributory Shares and the Investment Shares (collectively, the “Securities”)
are restricted securities within the meaning of Rule 144 of the Securities
and
Exchange Commission under the Securities Act of 1933, as amended (the
“Securities Act”), and none of the Securities may be sold except pursuant to an
effective registration statement under the Securities Act or under the
securities laws of any state, or in a transaction exempt from registration
under
the Securities Act.
The
Series A Financing transactions resulted in the issuance by CorNova of 3,050,000
shares of preferred stock. The preferred stock has a liquidation preference
equal to $1.00 per share, the original preferred stock purchase price and the
same voting rights as CorNova’s common stock. The CorNova preferred stock can be
converted on a share for share basis into CorNova common stock at the discretion
of the preferred stockholders. The preferred stock is subject to several
mandatory conversion requirements based on future events and subject to
redemption at a premium, which varies based on the redemption date. CorNova
currently also has outstanding warrants for the purchase of 150,000 shares
of
its common stock at $1.00 per share, issued in conjunction with its original
seed loans and warrants for the purchase 635,000 shares of its common stock
at
$1.10 per share, issued to an individual as a “finders” fee. Additionally,
CorNova’s shareholders have approved the 2004 Qualified Incentive Stock Option
Plan (“2004 Plan”) which authorized the Board of Directors of CorNova to grant
options to purchase up to 2,000,000 shares of CorNova’s common stock to
employees and consultants. At December 31, 2006, CorNova has granted
approximately 1,055,000 options under the 2004 Plan.
CardioTech
currently owns approximately 31% of the issued and outstanding common stock
of
CorNova and, accordingly, CardioTech has used the equity method of accounting
in
accordance with APB Opinion No. 18, “The Equity Method of Accounting for
Investments in Common Stock”, and recorded 31% of the net loss of CorNova in its
consolidated financial statements for the nine months ended December 31, 2006
and for three and nine months ended December 31,2005. During the three months
ended December 31, 2006, the Company recorded equity in the net loss of CorNova
of $0, and equity in comprehensive loss of CorNova of $0 (related to unrealized
holding losses on securities classified as available-for-sale). During the
three
months ended December 31, 2005, the Company recorded equity in the net loss
of
CorNova of $133,000, and equity in comprehensive loss of CorNova of $58,000
(related to unrealized holding losses on securities classified as
available-for-sale). The Company has invested $825,000 in CorNova, Inc. and
has
recorded cumulative net losses through December 31, 2006 of $825,000 from
CorNova. Therefore, no further losses will be recorded by the Company.
At
December 31, 2006, CorNova had total assets of $2,081,000, of which $716,000
was
cash and short-term investments, liabilities totaling $223,000 and Stockholders’
Equity of $1,858,000 of which $3,942,000 is a retained earnings deficit and
$610,000 is comprehensive loss related to the decline in market value of the
common stock of CardioTech and Implant held by CorNova and which was transferred
to CorNova in the transactions discussed above.
-
13
-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
15. |
Authorization
of Company Buy-Back of Common
Stock
|
In
June
2001, the Board of Directors authorized the purchase of up to 250,000 shares
of
the Company’s common stock, of which 174,687 shares have been purchased as of
December 31, 2006. In June 2004, the Board of Directors authorized the purchase
of up to 500,000 additional shares of the Company’s common stock. The Company
announced that purchases may be made from time-to-time in the open market,
privately negotiated transactions, block transactions or otherwise, at times
and
prices deemed appropriate by management.
16. |
New
Accounting Pronouncements
|
In
June
2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation No. 48, “Accounting for Uncertainty in Income Taxes,” an
interpretation of FASB Statement No. 109 (“FIN 48”). FIN 48 clarifies the
accounting for uncertainties in income taxes recognized in an enterprise’s
financial statements. The Interpretation requires that we determine whether
it
is more likely than not that a tax position will be sustained upon examination
by the appropriate taxing authority. If a tax position meets the more likely
than not recognition criteria, FIN 48 requires the tax position be measured
at
the largest amount of benefit greater than fifty percent (50%) likely of being
realized upon ultimate settlement. This accounting standard is effective for
fiscal years beginning after December 15, 2006. The Company does not expect
the
adoption of FIN 48 to have a material impact on its consolidated financial
statements.
-
14
-
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
Cautionary
Note Regarding Forward-Looking Statements
This
Report on Form 10-Q contains certain statements that are “forward-looking”
within the meaning of the Private Securities Litigation Reform Act of 1995
(the
“Litigation Reform Act”). These forward looking statements and other information
are based on our beliefs as well as assumptions made by us using information
currently available.
The
words
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “will,” “should” and
similar expressions, as they relate to us, are intended to identify
forward-looking statements. Such statements reflect our current views with
respect to future events and are subject to certain risks, uncertainties and
assumptions. Should one or more of these risks or uncertainties materialize,
or
should underlying assumptions prove incorrect, actual results may vary
materially from those described herein as anticipated, believed, estimated,
expected, intended or using other similar expressions.
