Table of Contents

 

 

 

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 March 31, 2012

 

Or

 

o         Transition report pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934

 

For the transition period from             to             

 

COMMISSION FILE NUMBER: 000-49798

 

THORATEC CORPORATION

(Exact name of registrant as specified in its charter)

 

California

 

94-2340464

(State or other jurisdiction of incorporation

 

(I.R.S. Employer Identification No.)

or organization)

 

 

 

 

 

6035 Stoneridge Drive, Pleasanton, California

 

94588

(Address of principal executive offices)

 

(Zip Code)

 

(925) 847-8600

(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  x  No  o

 

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 during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes  x  No  o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer x

 

Accelerated filer o

 

 

 

Non-accelerated filer o

 

Smaller reporting company o

(Do not check if 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 o No x

 

As of April 27, 2012, the registrant had 58,670,388 shares of common stock outstanding.

 

 

 



Table of Contents

 

THORATEC CORPORATION

 

TABLE OF CONTENTS

 

Part I. Financial Information

 

Item 1. Unaudited Condensed Consolidated Financial Statements

3

Condensed Consolidated Balance Sheets as of March 31, 2012 and December 31, 2011

3

Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2012 and April 2, 2011

4

Condensed Consolidated Statements of Comprehensive Income for the Three Months Ended March 31, 2012 and April 2, 2011

5

Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2012 and April 2, 2011

6

Notes to Condensed Consolidated Financial Statements

7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

23

Item 3. Quantitative and Qualitative Disclosures About Market Risk

29

Item 4. Controls and Procedures

30

Part II. Other Information

 

Item 1 Legal Proceedings

31

Item 1A. Risk Factors

31

Item 2. Unregistered Sale of Equity Securities and Use of Proceeds

32

Item 6. Exhibits

33

Signatures

34

Exhibits

 

EX-10.34

 

EX-31.1

 

EX-31.2

 

EX-32.1

 

EX-32.2

 

EX-101 INSTANCE DOCUMENT

 

EX-101 SCHEMA DOCUMENT

 

EX-101 CALCULATION LINKBASE DOCUMENT

 

EX-101 LABELS LINKBASE DOCUMENT

 

EX-101 PRESENTATION LINKBASE DOCUMENT

 

 

Thoratec, the Thoratec logo, Thoralon, HeartMate, HeartMate II, and GoGear are registered trademarks of Thoratec Corporation, and IVAD is a trademark of Thoratec Corporation.

 

CentriMag and PediMag are registered trademarks of Thoratec LLC and PediVAS is a registered trademark of Thoratec Switzerland GmbH.

 

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PART I. FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

THORATEC CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

 

(unaudited)

(in thousands)

 

 

 

March 31, 2012

 

December 31, 2011

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

86,879

 

$

42,661

 

Short-term available-for-sale investments

 

144,667

 

150,753

 

Receivables, net of allowances of $2,208 and $2,153, respectively

 

70,263

 

59,292

 

Inventories

 

47,754

 

55,691

 

Deferred tax assets

 

10,120

 

10,116

 

Income tax receivable

 

2,976

 

12,112

 

Prepaid expenses and other assets

 

7,253

 

6,640

 

Total current assets

 

369,912

 

337,265

 

Property, plant and equipment, net

 

39,452

 

38,928

 

Goodwill

 

194,458

 

191,193

 

Purchased intangible assets, net

 

89,938

 

92,279

 

Long-term available-for-sale investments

 

15,914

 

16,090

 

Other long-term assets

 

5,543

 

5,233

 

Total Assets

 

$

715,217

 

$

680,988

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

12,178

 

$

12,559

 

Accrued compensation

 

14,765

 

15,739

 

Other accrued liabilities

 

23,700

 

14,936

 

Total current liabilities

 

50,643

 

43,234

 

Long-term deferred tax liability

 

19,616

 

20,429

 

Other long-term liabilities

 

11,322

 

10,823

 

Contingent liabilities (Note 2)

 

17,115

 

22,052

 

Total Liabilities

 

98,696

 

96,538

 

Shareholders’ equity:

 

 

 

 

 

Common shares: no par, authorized 100,000; issued and outstanding 58,664 and 58,368 as of March 31, 2012 and December 31, 2011, respectively

 

 

 

Additional paid-in capital

 

586,434

 

578,293

 

Retained earnings

 

46,462

 

24,190

 

Accumulated other comprehensive loss:

 

 

 

 

 

Unrealized loss on investments

 

(1,637

)

(1,664

)

Cumulative translation adjustments

 

(14,738

)

(16,369

)

Total accumulated other comprehensive loss

 

(16,375

)

(18,033

)

Total Shareholders’ Equity

 

616,521

 

584,450

 

Total Liabilities and Shareholders’ Equity

 

$

715,217

 

$

680,988

 

 

See notes to the unaudited condensed consolidated financial statements.

 

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THORATEC CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended

 

 

 

March 31,
2012

 

April 2,
 2011

 

 

 

 

 

 

 

Product sales

 

$

126,769

 

$

99,530

 

Cost of product sales

 

38,887

 

31,772

 

Gross profit

 

87,882

 

67,758

 

Operating expenses:

 

 

 

 

 

Selling, general and administrative

 

31,201

 

24,919

 

Research and development

 

19,696

 

15,754

 

Total operating expenses

 

50,897

 

40,673

 

Income from operations

 

36,985

 

27,085

 

Other income and (expense):

 

 

 

 

 

Interest expense and other

 

(3

)

(2,880

)

Interest income and other

 

734

 

755

 

Income before income taxes

 

37,716

 

24,960

 

Income tax expense

 

(12,230

)

(8,501

)

Net income

 

$

25,486

 

$

16,459

 

 

 

 

 

 

 

Net Income per share:

 

 

 

 

 

Basic

 

$

0.44

 

$

0.28

 

Diluted

 

$

0.43

 

$

0.27

 

 

 

 

 

 

 

Shares used to compute net income per share:

 

 

 

 

 

Basic

 

58,438

 

57,932

 

Diluted

 

59,382

 

65,881

 

 

See notes to the unaudited condensed consolidated financial statements.

 

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THORATEC CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

 

(unaudited)

(in thousands)

 

 

 

Three Months Ended

 

 

 

March 31,
2012

 

April 2,
 2011

 

 

 

 

 

 

 

Net Income

 

$

25,486

 

$

16,459

 

Unrealized gains on investments (net of taxes of $16 and $95 for the three months ended March 31, 2012 and April 2, 2011, respectively)

 

27

 

141

 

Foreign currency translation adjustments

 

1,631

 

849

 

Total other comprehensive income

 

1,658

 

990

 

Comprehensive Income

 

$

27,144

 

$

17,449

 

 

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THORATEC CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

(unaudited)

(in thousands)

 

 

 

Three Months Ended

 

 

 

March 31,
2012

 

April 2,
2011

 

Cash flows from operating activities:

 

 

 

 

 

Net Income

 

$

25,486

 

$

16,459

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

 

 

Depreciation and amortization

 

4,852

 

4,108

 

Investment premium amortization, net

 

493

 

1,260

 

Allowance for bad debt

 

(42

)

 

Non-cash interest income and other

 

(361

)

765

 

Non-cash interest expense

 

 

2,776

 

Tax benefit related to stock options

 

1,552

 

706

 

Share-based compensation expense

 

4,899

 

3,963

 

Excess tax benefits from share-based compensation

 

(1,468

)

(706

)

Loss on disposal of assets

 

1

 

99

 

Change in net deferred tax liability

 

(824

)

(1,560

)

Changes in assets and liabilities:

 

 

 

 

 

Receivables

 

(10,532

)

1,184

 

Inventories

 

7,542

 

(6,784

)

Other current and non-current assets

 

(1,100

)

(531

)

Accounts payable

 

(610

)

1,573

 

Accrued income taxes

 

9,314

 

4,708

 

Other current and non-current liabilities

 

2,054

 

(9,715

)

Net cash provided by operating activities

 

41,256

 

18,305

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

Purchases of available-for-sale investments

 

(56,388

)

(103,821

)

Sales and maturities of available-for-sale investments

 

62,195

 

142,442

 

Purchases of property, plant and equipment, net

 

(1,558

)

(1,842

)

Net cash provided by investing activities

 

4,249

 

36,779

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

Payment of contingent considerations

 

(1,518

)

 

Proceeds from stock option exercises

 

3,050

 

6,133

 

Excess tax benefits from share-based compensation

 

1,468

 

706

 

Repurchase and retirement of common shares

 

(4,736

)

(53,480

)

Net cash used in financing activities

 

(1,736

)

(46,641

)

Effect of exchange rate changes on cash and cash equivalents

 

449

 

(363

)

 

 

 

 

 

 

Net increase in cash and cash equivalents

 

44,218

 

8,080

 

Net cash and cash equivalents at beginning of period

 

42,661

 

56,887

 

Net cash and cash equivalents at end of period

 

$

86,879

 

$

64,967

 

 

 

 

 

 

 

Supplemental disclosure of consolidated cash flow information:

 

 

 

 

 

Cash paid for taxes

 

$

2,222

 

$

4,677

 

Supplemental disclosure of consolidated non-cash investing and financing activities:

 

 

 

 

 

Transfers of equipment from inventory

 

$

246

 

$

587

 

Purchases of property, plant and equipment through accounts payable and accrued liabilities

 

$

132

 

$

263

 

 

See notes to the unaudited condensed consolidated financial statements.

 

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THORATEC CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

(unaudited)

 

Note 1. Operations and Significant Accounting Policies

 

Basis of Presentation

 

The interim unaudited condensed consolidated financial statements of Thoratec Corporation (“we,” “our,” “us,” or the “Company”) have been prepared and presented in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”), without audit, and reflect all adjustments necessary (consisting only of normal recurring adjustments) to present fairly our financial position, results of operations and cash flows as of and for the periods presented. Certain information and footnote disclosures normally included in our annual financial statements, prepared in accordance with GAAP, have been condensed or omitted. The accompanying financial statements should be read in conjunction with our fiscal 2011 consolidated financial statements, and the accompanying notes thereto, filed with the SEC in our Annual Report on Form 10-K (the “2011 Annual Report”). The operating results for any interim period are not necessarily indicative of the results that may be expected for any future period.

 

The preparation of our unaudited condensed consolidated financial statements necessarily requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities on the unaudited condensed consolidated balance sheet dates and the reported amounts of revenues and expenses for the periods presented.  The actual amounts could differ from those estimated amounts.

 

Financial Statement Presentation Matters

 

Subsequent to the issuance of our condensed consolidated financial statements for the three months ended April 2, 2011, management determined that amortization of core technology and developed technology should have been presented within cost of product sales. In addition, amortization of patents and trademarks for the same period has been reclassified to selling, general and administrative to conform to current period presentation. Previously, amortization of these purchased intangible assets was reported as a separate line item within operating expenses.

