10-Q 1 form10-q.htm FORM 10-Q FOR QUARTER ENDED OCTOBER 26, 2012 form10-q.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 10-Q
 
(Mark One)
[X]
Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended October 26, 2012 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:  0-19806
CYBERONICS LOGO
CYBERONICS, INC.

(Exact name of registrant as specified in its charter)

Delaware
76-0236465
(State or other jurisdiction of
(I.R.S. Employer
incorporation or organization)
Identification No.)
   
100 Cyberonics Boulevard
 
Houston, Texas
77058
(Address of principal executive offices)
(Zip Code)

(281) 228-7200
(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   þ No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).          Yes    þ 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.

 Large accelerated filer
¨
 
Accelerated filer
þ
 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  þ

Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.

Class
Outstanding at November 13, 2012
Common Stock $0.01 par value
27,720,469


 
 
 
1

 



CYBERONICS, INC.

INDEX

   
PAGE NO.
 
PART I.  FINANCIAL INFORMATION
 
Item 1
Condensed Consolidated Financial Statements
 
 
3
 
4
 
5
 
6
 
7
Item 2
19
Item 3
31
Item 4
31
     
 
PART II.  OTHER INFORMATION
 
     
Item 1
32
Item 1A
32
Item 2
32
Item 6
33


In this Quarterly Report on Form 10-Q, “Cyberonics,” “we,” “us” and “our” refer to Cyberonics, Inc. and its consolidated subsidiaries (Cyberonics Europe BVBA, Cyberonics France Sarl, Cyberonics Holdings LLC, CYBX Netherlands C.V., Cyberonics Spain, S.L., Cyberonics Latam S.R.L.).
______________



 
 
 
2

 
Index

PART I.  FINANCIAL INFORMATION

ITEM 1.     CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

CYBERONICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

   
For the Thirteen Weeks Ended
 
For the Twenty-Six Weeks Ended
   
October 26, 2012
 
October 28, 2011
 
October 26, 2012
 
October 28, 2011
                                 
Net sales
 
$
62,955,645
   
$
53,695,061
   
$
123,276,816
   
$
106,357,137
 
Cost of sales
   
5,169,804
     
4,160,664
     
10,180,981
     
11,082,699
 
Gross profit
   
57,785,841
     
49,534,397
     
113,095,835
     
95,274,438
 
Operating expenses:
                               
Selling, general and administrative
   
27,569,480
     
25,580,233
     
55,892,796
     
51,588,663
 
Research and development
   
10,042,416
     
8,887,425
     
19,761,719
     
17,108,850
 
Total operating expenses
   
37,611,896
     
34,467,658
     
75,654,515
     
68,697,513
 
Income from operations
   
20,173,945
     
15,066,739
     
37,441,320
     
26,576,925
 
Interest income
   
12,426
     
80,282
     
19,505
     
160,319
 
Interest expense
   
(59,988
)
   
(89,782
)
   
(88,773
)
   
(180,819
)
Impairment of investment
   
––
     
––
     
(4,058,768
)
   
––
 
Gain on warrants' liability
   
1,327,686
     
––
     
1,327,686
     
––
 
Other expense, net
   
(125,243
)
   
(329,483
)
   
(57,895
)
   
(211,929
)
Income before income taxes
   
21,328,826
     
14,727,756
     
34,583,075
     
26,344,496
 
Income tax expense
   
7,761,922
     
5,699,982
     
12,941,138
     
10,432,168
 
Net income
 
$
13,566,904
   
$
9,027,774
   
$
21,641,937
   
$
15,912,328
 
                                 
Basic income per share
 
$
0.49
   
$
0.32
   
$
0.78
   
$
0.57
 
Diluted income per share
 
$
0.48
   
$
0.32
   
$
0.77
   
$
0.56
 
                                 
Shares used in computing basic income  per share
   
27,649,103
     
27,883,020
     
25,571,261
     
28,053,557
 
Shares used in computing diluted income per share
   
28,063,199
     
28,321,810
     
27,995,630
     
28,529,498
 


See accompanying notes to the unaudited condensed consolidated financial statements.

 
 
 
3

 
Index
CYBERONICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

   
For the Thirteen Weeks Ended
 
For the Twenty-Six Weeks Ended
   
October 26, 2012
 
October 28, 2011
 
October 26, 2012
 
October 28, 2011
                               
Net income
 
$
13,566,904
   
$
9,027,774
   
$
21,641,937
   
$
15,912,328
Other comprehensive income (loss):
                             
Foreign currency translation adjustment
   
391,608
     
113,846
     
(288,187
   
278,145
Total other comprehensive income (loss)
   
391,608
     
113,846
     
(288,187
   
278,145
Total comprehensive income
 
$
13,958,512
   
$
9,141,620
   
$
21,353,750
   
$
16,190,473

See accompanying notes to the unaudited condensed consolidated financial statements.

 
 
 
4

 
Index


CYBERONICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

         
October 26, 2012
        April 27, 2012
ASSETS
                       
Current Assets:
                       
Cash and cash equivalents
     
$
118,498,359
     
$
 
96,654,275
 
Accounts receivable, net
       
36,882,532
         
29,266,847
 
Inventories
       
17,234,393
         
14,385,875
 
Deferred tax assets
       
5,188,141
         
16,994,209
 
Other current assets
       
2,088,527
         
3,801,705
 
Total Current Assets
       
179,891,952
         
161,102,911
 
Property, plant and equipment, net
       
24,344,266
         
22,160,671
 
Intangible assets, net
       
6,593,762
         
4,509,612
 
Long-term investments
       
8,038,200
         
9,508,768
 
Deferred tax assets
       
14,265,574
         
14,265,574
 
Other assets
       
395,223
         
360,659
 
Total Assets
     
$
233,528,977
     
$
 
211,908,195
 
LIABILITIES AND STOCKHOLDERS' EQUITY
                       
Current Liabilities:
                       
Accounts payable
     
$
5,398,757
     
$
 
4,886,448
 
Accrued liabilities
       
18,653,060
         
18,146,188
 
Convertible notes
       
         
4,000
 
Total Current Liabilities
       
24,051,817
         
23,036,636
 
Long-term liabilities
       
4,653,682
         
5,402,189
 
Total Liabilities
       
28,705,499
         
28,438,825
 
Commitments and Contingencies
                       
Stockholders' Equity:
                       
Preferred Stock, $.01 par value per share; 2,500,000 shares authorized; no shares issued and outstanding
       
         
 
Common stock, $.01 par value per share; 50,000,000 shares authorized; 31,138,057 shares issued and 27,720,469 shares outstanding at October 26, 2012; and 30,638,605 shares issued and 27,529,320 shares outstanding at April 27, 2012
       
311,380
         
306,386
 
Additional paid-in capital
       
351,141,020
         
321,960,886
 
Common stock warrants
       
8,400,000
         
25,200,000
 
Treasury stock, 3,417,588 and 3,109,285 common shares at October 26, 2012 and April 27, 2012, respectively, at cost
       
(95,535,983
)
       
(83,151,212
)
Accumulated other comprehensive income
       
133,615
         
421,801
 
Accumulated deficit
       
(59,626,554
)
       
(81,268,491
)
Total Stockholders' Equity
       
204,823,478
         
183,469,370
 
Total Liabilities and Stockholders' Equity
     
$
233,528,977
     
$
 
211,908,195
 

See accompanying notes to the unaudited condensed consolidated financial statements.

 
 
 
5

 
Index

CYBERONICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS


   
For the Twenty-Six Weeks Ended
     
October 26, 2012
     
October 28, 2011
 
                 
Cash Flow From Operating Activities:
               
Net income
 
$
21,641,937
   
$
15,912,328
 
Non-cash items included in net income:
               
Depreciation
   
1,901,737
     
1,582,712
 
Amortization
   
415,850
     
385,256
 
Stock-based compensation
   
6,846,188
     
5,589,595
 
Deferred income taxes
   
11,279,443
     
9,369,864
 
Deferred license revenue amortization
   
(746,984
)
   
(746,984
)
Impairment of investment
   
4,058,768
     
 
Gain on warrants liability
   
(1,327,686
)
   
 
Unrealized loss in foreign currency transactions and other
   
136,713
     
40,322
 
Changes in operating assets and liabilities:
               
Accounts receivable, net
   
(7,660,128
)
   
(1,720,585
)
Inventories
   
(2,946,896
)
   
1,538,178
 
Other current assets
   
1,686,282
     
1,780,206
 
Other assets
   
4,908
     
307,989
 
Accounts payable and accrued liabilities
   
(1,213,060
)
   
(2,392,617
)
Net cash provided by operating activities
   
34,077,072
     
31,646,264
 
                 
Cash Flow From Investing Activities:
               
Investment in convertible preferred stock
   
(2,588,200
)
   
(4,000,000
)
Intangible asset purchases
   
(2,500,000
)
   
(500,000
)
Purchases of property, plant and equipment
   
(4,086,775
)
   
(15,232,296
)
Net cash used in investing activities
   
(9,174,975
)
   
(19,732,296
)
                 
Cash Flow From Financing Activities:
               
Proceeds from exercise of options for common stock
   
8,979,217
     
934,937
 
Purchase of treasury stock
   
(12,384,771
)
   
(32,890,411
)
Realized excess tax benefits – stock compensation based
   
526,625
     
 
Net cash used in financing activities
   
(2,878,929
)
   
(31,955,474
)
                 
Effect of exchange rate changes on cash and cash equivalents
   
(179,084
)
   
558,611
 
Net increase (decrease) in cash and cash equivalents
   
21,844,084
     
(19,482,895
)
Cash and cash equivalents at beginning of period
   
96,654,275
     
89,313,850
 
Cash and cash equivalents at end of period
 
$
118,498,359
   
$
69,830,955
 
                 
Supplementary Disclosures of Cash Flow Information:
               
Cash paid for interest
 
$
56,755
   
$
156,283
 
Cash paid for income taxes
 
$
1,484,733
   
$
798,950
 
Supplementary Disclosures of Non-Cash Investing and Financing Activities:
               
Purchases of property and equipment in accounts payable and accrued liabilities
 
$
239,733
   
$
133,856
 
Reclassification from common stock warrants to warrants' liability
 
$
(3,649,637
)
   
 
Reclassification from common stock warrants to additional paid-in-stock
 
$
(13,150,363
)
 
$
 

See accompanying notes to the unaudited condensed consolidated financial statements.

