form10q_q1fy09.htm
Table of Contents
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark One)
|
R
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the quarterly period ended June 30, 2008
Or
|
£
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the transition period from _____________to ____________
Commission
File Number: 000-51323
Micrus
Endovascular Corporation
(Exact
name of registrant as specified in its charter)
Delaware
|
23-2853441
|
(State
or other jurisdiction of
|
(I.R.S.
Employer Identification No.)
|
incorporation
or organization)
|
|
821
Fox Lane
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|
San
Jose, California
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95131
|
(Address
of principal executive offices)
|
(Zip
Code)
|
(408)
433-1400
(Registrant’s
telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes R No £
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
£ Large
accelerated filer R Accelerated
filer £ Non-accelerated
filer £ Smaller
reporting
company
(Do not
check if a smaller reporting company)
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes £ No R
As of
August 4, 2008, there were 15,662,892 shares of common stock, par value $0.01,
of the registrant outstanding.
MICRUS
ENDOVASCULAR CORPORATION
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Page
Number
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3
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3
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4
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5
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6
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19
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|
27
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|
28
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|
|
|
28
|
|
29
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|
44
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44
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44
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45
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45
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46
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PART I — FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
MICRUS
ENDOVASCULAR CORPORATION
(unaudited)
(in
thousands, except share and per share amounts)
|
|
June
30,
|
|
|
March
31,
|
|
|
|
2008
|
|
|
2008
|
|
ASSETS
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
16,917 |
|
|
$ |
25,526 |
|
Accounts
receivable, net of allowance for doubtful accounts
|
|
|
|
|
|
|
|
|
of
$98 at June 30, 2008 and $95 at March 31, 2008
|
|
|
9,474 |
|
|
|
11,297 |
|
Inventories
|
|
|
11,688 |
|
|
|
11,495 |
|
Prepaid
expenses and other current assets
|
|
|
1,175 |
|
|
|
1,570 |
|
Deferred
tax assets
|
|
|
110 |
|
|
|
- |
|
Total
current assets
|
|
|
39,364 |
|
|
|
49,888 |
|
Property
and equipment, net
|
|
|
5,771 |
|
|
|
5,285 |
|
Goodwill
|
|
|
9,006 |
|
|
|
8,549 |
|
Intangible
assets, net
|
|
|
6,716 |
|
|
|
7,153 |
|
Deferred
tax assets
|
|
|
9 |
|
|
|
9 |
|
Other
assets
|
|
|
1,323 |
|
|
|
1,448 |
|
Total
assets
|
|
$ |
62,189 |
|
|
$ |
72,332 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
4,036 |
|
|
$ |
3,680 |
|
Accrued
payroll and other related expenses
|
|
|
4,547 |
|
|
|
7,930 |
|
Deferred
tax liabilities
|
|
|
- |
|
|
|
43 |
|
Accrued
liabilities
|
|
|
8,238 |
|
|
|
9,431 |
|
Total
current liabilities
|
|
|
16,821 |
|
|
|
21,084 |
|
Deferred
tax liabilities
|
|
|
247 |
|
|
|
314 |
|
Other
non-current liabilities
|
|
|
1,748 |
|
|
|
2,754 |
|
Total
liabilities
|
|
|
18,816 |
|
|
|
24,152 |
|
Commitments
and contingencies (Note 6)
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Common
stock, $0.01 par value;
|
|
|
|
|
|
|
|
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Authorized:
50,000,000 shares
|
|
|
|
|
|
|
|
|
Issued
and outstanding:15,647,912 shares at June 30, 2008 and 15,614,760
shares
|
|
|
|
|
|
|
|
|
at
March 31, 2008
|
|
|
156 |
|
|
|
156 |
|
Additional
paid-in capital
|
|
|
121,770 |
|
|
|
119,897 |
|
Accumulated
other comprehensive loss
|
|
|
(589 |
) |
|
|
(511 |
) |
Accumulated
deficit
|
|
|
(77,964 |
) |
|
|
(71,362 |
) |
Total
stockholders' equity
|
|
|
43,373 |
|
|
|
48,180 |
|
Total
liabilities and stockholders' equity
|
|
$ |
62,189 |
|
|
$ |
72,332 |
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
MICRUS
ENDOVASCULAR CORPORATION
Condensed Consolidated Statements of
Operations
(unaudited)
(in
thousands, except per share amounts)
|
|
Three
months ended
|
|
|
|
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
Revenues
|
|
$ |
18,324 |
|
|
$ |
16,790 |
|
Cost
of goods sold
|
|
|
4,593 |
|
|
|
3,735 |
|
Gross
profit
|
|
|
13,731 |
|
|
|
13,055 |
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
2,973 |
|
|
|
1,965 |
|
Sales
and marketing
|
|
|
8,118 |
|
|
|
6,510 |
|
General
and administrative
|
|
|
9,562 |
|
|
|
6,276 |
|
Total
operating expenses
|
|
|
20,653 |
|
|
|
14,751 |
|
Loss
from operations
|
|
|
(6,922 |
) |
|
|
(1,696 |
) |
Interest
income
|
|
|
110 |
|
|
|
360 |
|
Interest
expense
|
|
|
(4 |
) |
|
|
- |
|
Other
income (expense), net
|
|
|
(2 |
) |
|
|
78 |
|
Loss
before income taxes
|
|
|
(6,818 |
) |
|
|
(1,258 |
) |
Provision
(benefit) for income taxes
|
|
|
(216 |
) |
|
|
135 |
|
Net
loss
|
|
$ |
(6,602 |
) |
|
$ |
(1,393 |
) |
Net
loss per share attributable to common stockholders:
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$ |
(0.42 |
) |
|
$ |
(0.09 |
) |
Weighted-average
number of shares used in per share calculations:
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
|
15,621 |
|
|
|
15,291 |
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
MICRUS
ENDOVASCULAR CORPORATION
Condensed Consolidated Statements of Cash Flows
(unaudited)
(in
thousands)
|
|
Three
months ended
|
|
|
|
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(6,602 |
) |
|
$ |
(1,393 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
806 |
|
|
|
791 |
|
Provision
for doubtful accounts
|
|
|
3 |
|
|
|
23 |
|
Loss
on disposal of equipment
|
|
|
- |
|
|
|
27 |
|
Provision
for excess and obsolete inventories
|
|
|
30 |
|
|
|
153 |
|
Unremitted
issuance of stock for tentative settlement of patent
litigation
|
|
|
1,650 |
|
|
|
- |
|
Stock-based
compensation
|
|
|
1,549 |
|
|
|
1,056 |
|
Deferred
income taxes
|
|
|
(217 |
) |
|
|
- |
|
Changes
in operating assets and liabilities, net of effect of
acquisitions
|
|
|
|
|
|
|
|
|
and
tentative settlement of patent litigation:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
1,684 |
|
|
|
(873 |
) |
Inventories
|
|
|
(255 |
) |
|
|
(1,466 |
) |
Prepaid
expenses and other current assets
|
|
|
386 |
|
|
|
(363 |
) |
Other
assets
|
|
|
122 |
|
|
|
6 |
|
Accounts
payable
|
|
|
369 |
|
|
|
186 |
|
Accrued
payroll and other related expenses
|
|
|
(3,362 |
) |
|
|
(2,101 |
) |
Accrued
liabilities
|
|
|
549 |
|
|
|
277 |
|
Other
non-current liabilties
|
|
|
(1,003 |
) |
|
|
(76 |
) |
Net
cash used in operating activities
|
|
|
(4,291 |
) |
|
|
(3,753 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Acquisition
of property and equipment
|
|
|
(843 |
) |
|
|
(487 |
) |
Earn-out
payment in connection with acquisition of Neurologic UK
Ltd.
|
|
|
(3,454 |
) |
|
|
(2,232 |
) |
Earn-out
payment in connection with acquisition of VasCon, LLC
|
|
|
(378 |
) |
|
|
- |
|
Net
cash used in investing activities
|
|
|
(4,675 |
) |
|
|
(2,719 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Proceeds
from exercise of stock options
|
|
|
302 |
|
|
|
522 |
|
Net
cash provided by financing activities
|
|
|
302 |
|
|
|
522 |
|
|
|
|
|
|
|
|
|
|
Effect
of foreign exchange rate changes on cash
|
|
|
55 |
|
|
|
(28 |
) |
Net
decrease in cash and cash equivalents
|
|
|
(8,664 |
) |
|
|
(5,950 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
25,526 |
|
|
|
34,536 |
|
Cash
and cash equivalents at end of period
|
|
$ |
16,917 |
|
|
$ |
28,558 |
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
MICRUS
ENDOVASCULAR CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note 1 — Formation and Business of
the Company
Micrus
Endovascular Corporation (the “Company”) was incorporated under the laws of the
state of Delaware in June 1996. The Company develops, manufactures and markets
both implantable and disposable medical devices used in the treatment of
cerebral vascular diseases. The Company’s products are used by interventional
neuroradiologists, interventional neurologist, and neurosurgeons to treat both
cerebral aneurysms responsible for hemorrhagic stroke and intracranial
atherosclerosis, which may lead to ischemic stroke. Hemorrhagic and ischemic
stroke are both significant causes of death and disability
worldwide.
Interim
unaudited financial information
The
accompanying unaudited condensed consolidated financial statements have been
prepared in accordance with accounting principles generally accepted in the
United States of America (“GAAP”) for interim financial information and in
accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X
of the Securities and Exchange Commission (“SEC”). Accordingly, they do not
include all of the information and footnotes required by generally accepted
accounting principles for complete financial statements. The unaudited interim
condensed consolidated financial statements have been prepared on the same basis
as the annual financial statements. In the opinion of management, the
accompanying unaudited condensed consolidated financial statements reflect all
adjustments (consisting only of normal recurring adjustments) considered
necessary for a fair presentation of the Company’s financial position as of the
date of the interim balance sheet and results of operations and cash flows for
the interim periods. These financial statements should be read in conjunction
with the audited financial statements and notes thereto for the preceding fiscal
year included in the Company’s Annual Report on Form 10-K for the fiscal year
ended March 31, 2008 which was filed with the SEC on June 12, 2008. Certain
information and footnote disclosures normally included in financial statements
prepared in accordance with GAAP have been condensed or omitted pursuant to such
rules and regulations. The condensed consolidated balance sheet at March 31,
2008 was derived from audited financial statements, but does not include all
disclosures required by GAAP.
The
results of operations for the interim periods ended June 30, 2008 may not
necessarily be indicative of the results that may be expected for the fiscal
year ended March 31, 2009, or any future period.
Liquidity
The
Company has incurred net losses since inception. Management believes that the
Company’s current cash position as of June 30, 2008 and the cash expected to be
generated from product sales will be sufficient to meet the Company’s working
capital and capital expenditure requirements for at least the next twelve
months. There is no assurance that the Company will be profitable in the
foreseeable future. To the extent that existing cash and cash generated from
operations are insufficient to fund its future activities, the Company may need
to raise additional funds through public or private equity or debt financing.
Additional funds may not be available on terms favorable to the Company or at
all.
Note 2 — Summary of Significant
Accounting Policies
Principles
of consolidation
The
consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries. All significant intercompany balances and
transactions have been eliminated in consolidation.
The
Company’s international subsidiaries use their local currency as the functional
currency. Assets and liabilities are translated at exchange rates prevailing at
the balance sheet date. Revenue, expense, gain and loss accounts are translated
at average exchange rates during the period. Resulting translation adjustments
are recorded directly to accumulated other comprehensive income
(loss).
Reclassifications
Certain
amounts in the prior year consolidated financial statements have been
reclassified to conform to the current year presentation. These
reclassifications had no impact on previously reported total assets,
stockholders’ equity or net loss.
Use
of estimates
The
preparation of consolidated financial statements in conformity with accounting
principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at
the dates of the consolidated financial statements and the reported amounts of
revenues and expenses during the reporting periods. Actual results could differ
from these estimates. These estimates and assumptions include reserves and
write-downs related to accounts receivable and inventories, the recoverability
of long-term assets, deferred tax assets and liabilities and related valuation
allowances and valuation of equity instruments.
Revenue
recognition – sales made to Latin American distributors
Sales
made to the Company’s Latin American distributors are made according to similar
contractual terms as sales made to other customers. However, due to historically
longer delays in receiving payments and a higher level of write-offs relating to
our Latin American distributors, the Company had concluded in previous fiscal
periods that collectibility was not reasonably assured at the time that the
customer took title to the inventory on sales to Latin American customers.
Accordingly, the Company had recognized revenues from its sales to Latin
American distributors when cash was collected. The Company has evaluated its
experience with its Latin American distributors and has concluded that
collectibility is now reasonably assured upon shipment, and began recognizing
revenue upon shipment to these distributors in the quarter ended June 30, 2008.
Revenues recognized upon shipment on sales made to the Company’s Latin American
distributors were $0.7 million for the three months ended June 30, 2008.
Additionally, the deferred revenue balance at March 31, 2008 of $0.7
million for these customers and the related cost of goods sold of $273,000 that
had been deferred has been recognized as revenue and cost of goods sold,
respectively, in the three months ended June 30, 2008.
Revenues
recognized for the Company’s Latin American distributors were $349,000 for the
three months ended June 30, 2007. Revenues recognized for these customers were
$1.6 million, $1.1 million and $0.8 million for the fiscal years ended March 31,
2008, 2007 and 2006, respectively.
Comprehensive
loss
Comprehensive
loss generally represents all changes in stockholders’ equity except those
resulting from investments or contributions by stockholders. Accumulated other
comprehensive loss as of June 30, 2008 and March 31, 2008 was comprised entirely
of foreign currency translation adjustments. Total comprehensive loss for the
three months ended June 30, 2008 and 2007 was $6.7 million and $1.4 million,
respectively. This included other comprehensive loss of ($78,000) and ($42,000)
respectively, related to foreign currency translation adjustments.
Net
loss per share
Basic net
loss per share is computed by dividing net loss by the weighted average number
of common shares outstanding during the period. Diluted net loss per share is
computed by giving effect to all potential dilutive common shares, including
stock options, employee stock purchase plan shares and restricted stock units.
There is no difference between basic and diluted net loss per share for all
periods presented due to the Company’s net losses.
Anti-dilutive
securities
The
following outstanding stock options, employee stock purchase plan shares and
restricted stock units were excluded from the computation of diluted net loss
per common share for the periods presented because their impact would have been
anti-dilutive (in thousands):
|
|
Three
months ended
|
|
|
|
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
Shares
issuable upon exercise of common stock options
|
|
|
4,095 |
|
|
|
3,239 |
|
Shares
issuable upon settlement of restricted stock units
|
|
|
4 |
|
|
|
7 |
|
Shares
issuable under employee stock purchase plan
|
|
|
36 |
|
|
|
16 |
|
|
|
|
4,135 |
|
|
|
3,262 |
|
Table of Contents
Stock-based
compensation
The
Company has adopted various stock plans that provide for the grant of stock
awards to employees, non-employee directors and consultants. The Company also
has an employee stock purchase plan which enables employees to purchase the
Company’s common stock.
On
April 1, 2006, the Company adopted the provisions of, and accounts for
stock-based compensation in accordance with the Financial Accounting Standards
Board’s (“FASB”) Statement of Financial Accounting Standards No. 123 —
revised 2004 (“SFAS 123R”), “Share-Based Payment” which replaced Statement
of Financial Accounting Standards No. 123 (“SFAS 123”), “Accounting
for Stock-Based Compensation” and supersedes APB Opinion No. 25 (“APB 25”),
“Accounting for Stock Issued to Employees.” Under the fair value recognition
provisions of SFAS 123R, stock-based compensation cost is measured at the
grant date based on the fair value of the award and is recognized as expense on
a straight-line basis over the requisite service period, which is generally the
vesting period. The Company elected the modified-prospective method of
transition, under which prior periods were not revised for comparative purposes.
The valuation provisions of SFAS 123R apply to new grants and to grants
that were outstanding prior to the effective date and are subsequently modified.
Estimated compensation for grants that were outstanding as of the effective date
will be recognized over the remaining service period using the compensation cost
estimated for the SFAS 123 pro forma disclosures.
Due to
the adoption of SFAS 123R, some exercises result in tax deductions in
excess of previously recorded benefits based on the option value at the time of
grant (“windfall” tax benefits). The Company recognizes windfall tax benefits
associated with the exercise of stock options directly to stockholders’ equity
only when realized. Accordingly, deferred tax assets are not recognized for net
operating loss carryforwards resulting from windfall tax benefits occurring from
April 1, 2006 onward. A windfall tax benefit occurs when the actual tax
benefit realized by a company upon an employee’s disposition of a share-based
award exceeds the deferred tax asset, if any, associated with the award that a
company had recorded. When assessing whether a tax benefit relating to
share-based compensation has been realized, the Company has elected to follow
the tax law ordering method, under which current year share-based compensation
deductions are assumed to be utilized before net operating loss carryforwards
and other tax attributes. Also, the Company has elected to ignore the indirect
tax effects of share-based compensation deductions in computing its research and
development tax credit. The Company will recognize the full effect of these
deductions in the statements of operations when the valuation allowance is
released.
Recent
accounting pronouncements
In
December 2007, the FASB issued Statement of Financial Accounting Standard
(“SFAS”) No. 141R (revised 2007), “Business Combinations,” which replaces
SFAS 141. SFAS 141R requires the acquiring entity in a business
combination to recognize at full fair value all the assets acquired and
liabilities assumed in the transaction; establishes the acquisition-date fair
value as the measurement objective for all assets acquired and liabilities
assumed; and requires the acquirer to disclose information needed to evaluate
and understand the nature and financial effect of the business combination.