 

The impact of the correction and reclassification on specific line items in our condensed consolidated statements of operations is presented below:

 

 

 

Three Months Ended
April 2, 2011

 

 

 

As
previously
reported

 

As
reported

 

 

 

(in thousands)

 

Cost of product sales

 

$

29,735

 

$

31,772

 

Gross profit

 

69,795

 

67,758

 

Selling, general, and administrative

 

24,654

 

24,919

 

Amortization of purchased intangible assets

 

2,302

 

 

Total operating expenses

 

42,710

 

40,673

 

 

This had no impact on previously reported product sales, income before taxes, net income, earnings per share, or any consolidated balance sheet or statement of cash flow categories.

 

New Accounting Standards Adopted

 

In May 2011, the Financial Accounting Standards Board (“FASB”) amended existing rules covering fair value measurement and disclosure to clarify guidance and minimize differences between U.S. GAAP and International Financial Reporting Standards (“IFRS”). The new guidance requires entities to provide information about valuation techniques and unobservable inputs used in Level 3 fair value measurements and provide a narrative description of the sensitivity of Level 3 measurements to changes in unobservable inputs. We adopted this standard in the first quarter of fiscal 2012 and it did not have an impact on our financial statements but did expand our disclosures about our Level 3 fair value measurements. Refer to Note 3 for additional information.

 

In September 2011, the FASB modified existing rules to allow entities to use a qualitative approach to test goodwill for impairment. The revised guidance permits an entity to perform a qualitative assessment to determine whether it is more likely than not that the fair

 

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value of a reporting unit is less than its carrying value. If impairment is deemed more likely than not, management would perform the currently prescribed two-step goodwill impairment test. Otherwise, the two-step goodwill impairment test is not required. This standard is effective for us starting in fiscal year 2012 and we will implement these qualitative factors during our annual goodwill assessment in the fourth quarter of the year.  Adoption of this amended standard is not expected to have an impact on our results of operations or financial position.

 

Note 2. Levitronix Medical

 

On August 3, 2011, we acquired 100% of the medical business of Levitronix (“Levitronix Medical” or “Levitronix Medical acquisition”) for an upfront cash payment of $110 million, plus additional cash earn-out amounts (not to exceed $40 million in aggregate) payable annually over the next four years contingent upon achievement of certain product revenue targets. The earn out is calculated based on 36 percent of sales from Levitronix Medical in excess of sales of approximately $24 million per year over the next four years commencing from the date of acquisition. The fair value of the contingent consideration is calculated using the discounted cash flow approach, utilizing various revenue assumptions and applying a probability to each outcome. By applying this method, the estimated undiscounted range of outcomes was from $9.7 million to $37.4 million. The fair value of the contingent consideration as of the acquisition date was estimated and recorded at $23.6 million. The fair value of the contingent consideration is remeasured at the estimated fair value at each reporting period with the change in fair value recorded within operating expense within our condensed consolidated statements of operations. Actual amounts paid may differ from the obligations recorded. During the first quarter of 2012, we paid out $1.5 million of the contingent consideration related to sales in 2011. As of March 31, 2012, the fair value of the contingent consideration was approximately $22.0 million, of which $4.9 million is included in “Other current liabilities” and $17.1 million is reported in “Contingent liabilities” on the condensed consolidated balance sheet.

 

Prior to the acquisition, we distributed and provided clinical support for the CentriMag in the U.S., under an agreement that would have expired at the end of 2011. We had also collaborated with Levitronix Medical on the development of the fully magnetically levitated motor technology employed in the HeartMate III left ventricular assist system, which is currently in preclinical testing. This acquisition allowed us to acquire the CentriMag Acute Circulatory System (“CentriMag”) and PediMag/PediVAS Acute Circulatory System (“PediMad/PediVAS”) product lines and secures completely the fully magnetically levitated patented technology related to the HeartMate III.

 

In accordance with accounting standards for business combinations, we accounted for the acquisition of Levitronix Medical under the acquisition method. Under the acquisition method, the assets and liabilities assumed at the date of acquisition are recorded in the consolidated financial statements at their respective fair values at the acquisition date. The excess of the purchase price over the fair value of the acquired net assets has been recorded as goodwill in the amount of $113.0 million. Levitronix Medical’s results of operations are included in the consolidated financial statements from the date of acquisition.

 

The determination of the estimated fair value of the acquired assets and liabilities requires management to make significant estimates and assumptions. We determined the fair value by applying established valuation techniques, based on information that management believed to be relevant to this determination. We also hired independent third parties to assist in the valuation of purchased intangible assets, goodwill and contingent consideration.

 

The purchase price consideration of cash and the fair value of the contingent earn-out consideration were as follows:

 

 

 

(in
thousands)

 

Cash

 

$

110,000

 

Contingent consideration earn-out

 

23,570

 

Total fair value consideration

 

$

133,570

 

 

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The following table summarizes the purchase price allocation of the fair value of the assets acquired and liabilities assumed at the date of acquisition:

 

 

 

 

(in thousands)

 

Amortization
Period

 

Assets

 

 

 

 

 

Short-term:

 

 

 

 

 

Cash and cash equivalents

 

$

26

 

 

 

Accounts receivable

 

2,300

 

 

 

Inventory

 

6,179

 

 

 

Other current assets

 

11

 

 

 

Long-term:

 

 

 

 

 

Property, plant and equipment

 

185

 

 

 

Identifiable purchased intangible assets

 

 

 

 

 

Developed technology

 

6,270

 

3 to 10 years

 

Patents and trademarks

 

2,700

 

10 years

 

Pre-existing license agreements

 

2,300

 

7 years

 

Customer based relationships and other

 

4,270

 

3 to 6 years

 

Goodwill

 

113,034

 

 

 

Deferred tax asset

 

1,144

 

 

 

Total Assets

 

138,419

 

 

 

Liabilities

 

 

 

 

 

Short-term:

 

 

 

 

 

Accrued liabilities

 

1,419

 

 

 

Warranty accrual

 

161

 

 

 

Contingent liabilities

 

580

 

 

 

Long-term:

 

 

 

 

 

Deferred tax liability

 

3,269

 

 

 

Contingent liabilities

 

22,990

 

 

 

Net Assets Purchased

 

$

110,000

 

 

 

 

All straight-line methods of amortization above are based on the expected pattern of future benefits related to those respective intangible assets.

 

We expensed $3.6 million for all legal, consulting and other costs directly related to the acquisition and have recorded these costs as a component of selling, general and administrative expenses in 2011.

 

Goodwill of approximately $113.0 million represents the excess of the purchase price over the fair value of the underlying net tangible and intangible assets and represents the future economic benefits of maintaining the access to the U.S. CentriMag market and expected synergies. The majority of goodwill is deductible for U.S. tax purposes, but non-deductible for foreign tax purposes.

 

The following table includes unaudited pro forma financial information for the three months ended April 2, 2011 as if the acquisition of Levitronix Medical had occurred as of the beginning of the 2010 period. The pro forma financial information is provided for comparative purposes only and is not necessarily indicative of what actual results would have been had the acquisition occurred as of the beginning of 2010 period, nor do they give effect to synergies, cost savings, fair market value adjustments, profit in inventory, immaterial depreciation expense and other changes expected to result from the acquisition. Accordingly, the pro forma financial results do not purport to be indicative of consolidated results of operations as of the date hereof, for any period ended on the date hereof, or for any other future date or period.

 

 

 

Three Months
Ended

April 2, 2011

 

 

 

(in thousands)

 

Product sales

 

$

102,916

 

Income before taxes

 

31,531

 

Net Income

 

19,390

 

 

The consolidated pro forma results include the following non-recurring pro-forma adjustments that were directly attributable to the acquisition:

 

·                  Amortization expense related to the acquired intangible assets of $0.6 million for the three months ended April 2, 2011.

 

·                  Actual acquisition-related transaction costs incurred were not significant for the three months ended April 2, 2011.

 

·                  Fair value adjustment related to inventory was excluded from the pro forma results above for the three months ended April 2, 2011 as the fair value adjustment was recorded in 2010 as if the inventory as of the acquisition date was sold in the 2010 period.

 

·                  Intercompany revenues are excluded from the pro forma consolidated results of operations as if Levitronix Medical operations are consolidated at the beginning of fiscal 2010.

 

Pro forma adjustments are tax-effected using our effective tax rate for three month ended April 2, 2011.

 

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Note 3. Fair Value Measurements

 

Our financial assets and liabilities carried at fair value are primarily comprised of investments in money market funds, municipal and corporate bonds, variable demand notes, auction rate securities, derivative contracts, certain investments held as assets under the deferred compensation plan, and the contingent consideration in connection with the Levitronix Medical acquisition. The fair value accounting guidance requires that assets and liabilities be carried at fair value and classified in one of the following three categories:

 

Level 1: Quoted prices in active markets for identical assets or liabilities that we have the ability to access

 

Level 2: Observable market based inputs or unobservable inputs that are corroborated by market data such as quoted prices, interest rates and yield curves

 

Level 3: Inputs that are unobservable data points that are not corroborated by market data

 

We review the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels of certain securities within the fair value hierarchy. We recognize transfers into and out of levels within the fair value hierarchy in which the actual event or change in circumstances that caused the transfer occurs. There were no significant transfers between Level 1, Level 2, and Level 3 during the three months ended March 31, 2012 and April 2, 2011.

 

The following table represents the fair value hierarchy for our financial assets and financial liabilities measured at fair value on a recurring basis:

 

 

 

Total Fair
Value

 

Quoted
Prices in
Active
Markets
(Level 1)

 

Significant
Other
Observable
Inputs
(Level 2)

 

Significant
Unobservable
Inputs
(Level 3)

 

 

 

(in thousands)

 

As of March 31, 2012:

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

Money market funds

 

$

65,108

 

$

65,108

 

$

 

$

 

Municipal bonds

 

3,606

 

 

 

3,606

 

 

 

Short-term investments:

 

 

 

 

 

 

 

 

 

Municipal bonds

 

100,575

 

 

100,575

 

 

Variable demand notes

 

28,105

 

 

28,105

 

 

Corporate bonds

 

15,787

 

 

15,787

 

 

Auction rate securities

 

200

 

 

 

200

 

Prepaid expenses and other assets:

 

 

 

 

 

 

 

 

 

Mark-to-market on foreign exchange contracts

 

21

 

 

21

 

 

Long-term investments:

 

 

 

 

 

 

 

 

 

Auction rate securities

 

15,914

 

 

 

15,914

 

Other long-term assets:

 

 

 

 

 

 

 

 

 

Investments included in our deferred compensation plan

 

2,392

 

 

2,392

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

Other accrued liabilities:

 

 

 

 

 

 

 

 

 

Mark-to-market on foreign exchange contracts

 

$

2,495

 

$

 

$

2,495

 

$

 

Contingent consideration ($4.9 million included in “Other accrued liabilities; $17.1 million included in “Contingent liabilities”)

 

22,052

 

 

 

22,052

 

 

10



Table of Contents

 

 

 