 
 
 
6

 
Index

CYBERONICS, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

For the Period Ended October 26, 2012

Note 1.  Basis of Presentation and Use of Accounting Estimates

The accompanying condensed consolidated balance sheet at April 27, 2012 of Cyberonics, Inc. and its consolidated subsidiaries (“Cyberonics”), which has been derived from audited consolidated financial statements, and  unaudited condensed consolidated financial statements 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 the adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the twenty-six weeks ended October 26, 2012 are not necessarily indicative of the results that may be expected for any other interim period or the full year ending April 26, 2013. 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 27, 2012 (“2012 Form 10-K”).

The preparation of the condensed consolidated financial statements, in conformity with U.S. GAAP, requires us to make estimates and assumptions that affect the amounts reported in the condensed 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 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.

The fiscal years 2013 and 2012 will end or ended on April 26, 2013 and April 27, 2012, respectively.

Note 2.  Accounts Receivable

Accounts receivables, net consisted of the following:

   
October 26, 2012
   
April 27, 2012
 
Accounts receivable
 
$
37,209,551
   
$
29,851,433
 
Allowance for bad debt
   
(327,019
)
   
(584,586
)
   
$
36,882,532
   
$
29,266,847
 

Note 3.  Inventories

Inventories consisted of the following:

   
October 26, 2012
 
April 27, 2012
Raw materials
 
$
7,790,383
 
$
4,852,086
Work-in-process
   
4,105,161
   
4,057,838
Finished goods
   
5,338,849
   
5,475,951
   
$
17,234,393
 
$
14,385,875


 
 
 
7

 
Index

Note 4.  Property, Plant and Equipment

Property, plant and equipment consisted of the following:

   
October 26, 2012
 
April 27, 2012
Land
 
 $
1,128,813
   
 $
631,000
 
Building and building improvements
   
16,061,793
     
15,810,649
 
Equipment, furniture and fixtures
   
31,833,307
     
30,258,410
 
Leasehold improvements
   
1,015,106
     
1,018,710
 
Capital investment in process
   
3,966,524
     
2,273,540
 
     
54,005,543
     
49,992,309
 
Accumulated depreciation
   
(29,661,277
)
   
(27,831,638
)
   
 $
24,344,266
   
 $
22,160,671
 

Note 5.  Intangible Assets

Schedules of finite-lived intangible assets:

   
For the Twenty-Six Weeks Ended October 26, 2012
   
Developed
Technology Rights (1)
 
License
Agreements (2)
 
Total
Beginning balance gross carrying amount
 
$
5,660,000
   
$
125,000
   
$
5,785,000
 
Investments
   
2,500,000
     
––
     
2,500,000
 
Ending balance gross carrying amount
   
8,160,000
     
125,000
     
8,285,000
 
Accumulated amortization
   
(1,668,737
)
   
(22,501
)
   
(1,691,238
)
Net
 
$
6,491,263
   
$
102,499
   
$
6,593,762
 

   
For the Twenty-Six Weeks Ended October 28, 2011
   
Developed
Technology Rights (1)
 
License
Agreements (2)
 
Total
Beginning balance gross carrying amount
 
$
5,370,000
   
$
474,401
   
$
5,844,401
 
Investments
   
500,000
     
––
     
500,000
 
Ending balance gross carrying amount
   
5,870,000
     
474,401
     
6,344,401
 
Accumulated amortization
   
(951,106
)
   
(40,694
)
   
(991,800
)
Net
 
$
4,918,894
   
$
433,707
   
$
5,352,601
 

(1)
Developed Technology Rights include purchased exclusive patent and know-how licenses with finite lives, primarily related to seizure detection algorithms, wireless communication technology, rechargeable battery technology and a magnetic resonance imaging (“MRI”) compatible implantable lead.
(2)
License Agreements include purchased non-exclusive technology licenses with finite lives primarily related to chip architecture for the detection and processing of heart signals.


 
 
 
8

 
Index

The weighted average amortization period in years for our intangible assets at October 26, 2012:

Developed Technology Rights
11
License Agreements
9

Aggregate intangible asset amortization for the twenty-six weeks ended October 26, 2012 and October 28, 2011 was $415,850 and $385,256, respectively, which was reported in research and development expense in the condensed consolidated statements of net income. Estimated future amortization expense based on our finite-lived intangible assets at October 26, 2012:

For the remaining periods in fiscal year 2013
 $
434,758
Fiscal year 2014
 
869,516
Fiscal year 2015
 
869,516
Fiscal year 2016 (53 week year)
 
886,237
Fiscal year 2017
 
869,516

Note 6. Long-Term Investments in Debt and Equity Securities

Detail of long-term investments in debt and equity securities:

   
October 26, 2012
 
April 27, 2012
Available-for-sale convertible debt security (1)
 
$
1,450,000
 
$
5,508,768
Cost-method equity securities (2)
   
6,588,200
   
4,000,000
Carrying amount – long-term investments
 
$
8,038,200
 
$
9,508,768

(1)
The available-for-sale convertible debt security was issued by NeuroVista Corporation (“NeuroVista”). NeuroVista is a privately-held company focused on the development of an implantable device that is intended to inform patients when seizures are likely to occur, as well as to alert caregivers when seizures do occur. Under its terms, this debt matures in May 2013, unless earlier converted to stock. The interest rate on this debt is 6%, which is payable at maturity or convertible to stock. Cumulative interest was included in the carrying value of the investment as of April 27, 2012. During the quarter ended July 27, 2012, we recorded an other-than-temporary impairment loss of $4,508,768 based on our determination that the fair value of the investment was below the carrying value. Refer to “Note 15. Fair Value Measurements” for further details regarding this security, its fair value assessment and the impairment loss recorded.
(2)
In October 2011, we invested $4.0 million in the convertible preferred stock of ImThera Medical, Inc. (“ImThera”). ImThera is a privately-held company focused on developing a neurostimulation device system for the treatment of obstructive sleep apnea. In September 2012, we invested $2,588,200 in the preferred stock of Cerbomed GmbH (“Cerbomed”). Cerbomed is a privately-held German company focused on developing transcutaneous vagus nerve stimulation device for the treatment of epilepsy. Neither of these investments provided us significant influence over the entity involved.  See “Note 15. Fair Value Measurements” for further details regarding our impairment policy for these securities.


 
 
 
9

 
Index

Note 7.  Accrued Liabilities

Accrued liabilities consisted of the following:

   
October 26, 2012
   
April 27, 2012
Payroll and other compensation
 
$
12,635,830
   
$
14,540,169
Warrants' liability (1)
   
2,321,951
     
––
Clinical costs
   
822,136
     
790,081
Income tax and other tax accruals
   
829,893
     
1,011,457
Other
   
2,043,250
     
1,804,481
   
$
18,653,060
   
$
18,146,188

(1)
See “Note 8. Warrants” for further information.

Note 8. Warrants

In September 2005, in conjunction with the issuance of $125 million of senior subordinated convertible notes, all of which have been retired as of September 27, 2012, we sold warrants for $25.2 million to Merrill Lynch International. The warrants were recorded in stockholders’ equity on our condensed consolidated balance sheets. The warrants entitle the holder to receive the net value for the purchase of 3,012,050 shares of our common stock at $50.00 per share. The warrant agreement was amended on September 11, 2012, changing the settlement measurement period, so that  the warrants are now settled based on our stock trading activity over a period of 60 trading days, or tranches, which commenced on September 12, 2012 and is expected to end on December 7, 2012. The settlement is equal to the amount in excess of $50.00 per share of the daily volume-weighted average price of our common stock, if any, for approximately 50,000 warrants for each of the 60 tranches. The warrants are segregated into three 20 tranche groups, each of which could be settled in cash or net shares at our election prior to the first tranche of the group. During the quarter ended October 26, 2012, we elected cash settlement for the first two groups of tranches, or 40 tranches. The settlement periods for these two groups ended on October 9, 2012 and November 8, 2012, respectively. The final group of 20 tranches will be net share settled, and we expect this group’s settlement period will end December 7, 2012. We expect settlement with Merrill Lynch, both cash and net-share, to take place on December 8, 2012.

Because our election of cash settlement for the first 40 tranches was prior to determination of the amount of liability, as determined by the amended warrant, we used liability accounting for these tranches. As a result, we reclassified these tranches from common stock warrants to warrants' liability at a fair value of $3.6 million, refer to “Note 15. Fair Value Measurements – Derivative Liability.” The remaining balance of common stock warrants related to the first 40 tranches of $13.2 million was reclassified to additional paid-in-capital in the consolidated balance sheet, leaving a balance of $8.4 million in common stock warrants in the consolidated balance sheet at October 26, 2012. The warrants' liability was revalued at October 26, 2012, at $2.3 million, refer to “Note 7. Accrued Liabilities” and $1.3 million was recorded in the consolidated statement of income.

Note 9.  Long-Term Liabilities

Long-term liabilities consisted of the following:

   
October 26, 2012
   
April 27, 2012
Liability for uncertain tax benefits
 
$
2,260,226
   
$
2,260,226
Deferred license revenue
   
2,214,853
     
2,961,837
Accrued clinical studies and other
   
178,603
     
180,126
   
$
4,653,682
   
$
5,402,189


 
 
 
10

 
Index

Note 10.  Commitments and Contingencies

Litigation.

