Nordicus Partners Corp - Quarter Report: 2007 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,
2007
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)
Delaware
(State
or other jurisdiction of
incorporation
or organization)
|
04-3186647
(I.R.S.
Employer Identification No.)
|
|
229
Andover Street, Wilmington, Massachusetts
(Address
of principal executive offices)
|
01887
(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 14, 2008, there were 21,067,313 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, 2007 and March 31,
2007
|
3
|
|
Condensed
Consolidated Statements of Operations for the three and nine
months
ended
December 31, 2007 and 2006
|
4
|
|
Condensed
Consolidated Statements of Cash Flows for the nine months
ended
December
31, 2007 and 2006
|
5
|
|
Notes
to Condensed Consolidated Financial Statements
|
6-17
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
18-29
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
29
|
Item
4.
|
Controls
and Procedures
|
29
|
PART
II.
|
OTHER
INFORMATION
|
|
Item
1.
|
Legal
Proceedings
|
30
|
Item
1A.
|
Risk
Factors
|
30
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
30
|
Item
3.
|
Defaults
Upon Senior Securities
|
30
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
30
|
Item
5.
|
Other
Information
|
31
|
Item
6.
|
Exhibits
|
31
|
Signatures
|
32
|
-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,
|
|||||||
2007
|
2007
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 6,652 | $ | 4,066 | ||||
Accounts
receivable-trade, net of allowance of $10 and
$93
as of December 31, 2007 and March 31, 2007, respectively
|
646 | 592 | ||||||
Accounts
receivable-other
|
449 | 553 | ||||||
Inventories
|
784 | 453 | ||||||
Prepaid
expenses and other current assets
|
183 | 115 | ||||||
Current
assets of discontinued operations
|
- | 6,962 | ||||||
Total
current assets
|
8,714 | 12,741 | ||||||
Property,
plant and equipment, net
|
3,905 | 3,242 | ||||||
Goodwill
|
487 | 487 | ||||||
Other
assets
|
76 | 3 | ||||||
Non-current
assets of discontinued operations
|
- | 1,428 | ||||||
Total
assets
|
$ | 13,182 | $ | 17,901 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 340 | $ | 432 | ||||
Accrued
expenses
|
555 | 452 | ||||||
Deferred
revenue
|
351 | 198 | ||||||
Current
liabilities of discontinued operations
|
149 | 1,856 | ||||||
Total
current liabilities
|
1,395 | 2,938 | ||||||
Non-current
liabilities held for sale
|
- | 116 | ||||||
Commitments
and contingencies (Note 18)
|
||||||||
Stockholders'
equity:
|
||||||||
Preferred
stock; $.01 par value; 5,000,000 shares authorized;
500,000
shares issued and none outstanding as of
December
31, 2007 and March 31, 2007
|
- | - | ||||||
Common
stock; $0.001 par value; 50,000,000 shares authorized;
21,067,313
and 20,031,650 shares issued and outstanding as of
December
31, 2007 and March 31, 2007, respectively
|
21 | 20 | ||||||
Additional
paid-in capital
|
38,462 | 37,128 | ||||||
Accumulated
deficit
|
(26,696 | ) | (22,301 | ) | ||||
Total
stockholders' equity
|
11,787 | 14,847 | ||||||
Total
liabilities and stockholders' equity
|
$ | 13,182 | $ | 17,901 |
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,
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Revenues:
|
||||||||||||||||
Product
sales
|
$ | 1,133 | $ | 1,042 | $ | 3,325 | $ | 3,213 | ||||||||
Royalties
and development fees
|
459 | 365 | 1,405 | 943 | ||||||||||||
1,592 | 1,407 | 4,730 | 4,156 | |||||||||||||
Cost
of sales
|
1,406 | 1,097 | 3,804 | 3,426 | ||||||||||||
Gross
margin
|
186 | 310 | 926 | 730 | ||||||||||||
Operating
expenses:
|
||||||||||||||||
Research,
development and regulatory
|
235 | 207 | 777 | 501 | ||||||||||||
Selling,
general and administrative
|
1,351 | 1,149 | 3,244 | 2,840 | ||||||||||||
1,586 | 1,356 | 4,021 | 3,341 | |||||||||||||
Loss
from operations
|
(1,400 | ) | (1,046 | ) | (3,095 | ) | (2,611 | ) | ||||||||
Interest
and other income and expense:
|
||||||||||||||||
Interest
expense
|
- | - | (1 | ) | (1 | ) | ||||||||||
Interest
income
|
70 | 24 | 175 | 57 | ||||||||||||
Other
income, net
|
10 | 124 | 18 | 226 | ||||||||||||
Interest
and other income, net
|
80 | 148 | 192 | 282 | ||||||||||||
Equity
in net loss of CorNova, Inc.
|
- | - | - | (278 | ) | |||||||||||
Net
loss from continuing operations
|
(1,320 | ) | (898 | ) | (2,903 | ) | (2,607 | ) | ||||||||
(Loss)
income from discontinued operations
|
(10 | ) | 72 | (319 | ) | 225 | ||||||||||
Loss
on sale of Gish
|
- | - | (1,173 | ) | - | |||||||||||
Net
(loss) income from discontinued operations
|
(10 | ) | 72 | (1,492 | ) | 225 | ||||||||||
Net
loss
|
$ | (1,330 | ) | $ | (826 | ) | $ | (4,395 | ) | $ | (2,382 | ) | ||||
Net
loss per common share, basic and diluted:
|
||||||||||||||||
Net
loss per share, continuing operations
|
$ | (0.06 | ) | $ | (0.04 | ) | $ | (0.14 | ) | $ | (0.13 | ) | ||||
Net
(loss) income per common share, discontinued
operations
|
- | - | (0.08 | ) | 0.01 | |||||||||||
Net
loss per common share
|
$ | (0.06 | ) | $ | (0.04 | ) | $ | (0.22 | ) | $ | (0.12 | ) | ||||
Shares
used in computing net loss per common
share,
basic and diluted
|
20,695 | 19,832 | 20,257 | 19,826 |
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,
|
||||||||
2007
|
2006
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (4,395 | ) | $ | (2,382 | ) | ||
Less:
Net loss (income) from discontinued operations
|
1,492 | (225 | ) | |||||
Net
loss from continuing operations
|
(2,903 | ) | (2,607 | ) | ||||
Adjustments
to reconcile net loss from continuing
operations
to net cash flows:
|
||||||||
Depreciation
and amortization
|
369 | 179 | ||||||
Equity
in net loss of CorNova, Inc.
|
- | 278 | ||||||
Provision
for doubtful accounts
|
(31 | ) | 82 | |||||
Provision
for inventory obsolescence
|
125 | - | ||||||
Stock-based
compensation
|
387 | 21 | ||||||
Changes
in assets and liabilities:
|
||||||||
Accounts
receivable-trade, net
|
(23 | ) | 149 | |||||
Accounts
receivable-other
|
104 | (23 | ) | |||||
Inventories
|
(456 | ) | (229 | ) | ||||
Prepaid
expenses and other current assets
|
(68 | ) | 74 | |||||
Accounts
payable
|
(164 | ) | (246 | ) | ||||
Accrued
expenses
|
103 | (48 | ) | |||||
Deferred
revenue
|
153 | 282 | ||||||
Net
cash flows used in operating activities of continuing
operations
|
(2,404 | ) | (2,088 | ) | ||||
Net
cash flows used in operating activities of
discontinued
operations
|
(960 | ) | (37 | ) | ||||
Net
cash flows used in operating activities
|
(3,364 | ) | (2,125 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Purchases
of property, plant and equipment
|
(960 | ) | (652 | ) | ||||
Proceeds
from sale of Gish, net of transaction costs
|
6,051 | - | ||||||
(Increase)
decrease in other assets
|
(73 | ) | 8 | |||||
Net
cash flows provided by (used in) investing activities of continuing
operations
|
5,018 | (644 | ) | |||||
Net
cash flows used in investing activities of discontinued
operations
|
(16 | ) | (1,047 | ) | ||||
Net
cash flows provided by (used in) investing activities
|
5,002 | (1,691 | ) | |||||
Cash
flows from financing activities:
|
||||||||
Net
proceeds from issuance of common stock
|
948 | 61 | ||||||
Purchase
of treasury stock
|
- | (1 | ) | |||||
Net
cash flows provided by financing activities of continuing
operations
|
948 | 60 | ||||||
Net
change in cash and cash equivalents
|
2,586 | (3,756 | ) | |||||
Cash
and cash equivalents at beginning of period
|
4,066 | 6,841 | ||||||
Cash
and cash equivalents at end of period
|
$ | 6,652 | $ | 3,085 |
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 innovative products and materials for the
treatment of cardiovascular, orthopedic, oncological, urological and other
diseases. The Company’s business model calls for leveraging its
technological and manufacturing expertise in order to expand its royalty,
development and license fee income, develop next generation polymers and
manufacture new and complex medical devices. The Company is focused
on developing and marketing polymers that can be used in products that are
designed to reduce risk, trauma, cost and surgical procedure
time. The Company’s subsidiaries and divisions from continuing
operations are Catheter and Disposables Technology, Inc. (“CDT” or “engineering
services and contract manufacturing”) and CT Biomaterials (“advanced polymers”
or “materials science technology”), collectively the “Continuing
Subsidiaries.” The Company operates in one segment, medical device
manufacturing and sales.
On July
6, 2007, the Company completed the sale of Gish, the Company’s former developer
and manufacturer of single use cardiopulmonary bypass products, to Medos Medizintechnik AG,
a German corporation (“Medos”). The sale of Gish to Medos was effected
pursuant to a Stock Purchase Agreement (the “Purchase Agreement”) entered into
by the parties on July 3, 2007. The Purchase Agreement provided for
the sale of Gish to Medos for a purchase price of approximately $7.5 million in
cash. The Purchase Agreement also contained representations,
warranties and indemnities that are customary in a transaction involving the
sale of all or substantially all of a company or its assets. The
indemnifications include items such as compliance with legal and regulatory
requirements, product liability, lawsuits, environmental matters, product
recalls, intellectual property, and representations regarding the fairness of
certain financial statements, tax audits and net operating losses.
