Form 10-Q
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

 

x QUARTERLY REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended July 1, 2011

or

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from             to             

Commission File Number 1-7598

 

 

VARIAN MEDICAL SYSTEMS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   94-2359345

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

3100 Hansen Way,

Palo Alto, California

  94304-1030
(Address of principal executive offices)   (Zip Code)

(650) 493-4000

(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  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x    No  ¨

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See 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   ¨
Non-accelerated filer   ¨  (Do not check if a smaller reporting company)    Smaller reporting company   ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  x

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 117,184,197 shares of common stock, par value $1 per share, outstanding as of July 29, 2011.

 

 

 


Table of Contents

VARIAN MEDICAL SYSTEMS, INC.

FORM 10-Q for the Quarter Ended July 1, 2011

INDEX

 

Part I.

   Financial Information      3   

Item 1.

   Unaudited Financial Statements   
   Condensed Consolidated Statements of Earnings      3   
   Condensed Consolidated Balance Sheets      4   
   Condensed Consolidated Statements of Cash Flows      5   
   Notes to the Condensed Consolidated Financial Statements      6   

Item 2.

   Management’s Discussion and Analysis of Financial Condition and Results of Operations      28   

Item 3.

   Quantitative and Qualitative Disclosures About Market Risk      48   

Item 4.

   Controls and Procedures      49   

Part II.

   Other Information      50   

Item 1.

   Legal Proceedings      50   

Item 1A.

   Risk Factors      50   

Item 2.

   Unregistered Sales of Equity Securities and Use of Proceeds      71   

Item 3.

   Defaults Upon Senior Securities      71   

Item 4.

   Removed and reserved      71   

Item 5.

   Other Information      71   

Item 6.

   Exhibits      72   

Signatures

     73   

Index to Exhibits

     74   

 

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Table of Contents

PART I

FINANCIAL INFORMATION

Item 1. Financial Statements

VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF EARNINGS

(Unaudited)

 

     Three Months Ended     Nine Months Ended  
(In thousands, except per share amounts)    July 1,
2011
    July 2,
2010
    July 1,
2011
    July 2,
2010
 

Revenues:

        

Product

   $ 490,419      $ 440,884      $ 1,420,956      $ 1,305,434   

Service contracts and other

     159,019        137,167        456,789        399,094   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     649,438        578,051        1,877,745        1,704,528   
  

 

 

   

 

 

   

 

 

   

 

 

 

Cost of revenues:

        

Product

     291,080        252,809        817,473        751,124   

Service contracts and other

     78,603        70,861        224,684        204,028   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total cost of revenues

     369,683        323,670        1,042,157        955,152   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross margin

     279,755        254,381        835,588        749,376   

Operating expenses:

        

Research and development

     44,426        38,874        126,801        116,182   

Selling, general and administrative

     94,838        84,742        280,072        247,786   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     139,264        123,616        406,873        363,968   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating earnings

     140,491        130,765        428,715        385,408   

Interest income

     584        654        2,022        2,182   

Interest expense

     (504     (1,472     (1,868     (3,675
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings from continuing operations before taxes

     140,571        129,947        428,869        383,915   

Taxes on earnings

     41,966        38,003        130,696        122,082   
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings from continuing operations

     98,605        91,944        298,173        261,833   

Loss from discontinued operations, net of taxes

     —          (6,450     —          (6,450
  

 

 

   

 

 

   

 

 

   

 

 

 

Net earnings

   $ 98,605      $ 85,494      $ 298,173      $ 255,383   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net earnings (loss) per share - Basic

        

Continuing operations

   $ 0.84      $ 0.75      $ 2.54      $ 2.13   

Discontinued operations

   $ 0.00      $ (0.05   $ 0.00      $ (0.05
  

 

 

   

 

 

   

 

 

   

 

 

 

Net earnings per share

   $ 0.84      $ 0.70      $ 2.54      $ 2.08   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net earnings (loss) per share - Diluted

        

Continuing operations

   $ 0.83      $ 0.74      $ 2.49      $ 2.10   

Discontinued operations

   $ 0.00      $ (0.05   $ 0.00      $ (0.05
  

 

 

   

 

 

   

 

 

   

 

 

 

Net earnings per share

   $ 0.83      $ 0.69      $ 2.49      $ 2.05   
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in the calculation of net earnings per share:

        

Weighted average shares outstanding - Basic

     116,874        122,072        117,614        122,871   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares outstanding - Diluted

     119,064        124,511        119,831        124,531   
  

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes to the condensed consolidated financial statements.