On July 24, 2012, the United States District Court for the District of New Jersey unsealed a qui tam action filed against Cyberonics, Inc. under the federal False Claims Act (“FCA”) and the false claims statutes of 21 different states.  The FCA prohibits the submission of a false claim or the making of a false record or statement in order to secure reimbursement from, or limit reimbursement to, a government-sponsored program.  A “qui tam” action is a lawsuit brought by a private individual purporting to act on behalf of the government.  The government, after reviewing and investigating the allegations, may elect to participate, or intervene, in the lawsuit.  The United States Department of Justice declined to intervene in this qui tam action, which was filed under seal on March 9, 2010 by Stefan P. Kruszewski, M.D., but reserved the right to do so in the future. In September 2012, the plaintiff voluntarily dismissed the complaint without prejudice, and the United States consented to the voluntary dismissal.  Thereafter, the district court dismissed the lawsuit without prejudice, concluding the matter.

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 net income.

Post-Approval Conditions.  Pursuant to the post-approval conditions specified as part of our U.S. Food and Drug Administration (“FDA”) marketing approval for TRD in July 2005, we were required to conduct a longitudinal registry that follows patients with TRD for up to five years in two groups – one group of patients with TRD receiving VNS Therapy and one other group of patients with TRD receiving ongoing treatment-as-usual. We expect the TRD registry to be completed in calendar year 2015. We expect to spend $0.3 million over the next three years for the TRD registry. In addition, we have agreements associated with other clinical studies and registries, in connection with which we expect to spend approximately $3.4 million over the next three years.

Licensing and Investment Agreements.

We executed a license agreement dated March 15, 1988 with Dr. Jacob Zabara providing us with worldwide exclusive rights under a number of U.S. patents (and their international counterparts) covering the method and devices of the VNS Therapy® System for vagus nerve and other cranial nerve stimulation for the control of epilepsy and other movement disorders, as well as a number of other conditions and disorders including depression. Under the terms of this license agreement, we paid royalties at a rate of 3% of net sales of generators and leads. We discontinued paying this royalty on July 16, 2011, the date the last of these patents expired. The royalty payments pursuant to this agreement were expensed as cost of goods sold as incurred and amounted to $1.2 million for the thirteen weeks ended July 29, 2011. Since then we have had no other royalty payments as a component of cost of goods sold.

Effective December 17, 2007, we entered into a license agreement granting an exclusive license to a third party under certain of our patents and patent applications pertaining to weight reduction, hypertension and diabetes in exchange for an up-front, non-refundable payment, plus a royalty on future commercial sales of any product covered by the licensed patents. The unamortized deferred revenue in our condensed consolidated balance sheet as of October 26, 2012 is $2.2 million. 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.

In October 2009, we entered into a contractual arrangement with Flint Hills Scientific, L.L.C. related primarily to cardiac-based seizure response patents. We agreed to future cancellable minimum or milestone-based fees for intellectual property licensing, patent issuance fees, and consulting and royalty fees. We expect future minimum expenditures of $2.9 million through fiscal year 2018 under our agreement with Flint Hills.

In October 2011, we entered into an investment agreement with ImThera, a private medical start-up developing a neurostimulation medical device for the treatment of obstructive sleep apnea. We agreed to future milestone-based investments and expect future investments of $4.0 million in fiscal year 2013.

 
 
 
11

 
Index

In June 2012, we entered into a patent license agreement and an agreement with Imricor Medical Systems, Inc., for the integration of MRI-compatibility in our leads. We agreed to future milestone-based payments and minimum royalties, and expect future minimum expenditures of $4.3 million through fiscal year 2018.

In September 2012, we entered into an investment agreement and marketing arrangement with Cerbomed, a privately-held development-stage company working on a transcutaneous (non-invasive) vagus nerve stimulation device for the treatment of epilepsy. This agreement includes future optional milestone-based payments of €3.5 million.

Lease Agreements.  We lease the following facilities and equipment with non-cancellable leases accounted for as operating leases: (i) an off-site facility in Austin, Texas as part of our disaster contingency plans, (ii) an administrative and sales office in Brussels, Belgium, (iii) sales offices elsewhere in Europe, (iv) sales offices in Beijing, China and Hong Kong and (v) transportation and office equipment. During the quarter ended October 28, 2011, we acquired the land and building in which we headquarter our operations in Houston, Texas and terminated the related lease. In addition, as part of our planning to move our Brussels offices to a new building by the end of fiscal year 2013, we committed to a new $2.2 million, nine-year lease beginning March 2013.

Land purchase and building construction contracts.  We have contracted to purchase land and construct a manufacturing building shell in Costa Rica. Future expenditures under this contract are expected to amount to $1.8 million and are expected to be paid prior to August 2013.

Distribution Agreements. We have distribution agreements with independent distributors that grant the right to distribute our products in designated territories located in Canada, Mexico, Central and South America, Asia, including Japan, Australia, the Middle East, Africa and parts of Europe. The distribution agreements generally grant the distributor exclusive rights for the designated territory for a specified period of time, generally one to three years. Under the terms of the distribution agreements, we may be required to compensate the distributor in the event that the agreement is terminated by us or is not renewed upon expiration.

Note 11.  Stock Incentive and Purchase Plans

Stock-Based Compensation

Amounts of stock-based compensation recognized in the condensed consolidated statement of income by expense category are as follows:

   
For the Thirteen Weeks Ended
 
For the Twenty-Six Weeks Ended
     
October 26, 2012
     
October 28, 2011
     
October 26, 2012
     
October 28, 2011
 
Cost of goods sold
 
$
104,203
   
$
162,492
   
$
286,710
   
$
324,539
 
Selling, general and administrative
   
1,696,022
     
2,176,292
     
4,481,341
     
4,374,957
 
Research and development
   
639,430
     
535,878
     
2,078,137
     
890,099
 
Total stock-based compensation expense
 
$
2,439,655
   
$
2,874,662
   
$
6,846,188
   
$
5,589,595
 

Amounts of stock-based compensation expense recognized in the condensed consolidated statement of income by type of arrangement are as follows:

   
For the Thirteen Weeks Ended
 
For the Twenty-Six Weeks Ended
     
October 26, 2012
     
October 28, 2011
     
October 26, 2012
     
October 28, 2011
 
Stock option awards
 
$
684,012
   
$
698,551
   
$
1,554,659
   
$
1,335,240
 
Service-based restricted and restricted stock unit awards
   
1,020,267
     
1,230,385
     
2,996,070
     
3,056,222
 
Performance-based restricted stock and restricted stock unit awards
   
735,376
     
945,726
     
2,295,459
     
1,198,133
 
Total stock-based compensation expense
 
$
2,439,655
   
$
2,874,662
   
$
6,846,188
   
$
5,589,595
 


 
 
 
12

 
Index

Stock Option Activity

The following table details the activity for stock option awards:

   
For the Twenty-Six Weeks Ended October 26, 2012
Options
 
Number of Shares
   
Wtd. Avg. Exercise Price
 
Wtd. Avg. Remaining Contractual Term (years)
 
Aggregate Intrinsic
Value (1)
Outstanding — at April 27, 2012
 
1,441,057
   
 $
23.75
           
Granted
 
197,500
     
42.60
           
Exercised
 
(371,725
)
   
24.05
           
Forfeited
 
(7,161
)
   
26.75
           
Expired
 
(1,000
)
   
42.51
           
Outstanding — at October 26, 2012
 
1,258,671
     
26.59
   
6.37
 
$
24,776,062
Fully vested and exercisable — end of period
 
680,694
     
23.44
   
4.51
   
15,487,186
Fully vested and expected to vest — end of period (2)
 
1,220,902
     
26.41
   
6.29
   
24,247,610

(1)
The intrinsic value of an option is the difference between the fair market value of the underlying stock at October 26, 2012, using the market closing stock price, and the option exercise price for in-the-money options.
(2)
Fully vested and expected to vest factors in expected forfeitures.

Restricted Stock and Restricted Stock Unit Awards

The following table details the activity for service-based restricted stock and restricted stock unit awards:

     
For the Twenty-Six Weeks Ended October 26, 2012
       
Number of Shares
     
Wtd. Avg. Grant Date Fair Value
 
Non-vested shares at April 27, 2012
     
639,033
   
$
20.75
 
Granted
     
98,846
     
43.51
 
Vested
     
(351,841
)
   
16.28
 
Forfeited
     
(3,189
)
   
26.18
 
Non-vested shares at October 26, 2012
     
382,849
   
$
30.69
 

The following table details the activity for performance-based restricted stock and restricted stock unit awards and restricted stock market-based awards:

     
For the Twenty-Six Weeks Ended October 26, 2012
       
Number of Shares
     
Wtd. Avg. Grant Date Fair Value
 
Non-vested shares at April 27, 2012
     
464,125
   
$
25.36
 
Granted
     
8,982
     
50.10
 
Vested
     
(70,514
)
   
26.88
 
Forfeited
     
––
     
––
 
Non-vested shares at October 26, 2012
     
402,593
   
$
25.65
 


 
 
 
13

 
Index

Note 12.  Income Taxes

Our effective tax rate for the thirteen and twenty-six weeks ended October 26, 2012 was 36.4% and 37.4%, respectively, which was primarily due to our federal income tax rate of 35% plus state and foreign income taxes, and permanent differences including the non-taxability of the gain on the warrants' liability, refer to “Note 8. Warrants” for a description of the warrants. Our effective tax rate for the thirteen and twenty-six weeks ended October 28, 2011 was 38.6% and 39.6%, respectively, which was primarily due to our federal income tax rate of 35% plus state and foreign income taxes and the impact of shortfalls resulting from stock option exercises or cancellations and restricted stock vesting.