Pursuant
to the terms of the Purchase Agreement, the Company has placed $1 million in
escrow as a reserve for the Company’s indemnification obligations to Medos, if
any, as described above. The escrowed
amount, less any agreed upon amount necessary to satisfy any indemnification
obligations, may be made available to the Company on July 5,
2008. The realization of the escrow fund is also contingent
upon the realizability of the Gish accounts receivable and inventory that were
transferred to Medos for one year from the sale date. The $1 million
of proceeds being held in escrow is not included in the calculation of the loss
on sale of Gish.
Medos has
advised the Company that it may assert certain indemnity claims against the
Company relating to certain representations and warranties up to the full amount
of the $1 million escrow balance. The Company has advised Medos that
it believes any such claims, if made, would be without merit under the Purchase
Agreement. The Company has concluded that a loss resulting from these
potential claims by Medos is not probable as of December 31, 2007.
The
Company has been notified by Medos as to their assertion that the Company may be
liable for up to one year of severance costs related to the termination of a key
Gish employee by Medos whose termination was effected by Medos subsequent to the
acquisition date. The Company has reviewed the assertion by Medos,
and has concluded that a loss resulting from this asserted claim is not probable
as of December 31, 2007.
After transaction expenses
and certain post-closing adjustments, the Company realized approximately $5.8
million in proceeds from the sale of Gish. Assuming the disbursement
to the Company of all funds held in escrow after July 5, 2008, up to an
additional $1 million may be realized. Under the
terms of the Purchase Agreement, the Company owes Medos $149,000 as a result of
the change in stockholder’s equity of Gish from March 31, 2007 to June 30,
2007. This amount was recorded as a current liability as of June 30,
2007, has not been paid to Medos, and is reflected as a current liability as of
December 31, 2007. This adjustment is included in the calculation of
the loss on sale of Gish through December 31, 2007. Under the terms of the
Purchase Agreement, the Company retained Gish’s cash assets of approximately
$2.0 million as of June 29, 2007.
In
connection with the sale of Gish, the Company and Gish entered into a
non-exclusive, royalty-free license (the “License Agreement”) that provides for
the Company’s use of certain patented technology of Gish in Company products and
services, provided such products and services do not compete with the cardiac
bypass product development and manufacturing businesses of Gish or
Medos. The Company has determined the License Agreement has de
minimus value, and accordingly no value has been ascribed to the
license.
The
Company is in the process of reviewing several strategic alternatives for its
Catheter and Disposables Technology, Inc. subsidiary (“CDT”), which includes,
but not limited to, a sale of the business. The Company believes a
sale of CDT will permit the redeployment of capital into the Company’s ongoing
growth initiatives, however there can be no assurance that a sale will be
consummated at all or on terms acceptable to us.
-6-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
CardioTech
has partnered with CorNova, Inc. (“CorNova”) to develop a drug-eluting
stent. As of December 31, 2007, the Company owned approximately 25%
of the issued and outstanding shares of common stock of CorNova. The
Company’s ownership interest in the equity of CorNova is approximately 15%,
assuming the conversion to common stock of all of the shares of preferred stock
of CorNova. (See Note 14).
The
Company’s corporate and materials science technology headquarters are located in
Wilmington, Massachusetts, with CDT’s manufacturing operations located in
Minnesota.
2.
|
Interim
Financial Statements and Basis of
Presentation
|
The
accompanying condensed consolidated financial statements of the Company have
been prepared in accordance with U.S. generally accepted accounting principles
(“U.S. GAAP”). In the opinion of management, the accompanying
condensed consolidated financials statements include all adjustments (consisting
only of normal recurring adjustments), which 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 periods presented. The results of
operations and cash flows for the three and nine months ended December 31, 2007
may not necessarily be indicative of results that may be expected for any
succeeding quarter or for the entire fiscal year. The information
contained in this Form 10-Q should be read in conjunction with the Company’s
audited financial statements, included in our Form 10-K/A as of and for the year
ended March 31, 2007 filed with the Securities and Exchange Commission (the
“SEC”).
The
balance sheet at March 31, 2007 has been derived from our audited consolidated
financial statements at that date but does not include all of the information
and footnotes required by U.S. GAAP for complete financial
statements.
The
accompanying condensed consolidated financial statements include the accounts of
the Company and the Continuing Subsidiaries. All intercompany
balances have been eliminated in consolidation. As a result of the
sale of Gish pursuant to the Purchase Agreement, the Company’s financial
statements have reflected the assets and liabilities of Gish in its balance
sheet as assets and liabilities, respectively, of discontinued operations as of
March 31, 2007 and the statement of operations of Gish as discontinued
operations for the three and nine months ended December 31, 2007 and 2006,
respectively. Additionally, the related information contained in the
notes to the condensed consolidated financial statements includes those of the
Company’s continuing operations unless specifically identified as disclosures
related to discontinued operations.
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.”
Significant
accounting policies are described in Note A to the financial statements included
in Item 7 of the Company’s Form 10-K/A as of March 31,
2007. Management's discussion and analysis of the Company's financial
condition and results of operations are based upon the financial statements,
which have been prepared in accordance with U.S. GAAP. The preparation of
financial statements in conformity with U.S. GAAP requires management to make
estimates and judgments, which are evaluated on an ongoing basis, that affect
the amounts reported in the Company's condensed consolidated financial
statements and accompanying notes. Management bases its estimates on
historical experience and on various other assumptions that it believes are
reasonable under the circumstances, the results of which form the basis for
making judgments about the carrying values of assets and liabilities and the
amounts of revenues and expenses that are not readily apparent from other
sources. Actual results could differ from those estimates and
judgments. In particular, significant estimates and judgments include
those related to revenue recognition, allowance for doubtful accounts, useful
lives of property and equipment, inventory reserves, valuation for goodwill and
acquired intangible assets.
3.
|
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
advanced polymers. 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.
-7-
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.
4.
|
Stock
Based Compensation
|
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, 2007 and 2006
includes: (a) compensation cost for all stock-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 stock-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.
The
Company recorded stock-based compensation expense for options that vested of
approximately $224,000 and $13,000 for the three months ended December 31, 2007
and 2006, respectively, and $387,000 and $21,000 for the nine months ended
December 31, 2007 and 2006, respectively. As of December 31, 2007,
the Company has approximately $521,000 of unrecognized compensation cost related
to stock options that is expected to be recognized as expense over a weighted
average period of 1.80 years.
The
valuation of employee stock options is an inherently subjective process, since
market values are generally not available for long-term, non-transferable
employee stock options. Accordingly, an option pricing model is
utilized to derive an estimated fair value. 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 calculating the estimated fair value of our stock
options we use the Black-Scholes pricing model, which requires the consideration
of the following six variables for purposes of estimating fair
value:
·
|
the
stock option exercise price,
|
·
|
the
expected term of the option,
|
·
|
the
grant price of our common stock, which is issuable upon exercise of the
option,
|
·
|
the
expected volatility of our common
stock,
|
·
|
the
expected dividends on our common stock (we do not anticipate paying
dividends in the foreseeable future),
and
|
·
|
the
risk free interest rate for the expected option
term.
|
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.
-8-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The fair
value of each option granted during the three and nine months ended December 31,
2007 and 2006 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
December
31,
|
|||||||
2007
|
2006
|
2007
|
2006
|
|||||
Dividend
yield
|
None
|
None
|
None
|
None
|
||||
Expected
volatility
|
70.10
|
103.00
|
70.40
|
103.00
|
||||
Risk-free
interest rate
|
4.59%
|
4.67%
|
4.67%
|
4.68%
|
||||
Expected
life
|
6.5
years
|
6.5
years
|
6.5
years
|
6.5
years
|
The
weighted average fair value of stock options granted during the three months
ended December 31, 2007 and 2006 was $0.82 and $1.73 per share,
respectively. The weighted average fair value of stock options
granted during the nine months ended December 31, 2007 and 2006 was $0.84 and
$1.76 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 Plan. Under the terms of the 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 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”), which authorizes the issuance of 3,000,000 shares of common stock with
terms similar to the 1996 Plan. In January 2006, the Company filed
Form S-8 with the Securities and Exchange Commission registering an additional
489,920 shares of common stock in the 1996 Plan and 2003 Plan. Total
shares of common stock registered for the 1996 Plan and 2003 Plan are
10,489,920. 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 in the
2003 Plan. Normally, options granted expire ten years from the grant
date.
Information
regarding option activity for the nine months ended December 31, 2007 under the
1996 Plan and 2003 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, 2007
|
5,426,018 | $ | 2.16 | 6.15 | $ | 1,207,568 | ||||||||||
Granted
|
703,750 | 1.44 | ||||||||||||||
Exercised
|
(1,035,663 | ) | 0.91 | |||||||||||||
Cancelled
and forfeited
|
(2,378,909 | ) | 2.63 | |||||||||||||
Options
outstanding as of December 31, 2007
|
2,715,196 | $ | 1.99 | 6.89 | $ | 20,160 | ||||||||||
Options
exercisable as of December 31, 2007
|
2,146,193 | $ | 2.16 | 6.20 | $ | 20,160 | ||||||||||
Options
vested and expected to vest as
of
December 31, 2007
|
2,146,193 | $ | 2.16 | 6.20 | $ | 20,160 |
Included
in options cancelled and forfeited were 1,614,000 shares underlying stock
options of the Company’s former Chairman and CEO, which expired on November 5,
2007.
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 31, 2007 of $0.68 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, 2007. Total intrinsic value
of stock options exercised under the Plan for the nine months ended December 31,
2007 was approximately $230,000.
