ITEM
1. FINANCIAL
STATEMENTS
|
CYBERONICS,
INC. AND SUBSIDIARY
CONSOLIDATED
BALANCE SHEETS
|
|
October
24, 2008
|
|
|
April
25, 2008
|
|
|
|
(Unaudited)
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
69,340,855
|
|
|
$
|
91,058,692
|
|
Restricted
cash
|
|
|
1,000,000
|
|
|
|
1,000,000
|
|
Accounts
receivable, net of allowances of $356,920 and $240,925,
respectively
|
|
|
20,155,709
|
|
|
|
20,039,832
|
|
Inventories
|
|
|
12,580,660
|
|
|
|
12,829,710
|
|
Other
current assets
|
|
|
1,991,727
|
|
|
|
2,108,185
|
|
Total
Current Assets
|
|
|
105,068,951
|
|
|
|
127,036,419
|
|
Property and equipment,
net of accumulated depreciation of $
21,849,562
and
$20,935,788, respectively
|
|
|
4,888,675
|
|
|
|
5,503,139
|
|
Other
assets
|
|
|
2,511,820
|
|
|
|
3,691,529
|
|
Total
Assets
|
|
$
|
112,469,446
|
|
|
$
|
136,231,087
|
|
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
3,608,500
|
|
|
$
|
2,740,075
|
|
Accrued
liabilities
|
|
|
12,109,560
|
|
|
|
14,547,877
|
|
Total
Current Liabilities
|
|
|
15,718,060
|
|
|
|
17,287,952
|
|
Long-Term
Liabilities:
|
|
|
|
|
|
|
|
|
Convertible
notes
|
|
|
84,650,000
|
|
|
|
125,000,000
|
|
Deferred
license revenue and other
|
|
|
8,413,214
|
|
|
|
9,166,440
|
|
Total
Long-Term Liabilities
|
|
|
93,063,214
|
|
|
|
134,166,440
|
|
Total
Liabilities
|
|
|
108,781,274
|
|
|
|
151,454,392
|
|
Commitments
and Contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
Equity (Deficit):
|
|
|
|
|
|
|
|
|
Preferred
stock, $0.01 par value per share; 2,500,000 shares authorized; no shares
issued and outstanding
|
|
|
––
|
|
|
|
––
|
|
Common
stock, $0.01 par value per share; 50,000,000 shares authorized; 28,143,889
shares issued and 27,321,552 shares outstanding at October 24, 2008; and
27,712,248 shares issued and 26,925,611 shares outstanding at April 25,
2008.
|
|
|
281,439
|
|
|
|
277,122
|
|
Additional
paid-in capital
|
|
|
254,121,289
|
|
|
|
282,788,451
|
|
Common
stock warrants
|
|
|
25,200,000
|
|
|
|
25,200,000
|
|
Hedges
on convertible notes
|
|
|
––
|
|
|
|
(38,200,000
|
)
|
Treasury
stock, 822,377 and 786,637 common shares at October 24, 2008 and April 25,
2008, respectively, at cost
|
|
|
(16,831,128
|
)
|
|
|
(16,298,835
|
)
|
Accumulated
other comprehensive income
|
|
|
(244,994
|
)
|
|
|
251,394
|
|
Accumulated
deficit
|
|
|
(258,838,434
|
)
|
|
|
(269,241,437
|
)
|
Total
Stockholders' Equity (Deficit)
|
|
|
3,688,172
|
|
|
|
(15,223,305
|
)
|
Total
Liabilities and Stockholders' Equity (Deficit)
|
|
$
|
112,469,446
|
|
|
$
|
136,231,087
|
|
See
accompanying Notes to Consolidated Financial Statements
(Unaudited).
CYB
ERONICS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
|
|
For
the Thirteen Weeks Ended
|
|
For
the Twenty-Six Weeks Ended
|
|
|
October
24, 2008
|
|
October
26, 2007
|
|
October
24, 2008
|
|
October
26, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
sales
|
|
$
|
36,031,971
|
|
|
$
|
28,946,696
|
|
|
$
|
69,763,829
|
|
|
$
|
58,022,165
|
|
Cost
of sales
|
|
|
5,177,800
|
|
|
|
4,576,104
|
|
|
|
9,994,562
|
|
|
|
10,127,871
|
|
Gross
profit
|
|
|
30,854,171
|
|
|
|
24,370,592
|
|
|
|
59,769,267
|
|
|
|
47,894,294
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling,
general and administrative
|
|
|
21,531,424
|
|
|
|
22,092,842
|
|
|
|
43,056,191
|
|
|
|
47,217,935
|
|
Research
and development
|
|
|
4,806,220
|
|
|
|
5,886,095
|
|
|
|
9,414,395
|
|
|
|
12,193,818
|
|
Total
operating expenses
|
|
|
26,337,644
|
|
|
|
27,978,937
|
|
|
|
52,470,586
|
|
|
|
59,411,753
|
|
Income
(loss) from operations
|
|
|
4,516,527
|
|
|
|
(3,608,345
|
)
|
|
|
7,298,681
|
|
|
|
(11,517,459
|
)
|
Interest
income
|
|
|
433,646
|
|
|
|
1,032,800
|
|
|
|
941,933
|
|
|
|
2,150,031
|
|
Interest
expense
|
|
|
(929,018
|
)
|
|
|
(1,402,789
|
)
|
|
|
(2,090,668
|
)
|
|
|
(2,799,996
|
)
|
Gain
on early extinguishment of debt, net
|
|
|
4,612,845
|
|
|
|
––
|
|
|
|
4,612,845
|
|
|
|
––
|
|
Other
expense, net
|
|
|
(162,494
|
)
|
|
|
(83,664
|
)
|
|
|
(145,260
|
)
|
|
|
(41,098
|
)
|
Income
(loss) before income taxes
|
|
|
8,471,506
|
|
|
|
(4,061,998
|
)
|
|
|
10,617,531
|
|
|
|
(12,208,522
|
)
|
Income
tax expense
|
|
|
121,304
|
|
|
|
15,342
|
|
|
|
214,528
|
|
|
|
32,281
|
|
Net income
(loss)
|
|
$
|
8,350,202
|
|
|
$
|
(4,077,340
|
)
|
|
$
|
10,403,003
|
|
|
$
|
(12,240,803
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
income (loss) per share
|
|
$
|
0.31
|
|
|
$
|
(0.15
|
)
|
|
$
|
0.39
|
|
|
$
|
(0.46
|
)
|
Diluted
income (loss) per share
|
|
$
|
0.14
|
|
|
$
|
(0.15
|
)
|
|
$
|
0.23
|
|
|
$
|
(0.46
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
used in computing basic income (loss) per share
|
|
|
26,680,551
|
|
|
|
26,529,485
|
|
|
|
26,550,667
|
|
|
|
26,441,601
|
|
Shares
used in computing diluted income (loss) per share
|
|
|
27,516,723
|
|
|
|
26,529,485
|
|
|
|
27,632,656
|
|
|
|
26,441,601
|
|
See
accompanying Notes to Consolidated Financial Statements
(Unaudited).
CYB
ERONICS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
For
the Twenty-Six Weeks Ended
|
|
|
|
October
24, 2008
|
|
|
October
26, 2007
|
|
|
|
|
|
|
|
|
Cash
Flow From Operating Activities:
|
|
|
|
|
|
|
|
|
Net
income (loss)
|
|
$
|
10,403,003
|
|
|
$
|
(12,240,803
|
)
|
Non-cash
items included in net income (loss):
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
1,209,057
|
|
|
|
1,707,179
|
|
Loss
on disposal of assets
|
|
|
1,578
|
|
|
|
1,483
|
|
Gain
on early extinguishment of debt, net
|
|
|
(4,612,845
|
)
|
|
|
––
|
|
Unrealized
loss in foreign currency transactions
|
|
|
412,790
|
|
|
|
69,156
|
|
Stock-based
compensation
|
|
|
5,221,077
|
|
|
|
5,846,173
|
|
Amortization
of financing costs and other items
|
|
|
355,376
|
|
|
|
390,669
|
|
Other
non-cash items
|
|
|
––
|
|
|
|
18,215
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable, net
|
|
|
(1,117,839
|
)
|
|
|
1,298,991
|
|
Inventories
|
|
|
405,696
|
|
|
|
2,121,000
|
|
Other
current assets
|
|
|
(54,465
|
)
|
|
|
499,521
|
|
Other
assets, net
|
|
|
39,309
|
|
|
|
95,477
|
|
Accounts
payable and accrued liabilities
|
|
|
(800,228
|
)
|
|
|
(4,731,131
|
)
|
Deferred
license revenue
|
|
|
(746,984
|
)
|
|
|
––
|
|
Deferred
income taxes
|
|
|
2,626
|
|
|
|
––
|
|
Other
|
|
|
(81,481
|
)
|
|
|
6,828
|
|
Net
cash provided by (used in) operating activities
|
|
|
10,636,670
|
|
|
|
(4,917,242
|
)
|
|
|
|
|
|
|
|
|
|
Cash
Flow From Investing Activities:
|
|
|
|
|
|
|
|
|
Purchases
of property and equipment
|
|
|
(659,361
|
)
|
|
|
(512,219
|
)
|
Net
cash used in investing activities
|
|
|
(659,361
|
)
|
|
|
(512,219
|
)
|
|
|
|
|
|
|
|
|
|
Cash
Flow From Financing Activities:
|
|
|
|
|
|
|
|
|
Payments
on financing obligations
|
|
|
––
|
|
|
|
(58,620
|
)
|
Early
extinguishment of debt
|
|
|
(34,902,750
|
)
|
|
|
––
|
|
Proceeds
from exercise of options for common stock
|
|
|
4,256,353
|
|
|
|
5,098,790
|
|
Purchase
of treasury stock
|
|
|
(532,293
|
)
|
|
|
(115,313
|
)
|
Net
cash provided by (used in) financing activities
|
|
|
(31,178,690
|
)
|
|
|
4,924,857
|
|
|
|
|
|
|
|
|
|
|
Effect
of exchange rate changes on cash and cash equivalents
|
|
|
(516,456
|
)
|
|
|
(13,734
|
)
|
Net
decrease in cash and cash equivalents
|
|
|
(21,717,837
|
)
|
|
|
(518,338
|
)
|
Cash
and cash equivalents at beginning of period
|
|
|
91,058,692
|
|
|
|
84,804,876
|
|
Cash
and cash equivalents at end of period
|
|
$
|
69,340,855
|
|
|
$
|
84,286,538
|
|
|
|
|
|
|
|
|
|
|
Supplementary
Disclosures of Cash Flow Information:
|
|
|
|
|
|
|
|
|
Cash
paid for interest
|
|
$
|
1,515,334
|
|
|
$
|
2,698,088
|
|
Cash
paid for income taxes
|
|
$
|
268,205
|
|
|
$
|
30,812
|
|
See
accompanying Notes to Consolidated Financial Statements
(Unaudited).