Total Fair
Value

 

Quoted
Prices in
Active
Markets
(Level 1)

 

Significant
Other
Observable
Inputs
(Level 2)

 

Significant
Unobservable
Inputs
(Level 3)

 

 

 

(in thousands)

 

As of December 31, 2011:

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

Money market funds

 

$

37,986

 

$

37,986

 

$

 

$

 

Short-term investments:

 

 

 

 

 

 

 

 

 

Municipal bonds

 

97,560

 

 

97,560

 

 

Variable demand notes

 

48,800

 

 

48,800

 

 

Corporate bonds

 

4,393

 

 

4,393

 

 

Prepaid expenses and other assets:

 

 

 

 

 

 

 

 

 

Mark to market on foreign exchange contracts

 

674

 

 

674

 

 

Long-term investments:

 

 

 

 

 

 

 

 

 

Auction rate securities

 

16,090

 

 

 

16,090

 

Other long-term assets:

 

 

 

 

 

 

 

 

 

Investments included in our deferred compensation plan

 

2,171

 

 

2,171

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

Contingent consideration ($1.5 million included in “Other accrued liabilities; $22.1 million included in “Contingent liabilities”)

 

$

23,570

 

$

 

$

 

$

23,570

 

 

Financial assets and liabilities are considered Level 2 when their fair values are determined using inputs that are observable in the market or can be derived principally from or corroborated by observable market data such as pricing for similar securities, recently executed transactions, cash flow models with yield curves, and benchmark securities. Our Level 2 financial assets and liabilities include short-term investments, foreign exchange instruments and certain of our deferred compensation plan securities. In addition, Level 2 financial instruments are valued using comparisons to like-kind financial instruments and models that use readily observable market data as their basis.

 

Financial assets and liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies, or similar techniques, and at least one significant model assumption or input is unobservable. Level 3 financial assets include the auction rate securities for which there is limited market activity such that the determination of fair value requires significant judgment or estimation. The auction rate securities were valued using a discounted cash-flow model over a five-year period based on estimated interest rates, the present value of future principal payments, and interest payments discounted at rates considered to reflect the current market conditions and the credit quality of auction rate securities. In addition, Level 3 financial liabilities include the contingent consideration related to the acquisition of Levitronix Medical, because the fair value includes significant management judgment or estimation. The contingent consideration was valued using discounted cash flow models for five revenue scenarios which include a base case (the most likely scenario), two scenarios that incorporate the likelihood of achieving lower revenues than the estimated base case, and two scenarios that incorporate the likelihood of achieving higher revenues than the estimated base case. To calculate the fair value of the contingent considerations, the probability of the fair value of each scenario was weighted.

 

Available-for-sale investments are carried at fair value and are included in the tables above under short- and long-term investments. The aggregate market value, amortized cost basis and gross unrealized gains and losses of available-for-sale investments by major security type are as follows:

 

 

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Fair
Value

 

 

 

(in thousands)

 

As of March 31, 2012:

 

 

 

 

 

 

 

 

 

Short-term investments:

 

 

 

 

 

 

 

 

 

Municipal bonds

 

$

100,434

 

$

173

 

$

(32

)

$

100,575

 

Variable demand notes

 

28,105

 

 

 

28,105

 

Corporate bonds

 

15,765

 

27

 

(5

)

15,787

 

Auction rate securities

 

200

 

 

 

200

 

Total short-term investments

 

$

144,504

 

$

200

 

$

(37

)

$

144,667

 

Long-term investments:

 

 

 

 

 

 

 

 

 

Auction rate securities

 

$

18,700

 

$

 

$

(2,786

)

$

15,914

 

As of December 31, 2011:

 

 

 

 

 

 

 

 

 

Short-term investments:

 

 

 

 

 

 

 

 

 

Municipal bonds

 

$

97,406

 

$

160

 

$

(6

)

$

97,560

 

Variable demand notes

 

48,800

 

 

 

48,800

 

Corporate bonds

 

4,398

 

2

 

(7

)

4,393

 

Total short-term investments

 

$

150,604

 

$

162

 

$

(13

)

$

150,753

 

Long-term investments:

 

 

 

 

 

 

 

 

 

Auction rate securities

 

$

18,900

 

$

 

$

(2,810

)

$

16,090

 

 

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Table of Contents

 

As of March 31, 2012, we owned approximately $18.7 million face amount of auction rate securities classified as long-term and $0.2 million classified as short-term. The assets underlying these investments are student loans backed by the U.S. government under the Federal Family Education Loan Program or by private insurers and are rated between AAA and BB. Historically, these securities have provided liquidity through a Dutch auction process that resets the applicable interest rate periodically every seven to thirty-five days. Beginning in February of 2008, these auctions began to fail. The principal amount of these auction rate securities will not be accessible until future auctions for these securities are successful, a secondary market is established, these securities are called for redemption, or they are paid at maturity.

 

As of March 31, 2012, we had recorded an estimated cumulative unrealized loss of $2.8 million ($1.7 million, net of tax) related to the temporary impairment of the auction rate securities, which was included in accumulated other comprehensive income (loss) within the consolidated shareholders’ equity. In addition, our management reviews impairments and credit loss associated with our investments, including auction rate securities, to determine the classification of the impairment as “temporary” or “other-than-temporary” and to bifurcate the credit and non-credit component of an other-than-temporary impairment event. We (i) do not intend to sell any of the auction rate securities prior to maturity at an amount below the original purchase value; (ii) intend to hold the investment to recovery and, based on a more-likely-than-not probability assessment, will not be required to sell the security before recovery; and (iii) deem that it is not probable that we will receive less than 100% of the principal and accrued interest from the issuer. Therefore, 100% of the impairment was charged to other comprehensive income (loss). Our auction rate securities are primarily classified as long-term and are valued at $15.9 million using significant unobservable inputs. Further, we continue to liquidate investments in auction rate securities as opportunities arise. There were no settlements of our auction rate securities during the three months ended March 31, 2012. In March 2012, $0.2 million of our auction rate securities were called at par and were settled in April 2012. We have reported the $0.2 million as short-term available-for-sale investments on the condensed consolidated balance sheet as of March 31, 2012. Furthermore, an additional $6.0 million of our auction rate securities were called at par on May 1, 2012 and will be settled in the second quarter of 2012.

 

If the issuers of the auction rate securities are unable to successfully complete future auctions and their credit ratings deteriorate, we may in the future be required to record an impairment charge to earnings on these investments. It could conceivably take until the final maturity of the underlying notes (up to 30 years) to realize the investments’ fair value.

 

Our deferred compensation plan includes our corporate owned life insurance policies and mutual fund investments. The underlying mutual fund investments are deemed trading securities. The mutual fund investments’ fair value and the cash surrender value of our corporate-owned life insurance policies are classified in the condensed consolidated balance sheets in “Other long-term assets.” The aggregate value of our deferred compensation plan assets was as follows:

 

 

 

March 31, 2012

 

December 31, 2011

 

 

 

(in thousands)

 

Deferred compensation plan

 

$

4,025

 

$

3,763

 

 

The unrealized gain before tax from the change in the value of the deferred compensation plan was $0.2 million during the three months ended March 31, 2012 and April 2, 2011.

 

The amortized cost and fair value of available-for-sale debt investments, by contractual maturity, were as follows as of March 31, 2012:

 

 

 

Amortized
Cost

 

Fair
Value

 

 

 

(in thousands)

 

Maturing within 1 year

 

$

108,152

 

$

108,280

 

Maturing after 1 year through 5 years

 

36,152

 

36,187

 

Short-term available-for-sale investments

 

144,304

 

144,467

 

Maturing after 5 years

 

18,900

 

16,114

 

 

 

$

163,204

 

$

160,581

 

 

12



Table of Contents

 

The following table provides a rollforward of the fair value, as determined by Level 3 inputs, of the auction rate securities during the three months ended March 31, 2012:

 

 

 

Auction
Rate
Securities

 

 

 

(in thousands)

 

Balance as of December 31, 2011

 

$

16,090

 

Settlements at par

 

 

Unrealized holding gain on auction rate securities, included in other comprehensive income (loss)

 

24

 

Balance as of March 31, 2012

 

$

16,114

 

 

We continue to monitor the market for auction rate securities and consider its impact (if any) on the fair value of our investments. If the current market conditions deteriorate further, or the anticipated recovery in fair values does not occur, we may be required to record additional unrealized losses in other comprehensive income or other-than-temporary impairment charges to the condensed consolidated statements of operations in future periods.

 

The following table provides a rollforward of the fair value, as determined by Level 3 inputs, of contingent consideration during the three months ended March 31, 2012:

 

 

 

Contingent
Consideration

 

 

 

(in thousands)

 

Balance as of December 31, 2011

 

$

23,570

 

Payments

 

(1,518

)

Change in fair value

 

 

Balance as of March 31, 2012

 

$

22,052

 

 

The following table presents quantitative information about the inputs and valuation methodologies used for our fair value measurements classified in Level 3 of the fair value hierarchy as of March 31, 2012:

 

 

 

Fair Value at
March 31, 2012

(in millions)

 

Valuation Technique

 

Significant Unobservable Input

 

weighted average (range)

 

Auction rate securities

 

$

16.1

 

Discounted cash flow

 

Discount rate

 

1.03% (1.03%)

 

 

 

 

 

 

 

Market credit spread

 

3.869% (0.69% - 5.67%)

 

 

 

 

 

 

 

Liquidity factor

 

0.86% (0.78% - 0.95%)

 

 

 

 

 

 

 

 

 

 

 

Contingent considerations

 

$

22.0

 

Multiple outcome discounted cash flow

 

Revenue

 

$39.5 million ($25.5 million to $46.7 million)

 

 

 

 

 

 

 

Discount rate

 

1.67% (1.17% to 2.24%)

 

 

 

 

 

 

 

Probability of occurrence

 

20% (10% to 50%)

 

 

Auction rate securities

 

The significant unobservable inputs used in the fair value measurement of the auction rate securities are the weighted average discount rate, market credit spread and liquidity factor. A significant increase (decrease) in the discount rate in isolation could result in a significantly higher (lower) fair value measurement, whereas a significant increase (decrease) in the market credit spread and liquidity factor in isolation could result in significant lower (higher) fair value measurement. Although the discount rate and the market credit spread and liquidity factor are not directly interrelated, they will generally move in opposite directions.

 

The fair value of auction rate securities is calculated on a quarterly basis by senior management based on a collaborative effort of the our Corporate treasury and accounting groups. To assess the reasonableness of the fair value measurement, management compares its fair value measurement to the values calculated by independent third-parties.

 

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Table of Contents

 

Contingent consideration

 

The estimated fair value of the liability for contingent consideration represents revenue targets related to the Levitronix Medical acquisition. The fair value of the liability is determined using a discounted cash flow technique with significant inputs that include projected revenue, discount rate and percent probability of occurrence. A significant increase (decrease) in the projected revenue in isolation could result in a significantly higher (lower) fair value measurement; a significant increase (decrease) in the discount rate in isolation could result in a significantly lower (higher) fair value measurement; and the changes in the probability of occurrence between the outcomes in isolation could result in a significantly lower (higher) fair value measurement.