-9-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In June
2007, the board of directors of the Company authorized the CardioTech
International, Inc. Employee Stock Purchase Plan (the “ESP Plan”) and the
shareholders of the Company approved the ESP Plan at the 2007 Annual
Meeting. The ESP Plan provides a method whereby employees of the
Company will have an opportunity to acquire an ownership interest in the Company
through the purchase of shares of common stock of the Company through payroll
deductions. All employees who meet eligibility requirements to
participate, pursuant to the terms of the ESP Plan, can defer up to 10% of their
wages into the ESP Plan, with a maximum of $25,000 in any calendar
year. The purchase price of the common stock is calculated at 85% of
the closing price of the common stock on the last day of the semi-annual plan
period. The semi-annual periods begin March 1 and September 1 of each
year. Participants may withdraw at any time by giving written notice
to the Company and will be credited the amounts of deferrals in their
account. The maximum annual number of shares eligible to be issued
under the ESP Plan is 500,000. Eligible employees may begin
participation in the ESP Plan on March 1, 2008.
5.
|
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, foreign currency translation adjustments and minimum pension
liability adjustments. During the three and nine months ended
December 31, 2007 and 2006, 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
December
31,
|
Nine
Months Ended
December
31,
|
|||||||||||||||
(In
thousands)
|
2007
|
2006
|
2007
|
2006
|
||||||||||||
Net
loss
|
$ | (1,330 | ) | $ | (826 | ) | $ | (4,395 | ) | $ | (2,382 | ) | ||||
Other
comprehensive loss
|
- | - | - | (40 | ) | |||||||||||
Comprehensive
loss
|
$ | (1,330 | ) | $ | (826 | ) | $ | (4,395 | ) | $ | (2,422 | ) |
6.
|
Related
Party Transactions
|
On
January 1, 2007, the Company entered into a consulting agreement with Michael L.
Barretti, a member of its Board of Directors, for an annualized fee of
$50,000. During the three and nine months ended December 31, 2007,
the Company recognized approximately $12,500 and $37,500, respectively, of
expense related to services incurred under this agreement, which was recorded as
selling, general and administrative expense. There were no expenses
related to this consulting agreement during the three and nine months ended
December 31, 2006.
7.
|
Inventories
|
Inventories
consist of the following:
(in
thousands)
|
December
31,
2007
|
March
31,
2007
|
||||||
Raw
materials
|
$ | 379 | $ | 155 | ||||
Work
in progress
|
295 | 210 | ||||||
Finished
goods
|
110 | 88 | ||||||
Total
inventories
|
$ | 784 | $ | 453 |
-10-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONDOLIDATED FINANCIAL
STATEMENTS
8.
|
Property,
Plant and Equipment
|
Property,
plant and equipment consists of the following:
(in
thousands)
|
December
31,
2007
|
March
31,
2007
|
||||||
Land
|
$ | 500 | $ | 500 | ||||
Building
|
2,153 | 2,153 | ||||||
Building
improvements
|
369 | - | ||||||
Machinery,
equipment and tooling
|
1,917 | 1,286 | ||||||
Furniture,
fixtures and office equipment
|
525 | 494 | ||||||
Leasehold
improvements
|
58 | 57 | ||||||
5,522 | 4,490 | |||||||
Less: accumulated
depreciation and amortization
|
(1,617 | ) | (1,248 | ) | ||||
$ | 3,905 | $ | 3,242 |
For the three months ended December 31, 2007 and 2006, depreciation expense was $144,000 and $83,000, respectively. For the nine months ended December 31, 2007 and 2006, depreciation expense was $369,000 and $179,000 respectively.
9.
|
Deferred
Revenue
|
Beginning
in fiscal 2005 and continuing into fiscal 2006, the Company started shipping
branded catheter products in its contract manufacturing 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. Due to the uncertainty of acceptance of
products by the End User, the Company recorded deferred revenues of $397,000
related to shipments of branded catheter products to the End User as of June 30,
2006. This deferral of $397,000 was recognized as revenues in the
statement of operations during the three months ended September 30,
2006, as there was no further uncertainty around customer
acceptance. There were no additional shipments of branded catheters
to the End User subsequent to the three month period ended June 30,
2006.
Deferred
revenue as of December 31, 2007 consists primarily of annual royalty and
development fees received by the Company, as well as from customer
deposits. Revenue is recognized ratably over the respective
contractual periods or as product is supplied.
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.
As of
December 31, 2007 and 2006, potentially dilutive shares of 3,595,927 and
6,430,916, respectively, were excluded from the earnings per share calculation
because their effect would be antidilutive. Shares deemed to be
antidilutive for the nine months ended December 31, 2007 and 2006 include
outstanding stock options totaling 2,715,196 and 5,550,185 shares, respectively,
and outstanding warrants totaling 880,731 and 880,731 shares,
respectively.
-11-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONDOLIDATED FINANCIAL STATEMENTS
11.
|
Enterprise
and Related Geographic Information
|
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.”
The
Company has no long-lived assets outside the United States.
Revenues
for the presented periods are as follows:
Three
Months Ended
December
31,
|
Nine
Months Ended
December
31,
|
|||||||||||||||
(in
thousands)
|
2007
|
2006
|
2007
|
2006
|
||||||||||||
Medical
devices
|
$ | 973 | $ | 880 | $ | 2,810 | $ | 2,737 | ||||||||
Engineering
services
|
160 | 162 | 515 | 476 | ||||||||||||
Royalties
and development fees
|
459 | 365 | 1,405 | 943 | ||||||||||||
$ | 1,592 | $ | 1,407 | $ | 4,730 | $ | 4,156 |
12.
|
Stockholders’
Equity
|
The
Company, originally incorporated as a Massachusetts corporation at inception,
was reincorporated as a Delaware corporation, as approved by the Company’s
stockholders, in October 2007. As a result of the reincorporation,
the par value of the Company’s common stock, which was previously $0.01 per
share, is now $0.001 per share. Accordingly, the stockholders’ equity
section of both balance sheets presented reflects the change in par
value.
During
the three months ended December 31, 2007 and 2006, the Company issued 995,663
and 0 shares, respectively, of common stock as a result of the exercise of
options, generating cash proceeds of approximately $916,000 and $0,
respectively. During the nine months ended December 31, 2007 and
2006, the Company issued 1,035,663 and 36,250 shares of common stock,
respectively, as a result of the exercise of options, generating cash proceeds
of approximately $948,000 and $61,000, respectively.
During
the nine months ended December 31, 2006, the Company repurchased 600 shares of
its common stock at a cost of approximately $1,000. The Company did
not repurchase any of its shares of common stock during the three months ended
December 31, 2007 and 2006; and during the nine months ended December 31,
2007.
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, 2007 and 2006, 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 (“Implant”), and
CorNova, Inc. (“CorNova”). CorNova is a privately-held, development
stage company, incorporated as a Delaware corporation on October 12,
2003. CorNova’s focus is the development of a next-generation
drug-eluting stent. On March 5, 2004, CardioTech issued to CorNova
12,931 shares of its common stock (the “Contributory Shares”) in exchange for
1,500,000 shares of CorNova’s common stock. The number of
Contributory Shares issued reflects the fair market value of CardioTech’s common
stock as of November 18, 2003, for an aggregate value of
$75,000. This also resulted in CardioTech receiving a thirty percent
(30%) ownership interest in CorNova at the time of issuance. Pursuant
to the terms of the Agreement, CardioTech issued an additional 308,642 shares of
its common stock (the “Investment Shares”) upon the completion by CorNova of a
$3 million financing on February 4, 2005 (the “Series A
Financing”). 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, for use on drug-eluting
stents.
-12-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONDOLIDATED FINANCIAL STATEMENTS
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.
As of
December 31, 2007, CardioTech has an approximate 25% ownership interest in the
issued and outstanding shares of 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.” Assuming the conversion to
common stock of all of the shares of preferred stock of CorNova, as of December
31, 2007 the Company’s ownership interest in the equity of CorNova is
approximately 15%.
During
the nine months ended December 31, 2006, the Company recorded equity in the net
loss of CorNova of $278,000, and equity in comprehensive income of CorNova of
$40,000 (related to unrealized holding gains or losses on securities classified
as available-for-sale). 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. As of December 31,
2007, CorNova owned no shares of CardioTech.
The
Series A Financing transaction 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 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 1,000,000
shares of CorNova’s common stock to employees and consultants.
15.
|
Discontinued
Operations
|
On July
3, 2007, the Company entered into a Stock Purchase Agreement (the “Purchase
Agreement”) with Medos Medizintechnik AG, a German corporation (“Medos”), for
the sale of all of the common stock of Gish Biomedical, Inc. (“Gish”), the
Company’s then wholly-owned subsidiary engaged in the development and
manufacture of single use cardiopulmonary bypass products having a disposable
component. The Purchase Agreement provided for the sale of Gish to
Medos for a purchase price of approximately $7.5 million in cash, of which $1
million will remain in escrow until July 5, 2008 as a reserve for the Company’s
indemnification obligations to Medos, if any. The Purchase Agreement
also contained representations, warranties and indemnities that are customary in
a transaction involving the sale of all or substantially all of a company or its
assets. The indemnifications include items such as compliance with
legal and regulatory requirements, product liability, lawsuits, environmental
matters, product recalls, intellectual property, and representations regarding
the fairness of certain financial statements, tax audits and net operating
losses. In addition, the realization of the escrow fund is contingent
upon the realizability of the Gish accounts receivable and inventory that were
transferred to Medos for one year from the sale date. Therefore, the
Company has not included the $1 million of proceeds being held in escrow in the
calculation on the loss of sale of Gish. On July 6, 2007, the
Company received $6.45 million in cash from Medos, which excludes $1
million that may remain in escrow until July 5, 2008. Pursuant to the terms of
the Purchase Agreement, the Company owes Medos $149,000 as a result of the
change in the stockholder’s equity of Gish from March 31, 2007 to June 30,
2007. This adjustment is included in the calculation of the loss on
sale of Gish through December 31, 2007. As of December 31, 2007, the
Company has not paid Medos any amounts with respect to the above change in
stockholder’s equity and therefore this liability is included in the December
31, 2007 balance sheet.