SFAS 141R is effective for fiscal years beginning after December 15,
2008 and is to be applied prospectively to business combinations completed on or
after the date of adoption. The Company is currently evaluating the impact of
adopting SFAS 141R on the Company’s consolidated financial position,
results of operations or cash flows.
In
February 2008, the FASB issued Financial Standard Position (“FSP”)
SFAS 157-2, “Effective Date for FASB Statement No. 157.” This FSP
permits the delayed application of SFAS 157 for all nonrecurring fair value
measurements of non-financial assets and non-financial liabilities until fiscal
years beginning after November 15, 2008. The Company is currently
evaluating the impact of adopting the provisions of SFAS 157 for
non-financial assets and liabilities that are recognized or disclosed on a
non-recurring basis.
In April
2008, the FASB issued FASB Staff Position (“FSP”) SFAS No. 142-3,
“Determination of the Useful Life of Intangible Assets” (“FSP SFAS 142-3”). FSP
SFAS 142-3 amends the factors that should be considered in developing renewal or
extension assumptions used to determine the useful life of a recognized
intangible asset under SFAS 142, “Goodwill and Other Intangible Assets.”
The intent of this FSP is to improve the consistency between the useful life of
a recognized intangible asset and the period of expected cash flows used to
measure the fair value of the asset under SFAS 141 (revised 2007),
“Business Combinations” and other U.S. generally accepted accounting
principles (GAAP). FSP SFAS 142-3 is effective for the Company on
April 1, 2009. The Company is currently evaluating the impact of adopting
FSP SFAS 142-3 on the Company’s consolidated financial position, results of
operations or cash flows.
Table of Contents
In May
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally
Accepted Accounting Principles” (“SFAS 162”), which becomes effective
60 days following the SEC’s approval of the Public Company Accounting
Oversight Board (“PCAOB”) amendments to US Auditing Standards (“AU”)
Section 411, “The Meaning of Present Fairly in Conformity With Generally
Accepted Accounting Principles.” SFAS 162 identifies the sources of
accounting principles and the framework for selecting the principles to be used
in the preparation of financial statements of nongovernmental entities that are
presented in conformity with US GAAP. This standard is not expected to have an
impact on the Company’s consolidated financial position, results of operations
or cash flow.
Note 3 — Fair Value
Measurements
Effective
April 1, 2008, the Company adopted the provisions of SFAS 157 for financial
assets and liabilities, as well as for any other assets and liabilities that are
carried at fair value on a recurring basis. The adoption of the provisions of
SFAS 157 did not materially impact the Company’s consolidated financial
position and results of operations.
SFAS 157
defines fair value as the exchange price that would be received for an asset or
paid to transfer a liability (an exit price) in the principal or most
advantageous market for the asset or liability in an orderly transaction between
market participants on the measurement date. SFAS 157 also establishes a
fair value hierarchy, which requires an entity to maximize the use of observable
inputs and minimize the use of unobservable inputs when measuring fair value.
SFAS 157 describes three levels of inputs that may be used to measure fair
value:
|
|
|
Level
1
|
|
Unadjusted
quoted prices in active markets that are accessible at the measurement
date for identical, unrestricted assets or liabilities.
|
|
|
|
Level
2
|
|
Quoted
prices in markets that are not active; or other inputs that are
observable, either directly or indirectly, for substantially the full term
of the asset or liability.
|
|
|
|
Level
3
|
|
Prices
or valuation techniques that require inputs that are both significant to
the fair value measurement and
unobservable.
|
The
Company’s cash equivalents are classified within Level 1 of the fair value
hierarchy because they are valued using quoted market prices, broker or dealer
quotations, or alternative pricing sources with reasonable levels of price
transparency.
The
following table presents assets measured at fair value on a recurring basis at
June 30, 2008 (in thousands):
|
|
Level
1
|
|
|
Level
2
|
|
|
Level
3
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money
Market Mutual Funds
|
|
$ |
13,013 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
13,013 |
|
The
Company’s financial liabilities that are required to be carried at fair value at
June 30, 2008 were not material.
Table of Contents
Note 4 — Balance Sheet
Components
Inventories
Inventories
consisted of the following (in thousands):
|
|
June
30,
|
|
|
March
31,
|
|
|
|
2008
|
|
|
2008
|
|
Raw
materials
|
|
$ |
2,037 |
|
|
$ |
2,154 |
|
Work-in-progress
|
|
|
2,183 |
|
|
|
1,667 |
|
Finished
goods
|
|
|
3,202 |
|
|
|
3,002 |
|
Consigned
inventory
|
|
|
4,198 |
|
|
|
4,331 |
|
Inventory
held by distributor
|
|
|
68 |
|
|
|
341 |
|
|
|
$ |
11,688 |
|
|
$ |
11,495 |
|
Consigned
inventory is held at customer locations, primarily hospitals, and is under the
physical control of the customer. The Company retains title to the inventory
until used and purchased by the customer, generally when used in a medical
procedure.
Inventory
held by distributor at June 30, 2008 was held by the Company’s Chinese
distributor (see Note 2 in Notes to Condensed Consolidated Financial
Statements). Inventory held by distributors at March 31, 2008 consists of
$273,000 in inventory that was held by the Company’s Latin American distributors
and $68,000 in inventory that was held by the Company’s Chinese
distributor.
Property
and equipment, net
Property
and equipment, net, consisted of the following (in thousands):
|
|
June
30,
|
|
|
March
31,
|
|
|
|
2008
|
|
|
2008
|
|
Computer
equipment and software
|
|
$ |
1,793 |
|
|
$ |
1,728 |
|
Furniture,
fixtures and equipment
|
|
|
5,568 |
|
|
|
5,403 |
|
Leasehold
improvements
|
|
|
1,014 |
|
|
|
1,010 |
|
Construction
in progress
|
|
|
1,040 |
|
|
|
447 |
|
Total
cost
|
|
|
9,415 |
|
|
|
8,588 |
|
Less
accumulated depreciation and amortization
|
|
|
(3,644 |
) |
|
|
(3,303 |
) |
|
|
$ |
5,771 |
|
|
$ |
5,285 |
|
Goodwill
Activity
related to goodwill consisted of the following (in thousands):
|
|
June
30,
|
|
|
March
31,
|
|
|
|
2008
|
|
|
2008
|
|
Balance
beginning of period
|
|
$ |
8,549 |
|
|
$ |
5,552 |
|
Addition
related to Neurologic earn-out payment
|
|
|
457 |
|
|
|
2,997 |
|
Balance
end of period
|
|
$ |
9,006 |
|
|
$ |
8,549 |
|
|
|
|
|
|
|
|
|
|
Table of Contents
At March
31, 2008, the Company accrued for additional consideration of approximately $3.0
million for the third year earn-out associated with the purchase of Neurologic
UK Ltd. (“Neurologic”), which was recorded as goodwill and paid the accrued
earn-out in April 2008. In June 2008, the Company paid the final earn-out for
periods April and May of approximately $457,000.
Intangible
assets, net
Intangible
assets, net, consisted of the following (in thousands):
|
|
Useful
|
|
|
Gross
Carrying Amount
|
|
|
Accumulated
Amortization
|
|
|
Net
|
|
|
|
Life
|
|
|
March
31,
|
|
|
Additions
|
|
|
June
30
|
|
|
March
31,
|
|
|
(Additions)
|
|
|
June
30,
|
|
|
June
30,
|
|
|
March
31,
|
|
|
|
(Years)
|
|
|
2008
|
|
|
|
|
|
2008
|
|
|
2008
|
|
|
|
|
|
2008
|
|
|
2008
|
|
|
2008
|
|
Existing
process technology
|
|
|
7 |
|
|
$ |
4,590 |
|
|
$ |
- |
|
|
$ |
4,590 |
|
|
$ |
(874 |
) |
|
$ |
(164 |
) |
|
$ |
(1,038 |
) |
|
$ |
3,552 |
|
|
$ |
3,716 |
|
Distribution
agreements
|
|
|
5 |
|
|
|
2,300 |
|
|
|
- |
|
|
|
2,300 |
|
|
|
(1,164 |
) |
|
|
(115 |
) |
|
|
(1,279 |
) |
|
|
1,021 |
|
|
|
1,136 |
|
Capitalized
license fee
|
|
|
7 |
|
|
|
1,565 |
|
|
|
- |
|
|
|
1,565 |
|
|
|
(336 |
) |
|
|
(56 |
) |
|
|
(392 |
) |
|
|
1,173 |
|
|
|
1,229 |
|
Patents -
microcoil
|
|
|
10 |
|
|
|
1,100 |
|
|
|
- |
|
|
|
1,100 |
|
|
|
(880 |
) |
|
|
(27 |
) |
|
|
(907 |
) |
|
|
193 |
|
|
|
220 |
|
Non-compete
agreements
|
|
|
6 |
|
|
|
700 |
|
|
|
- |
|
|
|
700 |
|
|
|
(294 |
) |
|
|
(29 |
) |
|
|
(323 |
) |
|
|
377 |
|
|
|
406 |
|
Customer
relationships
|
|
|
5 |
|
|
|
900 |
|
|
|
- |
|
|
|
900 |
|
|
|
(454 |
) |
|
|
(46 |
) |
|
|
(500 |
) |
|
|
400 |
|
|
|
446 |
|
|
|
|
|
|
|
$ |
11,155 |
|
|
$ |
- |
|
|
$ |
11,155 |
|
|
$ |
(4,002 |
) |
|
$ |
(437 |
) |
|
$ |
(4,439 |
) |
|
$ |
6,716 |
|
|
$ |
7,153 |
|
Amortization
of intangible assets included in the results of operations is as follows (in
thousands):
|
|
Three
months ended
|
|
|
|
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
$ |
220 |
|
|
$ |
260 |
|
Operating
expenses
|
|
|
217 |
|
|
|
217 |
|
Total
|
|
$ |
437 |
|
|
$ |
477 |
|
The
expected future amortization of intangible assets is as follows (in
thousands):
For
Years Ended March 31,
|
|
Amortization
|
|
2009
(remaining 9 months)
|
|
$ |
1,309 |
|
2010
|
|
|
1,746 |
|
2011
|
|
|
1,298 |
|
2012
|
|
|
935 |
|
2013
|
|
|
879 |
|
Thereafter
|
|
|
549 |
|
Total
|
|
$ |
6,716 |
|
Table of Contents
Accruals
Accrued
payroll and other related expenses consisted of the following (in
thousands):
|
|
June
30,
|
|
|
March
31,
|
|
|
|
2008
|
|
|
2008
|
|
Accrued
bonuses
|
|
$ |
1,164 |
|
|
$ |
2,642 |
|
Accrued
salaries
|
|
|
534 |
|
|
|
1,071 |
|
Accrued
vacation
|
|
|
1,892 |
|
|
|
1,750 |
|
Accrued
401K
|
|
|
68 |
|
|
|
- |
|
Accrued
commissions
|
|
|
455 |
|
|
|
1,660 |
|
Accrued
payroll taxes
|
|
|
434 |
|
|
|
807 |
|
|
|
$ |
4,547 |
|
|
$ |
7,930 |
|
Accrued
liabilities consisted of the following (in thousands):
|
|
June
30,
|
|
|
March
31,
|
|
|
|
2008
|
|
|
2008
|
|
Tentative
settlement of patent litigation with Boston Scientific
|
|
$ |
1,650 |
|
|
$ |
- |
|
Milestone
fee to The Cleveland Clinic Foundation
|
|
|
1,500 |
|
|
|
500 |
|
Professional
fees
|
|
|
1,452 |
|
|
|
1,715 |
|
VAT
payable
|
|
|
540 |
|
|
|
560 |
|
Accrued
travel and entertainment
|
|
|
471 |
|
|
|
492 |
|
Biotronik
AG development costs
|
|
|
282 |
|
|
|
443 |
|
Development
costs
|
|
|
173 |
|
|
|
288 |
|
Milestone
fee to Genesis Medical Interventional, Inc.
|
|
|
150 |
|
|
|
150 |
|
Deferred
revenue from Japan distribution agreement
|
|
|
113 |
|
|
|
113 |
|
Earn-out
payment in connection with Neurologic acquisition
|
|
|
- |
|
|
|
2,997 |
|
Earn-out
payment in connection with VasCon, LLC
|
|
|
- |
|
|
|
378 |
|
Other
|
|
|
1,907 |
|
|
|
1,795 |
|
|
|
$ |
8,238 |
|
|
$ |
9,431 |
|
Other
non-current liabilities
Other
non-current liabilities consisted of the following (in thousands):
|
|
June
30,
|
|
|
March
31,
|
|
|
|
2008
|
|
|
2008
|
|
Contingent
purchase price
|
|
$ |
1,218 |
|
|
$ |
1,218 |
|
Deferred
revenue from Japan distribution agreement
|
|
|
253 |
|
|
|
281 |
|
Swiss
pension plan obligation
|
|
|
80 |
|
|
|
82 |
|
Milestone
fee to The Cleveland Clinic Foundation
|
|
|
- |
|
|
|
1,000 |
|
Other
non-current liabilities
|
|
|
197 |
|
|
|
173 |
|
|
|
$ |
1,748 |
|
|
$ |
2,754 |
|
|
|
|
|
|
|
|
|
|
|
|
The
negative goodwill of $1.6 million associated with the purchase of
VasCon has been recorded as a contingent purchase price. The amount
is being reduced by any earned contingent consideration of up to $10.0 million
that will be paid over the next three years, with any additional contingent
consideration being recorded as goodwill. The Company paid the first year
earn-out of approximately $378,000 in April 2008.
Table of Contents
Note 5 — Income
Taxes
The
Company has incurred net operating losses for both federal and state purposes
since inception and, as a result, the Company has paid no federal or state
income tax. For the three months ended June 30, 2008, the Company recorded an
income tax benefit of approximately $216,000. The income tax benefit for the
three months ended June 30, 2008 includes income tax benefit of $150,000 related
to net operating losses for its Swiss subsidiary, and a non-current tax benefit
of approximately $66,000 for the tax effect of the amortization related to the
identifiable intangible assets acquired in the Neurologic transaction which are
amortized for tax purposes and the tax benefit from net operating
losses for its United Kingdom subsidiary.
As of
March 31, 2008, the Company had federal, state and foreign net operating loss
carryforwards (“NOLs”) that are available to reduce future taxable income of
approximately $42.5 million, $27.6 million and $1.6 million, respectively. The
federal NOLs will expire at various dates beginning in 2012, state NOLs will
expire beginning in 2013 and the foreign NOLs will expire beginning in 2013. The
Company also has federal and state tax research and development credit
carryforwards of approximately $1.2 million and $1.1 million, respectively. The
federal tax credit carryforwards will expire beginning in 2012. The state tax
credit carryforwards can be carried forward indefinitely. Due to the uncertainty
of its ability to generate sufficient taxable income to realize the
carryforwards prior to their expiration, the Company has recorded a valuation
allowance at June 30, 2008 to offset its federal and state deferred tax
assets.
Since the
implementation of FIN 48, the Company has recognized a $232,000 increase in its
unrecognized tax benefits. The Company does not expect its unrecognized tax
benefits to change significantly over the next twelve months. At June 30, 2008,
the Company had no accrued interest or penalties related to tax
contingencies.
Note 6 — Commitments and
Contingencies
Indemnification
In the
normal course of business, the Company enters into contracts and agreements that
contain a variety of representations and warranties and provide for general
indemnification. The Company’s exposure under these agreements is unknown
because it involves claims that may be made against the Company in the future,
but have not yet been made. To date, the Company has not paid any claims or been
required to defend any action related to its indemnification obligations, and
accordingly, the Company has not accrued any amounts for such indemnification
obligations. However, the Company may record charges in the future as a result
of these indemnification obligations.
Litigation
The
Company is from time to time subject to various lawsuits. The Company does not
believe that it is probable that resolution of pending litigation will have a
material adverse effect on the Company’s consolidated financial statements;
however the outcome of litigation is inherently uncertain.
FCPA
investigation
In August
2004, while reviewing sales and payment procedures, the Company identified
certain payments made to physicians outside the United States that may have
violated the Foreign Corrupt Practices Act (“FCPA”) and the laws of certain
foreign countries. In September 2004, following an internal investigation, the
Company voluntarily disclosed to the United States Department of Justice (“DOJ”)
the factual information obtained in its internal investigation of potential
violations of the FCPA.
After
reviewing the results of the internal investigation and the compliance
procedures implemented by the Company, the DOJ entered into an agreement (the
“DOJ Agreement”) with the Company in February 2005. Pursuant to that agreement,
the DOJ agreed not to prosecute the Company for the conduct disclosed to the
DOJ, and the Company agreed to various conditions, including establishing
policies and procedures to assure compliance with the FCPA and other relevant
anti-bribery laws, retaining an independent law firm to act as a monitor for
purposes of reporting to the DOJ for a period of three years as to its
compliance with the DOJ Agreement and to monitor its implementation of and
adherence to FCPA compliance policies and procedures, and fully cooperating with
the DOJ, the independent monitor, and the SEC.