Note 13.  Income Per Share

The following table sets forth the computation of basic and diluted net income per share of our common stock:

   
For the Thirteen Weeks Ended
 
For the Twenty-Six Weeks Ended
   
October 26, 2012
 
October 28, 2011
 
October 26, 2012
 
October 28, 2011
Numerator:
                               
Net income
 
$
13,566,904
   
$
9,027,774
   
$
21,641,937
   
$
15,912,328
 
Add effect of Convertible Notes
   
––
     
39,726
     
––
     
79,451
 
Diluted income
 
$
13,566,904
   
$
9,067,500
   
$
21,641,937
   
$
15,991,779
 
 
                               
Denominator:
                               
Basic weighted average shares outstanding
   
27,649,103
     
27,883,020
     
27,571,261
     
28,053,557
 
Stock options
   
414,096
     
268,959
     
424,369
     
306,110
 
Convertible Notes
   
––
     
169,831
     
––
     
169,831
 
Diluted weighted average shares outstanding
   
28,063,199
     
28,321,810
     
27,995,630
     
28,529,498
 
Basic income per share
 
$
0.49
   
$
0.32
   
$
0.78
   
$
0.57
 
Diluted income per share
 
$
0.48
   
$
0.32
   
$
0.77
   
$
0.56
 

Antidilutive securities excluded from the computation of earnings per share:

   
For the Thirteen Weeks Ended
 
For the Twenty-Six Weeks Ended
   
October 26, 2012
 
October 28, 2011
 
October 26, 2012
 
October 28, 2011
Stock options (1)
   
30,571
     
576,079
     
28,337 
     
477,542 
 
Restricted stock units (2)
   
59,987
     
46,875
     
62,104
     
23,437
 
Common stock warrants (3)
   
1,004,050
     
3,012,050
     
1,004,050
     
3,012,050
 

(1)
Outstanding options to purchase common shares that are excluded from the computation of earnings per share because to include them would have been anti-dilutive.
(2)
Restricted stock units that are non-participatory and contingently issuable based on future performance have been excluded from the computation of earnings per share.
(3)
In September 2005, in conjunction with the issuance of our Convertible Notes, we sold common stock warrants. The warrants entitle the holder to receive the net value for the purchase of 3,012,050 shares of our common stock at $50.00 per share. Refer to “Note 8. Warrants” for further information. At October 26, 2012,  warrants of 1,004,050  will be net share-settled. The net share-settlement warrants are anti-dilutive since the exercise price exceeded the average market price of our stock for the periods presented.


 
 
 
14

 
Index

Note 14. Derivatives

Foreign Currency Exposure

Because we operate in a number of international markets, we are exposed to the impact of foreign currency exchange rate movements on earnings, particularly with respect to the U.S. dollar versus the euro. At times, we enter into foreign currency forward contracts to partially offset our foreign currency exchange gains and losses. During the quarter ended July 29, 2011 and October 28, 2011, we entered into quarterly contracts with nominal amounts of €10.0 million. As a result of the settlement of our euro-based trade receivables due from our European subsidiary, Cyberonics Europe BVBA, and the simultaneous investment in the subsidiary during the quarter ended January 27, 2012, we have not entered into a foreign currency derivative after January 27, 2012; however, in the future we may hedge our exposure to foreign currency transactions.

The pre-tax net gain resulting from foreign currency forward contract activity was included in Other Expense on the condensed consolidated statements of income:

       
Amount of gain (loss) recognized in income
       
For the Thirteen Weeks Ended
 
For the Twenty-Six Weeks Ended
Derivative
 
Location of gain or loss recognized in income
 
October 26, 2012
 
October 28, 2011
 
October 26, 2012
 
October 28, 2011
Euro forward contracts
 
Other Expense, Net
 
$
––
   
$
(22,000
 
$
––
   
$
370,000
 

The gains or losses above were the result of net cash settlements of foreign currency derivative contracts.

Warrants' Liability

In September 2005, in conjunction with the issuance of $125 million of senior subordinated convertible notes, all of which have been retired as of September 27, 2012, we sold warrants for $25.2 million to Merrill Lynch International. The warrants were recorded in common stock warrants on our condensed consolidated balance sheets. The warrants entitle the holder to receive the net value for the purchase of 3,012,050 shares of our common stock at $50.00 per share. The warrant agreement was amended on September 11, 2012, and a portion of the common stock warrants were reclassed to warrants' liability at a fair value of $3.6 million, refer to “Note 8. Warrants” for further information. At October 26, 2012, we revalued the warrants' liability at $2.3 million, and recorded a gain of $1.3 million.

The pre-tax gain resulting from the revaluation of the warrants' liability at October 26, 2012 was included in the condensed consolidated statements of income as follows:

       
Amount of gain recognized in income
       
For the Thirteen Weeks Ended
 
For the Twenty-Six Weeks Ended
Derivative
 
Location of gain recognized in income
 
October 26, 2012
 
October 28, 2011
 
October 26, 2012
 
October 28, 2011
Warrants' liability
 
Gain on warrants' liability
 
$
1,327,686
   
$
––
   
$
1,327,686
   
$
––
 


 
 
 
15

 
Index

Note 15. Fair Value Measurements

Fair value is defined as the exit price, or the price that we would receive upon selling our assets in an orderly transaction with another market participant at the measurement date. The guidance also establishes a hierarchy for inputs used in measuring fair value. The hierarchy is broken down into three levels defined as follows:

Level 1
– Inputs are quoted prices in active markets for identical assets.
Level 2
– Inputs include quoted prices for similar assets in active markets, quoted prices for identical or similar assets in markets that are not active and inputs that are observable for the asset, either directly or indirectly.
Level 3
– Inputs are unobservable inputs for the asset.

Observable inputs are inputs market participants would use in valuing the asset based on market data obtained from sources independent of us. Unobservable inputs are inputs that reflect our assumptions about the factors market participants would use in valuing our asset and are developed based on the best information available in the circumstances. The categorization of assets within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. Level 3 financial assets include investment securities for which there is limited market activity such that the determination of fair value requires significant judgment or estimation. We have had no transfers of our investments between levels during the twenty-six weeks ended October 26, 2012 and October 28, 2011.

The following are the classes of assets and liabilities measured at fair value at October 26, 2012, on a recurring basis, using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2); and significant unobservable inputs (Level 3):

   
Fair Value Measurements Using Inputs Considered, as of October 26, 2012:
     
Level 1
     
Level 2
     
Level 3
     
Total
 
Assets:
                               
Convertible debt security
 
$
––
   
$
––
   
$
1,450,000
   
$
1,450,000
 

Investment in Convertible Debt Security. In August 2010, we purchased a convertible debt security issued by NeuroVista. This security is considered ‘available-for-sale’, which we measure at fair value. At April 27, 2012, we estimated that the carrying cost, which consisted of the initial investment of $5.0 million plus accumulated unpaid interest, was equal to fair value.  During the quarter ended July 27, 2012, we determined that the fair value of this investment was less than the carrying value and that the resulting impairment loss was other-than-temporary. During quarter ended October 26, 2012, NeuroVista advised us that an event of default had occurred under the terms of the convertible debt security, and we negotiated an agreement with NeuroVista pursuant to which we agreed to forbear in exercising our rights and remedies under the terms of the security and NeuroVista granted us a security interest in all of its assets. The inputs to our fair value assessment fell into Level 3 of the fair value hierarchy, as this investment was issued by a privately-held entity without quoted market prices. We used all financial information available to us related to the investee, including financial statements, credit reports, results of financing rounds, results of clinical trials and significant changes in the regulatory or technological environment of the investee. In addition, we also employed an independent consultant to analyze the fair value.  We estimated the fair value of the debt instrument at $1,450,000, which represents the fair value of the underlying assets, including intellectual property, clinical data, capital equipment and proprietary software. See “Note 6. Long-Term Investments in Debt and Equity Securities” for further information regarding our investments in this convertible debt security.


 
 
 
16

 
Index

The following table provides a reconciliation of the beginning and ending balance of the NeuroVista convertible debt instrument measured at fair value on a recurring basis for which we used significant unobservable inputs (Level 3):

     
Twenty-Six Weeks Ended
October 26, 2012
     
Twenty-Six Weeks Ended
October 28, 2011
Beginning Balance
 
$
5,508,768
   
$
5,209,590
Net purchases and settlements
   
––
     
––
Interest accrual
   
––
     
149,589
Transfers in/(out) of Level 3
   
––
     
––
Total other-than-temporary impairment included in net income
   
(4,058,768
)
   
––
Total unrealized gains/(losses) included in other comprehensive income
   
––
     
––
Ending Balance
 
$
1,450,000
   
$
5,359,179

Warrants' liability. We reclassed the first 40 tranches of our 60 tranche warrant from common stock warrants to warrants' liability at fair value of $3.6 million during the quarter ended October 26, 2012, refer to “Note 8. Warrants” for further information. Fair value was determined using a Black Scholes valuation model with the following Level 2 inputs; the warrant settlement periods, a risk-free interest rate of 0.13% and a volatility factor of 25.0% derived from our stock price movements. At October 26, 2012, we revalued the warrants' liability to $2.3 million based on cash settlement results under the warrant settlement provisions, which resulted in a gain in our consolidated statement of income of $1.3 million.

Investment in Equity Securities. Our investments in equity securities consist of the preferred stock of two privately held development stage companies: ImThera and Cerbomed. See “Note 6. Long-Term Investments in Debt and Equity Securities” for more details. Both investments are carried at cost and not marked-to-market. Each reporting period we review all information available to us related to these investees to identify any significant adverse effect on the fair value of our investment. If we identify events or changes in circumstances that indicate a decrease in investment value that is other than temporary, we recognize the loss. The inputs to our fair value measurement are considered Level 3 in the fair value hierarchy. As of October 26, 2012, we have not identified an impairment in these investments.

Note 16.  New Accounting Pronouncements

In May 2011, the Financial Accounting Standards Board (“FASB”) issued a FASB Accounting Standards Update (“ASU”) to the Fair Value Measurement Topic of the FASB Accounting Standards Codification (“ASC”). This FASB ASU was issued in order to achieve common fair value measurement and disclosure requirements in U.S. GAAP and International Financial Reporting Standards (“IFRS”). The FASB ASU clarifies that (i) the highest and best use concept applies only to the fair value measurement of nonfinancial assets, (ii) specific requirements pertain to measuring the fair value of instruments classified in a reporting entity’s shareholders’ equity, and (iii) a reporting entity should disclose quantitative information about unobservable inputs used in a fair value measurement that is categorized within Level 3 of the fair value hierarchy. The FASB ASU changes requirements with regard to the fair value of financial instruments that are managed within a portfolio and with regard to the application of premiums or discounts in a fair value measurement. In addition, the FASB ASU increased disclosure requirements regarding Level 3 fair value measurements to include the valuation processes used by the reporting entity and the sensitivity of the fair value measurement to changes in unobservable inputs and the interrelationships between the unobservable inputs, if any. The FASB ASU is effective for interim and annual periods beginning after December 15, 2011. We adopted this FASB ASU for the quarter ended July 27, 2012. The adoption of this FASB ASU had no impact to our condensed consolidated financial statements of income or financial position other than a presentation impact in the Notes to our condensed consolidated financial statements.