CYB
ERONICS, INC. AND SUBSIDIARY
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For
the Thirteen and Twenty-Six Weeks Ended October 24, 2008 and October 26,
2007
Note
1. Basis of Presentation
The
accompanying unaudited consolidated financial statements of Cyberonics, Inc.
(“we”,”us” and “our”) have been prepared in accordance with generally accepted
accounting principles (“GAAP”) in the United States of America (“U.S.”) (“U.S.
GAAP”) for interim financial information and the instructions to Form 10-Q and
Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the
information and footnotes required by U.S. GAAP for complete financial
statements. In the opinion of management, all adjustments (consisting of normal
recurring accruals) considered necessary for a fair presentation have been
included. Operating results for the thirteen and twenty-six weeks ended October
24, 2008 are not necessarily indicative of the results that may be expected for
any other interim period or the full year ending April 24, 2009. The financial
information presented herein should be read in conjunction with the audited
consolidated financial statements and notes thereto included in our Annual
Report on Form 10-K for the period ended April 25, 2008 (“2008 Form
10-K”).
Note
2. Stock Incentive and Purchase Plan
Stock Options
. We
adopted the Financial Accounting Standards Board (“FASB”) Statement No. 123
(revised 2004), “
Share-Based
Payment
” (“FAS 123(R)”) effective April 29, 2006, which was the first day
of our fiscal year 2007, using the Black-Scholes option pricing model and the
Modified Prospective Method, which requires compensation cost to be recognized
for grants issued after the adoption date and the unvested portion of grants
issued prior to the adoption date.
We may
grant options to directors, officers and key employees. Options we
grant generally vest ratably over the period ending with the fourth or fifth
anniversary of the grant date and have a maximum life of 10
years. Stock option grant prices are set according to the applicable
stock option plan and are equal to either the closing price of our common stock
on the last trading day prior to the grant date or the closing price of our
common stock on the day of the grant. There are no post-vesting
restrictions on the shares issued. We issue new shares upon share
option exercise. We use the Black-Scholes option pricing methodology to
calculate the grant date fair market value of stock option grants.
During
the thirteen weeks ended October 24, 2008, we granted options on a total of
23,250 shares to key employees at a fair market value of $8.62 per share
optioned. During the twenty-six weeks ended October 24, 2008 we granted options
on a total of 320,541 shares to officers and key employees at an average fair
market value of $11.42 per share optioned. All options issued during
the current fiscal year vest at a rate of 25% on each of the first four
anniversaries of the grant date. As of October 24, 2008, unrecognized
compensation expense related to stock options was $8.9 million, which is
expected to be recognized over a weighted average period of 2.76
years.
Restricted Stock, Restricted Stock
Units and Other Stock-Based Awards
. We may grant restricted
stock, restricted stock units or stock awards to directors, officers and key
employees. Typically, grants are service-based and either vest
ratably over four years or cliff vest in three years. Compensation cost is
expensed ratably over the service period. We may also grant
restricted stock subject to performance or market conditions that can vest based
on the satisfaction of the conditions of the grant. Restricted stock, restricted
stock units or stock awards have no purchase cost to the
grantee. Nonvested stock entitles the grantees to dividends, if any,
and voting rights for their respective shares. Sale or transfer of
the shares is restricted until vested. Generally, the fair market
value of restricted stock is determined for accounting purposes using the market
closing price on the grant date. The fair market value and derived service
period of market condition-based grants is determined using the Monte Carlo
simulation method. The derived service period for performance-based grants is
estimated based on our judgment of likely future performance. We issue new
shares for the granting of restricted stock. We expect to repurchase
no more than approximately 14,000 treasury shares upon vesting of restricted
stock subject to performance conditions next quarter in order to meet the
minimum statutory tax withholding requirements resulting from the
exercises.
During
the thirteen weeks ended October 24, 2008 we granted a total of 23,665
restricted shares to key employees at a fair market value of $18.85 per share.
During the twenty-six weeks ended October 24, 2008 we granted a total of 152,612
restricted shares to officers and key employees at an average fair market value
of $20.62 per share. All restricted shares granted during the current
fiscal year either cliff vest on the third anniversary of the grant date or vest
at a rate of 25% on each of the first four anniversaries of the grant date. At
October 24, 2008, unrecognized compensation expense related to restricted shares
was $7.2 million, which is expected to be recognized over a weighted average
vesting period of 2.30 years.
Our net
income for the thirteen and twenty-six weeks ended October 24, 2008 is net of
$2.7 million and $5.3 million, respectively, of stock-based compensation
expense. Our net loss for the thirteen and twenty-six weeks ended
October 26, 2007 is net of $2.6 million and $6.3 million, respectively, of
stock-based compensation expense. Because of our prior year net operating
losses, our deferred tax benefits related to our stock-based compensation
expense are offset by a valuation allowance. In addition, because of
our prior year net operating losses, our current tax benefits related to all of
our stock-based compensation arrangements are unrealized and
unrecognized.
Employee Stock Purchase
Plan.
Under our 1991 Employee Stock Purchase Plan (“Stock
Purchase Plan”), 950,000 shares of our common stock have been reserved for
issuance. Subject to certain limits, the Stock Purchase Plan allows
eligible employees to purchase shares of our common stock through payroll
deductions of up to 15% of their respective current compensation at a price
equaling 95% of the fair market value of our common stock on the last business
day of the purchase period. Purchase periods, under provisions of the
Stock Purchase Plan, are six months in length and begin on the first business
days of June and December. As of October 24, 2008, 410,413 shares
remain available for future issuances under the Stock Purchase
Plan. No compensation expense is recorded for the Stock Purchase
Plan.
Note
3. Inventories
Inventories
consist of the following:
|
|
October 24,
2008
|
|
|
April 25,
2008
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Raw
materials and components
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
4. Accrued Liabilities
Accrued
liabilities are as follows:
|
|
October
24, 2008
|
|
|
April
25, 2008
|
|
|
(Unaudited)
|
|
|
|
Payroll
and other compensation
|
|
$
|
6,677,153
|
|
|
$
|
7,987,219
|
Clinical
costs
|
|
|
1,322,672
|
|
|
|
1,978,942
|
Royalties
|
|
|
1,042,017
|
|
|
|
994,398
|
Tax
accruals
|
|
|
1,027,861
|
|
|
|
849,680
|
Other
|
|
|
2,039,857
|
|
|
|
2,737,638
|
|
|
$
|
12,109,560
|
|
|
$
|
14,547,877
|
Note
5. Warranties
We offer
warranties on our leads and generators for one to two years from the date of
implantation, depending on the product in question. We provide, at the time of
shipment, for costs estimated to be incurred under our product
warranties. Provisions for warranty expenses are made based upon
projected product warranty claims.
Changes
in our liability for product warranties are recorded under accrued liabilities
and are as follows:
|
|
For
the Thirteen Weeks Ended
|
|
For
the Twenty-Six Weeks Ended
|
|
|
October
24, 2008
|
|
October
26, 2007
|
|
October
24, 2008
|
|
October
26, 2007
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
Balance
at the beginning of the period
|
|
$
|
81,890
|
|
|
$
|
89,709
|
|
|
$
|
79,055
|
|
|
$
|
68,822
|
|
Warranty
expense (credit) recognized
|
|
|
(1,501
|
)
|
|
|
(9,589
|
)
|
|
|
1,334
|
|
|
|
11,948
|
|
Warranty
settled
|
|
|
––
|
|
|
|
––
|
|
|
|
––
|
|
|
|
(650
|
)
|
Balance
at the end of the period
|
|
$
|
80,389
|
|
|
$
|
80,120
|
|
|
$
|
80,389
|
|
|
$
|
80,120
|
|
Note 6. Convertible
Notes
On
September 27, 2005, we issued $125.0 million of convertible notes (the
“Convertible Notes”). Interest on the Convertible Notes at the rate of 3% per
year on the principal amount is payable semi-annually in arrears in cash on
March 27 and September 27 of each year beginning March 27, 2006. The
Convertible Notes are unsecured and subordinated to all of our existing and
future senior debt and equal in right of payment with our existing and future
senior subordinated debt. Holders may convert their Convertible Notes, which
were issued in the form of $1,000 bonds, into 24.0964 shares of our common
stock per bond, which equals a conversion price of $41.50 per share, subject to
adjustments, at any time prior to maturity. Holders who convert their
Convertible Notes in connection with certain fundamental changes may be entitled
to a make-whole premium, in the form of an increase in the conversion rate. A
fundamental change will be deemed to have occurred upon a change of control,
liquidation or a termination of trading. The make-whole premium, depending on
the price of the stock and the date of the fundamental change, may range from
6.0241 to 0.1881 shares per bond, when the stock price ranges from $33.20
to $150.00, respectively. If a fundamental change of our company occurs, the
holder may require us to purchase all or a part of their Convertible Notes at a
price equal to 100% of the principal amount of the Convertible Notes to be
purchased plus accrued and unpaid interest, if any. We may, at our option,
instead of paying the fundamental change purchase price in cash, pay it in our
common stock valued at a 5% discount from the market price of our common stock
for the 20 trading days immediately preceding and including the third day prior
to the date we are required to purchase the Convertible Notes, or in any
combination of cash and shares of our common stock.