 

The fair value of the contingent considerations is calculated on a quarterly basis by management based on a collaborative effort of the our operation, finance and accounting groups. Potential valuation adjustments are made as additional information becomes available, including the progress toward achieving revenue targets as compared to initial projections, the impact of market competition, and changes in actual and projected product mix and average selling price, with the impact of such adjustments being recorded in the condensed consolidated statement of operations. No adjustments were made for the three months ended March 31, 2012.

 

Assets and Liabilities That Are Measured at Fair Value on a Nonrecurring Basis

 

Non-financial assets such as goodwill, intangible assets, and property, plant, and equipment are evaluated for impairment and adjusted to fair value using Level 3 inputs, only when an impairment is recognized. Fair values are considered Level 3 when management makes significant assumptions in developing a discounted cash flow model based upon a number of considerations including projections of revenues, earnings and a discount rate. In addition, in evaluating the fair value of goodwill impairment, further corroboration is obtained using our market capitalization. There was no impairment recorded in the three months ended March 31, 2012.

 

Note 4. Foreign Exchange Instruments

 

We utilize foreign currency forward exchange contracts and options with recognized financial institutions to manage our exposure to the impact of fluctuations in foreign currency exchange rates on certain intercompany balances and foreign currency denominated sales and purchase transactions. We do not use derivative financial instruments for speculative or trading purposes. These derivatives are not designated as hedging instruments for accounting purposes. Principal hedged currencies include the Euro, British Pound Sterling, U.S. Dollar and Swiss Franc. The periods of these forward contracts is between 30 days to 9 months and have varying notional amounts that are intended to be consistent with changes in the underlying exposures. We intend to exchange foreign currencies for U.S. dollars at maturity.

 

Total gross notional amounts for outstanding derivatives instruments were as follows:

 

 

 

March 31,
2012

 

December 31,
2011

 

Forward contracts:

 

 

 

 

 

Euro (sell)

 

11.7 million

 

9.6 million

 

British Pound Sterling (sell)

 

£

1.1 million

 

£

0.8 million

 

U.S. Dollar (sell)

 

$

5.3 million

 

$

3.6 million

 

U.S. Dollar (buy)

 

$

77.6 million

 

$

76.2 million

 

U.S. Dollar (buy)

 

$

10.8 million

 

$

9.1 million

 

 

The following table shows the derivative instruments measured at gross fair value reported on the condensed consolidated balance sheets:

 

 

 

March 31, 2012

 

 

 

Prepaid expenses
and other assets

 

Other accrued
liabilities

 

 

 

(in thousands)

 

Derivatives not designated as hedging instruments (forward contracts)

 

$

21

 

$

2,495

 

 

 

 

December 31, 2011

 

 

 

Prepaid expenses
and other assets

 

Other accrued
liabilities

 

 

 

(in thousands)

 

Derivatives not designated as hedging instruments (forward contracts)

 

$

674

 

$

 

 

14



Table of Contents

 

The following table shows the effect of derivative instruments not designated as hedging instruments and foreign currency transactions gains and losses which were included in “Interest income and other” in the condensed consolidated statements of operations:

 

 

 

Three Months Ended

 

 

 

March 31, 2012

 

April 2, 2011

 

 

 

(in thousands)

 

Foreign currency exchange gain (loss) on foreign contracts

 

$

(2,925

)

$

(365

)

Foreign currency transactions gain (loss)

 

3,114

 

(136

)

 

Note 5. Balance Sheet Information

 

The following tables provide details of selected condensed consolidated balance sheets items as of the end of each period:

 

Inventories consisted of the following:

 

 

 

March 31,
2012

 

December 31,
2011

 

 

 

(in thousands)

 

Finished goods

 

$

16,839

 

$

20,911

 

Work in process

 

9,713

 

11,296

 

Raw materials

 

21,202

 

23,484

 

Total

 

$

47,754

 

$

55,691

 

 

Property, plant and equipment, net consisted of the following:

 

 

 

March 31,
2012

 

December 31,
2011

 

 

 

(in thousands)

 

Land, building and improvements

 

$

20,113

 

$

20,116

 

Equipment and capitalized software

 

41,123

 

38,829

 

Furniture and leasehold improvements

 

23,605

 

23,406

 

Total

 

84,841

 

82,351

 

Less accumulated depreciation

 

(45,389

)

(43,423

)

Total

 

$

39,452

 

$

38,928

 

 

Depreciation expense for the three months ended March 31, 2012 and April 2, 2011 were $2.1 million and $1.8 million, respectively.

 

Warranty provision, included in “Other accrued liabilities” on the condensed consolidated balance sheets, and the changes in the balances were as follows:

 

 

 

March 31,
2012

 

April 2,
2011

 

 

 

(in thousands)

 

Balance, beginning of the period

 

$

2,452

 

$

3,057

 

Additions

 

540

 

226

 

Settlements

 

(282

)

(477

)

Balance, end of the period

 

$

2,710

 

$

2,806

 

 

Note 6. Goodwill and Intangible Assets, net

 

The carrying amount of goodwill and the changes in the balances for the three months ended March 31, 2012 are as follows:

 

Balance, beginning of the period

 

$

191,193

 

Foreign currency translation impact

 

3,265

 

Balance, end of the period

 

$

194,458

 

 

15



Table of Contents

 

In February 2001, we merged with Thermo Cardiosystems, Inc. The components of identifiable intangible assets related to the merger included patents and trademarks, core technology (Thoralon, our proprietary bio-material), and developed technology (patented technology, other than core technology, acquired in the merger).

 

As a result of the our acquisition of Levitronix Medical in August 2011, we recorded patents and trademarks of $2.7 million, developed technology of $6.3 million, pre-existing license agreements of $2.3 million, and customer based relationships and other of $4.3 million.

 

Intangibles (net) consisted of the following:

 

 

 

As of March 31, 2012

 

 

 

Gross
Amount

 

Accumulated
Amortization

 

Net
Amount

 

 

 

(in thousands)

 

Patents and trademarks

 

$

43,444

 

$

(32,465

)

$

10,979

 

Core technology

 

37,180

 

(19,929

)

17,251

 

Developed technology

 

127,867

 

(71,557

)

56,310

 

Pre-existing license agreement

 

2,300

 

(219

)

2,081

 

Customer based relationships and other

 

4,146

 

(1,245

)

2,901

 

 

 

214,937

 

(125,415

)

89,522

 

Foreign currency translation impact

 

416

 

 

416

 

Total purchased intangible assets

 

$

215,353

 

$

(125,415

)

$

89,938

 

 

 

 

As of December 31, 2011

 

 

 

Gross
Amount

 

Accumulated
Amortization

 

Net
Amount

 

 

 

(in thousands)

 

Patents and trademarks

 

$

43,531

 

$

(31,836

)

$

11,695

 

Core technology

 

37,180

 

(19,445

)

17,735

 

Developed technology

 

128,072

 

(69,262

)

58,810

 

Pre-existing license agreement

 

2,300

 

(145

)

2,155

 

Customer based relationships and other

 

4,270

 

(493

)

3,777

 

 

 

215,353

 

(121,181

)

94,172

 

Foreign currency translation impact

 

(1,893

)

 

(1,893

)

Total purchased intangible assets

 

$

213,460

 

$

(121,181

)

$

92,279

 

 

Amortization of intangible assets above is based on a straight-line method, which represents the expected pattern of future benefits related to those respective intangible assets. Amortization expense related to identifiable intangible assets was $2.8 million and $2.3 million for the three months ended March 31, 2012 and April 2, 2011, respectively.

 

Estimated amortization expenses for the next five fiscal years and all years thereafter are as follows:

 

 

 

(in thousands)

 

Fiscal year:

 

 

 

Remainder of 2012

 

$

8,496

 

2013

 

11,328

 

2014

 

10,304

 

2015

 

10,100

 

2016

 

10,051

 

Thereafter

 

39,659

 

Total

 

$

89,938

 

 

16



Table of Contents

 

Note 7. Debt and Other Financing Arrangements

 

Senior Subordinated Convertible Notes

 

In 2004, we completed the sale of $143.8 million of initial principal amount of senior subordinated convertible notes due in 2034. The convertible notes were sold to “qualified institutional buyers” pursuant to the exemption from the registration requirements of the Securities Act of 1933, as amended, provided by Rule 144A thereunder.

 

The senior subordinated convertible notes were issued at an issue price of $580.98 per note, which is 58.098% of the principal amount at maturity of the notes. The senior subordinated convertible notes bore interest at a rate of 1.3798% per year on the principal amount at maturity, payable semi-annually in arrears in cash on May 16 and November 16 of each year, from November 16, 2004 until May 16, 2011.

 

Holders of the senior subordinated convertible notes were able to convert their convertible notes into shares of our common stock at a conversion rate of 29.4652 shares per $1,000 principal amount of senior subordinated convertible notes, which represents a conversion price of $19.72 per share, subject to adjustments upon the occurrence of certain events as set forth in the indenture. If holders elected conversion, we could elect, at our option, to deliver shares of common stock, pay a holder in cash, or deliver a combination of shares and cash, as determined pursuant to the terms of the notes.

 

Holders could require us to repurchase all or a portion of their senior subordinated convertible notes on each of May 16, 2011, 2014, 2019, 2024 and 2029 at a repurchase price equal to 100% of the issue price, plus accrued original issue discount, if any. On March 31, 2011, pursuant to our rights under the terms of the Notes we gave notice of our intention to redeem all of our outstanding senior subordinated convertible notes on May 17, 2011. During the second quarter of 2011, prior to or on May 16, 2011, bondholders converted 243,367 bonds, and we elected to pay $164.4 million in cash and issue 2,397,535 shares with an estimated fair value at conversion of $82.7 million. In addition, on May 17, 2011, we redeemed the remaining outstanding 15 bonds for cash. We accounted for the extinguishment in accordance with accounting standards, and there was no gain or loss reported for the fiscal year ended December 31, 2011. The difference of $105.7 million between the fair value of the aggregate consideration paid of $247.1 million and the face value of the senior subordinated convertible notes of $141.4 million was recorded to additional paid-in capital.

 

In accordance with accounting standards for certain convertible debt instruments that may be settled in cash or other assets, or partially in cash, upon conversion, we recorded the long-term debt and equity components on the senior subordinated convertible notes separately. This accounting pronouncement increased interest expense associated with our senior subordinated convertible notes by adding a non-cash component to amortize a debt discount calculated based on the difference between the cash coupon rate (2.375% per year) of the senior subordinated convertible notes and the effective interest rate on debt borrowing (9% per year). The discount, which represents the non-cash interest expense, classified as interest expense on the consolidated statements of operations, was being amortized to interest expense over a seven-year period ending May 16, 2011 (the expected life of the liability component) using the effective interest method. Additionally, we allocated transaction costs on the same percentage as the liability and equity component, such that a portion of the deferred debt issuance costs was allocated to the liability component to be amortized using the effective interest method until May 16, 2011, and the equity component to be included in additional paid-in capital.