Medos has
advised the Company that it may assert certain indemnity claims against the
Company relating to certain representations and warranties up to the full amount
of the $1 million escrow balance. The Company has advised Medos that
it believes any such claims, if made, would be without merit under the Purchase
Agreement. The Company has concluded that a loss resulting from these
potential claims by Medos is not probable as of December 31, 2007.
-13-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONDOLIDATED FINANCIAL STATEMENTS
The
Company has been notified by Medos as to their assertion that the Company may be
liable for up to one year of severance costs related to the termination of a key
Gish employee by Medos whose termination was effected by Medos subsequent to the
acquisition date. The Company has reviewed the assertion by Medos,
and has concluded that a loss resulting from this asserted claim is not probable
as of December 31, 2007.
The sale
of Gish, pursuant to the Purchase Agreement, was completed on July 6,
2007. Simultaneous with the completion of the sale of Gish, the
Company and Gish entered into a non-exclusive, royalty-free license (the
“License Agreement”) which provides for the Company’s use of certain patented
technology of Gish in Company products and services, provided such products and
services do not compete with the cardiac bypass product development and
manufacturing businesses of Gish or Medos. The Company has determined
the License Agreement has de minimus value, accordingly no value has been
ascribed to the license.
After
transaction expenses and post-closing adjustments, and assuming the disbursement
to the Company of all funds held in escrow after July 5, 2008, the Company may
realize approximately $6.8 million in proceeds from the sale of
Gish. Under the terms of the Purchase Agreement, the Company retained
Gish’s cash assets of approximately $2.0 million as of June 29,
2007.
In
accordance with Statement of Financial Accounting Standards No.144, “Accounting for the Impairment or
Disposal of Long-Lived Assets,” the December 31, 2007 financial
statements have been prepared and historical statements of operations have been
reclassified to present the results of Gish as discontinued
operations. As noted above, the Company’s Board of Directors approved
a plan to sell Gish in June 2007. The Company executed the Purchase
Agreement on July 3, 2007 and closed on July 6, 2007. The Company has
(i) eliminated Gish’s financial results from its ongoing operations, (ii)
determined that Gish, which operated as a separate subsidiary, was a separate
component of its aggregated business as, historically, management reviewed
separately the Gish financial results and cash flows apart from its ongoing
continuing operations, and (iii) determined that it will have no further
continuing involvement in the operations of Gish or cash flows from Gish after
the sale.
The
assets and liabilities of Gish as of March 31, 2007 are as follows:
Assets
of Discontinued Operations:
|
(in
thousands)
|
|||
Current
assets of discontinued operations:
|
||||
Accounts
receivable-trade
|
$ | 2,120 | ||
Inventories
|
4,752 | |||
Prepaid
expenses and other current assets
|
90 | |||
6,962 | ||||
Non-current
assets of discontinued operations:
|
||||
Property,
plant and equipment, net
|
840 | |||
Deposits
|
120 | |||
Amortizable
intangibles
|
468 | |||
1,428 | ||||
Liabilities
of Discontinued Operations
|
||||
Current
liabilities of discontinued operations:
|
||||
Accounts
payable
|
$ | 1,446 | ||
Accrued
expenses
|
410 | |||
1,856 | ||||
Non-current
liabilities of discontinued operations:
|
||||
Deferred
rent
|
116 |
The
current liabilities of discontinued operations as of December 31, 2007 is
comprised of the amounts owed to Medos due to the change in the stockholders
equity of Gish from March 31, 2007 through June 30, 2007.
-14-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONDOLIDATED FINANCIAL STATEMENTS
Condensed
results of operations relating to Gish for the three and nine months ended
December 31, 2007 and 2006 are as follows:
Three
Months Ended
December
31,
|
Nine
Months Ended
December
31,
|
|||||||||||||||
(in
thousands)
|
2007
|
2006
|
2007
|
2006
|
||||||||||||
Revenues
|
$ | - | $ | 4,007 | $ | 3,849 | $ | 11,509 | ||||||||
Gross
margin
|
- | 1,056 | 815 | 3,066 | ||||||||||||
(Loss)
income from discontinued operations
|
(10 | ) | 72 | (319 | ) | 225 | ||||||||||
Loss
on sale of Gish
|
- | - | (1,173 | ) | - | |||||||||||
Net
(loss) income from discontinued operations
|
(10 | ) | 72 | (1,492 | ) | 225 |
Revenues
and gross margin for Gish for the nine months ended December 31, 2007, as shown
in the above table, include results for the three months ended June 30, 2007, as
the Company sold Gish on July 6, 2007.
16.
|
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, in the aggregate, have been
purchased through December 31, 2007. 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. There were no repurchases of the Company’s common stock
during the three and nine months ended December 31, 2007.
17.
|
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 the Company determines 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 adopted FIN 48 on April, 1, 2007. The adoption did
not have a material impact on its consolidated financial
statements.
In
September 2006, the FASB issued Statement of Financial Accounting Standards
(“SFAS”) No. 157, “Fair Value
Measurements.” This new standard provides guidance for using
fair value to measure assets and liabilities. The FASB believes SFAS
No. 157 also responds to investors’ requests for expanded information about the
extent to which companies measure assets and liabilities at fair value, the
information used to measure fair value, and the effect of fair value
measurements on earnings. SFAS No. 157 applies whenever other
standards require (or permit) assets or liabilities to be measured at fair value
but does not expand the use of fair value in any new
circumstances. SFAS No. 157 is effective for fiscal years beginning
after November 15, 2007. Adoption of SFAS No. 159 is not expected to
have a material impact on the Company’s results of operations or financial
position.
In
February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for Financial
Assets and Financial Liabilities,” which provides companies with an
option to report selected financial assets and liabilities at fair
value. The objective of SFAS No. 159 is to reduce both complexity in
accounting for financial instruments and the volatility in earnings caused by
measuring related assets and liabilities differently. SFAS No. 159
establishes presentation and disclosure requirements designed to facilitate
comparisons between companies that choose different measurement attributes for
similar types of assets and liabilities and to more easily understand the effect
of the company’s choice to use fair value on its earnings. SFAS No.
159 also requires entities to display the fair value of the selected assets and
liabilities on the face of the balance sheet. SFAS No. 159 does not
eliminate disclosure requirements of other accounting standards, including fair
value measurement disclosures in SFAS No. 157. This Statement is
effective as of the beginning of an entity’s first fiscal year beginning after
November 15, 2007. Early adoption is permitted as of the beginning of
the previous fiscal year provided that the entity makes that choice in the first
120 days of that fiscal year and also elects to apply the provisions of
Statement No. 157. Adoption of SFAS No. 159 is not expected to have a
material impact on the Company’s results of operations or financial
position.
-15-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONDOLIDATED FINANCIAL STATEMENTS
18.
|
Contingencies
|
The
Company has been notified that a customer (the “Customer”), for whom the Company
performs contract manufacturing services, has been named in a suit by another
medical device manufacturer which alleges patent infringement by the
Customer. The Company manufactures multilumen catheter products for
the Customer and is not named in the lawsuit. Under the terms of its
purchase orders with the Customer, the Company believes it is indemnified by the
Customer against patent infringement lawsuits. The lawsuit seeks
unspecified damages against the Customer, including enhanced damages and
attorneys fees and costs, and an injunction against certain manufacturing
techniques. The Company is currently in the process of evaluating
this case, and has concluded that a loss is not probable or estimable as of
December 31, 2007.
Medos has
advised the Company that it may assert certain indemnity claims against the
Company relating to certain representations and warranties up to the full amount
of the $1 million escrow balance. The Company has advised Medos that
it believes any such claims, if made, would be without merit under the Purchase
Agreement. The Company has concluded that a loss resulting from these
potential claims by Medos is not probable as of December 31, 2007.
The
Company has been notified by Medos as to their assertion that the Company may be
liable for up to one year of severance costs related to the termination of a key
Gish employee by Medos whose termination was effected by Medos subsequent to the
acquisition date. The Company has reviewed the assertion by Medos,
and has concluded that a loss resulting from this asserted claim is not probable
as of December 31, 2007.
The
Company is not a party to any other 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 results of
operations.
19.
|
Subsequent
Events
|
Stockholders’
Rights Plan
The
Company’s board of directors approved the adoption of a stockholder rights plan
(the “Rights Plan”) under which all stockholders of record as of February 8,
2008 will receive rights to purchase shares of a new series of preferred stock
(the “Rights”). The Rights will be distributed as a
dividend. Initially, the Rights will attach to, and trade with, the
Company’s common stock. Subject to the terms, conditions and
limitations of the Rights Plan, the Rights will become exercisable if (among
other things) a person or group acquires 15% or more of the Company’s common
stock. Upon such an event and payment of the purchase price, each
Right (except those held by the acquiring person or group) will entitle the
holder to acquire shares of the Company’s common stock (or the economic
equivalent thereof) having a value equal to twice the purchase
price. The Company’s board of directors may redeem the Rights prior
to the time they are triggered. In the event of an unsolicited
attempt to acquire the Company, the Rights Plan is intended to facilitate the
full realization of stockholder value in the Company and the fair and equal
treatment of all Company stockholders. The Rights Plan will not
prevent a takeover attempt. Rather, it is intended to guard against
abusive takeover tactics and encourage anyone seeking to acquire the Company to
negotiate with the board of directors. The Company did not adopt the
Rights Plan in response to any particular proposal.