The
issuance of the Convertible Notes provided net proceeds of approximately
$121.0 million. We used the proceeds for (1) a simultaneous share
buyback of 301,000 shares at $33.20 for a total of approximately
$10.0 million and (2) the net cost of $13.0 million related to
the call options to buy approximately 3.0 million shares of our common stock at
an exercise price of $41.50 per share (the “Note Hedge”) and warrants to sell
approximately 3.0 million shares of our common stock at an exercise price of
$50.00 per share (the “Warrants”). The Note Hedge and Warrants were
designed to limit our exposure to potential dilution from conversion of the
Convertible Notes. These transactions reduced net cash proceeds from the
issuance of the Convertible Notes to approximately
$98.3 million.
Pursuant
to the indenture that governs the Convertible Notes (the “Indenture”), we are
required to deliver to the trustee of the Convertible Notes (the “Trustee”),
“within 15 days after we file them” with the Securities and Exchange
Commission (the “SEC”), copies of all Annual Reports on Form 10-K and other
information, documents and other reports that we are required to file with the
SEC pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934,
as amended (“Exchange Act”). In July 2006, the Trustee asserted that we failed
to comply with this requirement. As part of the settlement of the
resulting litigation, the parties executed a supplemental indenture dated April
18, 2008 (the “Supplemental Indenture”). The Supplemental Indenture
obligates us to repurchase for par value any of the Convertible Notes tendered
to us on December 27, 2011, nine months prior to the maturity date. The
Supplemental Indenture makes no additional changes to the terms of the original
Indenture.
During
the thirteen weeks ended October 24, 2008 we repurchased approximately $40.4
million of aggregate principal amount of our Convertible Notes in
privately-negotiated transactions at a purchase price of approximately $34.9
million, for a favorable impact of $5.4 million. As a result of the
purchases, we wrote off approximately $0.8 million in unamortized bond issue
costs for a net gain on early extinguishment of debt of approximately $4.6
million.
The
estimated fair value of the Convertible Notes was approximately
$52.5 million, based on the outstanding liability of approximately $84.7
million as of October 24, 2008, and approximately $105.8 million,
based on the outstanding liability of $125.0 million, as of April 25, 2008.
Market quotes obtained from brokers were used to estimate the fair value of this
debt.
Note
7. Convertible Note Hedge and Warrants
On
September 27, 2005, in conjunction with the issuance of $125.0 million
of Convertible Notes, we purchased the Note Hedge and sold the Warrants. The
Note Hedge and the Warrants are recorded in stockholders’ equity (deficit) on
our consolidated balance sheets. On May 5, 2008 we received from
Merrill Lynch International (“MLI”) a notice that the Note Hedge was terminated
effective May 6, 2008 in accordance with its terms. It was determined
that the Supplemental Indenture constituted an “Amendment Event” (as such term
is defined in the Note Hedge confirmation) that resulted in the occurrence of an
“Additional Termination Event” (as such term is defined in the Note Hedge
confirmation) and gave rise to a right to termination. As a
consequence of that action, we have reflected the termination of the Note Hedge
as a $38.2 million reduction of paid-in capital in the thirteen weeks ended July
25, 2008. The termination had no effect on our consolidated
statements of operations, however, the Warrants remain outstanding and could be
exercised if our stock price exceeds $50.00 per share.
Note
8. Comprehensive Income (Loss)
We follow
FASB Statement No. 130,
"Reporting Comprehensive
Income"
(“FAS 130”) in accounting for comprehensive income (loss) and its
components. The comprehensive income for the thirteen and twenty-six
weeks ended October 24, 2008 was approximately $7.9 million and $9.9 million,
respectively. The comprehensive loss for the thirteen and twenty-six
weeks ended October 26, 2007 was approximately $3.9 million and $12.3 million,
respectively.
Note 9. Income
Taxes
We
account for income taxes under FASB Statement No. 109, “
Accounting for Income Taxes
"
("FAS 109"). Under this method, deferred income taxes reflect the impact of
temporary differences between financial accounting and tax basis of assets and
liabilities. The differences relate primarily to the deductibility of certain
accruals and reserves and the effect of tax loss and tax credit carry-forwards
not yet utilized. Deferred tax assets are evaluated for realization based on a
more-likely-than-not criterion in determining if a valuation allowance should be
provided.
We
estimate our effective tax rate for the twenty-six weeks ended October 24, 2008
to be less than 3%, due primarily to the change in the balance of our valuation
allowance combined with federal income tax, state and local taxes and tax on
foreign operations. The effective tax rate represents our best
estimate of the rate expected to be applicable for the full fiscal
year. In the past we have experienced ownership changes as defined in
Section 382 of the Internal Revenue Code ("IRC"), and most recently we
experienced an ownership change in August 2006. As a result, our ability to
utilize certain net operating losses to offset future taxable income in any
particular year may be limited. Due to our operating loss history and
possible limitations pursuant to Section 382 of the IRC, we have established a
valuation allowance that fully offsets our net federal deferred tax assets,
including those related to tax loss carry-forwards, resulting in no regular U.S.
federal income tax expense or benefit for financial reporting
purposes.
In June
2006, the FASB issued Financial Accounting Standard Interpretation No. 48,
“Accounting for Uncertainty in
Income Taxes — an interpretation of FASB Statement No. 109”
(“FIN 48”).
FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an
enterprise’s financial statements in accordance with FAS 109. This
interpretation prescribes a recognition threshold and measurement attribute for
the financial statement recognition and measurement of a tax position taken or
expected to be taken in a tax return. This interpretation also provides guidance
on derecognition, classification, interest and penalties, accounting in interim
periods, disclosure and transition.
The
amount of unrecognized tax benefits, as determined under FIN 48, did not
materially change during the twenty-six weeks ended October 24, 2008. We expect
that the amount of unrecognized tax benefits will decrease by approximately $0.2
million in fiscal year 2009 due to expiring credit carryforwards; however, we do
not expect the change to have any impact on our consolidated results of
operations or financial position because of the existence of the valuation
allowance. If the unrecognized tax benefits are ultimately
recognized, they would have no impact on the effective tax rate due to the
existence of the valuation allowance.
Our
policy is to recognize interest and penalties accrued on unrecognized tax
benefits as a component of administrative expense. As of the date of
adoption of FIN 48, we did not have any accrued interest or penalties associated
with any unrecognized tax benefits, and we did not recognize any interest
expense during the twenty-six weeks ended October 24, 2008.
We have
been under a limited scope audit by the Internal Revenue Service (“IRS”) since
November 2007 in connection with our stock option activity. In
October 2008 we received a final close out notice from the IRS regarding the
examination which stated that no changes to the tax we reported were
made. We are subject to income tax examinations for our U.S. federal
income taxes, non-U.S. income taxes and state and local income taxes for fiscal
year 1995 and subsequent years, with certain exceptions.
Note 10. Income
(Loss) Per Share
FASB
Statement No. 128, "
Earnings
Per Share
" ("FAS 128") requires dual presentation of earning per share
("EPS"): basic EPS and diluted EPS. Basic EPS is computed by dividing net income
or loss applicable to common stockholders by the weighted average number of
common shares outstanding for the period. Diluted EPS is computed by dividing
diluted income or loss applicable to common stockholders by the diluted weighted
average number of common shares outstanding for the period. In
accordance with FAS 128 diluted income or loss includes an estimate of the
effects of conversion of share-based instruments at the beginning of the period
would have on net income. Diluted shares includes dilutive stock
options and unvested restricted stock that are considered common stock
equivalents using the "
treasury stock
" method of FAS
128 and convertible debt considered common stock equivalents using the "
if-converted
" method of FAS
128.