In
accordance with the provisions of the Litigation Reform Act, we are making
investors aware that such forward-looking statements, because they relate to
future events, are by their very nature subject to many important factors that
could cause actual results to differ materially from those contemplated by
the
forward-looking statements contained in this Report on Form 10-Q. For example,
the
Company
may encounter competitive, technological, financial and business challenges
making it more difficult than expected to continue to develop and market its
products; the market may not accept the Company’s existing and future products;
the Company may not be able to retain its customers; the Company may be unable
to retain existing key management personnel; and there may be other material
adverse changes in the Company’s operations or business. Certain important
factors affecting the forward-looking statements made herein also include,
but
are not limited to (i) continued downward pricing pressures in the Company’s
targeted markets, (ii) the continued acquisition of the Company’s customers by
certain of its competitors, and (iii) continued periods of net losses, which
could require the Company to find additional sources of financing to fund
operations, implement its financial and business strategies, meet anticipated
capital expenditures and fund research and development costs. In addition,
assumptions relating to budgeting, marketing, product development and other
management decisions are subjective in many respects and thus susceptible to
interpretations and periodic revisions based on actual experience and business
developments, the impact of which may cause the Company to alter its marketing,
capital expenditure or other budgets, which may in turn affect the Company’s
financial position and results of operations. For all of these reasons, the
reader is cautioned not to place undue reliance on forward-looking statements
contained herein, which speak only as of the date hereof. The Company assumes
no
responsibility to update any forward-looking statements as a result of new
information, future events, or otherwise except as required by law.. For further
information you are encouraged to review CardioTech’s filings with the
Securities and Exchange Commission, including its Annual Report on Form 10-K
for
the fiscal year ended March 31, 2006 and its Quarterly Reports on Form 10-Q
for
the fiscal quarters ended June 30, 2006 and September 30, 2006.
Overview
History
CardioTech
International, Inc. (“CardioTech’ or the “Company”) was founded in 1993 as a
subsidiary of PolyMedica Corporation (“PMI”). In June 1996, PMI distributed all
of the shares of CardioTech’s common stock, par value $0.01 per share, that PMI
owned, to PMI stockholders of record. The Company’s proprietary ChronoFlex
polyurethane materials have been sold through its CT Biomaterials division
since
the formation of the Company as biomaterials for the manufacture of medical
devices. These premium biomaterials are sold under the tradenames: ChronoFlex,
ChronoThane, HydroThane, ChronoFilm, HydroMed and Hydroslip, and are used by
the
Company’s customers for use in both acute and chronically implanted devices such
as stents, artificial hearts, and vascular ports.
In
July
1999, Dermaphylyx International, Inc. (“Dermaphylyx”), was formed by certain
affiliates of CardioTech to develop advanced wound healing products. Dermaphylyx
was merged with and into CardioTech effective March 2004. In June 2006, the
Company’s Board of Directors decided to cease the operations of Dermaphylyx, the
costs of which are immaterial to the Company’s operations.
In
April
2001, the Company acquired Catheter and Disposables Technology, Inc. (“CDT”).
CDT is an original equipment manufacturer and supplier of private-label advanced
disposable medical devices from concept to finished packaged and sterilized
products. Certain devices designed, developed and manufactured for customers
by
CDT include sensing, balloon, and drug delivery catheters; disposable
endoscopes; and in-vitro diagnostic and surgical disposables.
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15
-
In
April
2003, the Company merged with Gish Biomedical, Inc. (“Gish”). Gish manufacturers
single use cardiopulmonary bypass products that have a disposable
component.
In
March
2004, CardioTech joined with Implant Sciences Corporation (“Implant”) to
participate in the funding of CorNova. CorNova was formed to develop a novel
coronary drug eluting stent using the combined capabilities and technology
of
CorNova, Implant Sciences and CardioTech. Assuming
the conversion to common stock of all of CorNova’s issued and outstanding shares
of preferred stock, the Company’s shares of CorNova common stock would represent
approximately 17% of the issued and outstanding equity of CorNova.
Although CorNova is expected to incur future operating losses, the Company
has
no obligation to fund CorNova.
The
Company has one operating segment, medical device manufacturing and sales,
and
operates as three divisions: (i) biomaterials, (ii) private-label medical device
manufacturing and (iii) cardiopulmonary products.
Technology
and Intellectual Property
CardioTech
owns a number of patents relating to its vascular graft manufacturing
technology. In addition, PMI has granted to CardioTech an exclusive, perpetual,
worldwide, royalty-free license for the use of one polyurethane patent and
related technology in the field consisting of the development, manufacture
and
sale of implantable medical devices and biodurable polymer material to third
parties for the use in medical applications (the “Implantable Device and
Materials Field”). PMI also owns, jointly with Thermedics, Inc., an unrelated
company that manufactures medical grade polyurethane, the ChronoFlex
polyurethane patents relating to the ChronoFlex technology (“Joint Technology”).
PMI has granted to CardioTech a non-exclusive, perpetual, worldwide,
royalty-free sublicense of these patents for use in the Implantable Devices
and
Materials Field.
In
October 2006, the Company announced that it had signed a supply and
royalty agreement with a leading developer and manufacturer of orthopedic
devices. Under the terms of the in-perpetuity agreement, the Company provides
exclusive use and supply of its proprietary ChronoFlex® polymer material that is
specifically formulated for the development of orthopedic implant
devices.
ChronoFilm
is a registered trademark of PMI. ChronoFlex is a registered trademark of
CardioTech. ChronoThane, ChronoPrene, HydroThane, PolyBlend and PolyWeld are
tradenames of CardioTech. DuraGraft and CardioPass are trademarks of
CardioTech.
Research
and Development
CardioTech
is incorporating its proprietary polymer technology into a wide range of
breakthrough medical applications, starting with coronary artery bypass. The
Company’s business model calls for vertically leveraging its technological and
manufacturing expertise in order to expand royalty income, develop next
generation polymers and manufacture new and complex medical
devices.
CardioTech’s
customers include large medical device companies in the U.S. and abroad.
The
CardioPass graft is the Company’s proprietary, synthetic coronary artery bypass
graft (“SynCAB”). The Company is developing the CardioPass graft, using
specialized ChronoFlex polyurethane materials, to produce a synthetic graft
of
5mm in diameter specifically designed for use in coronary artery bypass graft
(“CABG”) surgery. If successfully developed, the Company believes that the
SynCAB may be used initially to provide an alternative to patients with
insufficient or inadequate (“suboptimal”) native vessels for use in bypass
surgery as a result of repeat procedures, trauma, disease or other factors.