Table of Contents
The
monitor filed his final report with the DOJ in May 2008, and in July 2008, the
DOJ confirmed that the monitorship had concluded. The Company has reaffirmed its
commitment to take all reasonable steps to ensure that it remains in
compliance with the FCPA.
The
payments made to physicians in France, Germany, Spain and Turkey also may likely
have violated the applicable laws in those foreign jurisdictions. The
Company has not
been notified by the authorities in France, Germany, Spain or Turkey whether or
not such authorities intend to bring any action or impose any penalties on us
relating to our activities in their respective countries. Therefore, we are
unable to determine at this time what penalties or other sanctions, if
any, such authorities may impose as a result of such violations. Such amounts
could be material to the financial position, results of operations or cash flows
of the Company.
Patent
litigation
In
September 2004, Boston Scientific Corporation and Target Therapeutics, Inc., a
subsidiary of Boston Scientific Corporation, (collectively “Boston Scientific”),
filed a patent infringement suit in the United States District Court for the
Northern District of California, alleging that the Company’s embolic coil
products infringe two patents (United States Patent Nos. 5,895,385 (the “’385
Patent”) and 6,010,498 (the “’498 Patent”)) owned by the Regents of the
University of California (the “Regents”) and exclusively licensed to Boston
Scientific and that this infringement is willful. Sales of the Company’s embolic
coil products currently represent approximately 94% of the Company’s revenues.
Boston Scientific is a large, publicly-traded corporation with significantly
greater financial resources than the Company.
In
November 2004, the Company answered Boston Scientific’s complaint and
counterclaimed, alleging that Boston Scientific’s embolic coil products, and
their use, infringe three of the Company’s patents. In addition, the Company
alleged that Boston Scientific has violated United States antitrust laws, and
has violated certain California state laws by committing unfair business
practices, disparaging its products, and interfering with its prospective
economic advantage. Each party seeks an injunction preventing the making, using,
selling, offering to sell, importing into the United States or exporting from
the United States, of the other’s embolic coil products in the United States,
damages for past infringement, which may be trebled, and payment of its legal
fees and costs. In addition, each party seeks a declaration that the patents of
the other are invalid and not infringed and has alleged that certain of the
asserted patents of the other are unenforceable due to inequitable
conduct.
In
January 2005, Boston Scientific filed a motion to dismiss the Company claims for
disparagement, interference with prospective economic advantage and unfair
business practices. In June 2008, the court issued an order dismissing these
claims without prejudice and granting the Company leave to amend its
counterclaims. The Company filed amended counterclaims in July 2008. Boston
Scientific has not responded to the Company’s amended
counterclaims.
In
November 2006, the Company withdrew one of its three asserted patents from the
litigation to pursue a reissue application filed with the United States Patent
and Trademark Office (“USPTO”).
A hearing
on claim construction was held in June 2007. In March 2008, the Court issued an
order construing certain claim terms of patents that were asserted by Boston
Scientific against Micrus or asserted by Micrus against Boston Scientific. On
April 23, 2008, the district court entered a scheduling order on future
events in this action, including the close of all discovery on January 26,
2009. A trial date has not been set by the district court.
Boston
Scientific has also been a party in two other lawsuits against Cordis and Micro
Therapeutics, Inc./ev3, Inc./Dendron GmbH (collectively “MTI”) in which the two
Boston Scientific patents asserted against the Company are or were also at
issue. An outcome of either of these lawsuits adverse to Cordis or MTI, and
related to the same patent claims Boston Scientific asserts against the Company,
could have an adverse impact on certain of the Company defenses in its
litigation with Boston Scientific.
According
to court records, the Regents, Boston Scientific and MTI entered into a
settlement agreement on March 21, 2008, and on April 4, 2008 the
Regents, Boston Scientific and MTI dismissed the action, including all claims
and counter-claims, with prejudice.
On
January 18, 2008, in the Cordis case, the district court granted Boston
Scientific’s motion for summary judgment that Cordis’ TRUFILL Detachable Coil
System infringed claim 7 of the ’385 Patent under the doctrine of equivalents.
On January 25, 2008, the district court granted Boston Scientific’s motion
for summary judgment against Cordis that claims 10 and 35 of the ’385 patent,
and claims 1, 3, 7, 9, and 10 of the ’498 patent, are not invalid for having
been on-sale or in public use before the statutory bar period. On March 21,
2008, the district court granted-in-part Boston Scientific’s motion for
summary judgment that the ’385 patent and ’498 patent are not unenforceable for
inequitable conduct. The district court also denied-in-part Boston
Scientific’s motion on the ground that triable issues of fact remained
concerning the patent applicants’ representations to the patent examiner during
the application process. The district court’s determinations on the validity and
enforceability of the ’385 and ’498 patents are important because
Boston
Scientific is asserting these same patents against the Company in its lawsuit
and the Company is alleging that these patents are invalid and
unenforceable.
In
October 2004, Cordis requested ex parte reexamination of
certain claims in Boston Scientific’s ’385 and ’498 patents. In April 2007, the
USPTO issued a Notice of Intent to Issue Ex Parte Reexamination Certificate for
the ’498 patent, apparently confirming all of the claims of that patent. In
December 2006, the USPTO issued a Notice of Allowance for the ’385 patent in
which it apparently confirmed the patentability of the claims in that
patent.
The
Company is currently in the process of negotiating a
settlement with Boston Scientific and the U.C. Regents (which licensed some of
the patents-in-suit to Boston Scientific but is not a party to the
lawsuit). These negotiations currently contemplate the issuance by
the Company of approximately $1.7 million in stock that would accompany patent
cross-licenses between the Company and Boston Scientific. The accrued
cost of approximately $1.7 million in connection with the tentative settlement
of patent litigation with Boston Scientific was recorded as general
and administrative expense in the first quarter of fiscal 2009. This
issuance of stock, together with a payment of approximately $1.0 million by
Boston Scientific to the U.C. Regents, would be made to the U.C. Regents to
satisfy the Regents' claim related to these patents. However, there can be
no assurance that a settlement agreement will be finalized on these or any
terms.
Note 7 — Stock-based
Compensation
Stock
options
The
Company’s stock option program is a long-term retention program that is intended
to attract, retain and provide incentives for talented employees, officers and
directors, and to align stockholder and employee interests. The Company
considers the stock option program critical to its operations and productivity.
As of June 30, 2008, the Company has three stock option plans: the 1996 Stock
Option Plan (the “1996 Plan”), the 1998 Stock Plan (the “1998 Plan”), and the
2005 Equity Incentive Plan (the “2005 Plan”). Currently, the Company grants
options from the 2005 Plan, which permits the Company to grant options to all
employees, including executive officers, and outside consultants, and directors.
Effective June 16, 2005, no new options may be granted under the 1996 Plan or
the 1998 Plan. As of June 30, 2008, there were no outstanding options under the
1996 Plan and 1,056,976 outstanding options under the 1998 Plan. As of June 30,
2008, there were 4,304,313 remaining shares reserved for issuance under the 2005
Plan, of which 1,262,841 were available for grant, 3,038,139 shares were subject
to outstanding options and 3,333 shares were subject to outstanding restricted
stock units. Stock options issued under the Company’s stock option plans
generally vest based on 4 years of continuous service and have 10-year
contractual terms.
2005
Employee stock purchase plan
The 2005
Employee Stock Purchase Plan (the “Purchase Plan”) became effective upon the
Company’s initial public offering. The Purchase Plan provides employees with an
opportunity to purchase the Company’s common stock through accumulated payroll
deductions. As of June 30, 2008, there were 678,572 shares reserved for issuance
under the Purchase Plan.
Stock-based
compensation
On April
1, 2006, the Company adopted the provisions of SFAS 123R. The Company’s
financial statements for the three months ended June 30, 2008 and 2007 reflect
the impact of SFAS 123R. The Company currently uses the Black-Scholes option
pricing model to determine the fair value of employee stock options and employee
stock purchase plan shares. The determination of the fair value of employee
stock options and employee stock purchase plan shares has been estimated using
the following weighted-average valuation assumptions:
Table of Contents
|
|
Three
months ended
|
|
|
|
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
Employee
Stock Option Plans
|
|
|
|
|
|
|
Expected
term (in years)
|
|
|
6 |
|
|
|
6 |
|
Volatility
|
|
|
35 |
% |
|
|
42 |
% |
Risk-free
interest rate
|
|
|
3.3 |
% |
|
|
4.8 |
% |
Expected
dividend yield
|
|
|
0 |
% |
|
|
0 |
% |
Weighted
average fair value at date of grant
|
|
$ |
4.52 |
|
|
$ |
10.96 |
|
|
|
|
|
|
|
|
|
|
Employee
Stock Purchase Plan
|
|
|
|
|
|
|
|
|
Expected
term (in years)
|
|
|
0.5 |
|
|
|
0.5 |
|
Volatility
|
|
|
49 |
% |
|
|
41 |
% |
Risk-free
interest rate
|
|
|
3.0 |
% |
|
|
5.1 |
% |
Expected
dividend yield
|
|
|
0 |
% |
|
|
0 |
% |
The fair
value of each purchase right granted under the Company’s Purchase Plan during
the three months ended June 30, 2008 and 2007 was estimated at the date of grant
using the Black-Scholes option pricing model, and is not subject to revaluation
as a result of subsequent stock price fluctuations.
The
stock-based compensation expense related to SFAS 123R is as follows (in
thousands):
|
|
Three
months ended
|
|
|
|
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
Cost
of goods sold
|
|
$ |
117 |
|
|
$ |
110 |
|
Research
and development
|
|
|
169 |
|
|
|
112 |
|
Sales
and marketing
|
|
|
441 |
|
|
|
240 |
|
General
and administrative
|
|
|
822 |
|
|
|
535 |
|
Total
|
|
$ |
1,549 |
|
|
$ |
997 |
|
Additionally,
approximately $178,000 and $115,000 in stock-based compensation expense related
to SFAS 123R has been capitalized in inventory as of June 30, 2008 and 2007,
respectively.
As of
June 30, 2008, there was approximately $14.1 million of total stock-based
compensation expense, after estimated forfeitures, related to unvested employee
stock options and restricted stock units, which is expected to be recognized
over an estimated weighted average amortization period of 2.7
years.
Stock-based
compensation expense recognized for the three months ended June 30, 2008 and
2007 related to the amortization of deferred stock-based compensation was $0 and
$53,000, respectively. The Company had fully recognized amortization of deferred
stock-based compensation in the fourth quarter ending March 31,
2008.
Stock-based
compensation expense recognized for the three months ended June 30, 2008 and
2007 related to non-employee options was $0 and $6,000, respectively. There were
no unvested non-employee options for the three months ended June 30,
2008.
Table of Contents
Total
stock-based compensation expense included in the results of operations is as
follows (in thousands):
|
|
Three
months ended
|
|
|
|
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
Cost
of goods sold
|
|
$ |
117 |
|
|
$ |
116 |
|
Research
and development
|
|
|
169 |
|
|
|
112 |
|
Sales
and marketing
|
|
|
441 |
|
|
|
245 |
|
General
and administrative
|
|
|
822 |
|
|
|
583 |
|
Total
|
|
$ |
1,549 |
|
|
$ |
1,056 |
|
General
stock option information
The
following table sets forth the summary of stock options activity for the three
months ended June 30, 2008:
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
Aggregate |
|
|
|
|
|
|
Exercise
|
|
|
Contractual
|
|
|
Intrinsic
|
|
|
|
Shares
|
|
|
Price
|
|
|
Term
|
|
|
Value
|
|
|
|
(in
thousands)
|
|
|
|
|
|
(in
years)
|
|
|
(in
thousands)
|
|
Options
outstanding at March 31, 2008
|
|
|
3,656 |
|
|
$ |
13.02 |
|
|
|
|
|
|
|
Options
granted
|
|
|
528 |
|
|
$ |
11.35 |
|
|
|
|
|
|
|
Options
exercised
|
|
|
(31 |
) |
|
$ |
9.81 |
|
|
|
|
|
|
|
Options
forfeited
|
|
|
(39 |
) |
|
$ |
15.08 |
|
|
|
|
|
|
|
Options
expired
|
|
|
(19 |
) |
|
$ |
7.31 |
|
|
|
|
|
|
|
Options
outstanding at June 30, 2008
|
|
|
4,095 |
|
|
$ |
12.83 |
|
|
|
8.0 |
|
|
$ |
13,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
exercisable at June 30, 2008
|
|
|
1,851 |
|
|
$ |
9.83 |
|
|
|
7.0 |
|
|
$ |
9,668 |
|
The total
aggregate intrinsic value of options exercised during the three months ended
June 30, 2008 and 2007 was $90,000 and $1.4 million, respectively. The closed
market value per share of the Company’s common stock as of June 30, 2008 was
$14.02 per share as reported by The NASDAQ Stock Market.
The
following table sets forth the summary of restricted stock units activity for
the three months ended June 30, 2008:
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
|
|
|
|
|
|
|
Exercise
|
|
|
Contractual
|
|
|
Aggregate
|
|
|
|
Shares
|
|
|
Price
|
|
|
Term
|
|
|
Intrinsic
Value
|
|
|
|
(in
thousands)
|
|
|
|
|
|
(in
years)
|
|
|
(in
thousands)
|
|
Non-vested
restricted stock units at March 31, 2008
|
|
|
7 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Awarded
|
|
|
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Released
|
|
|
(3 |
) |
|
$ |
- |
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Non-vested
restricted stock units at June 30, 2008
|
|
|
4 |
|
|
$ |
- |
|
|
|
1.0 |
|
|
$ |
47 |
|
Note 8 — Segment and Geographic
Information
Revenues
from unaffiliated customers by geographic area, based on the customer’s shipment
locations were as follows (in thousands):
|
|
Three
months ended
|
|
|
|
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
United
States
|
|
$ |
8,696 |
|
|
$ |
8,666 |
|
Japan
|
|
|
1,874 |
|
|
|
1,139 |
|
United
Kingdom
|
|
|
1,943 |
|
|
|
2,255 |
|
Rest
of the world
|
|
|
5,811 |
|
|
|
4,730 |
|
Total
revenues
|
|
$ |
18,324 |
|
|
$ |
16,790 |
|
The
Company’s long lived assets by geographic area were as follows (in
thousands):
|
|
June
30,
|
|
|
March
31,
|
|
|
|
2008
|
|
|
2008
|
|
United
States
|
|
$ |
5,382 |
|
|
$ |
4,907 |
|
United
Kingdom
|
|
|
120 |
|
|
|
124 |
|
Rest
of the world
|
|
|
269 |
|
|
|
254 |
|
|
|
$ |
5,771 |
|
|
$ |
5,285 |
|
The
Company identifies its operating segments based on how management views and
evaluates the Company’s operations, which is primarily based on geographic
location. The Company has determined it operates in four business segments,
the Americas, Europe (excluding the United Kingdom), the United Kingdom and Asia
Pacific. The products and services sold by each segment are substantially the
same and the Company evaluates performance and allocates resources primarily
based on revenues and gross profit. Prior to the Company's annual report on Form
10-K for the fiscal year ended March 31, 2008, the Company's Europe
(excluding the United Kingdom) and the United Kingdom segments were aggregated
as a single business segment. Prior year information in the tables that follow
have been restated to conform with the current year classification.
Revenues
and gross profit for these segments were as follows (in thousands):
|
|
Three
months ended
|
|
|
|
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
Revenues:
|
|
|
|
|
|
|
Americas
|
|
$ |
10,533 |
|
|
$ |
9,474 |
|
Europe
(excluding the United Kingdom)
|
|
|
3,702 |
|
|
|
3,613 |
|
United
Kingdom
|
|
|
1,943 |
|
|
|
2,255 |
|
Asia
Pacific
|
|
|
2,146 |
|
|
|
1,448 |
|
Total
|
|
$ |
18,324 |
|
|
$ |
16,790 |
|
Gross
Profit:
|
|
|
|
|
|
|
|
|
Americas
|
|
$ |
8,141 |
|
|
$ |
7,950 |
|
Europe
(excluding the United Kingdom)
|
|
|
2,681 |
|
|
|
2,464 |
|
United
Kingdom
|
|
|
1,522 |
|
|
|
1,728 |
|
Asia
Pacific
|
|
|
1,387 |
|
|
|
913 |
|
Total
|
|
$ |
13,731 |
|
|
$ |
13,055 |
|
Table of Contents
The
Company’s total assets by operating segment were as follows (in
thousands):
|
|
June
30,
|
|
|
March
31,
|
|
|
|
2008
|
|
|
2008
|
|
Americas
|
|
$ |
42,868 |
|
|
$ |
52,043 |
|
Europe
(excluding the United Kingdom)
|
|
|
6,273 |
|
|
|
7,265 |
|
United
Kingdom
|
|
|
13,048 |
|
|
|
13,024 |
|
|
|
$ |
62,189 |
|
|
$ |
72,332 |
|
Item 2.
Management’s Discussion and Analysis of Financial Conditions and
Results of
Operations.
The following discussion and
analysis of the financial condition and results of operations of the Company
should be read in conjunction with the condensed consolidated financial
statements and the related notes included elsewhere in this report, and with
other factors described from time to time in our other filings with the
Securities and Exchange Commission. This Quarterly Report on Form 10-Q contains
forward-looking statements that involve risks and uncertainties. Actual results and
the timing of events may differ materially from those contained in the
forward-looking statements due to a number of factors, including those discussed
in Part II, Item 1A “Risk Factors” in this Quarterly Report on Form
10-Q.