 
 
 
17

 
Index

 
In June 2011, the FASB issued a FASB ASU to the Comprehensive Income Topic of the FASB ASC. This FASB ASU was issued in order to improve the comparability, consistency and transparency of financial statements that include components of other comprehensive income, as well as to facilitate the convergence of U.S. GAAP with IFRS. This FASB ASU requires that comprehensive income be presented either: (i) as a continuous statement including net income and comprehensive income, or (ii) as two separate and consecutive statements. This FASB ASU is to be applied retrospectively and is effective for fiscal years, and interim periods within those years, beginning after December 15, 2011. We adopted this FASB ASU for the quarter ended July 27, 2012. The adoption of this FASB ASU had no impact, other than presentation, on our condensed consolidated financial statements of income or financial position.

 
 
 
18

 
Index

ITEM 2.  MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Cautionary Statement Regarding 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”). The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for certain forward-looking statements. The words “believe,” “expect,” “anticipate,” “plan,” “intend,” “foresee,” “should,” “would,” “could,” “may” 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 and 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;
Regulatory activities and announcements;
Effectiveness of our internal controls over financial reporting;
Fluctuations in future quarterly operating results;
Failure to comply with, or changes in laws, regulations or administrative practices affecting government regulation of our products, including, but not limited to, United States (“U.S.”) Food and Drug Administration (“FDA”) laws and regulations;
Failure to expand or maintain market acceptance or reimbursement for the use of vagus nerve stimulation therapy (“VNS Therapy”) or any component which comprises the VNS Therapy® System for the treatment of epilepsy and depression;
Any legislative or administrative reform to the healthcare system, including the U.S. Medicare or Medicaid systems, or the 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 epilepsy and depression indications;
Failure to obtain insurance coverage and reimbursement for our depression 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, expiration and validity of our intellectual property;
Changes in technology, including the development of superior or alternative technology or devices by competitors;
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 attract or retain key personnel;
Outcomes of pending or future lawsuits and governmental investigations;
Changes in accounting rules that adversely affect the characterization of our consolidated results of  income, financial position or cash flows;
Changes in customer spending patterns;
Continued volatility in the global market and worldwide economic conditions; and
Changes in tax laws or exposure to additional income tax liabilities.


 
 
 
19

 
Index

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 27, 2012, (“2012 Form 10-K”), (3) our reports and registration statements filed and furnished from time to time with the U.S. Securities and Exchange Commission (the “SEC”) and (4) 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 update or revise any forward-looking statements after the date they are made, whether as a result of new information, future events or otherwise. You should read the following discussion and analysis in conjunction with our unaudited condensed consolidated financial statements and related notes included elsewhere in this report. Operating results for the thirteen and twenty-six weeks ended October 26, 2012 are not necessarily indicative of future results, including the full fiscal year. You should also refer to our Annual Consolidated Financial Statements, Notes thereto, and Management’s Discussion and Analysis of Financial Condition and Results of Operations and “Risk Factors” contained in our 2012 Form 10-K.

Business Overview

We are a medical device company, incorporated as a Delaware corporation in 1987, engaged in the design, development, sales and marketing of implantable medical devices that provide a unique neuromodulation therapy, VNS Therapy, for the treatment of refractory epilepsy and treatment-resistant depression (“TRD”) and other device solutions for the management of epilepsy.

Our proprietary VNS Therapy System includes the following:

an implantable pulse generator to provide the appropriate stimulation to the vagus nerve;
a lead that connects the generator to the vagus nerve;
equipment to assist with the implant procedure;
equipment to assist the treating physician with setting the stimulation parameters for each patient;
instruction manuals; and
magnets to temporarily suspend or induce stimulation manually.

The VNS Therapy pulse generator and lead are surgically implanted, generally during an outpatient procedure.  The battery contained in the 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 implant a new generator, 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, certain countries in Eastern Europe, Russia, South America, Africa, Australia and certain countries in Asia, including Japan, China and Taiwan, have approved the VNS Therapy System 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 treatment-intolerant depressive episode without age restrictions.

We sell the VNS Therapy System for refractory epilepsy to hospitals and ambulatory surgery centers (“ASCs”) on payment terms that are generally 30 days from the shipment date. In addition to maintaining regulatory approval, 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.  This coverage allows our customers to invoice and be paid by third-party payers. 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 System implants, issues an annual update to the reimbursement amounts received by our customers.


 
 
 
20

 
Index

We believe reimbursement or payment rates from private insurers were largely unchanged over the past year.  In November 2012, CMS announced calendar year 2013 final reimbursement rates, which increased over the calendar year 2012 rates by 5.7% for full systems, 7.9% for generator-only replacements and by more than 200% for lead replacement surgeries.

There can be no assurance that future changes to CMS reimbursement will not have an adverse effect on our future operating results. Any decrease in reimbursement rates or change in reimbursement methodology by CMS could have an adverse impact on our business and our future operating results.

We continue to invest in and support the development of future generations of our VNS Therapy System, including generators employing new stimulation paradigms, cardiac and brain-based seizure detection, rechargeable battery technology, wireless communication technology and improved lead technology. We also continue to fund and develop other devices that support our focus on device solutions for epilepsy management, such as seizure monitoring, logging and notification technology using external heart monitoring and movement-related sensor advancements. In addition, we are investing in a pilot study related to the use of VNS Therapy for the treatment of chronic heart failure.

In August 2011, we announced that we discovered a hardware-related design issue with the AspireHC™ (High Capacity) Model 105 and AspireSR™ (Seizure Response) Model 106 generators. The hardware-related design issue did not affect earlier models of our pulse generator, and we continued to sell earlier models. We found that the stimulation output current delivered by the AspireHC and AspireSR generators to a patient’s nerve could be less than the output current programmed by a physician and withdrew the generators from the field.

In December 2011, the FDA approved our re-designed AspireHC generator, and we resumed full commercial release of the generator in the U.S. With CE Mark approval in November 2011, we also resumed limited commercial release in Europe.

In April 2011, we commenced a European clinical trial (designated “E-36”) to support regulatory approval in Europe of our AspireSR generator. The AspireSR generator is a device that employs a cardiac-based seizure detection system and delivers responsive VNS Therapy. We suspended this trial in August 2011; however, we re-submitted the appropriate applications to re-start this trial in June 2012 and we continue to enroll patients. In September 2012, we submitted to the FDA an Investigational Device Exemption (“IDE”) request for the purpose of conducting a U.S. pilot study for the AspireSR generator (designated “E-37”). The IDE was conditionally approved in October 2012, and we are initiating study start-up activities, including investigator qualification, clinical study agreements and Institutional Review Board approvals.

    The VNS Therapy System is indicated as an adjunctive treatment 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 antidepressant treatments. In Canada and the European Union, the VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are in a treatment-resistant or treatment-intolerant major depressive episode. Pursuant to the post-market surveillance conditions specified as part of our FDA marketing approval, we were required to conduct two clinical studies on TRD patients:

 
 
 
21

 
Index


One post-approval study, the dosing study, was a randomized study assessing three different stimulation intensities. We completed the 331-patient dosing study in February 2010 and submitted our final study report to the FDA in August 2010. In April 2012, we received notification from the FDA that we had fulfilled all study requirements related to the dosing study. Based on the results of the post-approval dosing study, our objective is to submit a request for reconsideration of the non-coverage decision issued by the CMS in May 2007 with the objective of obtaining coverage and reimbursement in depression, although there can be no assurance that this objective will be met. A determination by CMS not to approve our request for reconsideration or not to reverse its non-coverage decision could have a material negative impact on our stock price.
   
The other post-approval study, the TRD Registry, is a longitudinal study intended to follow patients with TRD in two treatment groups - one group receiving adjunctive VNS Therapy and the other group receiving treatment-as-usual. We expect the TRD registry to be completed in calendar year 2015.

Proprietary protection for our products is important to our business. We seek U.S. and foreign patents on selected inventions, acquire licenses under selected patents of third parties, and enter into 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. Under the terms of our epilepsy patent license agreement we were paying royalties at a rate of 3% of net sales of generators and leads. The epilepsy patent expired on July 16, 2011 in the U.S. and, and as a result, we discontinued paying this royalty after the expiration date.  As a result of the epilepsy patent expiration in the U.S., it is possible that one or more competitors may enter the U.S. market. The epilepsy patent expired in Europe five years ago; we are aware of five competitive medical devices approved for sale in the European market. We invested in one of the European competitors, Cerbomed GmbH (“Cerbomed”). Cerbomed is a privately-held, development-stage company working on a transcutaneous vagus nerve stimulation device for the treatment of epilepsy. We do not have indication-specific patent coverage for vagus nerve stimulation for epilepsy or for neuropsychiatric disorders (depression) in the U.S. or Europe.

We continuously evaluate whether to out-license or to in-license intellectual property rights to optimize our portfolio. This includes identifying our intellectual property rights for indications we do not have plans to develop and determining whether these rights can be licensed or otherwise granted to third parties. It also involves assessing the intellectual property rights owned by third parties to determine whether we should attempt to license or otherwise acquire those rights. We have entered into several license and investment agreements that may involve substantial future payments; see “Note 16. Commitments and Contingencies – License Agreements” in our condensed consolidated financial statements for additional information.