The
following table sets forth the computation of basic and diluted income (loss)
per share of common stock:
|
|
For
the Thirteen Weeks Ended
|
|
For
the Twenty-Six Weeks Ended
|
|
|
October
24, 2008
|
|
October
26, 2007
|
|
October
24, 2008
|
|
October
26, 2007
|
|
|
|
(Unaudited)
|
|
|
|
(Unaudited)
|
|
|
|
(Unaudited)
|
|
|
|
(Unaudited)
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss)
|
|
$
|
8,350,202
|
|
|
$
|
(4,077,340
|
)
|
|
$
|
10,403,003
|
|
|
$
|
(12,240,803
|
)
|
Deduct
effect of Convertible Notes
|
|
|
(4,440,387
|
)
|
|
|
––
|
|
|
|
(4,081,999
|
)
|
|
|
––
|
|
Diluted
income (loss)
|
|
$
|
3,909,815
|
|
|
$
|
(4,077,340
|
)
|
|
$
|
6,321,004
|
|
|
$
|
(12,240,803
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
weighted average shares outstanding
|
|
|
26,680,551
|
|
|
|
26,529,485
|
|
|
|
26,550,667
|
|
|
|
26,441,601
|
|
Add
effect of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
options and restricted stock
|
|
|
342,752
|
|
|
|
––
|
|
|
|
349,134
|
|
|
|
––
|
|
Convertible
Notes
|
|
|
493,420
|
|
|
|
––
|
|
|
|
732,855
|
|
|
|
––
|
|
Diluted
weighted average shares outstanding
|
|
|
27,516,723
|
|
|
|
26,529,485
|
|
|
|
27,632,656
|
|
|
|
26,441,601
|
|
Basic
income (loss) per share
|
|
$
|
0.31
|
|
|
$
|
(0.15
|
)
|
|
$
|
0.39
|
|
|
$
|
(0.46
|
)
|
Diluted
income (loss) per share
|
|
$
|
0.14
|
|
|
$
|
(0.15
|
)
|
|
$
|
0.23
|
|
|
$
|
(0.46
|
)
|
Excluded
from the computation of diluted EPS for the thirteen and twenty-six weeks ended
October 24, 2008 were outstanding options to purchase approximately 1.2 million
common shares, because to include them would have been anti-dilutive as a result
of the exercise price of the options exceeding their current fair market
value. Excluded from the computation of diluted EPS for the thirteen
and twenty-six weeks ended October 26, 2007 were outstanding options to purchase
stock and unvested restricted stock of approximately 5.1 million common shares,
because to include them would have been anti-dilutive due to the net losses we
incurred during those periods.
The
Convertible Notes outstanding at October 24, 2008, approximately $84.7 million,
are convertible into approximately 2.0 million shares of our common stock, but
are not included in dilutive shares because under the “
if-converted
” method of FAS
128 they are anti-dilutive. We issued Warrants to sell approximately
3.0 million shares of our common stock at an exercise price of $50.00 per
share. In accordance with the “
treasury stock
” method of FAS
128, the Warrants are not included in the computation of diluted EPS because the
Warrants’ exercise price is greater than the average market price of our common
shares.
During
the thirteen weeks ended October 24, 2008 we purchased approximately $40.4
million of aggregate principal amount of our Convertible Notes in
privately-negotiated transactions. Under FASB’s Emerging Issues Task Force
("EITF") D-53,
"Computation of
Earnings per Share for a Period That Includes a Redemption or an Induced
Conversion of a Portion of a Class of Preferred Stock"
, ("EITF D-53") we
are required to determine the dilutive effect of the repurchased Convertible
Notes separately from the Convertible Notes outstanding at October 24,
2008. Under the
“if-converted
” method of FAS
128, Convertible Notes repurchased during the thirteen and twenty-six weeks
ended October 24, 2008 are treated as having been converted to common stock
equivalents at the start of the period. Adjustments to dilutive net
income related to the repurchased Convertible Notes consist primarily of
removing the gain related to the repurchases and similarly removing the effects
of interest expense and other items.
Note 11. Litigation
We are
named as a defendant in lawsuits or are the subject of governmental inquiries
from time to time arising in the ordinary course of business. The outcome of
such lawsuits or other proceedings cannot be predicted with certainty and may
have a material adverse effect on our consolidated financial position or results
of our operations.
Securities
Class Action Lawsuit
As
previously disclosed in our 2008 Form 10-K, the consolidated securities
litigation styled
In re
Cyberonics, Inc. Securities Litigation
, Civil Action No. H-05-2121 was
dismissed with prejudice by the federal district court in Houston, Texas in
October 2007, and the plaintiffs appealed that decision. On September
8, 2008, the U.S. Court of Appeals for the Fifth Circuit affirmed the district
court's dismissal with prejudice. The plaintiffs have not indicated
any plans to seek further review of the decision. However, if the
plaintiffs filed a petition for writ of certiorari with the U.S. Supreme Court
and if the writ were granted and the dismissal of the case were reversed, an
adverse result in this lawsuit could have a material adverse effect on us, our
consolidated financial positions, results of operations, and cash
flows.
Governmental
Investigation of Options Granting Practices
In
June 2006, the staff of the SEC advised us that it had commenced an
informal inquiry of some of our stock option grants, and we received a subpoena
from the Office of the U.S. Attorney for the Southern District of New York
requesting documents related to our stock option grants practices and
procedures. In October 2006, the SEC staff made an additional request for
certain documents and information related to our revised guidance on
February 8, 2006 and our financial results announced on May 1, 2006,
our sales for the quarter ended April 28, 2006, coverage or potential
coverage of our VNS Therapy System by Blue Cross and Blue Shield of Alabama and
Aetna and aging of our accounts receivable since January 1, 2003. We are
cooperating with the SEC staff and the U.S. Attorney’s Office.
At the
direction of our Board, our Audit Committee, with the assistance of its
independent counsel and counsel’s forensic accountants, completed a review of
our stock option grants, practices and procedures, including compliance with
U.S. GAAP and all applicable statutes, rules and regulations. Our Audit
Committee concluded that incorrect measurement dates were used for certain stock
option grants made principally during the period from 1998 through 2003. Based
on our Audit Committee’s investigation, subsequent internal analysis and
discussions with our independent registered public accountants, our Board
concluded on November 18, 2006, that we needed to restate certain of our
historical consolidated financial statements to record non-cash charges for
compensation expense relating to past stock option grants. The effects of these
restatements are reflected in the consolidated financial statements, including
unaudited quarterly data. None of the restatements have any impact on net cash
provided by (used in) operating activities.
Note 12. Use
of Accounting Estimates
The
preparation of the consolidated financial statements, in conformity with U.S.
GAAP, requires us to make estimates and assumptions that affect the amounts
reported in the consolidated financial statements and accompanying notes. Our
estimates and assumptions are updated as appropriate, which in most cases is at
least quarterly. We base our estimates on historical experience or various
assumptions that are believed to be reasonable under the circumstances, and the
results form the basis for making judgments about the reported values of assets,
liabilities, revenues and expenses. Actual results may differ materially from
these estimates.
Note 13. New
Accounting Pronouncements
In
September 2006, the FASB issued FAS No. 157,
“Fair Value Measurements”
(“FAS 157”). FAS 157 defines fair value, establishes a framework for
measuring fair value in U.S. GAAP and expands disclosures about fair value
measurements. FAS 157 applies under other accounting pronouncements that require
or permit fair value measurements, the FASB having previously concluded in those
accounting pronouncements that fair value is the relevant measurement attribute.
Accordingly, FAS 157 does not require any new fair value measurements. However,
for some entities, the application of FAS 157 will change current practice.
FAS 157 is effective with fiscal years beginning after November 15,
2007. In February 2008, the FASB issued Staff Position,
“FSP FAS 157-2 – Effective date of
FAS No. 157”
(“FAS 157-2”). FAS 157-2 defers the
effective date of FAS 157 to fiscal years beginning after November 15, 2008, and
interim periods within those fiscal years for nonfinancial assets and
nonfinancial liabilities, except for items that are recognized or disclosed at
fair value in the financial statements on a recurring basis (at least annually).
Our implementation of FAS 157 as of April 26, 2008
did not have an impact in
our consolidated results of operations and financial position for the twenty-six
weeks ended October 24, 2008.
In
December 2007, the FASB issued FAS No. 160,
“Noncontrolling Interests in
Consolidated Financial Statements (as amended)”
(“FAS 160”). FAS 160 will
require noncontrolling interests (previously referred to as minority interests)
to be treated as a separate component of equity, rather than as a liability or
other item outside of permanent equity. FAS160 applies to the accounting for
noncontrolling interests and transactions with noncontrolling interest holders
in consolidated financial statements. FAS 160 is effective for the periods
beginning on or after December 15, 2008. Earlier application is prohibited. The
adoption of FAS 160 is not expected to have a material impact on our
consolidated results of operations and financial position.
In
December 2007, the FASB issued FAS No. 141(R),
“Business Combinations”
(“FAS 141(R)”). FAS 141(R) required most identifiable assets, liabilities,
noncontrolling interests and goodwill acquired in a business combination to be
recorded at “full fair value.” FAS 141(R) applies to all business combinations,
including combinations among mutual entities and combinations by contract alone.
Under FAS 141(R), all business combinations will be accounted for by applying
the acquisition method. FAS 141(R) is effective for periods beginning on or
after December 15, 2008. The adoption of FAS 141(R) is not expected to have a
material impact on our consolidated results of operations and financial
position.
In March
2008, the FASB issued FAS No. 161,
“Disclosures about Derivative
Instruments and Hedging Activities—an amendment of FASB Statement No. 133”
(“FAS 161”). FAS 161 amends FAS 133,
“Accounting for Derivative
Instruments and Hedging Activities”
(“FAS 133”), and requires companies
with derivative instruments to disclose information about how and why a company
uses derivative instruments, how derivative instruments and related hedged items
are accounted for under FAS 133, and how derivative instruments and related
hedged items affect a company’s financial positions, financial performance and
cash flows. The required disclosures include the fair value of derivative
instruments and their gains or losses in tabular format, information about
credit-risk-related contingent features in derivative agreements, counterparty
credit risk and the company’s strategies and objectives for using derivative
instruments. FAS 161 expands the current disclosure framework in FAS 133. FAS
161 is effective prospectively for fiscal years beginning on or after November
15, 2008, which will begin on April 25, 2009 for us. The adoption of FAS 161 is
not expected to have a material impact on our consolidated results of operations
and financial position.