The
Company believes, however, that the CardioPass Graft may ultimately be used
as a
substitute for native saphenous veins, thus avoiding the trauma and expense
associated with the surgical harvesting of the vein.
According
to the 2004 report of the American Heart Association, approximately 500,000
bypass operations were performed in the U.S. in 2003. The Company estimates
that
approximately 750,000 CABG procedures were performed worldwide during the same
year. The Company believes that approximately 20% of these CABG procedures
were
performed on patients who had previously undergone bypass surgery, and that
the
number of repeat procedures will continue to increase as a percentage of
procedures performed. Currently, approximately 70% of CABG procedures are
performed utilizing the saphenous vein.
The
Company initiated plans in fiscal 2006 to obtain European marketing approvals.
In May 2006, the Company received written acknowledgement from its Notified
Body
in Europe that its clinical trial plan had been accepted. The planned 10 patient
clinical trial protocol allows surgeons to intraoperatively decide to use the
SynCAB instead of suboptimal autologous vessels.
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16
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The
Company has hired a European-based contract research organization (“CRO”) to
assist in management of the entire clinical process. The CRO has helped the
Company review possible sites in the European Union in order to select
investigators who will follow the approved protocols. A site has been selected,
a Principal Investigator has signed a letter of agreement to conduct the trial
and provide the necessary data for the clinical research report and we have
received approval from the Ethics Committee. Our Principal Investigator has
participated in a wide range of cardiovascular clinical trials. Achievement
of
this important milestone fits within the Company’s planned timeline and is an
important benchmark in the commencement and completion of the clinical
trial. The Company has received approval from the Ministry of
Health. In January 2007, with the receipt of an export license from the FDA,
the
Company announced that the clinical trial for the CE Mark had
started.
The
Company now expects that actual selection of patients will begin in the last
quarter of fiscal 2007. The patient enrollment process is not an easy one for
a
long-term surgical implant that is designed to improve outcomes for very sick
patients. Prior to each surgery, the Company’s investigators must receive
patient consent for participation in the trials. The surgeon then decides at
the
time of the operation whether or not to utilize the graft. The Company plans
to
review data after a 90-day follow up has been completed on each of the first
three (3) patients. This review will help it determine, with a minimal
investment of time and money, if the process is as promising as the Company
believes.
Patients
will be followed for 90 days and assessed for graft patency and quality of
life
measures. Following the completed clinical trial, the analyzed data will be
submitted by CardioTech to the Notified Body in support of the Company’s CE Mark
application
LeMaitre
Vascular Products, Inc., a third party contractor, has manufactured coronary
grafts for our limited use. In October 2006, the Company purchased proprietary
equipment for $350,000 in cash which is designed for the future manufacture
of
its CardioPass grafts, as well as for the development of additional medical
devices.
While
the production of our own grafts depends on the results of clinical trials,
production may
be
further delayed as a result of the requirement for equipment validation and,
therefore may
adversely affect our business.
In
June
2006, the Company announced that it signed an agreement to develop innovative
medical solutions for the treatment of congestive heart failure. Development
at
the Company’s Gish Biomedical rapid prototype laboratories will utilize
proprietary antithrombogenic Gish Biocompatible Surface (“GBS”)
technology.
Business
Strategy
The
Company’s vision is to become a world-class, technology company focused on
customer driven solutions in the medical device industry. To
achieve this end, the Company’s goal is to better combine its proprietary core
polymer technology with new product applications and expand customers’ access to
the Company’s capabilities. The Company has begun the process to vertically
integrate its biomaterials division, the developer, manufacturer and marketer
of
the Company’s proprietary polymers, with its CDT unit, which designs and
manufactures disposable medical devices. An important initial step is the recent
senior management hires at CDT of a new Vice President and General Manager,
Product Development Engineering Director, and Regional Sales Manager.
In
January 2007, the Company retained Silverwood Partners, an investment banking
firm, to identify potential purchasers of its Gish Biomedical, Inc. unit
("Gish"), located in southern California and to manage the sale of Gish. The
Company believes that Gish is a strong brand name that has been associated
for
over 30 years with the provision of innovative, high quality, disposable medical
products. The Company believes that Gish is not a fit with CardioTech’s
strategic direction and the sale of Gish will permit the redeployment of capital
into CardioTech’s ongoing growth initiatives. The sale of Gish is an opportunity
to align the business with an acquirer that is focused on capitalizing on the
strength of the respected Gish brand in the worldwide medical device
marketplace.
The
Company recently completed an in-depth study of its strengths and weaknesses
and
the opportunities in the medical device marketplace. This effort was designed
to
make the Company more competitive than in the past. The research pinpointed
the
Company’s unique materials sciences strengths that have the potential to be
marketed to the Company’s existing customer base and to a broader range of
medical device developers. Most importantly, the Company also discovered a
major
void in the marketplace that it believes it can fill with its strong materials
sciences capabilities to maximize the early development phase of devices that
utilize polymers.
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17
-
To
fill
that void, the Company is now in the process of expanding its development
laboratory at the Company’s headquarters in Massachusetts. The expansion of the
Company development laboratory is a key element of the Company’s plan to
vertically integrate the Company’s OEM manufacturing operation in Minnesota with
the Company’s biomaterials operations here in Wilmington. The Company’s aim is
to better combine the Company core polymer technology with new product
applications and expand customers' access to the Company capabilities.
The
Company is also conducting a comprehensive review of intellectual property
held
by other companies in which the Company’s proprietary polymers are cited. The
results of this review may lead to additional opportunities to exercise the
Company strategy of seeking license and royalty arrangements for the exclusive
use of the Company polymers.