Overview
We
develop, manufacture and market implantable and disposable medical devices used
in the treatment of cerebral vascular diseases. Our products are used by
interventional neuroradiologists, interventional neurologists and neurosurgeons
to treat both cerebral aneurysms responsible for hemorrhagic stroke and
intracranial atherosclerosis, which may lead to ischemic stroke. Hemorrhagic and
ischemic stroke are both significant causes of death and disability worldwide.
Our product lines consist of endovascular systems that enable a physician to
gain access to the brain in a minimally invasive manner through the vessels of
the arterial system. We believe our products provide a safe and reliable
alternative to more invasive neurosurgical procedures for treating aneurysms.
Our proprietary three-dimensional, embolic coils automatically and rapidly
deploy within an aneurysm, forming a scaffold that conforms to a wide diversity
of aneurysm shapes and sizes. We also supply accessories for use with our
microcoils and other products for the treatment of neurovascular disease
including microcatheters, guidewires and stents. We plan on growing our business
by continuing to penetrate our existing hemorrhagic and ischemic stroke markets,
bringing new products and technologies to interventional neuroradiologists,
interventional neurologists and neurosurgeons, and by entering new geographic
territories such as Asia where we commenced selling our products in Japan
through our distribution partner, Goodman, Co., LTD (“Goodman”), in March 2006.
Additionally, on July 31, 2007, we entered into an exclusive distribution
agreement with Beijing Tianxinfu Medical Appliances Co., LTD (“TXF Medical”) to
market our products in China upon receiving regulatory approvals.
Our
revenues are derived primarily from sales of our microcoils. We also sell
stents, access products and accessories for use with our microcoils, which
accounted for approximately 4% and 5% of our revenues in the first quarter of
fiscal 2009 and 2008, respectively. Geographically, our revenues are generally
from sales to customers in the Americas, Europe and Asia. Our products are
shipped from our facilities in the United States, Switzerland, the United
Kingdom, and a logistics facility in the Netherlands, to either hospitals or
distributors. We invoice our customers upon shipment. In select hospitals, our
products are held on consignment, and remain on site, free of charge until
used.
We
anticipate that our cost of goods sold will generally increase in absolute
dollars during those quarters in which our sales increase or we incur additional
manufacturing costs in anticipation of the commercial introduction of new
products. Furthermore, our gross margin percentage may decrease in those
quarters in which we initiate sales of new products or product lines, or enter
new geographic territories.
Table of Contents
Our
product development efforts are primarily focused on expanding our current line
of microcoils and broadening our product offerings in the hemorrhagic and
ischemic stroke markets. In August 2004, we introduced our Cerecyte® microcoil
product line and we have launched six new products in the last 24 months,
including microcoils, stents, microcatheters and guidewires. During the first
quarter of fiscal 2009, we began beta evaluation on two new products — the
DeltaPaq™ microcoil system and Neuropath Guidecatheter. The DeltaPaq microcoil
system is a new product line of our microcoil intended for endovascular
embolization of intracranial aneurysms, other neurovascular abnormalities and
are also intended for arterial and venous embolizations in the peripheral
vasculature. The Neuropath Guidecatheter is used as a conduit for delivery of
the microcatheter or other devices to the aneurysm. We intend to continue this
product line expansion with the goal of continuing to increase our per-procedure
revenue.
In
June 2008, we obtained CE Mark authorization for our PHAROS™ Vitesse™
intracranial stent for commercial distribution in the European Union and all
other countries recognizing the CE Mark. The PHAROS Vitesse is our second
generation balloon-expandable stent for intracranial ischemic stenosis and
wide-neck aneurysm treatment. We will begin selling the PHAROS Vitesse stent in
the approved geographies through our direct sales and distribution networks in
the second quarter of fiscal 2009. Additionally, we plan to pursue regulatory
authorization in the United States (“U.S.”) for our PHAROS Vitesse
stent, which we believe represents a significant market opportunity for us. We
have received U.S. Food and Drug Administration conditional approval of our
PHAROS Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) clinical
trial designed to compare the clinical outcomes between patients treated with
our stent and another medical therapy. We are in the process of initiating study
sites in the United States, Europe and China.
We also
intend to continue to expand our direct sales force in the North America and
Europe as necessary and enter the Asian markets through distributors. In March
2006, we launched our sales and marketing efforts in Japan through our
distribution partner, Goodman. In December 2007, we received regulatory approval
to sell our stretch-resistant microcoils in Japan, and in July 2008, we received
regulatory approval to sell our Cerecyte microcoils in Japan. We recorded
product sales to Goodman of $1.9 million and $1.1 million in the first
quarter of fiscal 2009 and 2008, respectively. We are also preparing to enter
China and have selected TXF Medical to be our distributor in China. We will
begin selling our products in China upon receiving regulatory approvals.
However, the timing of these approvals are uncertain due to a pending review by
the Chinese State Food and Drug Administration (SFDA) of drug and medical device
approvals granted during the term of the former SFDA minister. We believe this
review process along with more stringent approval procedures will delay review
and approval of applications for new products. As a result, we did not recognize
revenues from sales in China in the first quarter of fiscal 2009. We do not
expect to recognize revenues from sales in China this fiscal year.
We
currently anticipate that the broadening of our product line, the worldwide
expansion of our direct sales force and our entry into the Asian market will be
primarily funded with our currently available cash and cash expected to be
generated from product sales.
We
introduced our first proprietary, three-dimensional microcoil in May 2000. Our
revenues have grown from $1.8 million in fiscal 2001 to $69.2 million
in fiscal 2008. Our revenues were $18.3 million in the first quarter of fiscal
2009.
Since
inception, we have been unprofitable. We have incurred net losses of $8.3
million in fiscal 2006, $5.5 million in fiscal 2007, $16.3 million in fiscal
2008 and $6.6 million in the first quarter of fiscal 2009. As of June 30, 2008,
we had cash and cash equivalents of $16.9 million. We believe that our
current cash position and the cash expected to be generated from product sales
will be sufficient to meet our working capital and capital expenditure
requirements for at least the next twelve months. There is no assurance that we
will be profitable in the foreseeable future as we expand our research and
development, manufacturing, and sales activities and expand geographically. As
of June 30, 2008, we had an accumulated deficit of
$78.0 million.
Table of Contents
Results
of Operations
The
following table sets forth the results of our operations, expressed as
percentages of revenues, for the three months ended June 30, 2008 and
2007:
|
|
Three
months ended
|
|
|
|
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
Consolidated
Statements of Operations Data:
|
|
|
|
|
|
|
Revenues
|
|
|
100 |
% |
|
|
100 |
% |
Cost
of goods sold
|
|
|
25 |
% |
|
|
22 |
% |
Gross
profit
|
|
|
75 |
% |
|
|
78 |
% |
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
17 |
% |
|
|
12 |
% |
Sales
and marketing
|
|
|
44 |
% |
|
|
39 |
% |
General
and administrative
|
|
|
52 |
% |
|
|
37 |
% |
Total
operating expenses
|
|
|
113 |
% |
|
|
88 |
% |
Loss
from operations
|
|
|
(38 |
%) |
|
|
(10 |
%) |
Interest
income
|
|
|
1 |
% |
|
|
2 |
% |
Interest
expense
|
|
|
0 |
% |
|
|
0 |
% |
Other
income (expense), net
|
|
|
0 |
% |
|
|
1 |
% |
Loss
before income taxes
|
|
|
(37 |
%) |
|
|
(7 |
%) |
Provision
(benefit) for income taxes
|
|
|
(1 |
%) |
|
|
1 |
% |
Net
loss
|
|
|
(36 |
%) |
|
|
(8 |
%) |
Accretion
of redeemable convertible preferred stock to
|
|
|
|
|
|
|
|
|
Three
Months Ended June 30, 2008 and 2007
Revenues
|
|
Three
months ended
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
Change
|
|
|
|
2008
|
|
|
2007
|
|
|
$ |
|
|
|
% |
|
|
|
(Dollars
in thousands)
|
|
|
|
|
|
Americas
|
|
$ |
10,533 |
|
|
$ |
9,474 |
|
|
$ |
1,059 |
|
|
|
11 |
% |
Europe
(excluding the United Kingdom)
|
|
|
3,702 |
|
|
|
3,613 |
|
|
|
89 |
|
|
|
2 |
% |
United
Kingdom
|
|
|
1,943 |
|
|
|
2,255 |
|
|
|
(312 |
) |
|
|
(14 |
%) |
Asia
Pacific
|
|
|
2,146 |
|
|
|
1,448 |
|
|
|
698 |
|
|
|
48 |
% |
Total
Revenues
|
|
$ |
18,324 |
|
|
$ |
16,790 |
|
|
$ |
1,534 |
|
|
|
9 |
% |
Our
revenues are derived primarily from sales of our microcoils used in the
treatment of cerebral vascular diseases. The overall increase in revenues in the
first quarter of fiscal 2009 compared to the first quarter of fiscal 2008 was
primarily due to an increase in the number of microcoil products sold during
this period. Factors driving the increase included growth in the overall market
for embolic coils, an increase in our share of both the domestic and foreign
markets in which we participate, expansion of our direct and distributor sales
force and the introduction of new products.
Table of Contents
Revenues
from embolic coils increased 11% to $17.5 million for the first quarter of
fiscal 2009 as compared to the first quarter of fiscal 2008 primarily due to the
increased market penetration of the Cashmere™ microcoil system launched in
the third quarter of fiscal 2008 and an increase in distributor sales primarily
in Japan and Latin America. Revenues from Asia Pacific increased to $2.1 million
in the first quarter of fiscal 2009 and included product sales to our
distributor in Japan of $1.9 million, compared with revenues of $1.4 million in
the first quarter of fiscal 2008 which included sales of $1.1 million to our
distributor in Japan. In December 2007, we received regulatory approval to sell
our stretch-resistant microcoils in Japan which had a favorable impact on
product sales to our distributor in Japan in the quarter. Revenues from Latin
America increased to $1.3 million in the first quarter of fiscal 2009
compared with revenues of $374,000 in the first quarter of fiscal 2008 primarily
due to the recognition of approximately $0.7 million in the quarter
resulting from a change in our revenue recognition policy for sales made to
Latin American distributors from a cash collection basis to upon shipment basis
(see Note 2 in Notes to Condensed Consolidated Financial Statements) and an
overall increase in product sales to our distributors in the region. Procedure
volume in the United Kingdom slowed in the first quarter of fiscal 2009,
resulting in a decline in revenue to $1.9 million compared with revenues of $2.3
million in the first quarter of fiscal 2008. Revenues from our non-embolic and
accessories products were $0.8 million in the first quarter of fiscal 2009
compared with revenues of $0.9 million in the first quarter of fiscal 2008. We
expect our embolic and non-embolic sales to increase in the future as a result
of market growth, continued market penetration of products released during the
past two years and our planned launch of the next-generation microcoil system
and an occlusion balloon catheter family. Products introduced in the past
24 months comprised 22% of our revenues in the first quarter of fiscal
2009.
In July
2008, we received regulatory approval to sell our Cerecyte microcoils in
Japan, and we will begin shipping these products to Goodman in the second
quarter of fiscal 2009. We will also begin selling our products in China upon
receiving regulatory approvals. However, the timing of product approvals in
China will be delayed due to a pending review by the SFDA of drug and medical
device approvals granted during the term of the former SFDA minister. We
currently believe this review process along with more stringent approval
procedures will delay review and approval of applications for new products. As a
result, we did not recognize revenues from sales in China in the first quarter
of fiscal 2009. We do not expect to recognize revenues from sales in China this
fiscal year.
Gross
Profit
|
|
Three
months ended
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
Change
|
|
|
|
2008
|
|
|
2007
|
|
|
$ |
|
|
|
% |
|
|
|
(Dollars
in thousands)
|
|
|
|
|
|
Cost
of goods sold
|
|
$ |
4,593 |
|
|
$ |
3,735 |
|
|
$ |
858 |
|
|
|
23 |
% |
Gross
profit
|
|
$ |
13,731 |
|
|
$ |
13,055 |
|
|
$ |
676 |
|
|
|
5 |
% |
|
|
Cost of
goods sold consists primarily of materials, direct labor, depreciation, overhead
costs associated with manufacturing, impairments of inventory, warranty
expenses, amortization of intangible assets that were acquired by us as part of
the acquisition of VasCon, LLC (“VasCon”), amortization of capitalized license
technology associated with our PHAROS stent product and royalties related
to certain access device products. The increase in cost of goods sold during the
first quarter of fiscal 2009 as compared to the first quarter of fiscal 2008 was
primarily related to the increase in sales of our products.
Gross
margin was 75% in the first quarter of fiscal 2009 and 78% in the first quarter
of fiscal 2008. The decrease was primarily due to higher sales to distributors
at lower margins primarily in Japan and Latin America. We expect our gross
margin to fluctuate in future periods based on the mix of our product sales and
the level of distributor sales.
Table of Contents
Operating
Expenses
Research
and Development
|
|
Three
months ended
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
Change
|
|
|
|
2008
|
|
|
2007
|
|
|
$ |
|
|
|
% |
|
|
|
(Dollars
in thousands)
|
|
|
|
|
|
Research
and development
|
|
$ |
2,973 |
|
|
$ |
1,965 |
|
|
$ |
1,008 |
|
|
|
51 |
% |
Research
and development expenses consist primarily of costs associated with the design,
development, and testing of new products. Such costs are expensed as they are
incurred and include salaries and related personnel costs, fees paid to outside
consultants, and other direct and indirect costs related to research and product
development. Research and development expenses increased in the first quarter of
fiscal 2009 compared to the first quarter of fiscal 2008 primarily due to an
increase of $498,000 related to increased headcount and an increase of $321,000
related to product testing, outside services and supplies.
Sales
and Marketing
|
|
Three
months ended
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
Change
|
|
|
|
2008
|
|
|
2007
|
|
|
$ |
|
|
|
% |
|
|
|
(Dollars
in thousands)
|
|
|
|
|
|
Sales
and marketing
|
|
$ |
8,118 |
|
|
$ |
6,510 |
|
|
$ |
1,608 |
|
|
|
25 |
% |
Sales and
marketing expenses consist primarily of compensation costs of our direct sales
force and marketing personnel, as well as overhead costs related to these
activities. Also included are costs associated with promotional literature and
videos, trade show participation, and education and training of physicians.
Sales and marketing expenses increased in the first quarter of fiscal 2009
compared to the first quarter of fiscal 2008 primarily due to an increase of
$0.6 million in travel, recruiting and personnel costs due to an increase in
sales and marketing personnel in the North America, Europe and Asia, an increase
of $420,000 in sales incentives resulting from the higher level of sales and
changes in the sales compensation structure, an increase of $197,000 in trade
show, meeting and conference costs, as well as an increase of $196,000 in
stock-based compensation expense.
General
and Administrative
|
|
Three
months ended
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
Change
|
|
|
|
2008
|
|
|
2007
|
|
|
$ |
|
|
|
% |
|
|
|
(Dollars
in thousands)
|
|
|
|
|
|
General
and administrative
|
|
$ |
9,562 |
|
|
$ |
6,276 |
|
|
$ |
3,286 |
|
|
|
52 |
% |
General
and administrative expenses consist primarily of compensation and related costs
for finance, human resources, regulatory, insurance, and professional
services. Professional services are principally comprised of outside legal,
audit and Sarbanes Oxley compliance. General and administrative expenses
increased in the first quarter of fiscal 2009 compared to the first quarter of
fiscal 2008 primarily due to the accrued costs of approximately $1.7
million in connection with the tentative settlement of patent litigation with
Boston Scientific, an increase of $0.7 million related to higher finance
and administrative personnel costs due to increased headcount, an increase of
$335,000 in legal fees primarily related to professional fees for the services
of attorneys and third-party accountants in connection with the United States
Department of Justice monitorship, which has now concluded and an increase of
$239,000 in stock-based compensation expense.
Other
Income, Net
Other
income, net consists primarily of interest and investment income and foreign
currency gains and losses. Total other income, net decreased in the first
quarter of fiscal 2009 compared to the first quarter of fiscal 2008 primarily
due to a decrease in interest income resulting from lower average cash and cash
equivalent balances earning interest.
|
|
Three
months ended
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
Change
|
|
|
|
2008
|
|
|
2007
|
|
|
$ |
|
|
|
% |
|
|
|
(Dollars
in thousands)
|
|
|
|
|
|
Interest
income
|
|
$ |
110 |
|
|
$ |
360 |
|
|
$ |
(250 |
) |
|
|
(69 |
%) |
Interest
expense
|
|
|
(4 |
) |
|
|
- |
|
|
|
(4 |
) |
|
|
0 |
% |
Other
income (expense), net
|
|
|
(2 |
) |
|
|
78 |
|
|
|
(80 |
) |
|
|
(103 |
%) |
Total
other income, net
|
|
$ |
104 |
|
|
$ |
438 |
|
|
$ |
(334 |
) |
|
|
(76 |
%) |
Income
Taxes
We have
incurred net operating losses for both federal and state purposes since
inception and, as a result, we have paid no federal or state income tax. For the
three months ended June 30, 2008, we recorded an income tax benefit of
approximately $216,000. The income tax benefit for the three months ended June
30, 2008 includes income tax benefit of $150,000 related to net operating losses
for our Swiss subsidiary, and a non-current tax benefit of approximately $66,000
for the tax effect of the amortization related to the
identifiable intangible assets acquired in the Neurologic transaction which
are amortized for tax purposes and the tax benefit from net operating losses for
our United Kingdom subsidiary.