In May
2008, the FASB issued Financial Staff Position (“FSP”) APB 14-1, “
Accounting for Convertible Debt
Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash
Settlement)”
(“FSP APB 14-1”). The FSP requires issuers of convertible
debt that may be settled wholly or partly in cash to account for the debt and
equity components separately. The FSP is effective for financial
statements issued for fiscal years beginning after December 15, 2008 and interim
periods within those years, and must be applied retrospectively to all periods
presented. We are currently evaluating the impact that the
implementation of FSP APB 14-1 will have on our consolidated results of
operations and financial position.
In June
2008, the FASB issued EITF No. 03-6-1,
“Determining Whether Instruments
Granted in Share-Based Payment Transactions Are Participating Securities”
(“EITF 03-6-1”). EITF 03-6-1 requires unvested share-based payment awards that
contain non-forfeitable rights to dividends to be treated as participating
securities for purposes of determining basic earnings per share (“EPS”) as
defined in EITF Issue No. 03-6, “Participating Securities and the Two-Class
Method under FASB Statement No. 128”. EITF 03-6-1 is effective for financial
statements issued for fiscal years beginning after December 15, 2008, and
interim periods within those years. Upon adoption, all previously
reported EPS data, including interim financial statements, summaries of
earnings, and selected financial data should be adjusted retrospectively to be
in conformance with the requirements of the FSP. The adoption of EITF
03-6-1 is not expected to have a material impact on our consolidated results of
operations and financial position.
In July
2008, the FASB issued FAS No. 162,
“The Hierarchy of Generally Accepted
Accounting Principles”
(“FAS 162”). FAS 162 identifies the sources of
accounting principles and the framework for selecting the principles used in the
preparation of financial statements of nongovernmental entities that are
presented in conformity with U.S. GAAP. The levels of authority
of the accounting principles available for the preparation of financial
statements are called the GAAP hierarchy. The U.S. GAAP hierarchy had previously
been issued by the Auditing Standards Board (“ASB”) of the American Institute of
Certified Public Accountants (“AICPA”), but the FASB decided that the accounting
principles applicable to GAAP are not a function of auditing and should be
adopted as a FASB Statement. FAS 162 does not set an explicit
mandatory effective date; rather, it will become effective 60 days following
approval by the SEC of amendments made by the Public Accounting Oversight Board
(“PCAOB”) to AU Section 411,
“The Meaning of Present Fairly in
Conformity with Generally Accepted Accounting Principles.”
Any effect of
applying the provisions of FAS 162 must be reported as a change in accounting
principle in accordance with FAS No. 154,
“Accounting Changes and Error
Corrections”
(“FAS 154”). An entity must follow the disclosure
requirements of FAS 154 and disclose the accounting principles that were used
before and after the application of the provisions of FAS 162 and the reasons
why applying this Statement resulted in a change in accounting
principle. We are currently evaluating the impact that the
implementation of FAS 162 may have on our consolidated results of operations and
financial position.
Note
14. Commitments and Contingencies
Post-market Clinical
Surveillance.
Pursuant to the post-market surveillance
conditions specified as part of our FDA marketing approval, we are required to
conduct two clinical studies on treatment-resistant depression (“TRD”) patients.
One study of 460 patients, the dosing study, is a randomized controlled
study assessing three different stimulation paradigms. The other study, the TRD
registry, is a longitudinal registry that will follow 500 VNS patients and 500
non-VNS patients for up to five years. Enrollment in both studies is ongoing. We
expense the costs related to these long-term follow-up activities as they are
incurred and establish accruals for such costs incurred but not paid as of the
respective balance sheet dates. Since fiscal year 2006 when the studies were
initiated to the end of fiscal year 2008, we have incurred direct expenses of
approximately $4.2 million for the dosing study and $2.0 million for the TRD
registry. For the twenty-six weeks ended October 24, 2008 we have incurred
direct expenses of approximately $2.0 million for the dosing study and
approximately $0.5 million for the TRD registry.
License
Agreements.
Effective December 17, 2007, we entered into a licensing
agreement granting an exclusive license to certain patents and patent
applications pertaining to weight reduction, hypertension or diabetes in
exchange for an up-front, non-refundable payment of $9.5 million plus a royalty
on future commercial sales of any product covered by the licensed
patents. We retained the responsibility to prosecute the licensed
patent applications and to maintain the licensed patents, including the
obligation to pay related expenses for U.S. patents and
applications. We estimate that our obligation to prosecute the
licensed patent applications will be satisfied by the end of April 2014.
Accordingly, we are recognizing the $9.5 million up-front payment on a
straight-line basis from the date of execution of the agreement to April
2014. The unrecognized portion of the $9.5 million up-front payment is
included in other long-term liabilities on the consolidated balance sheet as of
October 24, 2008.
Lease
Agreements
. We lease facilities in Houston, Texas and several
sales offices in Europe, as well as transportation and office equipment, under
noncancelable operating leases. In the third quarter of fiscal year
2008 we abandoned a portion of our leased facilities in Houston and recorded a
liability of approximately $248,000 representing the minimum lease payments
applicable to the surrendered square footage offset by the net present value of
the estimated proceeds from the sub-lease of the space
surrendered. During the thirteen weeks ended October 24, 2008 we
reduced the estimate of the net present value of the proceeds from sub-leasing
by approximately $70,000 and charged operating expenses for the change in
estimate. At October 24, 2008 the unamortized balance of the
liability for the abandonment of lease space was approximately
$107,000.
Other
Commitments.
We have agreements whereby we indemnify our
officers and directors for certain events or occurrences while the officer or
director is, or was, serving at our request in such a capacity. The term of the
indemnification period is for the officer’s or director’s lifetime. The maximum
potential amount of future payments we could be required to make under these
indemnification agreements is unlimited, however, we believe the fair value of
these indemnification agreements is not estimable.
ITE
M 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Cautionary
Statement Regarding Forward Looking Statements
The
Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for
certain forward-looking statements. This Quarterly Report on Form 10-Q (“Form
10-Q”) contains forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities Exchange Act of
1934, as amended (the “Exchange Act”). We have made statements that may
constitute “forward-looking statements.” The words “believe,” “expect,”
“anticipate,” “plan,” “intend,” “foresee,” “should,” “would,” “could” or other
similar expressions are intended to identify forward-looking statements. These
forward-looking statements are based on our current expectations and beliefs
concerning future developments and their potential effects on us. There can be
no assurance that future developments affecting us will be those that we
anticipate. All comments concerning our expectations for future revenues and
operating results are based on our forecasts for our existing operations. These
forward-looking statements involve significant risks, uncertainties (some of
which are beyond our control) and assumptions. They are subject to change based
upon various factors, including but not limited to the risks and uncertainties
summarized below:
—
|
Changes
in our common stock price;
|
—
|
Changes
in our profitability;
|
—
|
Effectiveness
of our internal controls over financial reporting;
|
—
|
Fluctuations
in future quarterly operating results;
|
—
|
Compliance
with applicable regulations or changes in laws, regulations or
administrative practices affecting government regulation of our products,
such as the United States (“U.S.”) Food and Drug Administration (“FDA”)
laws and regulations that increase the time and/or expense of obtaining
approval for products or impose additional burdens on the manufacture and
sale of our products;
|
—
|
Our
indebtedness and debt services, which could adversely affect our
financial condition;
|
—
|
Our
ability to access capital;
|
—
|
Failure
to expand or maintain market acceptance or reimbursement for the use of
vagus nerve stimulation therapy (“VNS Therapy™”) or any
component that comprises the VNS Therapy system (the “VNS Therapy System”)
for the treatment of epilepsy and depression;
|
—
|
Any
legislative or administrative reform to the U.S. Medicare or Medicaid
systems or international reimbursement systems that significantly reduces
reimbursement for procedures using the VNS Therapy System or any component
thereof, or denies coverage for such procedures, as well as adverse
decisions relating to our products by administrators of such systems on
coverage or reimbursement issues;
|
—
|
Failure
to maintain the current regulatory approvals for our depression indication
and minimizing our required investment for this
indication;
|
—
|
Failure
to develop VNS Therapy for the treatment of other
indications;
|
—
|
Unfavorable
results from clinical studies;
|
—
|
Variations
in sales and operating expenses relative to estimates;
|
—
|
Our
dependence on certain suppliers and manufacturers to provide certain
materials, components and contract services necessary for the production
of the VNS Therapy System;
|
—
|
Product
liability-related losses and costs;
|
—
|
Protection
and validity of the intellectual property that relates to VNS
Therapy;
|
—
|
Changes
in technology;
|
—
|
Failure
to comply with applicable laws and regulations, including federal and
state privacy and security laws and regulations;
|
—
|
International
operational and economic risks and concerns;
|
—
|
Failure
to retain or attract key personnel;
|
—
|
Outcomes
of pending or future lawsuits and governmental
investigations;
|
—
|
Changes
in accounting rules that adversely affect the characterization of our
results of operations, financial position or cash
flows;
|
—
|
Availability
and cost of credit;
|
—
|
Changes
in customer spending patterns, and;
|
—
|
Continued
volatility in the global market and worldwide economic
conditions.
|
Other
factors that could cause our actual results to differ from our projected results
are described in (1) Part II, Item 1A and elsewhere in this Form 10-Q, (2) our
Annual Report on Form 10-K for the period ended April 25, 2008 (“2008 Form
10-K”), (3) our Quarterly Report on Form 10-Q for the period ended July 25,
2008, (4) our reports and registration statements filed and furnished from time
to time with the SEC and (5) other announcements we make from time to
time.