To secure our future in our current manufacturing and headquarters facility and to realize operating efficiencies, we purchased the building in which we are headquartered during the quarter ended October 28, 2011. Our headquarters building is located in Houston, Texas and has approximately 144,000 square feet of manufacturing and office space, and we currently occupy approximately 80% of this space.

In order to accommodate expected growth of our business, we have created the following subsidiaries: Cyberonics Holdings LLC, CYBX Netherlands C.V., Cyberonics Spain, S.L. and Cyberonics Latam S.R.L. In September 2012, our new subsidiary, Cyberonics, Latam S.R.L., contracted to purchase land and construct a manufacturing facility in Costa Rica. We intend for this facility to manufacture product for our international markets and to be completed in fiscal year 2014 and operational in fiscal year 2015.

 
 
 
22

 
Index

We lease a 19,800 square foot Austin, Texas facility that we utilize for warehousing and distribution. In addition, as part of our planning to move our Brussels, Belgium offices to a new building by the end fiscal year 2013, we committed to a new nine-year lease beginning in March 2013.

During the quarter ended July 27, 2012, we determined that the fair value of our investment in NeuroVista’s convertible debt security had fallen below the carrying value. Based upon our fair value review, we recorded an other-than-temporary impairment loss in the condensed consolidated statement of income of $4.1 million.

Significant Accounting Policies and Critical Accounting Estimates

For a full discussion of accounting policies that we identified as critical in the preparation of our consolidated results of operations and financial position, please refer to our 2012 Form 10-K.

The preparation of our condensed consolidated financial statements, in conformity with U.S. GAAP, requires us to make estimates and assumptions that affect the amounts reported in our condensed consolidated financial statements and the related notes. Actual results could differ from those estimates. Critical estimates that require management’s judgment relate to the allowance for doubtful accounts, inventory valuation, useful lives for property and equipment, sales returns and allowances, and recognition of licensing revenue, as well as the following:

Intangible Assets

Intangible assets, as shown on the condensed consolidated balance sheets, consist of purchased licenses of patents and technology rights that we have acquired to develop and maintain our competitive position. The patent and technology rights we have purchased pertain primarily to seizure detection, wireless communication, rechargeable battery technology, external charging accessory hardware and associated software, a MRI-compatible implantable lead and microprocessor technologies. We amortize our intangible assets on a straight-line basis, over an average period of 11 years, beginning with the effective date of the license agreement and ending with the shorter of either the expiration of the patent or license or the estimated useful life of the product. We evaluate our intellectual property each reporting period to determine whether events and circumstances warrant either a different amortization period or impairment. The intangible asset is impaired if the technology no longer factors into our product commercialization plans or the carrying value exceeds future cash flows. The risks associated with achieving commercialization include, but are not limited to, failure of the acquired technology to function as planned, failure to obtain regulatory approvals, failure of clinical trials, failure to obtain third-party reimbursement and patent litigation. Amortization and impairment are subject to a high degree of estimation and management judgment. If we change our estimate of the useful lives of our intellectual property, we amortize the carrying amount over the revised remaining useful life. If we identify an impairment indicator, we test the intellectual property for recoverability, and if the carrying amount is not recoverable and exceeds its fair value, impairment is recognized. The carrying value of our intangible assets amounted to $6.6 million at October 26, 2012.

 
 
 
23

 
Index

Investments in Debt and Equity Securities

We have invested in three privately-held, development-stage medical device companies, with a total carrying value of approximately $8.0 million as of October 26, 2012. The first investment is a convertible debt instrument, which we account for at fair value as an available-for-sale debt security. During the quarter ended July 27, 2012, we determined that the fair value of this investment was below the carrying value and recorded an other-than-temporary impairment loss of $4.1 million in the condensed consolidated statement of income. The second and third investments consist of preferred shares accounted for under the cost method. If we identify events or changes in circumstances that indicate a decrease in value of these cost-method investments that is other-than-temporary, we  recognize a loss. Fair value and impairment loss adjustments are subject to a high degree of management judgment as these investments do not have quoted market prices. We cannot guarantee that our investments will be successful or that further impairments will not adversely affect our consolidated balance sheets, statements of income or cash flows. See “Note 6. Long-Term Investments in Debt and Equity Securities” and “Note 15. Fair Value Measurements” for further details of these investments.

Stock-Based Compensation

Market and Performance-Based Restricted Stock and Performance-Based Restricted Stock Units. We grant restricted stock and restricted stock unit awards that vest based on the satisfaction of market or performance conditions. The fair market values of market condition-based awards are determined using the Monte Carlo simulation method. The Monte Carlo simulation method is subject to variability as several factors utilized must be estimated, including the derived service period estimate based on our judgment of likely future performance and our stock price volatility. The fair value of performance-based awards is based on the market closing price of our common stock on the grant date. Compensation expense for performance-based awards is estimated based on our judgment of likely future performance and may be adjusted significantly in future periods, depending on actual performance.

Recognized compensation cost for performance-based and market-based restricted stock and restricted stock unit awards for the twenty-six weeks ended October 26, 2012 and October 28, 2011 was $6.8 million and $5.6 million, respectively.

Income taxes

Our effective tax rate is based on income, statutory tax rates, and permanent differences. We establish reserves when we believe that certain tax positions are likely to be challenged and we may not prevail. If we determine that a tax position is more likely than not of being sustained upon audit, based solely on the technical merits of the position, we recognize the benefit. We measure the benefit by determining the amount that is greater than 50 percent likely of being realized upon settlement. We presume that all tax positions will be examined by a taxing authority with full knowledge of all relevant information. We regularly monitor our tax positions and tax liabilities and reevaluate the technical merits of our tax positions. Our reserve for uncertain tax positions is subject to a high degree of estimation and management judgment. Although we believe that we have adequate reserves, positions taken by taxing authorities could have a material impact on our effective tax rate in future periods.

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 the fiscal year 1992 and subsequent years, with certain exceptions. During the quarter ended October 26, 2012, we agreed upon adjustments with the Internal Revenue Service (“IRS”) in connection with our fiscal years ended April 24, 2009 and April 30, 2010.   These adjustments did not materially impact our financial statements. In addition, during the quarter ended October 26, 2012, we were notified that our European subsidiary, Cyberonics Europe BVBA, is under examination by the Belgium tax authority with respect to transfer pricing.  This audit has just begun and we are unable to assess the impact it may have on our consolidated financial statements, but it appears there will be no material impact to our financial statements

 
 
 
24

 
Index

Our effective tax rate for the thirteen and twenty-six weeks ended October 26, 2012 was 36.4% and 37.4%, respectively, which was primarily due to our federal income tax rate of 35%, plus state and foreign income taxes, and permanent differences including the non-taxability of the gain on the warrants, refer to “Note 8. Warrants” in the Notes to Condensed Consolidated Financial Statements for a description of the warrants. This rate does not include the impact of the federal research and development tax credit because the credit has not yet been extended for calendar year 2012.

Restricted stock, restricted stock units and stock options vested or were exercised during the thirteen and twenty-six weeks ended October 26, 2012. The difference between the tax deduction on the vesting or exercise date and the financial statement expense creates an excess tax benefit (windfall) or tax deficiency (shortfall).  If a windfall benefit can be utilized to reduce income taxes payable, the windfall benefit will offset the shortfall deficiency; if not, then the shortfall is recognized as a discrete item in the quarter in which it occurs. Due to our net operating losses and the utilization of net operating loss carryforwards, prior to the quarter ended July 27, 2012, we were unable to offset shortfalls with windfalls and were required to recognize shortfalls as a discrete tax expense in the quarter in which they occur.  For the fiscal year ending April 26, 2013, we are forecasting the utilization of windfall benefits to offset income taxes payable; therefore, shortfalls should have no impact on the effective tax rate.

As of the quarter ended October 26, 2012, we have not provided for U.S. income taxes for the undistributed earnings of our foreign subsidiaries. These earnings, while not material to our consolidated statement of income, are intended to be permanently reinvested outside the United States.

Results of Operations

Net Sales

The table below illustrates comparative net product revenue and unit sales by geographic area and our licensing revenues.  Product shipped to destinations outside the U.S. is classified as “International” sales, (in thousands, except unit sales and percentages):

   
For the Thirteen Weeks Ended
   
October 26, 2012
   
October 28, 2011
     
% Change
 
Net Product Sales by Geographic Area:
                       
U.S.
 
$
51,503
   
$
44,684
     
15.3%
 
International
   
11,079
     
8,638
     
28.3%
 
Total net product sales
 
$
62,582
   
$
53,322
     
17.4%
 
                         
Unit Sales by Geographic Area:
                       
U.S.
   
2,339
     
2,091
     
11.9%
 
International
   
891
     
693
     
28.6%
 
Total unit sales
   
3,230
     
2,784
     
16.0%
 
                         
Licensing Revenue
 
$
373
   
$
373
     
0.0%
 

   
For the Twenty-Six Weeks Ended
   
October 26, 2012
   
October 28, 2011
     
% Change
 
Net Product Sales by Geographic Area:
                       
U.S.
 
$
102,386
   
$
88,032
     
16.3%
 
International
   
20,144
     
17,578
     
14.6%
 
Total net product sales
 
$
122,530
   
$
105,610
     
16.0%
 
                         
Unit Sales by Geographic Area:
                       
U.S.
   
4,650
     
4,143
     
12.2%
 
International
   
1,636
     
1,441
     
13.5%
 
Total unit sales
   
6,286
     
5,584
     
12.6%
 
                         
Licensing Revenue
 
$
747
   
$
747
     
0.0%
 

 
 
 
25

 
Index

U.S. net product sales for the thirteen weeks ended October 26, 2012 increased by $6.8 million, or 15.3%, as compared to the thirteen weeks ended October 28, 2011, due to a sales volume increase of 11.9% and increased average selling prices of 3.4%. The average selling price increased due to continued higher market penetration of our AspireHC generator and price increases in January 2012.