 

Interest expense primarily includes interest and amortization of discount related to senior subordinated convertible notes, in which the cash and non-cash component were $840,000 and $2,038,000, respectively for the period ended April 2, 2011. There was no interest expense — cash or non-cash component for the three months ended March 31, 2012.

 

Credit Facility

 

On December 19, 2011, we signed an unsecured revolving credit facility agreement that provides for up to $50 million revolving credit that will expire on December 19, 2016. The interest rate charged on the amounts borrowed is LIBOR plus a margin (ranging from 0.75% to 1.25%). The credit agreement contains financial covenants. We were in compliance with all covenants as of March 31, 2012. The credit agreement permits us to use the facility for working capital and general corporate purposes. As of March 31, 2012, there were no borrowings under this credit facility.

 

Note 8. Share-Based Compensation

 

Our Board of Directors authorized the 2006 Incentive Stock Plan (the “2006 Plan”). The 2006 Plan was last amended in December 2011. Participation in the 2006 Plan is limited to employees, directors, and consultants. Shares reserved for future issuance under the 2006 Plan may be used for grants of stock options (“options”), restricted stock units (“RSUs”), and other types of awards. Options granted under the 2006 Plan are either incentive or nonqualified stock options and generally become exercisable in increments over a period of four years from the date of grant and expire generally ten years from the grant date. RSUs generally vest over a four-year period.

 

The Board of Directors authorizes the granting of options, RSUs and other type of awards, and determines the employees and consultants to whom options, RSUs, or other awards are to be granted, the number of shares, term, vesting schedule and other terms

 

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Table of Contents

 

and conditions of the options, RSUs or other stock awards. The exercise prices of the options shall not be less than the fair market value of common stock on the date of grant. The fair value of RSUs granted is determined based on the number of RSUs granted and the quoted price of our common stock on the date of grant. As of March 31, 2012, approximately 1.4 million shares remained available for grant under the 2006 Plan.

 

Additionally, we sponsor the Employee Stock Purchase Plan (the “ESPP”) in which eligible employees may contribute up to 15% of their base compensation to purchase shares of common stock at a price equal to 85% of the lower of the market value of the stock at the beginning or end of each six-month offer period. As of March 31, 2011, approximately 541,975 shares remained available for issuance under this plan.

 

Share-based compensation included in the condensed consolidated statements of operations consists of the following:

 

 

 

Three Months Ended

 

 

 

March 31, 2012

 

April 2, 2011

 

 

 

(in thousands)

 

Cost of goods sold

 

$

565

 

$

331

 

Selling, general and administrative

 

2,979

 

2,529

 

Research and development

 

1,516

 

1,103

 

Total share-based compensation expense before taxes

 

5,060

 

3,963

 

Tax benefit for share-based compensation expense

 

1,891

 

1,323

 

Total share-based compensation (net of taxes)

 

$

3,169

 

$

2,640

 

 

Share-based compensation cost of $0.5 million and $0.4 million was capitalized to inventory as of March 31, 2012 and December 31, 2011, respectively.

 

Stock Options

 

The fair value of each option is estimated at the date of grant using the Black-Scholes option pricing model with the following assumptions:

 

 

 

Three Months Ended

 

 

 

March 31, 2012

 

April 2, 2011

 

Risk-free interest rate

 

1.43

%

2.81

%

Expected volatility

 

43

%

44

%

Expected option life

 

4.81 to 5.83 years

 

4.80 to 5.85 years

 

Dividends

 

None

 

None

 

 

Determining Fair Value for Options

 

·                  Valuation and amortization method — We estimate the fair value of stock options granted using the Black-Scholes-option pricing formula. This fair value is then amortized over the requisite service periods of the awards, which is generally the vesting period.

 

·                  Expected Term — The expected term of options represents the period of time that options are expected to be outstanding. We use separate assumptions for groups of employees (for example, officers) that have similar historical exercise behavior, giving consideration to the contractual terms of the share-based awards, vesting schedules and expectations of future employee behavior as influenced by changes to the terms of our share-based awards. The range above reflects the expected option impact of these separate groups.

 

·                  Expected Volatility — Our expected volatility was based on a combination of historical volatility trends and market-based implied volatility because we determined that this combination of historical volatility trends and market-based implied trends is reflective of market conditions. The decision to incorporate implied volatility was based on our assessment that implied volatility of publicly traded options in our common stock is reflective of market conditions and is generally reflective of both historical volatility and expectations of how future volatility will differ from historical volatility. In determining the extent of use of implied volatility, we considered: (i) the volume of market activity of traded options; (ii) the ability to reasonably match the input variables of traded options to those of stock options granted by us, including the date of grant; (iii) the similarity of the exercise prices; and (iv) the length of term of traded options.

 

·                  Risk-Free Interest Rate — The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant.

 

·                  Expected Dividend—The expected dividend assumption is based on our current expectations about our anticipated dividend policy.

 

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Stock option activity is summarized as follows:

 

 

 

Number of
Options
(in thousands)

 

Weighted
Average Exercise
Price Per Share

 

Weighted Average
Remaining Contract
Life (years)

 

Outstanding options at December 31, 2011

 

2,538

 

$

22.46

 

5.96

 

Granted

 

525

 

33.94

 

 

 

Exercised

 

(170

)

17.93

 

 

 

Forfeited or expired

 

(51

)

30.66

 

 

 

Outstanding options at March 31, 2012

 

2,842

 

$

24.71

 

6.55

 

Outstanding options exercisable at March 31, 2012

 

1,651

 

$

20.36

 

4.67

 

Outstanding options vested at March 31, 2012 and expected to vest

 

2,751

 

$

24.49

 

6.46

 

 

As of March 31, 2012, there was $11.1 million of unrecognized compensation expense, net of estimated forfeitures, related to stock options, which expense we expect to recognize over a weighted average period of 2.03 years.

 

Restricted Stock Units

 

Restricted stock unit activity is summarized as follows:

 

 

 

Number of
Units
(in thousands)

 

Weighted Average
Grant Date Fair
Value

 

Weighted Average
Remaining Contract
Life (in years)

 

Outstanding units at December 31, 2011

 

1,151

 

$

28.88

 

1.50

 

Granted

 

494

 

33.93

 

 

 

Released

 

(262

)

27.28

 

 

 

Forfeited or expired

 

(49

)

30.53

 

 

 

Outstanding units at March 31, 2012

 

1,334

 

$

31.02

 

1.93

 

 

As of March 31, 2012, we had $36.0 million of unrecognized compensation expense, net of estimated forfeitures, related to restricted stock units, which amount we expect to recognize over 3.01 years.

 

Employee Stock Purchase Plan

 

The estimated subscription date fair value of the offering under the ESPP for each of the three months ended March 31, 2012 and April 2, 2011 was $0.6 million using the Black-Scholes option pricing model and the following assumptions:

 

 

 

Three Months Ended

 

 

 

March 31, 2012

 

April 2, 2011

 

Risk-free-interest rate

 

0.05

%

0.16

%

Expected volatility

 

36

%

46

%

Expected option life

 

0.50 years

 

0.50 years

 

Dividends

 

None

 

None

 

 

As of March 31, 2012, there was approximately $0.1 million of unrecognized compensation expense related to ESPP subscriptions that began on November 1, 2011, which amount we expect to recognize during the second quarter of 2012.

 

Note 9.  Common and Preferred Stock

 

During the first quarter of fiscal 2011, under a $100 million repurchase program publicly announced on February 14, 2011 (“February 2011 program”), we paid an aggregate of $50 million to repurchase 1,783,267 shares of our common stock. On November 7, 2011 we announced that our Board of Directors authorized a new publicly announced program for the repurchase of up to $50 million worth of shares of our common stock. Additionally, the Board of Directors extended the expiration date for the $50 million remaining under the

 

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February 2011 program to November 4, 2012. There was no repurchase of shares during the three months ended March 31, 2012 under these publicly announced programs.

 

Shares of our common stock purchased that were not part of our publicly announced repurchase programs represent the surrender value of shares of restricted stock awards and units withheld in order to satisfy tax withholding tax obligations upon vesting. The shares purchased do not reduce the dollar value that may yet be purchased under our publicly announced repurchase programs. The aggregate value of 136,430 shares purchased during the three months ended March 31, 2012 was $4.7 million, and the aggregative value of 126,342 shares purchased during the three months ended April 2, 2011 was $3.5 million.

 

Note 10. Income Taxes

 

Our effective income tax rates for the three months ended March 31, 2012 and April 2, 2011, were 32.4% and 34.1%, respectively.  The decrease is primarily attributable to a greater percentage of earnings generated in lower-tax jurisdictions, a function of the acquisition of Levitronix Medical. This rate benefit was partially offset by the lack of federal R&D credits in the absence of enacted legislation.

 

During the next twelve months, it is reasonably possible that audit resolutions and the expiration of statutes of limitations could potentially reduce our unrecognized tax benefits by up to $2.0 million. However, this amount may change because we continue to have ongoing negotiations with various taxing authorities throughout the year.

 

Note 11. Segment and Geographic Information

 

The accounting standard for segment reporting establishes standards for reporting information about operating segments in annual financial statements and requires selected information for those segments to be presented in interim financial reports of public business enterprises. It also establishes standards for related disclosures about products and services, geographic areas and major customers. As a result of this evaluation, in which we have also considered the Levitronix Medical acquisition, we determined that we have one operating segment: Cardiovascular group. This segment is organized and operates to develop and manufacture mechanical circulatory products to support the cardiovascular systems of humans.

 

Product sales attributed to a country or region includes product sales to hospitals, physicians and distributors and is based on final destination where the products are sold. No individual customer and no individual country outside of the U.S. accounted for more than 10% of product sales during the three months ended March 31, 2012 or April 30, 2011.