Readers
are cautioned not to place undue reliance on forward-looking statements, which
speak only as of the date hereof. We undertake no obligation to
publicly update or revise any forward-looking statements after the date they are
made, whether as a result of new information, future events or
otherwise.
Business
Overview
We are a
neuromodulation company incorporated as a Delaware corporation in 1987, engaged
in the design, development, sales and marketing of implantable medical devices
that provide a unique therapy, VNS Therapy, for the treatment of refractory
epilepsy and depression.
Our
proprietary VNS Therapy System includes the following:
—
|
A
generator to provide the appropriate stimulation to the vagus
nerve;
|
—
|
A
lead that is attached to both the generator and the vagus
nerve;
|
—
|
Associated
equipment to assist with necessary implantation
surgery;
|
—
|
Equipment
to assist with setting the stimulation parameters particular to the
patient;
|
—
|
Appropriate
instruction manuals; and
|
—
|
Magnets
to suspend or induce stimulation
manually.
|
The
implantation of the generator and lead into patients is generally performed on
an outpatient basis. The battery contained in this generator has a finite
life, which varies according to the model and the stimulation parameters and
settings used for each patient. At or near the end of the useful life of a
battery, a patient may, with the advice of a physician, choose to have a new
generator implanted, with or without replacing the original lead.
The FDA
approved our VNS Therapy System in July 1997 for use as an adjunctive therapy in
epilepsy patients over 12 years of age in reducing the frequency of partial
onset seizures that are refractory or resistant to antiepileptic drugs.
Regulatory bodies in Canada, the European Economic Area, South America, Africa,
Australia and certain countries in Eastern Asia have approved VNS Therapy for
the treatment of epilepsy, many without age restrictions or seizure-type
limitations. In July 2005, the FDA approved the VNS Therapy System for the
adjunctive long-term treatment of chronic or recurrent depression for patients
18 years of age or older who are experiencing a major depressive episode
and have not had an adequate response to four or more adequate anti-depressant
treatments. Regulatory bodies in the European Economic Area, Canada and
Israel have approved the VNS Therapy System for the treatment of chronic or
recurrent depression in patients who are in a treatment-resistant or in a
treatment-intolerant depressive episode without age restrictions.
Our
ability to successfully expand the commercialization of the VNS Therapy System
depends on obtaining and maintaining favorable insurance coverage, coding and
reimbursement for the device, the implant procedure and follow-up
care. Currently, there is broad coverage, coding and reimbursement
for VNS Therapy for the treatment of refractory epilepsy. The Centers for
Medicare and Medicaid Services, (“CMS”), which we estimate pays for
approximately 25% of the VNS Therapy implants, issues an annual update to the
reimbursement amounts received by our customers. Recently, CMS
announced a significant reduction in the rate reimbursed to our customers for
the insertion of the lead portion of the VNS Therapy System for calendar 2009,
and a small increase in the amount reimbursed for the insertion of the
generator. We are engaged in communications with CMS to address the change. This
decrease in reimbursement could have an adverse impact on our business and our
future operating results.
We are
focused on advancing the clinical foundation as a basis for establishing,
maintaining and extending reimbursement for VNS Therapy. This may
involve increased investment in research and development, specifically, seizure
detection, tele-medicine and associated technology, and could also include
additional investment in clinical studies using VNS Therapy for the treatment of
refractory epilepsy.
In May
2007, CMS issued a final determination of non-coverage with respect to
reimbursement of VNS Therapy for depression. In February 2008, we
announced that, after consulting with clinical and reimbursement experts, we had
developed a plan, including the conduct of an additional randomized clinical
study, or possibly more than one such clinical study, to obtain reimbursement
coverage for our depression indication. We also announced a plan to
transfer our depression business to a separate entity, in which we expected to
maintain at least a minority interest. We engaged an investment bank
to assist us in identifying a partner to provide the funding necessary to
execute this plan. This process has not resulted in the receipt of an
offer that provides sufficient value to our
stockholders. Accordingly, we are evaluating potential actions to
maintain the current regulatory approval, while minimizing our required
investment.
Our
clinical development program has included pilot and pivotal studies in using VNS
Therapy (1) as an adjunctive therapy for reducing the frequency of seizures
in patients over 12 years of age with partial onset seizures that are
refractory to antiepileptic drugs and (2) as an adjunctive treatment of
patients 18 years of age and older with chronic or recurrent
depression who are in a major depressive episode. We have also conducted or
provided support for small pilot studies for the use of VNS Therapy in the
treatment of Alzheimer’s disease, anxiety, bulimia, fibromyalgia, obesity,
obsessive-compulsive disorder, multiple sclerosis and other indications. These
studies have been conducted to determine the safety and effectiveness of VNS
Therapy in these new indications and to determine which new indications might be
considered for pivotal studies and, therefore, are an important component of our
clinical research activities.
Proprietary
protection for our products is important to our business. We maintain
a policy of seeking U.S. and foreign patents on selected inventions, acquiring
licenses under selected patents of third parties, and entering into invention
and confidentiality agreements with our employees, vendors and consultants with
respect to technology that we consider important to our business. We
also rely on trade secrets, unpatented know-how and continuing technological
innovation to develop and maintain our competitive position.
We are
actively engaged in determining how we can license intellectual property rights
to third parties in order to optimize our portfolio. This includes the
assessment and determination of which of our intellectual property rights for
particular indications we do not have immediate plans to develop and identifying
whether these rights should be licensed to third parties. It also involves the
assessment of the intellectual property rights of third parties in order to
determine whether we should attempt to acquire those rights through a license.
We recently granted rights to a third party to use our technology to treat
obesity. For more information on this arrangement, please see
“Licensing Agreements” under “Note 14. Commitments and Contingencies” to our
consolidated financial statements.
Since
inception, we have incurred substantial expenses, primarily for research and
development activities that include product and process development, clinical
studies and related regulatory activities, sales and marketing activities,
manufacturing start-up costs and systems infrastructure. We have also made
significant investments in connection with sales and marketing activities in the
U.S. and clinical research costs associated with new indications development,
most notably depression. As of October 24, 2008, we have incurred an accumulated
deficit of approximately $259.0 million.
Critical Accounting
Policies and Significant Accounting Estimates
The
preparation of the consolidated financial statements, in conformity with United
States generally accepted accounting principles (“U.S. GAAP”), requires us to
make estimates and assumptions that affect the amounts reported in the
consolidated financial statements and the related notes. Our estimates and
assumptions are updated as appropriate, which in most cases is at least
quarterly. We base our estimates on historical experience and assumptions that
we believe to be reasonable under the circumstances, and the results form the
basis for making judgments about the reported values of assets, liabilities,
revenues and expenses. Actual results may differ materially from these
estimates.
We
consider the following accounting policies to be the most critical because, in
management’s view, they are most important to the portrayal of our consolidated
financial position and results of operations and most demanding in terms of
requiring estimates and other exercises of judgment.
Use of
Estimates.
The preparation of consolidated financial
statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the amounts reported in the consolidated financial
statements and the accompanying notes. Actual results could differ from those
estimates. Critical estimates that require management’s judgment relate to the
allowance for doubtful accounts, estimates of any obsolete inventory, useful
lives for property and equipment, impairment of any long-lived assets, sales
returns and allowances, recognition of licensing revenue, product warranties,
stock option expenses and income tax valuation allowances.
Foreign Currency
Translation.
The assets and liabilities of our subsidiary,
Cyberonics Europe, NV are generally translated into U.S. dollars at
exchange rates in effect on reporting dates, while capital accounts are
translated at historical rates. Statements of Operations items are translated at
average exchange rates in effect during the financial statement period. The
gains and losses that result from this process are shown in the accumulated
other comprehensive income (loss) section of Stockholders’ Equity (Deficit) and
Comprehensive Income (Loss) and are not included in the determination of the
results of operations. Gains and losses resulting from foreign currency
transactions denominated in currency other than the functional currency are
included in other income and expense.
Accounts Receivable
. We
provide an allowance for doubtful accounts based upon specific customer risks
and a general provision based upon historical trends. An increase in losses
beyond that expected by management or that historically have been experienced by
us would negatively affect operations when they become known.
Inventories.
We
state our inventories at the lower of cost, the first-in first-out method or
market. Our calculation of cost includes the acquisition cost of raw materials
and components, direct labor and overhead net of obsolescence
provisions.
Property and
Equipment.
Property and equipment are carried at cost, less
accumulated depreciation. Maintenance, repairs and minor replacements are
charged to expense as incurred; significant renewals and betterments are
capitalized. We compute depreciation using the straight-line method over useful
lives ranging from two to nine years. Property and equipment under capital
leases are stated at the lower of the present value of minimum lease payments at
the beginning of the lease term or fair value at the inception of the lease.
Property and equipment under capital leases are depreciated using the
straight-line method over the shorter of the lease term or the estimated useful
life of the property.
Leases.
Financial
Accounting Standards Board (“FASB”) Statement No. 13,
“Accounting for Leases”
(“FAS
13”) establishes standards of financial accounting and reporting for leases by
lessees and lessors. We are a party to the contract of leased facilities and
other lease obligations recorded in compliance with FAS 13. The lease terms
provide for tenant improvement allowances that are recorded as deferred rent and
amortized, using the straight line method, as reduction to rent expense over the
term of the lease. Scheduled rent increases and paid holidays are recognized on
a straight-line basis over the term of the lease.