As of
March 31, 2008, we had federal, state and foreign net operating loss
carryforwards (“NOLs”) that are available to reduce future taxable income of
approximately $42.5 million, $27.6 million and $1.6 million, respectively. The
federal NOLs will expire at various dates beginning in 2012, state NOLs will
expire beginning in 2013 and the foreign NOLs will expire beginning in 2013. We
also have federal and state tax research and development credit carryforwards of
approximately $1.2 million and $1.1 million, respectively. The federal tax
credit carryforwards will expire beginning in 2012. The state tax credit
carryforwards can be carried forward indefinitely. Due to the uncertainty of our
ability to generate sufficient taxable income to realize the carryforwards prior
to their expiration, we have recorded a valuation allowance at June 30, 2008 to
offset our federal and state deferred tax assets.
Since the
implementation of FIN 48, we have recognized a $232,000 increase in our
unrecognized tax benefits. We do not expect our unrecognized tax benefits to
change significantly over the next twelve months. At June 30, 2008, we had no
accrued interest or penalties related to tax contingencies.
Liquidity
and Capital Resources
|
|
Three
months ended
|
|
|
|
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(in
thousands)
|
|
Cash
flow activities:
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
$ |
(4,291 |
) |
|
$ |
(3,753 |
) |
Net
cash used in investing activities
|
|
$ |
(4,675 |
) |
|
$ |
(2,719 |
) |
Net
cash provided by financing activities
|
|
$ |
302 |
|
|
$ |
522 |
|
Table of Contents
Since our
inception, we have funded our operations primarily through issuances of stock
and related warrants.
As of
June 30, 2008, we had cash and cash equivalents of $16.9 million, compared to
$25.5 million at March 31, 2008. We believe that our current cash position and
the cash expected to be generated from product sales will be sufficient to meet
our working capital and capital expenditure requirements for at least the next
twelve months.
Net cash
used in operating activities was $4.3 million during the first quarter of fiscal
2009 compared to $3.8 million during the first quarter of fiscal 2008. Net cash
used in operating activities during the first quarter of fiscal 2009 resulted
primarily from operating losses, an increase in inventory due to an increase in
the number of consignment locations, an increase in the number of units in
existing consignment locations due to new products released and the buildup of
finished goods inventory in anticipation of future sales upon regulatory
approvals in Japan, a decrease in accrued payroll and related expenses
attributable to the payment of fiscal 2008 employee cash bonuses and a decrease
in other non-current liabilities primarily due to a reclass of an accrued
milestone payment from long-term to short-term. These factors were partially
offset by a decrease in accounts receivable resulting from lower revenues during
the quarter, a decrease in prepaid expense and other assets, an increase in
accounts payable due to timing of payments made to our vendors, an increase in
accrued liabilities due to a reclass of an accrued milestone payment from
long-term to short-term, and non-cash items such as unremitted issuance of stock
for tentative settlement of patent litigation, stock-based compensation expense
primarily due to SFAS 123R, depreciation and amortization, deferred tax benefit
and provision for excess and obsolete inventories.
Net cash
used in operating activities during the first quarter of fiscal 2008 resulted
primarily from operating losses, an increase in accounts receivable primarily
due to an increase in the number of microcoil products sold, an increase in
inventory due to the buildup of finished goods inventory in anticipation of
future sales and an increase in the number of consignment locations, an increase
in prepaid expenses and other current assets primarily related to the payment of
directors and officers insurance premiums, a decrease in accrued payroll and
related expenses attributable to the payment of fiscal 2007 employee cash
bonuses. These factors were partially offset by an increase in accounts payable
due to timing of payments made to our vendors, an increase in accrued
liabilities due to accrued professional fees associated with legal fees and
Sarbanes Oxley compliance and higher VAT payables, and non-cash items such as
stock-based compensation expense primarily due to SFAS 123R, depreciation and
amortization, and provision for excess and obsolete inventories.
Net cash
used in investing activities was $4.7 million during the first quarter of fiscal
2009 compared to $2.7 million during the first quarter of fiscal 2008. Net cash
used in investing activities during the first quarter of fiscal 2009 was related
to the earn-out payment associated with the purchase of Neurologic and VasCon
and the purchase of capital equipment.
Net cash
used in investing activities during the first quarter of fiscal 2008 was
primarily related to the earn-out payment associated with the purchase of
Neurologic and the purchase of capital equipment.
Net cash
provided by financing activities was $302,000 during the first quarter of fiscal
2009 compared to $522,000 during the first quarter of fiscal 2008. Net cash
provided by financing activities during the first quarter of fiscal 2009 and
2008 consisted of proceeds from the exercise of stock options.
To the
extent that existing cash and cash generated from operations are insufficient to
fund our future activities, we may need to raise additional funds through public
or private equity or debt financing. Although we are currently not a party to
any definitive agreement with respect to potential investments in, or
acquisitions of, complementary businesses, services or technologies, we may
enter into such agreements in the future, which could require us to seek
additional funds through public or private equity or debt financing. Additional
funds may not be available on terms favorable to us or at all.
Table of Contents
Critical
Accounting Policies and Estimates
We
prepare our consolidated financial statements in accordance with accounting
principles generally accepted in the United States (GAAP). In doing so, we have
to make estimates and assumptions that affect our reported amounts of assets,
liabilities, revenues and expenses, as well as related disclosure of contingent
assets and liabilities. In many cases, we could reasonably have used different
accounting policies and estimates. In some cases, changes in the accounting
estimates are reasonably likely to occur from period to period. Accordingly,
actual results could differ materially from our estimates. To the extent that
there are material differences between these estimates and actual results, our
financial condition or results of operations will be affected. We base our
estimates on past experience and other assumptions that we believe are
reasonable under the circumstances, and we evaluate these estimates on an
ongoing basis. We refer to accounting estimates of this type as critical
accounting policies and estimates, which we discuss below. Our management has
reviewed our critical accounting policies and estimates with our accounting
advisors, audit committee and board of directors.
Our
significant accounting policies are fully described in Note 2 to our
Consolidated Financial Statements included in our annual report filed on Form
10-K for the fiscal year ended March 31, 2008, that was filed with the SEC on
June 12, 2008.
Recent
Accounting Pronouncements
In
December 2007, the FASB issued SFAS 141R (revised 2007), “Business
Combinations,” which replaces SFAS 141. SFAS 141R requires the acquiring entity
in a business combination to recognize at full fair value all the assets
acquired and liabilities assumed in the transaction; establishes the
acquisition-date fair value as the measurement objective for all assets acquired
and liabilities assumed; and requires the acquirer to disclose information
needed to evaluate and understand the nature and financial effect of the
business combination. SFAS 141R is effective for fiscal years beginning after
December 15, 2008 and is to be applied prospectively to business combinations
completed on or after the date of adoption. We are currently evaluating the
impact of adopting SFAS 141R on our consolidated financial position,
results of operations or cash flows.
In
February 2008, the FASB issued Financial Standard Position (“FSP”)
SFAS 157-2, “Effective Date for FASB Statement No. 157.” This FSP
permits the delayed application of SFAS 157 for all nonrecurring fair value
measurements of non-financial assets and non-financial liabilities until fiscal
years beginning after November 15, 2008. We are currently evaluating the
impact of adopting the provisions of SFAS 157 for non-financial assets and
liabilities that are recognized or disclosed on a non-recurring
basis.
In April
2008, the FASB issued FASB Staff Position (“FSP”) SFAS No. 142-3,
“Determination of the Useful Life of Intangible Assets” (“FSP SFAS 142-3”). FSP
SFAS 142-3 amends the factors that should be considered in developing renewal or
extension assumptions used to determine the useful life of a recognized
intangible asset under SFAS 142, “Goodwill and Other Intangible Assets.”
The intent of this FSP is to improve the consistency between the useful life of
a recognized intangible asset and the period of expected cash flows used to
measure the fair value of the asset under SFAS 141 (revised 2007),
“Business Combinations” and other U.S. generally accepted accounting
principles (GAAP). FSP SFAS 142-3 is effective for us on April 1,
2009. We are currently evaluating the impact of adopting FSP SFAS 142-3 on
our consolidated financial position, results of operations or cash
flows.
In May
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally
Accepted Accounting Principles” (“SFAS 162”), which becomes effective
60 days following the SEC’s approval of the Public Company Accounting
Oversight Board (“PCAOB”) amendments to US Auditing Standards (“AU”)
Section 411, “The Meaning of Present Fairly in Conformity With Generally
Accepted Accounting Principles.” SFAS 162 identifies the sources of
accounting principles and the framework for selecting the principles to be used
in the preparation of financial statements of nongovernmental entities that are
presented in conformity with US GAAP. This standard is not expected to have an
impact on our consolidated financial position, results of operations or
cash flow.
Table of Contents
Contractual
Obligations
We have
obligations under non-cancelable operating leases with various expiration dates
through 2013 and purchase commitments for inventory, capital equipment and
operating expenses, such as materials for research and development and
consulting.
As of
June 30, 2008, our contractual commitments were as follows:
|
|
Payments
Due by Period
|
|
|
|
|
|
|
Less
than
|
|
|
|
1-3 |
|
|
|
3-5 |
|
|
Beyond
|
|
Contractual
obligations:
|
|
Total
|
|
|
1
year
|
|
|
years
|
|
|
years
|
|
|
5
years
|
|
Non-cancelable
operating lease obligations
|
|
$ |
7,228 |
|
|
$ |
1,067 |
|
|
$ |
3,046 |
|
|
$ |
1,287 |
|
|
$ |
1,828 |
|
Purchase
obligations
|
|
|
4,089 |
|
|
|
4,089 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Minimum
milestone payments to The Cleveland Clinic
|
|
|
1,500 |
|
|
|
1,500 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Milestone
payment to Genesis
|
|
|
150 |
|
|
|
150 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Total
|
|
$ |
12,967 |
|
|
$ |
6,806 |
|
|
$ |
3,046 |
|
|
$ |
1,287 |
|
|
$ |
1,828 |
|
We paid
the first year earn-out amount of $378,000 associated with the purchase of
VasCon in April 2008. The future earn-out payments will be an amount not to
exceed $10.0 million based on the sales and manufacturing performance of
Micrus Design Technology, Inc. as set forth in the asset purchase
agreement.
We are
required to pay The Cleveland Clinic Foundation up to $5.0 million in
payments upon the achievement of certain milestones set forth in the stock
purchase agreement, with minimum milestone payments of at least
$2.0 million to The Cleveland Clinic Foundation upon the earlier of
achieving the milestones or October 26, 2010. The first milestone
payment in the amount of $500,000 was paid in March 2008.
Item 3. Quantitative and Qualitative Disclosures About Market
Risk.
Foreign Currency Market Risks.
Historically, we have been exposed to risks from fluctuations in currency
exchange rates due to intercompany loans made to Micrus SA, our Swiss
subsidiary, in 2001 in connection with its incorporation. These loans are
denominated in Swiss francs and will fluctuate in value against the U.S. dollar,
causing us to recognize foreign exchange gains and losses. The functional
currency of our Swiss subsidiary is the Swiss franc. The functional currency of
our UK subsidiary is the pound sterling. In Europe, our revenues are denominated
in Swiss francs, euros, pounds sterling and other currencies. Accordingly, we
are exposed to market risk related to changes between the Swiss franc and these
other currencies. If the Swiss franc appreciates against the currencies in which
our receivables are denominated, we will recognize foreign currency losses. For
the preparation of our consolidated financial statements, the financial results
of our Swiss subsidiary are translated into U.S. dollars based on average
exchange rates during the applicable period. A hypothetical 10% decline in the
value of the Swiss franc versus the U.S. dollar would cause us to recognize a
loss of $199,000 related to our loan with Micrus SA and a $67,000 decrease in
our comprehensive loss from our investment in Micrus SA as of June 30, 2008. A
hypothetical 10% decline in the value of the pound sterling versus the U.S.
dollar would cause us to recognize a $278,000 decrease in our comprehensive loss
from our investment in Micrus UK as of June 30, 2008. A hypothetical 10% decline
in the value of the Euro versus the Swiss franc would cause us to recognize a
loss of $230,000 based on our foreign denominated receivables as of June 30,
2008.
In the
first quarter of fiscal 2009, approximately 33% of our revenues were denominated
in currencies other than the U.S. dollar. In future periods, we believe a
greater portion of our revenues could be denominated in currencies other than
the U.S. dollar, thereby increasing our exposure to exchange rate gains and
losses on non-U.S. currency transactions. We do not currently enter into forward
exchange contracts to hedge exposure denominated in foreign currencies or any
other derivative financial instruments for trading or speculative purposes. In
the future, if we believe our currency exposure merits, we may consider entering
into transactions to help mitigate that risk.
Interest Rate Market Risk.
Our cash is invested in bank deposits and money market funds denominated
in U.S. dollars. The carrying value of these cash equivalents approximates fair
market value. Our investments in marketable securities are subject to interest
rate risk, which is the risk that our financial condition and results of
operations could be adversely affected due to movements in interest rates.
At June
30, 2008, our cash and cash equivalent balance was $16.9 million. Based on our
annualized average interest rate, a 10% decrease in the interest rate on such
balances would result in a reduction in interest income of approximately $40,000
on an annual basis.
Table of Contents
(1)
|
Disclosure
controls and procedures
|
Our
management, with the participation of our Chairman of the Board of Directors and
Chief Executive Officer, John T. Kilcoyne, and our Chief Financial Officer,
Gordon T. Sangster, evaluated the effectiveness of our disclosure controls and
procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act).
Based on their evaluation, they concluded that our disclosure controls and
procedures as of June 30, 2008 were effective in providing reasonable assurance
that material information relating to our company is made known to management on
a timely basis during the period when our periodic reports are being
prepared.
(2)
|
Changes
in internal controls
|
There
were no changes in our internal control over financial reporting (as defined in
Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended
June 30, 2008 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
FCPA
Investigation
See the
risk factor regarding international operations on page 34 below for a discussion
of the FCPA investigation we carried out in 2004 and our resulting agreement
with the Department of Justice.
The
monitor filed his final report with the DOJ in May 2008, and in July 2008,
the DOJ confirmed that the monitorship had concluded. We have reaffirmed our
commitment to take all reasonable steps to ensure that we remain in compliance
with the FCPA.
Patent
Litigation
See the
risk factor regarding patent litigation below on page 30 for a detailed
discussion of our patent litigation with Boston Scientific
Corporation.
A hearing
on claim construction was held in June 2007. In March 2008, the Court issued an
order construing certain claim terms of patents that were asserted by Boston
Scientific against Micrus or asserted by Micrus against Boston Scientific. On
April 23, 2008, the district court entered a scheduling order on future
events in this action, including the close of all discovery on January 26,
2009. A trial date has not been set by the district court.
We are is
in the process of negotiating a settlement with Boston Scientific and the U.C.
Regents (which licensed some of the patents-in-suit to Boston Scientific but is
not a party to the lawsuit). These negotiations currently contemplate
the issuance by us of approximately $1.7 million in stock that would accompany
patent cross-licenses between us and Boston Scientific. The accrued
cost of approximately $1.7 million in connection with the tentative settlement
of patent litigation with Boston Scientific was recorded as general
and administrative expense in the first quarter of fiscal 2009. This
issuance of stock, together with a payment of approximately $1.0 million by
Boston Scientific to the U.C. Regents, would be made to the U.C. Regents to
satisfy the Regents' claim related to these patents. However, there can be
no assurance that a settlement agreement will be finalized on these or any
terms.
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Certain
Factors that May Affect Our Business and Future Results
Some of
the information included herein contains forward-looking statements as defined
in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Such forward-looking statements are
based on the beliefs of, estimates made by and information currently available
to our management and are subject to certain risks, uncertainties and
assumptions. Any statements contained herein (including, without limitation,
statements to the effect that the Company, we, or management “may,” “will,”
“expects,” “anticipates,” “estimates,” “continues,” “plans,” “believes,” or
“projects,” or statements concerning “potential” or “opportunity,” and any
variations thereof, comparable terminology or the negative thereof) that are not
statements of historical fact should be construed as forward-looking statements.
Our actual results may vary materially from those expected in these
forward-looking statements. The realization of such forward-looking statements
may be impaired by risks including, but not limited to the
following:
Our
future success is dependent on the continued growth in embolic coiling
procedures and
our ability to convince a concentrated customer base of
neurointerventionalists to
use our products as an alternative to other available
products.
Our
future success and revenue growth are significantly dependent upon an increase
in the use of embolic coiling as a procedure to treat cerebral aneurysms. If the
number of embolic coiling procedures does not increase or if a new procedure
that does not employ our products becomes a more acceptable alternative among
neurointerventionalists, our business would be seriously harmed.
The
number of interventional neuroradiologists and neurosurgeons trained to conduct
embolic coiling procedures is relatively small, both in the United States and
abroad. There are currently approximately 300 neurointerventionalists in the
United States who perform embolic coiling procedures. We believe less than
one-third of these physicians perform a substantial majority of the total number
of embolic coiling procedures per year. For the first quarter of fiscal 2009, a
substantial portion of our product sales were to approximately 148 hospitals in
the United States. The growth in the number of interventional neuroradiologists
and neurosurgeons in the United States is constrained by the lengthy training
programs required to educate these physicians. Accordingly, our revenue growth
will be primarily dependent on our ability to increase sales of our products to
our existing customers and to increase sales of products to trained
neurointerventionalists that currently use products offered by our competitors.