International net product sales for the thirteen weeks ended October 26, 2012 increased by $2.4 million, or 28.3%, as compared to the thirteen weeks ended October 28, 2011, due to increased sales volume of 28.6%. The average selling price decreased by 0.3% due to an unfavorable foreign currency impact of $0.4 million, offset by favorable impact of reduced product discounting and a higher proportion of direct sales as opposed to sales to distributors. On a constant currency basis, international sales increased by 33.0%.

U.S. net product sales for the twenty-six weeks ended October 26, 2012 increased by $14.4 million, or 16.3%, as compared to the twenty-six weeks ended October 28, 2011, due to a sales volume increase of 12.2% and an increased average selling price of 4.1%. The average selling price increased due to continued higher market penetration of our AspireHC generator and price increases in January 2012.

International net product sales for the twenty-six weeks ended October 26, 2012 increased by $2.6 million, or 14.6%, as compared to the twenty-six weeks ended October 28, 2011, due to a sales volume increase of 13.5% and an increased average selling price of 1.1%. The average selling prices increased due to the favorable impact of reduced product discounting and a higher proportion of direct sales as opposed to sales to distributors, offset by an unfavorable foreign currency impact of $1.2 million. On a constant currency basis, international sales increased by 21.2%.

Cost of Sales and Expenses

The table below illustrates our cost of sales and major expenses as a percent of net sales:

 
For the Thirteen Weeks Ended
 
For the Twenty-Six Weeks Ended
 
October 26, 2012
 
October 28, 2011
 
October 26, 2012
 
October 28, 2011
Cost of sales
   
8.2%
     
7.7%
     
8.3%
     
10.4%
 
Selling, general and administrative
   
43.8%
     
47.6%
     
45.3%
     
48.5%
 
Research and development
   
16.0%
     
16.6%
     
16.0%
     
16.1%
 

Cost of Sales

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. Our cost of sales as a percent of net sales for the thirteen weeks ended October 26, 2012 increased by 0.5 percentage points to 8.2% when compared to the thirteen weeks ended October 28, 2011. This increase was primarily due to product mix and international markets having lower average selling prices as compared to the U.S. market.

Our cost of sales as a percent of net sales for the twenty-six ended October 26, 2012 decreased by 2.1 percentage points to 8.3% when compared to the twenty-six weeks ended October 28, 2011.  This decrease was primarily the result of the discontinuance of the 3% epilepsy patent royalty fee after the patent expiration date of July 16, 2011.  We paid no royalty fees pursuant to the epilepsy patent during the twenty-six weeks ended October 26, 2012; whereas, we paid $1.2 million in royalty fees during the twenty-six weeks ended October 28, 2011. The decrease was also partially due to product withdrawal costs of the AspireHC and AspireSR generators that were included in the cost of sales for the quarter ended July 29, 2011.  Refer to the ‘Product Withdrawal’ paragraph below for more information. Finally, the decrease was also partially due to the savings realized after the purchase of our headquarters building during the quarter ended October 28, 2011.

 
 
 
26

 
Index

Selling, General and Administrative (“SG&A”) Expenses

SG&A expenses are comprised of sales, marketing, general and administrative activities. SG&A expenses for the thirteen weeks and twenty-six weeks ended October 26, 2012, as a percentage of net sales, decreased by 3.8 percentage points to 43.8%, as compared to the thirteen weeks ended October 28, 2011, and decreased by 3.2 percentage points to 45.3% as compared to the twenty-six weeks ended October 28, 2011, due primarily to the result of more efficient use of our sales and marketing expenditures.

Research and Development (“R&D”) Expenses

R&D expenses consist of expenses related to our product and process development, product design efforts, clinical trial programs and regulatory activities. R&D expenses for the thirteen weeks ended October 26, 2012 decreased, as a percentage of net sales, by 0.6 percentage points to 16.0%, as compared to the thirteen weeks ended October 28, 2011. This decrease was due to a rate of increase in R&D spending that was less than the rate of increase in net sales. R&D expenditures increased on a period-over-period basis primarily due to our product development efforts for the treatment of refractory epilepsy and our pre-clinical development efforts with respect to VNS treatment of chronic heart failure

R&D expenses for the twenty-six weeks ended October 26, 2012 decreased, as a percentage of net sales, by 0.1 percentage points to 16.0%, as compared to the twenty-six weeks ended October 28, 2011. R&D spending increased primarily due to increased stock-based compensation related to both our product development efforts for the treatment of refractory epilepsy and our pre-clinical development efforts with respect to VNS treatment of chronic heart failure.

Impairment of Investment

During the quarter ended July 27, 2012, we determined that the fair value of our investment in a convertible debt instrument of NeuroVista, a privately-held, development-stage medical device company, was below the carrying value and recorded an other-than-temporary impairment loss of $4.1 million.

Affordable Care Act

We are evaluating the impact of section 4191 of the Internal Revenue Code, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act, which establishes a 2.3% excise tax on medical devices sold domestically. This excise tax will negatively impact our income before income taxes beginning in January 2013. We anticipate the impact to be no more than $1.5 million for the four-month period between enactment and the end of our fiscal year; the full-year impact of the tax in our fiscal year 2014 is expected to be no more than $5.0 million.

Income Taxes

Our effective tax rate for the thirteen and twenty-six weeks ended October 26, 2012 was 36.4% and 37.4%, respectively, which was primarily due to our federal income tax rate of 35%, plus state and foreign income taxes, and permanent differences including the non-taxability of the gain on the warrants, refer to “Note 8. Warrants” in the Notes to Condensed Consolidated Financial Statements for a description of the warrants. Our effective tax rate for the thirteen and twenty-six weeks ended October 28, 2011 was 38.6% and 39.6%, respectively, which was primarily due to our federal income tax rate of 35% plus state and foreign income taxes and the impact of shortfalls resulting from stock option exercises or cancellations and restricted stock vesting.

 
 
 
27

 
Index

Product Withdrawal

On August 15, 2011, we announced that we discovered a hardware-related design issue with the AspireHC and AspireSR generators. The hardware-related design issue did not affect earlier models of our pulse generator, and we continued to sell earlier models. We found that the stimulation output current delivered by the AspireHC and AspireSR generators to a patient’s nerve can be less than the output current programmed by a physician and withdrew the generators from the field. For the twenty-six weeks ended October 28, 2011, we recognized expense of $833,000, net of tax, related to the product withdrawal. In December 2011, the FDA approved our re-designed AspireHC generator, and we resumed full commercial release of the generator in the U.S. With CE Mark approval in November 2011, we also resumed limited commercial release in Europe. The AspireSR generator clinical trial was suspended in August 2011, however, we re-submitted the appropriate applications and resumed patient enrollment in May 2012.

Liquidity and Capital Resources

Cash and cash equivalents

Cash and cash equivalents increased by approximately $21.8 million to $118.5 million during the twenty-six weeks ended October 26, 2012. This increase was primarily due to cash from operations of $34.1 million, plus the proceeds from the exercise of compensatory stock options of $9.0 million, partially offset by investing activities of $9.2 million and repurchases of treasury stock of $12.4 million.

Cash Flows

Net cash provided by (used in) operating, investing and financing activities for the twenty-six weeks ended October 26, 2012 and October 28, 2011 was as follows (in thousands):

   
Twenty-Six Weeks Ended
     
October 26, 2012
     
October 28, 2011
     
Change
 
Operating activities
 
$
34,077
   
$
31,646
   
$
2,431
 
Investing activities
   
(9,175
)
   
(19,732
)
   
10,557
 
Financing activities
   
(2,879
)
   
(31,955
)
   
29,076
 
Effect of exchange rate changes on cash and cash equivalents
   
(179
)
   
558
     
(737
)
Net increase (decrease) in cash and cash equivalents
 
$
21,844
   
$
(19,483
)
 
$
41,327
 

Operating Activities

Cash provided by operating activities during the twenty-six weeks ended October 26, 2012 was $34.1 million and was primarily due to net income of $21.6 million, plus non-cash income and expense items of $22.6 million, offset by cash used in operating assets and liabilities of $10.1 million. Non-cash items consisted primarily of deferred income tax expense of $11.8 million, related primarily to utilization of net operating losses, stock-based compensation expense of $6.8 million and the impairment of our investment in the debt security of NeuroVista Corporation of $4.1 million. Cash used for operating assets and liabilities included an increase in accounts receivable of $7.7 million, due to increased sales, and an increase in inventories of $2.9 million, primarily due to a significant purchase of inventory parts intended to ensure an adequate supply over several years. In addition, accounts payable and other liabilities decreased by $1.2 million due to reduced compensation accruals based on timing of payments. Cash provided by operating assets included a decrease in other current assets of $1.7 million primarily due to the amortization of prepaid expenses.

 
 
 
28

 
Index

Investing Activities

Cash used in investing activities during the twenty-six weeks ended October 26, 2012 was $­9.2 million, consisting of $4.1 million for the purchases of land, plant and equipment, $2.5 million for intangible asset purchases focused on the integration of MRI compatibility with our leads and the development of a neurostimulation device with cardiac-based seizure detection capabilities, and $2.6 million for our cost-method investment in the preferred shares of Cerbomed. The property, plant and equipment investments consisted of contract payments for the purchase of land and the construction of a manufacturing facility in Costa Rica of $1.3 million, plus Houston-based infrastructure development of $2.8 million. We expect to expend approximately $14 million for infrastructure development during fiscal year 2013, including the Costa Rica project.

The construction of the Costa Rica manufacturing facility is expected to be completed in fiscal year 2014 and operational in fiscal year 2015. We purchased an option on additional land in Costa Rica in the event that we proceed with building additional manufacturing capacity.

Financing Activities

Cash used in financing activities during the twenty-six weeks ended October 26, 2012 was $2.9 million due to the purchases of treasury stock of $12.4 million, partially offset by proceeds from the exercise of compensatory stock options and excess tax benefit from the exercise of stock options and vesting of restricted shares of $9.5 million. Our Board of Directors authorizes purchases of our common stock on the open market. In November 2011, the Board authorized the repurchase of up to 1,000,000 shares, of which 640,000 shares were purchased through October 26, 2012. The volume of treasury stock purchased and the timing of such purchases depend on market conditions and other factors. Employee exercises of compensatory stock options also depend on market conditions and other factors.