 

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Table of Contents

VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

(In thousands, except par values)    July 1,
2011
    October 1,
2010 (1)
 
Assets     

Current assets:

    

Cash and cash equivalents

   $ 567,922      $ 520,221   

Accounts receivable, net of allowance for doubtful accounts of $5,644
at July 1, 2011 and $4,209 at October 1, 2010

     581,862        591,677   

Inventories

     438,483        363,933   

Prepaid expenses and other current assets

     130,960        87,267   

Deferred tax assets

     118,225        118,246   
  

 

 

   

 

 

 

Total current assets

     1,837,452        1,681,344   

Property, plant and equipment, net

     283,185        267,927   

Goodwill

     216,063        208,451   

Other assets

     176,579        166,230   
  

 

 

   

 

 

 

Total assets

   $ 2,513,279      $ 2,323,952   
  

 

 

   

 

 

 
Liabilities and Stockholders’ Equity     

Current liabilities:

    

Accounts payable

   $ 119,836      $ 119,018   

Accrued expenses

     300,391        287,851   

Product warranty

     51,969        53,233   

Deferred revenues

     131,012        141,916   

Advance payments from customers

     316,948        275,998   

Short-term borrowings

     —          20,000   

Current maturities of long-term debt

     11,689        5,525   
  

 

 

   

 

 

 

Total current liabilities

     931,845        903,541   

Long-term debt

     6,250        17,869   

Other long-term liabilities

     121,137        127,175   
  

 

 

   

 

 

 

Total liabilities

     1,059,232        1,048,585   
  

 

 

   

 

 

 

Commitments and contingencies (Note 10)

    

Stockholders’ equity:

    

Preferred stock of $1 par value: 1,000 shares authorized; none issued and outstanding

     —          —     

Common stock of $1 par value: 189,000 shares authorized; 117,075 and 118,007 shares issued and outstanding at July 1, 2011 and at October 1, 2010, respectively

     117,075        118,007   

Capital in excess of par value

     596,400        508,366   

Retained earnings

     768,810        686,598   

Accumulated other comprehensive loss

     (28,238     (37,604
  

 

 

   

 

 

 

Total stockholders’ equity

     1,454,047        1,275,367   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 2,513,279      $ 2,323,952   
  

 

 

   

 

 

 

 

(1) The condensed consolidated balance sheet as of October 1, 2010 was derived from audited financial statements as of that date, but does not include all disclosures required by accounting principles generally accepted in the United States of America.

See accompanying notes to the consolidated financial statements.

 

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VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

     Nine Months Ended  
(In thousands)    July 1,
2011
    July 2,
2010
 

Cash flows from operating activities:

    

Net earnings

   $ 298,173      $ 255,383   

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

    

Share-based compensation expense

     34,912        26,942   

Tax benefits from exercises of share-based payment awards

     23,597        11,246   

Excess tax benefits from share-based compensation

     (21,768     (8,972

Depreciation

     36,708        33,093   

Amortization of intangible assets

     2,280        2,563   

Deferred taxes

     9,585        (1,480

Provision for doubtful accounts receivable

     2,065        1,507   

Net change in fair value of derivatives and underlying commitments

     219        (2,484

Loss (gain) on equity investment in affiliate

     (4,488     405   

Other

     (185     987   

Changes in assets and liabilities:

    

Accounts receivable

     24,961        44,540   

Inventories

     (68,310     (80,684

Prepaid expenses and other current assets

     (24,627     (14,506

Accounts payable

     (2,497     (7,835

Accrued expenses

     (104     (23,718

Deferred revenues

     (10,904     (5,034

Product warranty

     (3,615     (170

Advance payments from customers

     40,935        54,318   

Other long-term liabilities

     (10,010     6,323   
  

 

 

   

 

 

 

Net cash provided by operating activities

     326,927        292,424   
  

 

 

   

 

 

 

Cash flows from investing activities:

    

Purchases of property, plant and equipment

     (52,289     (49,604

Investment in a privately held company

     (13,597     —     

Acquisition of businesses, net of cash acquired

     (8,399     (1,800

Decrease in cash surrender value of life insurance

     425        706   

Note repayment (receivable) from affiliate and other, net

     (7,492     98   

Other, net

     (3,495     (5,361
  

 

 

   

 

 

 

Net cash used in investing activities

     (84,847     (55,961
  

 

 

   

 

 

 

Cash flows from financing activities:

    

Repurchases of common stock

     (238,000     (242,635

Equity forward contracts

     (68,063     —     

Proceeds from issuance of common stock to employees

     132,524        45,747   

Net payments under line of credit agreements

     (20,000     (4,402

Excess tax benefits from share-based compensation

     21,768        8,972   

Employees’ taxes withheld and paid for restricted stock and restricted stock units

     (14,188     (7,302

Repayments of bank borrowings

     (5,459     (8,940

Other

     (52     (164
  

 

 

   

 

 

 

Net cash used in financing activities

     (191,470     (208,724
  

 

 

   

 

 

 

Effects of exchange rate changes on cash and cash equivalents

     (2,909     6,343   
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

     47,701        34,082   

Cash and cash equivalents at beginning of period

     520,221        553,529   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 567,922      $ 587,611   
  

 

 

   

 

 

 

Supplemental information:

VMS common stock valued at $41.3 million was received during the nine months ended July 1, 2011 upon settlement of the February 2011 Repurchase Agreement (see Note 13).