Manufacturing
Operations
The
Company generates approximately 97% of its product sales from manufacturing
operations at Gish and CDT.
Critical
Accounting Policies
Our
significant accounting policies are summarized in Note A to our consolidated
financial statements included in Item 7 of our Annual Report on Form 10-K for
the fiscal ended March 31, 2006. However, certain of our accounting policies
require the application of significant judgment by our management, and such
judgments are reflected in the amounts reported in our consolidated financial
statements. In applying these policies, our management uses its judgment to
determine the appropriate assumptions to be used in the determination of
estimates. Those estimates are based on our historical experience, terms of
existing contracts, our observance of market trends, information provided by
our
strategic partners and information available from other outside sources, as
appropriate. Actual results may differ significantly from the estimates
contained in our consolidated financial statements. There
has
been no change to our critical accounting policies through the fiscal quarter
ended December 31, 2006. Our
critical accounting policies are as follows:
· |
Revenue
Recognition. The
Company recognizes revenue in accordance with Staff Accounting Bulletin
(“SAB”) No. 104, “Revenue Recognition in Financial Statements.” The
Company recognizes revenue from product sales upon shipment, provided
that
a purchase order has been received or a contract has been executed,
there
are no uncertainties regarding customer acceptance, the sales price
is
fixed or determinable and collection is deemed probable. If uncertainties
regarding customer acceptance exist, the Company recognizes revenue
when
those uncertainties are resolved and title has been transferred to
the
customer. Amounts collected or billed prior to satisfying the above
revenue recognition criteria are recorded as deferred revenue. The
Company
also receives license and royalty fees for the use of its proprietary
biomaterials. CardioTech recognizes these fees as revenue in accordance
with the terms of the contracts. Contracted product design and development
projects are
recognized on a time and materials basis as services are
performed.
|
· |
Accounts
Receivable Valuation. We
perform various analyses to evaluate accounts receivable balances
and
record an allowance for bad debts based on the estimated collectibility
of
the accounts such that the amounts reflect estimated net realizable
value.
If actual uncollectible amounts significantly exceed the estimated
allowance, the Company’s operating results would be significantly and
adversely affected.
|
· |
Inventory
Valuation. We
value our inventory at the lower of our actual cost or the current
estimated market value. We regularly review inventory quantities
on hand
and inventory commitments with suppliers and record a provision for
excess
and obsolete inventory based primarily on our historical usage for
the
prior twelve to sixty month period. Although we make every effort
to
ensure the accuracy of our forecasts of future product demand, any
significant unanticipated change in demand or technological developments
could have a significant impact on the value of our inventory and
our
reported operating results.
|
· |
Intangibles.
Our
long-lived assets include intangible assets and goodwill. In assessing
the
recoverability of our intangible assets and goodwill, we must make
assumptions in determining the fair value of the asset by estimating
future cash flows and considering other factors, including our significant
changes in the manner or use of the assets, or negative industry
reports
or economic conditions. If those estimates or their related assumptions
change in the future, we may be required to record impairment charges
for
those assets. Under the provisions of Statement of Financial Accounting
Standards, or SFAS No. 142, “Goodwill and Other Intangible Assets,” we are
required to test our intangible assets for impairment on a periodic
basis
thereafter. The Company will be required to continue to perform a
goodwill
impairment test on an annual basis, or more frequently if indicators
of
impairment exist, and the next test is scheduled during the quarter
ending
March 31, 2007.
|
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18
-
Results
of Operations
Three
Months Ended December 31, 2006 vs. December 31, 2005
Revenues
The
following table presents revenues by group expressed as a percentage of total
revenues for the three months ended December 31,
(in
thousands)
|
2006
|
|
%
of
Revenues
|
|
2005
|
|
%
of
Revenues
|
||||||
Revenues:
|
|||||||||||||
Product
sales
|
$
|
5,049
|
93.3
|
%
|
$
|
5,240
|
95.8
|
%
|
|||||
Royalties
|
365
|
6.7
|
%
|
229
|
4.2
|
%
|
|||||||
$
|
5,414
|
100.0
|
%
|
$
|
5,469
|
100.0
|
%
|
The
following table presents product sales by group expressed as a percentage of
total product sales for the three months ended December 31,
2006
|
2005
|
||||||||||||
(in
thousands)
|
Product
sales
|
|
%
of Product sales
|
|
Product
sales
|
|
%
of Product sales
|
||||||
Medical
devices
|
$
|
4,887
|
96.8
|
%
|
$
|
4,958
|
94.6
|
%
|
|||||
Contracted
product design and development
|
162
|
3.2
|
%
|
282
|
5.4
|
%
|
|||||||
$
|
5,049
|
100.0
|
%
|
$
|
5,240
|
100.0
|
%
|
Medical
device revenues for the three months ended December 31, 2006 were $4,887,000
as
compared to $4,958,000 for the comparable prior year period, a decrease of
$71,000, or 1.4%. Medical devices are primarily composed of cardiopulmonary
bypass products, private-label products, and biomaterials typically used for
implantable devices. Medical device revenues of cardiopulmonary bypass products
were unchanged. There were fewer shipments of private-label products of
approximately $140,000, primarily due to the loss of a major customer. Shipments
of products for the biomaterial division increased by approximately
$70,000.
Contracted
product design and development revenues for the three months ended December
31,
2006 were $162,000 as compared to $282,000 for the comparable prior year period,
a decrease of $120,000 or 42.6%. Contracted product design and development
services are provided primarily to OEM suppliers and development companies
with
the expectation of manufacturing private-label medical devices following the
completion of these services. The decrease in contracted product design and
development services is a result of the Company’s previous shift towards the
manufacture and shipment of private-label medical device products, together
with
the transitioning to a new Regional Sales Manager.