Stock
Options.
Before April 29, 2006, we adopted the
disclosure-only provisions of FASB Statement No. 123,
“Accounting for Stock-Based
Compensation”
(“FAS 123”) and FASB Statement 148,
“Accounting for Stock-Based
Compensation — Transition
and Disclosure”
(“FAS 148”). Because of this election, we accounted
for our employee stock-based compensation plans under Accounting Principles
Board (“APB”) Opinion No. 25,
“Accounting for Stock Issued
to Employees”
(“APB
25”) and the related interpretations.
We
adopted FASB Statement No. 123 (revised 2004),
“Share-Based Payment”
(“FAS 123(R)”) on April 29, 2006 using the Black-Scholes option
pricing model and the Modified Prospective Method, which requires the
compensation cost to be recognized for grants issued after the adoption date and
the unvested portion of grants issued prior to the adoption date.
Restricted Stock, Restricted Stock
Units and Other Stock-Based Awards.
We may grant restricted
stock, restricted stock units or stock awards to directors, officers and key
employees. Nonvested restricted stock grantees are entitled to dividends, if
any, and voting rights for their respective shares. Sale or transfer of the
shares is restricted until they are vested. Share grants have no
purchase cost to the grantee. Typically, grants vest ratably and compensation
costs are expensed ratably over the service period of one to five years as
required under the agreement establishing the grant. We also grant restricted
stock subject to performance or market conditions that can vest based on the
satisfaction of the conditions of the grant. The fair value of restricted stock
is determined for accounting purposes, on grant date using the grant date fair
market value of our stock. We utilize the Monte Carlo simulation method to
establish the fair value and derived service period of the market conditions
based grants. The Monte Carlo simulation method is subject to variability as
several factors utilized must be estimated, including stock price
volatility.
Revenue
Recognition.
We recognize revenue when title to the goods and
risk of loss transfer to customers, providing there are no remaining performance
obligations required of us or any matters requiring customer acceptance. We
record estimated sales returns and discounts as a reduction of net sales in the
same period revenue is recognized. Our revenues are dependent upon sales to new
and existing customers pursuant to our current policies. Changes in these
policies or sales terms could impact the amount and timing of revenue
recognized.
Licensing
Revenue
. We evaluate our license agreements and recognize
licensing revenue considering the guidance provided by Staff Accounting Bulletin
(“SAB”) Topic 13,
“Revenue
Recognition,”
EITF 00-21,
“Revenue Arrangements with Multiple
Deliverables,”
Regulation S-X Rule 5-03(b)(1),
“Sales and Revenue,”
EITF
01-14,
“Income Statement
Characterization of Reimbursement of Out-of-Pocket Expenses”
and other
regulations as applicable.
Licensing
Expense.
We have executed license agreements under which we
have secured the rights provided under certain patents. Royalties payable under
the terms of these agreements are expensed as incurred.
Research and
Development.
All research and development costs are expensed
as incurred.
Income Taxes.
We
account for income taxes under FASB Statement No. 109,
“Accounting for Income Taxes”
(“FAS 109”). Under this method, deferred income taxes reflect the
impact of temporary differences between financial accounting and tax bases of
assets and liabilities. The differences relate primarily to the deductibility of
certain accruals and reserves and the effect of tax loss and tax credit
carry-forwards not yet utilized. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be recovered or
settled. The effect on deferred tax assets and liabilities of a
change in tax rates is recognized in operations in the period that includes the
enactment date. Deferred tax assets and liabilities are evaluated for
realization based on a more-likely-than-not criterion in determining if a
valuation allowance should be provided.
Results
of Operations
Net
Sales
We sell
VNS Therapy Systems to hospitals and ambulatory surgical centers (“ASCs”) for
both epilepsy and depression indications, but we often do not know the intended
use for a specific VNS Therapy System at the time of its sale. As a
result, we use information available from two separate internal databases to
estimate our sales by indication for use.
The FDA
has designated our VNS Therapy System, which is a Class III implantable medical
device, as a “tracked” device under the FDA’s Medical Device Tracking
regulation. Consistent with the tracking regulation, we urge each
implanting hospital or ASC to complete and return to us an implant card that
provides information from which we can identify the corresponding indication for
use. We maintain the returned information in an implant card
database. Separately, we accumulate information relating to
prospective and actual patients, prescribing and implanting physicians, and
hospitals and ASCs in a sales-related database.
We do not
receive an implant card for each device we sell, and we sometimes sell devices
that are not the subject of data included in our sales-related
database. In addition, the delay between the date of a sale and the
date of receipt of the corresponding implant card may result in an implant card
being received in a fiscal quarter subsequent to the fiscal quarter
corresponding to the date of the sale. We assume that any delay,
however, will affect each fiscal quarter by approximately the same
extent. By combining information derived from both the tracking and
sales-related databases, we form an estimate of the split between units and net
sales for the epilepsy and depression indications. The accuracy of
our estimates of sales by indication for use, however, may vary from one fiscal
quarter to the next, and investors should exercise caution in relying on these
estimates.
Net sales
for the thirteen weeks ended October 24, 2008 were approximately $36.0 million,
which consisted of U.S. net product sales of $29.1 million, international net
product sales of $6.6 million and licensing revenue of $0.4
million. Net sales for the twenty-six weeks ended October 24,
2008 were approximately $69.8 million, which consisted of U.S. net product
sales of $55.3 million, international net sales of $13.7 million
and licensing revenue of $0.8 million.
U.S. net
product sales for the thirteen weeks ended October 24, 2008 increased by
approximately $6.0 million, or 26%, as compared to the second quarter of fiscal
year 2008, due to 20% higher average selling prices and a 6% growth in unit
sales volumes. International net sales for the thirteen weeks ended
October 24, 2008 increased by approximately $0.7 million, or 12%, as compared to
the second quarter of fiscal year 2008, due primarily to higher average selling
prices. The increase in international average selling prices was negatively
affected by an unfavorable foreign currency exchange impact of 1%.
U.S. net
product sales for the twenty-six weeks ended October 24, 2008 increased by
approximately $9.2 million, or 20%, as compared to the twenty-six weeks ended
October 26, 2007 due to 15% higher average selling prices and a 5% growth in
unit sales volumes. International net sales for the twenty-six weeks
ended October 24, 2008 increased by approximately $1.8 million, or 15%, as
compared to the twenty-six weeks ended October 26, 2007 due to 16% higher
average selling prices offset by a 1% decrease in unit sales volume. The
increase in average selling prices was due in part to a favorable currency
exchange impact of 5%.
U.S. net
product sales attributable to the depression indication have declined
significantly since the May 2007 issuance by the CMS of a national non-coverage
determination with respect to VNS Therapy for depression. We estimate that our
U.S. net sales attributable to depression for the thirteen weeks ended October
24, 2008 were approximately $0.5 million compared to $1.4 million for the
corresponding period last fiscal year, a decrease of approximately
63%. We estimate that our U.S. net sales attributable to depression
for the twenty-six weeks ended October, 24, 2008 were approximately $1.0 million
as compared to $3.6 million for the twenty-six weeks ended October 26, 2007, a
decrease of 73%.
In
December 2007, we received a $9.5 million up-front payment relating to the
licensing of certain of our patent rights pertaining to weight reduction,
hypertension and diabetes. We are amortizing this up-front payment on
a straight-line basis until April 2014, the estimated end of our obligation to
prosecute the related licensed patent applications. During the
thirteen and twenty-six weeks ended October 24, 2008, we recognized licensing
revenue in the amount of approximately $0.4 and $0.8 million, respectively.
There was no licensing revenue in the corresponding quarters of the prior fiscal
year.
Gross
Profit
The gross
profit for product sales for the thirteen weeks ended October 24, 2008 was 85.5%
of net sales, compared to 84.2% in the corresponding quarter of last year. The
gross profit for the twenty-six weeks ended October 24, 2008 was 85.5% of net
sales, compared to 82.5% over the same period of the previous fiscal
year. These increases in gross profit margins were primarily a result
of higher average selling prices, with improvement in manufacturing efficiencies
also contributing to the increases.
Cost of
sales consists primarily of direct labor, allocated manufacturing overhead,
third-party contractor costs, royalties, and the acquisition cost of raw
materials and components. We are obligated to pay royalties at a rate
of approximately 3% of net sales. Gross profit can be expected to
fluctuate in future periods based upon the mix between U.S. and international
sales, direct and distributor sales, the VNS Therapy System selling price,
applicable royalty rates, and the levels of production volume.
Gross
profit in licensing revenue for the thirteen and twenty-six weeks ended October
24, 2008 was approximately $0.4 million and $0.8 million, respectively, or 100%,
of licensing revenue. We did not incur any licensing cost during the
thirteen and twenty-six weeks ended October 24, 2008. Licensing cost,
when incurred, represents legal fees to prosecute patent applications and
royalties paid applicable to the assignment of certain patents.
Operating
Expenses
Selling, General and Administrative
(“SG&A”) Expenses
. SG&A expenses are comprised of
sales, marketing, development, general and administrative
activities. SG&A expenses were approximately $21.5 million for
the thirteen weeks ended October 24, 2008, a decrease of approximately $0.6
million, or 3%, compared to the thirteen weeks ended October 26,
2007. SG&A expenses were approximately $43.0 million for the twenty-six
weeks ended October 24, 2008, a decrease in expenses of approximately $4.2
million, or 9%, compared to the same period in the previous fiscal
year. These decreases in SG&A expense were primarily due to the
expense incurred related to the personnel reductions last fiscal year and
reduced marketing and legal expenses this fiscal year.