We believe that neurointerventionalists who do not currently use our products
will not widely adopt our products unless they determine, based on experience,
clinical data and published peer reviewed journal articles, that our products
provide benefits or an attractive alternative to the clipping of aneurysms or
the use of competitors’ products. We believe neurointerventionalists base their
decision to use an alternative procedure or product on the following criteria,
among others:
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extent
of clinical evidence supporting patient
benefits;
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their
level of experience with the alternative
product;
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perceived
liability risks generally associated with the use of new products and
procedures;
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availability
of reimbursement within healthcare payment
systems; and
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costs
associated with the purchase of new products and
equipment.
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In
addition, we believe that recommendations and support of our products by
influential physicians are essential for market acceptance and adoption. If we
do not receive continued support from such influential physicians,
neurointerventionalists and hospitals may not use our products. In such
circumstances, we may not achieve expected revenue levels and our business will
suffer.
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We
are currently involved in a patent litigation action involving Boston
Scientific and,
if we do not prevail in this action, we could be liable for past damages and
be prevented
from making, using, selling, offering to sell, importing into the United
States
or exporting from the United States, our microcoils, our primary product
line.
In
September 2004, Boston Scientific, filed a patent infringement suit in the
United States District Court for the Northern District of California, alleging
that our embolic coil products infringe two patents (United States Patent Nos.
5,895,385 (the “’385 Patent”) and 6,010,498 (the “’498 Patent”)) owned by the
Regents of the University of California (the “Regents”) and exclusively licensed
to Boston Scientific and that this infringement is willful. Sales of our embolic
coil products currently represent approximately 94% of our revenues. Boston
Scientific is a large, publicly-traded corporation with significantly greater
financial resources than us.
In
November 2004, we answered Boston Scientific’s complaint and counterclaimed,
alleging that Boston Scientific’s embolic coil products, and their use, infringe
three of our patents. In addition, we alleged that Boston Scientific has
violated United States antitrust laws, and has violated certain California state
laws by committing unfair business practices, disparaging our products, and
interfering with our prospective economic advantage. Each party seeks an
injunction preventing the making, using, selling, offering to sell, importing
into the United States or exporting from the United States, of the other’s
embolic coil products in the United States, damages for past infringement, which
may be trebled, and payment of its legal fees and costs. In addition, each party
seeks a declaration that the patents of the other are invalid and not infringed
and has alleged that certain of the asserted patents of the other are
unenforceable due to inequitable conduct.
In
January 2005, Boston Scientific filed a motion to dismiss our claims for
disparagement, interference with prospective economic advantage and unfair
business practices. In June 2008, the court issued an order dismissing these
claims without prejudice and granting us leave to amend our counterclaims. We
filed amended counterclaims in July 2008. Boston Scientific has not responded to
our amended counterclaims.
In
November 2006, we withdrew one of our three asserted patents from the litigation
to pursue a reissue application filed with the United States Patent and
Trademark Office (“USPTO”).
A hearing
on claim construction was held in June 2007. In March 2008, the Court issued an
order construing certain claim terms of patents that were asserted by Boston
Scientific against Micrus or asserted by Micrus against Boston Scientific. On
April 23, 2008, the district court entered a scheduling order on future
events in this action, including the close of all discovery on January 26,
2009. A trial date has not been set by the district court.
Boston
Scientific has also been a party in two other lawsuits against Cordis and Micro
Therapeutics, Inc./ev3, Inc./Dendron GmbH (collectively “MTI”) in which the two
Boston Scientific patents asserted against us are or were also at issue. An
outcome of either of these lawsuits adverse to Cordis or MTI, and related to the
same patent claims Boston Scientific asserts against us, could have an adverse
impact on certain of our defenses in our litigation with Boston
Scientific.
According
to court records, the Regents, Boston Scientific and MTI entered into a
settlement agreement on March 21, 2008, and on April 4, 2008 the
Regents, Boston Scientific and MTI dismissed the action, including all claims
and counter-claims, with prejudice.
On
January 18, 2008, in the Cordis case, the district court granted Boston
Scientific’s motion for summary judgment that Cordis’ TRUFILL Detachable Coil
System infringed claim 7 of the ’385 Patent under the doctrine of equivalents.
On January 25, 2008, the district court granted Boston Scientific’s motion
for summary judgment against Cordis that claims 10 and 35 of the ’385 patent,
and claims 1, 3, 7, 9, and 10 of the ’498 patent, are not invalid for having
been on-sale or in public use before the statutory bar period. On March 21,
2008, the district court granted-in-part Boston Scientific’s motion for
summary judgment that the ’385 patent and ’498 patent are not unenforceable for
inequitable conduct. The district court also denied-in-part Boston
Scientific’s motion on the ground that triable issues of fact remained
concerning the patent applicants’ representations to the patent examiner during
the application process. The district court’s determinations on the validity and
enforceability of the ’385 and ’498 patents are important because Boston
Scientific is asserting these same patents against us in our lawsuit and we are
alleging that these patents are invalid and unenforceable.
In
October 2004, Cordis requested ex
parte reexamination of certain claims in Boston Scientific’s ’385 and
’498 patents. In April 2007, the USPTO issued a Notice of Intent to Issue Ex
Parte Reexamination Certificate for the ’498 patent, apparently confirming all
of the claims of that patent. In December 2006, the USPTO issued a Notice of
Allowance for the ’385 patent in which it apparently confirmed the patentability
of the claims in that patent.
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Patent
lawsuits involve complex legal and factual issues which can take a number of
years and a great deal of expense and management attention to resolve. We may
also be subject to negative publicity due to the litigation. In the event it is
determined that we infringe patent claims asserted by Boston Scientific and that
those claims are not invalid and not unenforceable we may, among other things,
be required to do one or more of the following:
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pay
damages, including up to treble damages and Boston Scientific’s attorney’s
fees and costs, which may be
substantial;
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cease,
because of an injunction, the making, using, selling, offering to sell,
importing into the United States or exporting from the United States of
our embolic coil products, which currently represent virtually all of our
revenues, found to infringe the patent claims asserted by Boston
Scientific;
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expend
significant resources to redesign our technology so that it does not
infringe the patent claims asserted by Boston Scientific, which may not be
possible;
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discontinue
manufacturing or other processes that incorporate technology that
infringes the patent claims asserted by Boston
Scientific;
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become
subject to a compulsory license order under which we would be required to
pay Boston Scientific a royalty on future sales of our products;
and/or
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obtain
a license from Boston Scientific to use the relevant patents, which may
not be available to us on acceptable terms, or at
all.
|
If our
embolic coil products were found to infringe, any development or acquisition of
products or technologies that do not infringe the patent claims asserted by
Boston Scientific could require the expenditure of substantial time and other
resources and could have a material adverse effect on our business and financial
results. If we were required to but could not obtain a license under the patent
claims asserted by Boston Scientific, we would likely be prevented from
commercializing or further commercializing the relevant products. We believe
that it is unlikely that we would be able to obtain a license under the patent
claims being asserted by Boston Scientific. If we need to redesign our products
to avoid the patent claims being asserted by Boston Scientific, we may suffer
significant regulatory delays associated with conducting additional studies or
submitting technical, manufacturing or other information related to the
redesigned product and, ultimately, in obtaining approval.
As a
result of Boston Scientific’s answer to our counterclaim that Boston Scientific
infringes our two remaining patents-in-suit, the validity of those patents is
now at issue in the lawsuit. The court could find that those patents are
invalid, which would prevent us from asserting those patents against third
parties.
We are is
in the process of negotiating a settlement with Boston Scientific and the U.C.
Regents (which licensed some of the patents-in-suit to Boston Scientific but is
not a party to the lawsuit). These negotiations currently contemplate
the issuance by us of approximately $1.7 million in stock that would accompany
patent cross-licenses between us and Boston Scientific. The accrued
cost of approximately $1.7 million in connection with the tentative settlement
of patent litigation with Boston Scientific was recorded as general
and administrative expense in the first quarter of fiscal 2009. This
issuance of stock, together with a payment of approximately $1.0 million by
Boston Scientific to the U.C. Regents, would be made to the U.C. Regents to
satisfy the Regents' claim related to these patents. However, there can be
no assurance that a settlement agreement will be finalized on these or any
terms.
An unfavorable outcome for
us in this patent litigation would significantly harm our business and may cause
us to materially change our business model. In
addition, costs of defense and any damages resulting from the litigation may
materially adversely affect our business and financial results. The litigation
may also harm our relationships with existing customers and subject us to
negative publicity, each of which could harm our business and financial
results.
Our
industry is experiencing increased scrutiny by governmental authorities, which
has led to increased compliance costs and potentially more rigorous
regulation
The
medical device industry is subject to rigorous regulation by the FDA and
numerous other federal, state and foreign governmental
authorities. These authorities have been increasing their scrutiny of
certain activities of medical device companies, including their conduct of
clinical trials, their handling of conflicts of interests and financial
arrangements with health care providers and consultants, and their product
promotional practices. We anticipate that government authorities will
continue to scrutinize our industry closely and we may be subject to more
rigorous regulation by governmental authorities in the future. This
increased government scrutiny has lead us to incur increased costs on
compliance, human resources costs and the diversion of management and employee
focus and we anticipate that such costs will continue to
increase. Though we have adopted a number of compliance procedures in
response to the increased scrutiny, we cannot assure you that our activities
will not be subject to inquiry or greater action or oversight by governmental
authorities or that we will be able to comply with any new
regulations. Any failure by us to adopt appropriate compliance
procedures and ensure that our employees and agents comply with applicable laws
and regulations could result in substantial penalties and/or restrictions in our
business activities and the sales of our products.
We
have a limited operating history, have incurred significant operating losses
since inception,
and expect to continue to incur losses, and we cannot assure you that we
will
achieve profitability.
We were
incorporated in the State of Delaware in 1996, and began commercial sales of our
microcoil products in 2000. We have yet to demonstrate that we can generate
sufficient sales of our products to become profitable. The extent of our future
operating losses and the timing of profitability are uncertain, and we may never
achieve profitability. We have incurred significant net losses since our
inception, including losses of approximately $16.3 million,
$5.5 million and $8.3 million for the fiscal years ended
March 31, 2008, 2007 and 2006, respectively. We incurred net losses of $6.6
million and $1.4 million in the first quarter of fiscal 2009 and 2008,
respectively. As of June 30, 2008, we had an accumulated deficit of
$78.0 million. It is possible that we will never generate sufficient
revenues from product sales to achieve profitability. Even if we do achieve
significant revenues from our product sales, we expect our operating expenses to
increase as we, among other things:
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grow
our internal and third-party sales and marketing forces to expand the
sales of our products in the United States and
internationally;
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increase
our research and development efforts to improve upon our existing products
and develop new products;
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perform
clinical research and trials on our existing products and product
candidates;
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expand
our regulatory resources in order to obtain governmental approvals for our
existing product enhancements and new
products;
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acquire
and/or license new
technologies; and
|
As a
result of these activities, we may never become profitable. Even if we do
achieve profitability, we may not be able to sustain or increase profitability
on an ongoing basis.
Our
quarterly operating and financial results and our gross margins are likely
to fluctuate
significantly in future periods.
Our
quarterly operating and financial results are difficult to predict and may
fluctuate significantly from period to period. The level of our revenues, gross
margins and results of operations at any given time will be based primarily on
the following factors:
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neurointerventionalist
and patient acceptance of our
products;
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changes
in the number of embolic coiling procedures performed to treat cerebral
aneurysms;
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the
seasonality of our product sales;
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the
mix of our products sold;
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stocking
patterns for distributors;
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the
development of new procedures to treat cerebral
aneurysms;
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results
of clinical research and trials on our existing products and products in
development;
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demand
for, and pricing of, our products;
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levels
of third-party reimbursement for our
products;
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timing
of new product offerings, acquisitions, licenses or other significant
events involving us or our
competitors;
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increases
in the costs of manufacturing and selling our
products;
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the
amount and timing of our operating
expenses;
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fluctuations
in foreign currency exchange rates;
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regulatory
approvals and legislative changes affecting the products we may offer or
those of our competitors;
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the
effect of competing technological and market
developments;
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changes
in our ability to obtain and maintain FDA and other domestic and foreign
regulatory approval or clearance for our
products;
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inventory
adjustments we may have to make in any
quarter;
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interruption
in the manufacturing or distribution of our
products;
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our
ability to maintain and expand our sales force and operational
personnel;
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the
ability of our suppliers to timely provide us with an adequate supply of
materials and components; and
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amount
and timing of capital expenditures and other costs relating to any
potential expansion of our
operations.
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Many of
the products we may seek to develop and introduce in the future will require FDA
approval or clearance and will be required to meet similar regulatory
requirements in other countries where we seek to market our products, without
which we cannot begin to commercialize them. Forecasting the timing of sales of
our products is difficult due to the delay inherent in seeking FDA and other
clearance or approval, or the failure to obtain such clearance or approval. In
addition, we will be increasing our operating expenses as we build our
commercial capabilities. Accordingly, we may experience significant,
unanticipated quarterly losses. Because of these factors, our operating results
in one or more future quarters may fail to meet the expectations of securities
analysts or investors, which could cause our stock price to decline
significantly.
We
may not be able to develop new products or product enhancements that will
be accepted
by the market.
Our
success will depend in part on our ability to develop and introduce new products
and enhancements to our existing products. We cannot assure you that we will be
able to successfully develop or market new products or that any of our future
products will be accepted by the neurointerventionalists who use our products or
the payors who reimburse for many of the procedures performed with our products.
The success of any new product offering or enhancement to an existing product
will depend on several factors, including our ability to:
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properly
identify and anticipate neurointerventionalist and patient
needs;
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develop
new products or enhancements in a timely
manner;
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obtain
the necessary regulatory approvals for new products or product
enhancements;
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provide
adequate training to potential users of our
products;
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receive
adequate reimbursement for our
procedures; and
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results
of clinical research and trials on our existing products and products in
development;
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demand
for, and pricing of, our products;
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levels
of third-party reimbursement for our
products;
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develop
an effective marketing and distribution
network.
|
If we do
not develop new products or product enhancements in time to meet market demand
or if there is insufficient demand for our products or enhancements, we may not
achieve expected revenue levels and our business will suffer.
Our
international operations and our relationships with physicians and other
consultants
require us to comply with a number of United States and international
regulations.
We are
required to comply with a number of international regulations related to sales
of medical devices and contractual relationships with physicians in countries
outside of the United States. In addition, we must comply with the Foreign
Corrupt Practices Act (“FCPA”) which prohibits United States companies or their
agents and employees from providing anything of value to a foreign official for
the purposes of influencing him or her to help obtain or retain business, direct
business to any person or corporate entity, or obtain any unfair
advantage.
In August
2004, while reviewing our sales and payment procedures, we identified certain
payments we made to physicians outside the United States that may have violated
the FCPA and the laws of certain foreign countries. Following an internal
investigation, we voluntarily disclosed to the United States Department of
Justice (“DOJ”) the factual information obtained in our internal investigation
of potential violations of the FCPA.
After
reviewing the results of the internal investigation and the compliance
procedures implemented by us, the DOJ entered into an agreement (the “DOJ
Agreement”) with us in February 2005. Pursuant to that agreement, the DOJ agreed
not to prosecute us for the conduct disclosed to the DOJ, and we agreed to
various conditions, including establishing policies and procedures to assure
compliance with the FCPA and other relevant anti-bribery laws, retaining an
independent law firm to act as a monitor for purposes of reporting to the DOJ
for a period of three years as to our compliance with the DOJ Agreement and to
monitor our implementation of and adherence to FCPA compliance policies and
procedures, and fully cooperating with the DOJ, the independent monitor, and the
SEC. The monitor filed his final report with the DOJ in May 2008, and in
July 2008, the DOJ confirmed that the monitorship had concluded. We have
reaffirmed our commitment take all reasonable steps to ensure that we
remain in compliance with the FCPA.
The
payments we made to physicians in France, Germany, Spain and Turkey are also
likely to have violated the applicable laws in those foreign
jurisdictions. We have
not been notified by the authorities in France, Germany, Spain or Turkey whether
or not such authorities intend to bring any action or impose any penalties on us
relating to our activities in their respective countries. Therefore,
we are unable to determine at this time what penalties or other
sanctions, if any, such authorities may impose on us as a result of such
violations. Such amounts could be material to our financial position, results of
operations or cash flows. We have been notified by the Swiss Federal Prosecutor
that it does not intend to bring any action or impose any penalties on us
relating to our activities in Switzerland.
Though we
have adopted a number of compliance procedures, including a Foreign Corrupt
Practices Act Policy and related procedures, and appointed a Compliance Officer,
we cannot assure you that we will be able to comply with the various regulations
in foreign jurisdictions, which vary from country to country. Implementing and
monitoring such compliance procedures in a number of foreign jurisdictions can
be very expensive and time-consuming. Any failure by us to adopt appropriate
compliance procedures and ensure that our employees and agents comply with
applicable laws and regulations in foreign jurisdictions could result in
substantial penalties and/or restrictions in our ability to sell products in
certain foreign jurisdictions.
We
are in a highly competitive market segment, face competition from large,
well-established
medical device manufacturers with significant resources, and may not
be
able to increase penetration in our markets or otherwise compete
effectively.