Royalties
for the three months ended December 31, 2006 were $365,000 as compared to
$229,000 for the comparable prior year period, an increase of $136,000 or 59.4%.
The
Company has agreements to license its proprietary biomaterials technology to
medical device manufacturers. Royalties are earned when these manufacturers
sell
medical devices which use the Company’s biomaterials. Accordingly, the increase
in royalties during the three months ended December 31, 2006 is a result of
increased shipments of product by these manufacturers.
Additionally, in October 2006, the Company announced that it had signed a supply
and
royalty agreement with a leading developer and manufacturer of orthopedic
devices. Under the terms of the in-perpetuity agreement, the Company provides
exclusive use and supply of its proprietary ChronoFlex® polymer material that is
specifically formulated for the development of orthopedic implant devices.
The
Company will recognize these fees as revenue in accordance with the terms of
the
contract.
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19
-
Gross
Margin
The
following table presents product sales gross margin and gross margin percentages
as a percent of the respective product sales for the three months ended December
31,
2006
|
2005
|
||||||||||||
(in
thousands)
|
Gross
Margin
|
|
%
Gross Margin
|
|
Gross
Margin
|
|
%
Gross Margin
|
||||||
Product
sales
|
$
|
1,057
|
20.9
|
%
|
$
|
777
|
14.8
|
%
|
Gross
margin on product sales (excluding royalty income) was $1,057,000, or 20.9%
as a
percentage of product revenue for the three months ended December 31, 2006,
as
compared to $777,000, or 14.8% for the comparable prior year
period.
The
6.1%
increase in gross margin as a percentage of product sales for the three months
ended December 31, 2006, as compared to December 31, 2005, is principally due
to
two offsetting factors. First, the Company recorded a $240,000 provision for
a
voluntary recall of certain cardiopulmonary products in the three months ended
December 31, 2005, thereby reducing gross margin percent from 18.7% to 14.8%
in
2005. Secondly, in 2006, the Company generated higher overall gross margin
in
its private-label business due to the cessation earlier in the year of lower
margin shipments to a major customer. See discussion below about the End User.
Research
and Development, Regulatory, and Engineering Expenses
The
following table presents research and development expenses as a percentage
of
revenues for the three months ended December 31,
(in
thousands)
|
2006
|
|
%
of
Revenues
|
|
2005
|
|
%
of
Revenues
|
||||||
Research
and development, regulatory and
engineering
|
$
|
426
|
7.9
|
%
|
$
|
358
|
6.5
|
%
|
Research
and development expenses for the three months ended December 31, 2006 were
$426,000 as compared to $358,000 for the comparable prior year period, an
increase of $68,000 or 19.0%. CardioTech’s research and development efforts are
focused on developing new applications of ChronoFlex, synthetic vascular graft
technologies, including the CardioPass graft, and Gish Biocompatible Surface
Coating applications. Research and development expenditures consisted primarily
of the salaries of full time employees and related expenses, and are expensed
as
incurred. The Company had additional staff for research and development in
the
three months ended December 31, 2006. These individuals work on a variety of
projects, including production support, and the Company believes it is operating
at the minimum staffing level to support its operating needs.
The
Company has an investment in CorNova, Inc., of which Dr. Eric Ryan is Chairman,
CEO and a major shareholder. The Company, on July 15, 2004, entered into a
two-year consulting agreement with Dr. Ryan, which provides for a range of
payments, in either cash or common stock, for the achievement of certain
milestones related to the manufacturing, commencement of European clinical
trials and the receipt of a restricted CE mark of the Company’s CardioPass
SynCAB. This agreement expired as of July 15, 2006. For the three months ended
December 31, 2005, there were no expenses recognized related to this
agreement.
Selling,
General and Administrative Expenses
The
following table presents selling, general and administrative expenses as a
percentage of revenues for the three months ended December 31,
(in
thousands)
|
2006
|
%
of Revenues
|
2005
|
%
of Revenues
|
|||||||||
Selling,
general and administrative
|
$
|
1,990
|
36.8
|
%
|
$
|
1,482
|
27.1
|
%
|
Selling,
general and administrative expenses for the three months ended December 31,
2006
were $1,990,000 as compared to $1,482,000 for the comparable prior year period,
an increase of $508,000 or 34.3%. This increase is attributable, in part, to
approximately $330,000 in costs, which include a strategic consulting study
and
incremental legal and recruiting fees. Without the effect of the above costs,
selling, general and administrative expenses for the three months ended December
31, 2006 increased $178,000, or by 12.0%, and were equal to 30.7% of revenues.
The remaining increase is primarily due to additional management
employees.
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20
-
Interest
and Other Income and Expense
Interest
and other income and expense, net for the three months ended December 31, 2006
was $168,000 as compared to $9,000 for the comparable prior year period, an
increase of $159,000, primarily due to: (i) the recovery of approximately
$124,000 from one customer’s previously written-off accounts receivable in
fiscal 2006 and (ii) increased interest income.
Equity
in Net Loss of CorNova, Inc.
The
Company has invested $825,000 in CorNova, Inc. During the three months ended
September 30, 2006 the Company recorded an additional $75,000 of equity in
net
loss in its investment in CorNova, which
resulted in the Company recording the maximum allowable cumulative net
loss.
Accordingly there was no additional recognition of equity in net loss of CorNova
for the three months ended December 31, 2006. The Company has no additional
obligation to contribute assets or additional common stock nor to assume any
liabilities or to fund any losses that CorNova may incur.