Assets
Held for Sale
As part
of CardioTech’s ongoing repositioning of its business, the Company is focusing
on building its materials science business to provide specialized polymers for
medical device manufacturers. Accordingly, the Company has decided to
evaluate strategic alternatives for its Catheter and Disposables Technology,
Inc. subsidiary and, in January 2008, retained an investment banker to assist
with the evaluation of these alternatives, which include, but are not limited
to, a sale of the business. As CDT is a wholly-owned subsidiary of
the Company, the manner of sale is expected to be a stock or asset
sale. The Company is unable to predict the timing of the
sale. However, through its investment banker, the Company is actively
soliciting indications of interest. Should the Company be unable to
find a buyer for or negotiate a sale of CDT on terms acceptable to the Company,
the cost to maintain CDT’s operations or to close CDT may be significant and may
have an adverse affect on the Company’s operations and financial
condition.
-16-
CARDIOTECH
INTERNATIONAL, INC.
NOTES
TO CONDENSED CONDOLIDATED FINANCIAL STATEMENTS
CDT’s
major classes of assets and liabilities included in the Company’s December 31,
2007 balance sheet are as follows: (i) current assets of $1.1
million, (ii) property and equipment, net of $0.6 million, and (iii) current
liabilities of $0.5 million. These amounts exclude all intercompany
balances.
For the
three months ended December 31, 2007, CDT generated a net loss of approximately
$0.7 million on revenues of $0.8 million. For the nine months ended
December 31, 2007, CDT generated a net loss of approximately
$1.3 million on revenues of $2.5 million.
The
Company has evaluated CDT for impairment pursuant to SFAS No. 144, “Accounting for the Impairment or
Disposal of Long-Lived Assets,” and determined that, as of December 31,
2007, no impairment is present. The Company's impairment analysis is based
on significant assumptions, including, but not limited to, the future
performance of CDT and the proceeds from the sale of CDT. Changes to these
estimates could result in impairment charges in the future.
-17-
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, we may encounter competitive, technological, financial and business
challenges making it more difficult than expected to continue to develop and
market our products; the market may not accept our existing and future products;
we may not be able to retain our customers; we may be unable to retain existing
key management personnel; and there may be other material adverse changes in our
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 our targeted markets, (ii) the continued
acquisition of our customers by certain of its competitors, and (iii) continued
periods of net losses, which could require us to find additional sources of
financing to fund operations, implement our 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 us to
alter our marketing, capital expenditure or other budgets, which may in turn
affect our 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. We assume 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
our filings with the Securities and Exchange Commission, including its Annual
Report on Form 10-K/A for the fiscal year ended March 31, 2007.
Overview
History
We were
incorporated in Massachusetts 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, which PMI owned, to PMI
stockholders of record. Our materials science technology is
principally based upon the ChronoFlex proprietary polymers which represent our
core technology.
In July
1999, we acquired the assets of Tyndale-Plains Hunter, Ltd., a manufacturer of
specialty hydrophilic polyurethanes.
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 net assets of Dermaphylyx
were immaterial to us.
In April
2001, we 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. Our engineering services and
contract manufacturing primarily operate through our CDT
subsidiary. 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.
The
Company is in the process of reviewing several strategic alternatives for its
Catheter and Disposables Technology, Inc. subsidiary (“CDT”), which includes,
but not limited to, a sale of the business. The Company believes a
sale of CDT will permit the redeployment of capital into the Company’s ongoing
growth initiatives, however there can be no assurance that a sale will be
consummated at all or on terms acceptable to us.
-18-
In April
2003, we acquired Gish Biomedical, Inc. (“Gish”), a manufacturer of single use
cardiopulmonary bypass products having a disposable component. Gish
was sold on July 6, 2007 as described in Note 15 of the accompanying condensed
consolidated financial statements.
In March
2004, we 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. We own common stock of
CorNova, representing an approximate 15% equity interest, based on the total
outstanding preferred and common stock of CorNova. Although CorNova
is expected to incur future operating losses, we have no obligation to fund
CorNova.
At the
Company’s 2007 Annual Meeting, the stockholders approved the reincorporation of
the Company from Massachusetts to Delaware. The Company’s Articles of
Charter Surrender in Massachusetts and Certificate of Incorporation and
Certificate of Conversion in Delaware were effective as of October 26,
2007.
We
operate as one segment, medical device manufacturing and sales.
Technology
and Intellectual Property
Our
unique materials science strengths are embodied in our family of proprietary
polymers. We manufacture and sell our custom polymers under the trade
names ChronoFilm, ChronoFlex, ChronoThane, ChronoPrene, HydroThane, and
PolyBlend. The ChronoFlex family of polymers has the potential to be
marketed beyond our existing customer base. Our goal is to fulfill
the market’s need for advanced materials science capabilities, thereby enabling
customers to improve devices that utilize polymers. Our chemists
continue to develop the ChronoFlex family of medical-grade
polymers. Conventional polymers are susceptible to degradation
resulting in catastrophic failure of long-term implantable devices such as
pacemaker leads. ChronoFlex and ChronoThane polymers are designed to
overcome such degradation and reduce the incidents of infections associated with
invasive devices.
Key
characteristics of our polymers are i) optional use as lubricious coatings for
smooth insertion of a device into the body, ii) antimicrobial properties that
are part of the polymer itself, and iii) mechanical properties, such as hardness
and elasticity, sufficient to meet engineering requirements. We
believe our technology has wide application in increasing biocompatibility, drug
delivery, infection control and expanding the utility of complex devices in the
hospital and clinical environment.
We also
manufacture and sell our proprietary HydroThane polymers to medical device
manufacturers that are evaluating HydroThane for use in their
products. HydroThane is a thermoplastic, water-absorbing,
polyurethane elastomer possessing properties which we believe make it well
suited for the complex requirements of a variety of catheters. In
addition to its physical properties, we believe HydroThane exhibits an inherent
degree of bacterial resistance, clot resistance and
biocompatibility. When hydrated, HydroThane has elastic properties
similar to living tissue.
We also
manufacture specialty hydrophilic polyurethanes that are primarily sold to
customers as part of an exclusive arrangement. Specifically, these
customers are supplied tailored, patented hydrophilic polyurethanes in exchange
for multi-year, royalty-bearing exclusive supply contracts.
The
development and manufacture of our products are subject to good laboratory
practices (“GLP”) and quality system regulations (“QSR”) requirements prescribed
by the Food and Drug Administration (“FDA”) and other standards prescribed by
the appropriate regulatory agency in the country of use. There can be
no assurance that we will be able to obtain or manufacture products in a timely
fashion at acceptable quality and prices, that we or any suppliers can comply
with GLP or the QSR, as applicable, or that we or such suppliers will be able to
manufacture an adequate supply of products. Our Minnesota facility is
ISO 13485 certified.
ChronoFilm
is a registered trademark of PMI. ChronoFlex is our registered
trademark. ChronoThane, ChronoPrene, HydroThane, and PolyBlend are
our tradenames. CardioPass is our trademark.
We own or
license 4 patents relating to our vascular graft manufacturing and polymer
technology and products. While we believe our patents secure our
exclusivity with respect to certain of our technologies, there can be no
assurance that any patents issued would afford us adequate protection against
competitors which sell similar inventions or devices, nor can there be any
assurance that our patents will not be infringed upon or designed around by
others. However, we intend to vigorously enforce all patents issued
to us.
-19-
In June
2007, we filed for a U.S. patent on our proprietary antimicrobial formulation
for ChronoFlex. Current technology in the marketplace uses antibiotic
drugs. The antimicrobial component of our polymers has been designed
to be non-leaching as a result of the polymerization process. In
addition, PMI has granted us 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 (the “Joint Technology”). PMI has granted us a
non-exclusive, perpetual, worldwide, royalty-free sublicense of these patents
for use in the Implantable Devices and Materials Field.
Development
We have developed a
synthetic coronary artery bypass graft (“SynCAB”), trademarked
CardioPassTM, using specialized
ChronoFlex polyurethane materials designed to provide improved performance in
the treatment of arterial disorders. We are not applying
any new resources to further develop of CardioPass and instead are applying
resources to the clinical trial. The grafts have three layers,
similar to natural arteries, and are designed to replicate the physical
characteristics of human blood vessels. We have developed a 4mm and
5mm SynCAB graft. We believe the SynCAB graft may be used initially
to provide an alternative to patients with insufficient or inadequate native
vessels for use in bypass surgery as a result of repeat procedures, trauma,
disease or other factors. We believe, however, that the SynCAB 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.
We
initiated plans in fiscal 2006 to obtain European marketing
approvals. In May 2006, we received written acknowledgement from our
Notified Body in Europe that our 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. We hired a European-based contract research
organization (“CRO”) to assist in management of the entire clinical
process. The CRO helped us review possible sites in the European
Union for the selection of investigators to 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 our planned timeline and is an important
benchmark in the commencement and completion of the clinical
trial. We have undergone a rigorous review by the Ministry of Health
and completed paperwork for an import license, and prepared for patient
selection.
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, our 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. Patients will be followed for 90 days and
assessed for graft patency and quality of life measures. Following
the completed clinical trial, we intend to submit the analyzed data to the
Notified Body in support of our application for CE Mark. In January
2007, we announced the initiation of these clinical trials with the first
patient surgically implanted in March 2007.
Manufacturing
Operations
We
generated approximately 61% and 59% of our revenues from manufacturing
operations during the three and nine months ended December 31, 2007,
respectively, as compared to approximately 63% and 66% of our revenues during
the three and nine months ended December 31, 2006, respectively.
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/A for
the fiscal year ended March 31, 2007. 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, 2007. Our critical accounting policies are as
follows:
|
·
|
Revenue
Recognition. We
recognize revenue in accordance with Staff Accounting Bulletin (“SAB”) No.