The
market for medical devices for treatment of cerebral vascular diseases is
intensely competitive, subject to rapid change and significantly affected by new
product introductions and other market activities of industry participants. We
compete primarily with the Target Therapeutics division of Boston Scientific,
the market leader, as well as Cordis, ev3/Micro Therapeutics and
Terumo/MicroVention. At any time, other companies may develop alternative
treatments, products or procedures for the treatment of cerebral aneurysms that
compete directly or indirectly with our products. If alternative treatments
prove to be superior to our microcoil or other products, continued use or
adoption of our products could be negatively affected and our future revenues
could suffer.
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In
addition, most of our current and potential competitors are either large
publicly traded or divisions or subsidiaries of large publicly traded companies,
and enjoy several competitive advantages over us, including:
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greater
financial and personnel resources;
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significantly
greater name recognition;
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established
relationships with
neurointerventionalists;
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established
distribution networks;
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greater
experience in obtaining and maintaining FDA, and other regulatory
approvals for products and product enhancements, and greater experience in
developing compliance programs for compliance with numerous federal,
state, local and similar laws in non-United States
jurisdictions;
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greater
resources for product research and
development;
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greater
experience in, and resources for, launching, marketing, distributing and
selling products; and
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Except
for our agreements with our distributors, we have no material long-term purchase
agreements with our customers, who may at any time switch to the use of our
competitors’ products.
For these
reasons, we may not be able to compete successfully against our current or
potential future competitors and sales of our products and our revenues may
decline.
Our
sales in international markets subject us to foreign currency exchange and
other risks
and costs that could harm our business.
A
substantial portion of our revenues are derived from outside the United States.
For the fiscal years ended March 31, 2008, 2007 and 2006, revenues from
customers outside the United States represented approximately 51%, 51% and 53%,
respectively, of our revenues. For the first quarter of fiscal 2009, revenues
from customers outside the United States represented 53% of our revenues. We
anticipate that revenues from international customers will continue to represent
a substantial portion of our revenues as we continue to expand in new
international markets including China and Japan. Because we generate revenues in
foreign currencies, we are subject to the effects of exchange rate fluctuations.
For the first quarter of fiscal 2009, approximately 33% of our revenues were
denominated in currencies other than the U.S. dollar. The functional
currency of our Swiss subsidiary is the Swiss franc. In Europe, our revenues are
denominated in Swiss francs, euros, pounds sterling and U.S. dollars.
Accordingly, we are exposed to market risk related to changes between the Swiss
franc and these other currencies in which we conduct business. If the Swiss
franc appreciates against the currencies in which our receivables are
denominated, we will recognize foreign currency losses. For the preparation of
our consolidated financial statements, the financial results of our Swiss and UK
subsidiaries are translated into U.S. dollars based on average exchange
rates during the applicable period. If the U.S. dollar appreciates against
the Swiss franc and pound sterling, the revenues we recognize from sales by our
European subsidiaries will be adversely impacted. Historically, we have also
been exposed to risks from fluctuations in currency exchange rates due to
intercompany loans made to Micrus Endovascular SA (“Micrus SA”), our Swiss
subsidiary, in 2001 in connection with its incorporation. These loans are
denominated in Swiss francs and will fluctuate in value against the
U.S. dollar, causing us to recognize foreign exchange gains and losses.
Foreign exchange gains or losses as a result of exchange rate fluctuations in
any given period could harm our operating results and negatively impact our
revenues. Additionally, if the effective price of our products were to increase
as a result of fluctuations in foreign currency exchange rates, demand for our
products could decline and adversely affect our results of operations and
financial condition. We currently do not enter into foreign currency forward
contracts and other arrangements intended to hedge our exposure to adverse
fluctuations in exchange rates.
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We are
subject to various additional risks as a consequence of doing business
internationally which could harm our business, including the
following:
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unexpected
delays or changes in regulatory
requirements;
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local
economic and political instability or other potentially adverse
conditions;
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lack
of experience in certain geographical
markets;
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increased
difficulty in collecting accounts receivables in certain foreign
countries;
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delays
and expenses associated with tariffs and other trade
barriers;
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difficulties
and costs associated with attracting and maintaining third party
distributors;
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compliance
with foreign laws and
regulations; and
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adverse
tax consequences or overlapping tax
structures.
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If
we fail to increase our direct sales force in a timely manner, our business
could suffer.
We have a
limited domestic and international direct sales force. We also have a
distribution network for sales in the major markets in Europe, Latin America,
Asia and the Middle East. As we launch new products and increase our marketing
efforts with respect to existing products, we will need to expand the number of
our direct sales personnel on a worldwide basis. The establishment and
development of a more extensive sales force will be expensive and time
consuming. There is significant competition for sales personnel experienced in
interventional medical device sales. If we are unable to attract, motivate and
retain qualified sales personnel and thereby increase our sales force, we may
not be able to increase our revenues.
If
we fail to properly manage our anticipated growth, our business could
suffer.
We have
experienced, and may continue to experience, periods of rapid growth and
expansion, which have placed, and will likely continue to place, a significant
strain on our limited personnel and other resources. In particular, the
expansion of our fabrication facility and the continuing expansion of our direct
sales force will require significant management, technical and administrative
resources. Any failure by us to manage our growth effectively, could have an
adverse effect on our ability to achieve our development and commercialization
goals.
To
achieve our revenue goals, we must successfully increase production in our
fabrication facility as required by customer demand. We may in the future
experience difficulties in increasing production, including problems with
production yields and quality control and assurance and in satisfying and
maintaining compliance with regulatory requirements. These problems could result
in delays in product availability and increases in expenses. Any such delay or
increased expense could adversely affect our ability to generate
revenues.
Future
growth will also impose significant added responsibilities on management,
including the need to identify, recruit, train and integrate additional
employees. In addition, rapid and significant growth will place a strain on our
administrative and operational infrastructure. In order to manage our operations
and growth we will need to continue to improve our operational, financial and
management controls, reporting systems and procedures. If we are unable to
manage our growth effectively, it may be difficult for us to execute our
business strategy and our operating results and business could
suffer.
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We
are required to evaluate our internal control over financial reporting
under Section 404
of the Sarbanes-Oxley Act of 2002 and are exposed to future risks of
non
compliance.
Pursuant
to Section 404 of the Sarbanes-Oxley Act of 2002 (“Section 404”), we
are required to furnish a report by our management on our internal control over
financial reporting. The report contains, among other matters, an assessment of
the effectiveness of our internal control over financial reporting as of the end
of our fiscal year, including a statement as to whether or not our internal
control over financial reporting is effective. This assessment must include
disclosure of any material weaknesses in our internal control over financial
reporting identified by management. The report must also contain a statement
that our independent registered public accounting firm has issued an attestation
report on the effectiveness of internal control over financial
reporting.
We
completed our assessment of our internal control over financial reporting as
required by Section 404 for the fiscal year ended March 31, 2008. Our
assessment, testing and evaluation resulted in our conclusion that as of
March 31, 2008, our internal control over financial reporting was
effective. Our independent registered accounting firm has also expressed the
opinion that our internal controls over financial reporting were effective
during that period. However, our controls, may not prove to be adequate for the
future periods, and we cannot predict the outcome of our testing in future
periods. If our internal controls are deemed to be ineffective in future
periods, our financial results or the market price of our stock could be
adversely affected. In any event, we will incur additional expenses and
commitment of management’s time in connection with further evaluations, which
may adversely affect our future operating results and financial
condition.
Our
future capital needs are uncertain and we may need to raise additional funds
in the
future, and such funds may not be available on acceptable terms or at
all.
We
believe that our current cash position, together with the cash to be generated
from expected product sales will be sufficient to meet our projected operating
requirements for at least the next 12 months. However, after such period we
may be required to seek additional funds from public and private stock or debt
offerings, borrowings under lease lines or other sources. Our capital
requirements will depend on many factors, including:
•
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the
revenues generated by sales of our
products;
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the
costs associated with expanding our sales and marketing
efforts;
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the
expenses we incur in manufacturing and selling our
products;
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the
costs of developing and or acquiring new products or
technologies;
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the
cost of obtaining and maintaining FDA and other domestic and foreign
approval or clearance of our products and products in
development;
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costs
associated with our litigation with Boston Scientific and our securities
litigation;
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the
expenses we incur related to compliance with the United States FCPA and
laws and regulations in non-United States
jurisdictions;
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costs
associated with compliance with the Sarbanes-Oxley Act of 2002 and rules
and regulations affecting public companies promulgated by the SEC and The
NASDAQ Stock Market;
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the
costs associated with our facilities expansion, if
any; and
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the
costs associated with increased capital
expenditures.
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As a
result of these factors, we may need to raise additional funds, and such funds
may not be available on favorable terms, or at all. Furthermore, if we issue
equity or debt securities to raise additional funds, our existing stockholders
may experience dilution, and the new equity or debt securities may have rights,
preferences and privileges senior to those of our existing stockholders. In
addition, if we raise additional funds through collaboration, licensing or other
similar arrangements, it may be necessary to relinquish valuable rights to our
potential products or proprietary technologies, or grant licenses on terms that
are not favorable to us. If we cannot raise funds on acceptable terms, we may
not be able to develop or enhance our products, execute our business plan, take
advantage of future opportunities, or respond to competitive pressures or
unanticipated customer requirements. In these events, our ability to achieve our
development and commercialization goals would be adversely
affected.
If
we choose to acquire new and complementary businesses, products or
technologies instead
of developing them ourselves, we may be unable to complete these
acquisitions or
to successfully integrate them in a cost effective and non-disruptive
manner.
Our
success depends on our ability to continually enhance and broaden our product
offerings in response to changing customer demands, competitive pressures and
technologies. We may in the future pursue the acquisition of additional
complementary businesses, products or technologies instead of developing them
ourselves. We do not know if we will be able to successfully complete any such
acquisitions, or whether we will be able to successfully integrate any acquired
business, product or technology or retain any key employees. Integrating any
business, product or technology we acquire could be expensive and time
consuming, disrupt our ongoing business and distract our management. If we are
unable to integrate any acquired businesses, products or technologies
effectively, our business will suffer. In addition, any amortization or charges
resulting from the costs of acquisitions could harm our business and operating
results.
We
are dependent on single source suppliers for components and materials used in
our devices,
and the loss of any of these suppliers, or their inability to supply us
with an
adequate supply of materials, could harm our
business.
We rely
on third-party suppliers for components and materials used in our products and
rely on single sources for many of the microcoil and delivery system components,
including tubing, connectors and sterilization services. Our dependence on
third-party suppliers involves several risks, including limited control over
pricing, availability, quality, delivery schedules and supplier compliance with
regulatory requirements. Any delays in delivery of such components or provision
of such services or shortages of such components could cause delays in the
shipment of our products, which could significantly harm our business. We
generally acquire our single source components pursuant to purchase orders
placed in the ordinary course of business, and we have no guaranteed supply
arrangements with any of our single source suppliers. Because of our reliance on
these vendors, we may also be subject to increases in component costs. These
increases could significantly harm our business. For us to be successful, our
third-party suppliers must also be able to provide us with the materials and
components of our products in substantial quantities, in compliance with
regulatory requirements, in accordance with agreed upon specifications, at
acceptable cost and on a timely basis. Our anticipated growth may strain the
ability of suppliers to deliver an increasingly large supply of materials and
components. If we are unable to obtain sufficient quantities of high quality
components and materials to meet customer demand on a timely basis, we could
lose customers, our reputation may be harmed and our business could suffer. If
any one or more of our third-party suppliers cease to provide us with sufficient
quantities of our materials or components in a timely manner or on terms
acceptable to us, we would have to seek alternative sources of supply. We could
incur delays while we locate and engage alternative qualified suppliers and we
might be unable to engage alternative suppliers on favorable terms. Any such
disruption or increased expenses could harm our commercialization efforts and
adversely affect our ability to generate revenues.
We rely
on independent contract manufacturers for the manufacture and assembly of
certain of our products and components. Reliance on independent contract
manufacturers involves several risks, including the potential inadequacy of
capacity, the unavailability of or interruptions in access to certain process
technologies and reduced control over product quality, compliance with
regulatory requirements, delivery schedules, manufacturing yields and costs.
Such manufacturers have possession of and at times title to molds for certain
manufactured components of our products. Shortages of raw materials, production
capacity constraints or delays by our contract manufacturers could negatively
affect our ability to meet our production obligations and result in increased
prices for affected parts. Any such reduction, constraint or delay may result in
delays in shipments of our products or increases in the prices of components,
either of which could have a material adverse effect on our business, operating
results and financial condition. We have no supply agreements with our current
contract manufacturers and utilize purchase orders which are subject to supplier
acceptance. The unanticipated loss of any of our contract manufacturers could
cause delays in our ability to deliver product while we identify and qualify a
replacement manufacturer. If our current or future independent contract
manufacturers are unable to meet our requirements for manufactured components,
our business could suffer.
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Our
operations are currently conducted at several locations that may be at risk
from earthquakes
or other natural disasters.
We
currently conduct our manufacturing, development and management activities at
two locations in Silicon Valley, California, near known earthquake fault zones
and in Doral, Florida, where there is a risk of hurricanes. We have taken
precautions to safeguard our facilities, including insurance, health and safety
protocols, and off-site storage of computer data. However, any future natural
disaster, such as an earthquake or hurricane, could cause substantial delays in
our operations, damage or destroy our equipment or inventory, and cause us to
incur additional expenses. A disaster could seriously harm our business and
results of operations.
If
we are unable to effectively manage our inventory held on consignment by
our intended
customers, we will not achieve our expected results.
A
significant portion of our inventory is held on consignment by hospitals that
purchase the inventory as they use it. In these consignment locations, we do not
have physical possession of the consigned inventory. We therefore have to rely
on information from our customers as well as periodic inspections by our sales
personnel to determine when our products have been used. We have in the past
experienced problems managing appropriate consigned inventory levels and as a
result we recorded an impairment of inventory for anticipated obsolescence in
fiscal 2004 and an impairment of excess inventory in both fiscal 2004 and 2005.
If we are not able to effectively manage appropriate consigned inventory levels,
we may suffer inventory losses that will reduce our gross profit levels. There
can be no assurance that any efforts to strengthen our monitoring and management
of consigned inventory will be adequate to meaningfully reduce the risk of
inventory loss.
We
are dependent on our senior management team, key clinical advisors and
scientific personnel,
and the loss of any of them could harm our business.
Our
continued success depends in part upon the continued availability and
contributions of our senior management team and the continued participation of
our key clinical advisors. We have entered into agreements with certain members
of our senior management team, but none of these agreements guarantee the
services of the individual for a specified period of time. We also rely on the
skills and talents of our scientific personnel because of the complexity of our
products. The loss of members of our senior management, key clinical advisors or
scientific personnel, or our inability to attract or retain other qualified
personnel or advisors could have a material adverse effect on our results of
operations and financial condition.
The
medical device industry is characterized by patent litigation, which could
be costly,
result in the diversion of management’s time and efforts and require us
to pay
damages.
The
medical device industry is characterized by extensive litigation and
administrative proceedings over patent and other intellectual property rights.
Accordingly, we may in the future be subject to further litigation and
administrative proceedings over such rights with other companies in our
industry. As we have discussed above with respect to our current litigation with
Boston Scientific, whether a product or method infringes a patent involves
complex legal and factual issues rendering the outcome of any patent dispute
largely unpredictable. In the future, other competitors may assert that at least
one of our products, its components, or the methods we employ in the use or
manufacture of our products are covered by and infringe the competitors’ United
States or foreign patents held by them. In addition, should our patents or
applications have claims that encompass the same scope as claims pending or
issued to a third party competitor, that third party may claim that its claims
have priority over ours because they invented the claimed subject matter first.
Because patent applications generally take many years to issue, there may be
third party applications presently pending of which we are unaware, that may in
the future result in issued patents that at least one of our products, its
components, or the methods we employ in the use or manufacture of our product(s)
may infringe. There could also be issued patents that one or more components of
our products may inadvertently be infringing, of which we are unaware. As the
number of participants in the market for cerebral vascular treatments and the
number of issued patents in this technology area grows, the possibility of being
charged with patent infringement increases.
As we
have discussed above with respect to our litigation with Boston Scientific, any
infringement claims against us may cause us to incur substantial costs, could
place a significant strain on our financial resources, divert the attention of
management from our core business and harm our reputation. If the relevant
patent claims are upheld as valid and enforceable and we are found to infringe,
we could be required to pay substantial damages and/or royalties and could be
prevented from selling our products unless we could obtain a license or were
able to redesign our products to avoid infringement. Any such license may not be
available on reasonable terms, if at all. If we fail to obtain any required
licenses or make any necessary changes to our products or technologies, we may
be unable to commercialize one or more of our products or practice the methods
we employ in the use or manufacture of our products.
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Our
ability to protect our intellectual property and proprietary technology
through patents
and other means is uncertain.