Nine
months ended December 31, 2006 vs. December 31, 2005
Revenues
The
following table presents revenues by group expressed as a percentage of total
revenues for the nine months ended December 31,
(in
thousands)
|
2006
|
|
%
of Revenues
|
|
2005
|
|
%
of Revenues
|
||||||
Revenues:
|
|||||||||||||
Product
sales
|
$
|
14,723
|
94.0
|
%
|
$
|
16,452
|
96.0
|
%
|
|||||
Royalties
|
943
|
6.0
|
%
|
692
|
4.0
|
%
|
|||||||
$
|
15,666
|
100.0
|
%
|
$
|
17,144
|
100.0
|
%
|
The
following table presents product sales by group expressed as a percentage of
total product sales for the nine months ended December 31,
2006
|
2005
|
||||||||||||
(in
thousands)
|
Product
sales
|
|
%
of Product sales
|
|
Product
sales
|
|
%
of Product sales
|
||||||
Medical
devices
|
$
|
14,247
|
96.8
|
%
|
$
|
15,550
|
94.5
|
%
|
|||||
Contracted
product design and development
|
476
|
3.2
|
%
|
902
|
5.5
|
%
|
|||||||
$
|
14,723
|
100.0
|
%
|
$
|
16,452
|
100.0
|
%
|
Medical
device revenues for the nine months ended December 31, 2006 were $14,247,000
as
compared to $15,550,000 for the comparable prior year period, a decrease of
$1,303,000, or 8.4%. Medical devices for the nine months ended December 31,
2006
are primarily composed of cardiopulmonary bypass products, private-label
products, and biomaterials typically used for implantable devices. Medical
device revenues decreased primarily due to fewer shipments of cardiopulmonary
bypass products of approximately $1,050,000, principally due to fewer
cardiopulmonary bypass procedures being performed and loss of customers. In
addition, there were fewer shipments of private-label products of approximately
$200,000, primarily due to the loss of the End User (as defined herein below)
as
a major customer.
Beginning
in fiscal 2005 and continuing into fiscal 2006, the Company started shipping
branded catheter products in its private label business on a purchase order
basis to a major customer (the “Intermediary”), who would then perform
additional manufacturing processes and ship these products to the end user
(the
“End User”). These products were developed previously by the End User who then
transferred manufacturing to the Intermediary. The Intermediary then engaged
the
Company to manufacture the products. In March 2006, the End User sought to
directly source products from the Company. On May 18, 2006, the Company was
notified by the End User that the End User had decided to cease using the
Company for future production. During this time, the End User also began an
alliance with a competitive supplier of branded catheters. The End User’s
decision in May 2006 was due to concerns about supply constraints related to
production specifications. The Company recorded revenues of $397,000 related
to
shipments of branded catheter products to the End User during the six months
ended September 30, 2006. There were no additional shipments of branded
catheters to the End User during the three month period ended December 31,
2006.
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21
-
Contracted
product design and development revenues for the nine months ended December
31,
2006 were $476,000 as compared to $902,000 for the comparable prior year period,
a decrease of $426,000 or 47.2%. Contracted product design and development
services are provided primarily to OEM suppliers and development companies
with
the expectation of manufacturing private-label medical devices following the
completion of these services. The decrease in contracted product design and
development services is a result of the Company’s previous shift towards the
manufacture and shipment of private-label medical device products, together
with
the transitioning to a new Regional Sales Manager.
Royalties
for the nine months ended December 31, 2006 were $943,000 as compared to
$692,000 for the comparable prior year period, an increase of $251,000 or 36.3%.
The Company has agreements to license its proprietary biomaterials technology
to
medical device manufacturers. Royalties are earned when these manufacturers
sell
medical devices which use the Company’s biomaterials, accordingly, the increase
in royalties during the nine months ended December 31, 2006 is a result of
increased shipments of product by these manufacturers.
Additionally, in October 2006, the Company announced that it had signed a supply
and
royalty agreement with a leading developer and manufacturer of orthopedic
devices. Under the terms of the in-perpetuity agreement, the Company provides
exclusive use and supply of its proprietary ChronoFlex® polymer material that is
specifically formulated for the development of orthopedic implant devices.
The
Company will recognize these fees as revenue in accordance with the terms of
the
contract.
Gross
Margin
The
following table presents product sales gross margin and gross margin percentages
as a percent of the respective product sales for the nine months ended December
31,
2006
|
2005
|
||||||||||||
(in
thousands)
|
Gross
Margin
|
|
%
Gross Margin
|
|
Gross
Margin
|
|
%
Gross Margin
|
||||||
Product
sales
|
$
|
3,019
|
20.5
|
%
|
$
|
3,106
|
18.9
|
%
|
Gross
margin on product sales (excluding royalty income) was $3,019,000 or 20.5%
as a
percentage of product revenue for the nine months ended December 31, 2006,
as
compared to $3,106,000, or 18.9% for the comparable prior year
period.
The
End
User’s decision in May 2006 was due to concerns about supply constraints related
to production specifications. The Company’s plans at that time were to (i)
identify, inspect and/or rework all products produced for the End User and
(ii)
to allow the End User to determine, in its sole discretion, whether the
Company’s products were consistent with the End User’s specifications. As the
contractual period for the End User to notify the Company of any defective
product had passed as of September 30, 2006, the Company determined that all
revenue recognition criteria had been met and the
Company recorded $397,000 in revenues from the End User. This amount represents
cash received during the six months ended September 30, 2006 from the End User.
As of June 30, 2006, $340,000 of this amount was deferred. Costs associated
with
this revenue have been recorded as period expenses in the three months ended
March 31, 2006 and June 30, 2006.
Without
the effect of the above described $397,000 in revenues related to the End User,
gross margin on product sales (excluding royalty income) was $2,622,000, or
18.4% as a percentage of product revenue for the nine months ended December
31,
2006, as compared to $3,106,000, or 18.9% for the comparable prior year
period.