Debt Instruments and Related Covenants

Convertible Notes

Holders tendered $7,044,000 of our Convertible Notes for redemption on December 27, 2011, leaving a balance of $4,000 payable. The remaining balance was tendered for redemption on September 27, 2012, as permitted by an amendment to our indenture for the Convertible Notes.

 
 
 
29

 
Index

Contractual Obligations

A summary of contractual obligations as of October 26, 2012 are as follows:

   
Less Than
One Year
 
One to
Three Years
 
Four to
Five Years
 
Over
Five Years
 
 Total Contractual Obligations
                                       
Contractual obligations related to off-balance sheet arrangements:
                                     
Operating leases (1)
 
1,024,594
   
$
1,310,192
   
$
945,143
   
$
1,274,711
   
4,554,640
Inventory purchases (2)
   
2,898,844
     
     
     
     
2,898,844
Other (3)
   
12,865,366
     
2,346,740
     
2,240,000
     
750,000
     
18,202,106
Total (4)
 
$
16,788,804
   
$
3,656,932
   
$
3,185,143
   
$
2,024,711
   
$
25,655,590

(1)
Reflects operating lease obligations related to facilities, office equipment and automobiles. The facility lease obligations relate primarily to our Austin, Texas facility and our foreign operations.
(2)
Reflects certain of our inventory purchase commitments that are material, legally binding and specify minimum purchase quantities. These purchase commitments do not exceed our projected manufacturing requirements and are in the normal course of business.
(3)
Reflects certain purchase contracts that are legally binding and specify minimum purchase amounts primarily in connection with sales, marketing and training events and an information technology service agreement. We included expected future payments for services under cancellable contracts for clinical research and  expected future payments for patent and technology licensing rights under cancellable contracts, including minimum royalty payments and required consulting fees. In addition, we included future contract payments related to the land purchase and construction contract for our manufacturing facility in Costa Rica and likely to be achieved milestone driven commitments for additional investments in our current cost-method equity investments.
(4)
The table above does not reflect the unrecognized tax benefits of $6.1 million due to our inability to make a reasonably reliable estimate of the timing of any payments.

We believe our current liquidity and capital resources will be adequate to fund anticipated business activities for the next 12 months. Our liquidity could be adversely affected by the factors affecting future operating results, including those referred to in “Item 1A. Risk Factors” previously.

Impact of New Accounting Pronouncements

See “Note 16. New Accounting Pronouncements” in the Notes to Condensed Consolidated Financial Statements for a description of the impact of new accounting pronouncements.


 
 
 
30

 
Index

ITEM 3.    QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are exposed to certain market risks as part of our ongoing business operations, including risks from foreign currency exchange rates and concentration of credit that could adversely affect our condensed consolidated balance sheet, net income and cash flow. We manage these risks through regular operating and financing activities and, at certain times, derivative financial instruments.

Foreign Currency Exchange Rate Risk

Due to the global reach of our business, we are also exposed to market risk from the impact of foreign currency exchange rate movements on earnings, particularly with respect to the U.S. dollar versus the euro and Great Britain pound. In the future, we may use non-speculative hedging to reduce our exposure to foreign currency transactions, depending on cash flow in our European operations. We choose not to offset other foreign currency exchange exposures for a variety of reasons, including but not limited to, immateriality, accounting considerations and the prohibitive economic cost of offsetting particular exposures. Based on our exposure to foreign currency exchange rate risk, and not taking into consideration foreign currency derivative offsets, a sensitivity analysis indicates that if the U.S. dollar had uniformly weakened 10% against the euro and the Great Britain pound, the effect on net income after tax for the twenty-six weeks ended October 26, 2012 would have been unfavorable by approximately $277,000 or 1.3%. Conversely, if the U.S. dollar had uniformly strengthened 10% against the euro and the Great Britain pound, the impact on net income after tax for the twenty-six weeks ended October 26, 2012 would have been favorable by approximately $262,000 or 1.2%.

Concentration of Credit Risk

Our trade accounts receivable represent potential concentrations of credit risk. This risk is limited due to the large number of customers, their dispersion across a number of geographic areas and our efforts to control our exposure to credit risk by monitoring our receivables and the use of credit approvals and credit limits. In addition, historically we have had strong collections and minimal write-offs. While we believe that our reserves for credit losses are adequate, essentially all of our trade receivables are concentrated in the hospital and healthcare sectors in the U.S. and several other countries, and accordingly, we are exposed to their respective business, economic and country-specific variables. Although we do not currently foresee a concentrated credit risk associated with these receivables, repayment is dependent on the financial stability of these industry sectors and the respective countries’ national economies and healthcare systems.

ITEM 4.   CONTROLS AND PROCEDURES

Evaluation and Disclosure Controls and Procedures

We maintain a system of disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. This information is also accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the most recent fiscal quarter reported on herein.  Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of October 26, 2012.

Changes in Internal Control over Financial Reporting

During the thirteen weeks ended October 26, 2012, there have been no changes that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.


 
 
 
31

 
Index

PART II.  OTHER INFORMATION

ITEM 1.  LEGAL PROCEEDINGS

We are the subject of various pending or threatened legal actions and proceedings that arise in the ordinary course of our business.  Such matters are subject to many uncertainties and outcomes that are not predictable with assurance and that may not be known for extended periods of time.  Our material legal proceedings, if any, are discussed in “Note 10. Commitments and Contingencies - Litigation” in the Notes to Condensed Consolidated Financial Statements and are incorporated herein by reference.  While it is not possible to predict the outcome of the legal proceedings discussed in Note 10, the costs associated with such proceedings could have a material adverse effect on our consolidated net income, financial position or cash flows.

ITEM 1A.  RISK FACTORS

Our business faces many risks. Any of the risks referenced below or elsewhere in this Form 10-Q or our other SEC filings could have a material impact on our business and consolidated financial position or results of operations.  Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also impair our business operations.

For a detailed discussion of the risk factors that should be understood by any investor contemplating investment in our stock, please refer to “Item 1A. Risk Factors” in our 2012 Form 10-K.  There has been no material change in the risk factors set forth in our 2012 Form 10-K. 

ITEM 2.  UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Purchase of equity securities by us and our affiliated purchasers:
 

Period
 
Total Number of Shares  Purchased
   
Average Price Paid per Share (1)
   
Total number of Shares  Purchased as Part of Publicly Announced Plans or Programs (2)
   
Maximum Number  of Shares that may yet be Purchased under the Plans or Programs (2)
July 28 – August 31, 2012
   
   
$
     
     
360,000
September 1 – September 28, 2012
   
8,379
   
$
50.1000
     
     
360,000
September 29 – October 26, 2012
   
     
     
     
360,000
Totals
   
8,379
   
$
50.1000
     
       



(1)
Shares are purchased at market price.
(2)
On November 15, 2011, the Board of Directors authorized a program to repurchase up to 1.0 million shares, and we have  repurchased 640,000 shares as of October 26, 2012.

 
 
 
32

 
Index

ITEM 6.   EXHIBITS

The exhibits marked with the asterisk symbol (*) are filed, or furnished in the case of Exhibit 32.1, with this Form 10-Q.

Exhibit Number
 
Document Description
 
Report or Registration Statement
 
SEC File or Registration Number
 
Exhibit Reference
3.1
 
Amended and Restated Certificate of Incorporation of Cyberonics, Inc.
 
Cyberonics, Inc. Registration Statement on Form S-3 filed on February 21, 2001
 
333-56022
 
3.1
3.2
 
Cyberonics, Inc. Amended and Restated Bylaws
 
Cyberonics, Inc. Current Report on Form 8-K filed on October 26, 2007
 
000-19806
 
3.2(i)
10.1
 
Warrant Amendment Agreement, dated September 11, 2012, between Cyberonics, Inc. and Merrill Lynch International through the agent Merrill Lynch, Pierce, Fenner & Smith Incorporated
 
Cyberonics, Inc. Current Report on Form 8-K filed on September 11, 2012
 
000-19806
 
10.1
31.1*
 
Certification of the Chief Executive Officer of Cyberonics, Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
           
31.2*
 
Certification of the Chief Financial Officer of Cyberonics, Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
           
32.1*
 
Certification of the Chief Executive Officer and Chief Financial Officer of Cyberonics, Inc. pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
           

 
 
 
33

 
Index


SIGNATURE

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:  November 19, 2012



 
/s/ GREGORY H. BROWNE
 
Gregory H. Browne
 
Senior Vice President, Finance and Chief Financial Officer
 
(Duly Authorized Officer and Principal Financial Officer)


 
 
 
34

 
Index
INDEX TO EXHIBITS

The exhibits marked with the asterisk symbol (*) are filed, or furnished in the case of Exhibit 32.1, with this Form 10-Q.

Exhibit Number
 
Document Description
 
Report or Registration Statement
 
SEC File or Registration Number
 
Exhibit Reference
3.1
 
Amended and Restated Certificate of Incorporation of Cyberonics, Inc.
 
Cyberonics, Inc. Registration Statement on Form S-3 filed on February 21, 2001
 
333-56022
 
3.1
3.2
 
Cyberonics, Inc. Amended and Restated Bylaws
 
Cyberonics, Inc. Current Report on Form 8-K filed on October 26, 2007
 
000-19806
 
3.2(i)
10.1
 
Warrant Amendment Agreement, dated September 11, 2012, between Cyberonics, Inc. and Merrill Lynch International through the agent Merrill Lynch, Pierce, Fenner & Smith Incorporated
 
Cyberonics, Inc. Current Report on Form 8-K filed on September 11, 2012
 
000-19806
 
10.1
31.1*
 
Certification of the Chief Executive Officer of Cyberonics, Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
           
31.2*
 
Certification of the Chief Financial Officer of Cyberonics, Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
           
32.1*
 
Certification of the Chief Executive Officer and Chief Financial Officer of Cyberonics, Inc. pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
           


 

 
 
 
35