104, “Revenue
Recognition in Financial Statements.” We recognize
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, we recognize 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. We also receive license and royalty fees for the use
of our proprietary advanced polymers. We recognize 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.
|
-20-
·
|
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, our 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 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 goodwill. In assessing the
recoverability of our 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. The next test is scheduled during the quarter ending
March 31, 2008.
|
·
|
Stock-Based
Compensation. Effective April 1, 2006, we adopted
Statement of Financial Accounting Standard No. 123R (SFAS 123R), “Share-Based Payment,”
which requires the expense recognition of the estimated fair value of all
stock-based payments issued to employees. Prior to the adoption
of SFAS 123R, the estimated fair value associated with such awards was not
recorded as an expense, but rather was disclosed in a footnote to our
financial statements.
|
The
valuation of employee stock options is an inherently subjective process, since
market values are generally not available for long-term, non-transferable
employee stock options. Accordingly, an option pricing model is
utilized to derive an estimated fair value. In calculating the
estimated fair value of our stock options we use the Black-Scholes pricing
model, which requires the consideration of the following six variables for
purposes of estimating fair value:
·
|
the
stock option exercise price,
|
·
|
the
expected term of the option,
|
·
|
the
grant price of our common stock, which is issuable upon exercise of the
option,
|
·
|
the
expected volatility of our common
stock,
|
·
|
the
expected dividends on our common stock (we do not anticipate paying
dividends in the foreseeable future),
and
|
·
|
the
risk free interest rate for the expected option
term.
|
Stock Option Exercise Price and
Grant Date Price of our Common Stock. The closing market price
of our common stock on the date of grant.
Expected Term. 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.
-21-
Expected
Volatility. The expected volatility is a measure of the amount
by which our stock price is expected to fluctuate during the expected term of
options granted. We determine the expected volatility solely based upon the
historical volatility of our common stock over a period commensurate with the
option’s expected term. We do not believe that the future volatility
of our common stock over an option’s expected term is likely to differ
significantly from the past.
Expected
Dividends. We have never declared or paid any cash dividends
on any of our capital stock and do not expect to do so in the foreseeable
future. Accordingly, we use an expected dividend yield of zero to
calculate the grant-date fair value of a stock option.
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.
Of the
variables above, the selection of an expected term and expected stock price
volatility are the most subjective. The majority of the stock option
expense recorded in the three months ended December 31, 2007 relates to the
vesting of stock options granted subsequent to April 1, 2006, as the majority of
our outstanding options were fully vested due to the acceleration of vesting of
certain stock option effective July 8, 2004.
Upon
adoption of SFAS 123R, we were also required to estimate the level of award
forfeitures expected to occur and record compensation expense only for those
awards that are ultimately expected to vest. This requirement applies
to all awards that are not yet vested, including awards granted prior to April
1, 2006. Due to the limited number of unvested options outstanding,
the majority of which are held by executives and members of our Board of
Directors, we have estimated a zero forfeiture rate. We will revisit
this assumption periodically and as changes in the composition of our option
pool dictate.
Changes
in the inputs and assumptions, as described above, can materially affect the
measure of estimated fair value of our stock-based compensation. We
anticipate the amount of stock-based compensation to increase in the future as
additional options are granted. As of December 31, 2007, there was
approximately $521,000 of unrecognized compensation cost related to stock option
awards that is expected to be recognized as expense over a weighted average
period of 1.80 years.
Results
of Operations
Three Months Ended December
31, 2007 vs. December 31, 2006
Revenues
The
following table presents revenue components and the percent of total revenues
for the three months ended December 31,
2007
|
2006
|
|||||||||||||||
(in
thousands)
|
Revenues
|
%
of Revenues
|
Revenues
|
%
of Revenues
|
||||||||||||
Product
sales
|
$ | 1,133 | 71.2 | % | $ | 1,042 | 74.1 | % | ||||||||
Royalties
and development fees
|
459 | 28.8 | % | 365 | 25.9 | % | ||||||||||
Revenues
|
$ | 1,592 | 100.0 | % | $ | 1,407 | 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,
|
2007
|
2006
|
||||||||||||||
(in
thousands)
|
Product
sales
|
%
of Product sales
|
Product
sales
|
%
of Product sales
|
||||||||||||
Medical
devices
|
$ | 973 | 85.9 | % | $ | 880 | 84.5 | % | ||||||||
Engineering
services
|
160 | 14.1 | % | 162 | 15.5 | % | ||||||||||
Product
sales
|
$ | 1,133 | 100.0 | % | $ | 1,042 | 100.0 | % |
-22-
Medical
device revenues for the three months ended December 31, 2007 were $973,000 as
compared to $880,000 for the comparable prior year period, an increase of
$93,000, or 10.6%. Medical devices are primarily composed of
private-label products and advanced polymers developed by our materials science
technology. Medical device revenues for the three months ended
December 31, 2007 from the sale of private-label products were unchanged and the
sale of advanced polymers increased by $126,000 compared to the year-earlier
period.
During
the three months ended December 31, 2007, we improved processes and procedures
to meet internal specifications and restarted production of our
polymers. As previously reported, during the three months ended
September 30, 2007, shipments of advanced polymers were lower than the
comparable prior year period due to our inability to produce certain polymers
that consistently met certain internal specifications. The increase
in revenues from advanced polymers during the three months ended December 31,
2007, as compared to the comparable prior year period, reflects the
recommencement of production and reduction of backlog from our fiscal 2008
second quarter production shortfalls. We continue to see a growth in
the number of inquiries for our advanced polymers by large and small companies
that span a broad range of medical device sectors.
In
January 2008, we hired a Global Sales Director – Materials Science, a first time
position in the Company, to launch a new sales campaign to introduce our
material science technology to medical device companies.
Engineering
services revenues for the three months ended December 31, 2007 were $160,000 as
compared to $162,000 for the comparable prior year period, a decrease of $2,000
or 1.2%. Engineering 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.
Royalties
and development fees for the three months ended December 31, 2007 were $459,000
as compared to $365,000 for the comparable prior year period, an increase of
$94,000 or 25.8%. We have agreements to license our proprietary
advanced polymer technology to medical device
manufacturers. Royalties are earned when these manufacturers sell
medical devices which use our materials science technology; accordingly, the
increase in royalties during the three months ended December 31, 2007 is a
result of increased shipments of existing and new products by these
manufacturers. Additionally, in October 2006, we began to generate
development fees from the supply of our proprietary ChronoFlex polymer material,
specifically formulated for the development of orthopedic implant devices, from
a leading developer and manufacturer of orthopedic devices.
Deferred
revenue as of December 31, 2007 consists primarily of annual royalty and
development fees we receive, as well as from customer
deposits. Revenue is recognized ratably over the respective
contractual periods or as product is supplied.
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,
(in
thousands)
|
Gross
Margin
|
%
Gross Margin
|
Gross Margin
|
%
Gross Margin
|
||||||||||||
Gross
margin
|
$ | (273 | ) | -24.1 | % | $ | (55 | ) | -5.3 | % |
Gross
margin on product sales (excluding royalties and development fees) was
($273,000), or (24.1%) as a percentage of product sales for the three months
ended December 31, 2007, as compared to ($55,000), or (5.3%) for the comparable
prior year period.
The
decrease in gross margin as a percentage of product sales for the three months
ended December 31, 2007, as compared to the comparable prior year period, is
primarily due to competitive pressures when determining selling prices, product
startup expenses, underutilization of plant capacity and additional labor
costs.
-23-
Research,
Development and Regulatory Expenses
The
following table presents research and development expenses as a percentage of
revenues for the three months ended December 31,
(in
thousands)
|
2007
|
%
of Revenues
|
2006
|
%
of Revenues
|
||||||||||||
Research,
development and regulatory expenses
|
$ | 235 | 14.8 | % | $ | 207 | 14.7 | % |
Research
development and regulatory expenses for the three months ended December 31, 2007
were $235,000 as compared to $207,000 for the comparable prior year period, an
increase of $28,000 or 13.5%. Our research and development efforts
are focused on developing new formulations of our advanced proprietary
polymers. Research and development expenditures consisted primarily
of the salaries of full time employees and related expenses, and are expensed as
incurred. We had additional staff for research and development in the
three months ended December 31, 2007. These individuals work on a
variety of projects, and we believe we are operating at the minimum staffing
level to support our operating needs. In addition, we incurred costs
of approximately $30,000 and $32,000 during the three months ended December 31,
2007 and 2006 for conducting clinical trials in Europe for
CardioPass.
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)
|
2007
|
%
of Revenues
|
2006
|
%
of Revenues
|
||||||||||||
Selling,
general and administrative expenses
|
$ | 1,351 | 84.9 | % | $ | 1,149 | 81.7 | % |
Selling,
general and administrative expenses for the three months ended December 31, 2007
were $1,351,000 as compared to $1,149,000 for the comparable prior year period,
an increase of $202,000 or 17.6%. This increase is primarily
attributable to additions in sales and administrative personnel, increases in
managerial salaries, increases in non-cash, stock-based compensation, and other
professional fees during the three months ended December 31, 2007, as compared
to the comparable prior year period
Interest
and Other Income and Expense
Interest
and other income and expense, net for the three months ended December 31, 2007
was $80,000, as compared to $148,000 for the comparable prior year period, a
decrease of $68,000 or 46.0%. Interest income increased to $70,000
during the three months ended December 31, 2007 from $24,000 in the comparable
prior year period, primarily due to earnings on cash proceeds from the sale of
Gish in July 2007. For the three months ended December 31, 2006, we
recovered approximately $124,000 from one customer’s previously written-off
accounts receivable in fiscal 2006.
Equity
in Net Loss of CorNova, Inc.