See accompanying notes to the condensed consolidated financial statements.

 

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VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Description of Business

Varian Medical Systems, Inc. (“VMS”) and subsidiaries (collectively, the “Company”) designs, manufactures, sells and services equipment and software products for treating cancer with radiotherapy, stereotactic radiosurgery and brachytherapy. The Company also designs, manufactures, sells and services x-ray tubes for original equipment manufacturers (“OEMs”); replacement x-ray tubes; and flat panel digital image detectors for filmless x-rays imaging in medical, dental, veterinary, scientific and industrial applications. It designs, manufactures, sells and services linear accelerators, digital image detectors, image processing software and image detection products for security and inspection purposes. The Company also develops, designs, manufacturers, sells and services proton therapy products and systems for cancer treatment.

Basis of Presentation

The condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and note disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. These condensed consolidated financial statements and the accompanying notes are unaudited and should be read in conjunction with the consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the year ended October 1, 2010 (the “2010 Annual Report”). In the opinion of management, the condensed consolidated financial statements herein include adjustments (consisting only of normal recurring adjustments) necessary for a fair statement of the Company’s financial position as of July 1, 2011 and October 1, 2010, results of operations for the three and nine months ended July 1, 2011 and July 2, 2010, and cash flows for the nine months ended July 1, 2011 and July 2, 2010. The results of operations for the three and nine months ended July 1, 2011 are not necessarily indicative of the operating results to be expected for the full fiscal year or any future period.

As discussed in Note 18 “Discontinued Operations,” the Company has classified the assets and liabilities of the scientific research instruments business (“Research Instruments”) of ACCEL Instruments GmbH (“ACCEL,” which has since changed its name to Varian Medical Systems Particle Therapy GmbH) as discontinued operations and presented its operating results as a discontinued operation in the Condensed Consolidated Statements of Earnings for all periods presented. Because amounts related to Research Instruments in the Condensed Consolidated Balance Sheets and the Condensed Consolidated Statements of Cash Flows were not material for any period presented, the Company has not segregated them from continuing operations. Unless noted otherwise, discussion in these notes pertains to the Company’s continuing operations.

Fiscal Year

The fiscal years of the Company as reported are the 52- or 53- week periods ending on the Friday nearest September 30. Fiscal year 2011 is the 52-week period ending September 30, 2011, and fiscal year 2010 was the 52-week period that ended on October 1, 2010. The fiscal quarters ended July 1, 2011 and July 2, 2010 were both 13-week periods.

Principles of Consolidation

The consolidated financial statements include those of VMS and its subsidiaries. Intercompany balances, transactions, and stock holdings have been eliminated in consolidation.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates.

 

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Table of Contents

VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

Fair Value of Financial Instruments

The carrying amounts of the Company’s financial instruments, including cash and cash equivalents, accounts receivable, net of allowance for doubtful accounts, accounts payable and short-term borrowings, approximate fair value due to their short maturities. The fair value of the Company’s long-term debt was estimated to be $19.3 million at July 1, 2011 and $25.4 million at October 1, 2010. The estimated fair value of long-term debt was based on the then-current rates available to the Company for debt of similar terms and remaining maturities and also took into consideration default and credit risk. The Company determined the estimated fair value amount by using available market information and commonly accepted valuation methodologies. However, considerable judgment is required in interpreting market data to develop estimates of fair value. Accordingly, the fair value estimate presented herein is not necessarily indicative of the amount that the Company or holders of the instruments could realize in a current market exchange. The use of different assumptions and/or estimation methodologies may have a material effect on the estimated fair value.

Allowance for Doubtful Accounts

The Company evaluates the creditworthiness of its customers prior to authorizing shipment for all major sale transactions. Except for government tenders, group purchases and orders with letters of credit in Oncology Systems, Security and Inspections Products (“SIP”) and Varian Particle Therapy (“VPT”), and orders in its X-ray Products business, the Company’s payment terms usually require payment of a small portion of the total amount due when the customer signs the purchase order, a significant amount upon transfer of risk of loss to the customer and the remaining amount upon completion of the installation. The Company offers extended payment terms, sometimes beyond one year, to qualified customers in some circumstances. On a quarterly basis, the Company evaluates the accounts receivable aging report and provides an allowance in an amount the Company deems adequate for doubtful accounts. In evaluating the adequacy of the allowance for doubtful accounts, the Company considers factors such as age of the accounts receivable balances, historical experience, creditworthiness, the type of customer, and economic conditions that may affect a customer’s ability to make payment. Account receivable balances deemed to be uncollectible or otherwise settled with a customer are charged to the allowance for doubtful accounts after all means of collection have been exhausted and the potential for recovery is considered remote.