Research and Development (“R&D”)
Expenses
. R&D expenses are comprised of expenses related
to our product and process development, product design efforts, clinical study
programs and regulatory activities. R&D expenses were approximately
$4.8 million for the thirteen weeks ended October 24, 2008 which represents a
decrease of approximately $1.1 million, or 18%, compared to fiscal year 2008
second quarter. R&D expenses were approximately $9.4 million for the
twenty-six weeks ended October 24, 2008, a decrease in expenses of approximately
$2.8 million, or 23%, as compared to the same period in the previous fiscal
year. These decreases in expense were primarily due to efforts to
reduce clinical and regulatory expenses related to the depression indication and
personnel reductions.
Early
Extinguishment of Debt
During
the thirteen weeks ended October 24, 2008 we repurchased approximately $40.4
million principal value of our 3% convertible notes due in December 2011 (the
“Convertible Notes”) in privately-negotiated transactions at a purchase price of
approximately $34.9 million for a favorable impact of $5.4
million. As a result of the purchases, we wrote-off approximately
$0.8 million in unamortized bond issue costs for a net gain on early
extinguishment of debt of approximately $4.6 million.
Interest
Income
Interest
income of approximately $0.4 million for the thirteen weeks ended October
24, 2008 represented a decrease of 58%, as compared to interest income of
approximately $1.0 million for the same period of fiscal year 2008, which was
primarily due to lower interest rates. Interest income of approximately $0.9
million for the twenty-six weeks ended October 24, 2008 represented a decrease
of 56%, as compared to interest income of $2.2 for the same period of fiscal
year 2008, which was primarily due to lower interest rates partially offset by
higher cash balances.
Interest
Expense
Interest
expense of approximately $0.9 million for the thirteen weeks ended October 24,
2008 represented a decrease of approximately $0.5 million, or 34%, as compared
to the fiscal year 2008 second quarter. Interest expense of
approximately $2.1 million for the twenty-six weeks ended October 24, 2008
decreased by approximately $0.7 million, or 25%, as compared to the twenty-six
weeks ended October 26, 2007. These changes were primarily due to our
repurchase of approximately $40.4 million principal value of our Convertible
Notes and to the termination, in January 2008, of the line of credit under the
revolving line of credit with Merrill Lynch Capital, a division of Merrill Lynch
Business Financial Services, Inc. (the “Credit Agreement”).
Other
Expense, Net
Other
expense, net was approximately $162,000 for the thirteen weeks ended October 24,
2008, compared to $84,000 for the corresponding period of fiscal year
2008. For the twenty-six weeks ended October 24, 2008, other
expense, net was approximately $145,000 as compared to $41,000 for the same
period of the previous fiscal year. The increases in other expense, net
primarily consist of the effects of transaction gains and losses associated with
changes in foreign currency exchange rates and realized gains and losses in
connection with the disposal of assets.
Income
Taxes
We
estimate our effective tax rate for the twenty-six weeks ended October 24, 2008
to be less than 3%, due primarily to the change in the balance of our valuation
allowance combined with federal income tax, state and local taxes and tax on
foreign operations. The effective tax rate represents our best
estimate of the rate expected to be applicable for the full fiscal
year. In the past we have experienced ownership changes as defined in
the Internal Revenue Code (“IRC”) Section 382, and most recently we experienced
an ownership change in August 2006. Our ability to utilize certain
net operating losses to offset future taxable income in any particular year may
be limited pursuant to IRC Section 382. Due to our operating loss
history and possible limitations pursuant to IRC Section 382, we have
established a valuation allowance that fully offsets our federal net deferred
tax assets, including those related to tax loss carry-forwards, resulting in no
regular U.S. federal income tax expense or benefit for financial reporting
purposes.
Liquidity
and Capital Resources
Overview
Net cash
decreased by $21.7 million during the twenty-six weeks ended October 24,
2008 due primarily to the increase in cash provided by operations of $10.6
million and stock option exercises of $4.3 million offset by cash used to
repurchased approximately $40.4 million principal value of our Convertible Notes
at a purchase price of approximately $34.9 million.
Cash Flows
Net cash
provided by (used in) operating, investing and financing activities for the
twenty-six weeks ended October 24, 2008 and October 26, 2007 were as
follows:
|
|
Twenty-Six
Weeks Ended
|
|
|
October
24, 2008
|
|
October
26, 2007
|
|
|
(Unaudited)
|
|
|
|
(Unaudited)
|
|
Operating
activities
|
|
$
|
10,636,670
|
|
|
$
|
(4,917,242
|
)
|
Investing
activities
|
|
|
(659,361
|
)
|
|
|
(512,219
|
)
|
Financing
activities
|
|
|
(31,178,690
|
)))
|
|
|
4,924,857
|
|
Operating
Activities
Net cash
provided by operating activities during the twenty-six weeks ended October 24,
2008 was $10.6 million as compared to net cash used in operating activities of
$4.9 million during the same period of the previous fiscal year. The
primary reasons for the increase in cash provided by operating activities were
increased sales and lower operating expenses.
Investing
Activities
Net cash
used in investing activities during the twenty-six weeks ended October 24, 2008
was $0.7 million compared to net cash used in investing activities of $0.5
million during the same period of the previous fiscal year. These
amounts represent investment in property and equipment. We estimate a total
investment of approximately $2.5 million during the current fiscal
year primarily to meet business requirements and to enhance business
infrastructure and facilities.
Financing
Activities
Net cash
used by financing activities during the twenty-six weeks ended October 24, 2008
was $31.2 million compared to net cash provided by financing activities of $4.9
million during the same period of the previous fiscal year. The
primary cause for the cash used by financing activities this year was the
repurchase of a portion of our Convertible Notes at a purchase price of $34.9
million, partially offset by the proceeds from issuance of common stock pursuant
to stock option exercises of $4.3 million. The primary source for cash provided
by financing activities during the twenty-six weeks ended October 26, 2007 was
the issuance of common stock pursuant to stock option exercises.
Debt
Instruments and Related Covenants
Convertible
Notes
In
September 2005, we issued $125.0 million of Convertible Notes. Interest on the
Convertible Notes at the rate of 3% per year on the principal amount is
payable semi-annually in arrears in cash on March 27 and September 27 of each
year, beginning March 27, 2006. The Convertible Notes are unsecured and
subordinated to all of our existing and future senior debt and equal in right of
payment with our existing and future senior subordinated debt. Holders may
convert their Convertible Notes, which were issued in the form of $1,000 bonds,
into 24.0964 shares of our common stock per bond, which equals a conversion
price of $41.50 per share, subject to adjustments, at any time prior to
maturity.
In
connection with the settlement of litigation relating to the Convertible Notes,
we executed a supplemental indenture dated April 18, 2008 (the
“Supplemental Indenture”) and, as a result, we are required to repurchase any
Convertible Notes at par that are tendered to us on December 27, 2011, which is
nine months prior to the original maturity. The Supplemental
Indenture otherwise made no additional changes to the terms of the original
Indenture.
During
the thirteen weeks ended October 24, 2008 we repurchased approximately $40.4
million aggregate principal amount of our Convertible Notes in
privately-negotiated transactions at a purchase price of approximately $34.9
million for a favorable impact of $5.4 million. As a result of the
purchases, we wrote off approximately $0.8 million in unamortized bond issue
costs for a net gain on early extinguishment of debt of approximately $4.6
million.
Contractual
Obligations
We are
party to a number of contracts pursuant to which we are obligated to pay for
clinical studies totaling $1.3 million as of October 24, 2008, which is included
in accrued liabilities.
The table
below reflects our current obligations under our material contractual
obligations as of October 24, 2008:
|
|
Notes
Issuance
(1)
|
|
Operating
Leases
(2)
|
|
Other
(3)
|
|
Total
Contractual
Obligations
|
Contractual
obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
Less
Than One Year
|
|
$
|
2,539,500
|
|
$
|
3,235,498
|
|
$
|
267,876
|
|
$
|
6,042,874
|
1-3
Years
|
|
|
5,079,000
|
|
|
5,755,483
|
|
|
20,068
|
|
|
10,854,551
|
4-5
Years
|
|
|
85,114,917
|
|
|
5,544,942
|
|
|
20,095
|
|
|
90,679,954
|
Over
5 Years
|
|
|
—
|
|
|
3,329,373
|
|
|
26,116
|
|
|
3,355,489
|
Total
Contractual Obligations
|
|
$
|
92,733,417
|
|
$
|
17,865,296
|
|
$
|
334,155
|
|
$
|
110,932,868
|
_________________________________
(1)
|
Consists
of principal and interest obligations related to the Convertible Notes
issuance presented as if terms of the Convertible Notes were to become due
and payable on December 27, 2011, in accordance with the Supplemental
Indenture.
|
|
|
(2)
|
Consists
of operating lease obligations related to our facilities and office
equipment.
|
|
|
(3)
|
Reflects
amounts we expect to expend in connection with sales, marketing and
training events and licensing
agreements.
|
We
believe our current financial and capital resources will be adequate to fund
anticipated business activities. However, our liquidity could be
adversely affected by the factors affecting future operating results, including
those discussed in Part II, Item 1A, “Risk Factors” below.
Impact
of New Accounting Pronouncements
See “Note
13. New Accounting Pronouncements” in the Notes to Consolidated Financial
Statements for a description of the impact of new accounting
pronouncements.