During
the three months ended December 31, 2007 and 2006, we recorded equity in the net
loss of CorNova of $0, and equity in comprehensive income of CorNova of $0
(related to unrealized holding gains on securities classified as
available-for-sale). We have invested $825,000 in CorNova and have
recorded cumulative net losses through September 30, 2006 of $825,000 from
CorNova. Therefore, the maximum portion of CorNova’s future losses
allocable to us were met. Accordingly, we recorded no equity in the
net loss of CorNova during the three month period ended December 31,
2007. We have no additional obligation to contribute assets or
additional common stock nor to assume any liabilities or to fund any losses that
CorNova may incur. As of December 31, 2007, CorNova owned no shares
of our common stock.
-24-
Nine Months Ended December
31, 2007 vs. December 31, 2006
Revenues
The
following table presents revenue components and the percent of total revenues
for the nine months ended December 31,
2007
|
2006
|
|||||||||||||||
(in
thousands)
|
Revenues
|
%
of Revenues
|
Revenues
|
%
of Revenues
|
||||||||||||
Product
sales
|
$ | 3,325 | 70.3 | % | $ | 3,213 | 77.3 | % | ||||||||
Royalties
and development fees
|
1,405 | 29.7 | % | 943 | 22.7 | % | ||||||||||
Revenues
|
$ | 4,730 | 100.0 | % | $ | 4,156 | 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,
2007
|
2006
|
|||||||||||||||
(in
thousands)
|
Product
sales
|
%
of Product sales
|
Product
sales
|
%
of Product sales
|
||||||||||||
Medical
devices
|
$ | 2,810 | 84.5 | % | $ | 2,737 | 85.2 | % | ||||||||
Engineering
services
|
515 | 15.5 | % | 476 | 14.8 | % | ||||||||||
Product
sales
|
$ | 3,325 | 100.0 | % | $ | 3,213 | 100.0 | % |
Medical
device revenues for the nine months ended December 31, 2007 were $2,810,000 as
compared to $2,737,000 for the comparable prior year period, an increase of
$73,000, or 2.7%. Medical devices are primarily composed of
private-label products and advanced polymers developed by our materials science
technology. The increase in medical device revenues for the nine
months ended December 31, 2007 was primarily a result of a $187,000 decrease
from the sale of private-label products offset by a $290,000 increase from the
sale of advanced polymers. During the three months ended June
30, 2006, we deferred approximately $397,000 in private-label shipments to a
major customer. The revenue associated with this deferral was
recognized during the quarter ended September 30, 2006. Without the
effect of the above $397,000 of revenue recognized in the nine months ended
September 30, 2006, shipments of private-label products increased by $107,000
during the nine months ended September 30, 2007 when compared to the comparable
prior year period.
The
decrease in private-label product shipments during the nine months ended
December 31, 2007 reflects the loss of the recurring revenues from the major
customer described above when compared to comparable prior year
period. The costs associated with the deferred revenue of $397,000
were expensed during the quarters ended March 31, 2006 and June 30, 2006 because
the net realizable value of the inventory was uncertain due to the likely return
and rework of the product.
The
increase in advanced polymer sales for the nine months ended December 31, 2007
is primarily a result of increased shipments of advanced polymers to a broader
base of customers for their end-user medical device products as compared to the
comparable prior year period.
Engineering
services revenues for the nine months ended December 31, 2007 were $515,000 as
compared to $476,000 for the comparable prior year period, an increase of
$39,000 or 8.2%. Engineering 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 increase in engineering services revenues is a result
of our renewed efforts to allocate resources to the growth of engineering
services.
Royalties
and development fees for the nine months ended December 31, 2007 were $1,405,000
as compared to $943,000 for the comparable prior year period, an increase of
$462,000 or 49.0%. We have agreements to license our proprietary
advanced polymer technology to medical device
manufacturers. Royalties are earned when these manufacturers sell
medical devices which use our materials science
technology. Accordingly, the increase in royalties during the nine
months ended December 31, 2007 is a result of increased shipments of existing
and new products by these manufacturers. Additionally, in October
2006, we began to generate development fees from the supply of our proprietary
ChronoFlex polymer material, specifically formulated for the development of
orthopedic implant devices from a leading developer and manufacturer of
orthopedic devices.
-25-
Deferred
revenue as of December 31, 2007 consists primarily of annual royalty and
development fees received by us, as well as from customer
deposits. Revenue is recognized ratably over the respective
contractual periods or as product is supplied.
Gross
Margin
The
following table presents product sales gross margins and gross margin
percentages as a percent of the respective product sales for the nine months
ended December 31,
2007
|
2006
|
|||||||||||||||
(in
thousands)
|
Gross
Margin
|
%
Gross Margin
|
Gross Margin
|
%
Gross Margin
|
||||||||||||
Gross
margin
|
$ | (479 | ) | -14.4 | % | $ | (213 | ) | -6.6 | % |
Gross
margin on product sales (excluding royalties and development fees) was
($479,000), or (14.4%) as a percentage of product revenue for the nine months
ended December 31, 2007, as compared to ($213,000), or (6.6%) for the comparable
prior year period.
The
decrease in gross margin as a percentage of product sales for the nine months
ended December 31, 2007, as compared to the comparable prior year period, is due
to several factors. For the nine months ended December 31, 2007,
gross margin decreased primarily due to competitive pressures when determining
selling prices, production startup expenses, underutilization of plant capacity,
material scrap costs and additional labor costs. Gross margin from
our private label business benefited during the nine months ended December 31,
2006 from the effect of realizing deferred revenues of $397,000.
Research,
Development and Regulatory Expenses
The
following table presents research and development expenses as a percentage of
revenues for the nine months ended December 31,
(in
thousands)
|
2007
|
%
of Revenues
|
2006
|
%
of Revenues
|
||||||||||||
Research,
development and regulatory expenses
|
$ | 777 | 16.4 | % | $ | 501 | 12.1 | % | ||||||||
Research,
development and regulatory expenses for the nine months ended December 31, 2007
were $777,000 as compared to $501,000 for the comparable prior year period, an
increase of $276,000 or 55.1%. Our research and development efforts
are focused on developing new applications of ChronoFlex, synthetic vascular
graft technologies, including the CardioPass graft. Research and
development expenditures consisted primarily of the salaries of full time
employees and related expenses, and are expensed as incurred. We had
additional staff for research and development in the nine months ended December
31, 2007. These individuals work on a variety of projects , and we
believe we are operating at the minimum staffing level to support our operating
needs. In addition, we incurred costs of approximately $118,000 and
$118,000 during the nine months ended December 31, 2007 and 2006, respectively,
for conducting clinical trials in Europe for CardioPass. As contacts
with potential customers grow for advanced polymers and our materials science
technology, we expect to add to our scientific and technical staff during fiscal
year 2008.
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)
|
2007
|
%
of Revenues
|
2006
|
%
of Revenues
|
||||||||||||
Selling,
general and administrative expenes
|
$ | 3,244 | 68.6 | % | $ | 2,840 | 68.3 | % |
-26-
Selling,
general and administrative expenses for the nine months ended December 31, 2007
were $3,244,000 as compared to $2,840,000 for the comparable prior year period,
an increase of $404,000 or 14.2%. This increase is primarily
attributable to additions in sales and administrative personnel, increases in
managerial salaries, and an increase in non-cash stock-based compensation
expense during the nine months ended December 31, 2007, when compared to the
year-earlier period.
Interest
and Other Income and Expense
Interest
and other income and expense, net for the nine months ended December 31, 2007
was $192,000, as compared to $282,000 for the comparable prior year period, an
decrease of $90,000 or 31.9%. Interest income increased to $175,000
during the nine months ended December 31, 2007 from $57,000 in the comparable
prior year period, primarily due to earnings from cash proceeds from the sale of
Gish in July 2007. For the nine months ended December 31, 2006, we
recovered approximately $200,000 from one customer’s previously written-off
accounts receivable in fiscal 2006.
Equity
in Net Loss of CorNova, Inc.
During
the nine months ended December 31, 2006, we recorded equity in the net loss of
CorNova of $278,000, and equity in comprehensive income of CorNova of $40,000
(related to unrealized holding gains or losses on securities classified as
available-for-sale). We have invested $825,000 in CorNova and have
recorded cumulative net losses through December 31, 2006 of $825,000 from
CorNova. Therefore, the maximum portion of CorNova’s future losses
allocable to us were met. Accordingly, we recorded no equity in the
net loss of CorNova during the nine month period ended December 31,
2007. We have no additional obligation to contribute assets or
additional common stock nor to assume any liabilities or to fund any losses that
CorNova may incur. As of December 31, 2007, CorNova owned no shares
of our common stock.
Net
(Loss) Income from Discontinued Operations
Net loss
from discontinued operations for the nine months ended December 31, 2007 was
$319,000, which included $1,173,000 of loss on sale of Gish. The loss
on sale of Gish includes transaction costs of approximately
$408,000. The loss from discontinued operations was $319,000 for the
nine months ended December 31, 2007 as compared to income from discontinued
operations of $225,000 for the comparable prior year period. At July
6, 2007, the closing date of the sale of Gish, we determined that the proceeds
from the sale of Gish, less the related transaction costs, were less than the
book value of the net assets sold and therefore gave rise to the loss on the
sale of $1,173,000 that was recorded in the nine months ended December 31,
2007
Liquidity
and Capital Resources
On July
6, 2007, we completed the sale of Gish, our former developer and manufacturer of
single use cardiopulmonary bypass products, pursuant to a Purchase Agreement
entered into with Medos, on July 3, 2007. The Purchase Agreement
provided for the sale of Gish to Medos for a purchase price of approximately
$7.5 million in cash. The Purchase Agreement also contained
representations, warranties and indemnities that are customary in a transaction
involving the sale of all or substantially all of a company or its
assets. The indemnifications include items such as compliance with
legal and regulatory requirements, product liability, lawsuits, environmental
matters, product recalls, intellectual property, and representations regarding
the fairness of certain financial statements, tax audits and net operating
losses.