The
0.5%
decrease in gross margin as a percentage of product sales for the nine months
ended December 31, 2006, which excludes the $397,000 in revenues related to
the
End User as compared to December 31, 2005 is due to offsetting factors: (i)
marketplace pricing pressures on revenues in the cardiopulmonary business in
2006, (ii) increased raw material costs in 2006 for the cardiopulmonary products
resulting from inflationary pressures on petrochemical-based supplies and (iii)
a $240,000 provision for a voluntary recall of certain cardiopulmonary products
in the three months ended December 31, 2005.
Research
and Development, Regulatory, and Engineering Expenses
-
22
-
The
following table presents research and development, regulatory and engineering
expenses as a percentage of revenues for the nine months ended December
31,
(in
thousands)
|
2006
|
%
of Revenues
|
2005
|
%
of Revenues
|
|||||||||
Research
and development, regulatory and engineering
|
$
|
1,170
|
7.5
|
%
|
$
|
1,061
|
6.2
|
%
|
Research
and development, regulatory and engineering expenses for the nine months ended
December 31, 2006 were $1,170,000 as compared to $1,061,000 for the comparable
prior year period, an increase of $109,000 or 10.3%. This increase is primarily
a result of the timing of activities associated with the development of and
clinical efforts associated with the CardioPass graft, the hire of additional
staff and activities for cardiopulmonary products.
The
Company has an investment in CorNova, Inc., of which Dr. Eric Ryan is President
and a major shareholder. The Company, on July 15, 2004, entered into a two-year
consulting agreement with Dr. Ryan, which provides for a range of payments,
in
either cash or common stock, for the achievement of certain milestones related
to the manufacturing, commencement of European clinical trials and the receipt
of a restricted CE mark of the Company’s CardioPass SynCAB. This agreement
expired as of July 15, 2006. For the nine months ended December 31, 2005,
several of the contract milestones had been achieved and, accordingly, costs
totaling $38,000 related to performance under this contract were recognized
as a
research and development expense.
Selling,
General and Administrative Expenses
The
following table presents selling, general and administrative expenses as a
percentage of revenues for the nine months ended December 31,
(in
thousands)
|
2006
|
%
of Revenues
|
2005
|
%
of Revenues
|
|||||||||
Selling,
general and administrative
|
$
|
5,223
|
33.3
|
%
|
$
|
4,430
|
25.8
|
%
|
Selling,
general and administrative expenses for the nine months ended December 31,
2006
were $5,223,000 as compared to $4,430,000 for the comparable prior year period,
an increase of $793,000 or 17.9%. This increase is, in part, attributable to
approximately $450,000 in such costs, which include a strategic consulting
study
and incremental legal, Board of Directors and recruiting fees. Without the
effect of the above costs, selling, general and administrative expenses for
the
three months ended December 31, 2006 increased $178,000, or by 7.7%, and were
equal to 30.5% of revenues. The remaining increase is primarily due to
additional management employees.
Interest
and Other Income and Expense
Interest
and other income and expense, net for the nine months ended December 31, 2006
was $327,000 as compared to $99,000 for the comparable prior year period, an
increase of $228,000, primarily due to the (i) recovery of approximately
$207,000 from one customer’s previously written-off accounts receivable in
fiscal 2006 and (ii) increased interest income.
Equity
in Net Loss of CorNova, Inc.
The
Company has invested $825,000 in CorNova, Inc. During the nine months ended
December 31, 2006, the Company recorded an additional $278,000 of equity in
net
loss in its investment in CorNova, which resulted in the Company recording
the
maximum allowable cumulative net loss. The Company has no additional obligation
to contribute assets or additional common stock nor to assume any liabilities
or
to fund any losses that CorNova may incur.
-
23
-
Liquidity
and Capital Resources
As
of
December 31, 2006, the Company had cash and cash equivalents and a short-term
investment of $4.1 million, a decrease of $2.7 million when compared with a
balance of $6.8 million as of March 31, 2006.
During
the nine months ended December 31, 2006, the Company had net cash outflows
of
$2.1 million from operating activities as compared to net cash outflows of
$1.5
million for the comparable prior year period. The approximate $650,000 increase
in net cash outflows used in operating activities during the nine months ended
December 31, 2006 as compared to the comparable prior year period was primarily
a result of: (i) an increase in net loss, due, in part, to $450,000 in expenses
described above and (ii) a decrease in aggregate accounts payable and accrued
expenses. During the nine months ended December 31, 2006, the Company had net
cash outflows of $1,691,000 from investing activities as compared to net cash
outflows of $327,000 for the comparable prior year period. The approximate
$1,364,000 increase in net cash outflows from investing activities is a result
of the purchase of a $1.0 million short-term investment and the purchase by
the
Company in October 2006 of proprietary equipment for $350,000 in cash which
is
designed for the future manufacture of the Company’s CardioPass grafts, as well
as for the development of additional medical devices.
During
the nine months ended December 31, 2006, the Company issued 36,250 shares of
the
Company’s common stock as a result of the exercise of options, generating cash
proceeds of approximately $61,000.
At
December 31, 2006, the Company had no debt. CardioTech believes its current
cash
position will be sufficient to fund its working capital and research and
development activities for at least the next twelve months.
In
January 2007, the Company retained Silverwood Partners, an investment banking
firm, to identify potential purchasers of its Gish Biomedical, Inc. unit
("Gish"), located in southern California and to manage the sale of Gish. The
Company believes that Gish is a strong brand name that has been associated
for
over 30 years with the provision of innovative, high quality, disposable medical
products. The Company believes that Gish is not a fit with CardioTech’s
strategic direction and the sale of Gish will permit the redeployment of capital
into CardioTech’s ongoing growth initiatives. The sale of Gish is an opportunity
to align the business with an acquirer that is focused on capitalizing on the
strength of the respected Gish brand in the worldwide medical device
marketplace.