 

 

 

Three Months Ended

 

 

 

March 31,
 2012

 

April 2,
 2011

 

 

 

(in thousands)

 

Product sales by geographic location:

 

 

 

 

 

Domestic

 

$

103,861

 

$

82,467

 

International

 

22,908

 

17,063

 

Total

 

$

126,769

 

$

99,530

 

 

 

 

Three Months Ended

 

 

 

March 31,
 2012

 

April 2,
 2011

 

 

 

(in thousands)

 

Product sales by product line:

 

 

 

 

 

HeartMate

 

$

111,690

 

$

87,263

 

Thoratec

 

5,788

 

7,295

 

CentriMag

 

8,654

 

4,452

 

Other

 

637

 

520

 

Total

 

$

126,769

 

$

99,530

 

 

 

 

Three Months Ended

 

 

 

March 31,
 2012

 

April 2,
 2011

 

 

 

(in thousands)

 

Product sales by category:

 

 

 

 

 

Pump

 

$

92,519

 

$

67,331

 

Non-Pump

 

33,613

 

31,679

 

Other

 

637

 

520

 

Total

 

$

126,769

 

$

99,530

 

 

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Note 12. Net Income Per Share

 

Restricted Stock Awards (“RSA”) previously granted under the 2006 Plan, are subject to repurchase, settled in shares of common stock upon vesting, and have non-forfeitable rights to receive dividends on an equal basis with common stock and therefore are considered participating securities. Under the two-class method, basic and diluted net income per common share are determined by calculating net income per share for common stock and participating securities based on participation rights in undistributed earnings. Dilutive net income per common share also considers the dilutive effect of the in-the-money stock options, and restricted stock units, calculated using the treasury stock method and the dilutive effect of the senior subordinated convertible notes, calculated using the if-converted method. Under the treasury stock method, the amount of assumed proceeds from unexercised stock options, restricted stock units includes the amount of unrecognized compensation cost attributable to future services, assumed proceeds from the exercise of the options, and the incremental income tax benefit or liability that would be recorded in additional-paid-in capital when the award becomes deductible. In addition, under the if-converted method, cash and non-cash interest expense from the senior subordinated convertible notes are added back to net income and the weighted average number of common shares that the notes convert into are included in the number of shares used to calculate diluted net income (loss) per share.

 

Basic and diluted net income per common share attributable to common shareholders under the two-class method were calculated as follows:

 

 

 

Three Months Ended

 

 

 

March 31, 2012

 

April 2, 2011

 

 

 

(stated in thousands, except per share amounts)

 

 

 

 

 

 

 

Basic net income per common share calculation

 

 

 

 

 

Net income

 

$

25,486

 

$

16,459

 

Net income allocated to participating securities

 

(20

)

(48

)

Net income attributable to common shareholders

 

$

25,466

 

$

16,411

 

 

 

 

 

 

 

Weighted average number of common shares used to compute basic net income per common share

 

58,438

 

57,932

 

 

 

 

 

 

 

Basic net income per common share

 

$

0.44

 

$

0.28

 

 

 

 

 

 

 

Diluted net income per common share calculation

 

 

 

 

 

Net income

 

$

25,486

 

$

16,459

 

Interest expense on senior subordinated convertible debt (net of taxes)

 

 

1,680

 

Net income for diluted share calculation

 

25,486

 

18,139

 

Net income from allocated to participating securities

 

(20

)

(47

)

Net income attributable to common shareholders

 

$

25,466

 

$

18,092

 

 

 

 

 

 

 

Weighted average number of common shares used to compute basic net income per common share attributable to common shares

 

58,438

 

57,932

 

Dilutive effect of stock-based compensation plans

 

944

 

778

 

Dilutive effect on conversion of senior subordinated convertible notes

 

 

7,171

 

Weighted average number of common shares used to compute diluted net income per common share

 

59,382

 

65,881

 

 

 

 

 

 

 

Diluted net income per common share

 

$

0.43

 

$

0.27

 

 

The weighted average unvested restricted stock awards outstanding were 46,427 and 169,781 for the three months ended March 31, 2012 and April 2, 2011, respectively.

 

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Potential common share equivalents excluded where the inclusion would be anti-dilutive are as follows:

 

 

 

Three Months Ended

 

 

 

March 31, 2012

 

April 2, 2011

 

 

 

(in thousands)

 

Options to purchase shares not included in the computation of diluted net income per common share because their inclusion would be antidilutive

 

253

 

613

 

 

The computation of diluted net income per common share for the three months ended April 2, 2011 excludes the effect of assuming the conversion of our senior subordinated convertible notes, which were convertible at $19.72 per share into 7.3 million shares of common stock, because the effect would have been antidilutive.

 

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Table of Contents

 

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

 

Forward-Looking Statements

 

This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the words “expects,” “projects,” “hopes,” “believes,” “intends,” “should,” “estimate,” “will,” “would,” “may,” “anticipates,” “plans,” “could” and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond our control. Therefore, readers are cautioned not to put undue reliance on these statements. Factors that could cause actual results or conditions to differ from those anticipated by these and other forward-looking statements include those more fully described in the “Risk Factors” section of our 2010 Annual Report on Form 10-K (the “2010 Annual Report”) and in other documents we file with the Securities and Exchange Commission (“SEC”). These forward-looking statements speak only as of the date hereof. We are not under any obligation, and we expressly disclaim any obligation, to publicly release any revisions or updates to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

 

The following presentation of management’s discussion and analysis of our financial condition and results of operations should be read together with our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

 

OVERVIEW

 

Continuing Operations—Cardiovascular Business

 

Thoratec Corporation (“we,” “our,” “us” or the “Company”) is the world leader in mechanical circulatory support with a product portfolio to treat the full range of clinical needs for advanced heart failure patients. We develop, manufacture and market proprietary medical devices used for circulatory support.

 

For the treatment of heart failure (“HF”) patients, we develop, manufacture and market proprietary medical devices used for mechanical circulatory support (“MCS”). For advanced HF, our primary product lines are our ventricular assist devices (“VADs”): the Thoratec Paracorporeal Ventricular Assist Device (“PVAD”), the Thoratec Implantable Ventricular Assist Device (“IVAD”), and the HeartMate II Left Ventricular Assist System (“HeartMate II”). We refer to the PVAD and the IVAD collectively as the “Thoratec product line” and we refer to the HeartMate II as the “HeartMate product line.” For acute HF, our product lines are the CentriMag Acute Circulatory System (“CentriMag”) and for pediatric patients the PediMag/PediVAS Acute Circulatory System (“PediMag/PediVAS”). The PVAD, IVAD, HeartMate XVE, HeartMate II, CentriMag and PediMag/PediVAS are approved by the U.S. Food and Drug Administration (“FDA”) and Conformité Européene (“CE”) Mark approved in Europe.

 

MCS devices supplement the pumping function of the heart in patients with HF. In most cases, a cannula connects the left ventricle of the heart to a blood pump. Blood flows from the left ventricle to the pump chamber via the cannula, powered by an electric or air driven mechanism that drives the blood through another cannula into the aorta. From the aorta, the blood then circulates throughout the body. Mechanical or tissue valves enable unidirectional flow in some devices. Currently, the power source remains outside the body for all FDA-approved MCS devices.

 

Certain MCS devices are implanted internally, while others are placed outside the body. Some external devices are placed immediately adjacent to the body (paracorporeal), while other external MCS devices are positioned at a distance from the body (extracorporeal).

 

On August 3, 2011, we announced that we acquired the medical business of Levitronix (“Levitronix Medical”), for an upfront cash payment of $110 million, as well as potential future cash earn-out payments of up to $40 million. This acquisition follows a successful strategic relationship between the two companies. Prior to the acquisition, we provided distribution and clinical support to Levitronix Medical in the U.S. for the CentriMag, under an agreement that would have expired at the end of 2011. We have also collaborated on the development of the fully magnetically levitated motor technology employed in the HeartMate III left ventricular assist system, which is currently in preclinical testing.

 

Our product portfolio of implantable and external MCS devices is described below.

 

The HeartMate II

 

The HeartMate II is an implantable, electrically powered, continuous flow, left ventricular assist device consisting of a rotary blood pump designed to provide intermediate and long-term MCS. The HeartMate II is designed to improve survival and quality of life for a

 

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Table of Contents

 

broad range of advanced HF patients. Significantly smaller than the HeartMate XVE and with only one moving part, the HeartMate II is simpler and designed to operate more quietly than pulsatile devices.

 

HeartMate II received FDA approval in April 2008 for bridge-to-transplantation (“BTT”) and received FDA approval for use in HF patients who are not eligible for heart transplantation (“Destination Therapy” or “DT”) in January 2010. In November 2005, the HeartMate II received CE Mark approval, allowing for its commercial sale in Europe. In May 2009, the HeartMate II was approved in Canada.

 

During the third quarter of 2009, we launched our new HeartMate external peripherals (GoGear), including new batteries, charger and power module, which are designed to provide an enhanced quality of life for HeartMate patients by providing them more freedom and mobility and the ability to more easily resume many aspects of a normal lifestyle.

 

The Paracorporeal Ventricular Assist Device

 

The PVAD is an external, pulsatile, ventricular assist device, FDA approved for BTT, including home discharge, and post-cardiotomy myocardial recovery and provides left, right and biventricular MCS. The PVAD is a paracorporeal device that is less invasive than implantable VADs since only the cannula is implanted. The paracorporeal nature of the PVAD has several benefits including shorter implantation times (approximately two hours) and the ability to use the device in smaller patients.

 

A pneumatic power source drives the PVAD. It is designed for short-to-intermediate duration use of a few weeks to several months, although this device has supported certain patients for nine to eighteen months. Offering left, right or biventricular support, the PVAD and the IVAD, described below, are the only biventricular support systems approved for use for BTT. This characteristic is significant because approximately 65% of BTT patients treated with the PVAD and the IVAD require right as well as left-sided ventricular assistance. The PVAD and the IVAD are also the only devices approved for both BTT and recovery following cardiac surgery. The PVAD incorporates our proprietary biomaterial, Thoralon, which has excellent tissue and blood compatibility and is resistant to blood clots.

 

The PVAD received FDA approval for BTT in December 1995 and for recovery (post-cardiotomy) in May 1998. In June 1998, the PVAD received CE Mark approval, allowing for its commercial sale in Europe. In November 1994, the PVAD was approved in Canada.

 

The Implantable Ventricular Assist Device

 

The IVAD is an implantable, pulsatile, ventricular assist device FDA approved for BTT, including home discharge, and post-cardiotomy myocardial recovery and provides left, right or biventricular MCS. The IVAD maintains the same blood flow path, valves and blood pumping mechanism as the PVAD, but has an outer housing made of a titanium alloy that makes it suitable for implantation.

 

The IVAD received FDA approval for BTT and recovery (post-cardiotomy) in August 2004. In June 2003, the IVAD received CE Mark approval, allowing for its commercial sale in Europe. In November 2004, the IVAD was approved in Canada.

 

The CentriMag

 

The CentriMag is an extracorporeal full-flow acute surgical support platform incorporating a polycarbonate pump, based on magnetically levitated bearingless motor technology. The CentriMag is 510(k) cleared by the FDA for use up to six hours in patients requiring short-term extracorporeal circulatory support during cardiac surgery. Additionally, CentriMag is approved under an FDA humanitarian device exemption to be used as a right ventricular assist device for periods of support up to thirty days in patients in cardiogenic shock due to acute right ventricular failure. In May 2008, Levitronix received approval to commence a U.S. pivotal trial to demonstrate safety and effectiveness of the CentriMag for periods of support up to thirty days. The CentriMag has CE Mark approval in Europe to provide support for up to thirty days for both cardiac and respiratory failure. In Canada, the CentriMag is approved for short-term cardiopulmonary support.