Our
success depends significantly on our ability to procure proprietary rights to
the technologies used in our products. We rely on patent protection, as well as
a combination of copyright, trade secret and trademark laws, and nondisclosure,
confidentiality and other contractual restrictions to protect our proprietary
technology. However, these legal means afford only limited protection and may
not be sufficient to adequately protect our intellectual property or permit us
to gain or keep any competitive advantage. For example, any of our pending
United States or foreign patent applications may ultimately not issue as a
patent or, alternatively, may issue with claims that are of little or no value
to us. In addition, once issued, a valuable patent may be challenged
successfully by third parties and invalidated, such as is being attempted by
Boston Scientific in our presently ongoing litigation. In addition, our patent
protection for material aspects of our products and methods is presently being
pursued with applications that have been filed but not issued, such that these
material aspects are not presently protected by patents. Competitors may further
be able to get around having to license our technology in order to avoid
infringement by designing around our issued and published patent claims, thereby
staying clear of our proprietary rights. Similarly, competitors may develop
products and methods that are equivalent or superior to ours. Our
confidentiality agreements and intellectual property assignment agreements with
our employees, consultants and advisors may not be enforceable or may not
provide meaningful protection for our trade secrets or other proprietary
information in the event of unauthorized use or disclosure or other breaches of
the agreements. Furthermore, the laws of some foreign countries may not protect
our intellectual property rights to the same extent as do the laws of the United
States. Both the process of procuring patent rights and the process of managing
patent disputes can be time consuming and expensive.
In the
event a competitor infringes upon our patent or other intellectual property
rights, enforcing those rights may be difficult and time consuming. Even if
successful, litigation to enforce our intellectual property rights or to defend
our patents against challenge could be prolonged, costly and could divert our
management’s attention. We may not have sufficient resources to enforce our
intellectual property rights or to defend our patents against a
challenge.
If
we fail to obtain, or experience significant delays in obtaining, FDA
clearances or
approvals for our future products or product enhancements, or to comply
with similar
regulatory requirements in other countries where we market our products,
our ability
to commercially distribute and market our products could
suffer.
Our
medical devices are subject to rigorous regulation by the FDA and numerous other
federal, state and foreign governmental authorities. Our failure to comply with
such regulations could lead to the imposition of injunctions, suspensions or
loss of regulatory clearances or approvals, product recalls, termination of
distribution or product seizures or the need to invest substantial resources to
comply with various existing or new requirements. In the more egregious cases,
criminal sanctions, civil penalties, disgorgement of profits or closure of our
manufacturing facilities are possible. The process of obtaining regulatory
clearances or approvals to market a medical device, particularly from the FDA,
can be costly and time consuming, and there can be no assurance that such
clearances or approvals will be granted on a timely basis, if at all. In
particular, the FDA permits commercial distribution of most new medical devices
only after the device has received 510(k) clearance or is the subject of an
approved pre-market approval application, or PMA. The FDA will clear the
marketing of a medical device through the 510(k) process if it is demonstrated
that the new product has the same intended use, is substantially equivalent to
another legally marketed device, including a 510(k)-cleared product, and
otherwise meets the FDA’s requirements. The PMA approval process is more costly,
lengthy and uncertain than the 510(k) clearance process and requires the
development and submission of clinical studies supporting the safety and
effectiveness of the device. Product modifications may also require the
submission of a new 510(k) clearance, or the approval of a PMA before the
modified product can be marketed. Changes in labeling and manufacturing site for
a PMA approved device may require the submission and approval of a PMA
supplement. Any products we develop that require regulatory clearance or
approval may be delayed, if approved at all. In addition, we believe that some
of our new products will require an approved PMA before we can commercially
distribute the device and we cannot assure you that any new products or any
product enhancements we develop will be subject to the shorter 510(k) clearance
process instead of the more lengthy PMA requirements. Additionally, certain of
our products under development may involve both device and drug or biologic
regulation and we will need to comply with drug and biologic regulations in
addition to medical device requirements. Accordingly, we anticipate that the
regulatory review and approval process for some of our future products or
product enhancements may take significantly longer than anticipated or that we
have experienced in the past. We will also be required to pay a medical device
user fee and may also be required to pay a drug or biologic user fee. There is
no assurance that the FDA will not require that a certain new product or product
enhancement go through the lengthy and expensive PMA approval process. We have
no experience in obtaining PMA approval. We also have no experience in obtaining
drug or biologic approval, and will need to rely on third party assistance in
navigating the regulatory approval pathway for future combination
products.
Further,
pursuant to FDA regulations, we can only market our products for cleared or
approved uses. Certain of our products may be used by physicians for indications
other than those cleared or approved by the FDA, but we cannot promote the
products for such off-label uses.
Modifications
to our marketed products may require new 510(k) clearances or pre-market
approvals, or may require us to cease marketing or recall the modified
products
until clearances are obtained.
Any
modification to a 510(k)-cleared device that could significantly affect its
safety or effectiveness, or that would constitute a change in its intended use,
requires a new 510(k) clearance or, possibly, PMA approval. The FDA requires
every manufacturer to make this determination in the first instance, but the FDA
may review a manufacturer’s decision. The FDA may not agree with any of our past
or future decisions regarding whether new clearances or approvals are necessary.
If the FDA requires us to seek 510(k) clearance or PMA approval for any
modification to a previously cleared product, we may be required to cease
marketing and/or to recall the modified product until we obtain clearance or
approval, and we may be subject to significant regulatory fines or penalties.
Further, our products could be subject to recall if the FDA determines, for any
reason, that our products are not safe, including but not limited to new safety
data from use of the product, or manufacturing defects. Any recall or FDA
requirement that we seek additional approvals or clearances could result in
delays, fines, costs associated with modification of a product, loss of revenue
and potential operating restrictions imposed by the FDA
If
we or our suppliers fail to comply with the FDA’s quality system regulations,
the manufacture
of our products could be delayed.
We and
our suppliers are required to comply with the FDA’s quality system regulations,
which cover the methods and documentation of the design, testing, production,
control, quality assurance, labeling, packaging, storage and shipping of our
products. The FDA enforces these quality system regulations through unannounced
inspections. If we or one of our suppliers fail a quality system regulations
inspection or if any corrective action plan is not sufficient, or is very
expensive or time consuming to implement, the manufacture of our products could
be delayed until satisfactory corrections are made, or in the event we are
unable to correct the problems we may not be able to continue manufacturing and
distributing the particular device or devices. Such a delay potentially could
disrupt our business, harm our reputation and adversely affect our sales and
revenues.
If
neurointerventionalists are unable to obtain sufficient reimbursement for
procedures
performed with our products, it is unlikely that our products will be
widely
used.
Successful
sales of our products will depend on the availability of adequate reimbursement
from third-party payors. Healthcare providers that purchase medical devices for
treatment of their patients, generally rely on third-party payors to cover the
use of the product for the particular procedure and reimburse all or part of the
costs and fees associated with the procedures performed with these devices.
Currently, the costs of our products distributed domestically are being
reimbursed by third party payors. There is no guarantee that coverage and
adequate reimbursement will be available in the future for our existing and/or
new products. Both public and private insurance reimbursement plans are central
to new product acceptance. Neurointerventionalists are unlikely to use our
products if they do not receive reimbursement adequate to cover the cost of our
products and related procedures.
In
international markets, market acceptance may depend, in part, upon the
availability of reimbursement within prevailing healthcare payment systems.
Reimbursement and healthcare payment systems in international markets vary
significantly by country, and include both government sponsored healthcare and
private insurance. Currently, the costs of our products distributed
internationally, other than in some Latin American countries, are being
reimbursed by public and private healthcare insurers. We may not obtain
international reimbursement approvals in a timely manner, if at all, our failure
to receive international reimbursement approvals would negatively impact market
acceptance of our products in the international markets in which those approvals
are sought.
In
addition, in certain countries, such as France, Germany, China and Japan, we are
required to obtain regulatory clearance for our products to be eligible for
reimbursements by third party payors, even though reimbursement for embolic
coiling procedures is already in place.
Future
reimbursement may be subject to increased restrictions both in the United States
and in international markets. Third-party reimbursement and coverage may not be
available or adequate in either the United States or international markets.
Future legislation, regulation or reimbursement policies of third-party payors
may adversely affect the demand for our existing products or our products
currently under development and limit our ability to sell our products on a
profitable basis.
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Changes
to existing accounting pronouncements or taxation rules or practices may
affect
how we conduct our business and affect our reported results of
operations.
New
accounting pronouncements or tax rules and varying interpretations of accounting
pronouncements or taxation practice have occurred and may occur in the future. A
change in accounting pronouncements or interpretations or taxation rules or
practices can have a significant effect on our reported results and may even
affect our reporting of transactions completed before the change is effective.
Changes to existing rules and pronouncements, future changes, if any, or the
questioning of current practices or interpretations may adversely affect our
reported financial results or the way we conduct our business.
We
may become subject to product liability claims which could require us to
pay damages
that exceed our insurance coverage.
Our
business exposes us to potential product liability claims that are inherent in
the testing, manufacture and sale of medical devices for neurointerventional
procedures. These procedures involve significant risk of serious complications,
including intracranial bleeding, brain injury, paralysis and even death. Any
product liability claim brought against us, with or without merit, could result
in the increase of our product liability insurance rates or the inability to
secure coverage in the future. In addition, we could have to pay an amount in
excess of policy limits, which would have to be paid out of cash reserves. If
longer-term patient results and experience indicate that our products or any
component cause tissue damage, motor impairment or other adverse effects, we
could be subject to significant liability. Finally, even a meritless or
unsuccessful product liability claim could harm our reputation in the industry,
lead to significant legal fees and could result in the diversion of management’s
attention from managing our business.
We
may be subject to damages resulting from claims that we or our employees
have wrongfully
used or disclosed alleged trade secrets of their former
employers.
Many of
our employees were previously employed at other medical device companies,
including our competitors or potential competitors. Although no claims against
us are currently pending, we may be subject to claims that these employees have
wrongfully used or disclosed alleged trade secrets of their former employers or
we have inadvertently or otherwise used or disclosed trade secrets or other
proprietary information of their former employers. Litigation may be necessary
to defend against these claims. Even if we are successful in defending against
these claims, litigation could result in substantial costs and be a distraction
to management. If we fail in defending such claims, in addition to paying
monetary damages, we may lose valuable intellectual property rights or
personnel. A loss of key research personnel or their work product could hamper
or prevent our ability to commercialize product candidates, which could severely
harm our business.
The
price of our common stock has fluctuated and we expect will continue to
fluctuate substantially
and you may not be able to sell your shares at or above your purchase
price.
The
market price of our common stock has been and we expect will continue to be
highly volatile and may fluctuate substantially due to many factors,
including:
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volume
and timing of orders for our
products;
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the
introduction of new products or product enhancements by us or our
competitors;
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disputes
or other developments with respect to intellectual property
rights;
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our
ability to develop, obtain regulatory clearance for, and market, new and
enhanced products on a timely
basis;
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product
liability claims or other
litigation;
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quarterly
variations in our or our competitors’ results of
operations;
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sales
of large blocks of our common stock, including sales by our executive
officers and directors;
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changes
in governmental regulations or in the status of our regulatory approvals
or applications;
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changes
in the availability of third-party reimbursement in the United States or
other countries;
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changes
in revenues or earnings estimates or recommendations by securities
analysts; and
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general
market conditions and other factors, including factors unrelated to our
operating performance or the operating performance of our
competitors.
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Furthermore,
to the extent there is an inactive market for our common stock, the value of
your shares and your ability to sell your shares at the time you wish to sell
them may be impaired. An inactive market may also impair our ability to raise
capital by selling shares and may impair our ability to acquire other companies,
products or technologies by using our shares as consideration.
Because
of their significant stock ownership, our executive officers, directors
and principal
stockholders may be able to exert control over us and our significant
corporate
decisions.
Based on
shares outstanding at June 30, 2008, our executive officers, directors, and
stockholders holding more than 5% of our outstanding common stock and their
affiliates, in the aggregate, beneficially owned approximately 52% of our
outstanding common stock. As a result, these persons, acting together, may have
the ability to determine the outcome of all matters submitted to our
stockholders for approval, including the election and removal of directors and
any merger, consolidation, or sale of all or substantially all of our assets.
This concentration of ownership may harm the market price of our common stock
by, among other things:
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delaying,
deferring or preventing a change in control of our
company;
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impeding
a merger, consolidation, takeover or other business combination involving
our company; or
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causing
us to enter into transactions or agreements that are not in the best
interests of all stockholders.
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Future
sales of our common stock may depress our stock price.
Our
current stockholders hold a substantial number of shares of our common stock
that they are able to sell in the public market A significant portion of these
shares are held by a small number of stockholders. Sales by our current
stockholders of a substantial number of shares could significantly reduce the
market price of our common stock. Moreover certain holders of our common stock
have the right to require us to file registration statements covering their
shares or to include their shares in registration statements that we may file
for ourselves or other stockholders.
We have
registered 6,749,963 shares of common stock that we may issue under our
1998 Stock Plan (the “1998 Plan”), 2005 Equity Incentive Plan (the “2005 Plan”)
and 2005 Employee Stock Purchase Plan. These shares can be freely sold in the
public market upon issuance. The sale by any of these holders of a large number
of securities in the public market could reduce the trading price of our common
stock and impede our ability to raise future capital.
We
do not intend to pay cash dividends.
We have
never declared or paid cash dividends on our capital stock. We currently intend
to retain all available funds and any future earnings for us in the operation
and expansion of our business and do not anticipate paying any cash dividends in
the foreseeable future. In addition, the terms of any future debtor credit
facility may preclude us from paying any dividends. As a result, capital
appreciation, if any, of our common stock will be your sole source of potential
gain for the foreseeable future.
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We
may become involved in securities class action litigation that could
divert management’s
attention and harm our business.
The stock
market in general, The NASDAQ Stock Market and the market for medical device
companies in particular, continues to experience extreme price and volume
fluctuations that are unrelated or disproportionate to companies’ operating
performance. Further, the market prices of securities of medical device
companies have been particularly volatile. These broad market and industry
factors may materially harm the market price of our common stock, regardless of
our operating performance. In the past, following periods of volatility in the
market price of a particular company’s securities, securities class action
litigation has often been brought against that company. We may become involved
in this type of litigation in the future. Litigation often is expensive and
diverts management’s attention and resources, which could materially harm our
financial condition and results of operations.
Anti-takeover
provisions in our organizational documents and Delaware law may discourage
or prevent a change of control, even an acquisition which would be beneficial
to our stockholders, and thereby affect our stock price adversely and
prevent
attempts by our stockholders to replace or remove our current
management.
Our
amended and restated certificate of incorporation and amended bylaws contain
provisions that could delay or prevent a change of control of our company or
changes in our board of directors that our stockholders might consider
favorable. Some of these provisions:
•
|
authorize
the issuance of preferred stock which can be created and issued by the
board of directors without prior stockholder approval, with rights senior
to those of the common stock;
|
•
|
provide
for a classified board of directors, with each director serving a
staggered three-year term;
|
•
|
prohibit
our stockholders from filling board vacancies, calling special stockholder
meetings, or taking action by written
consent;
|
•
|
prohibit
our stockholders from making certain changes to our amended and restated
certificate of incorporation or bylaws except with 66 2/3% stockholder
approval; and
|
•
|
require
advance written notice of stockholder proposals and director
nominations.
|
In
addition, we are subject to the provisions of Section 203 of the Delaware
General Corporation Law, which may prohibit certain business combinations with
stockholders owning 15% or more of our outstanding voting stock. These and other
provisions in our amended and restated certificate of incorporation, restated
bylaws and Delaware law could make it more difficult for stockholders or
potential acquirers to obtain control of our board of directors or initiate
actions that are opposed by our then-current board of directors, including
delaying or impeding a merger, tender offer, or proxy contest involving our
company. Any delay or prevention of a change of control transaction or changes
in our board of directors could cause the market price of our common stock to
decline.
Item 2. Unregistered Sales of
Equity Securities and Use of Proceeds
None
Item 3. Defaults Upon Senior
Securities.
None
Item 4. Submission of Matters to
a Vote of Security Holders.
None
Table of
Contents
None
See the
Index to Exhibits on Page 47 of this report
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
Date:
August 8, 2008
|
Chairman
and Chief Executive Officer
|
By:
|
/s/
Gordon T. Sangster
|
|
Table of
Contents
INDEX
TO EXHIBITS
Exhibit
Number
|
Description
|
|
|
3.1
|
Certificate
of Incorporation (incorporated by reference to Exhibit 3.2 of Amendment
No. 3 to the Registrant’s Registration Statement on Form S-1 filed on May
17, 2005 Registration No. 333-123154) (“Amendment No.
3”)
|
3.2
|
Bylaws
(incorporated by reference to Exhibit 3.4 of Amendment No.
3)
|
4.1
|
Specimen
Stock Certificate (incorporated by reference to Exhibit 4.1 of the
Registrant’s Registration Statement on
Form
S-1 filed on March 4, 2005 (Registration No. 333-123154) (“Form
S-1”)
|
4.2
|
Warrant
dated as of December 11, 2000 among the Registrant and Roberts Mitani
Capital, LLC (incorporated by reference to Exhibit 4.2 of Form
S-1)
|
4.3
|
Amended
and Restated Stockholders’ Rights Agreement dated as of February 21, 2005
among the Registrant and the parties listed therein (incorporated by
reference to Exhibit 4.3 of Form S-1)
|
4.4
|
Form
of Common Stock Warrant issued in connection with the Series E Preferred
Stock and Warrant Purchase Agreement dated February 21, 2005, among the
Registrant and the purchasers of the Registrant’s Series E Preferred Stock
(incorporated by reference to Exhibit 4.4 of Form 10-Q filed on February
14, 2006)
|
31.1#
|
Certification
of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
31.2#
|
Certification
of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
32#
|
Certifications
Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002
|
____________