The
Company’s future growth may depend upon its ability to raise capital from the
sale of Gish and other sources to support research and development activities
and to market and sell its vascular graft technology, specifically the coronary
artery bypass graft. CardioTech may require substantial funds for further
research and development, future pre-clinical and clinical trials, regulatory
approvals, establishment of commercial-scale manufacturing capabilities, and
the
marketing of its products. CardioTech’s capital requirements depend on numerous
factors, including but not limited to, the progress of its research and
development programs; the progress of pre-clinical and clinical testing; the
time and costs involved in obtaining regulatory approvals; the cost of filing,
prosecuting, defending and enforcing any intellectual property rights; competing
technological and market developments; changes in CardioTech’s development of
commercialization activities and arrangements; and the purchase of additional
facilities and capital equipment.
Contractual
obligations consist of the following as of December 31, 2006:
Payment
Due by Period
|
||||||||||||||||
(in
thousands)
|
Total
|
|
Less
than 1 Year
|
|
1
to 3 Years
|
|
3
to 5 Years
|
|
More
than 5 Years
|
|||||||
Operating
lease obligations
|
$
|
3,118
|
$
|
831
|
$
|
2,245
|
$
|
42
|
$
|
-
|
||||||
Purchase
obligations
|
$
|
2,039
|
2,039
|
-
|
-
|
-
|
||||||||||
$
|
5,157
|
$
|
2,870
|
$
|
2,245
|
$
|
42
|
$
|
-
|
Operating
lease obligations are for aggregate future minimum rental payments required
under operating leases for the California and Minnesota manufacturing
facilities. Purchase obligations primarily represent purchase orders issued
for
inventory used in production.
-
24
-
With
respect to the Exchange and Venture Agreement with CorNova, the Company has
no
additional obligation to contribute assets or additional common stock nor to
assume any liabilities or to fund any losses that CorNova may
incur.
Off-Balance
Sheet Arrangements
As
of
December 31, 2006, the Company had no off-balance sheet arrangements that have,
or are reasonably likely to have, a current or future material effect on its
consolidated financial condition, results of operations, liquidity, capital
expenditures or capital resources.
We
own
certain money market funds and a certificate of deposit that are sensitive
to
market risks as part of our investment portfolio. The investment portfolio
is
used to preserve our capital until it is required to fund operations, investing
or financing activities. None of the market-risk sensitive instruments held
in
our investment portfolio are held for trading purposes. We do not own derivative
financial instruments in our investment portfolio. We do not believe that the
exposure to market risks in our investment portfolio is material.
The
Company’s management, including the Chief Executive Officer and Chief Financial
Officer, conducted an evaluation of the Company’s disclosure controls and
procedures as of December 31, 2006. Based on this evaluation, the Chief
Executive Officer and Chief Financial Officer have determined that such controls
and procedures are effective to ensure that information relating to the Company,
including its consolidated subsidiaries, required to be disclosed in reports
that it files or submits under the Securities Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the
rules and forms of the Securities and Exchange Commission. There have been
no
changes in the Company’s internal controls over financial reporting that were
identified during the evaluation that occurred during the Company’s last fiscal
quarter of 2006 that have materially affected, or are reasonably likely to
materially affect, the Company’s internal control over financial reporting.
-
25
-
PART
II. OTHER
INFORMATION
The
Company is not a party to any legal proceedings, other than ordinary routine
litigation incidental to its business, which the Company believes will not
have
a material affect on its financial position or resolutions of
operations.
Item
1A. Risk
Factors
There
have not been any material changes from the risk factors previously disclosed
under Item 7A of the Company’s Annual Report on Form 10-K for the year ended
March 31, 2006.
Item
2. Unregistered
Sales of Equity Securities and Use of Proceeds
(a) None.
(b) Not
applicable.
(c) In
June
2001, the Board of Directors authorized the purchase of up to 250,000 shares
of
the Company’s common stock (the “2001 Repurchase Plan”), of which 174,687 shares
have been purchased as of December 31, 2006. During the three months ended
December 31, 2006 there were no shares of the Company’s common stock purchased
pursuant to the 2001 Repurchase Plan. In June 2004, the Board of Directors
authorized the purchase of up to 500,000 additional shares of the Company’s
common stock (the “2004 Repurchase Plan,” and collectively with the 2001
Repurchase Plan is hereinafter referred to as the “Repurchase Plans”). As of
December 31, 2006 there have been no purchases of the Company’s common stock
pursuant to the 2004 Repurchase Plan. The Company announced that purchases
pursuant to the Repurchase Plans may be made from time-to-time in the open
market, privately negotiated transactions, block transactions or otherwise,
at
times and prices deemed appropriate by management. As of December 31, 2006,
the
maximum number of shares of the Company’s common stock that may be purchased
pursuant to the Repurchase Plans is 575,313 shares.
None.
The
information required by this Item relating to our annual meeting of stockholders
held on October 11, 2006 was disclosed under Part II, Item 4 of our Quarter
Report on Form 10-Q for the quarter ended September 30, 2006 and is incorporated
herein by reference.
None.
Item
6. Exhibits
Exhibit
No.
31.1 |
Certification
of Principal Executive Officer pursuant to Section 3.02 of the
Sarbanes-Oxley Act of 2002.
|
31.2 |
Certification
of Principal Financial Officer pursuant to Section 3.02 of the
Sarbanes-Oxley Act of 2002.
|
32.1 |
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
32.2 |
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
-
26
-
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
CardioTech
International, Inc.
By:
/s/
Michael F. Adams
Michael
F. Adams
Chief
Executive Officer and President
By:
/s/
Eric G. Walters
Eric
G.
Walters
Vice
President and Chief Financial Officer
Dated:
February 14, 2007
-
27
-