 

The PediMag/PediVAS

 

The PediMag and PediVAS are identical, extracorporeal full-flow acute surgical support platforms incorporating a polycarbonate pump, based on magnetically levitated bearingless motor technology, designed to provide acute surgical support to pediatric patients. The brand names differ according to indication for use, duration of support, and regulatory approval. The PediMag is 510(k) cleared by the FDA for use, in conjunction with the CentriMag console and motor, for support periods of up to six hours. An Investigational Device Exemption (IDE) has been submitted to the FDA in order to begin a U.S. clinical trial examining the safety and probable

 

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Table of Contents

 

benefit of the device for use up to 30 days to support pediatric patients. Outside the U.S., the device is branded as PediVAS and has CE Mark approval for support durations of up to 30 days for both cardiac and respiratory failure. In Canada, PediVAS is approved for short cardiopulmonary support or extracorporeal life support.

 

Critical Accounting Policies and Estimates

 

Our condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. Preparation of these statements requires management to make judgments and estimates. Some accounting policies have a significant impact on amounts reported in these financial statements. A summary of significant accounting policies and a description of accounting policies that are considered critical may be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, in the Notes to the Consolidated Financial Statements (Note 1) and the Critical Accounting Policies and Estimates section in Management’s Discussion and Analysis of Financial Condition and Results of Operations. There have been no changes in these significant accounting policies during the three months ended March 31, 2012.

 

Results of Operations

 

The following table sets forth selected unaudited condensed consolidated statements of operations data for the periods indicated and as a percentage of total product sales:

 

 

 

Three Months Ended

 

 

 

(in thousands, except for percentage data)

 

 

 

March 31,
2012

 

%

 

April 2,
2011

 

%

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

$

126,769

 

100.0

%

$

99,530

 

100.0

%

Cost of product sales

 

38,887

 

30.7

 

31,772

 

31.9

 

Gross profit

 

87,882

 

69.3

 

67,758

 

68.1

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

31,201

 

24.6

 

24,919

 

25.0

 

Research and development

 

19,696

 

15.5

 

15,754

 

15.9

 

Total operating expenses

 

50,897

 

40.1

 

40,673

 

40.9

 

Income from operations

 

36,985

 

29.2

 

27,085

 

27.2

 

Other income and (expense):

 

 

 

 

 

 

 

 

 

Interest expense and other

 

(3

)

0.0

 

(2,880

)

(2.9

)

Interest income and other

 

734

 

0.6

 

755

 

0.7

 

Income before income tax expense

 

37,716

 

29.8

 

24,960

 

25.0

 

Income tax expense

 

(12,230

)

(9.7

)

(8,501

)

(8.5

)

Net income

 

$

25,486

 

20.1

 

$

16,459

 

16.5

 

 

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Table of Contents

 

Three months ended March 31, 2012 and April 2, 2011

 

Product Sales

 

Product sales consisted of the following:

 

 

 

Three Months Ended

 

 

 

 

 

March 31,
2012

 

April 2,
2011

 

% Change

 

 

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

Total product sales

 

$

126,769

 

$

99,530

 

27.4

%

 

During the three months ended March 31, 2012 as compared to the three months ended April 2, 2011, product sales increased by $27.2 million or 27.4% driven by strong sales volume of HeartMate and CentriMag products. The HeartMate product line contributed approximately $24.4 million to the increase, while CentriMag and PediMag contributed approximately $4.2 million, partially attributable to the Levitronix Medical acquisition which added $2.7 million of incremental revenues during the first quarter of 2012. In addition, sales of other products increased by $0.1 million. The increase was partially offset by a decline of approximately $1.5 million in sales of the Thoratec product line partially due to cannibalization by the HeartMate product line. From a regional perspective, the U.S. contributed approximately $21.4 million to the increase, while international sales contributed approximately $5.8 million. In the U.S., five HeartMate II centers were added during the first quarter of 2012, bringing the total to 154 centers. Internationally, we added one centers during the first quarter of 2012, bringing the total to 145 centers.

 

Sales originating outside of the U.S. and U.S. export sales accounted for approximately 18% and 17% of our total product sales for each of the three months ended March 31, 2012 and April 2, 2011, respectively.

 

Gross Profit

 

Gross profit and gross margin were as follows:

 

 

 

Three Months Ended

 

 

 

March 31,
2012

 

April 2,
2011

 

 

 

(in thousands, except percentages)

 

Total gross profit (A)

 

$

87,882

 

$

67,758

 

Total gross margin

 

69.3

%

68.1

%

 


(A)      Includes the effect of adjustments to cost of product sales for intangible amortization expense of $2.0 million for the three months ended April 2, 2011, previously presented within operating expense.  Refer to Note 1 in the condensed consolidated financial statements for details.

 

During the three months ended March 31, 2012 as compared to the three months ended April 2, 2011, gross margin percentage increased by 1.2% primarily due to favorable gross margins from, volume based efficiencies and the contribution from the acquisition of Levitronix Medical, and in part offset by timing of absorption variances.

 

Selling, General and Administrative

 

Selling, general and administrative expenses were as follows:

 

 

 

Three Months Ended

 

 

 

 

 

March 31,
2012

 

April 2,
2011

 

% Change

 

 

 

(in thousands)

 

 

 

Total selling, general and administration (B) 

 

$

31,201

 

$

24,919

 

25.2

%

 


(B)        Includes intangible amortization expense related to patents and trademarks of $0.3 million reclassified to selling, general and administrative expense for the three months ended April 2, 2011.

 

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In the first quarter of 2012 as compared to the first quarter of 2011, selling, general and administrative costs increased by $6.3 million primarily due to market development initiatives including sales force expansion, increased travel and other selling expenses which were attributed to the higher product sales, and an increase in amortization in connection of patents and trademarks as a result of the acquisition of Levitronix Medical in August 2011.

 

Research and Development

 

Research and development expenses were as follows:

 

 

 

Three Months Ended

 

 

 

 

 

March 31,
2012

 

April 2,
2011

 

% Change

 

 

 

(in thousands)

 

 

 

Total research and development

 

$

19,696

 

$

15,754

 

25.0

%

 

Research and development costs are largely project driven, and fluctuate based on the level of project activity planned and subsequently approved and conducted.

 

In the first quarter of 2012 as compared to the first quarter of 2011, R&D expenses increased by $3.9 million due to incremental R&D headcounts and activities in connection with the Levitronix Medical acquisition in August 2011, and next generation product development costs for HeartMate III, and other research and clinical studies performed.

 

Interest Expense and Other

 

Interest expense primarily relates to interest on the senior subordinated convertible notes as follows:

 

 

 

Three Months Ended

 

 

 

 

 

March 31,
2012

 

April 2,
2011

 

% Change

 

 

 

(in thousands)

 

 

 

Interest expense

 

$

(3

)

$

(2,779

)

(99.9

)%

Amortization of debt issuance costs related to senior subordinated convertible notes

 

 

(101

)

(100.0

)%

Total interest expense and other

 

$

(3

)

$

(2,880

)

 

 

 

Interest expense in 2011 pertained primarily to the senior subordinated convertible notes that were extinguished in May 2011.

 

Interest Income and Other

 

Interest income and other consisted of the following:

 

 

 

Three Months Ended

 

 

 

 

 

March 31,
2012

 

April 2,
2011

 

% Change

 

 

 

(in thousands)

 

 

 

Interest income

 

$

291

 

$

1,113

 

(73.9

)%

Foreign currency, net

 

189

 

(501

)

(137.7

)%

Other

 

254

 

143

 

77.6

%

Total interest income and other

 

$

734

 

$

755

 

 

 

 

Interest income during the three months ended March 31, 2012 decreased by $0.8 million compared to the three months ended April 2, 2011, mainly due to decline in interest rates. Foreign currency contributed a net increase of $0.7 million due to fluctuations in foreign exchange rates. Other items contributed increased by $0.1 million due to the change in the mark-to-market value of our deferred compensation plan assets during the period.

 

Income Taxes

 

Our effective income tax rates for the three months ended March 31, 2012 and April 2, 2011, were 32.4% and 34.1%, respectively.  The decrease is primarily attributable to a greater percentage of earnings generated in lower-tax jurisdictions, a function of the acquisition of Levitronix Medical. This rate benefit was partially offset by the lack of federal R&D credits in the absence of enacted legislation.

 

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Our effective tax rate is calculated based on the statutory tax rates imposed on projected annual pre-tax income or loss in various jurisdictions. Since changes in our forecasted profitability for 2012 can significantly affect our projected annual effective tax rate, we believe our quarterly tax rate will be dependent on our profitability and could fluctuate significantly.

 

Liquidity and Capital Resources

 

Cash, Cash Equivalents and Investments

 

Cash and cash equivalents include highly liquid financial instruments that are readily convertible to cash and have maturities of 90 days or less from the date of purchase.

 

Investments classified as short-term consist of various financial instruments such as municipal bonds, corporate bonds and variable demand notes. Bonds with high credit quality with maturities of greater than 90 days when purchased are classified as short-term available-for-sale investments. Investments classified as long-term consist of our investments in auction rate securities.

 

Following is a summary of our cash, cash equivalents and investments:

 

 

 

March 31,
2012

 

December 31,
2011

 

 

 

(in thousands)

 

Cash and cash equivalents

 

$

86,879

 

$

42,661

 

Short-term investments

 

144,667

 

150,753

 

Long-term investments

 

15,914

 

16,090

 

Total cash, cash equivalents and investments

 

$

247,460

 

$

209,504

 

 

We believe that cash and cash equivalents, short-term available-for-sale investments on hand and expected cash flows from operations will be sufficient to fund our operations, capital requirements, and share repurchase programs for at least the next twelve months.

 

Cash Flow Activities

 

 

 

March 31,
2012

 

April 2,
2011

 

% Change

 

 

 

(in thousands)

 

 

 

Net cash provided by operating activities

 

$

41,256

 

$

18,305

 

125.4

%

Net cash provided by investing activities

 

4,249

 

36,779

 

(88.4

)%

Net cash used in financing activities

 

(1,736

)

(46,641

)

96.3

%

Effect of exchange rate changes on cash and cash equivalents

 

449

 

(363

)

223.7

%

Net increase in cash and cash equivalents from continuing operations

 

44,218

 

8,080

 

 

 

 

Cash Provided by Operating Activities

 

Cash provided by operating activities is net income adjusted for certain non-cash items and changes in certain assets and liabilities. Cash provided by operating activities for the three months ended March 31, 2012 increased by approximately $23.0 million compared with the three months ended April 2, 2011. The increase was primarily due to higher net income of $9.0 million, a net decrease to inventories of $14.3 million, a net increase in accrued income taxes of $4.6 million and accrued compensation and other accrued liabilities of $11.8 million, an increase in non-cash charges of $2.3 million, an increase in the use of cash associated with a net increase in accounts receivable of $11.7 million and a net decrease in accounts payable of $2.2 million.