Pursuant
to the terms of the Purchase Agreement, we placed $1 million in escrow as a
reserve for our indemnification obligations to Medos, if any, as described
above. The escrowed
amount, less any agreed upon amount necessary to satisfy any indemnification
obligations, may be made available to us on July 5, 2008. The
realization of the escrow fund is also contingent upon the realizability of the
Gish accounts receivable and inventory that were transferred to Medos for one
year from the sale date. The $1 million of proceeds being held in
escrow is not included in the calculation of the loss on sale of
Gish.
Medos has
advised the Company that it may assert certain indemnity claims against the
Company relating to certain representations and warranties up to the full amount
of the $1 million escrow balance. The Company has advised Medos that
it believes any such claims, if made, would be without merit under the Purchase
Agreement. The Company has concluded that a loss resulting from these
potential claims by Medos is not probable as of December 31, 2007.
The
Company has been notified by Medos as to their assertion that the Company may be
liable for up to one year of severance costs related to the termination of a key
Gish employee by Medos whose termination was effected by Medos subsequent to the
acquisition date. The Company has reviewed the assertion by Medos,
and has concluded that a loss resulting from this asserted claim is not probable
as of December 31, 2007.
-27-
In
connection with the sale of Gish, we entered into a non-exclusive, royalty-free
license (the “License Agreement”) with Gish which provides for our use of
certain patented technology of Gish in our products and services, provided such
products and services do not compete with the cardiac bypass product development
and manufacturing businesses of Gish or Medos. We have determined the
License Agreement has de minimus value, accordingly no value has been ascribed
to the license.
After transaction expenses
and certain post-closing adjustments, the Company realized approximately $5.8
million in proceeds from the sale of Gish. Assuming the disbursement
to the Company of all funds held in escrow after July 5, 2008, up to an
additional $1 million may be realized. Under the terms of the
Purchase Agreement, the Company owes Medos $149,000 as a result of the change in
stockholder’s equity of Gish from March 31, 2007 to June 30,
2007. This amount was recorded as a current liability as of June 30,
2007, has not been paid to Medos, and is reflected as a current liability as of
December 31, 2007. This adjustment is included in the calculation of
the loss on sale of Gish through December 31, 2007. Under the terms of the
Purchase Agreement, the Company retained Gish’s cash assets of approximately
$2.0 million as of June 29, 2007.
As of
December 31, 2007, we had cash and cash equivalents of approximately $6.7
million, an increase of approximately $2.6 million when compared with a balance
of approximately $4.1 million as of March 31, 2007.
During
the nine months ended December 31, 2007, we had net cash outflows of
approximately $2.4 million from operating activities of continuing operations as
compared to net cash outflows of continuing operations of approximately $2.1
million for the comparable prior year period. The approximate $0.3
million increase in net cash outflows used in operating activities of continuing
operations during the nine months ended December 31, 2007, as compared to the
comparable prior year period was primarily a result of the approximate $0.3
million increase in net loss from continuing operations.
During
the nine months ended December 31, 2007, the Company had net cash inflows of
approximately $5.0 million from investing activities as compared to net cash
outflows of approximately $0.6 million for the comparable prior year
period. Net cash inflows results from proceeds of approximately $6.1
million from the sale of Gish offset by approximately $1.0 million in purchases
of property, plant and equipment during the nine months ended December 31,
2007.
During
the nine months ended December 31, 2007, there were 1,035,663 options exercised
for cash proceeds of approximately $0.9 million pursuant to the 1996 Plan and
the 2003 Plan.
At
December 31, 2007, we had no debt. We believe our December 31, 2007
cash position will be sufficient to fund our working capital and research
and development activities for at least the next twelve months.
As part
of our ongoing repositioning of our business, we
are focusing on building our materials science business to provide
specialized polymers for medical device
manufacturers. Accordingly, we have decided to evaluate
strategic alternatives for our Catheter and Disposables Technology, Inc.
subsidiary and, in January 2008, retained an investment banker to assist with
the evaluation of these alternatives, which include, but are not limited to, a
sale of the business. As CDT is our wholly-owned subsidiary, the
manner of sale is expected to be a stock or asset sale. We
are unable to predict the timing of the sale. However,
through our investment banker, we are actively soliciting
indications of interest. Should we be unable to find a buyer for
or negotiate a sale of CDT on terms acceptable to us, the cost to maintain CDT’s
operations or to close CDT may be significant and may have an adverse affect
on our operations and financial condition.
CDT’s
major classes of assets and liabilities included in our December 31, 2007
balance sheet are as follows: (i) current assets of $1.1 million,
(ii) property and equipment, net of $0.6 million, and (iii) current liabilities
of $0.5 million. These amounts exclude all intercompany
balances.
For the
three months ended December 31, 2007, CDT generated a net loss of approximately
$0.7 million on revenues of $0.8 million. For the nine months ended
December 31, 2007, CDT generated a net loss of approximately
$1.3 million on revenues of $2.5 million.
We
have evaluated CDT for impairment pursuant to SFAS No. 144, “Accounting for the Impairment or
Disposal of Long-Lived Assets,” and determined that, as of December 31,
2007, no impairment is present. Our impairment analysis is based on
significant assumptions, including, but not limited to, the future performance
of CDT and the proceeds from the sale of CDT. Changes to these estimates
could result in impairment charges in the future.
Our
future growth may depend upon our ability to raise capital to support research
and development activities and to market and sell its vascular graft technology,
specifically the coronary artery bypass graft. We 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. Our
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 our development of commercialization activities and
arrangements; the time and costs associated with the disposition of CDT through
sale or other strategic alternative; and the purchase of additional facilities
and capital equipment. Should the Company be unable to find a buyer
for or negotiate a sale of CDT on terms acceptable to the Company, the cost to
maintain CDT’s operations or to close CDT may be significant and may have an
adverse affect on the Company’s operations and financial condition over the next
one to two years.
As of
December 31, 2007, we had no off-balance sheet arrangements that have, or are
reasonably likely to have, a current or future material effect on our
consolidated financial condition, results of operations, liquidity, capital
expenditures or capital resources.
-28-
Contractual
obligations consist of the following as of December 31, 2007:
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
|
$ | 175 | $ | 131 | $ | 44 | $ | - | $ | - | ||||||||||
Purchase
obligations
|
167 | 167 | - | - | - | |||||||||||||||
$ | 342 | $ | 298 | $ | 44 | $ | - | $ | - |
Operating
lease obligations are for aggregate future minimum rental payments required
under operating leases for the Minnesota manufacturing
facilities. Purchase obligations primarily represent purchase orders
issued for inventory used in production.
With
respect to the Exchange and Venture Agreement with CorNova, we have no
additional obligation to contribute assets or additional common stock nor to
assume any liabilities or to fund any losses that CorNova may
incur.
Quantitative
and Qualitative Disclosures About Market
Risk.
|
We own
certain money market funds 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.
Controls
and Procedures
|
Our
management, including the Chief Executive Officer and Chief Financial Officer,
conducted an evaluation of our disclosure controls and procedures as of December
31, 2007. 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 us, including our consolidated
subsidiaries, required to be disclosed in reports that we file or submit 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. Our management concluded that there have been no
changes in our internal control over financial reporting that occurred during
the fiscal quarter ended December 31, 2007 that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
-29-
PART
II. OTHER
INFORMATION
Legal
Proceedings
|
We have
been notified that a customer (the “Customer”), with whom we perform contract
manufacturing services, has been named in a suit by another medical device
manufacturer which alleges patent infringement by the Customer. We
manufacture multilumen catheter products for the Customer and are not named in
the lawsuit. Under the terms of our purchase orders with the
Customer, we believe we are indemnified by the Customer against patent
infringement lawsuits. The lawsuit seeks unspecified damages against
the Customer, including enhanced damages and attorneys fees and costs, and an
injunction against certain manufacturing techniques. We are currently in the
process of evaluating this case, and have concluded that a loss is not probable
or estimable as of December 31, 2007.
We are
not a party to any other legal proceedings, other than ordinary routine
litigation incidental to our business, which we believe will not have a
material affect on our financial position or results of operations.
Item
1A.
|
Risk
Factors
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of
Proceeds
|
None.
Defaults
Upon Senior Securities
|
None.
Submission
of Matters to a Vote of Security
Holders
|
On
October 16, 2007, we held the 2007 Annual Meeting of Stockholders at which
stockholders of record as of August 16, 2007 were entitled to vote on the
following matters:
(1)
|
To
elect two (2) Class I directors to hold office until their successors
shall be elected and shall have
qualified;
|
(2)
|
To
approve the CardioTech International, Inc. Employee Stock Purchase
Plan;
|
(3)
|
To
approve the Company’s reincorporation from Massachusetts to Delaware;
and
|
(4)
|
To
ratify the selection of Ernst & Young LLP as CardioTech’s independent
accountants for the fiscal year ending March 31,
2008.
|
The
results of the votes are as follows:
Proposal
No. 1 – Election of Directors
|
For
|
Withheld
|
|
William
J. O’Neill, Jr. to serve as Class I Director
|
17,515,539
|
252,578
|
|
Michael
L. Barretti to serve as Class I director
|
16,843,557
|
925,407
|
|
For
|
Withheld
|
Abstain
|
|
Proposal
No. 2 – Approval of CardioTech International,
Inc.
Employee Stock Purchase Plan
|
7,583,410
|
494,824
|
38,704
|
Proposal
No. 3 – Approval of Reincorporation from
Massachusetts
to Delaware
|
17,445,492
|
262,221
|
60,304
|
Proposal
No. 4 – Ratification of Ernst & Young LLP to
Serve
as Independent Accountants for the Fiscal
Year
Ending March 31, 2008
|
17,608,221
|
115,587
|
44,308
|
-30-
Other
Information
|
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.
|
-31-
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
President
& Chief Executive Officer
By: /s/ Eric G.
Walters
Eric G.
Walters
Vice
President & Chief Financial Officer
Dated: February
14, 2008
-32-