 

Cash Provided by Investing Activities

 

Investing cash flows consist primarily of net investment purchases and maturities, and capital expenditures. Cash used in investing activities decreased by $32.5 million for the three months ended March 31, 2012 compared with the three months ended April 2, 2011. The decrease is primarily due to lower volume of available-for-sale investments purchases for the three months ended March 31, 2012 compared with the three months ended April 2, 2011.

 

Cash Used in Financing Activities

 

Financing cash flows consist primarily of repurchases of common stock, proceeds from exercises of stock options, and payment of contingent considerations. Net cash used in financing activities decreased by approximately $44.9 million for the three months ended

 

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March 31, 2012 compared with the three months ended April 2, 2011. The decrease is primarily due to no repurchases of common stock in the current quarter (compared to approximately $50 million in same period last year) and lower proceeds received from the exercises of stock options by $3.1 million, offset by the repayment of $1.5 million related to the contingent considerations in the current quarter.

 

Stock Repurchase Program

 

During the first quarter of fiscal 2011, under a $100 million repurchase program publicly announced on February 14, 2011 (“February 2011 program”), we paid an aggregate of $50 million to repurchase 1,783,267 shares of our common stock. On November 7, 2011 we announced that our Board of Directors authorized a new publicly announced program for the repurchase of up to $50 million worth of shares of our common stock. Additionally, the Board of Directors extended the expiration date for the $50 million remaining under the February 2011 program to November 4, 2012. There was no repurchase of shares during the three months ended March 31, 2012 under these publicly announced programs.

 

Shares of our common stock purchased that were not part of our publicly announced repurchase programs represent the surrender value of shares of restricted stock awards and units withheld in order to satisfy tax withholding tax obligations upon vesting. The shares purchased do not reduce the dollar value that may yet be purchased under our publicly announced repurchase programs. The aggregate value of 136,430 shares purchased during the three months ended March 31, 2012 was $4.7 million, and the aggregative value of 126,342 shares purchased during the three months ended April 2, 2011 was $3.5 million.

 

Off Balance Sheet Arrangements

 

We maintain an Irrevocable Standby Letter of Credit as part of our workers’ compensation insurance program. The Letter of Credit is not collateralized and automatically renews on June 30th of each year, unless terminated by one of the parties. As of March 31, 2012, our Letter of Credit balance was approximately $0.8 million.

 

Credit Facility

 

On December 19, 2011, we obtained an unsecured revolving credit facility that provides for up to $50.0 million in revolving credit that will expire on December 19, 2016. The interest rate charged on the amounts borrowed is LIBOR plus a margin (ranging from 0.75% to 1.25%). The agreement contains financial covenants. We were in compliance with all covenants as of March 31, 2012. The credit agreement permits us to use the facility for working capital and general corporate purposes. As of March 31, 2012, there were no borrowings under this credit facility.

 

Contractual Obligations

 

As of March 31, 2012, the liability for uncertain tax positions was $11.5 million, including interest and penalties. Due to the high degree of uncertainty regarding the timing of potential future cash flows associated with these liabilities, we are unable to make a reasonably reliable estimate of the amount and period in which these liabilities might be paid.

 

During the three months ended March 31, 2012 there were no material changes to our contractual obligations reported in our 2011 Annual Report on Form 10-K outside our normal course of business.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Interest Rate Risk

 

Our investment portfolio and cash equivalents that bear variable interest would have an immaterial impact to interest income, on the consolidated statements of operations, if interest rates would have fallen by 50 basis points. In addition, if interest rates rise, the market value of our investment portfolio may decline, which could result in a loss if we choose or are forced to sell an investment before its scheduled maturity. If interest rates were to rise or fall from current levels by 100 basis points, the change in our net unrealized loss on our short and long-term investments would be $1.8 million. We do not utilize derivative financial instruments to manage interest rate risks.

 

Foreign Currency Rate Fluctuations

 

The fair value of our forward currency-exchange contracts is sensitive to changes in currency exchange rates and is estimated based on the amount that we would pay or receive upon termination of the contract, taking into account the change in currency exchange rates. A 10% change in the non-functional currency exchange rates as of March 31, 2012 related to our contracts would result in an increase

 

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in the unrealized gain or loss on forward currency-exchange contracts of $10.0 million. The unrealized gains or losses on forward currency-exchange contracts resulting from changes in currency exchange rates are expected to approximately offset losses or gains on the currency exposures resulting from our operations.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Attached as exhibits to this Form 10-Q are certifications of our Chief Executive Officer and Interim Chief Financial Officer, which are required in accordance with Rule 13a-14 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). This “Controls and Procedures” section includes information concerning the controls and controls evaluation referred to in the certifications.

 

Disclosure Controls and Procedures

 

An evaluation was performed under the supervision and with the participation of our management, including our Chief Executive Officer and Interim Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rule 13a-15(e) under the Exchange Act, as of March 31, 2012. The evaluation of our disclosure controls and procedures included a review of our processes and implementation and the effect on the information generated for use in this Quarterly Report on Form 10-Q. In the course of this evaluation, we sought to identify any significant deficiencies or material weaknesses in our disclosure controls and procedures, to determine whether we had identified any acts of fraud involving personnel who have a significant role in our disclosure controls and procedures, and to confirm that any necessary corrective action, including process improvements, was taken. This type of evaluation is done quarterly so that our conclusions concerning the effectiveness of these controls can be reported in our periodic reports filed with the SEC. The overall goals of these evaluation activities are to monitor our disclosure controls and procedures and to make modifications as necessary. We intend to maintain these disclosure controls and procedures, modifying them as circumstances warrant.

 

Based on that evaluation, our management, including the Chief Executive Officer and Interim Chief Financial Officer, concluded that as of March 31, 2012 the Company’s disclosure controls and procedures, as defined in Rule 13a-15(e) under the Exchange Act, were effective to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and to provide reasonable assurance that such information is accumulated and communicated to our management, including our principal executive officer, as appropriate to allow timely decisions regarding required disclosures.

 

Changes to Internal Controls

 

There have been no changes in our internal controls over financial reporting during the three months ended March 31, 2012 that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

 

Inherent Limitations on Controls and Procedures

 

Our management, including the Chief Executive Officer and the Interim Chief Financial Officer, does not expect that our disclosure controls and procedures and our internal controls will prevent all error and all fraud. A control system, no matter how well designed and operated, can only provide reasonable assurances that the objectives of the control system are met. The design of a control system reflects resource constraints; the benefits of controls must be considered relative to their costs. Because there are inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been or will be detected. As these inherent limitations are known features of the financial reporting process, it is possible to design into the process safeguards to reduce, though not eliminate, these risks. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns occur because of simple error or mistake. Controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls is based in part upon certain assumptions about the likelihood of future events. While our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives, there can be no assurance that any design will succeed in achieving its stated goals under all future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with the policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

We intend to review and evaluate the design and effectiveness of our disclosure controls and procedures on an ongoing basis and to improve our controls and procedures over time and to correct any deficiencies that we may discover in the future. While our Chief Executive Officer and Interim Chief Financial Officer have concluded that, as of March 31, 2012, the design of our disclosure controls and procedures, as defined in Rule 13a-15(e) under the Exchange Act, was effective, future events affecting our business may cause us to significantly modify our disclosure controls and procedures.

 

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PART II. OTHER INFORMATION

 

ITEM 1: LEGAL PROCEEDINGS

 

From time to time we are involved in litigation arising out of claims in the normal course of business. Based on the information presently available, management believes that there are no claims or actions pending or threatened against us, the ultimate resolution of which will have a material effect on our financial position, liquidity or results of operations, although the results of litigation are inherently uncertain.

 

ITEM 1A. RISK FACTORS

 

You should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our 2011 Annual Report on Form 10-K, which could materially affect our business, financial condition or future results. The risks described in our 2011 Annual Report on Form 10-K are not the only risks facing us. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

 

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ITEM 2: UNREGISTERED SALE OF EQUITY SECURITIES AND USE OF PROCEEDS

 

There were no unregistered sales of our equity securities during the three months ended March 31, 2012.

 

The following table sets forth certain information about our common stock repurchased during the three months ended March 31, 2012:

 

 

 

Total number
of shares
purchased(1)

 

Average price
paid per share

 

Total number
of shares
purchased
as part of
publicly
announced plans or
programs(2)(3)

 

Approximate dollar
value (in $000) of
shares
that may yet be
purchased under
the plans or
programs(3)

 

 

 

(in thousands, except per share data)

 

January 1, 2012 through January 31, 2012

 

2,073

 

$

29.86

 

 

$

50,031

 

February 1, 2012 through February 29, 2012

 

55,367

 

$

35.51

 

 

$

50,031

 

March 1, 2012 through March 31, 2012

 

78,990

 

$

34.28

 

 

$

50,031

 

Total

 

136,430

 

$

34.71

 

 

$

50,031

 

 

During the first quarter of fiscal 2011, under a $100 million repurchase program announced on February 14, 2011 (“February 2011 program”), we paid an aggregate of $50 million to repurchase 1,783,267 shares of our common stock. On November 7, 2011 we announced that our Board of Directors authorized a new program for the repurchase of up to $50 million worth of shares of our common stock. Additionally, the Board of Directors extended the expiration date for the $50 million remaining under the February 2011 program to November 4, 2012.

 


(1)         Shares purchased that were not part of our publicly announced repurchase program represent the surrender value of shares of restricted stock awards and units withheld in order to satisfy tax withholding tax obligations upon vesting, and do not reduce the dollar value that may yet be purchased under our publicly announced repurchase program.

 

(2)   There was no repurchase of shares during the three months ended March 31, 2012.

 

(3)  Cumulative amounts through each respective month ending in 2012

 

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ITEM 6. EXHIBITS

 

10.34

 

Thoratec Corporation Corporate Executive Incentive Plan FY 2012, effective for certain executive officers of the Company.

 

 

 

31.1

 

Section 302 Certification of Chief Executive Officer.

 

 

 

31.2

 

Section 302 Certification of Interim Chief Financial Officer.

 

 

 

32.1

 

Section 906 Certification of Chief Executive Officer.

 

 

 

32.2

 

Section 906 Certification of Interim Chief Financial Officer.

 

 

 

101***

 

The following materials from Registrant’s Quarterly Report on Form 10-Q for the three months ended March 31, 2012, formatted in Extensible Business Reporting Language (XBRL) includes: (i) Condensed Consolidated Balance Sheets as of March 31, 2012 and December 31, 2011, (ii) Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2012 and April 2, 2011, (iii) Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2012 and April 2, 2011, and (iv) Notes to Condensed Consolidated Financial Statements, tagged as blocks of text.

 

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SIGNATURES

 

Pursuant to the requirements of the Security Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

THORATEC CORPORATION

 

 

Date: May 8, 2012

/s/ Gerhard F. Burbach

 

Gerhard F. Burbach

 

Chief Executive Officer

 

 

Date: May 8, 2012

/s/ Roxanne Oulman

 

Roxanne Oulman

 

Interim Chief Financial Officer and Principal Accounting Officer

 

34