Recent Accounting Pronouncements

In June 2011, the Financial Accounting Standards Board (“FASB”) amended Accounting Standards Codification (“ASC”) 220, “Presentation of Comprehensive Income.” This amendment will require companies to present the components of net income and other comprehensive income either as one continuous statement or as two consecutive statements. It eliminates the option to present components of other comprehensive income as part of the statement of changes in stockholders’ equity. The amended guidance, which must be applied retroactively, will be effective for the Company in the second quarter of fiscal year 2012. The adoption of this amendment concerns disclosure only and the Company does not expect it to have an impact on its consolidated financial position, results of operations or cash flows.

In May 2011, the FASB amended ASC 820, “Fair Value Measurement.” This amendment is intended to result in convergence between GAAP and International Financial Reporting Standards requirements for measurement of and disclosures about fair value. This guidance clarifies the application of existing fair value measurements and disclosures, and changes certain principles or requirements for fair value measurements and disclosures. The amendment will be effective for the Company in the second quarter of fiscal year 2012. The Company is currently assessing the potential impact, if any, this amendment may have on its consolidated financial position, results of operations and cash flows.

 

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VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

2. BALANCE SHEET COMPONENTS:

The components of inventories were as follows:

 

(In millions)        July 1,    
2011
     October 1,
2010
 

Inventories:

     

Raw materials and parts

   $ 234.7       $ 208.8   

Work-in-progress

     81.3         54.3   

Finished goods

     122.5         100.8   
  

 

 

    

 

 

 

Total inventories

   $ 438.5       $ 363.9   
  

 

 

    

 

 

 

The components of other long-term liabilities were as follows:

 

(In millions)        July 1,    
2011
     October 1,
2010
 

Long-term income taxes payable

   $ 48.9       $ 56.8   

Other

     72.2         70.4   
  

 

 

    

 

 

 

Total other long-term liabilities

   $ 121.1       $ 127.2   
  

 

 

    

 

 

 

3. FAIR VALUE

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. There is a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:

Level 1 — Quoted prices in active markets for identical assets or liabilities.

Level 2 — Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Level 1 instrument valuations are obtained from quotes for transactions in active exchange markets involving identical assets. Level 2 instrument valuations include valuations obtained from quoted prices for identical assets in markets that are not active. In addition, the Company has elected to use the income approach to value its derivative instruments using standard valuation techniques and Level 2 inputs, such as currency spot rates, forward points and credit default swap spreads. The Company’s derivative instruments are short-term in nature, typically one month to twelve months in duration. Level 3 contingent consideration liability valuations are based on the income approach, with key assumptions, including estimated probabilities of achievement of milestones related to market acceptance of the products of an acquired business, as well as estimated discount rates corresponding to the periods of expected payments.

There were no significant transfers of assets or liabilities between fair value measurement levels during the three and nine months ended July 1, 2011 and July 2, 2010. Transfers between fair value measurement levels are recognized at the end of the reporting period.

 

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VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

In the tables below, the Company has segregated all assets and liabilities that are measured at fair value on a recurring basis into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement date.

Assets/Liabilities Measured at Fair Value on a Recurring Basis

The following tables present the Company’s assets and liabilities that were measured at fair value on a recurring basis.

 

     Fair Value Measurement Using  

Type of Instruments

   Quoted Prices in
Active Markets
for Identical
Instruments
(Level 1)
     Significant
Other
Observable
Inputs

(Level 2)
    Significant
Unobservable
Inputs

(Level 3)
    Total
Balance
 

(In millions)

         

Assets at July 1, 2011:

         

Money market funds

   $ 4.1       $ —        $ —        $ 4.1   
  

 

 

    

 

 

   

 

 

   

 

 

 

Total assets measured at fair value

   $ 4.1       $ —        $ —        $ 4.1   
  

 

 

    

 

 

   

 

 

   

 

 

 

Liabilities at July 1, 2011:

         

Derivative liabilities

   $ —         $ (0.2   $ —        $ (0.2

Contingent consideration

     —           —          (0.5     (0.5
  

 

 

    

 

 

   

 

 

   

 

 

 

Total liabilities measured at fair value

   $ —         $ (0.2   $ (0.5   $ (0.7
  

 

 

    

 

 

   

 

 

   

 

 

 

Assets at October 1, 2010:

         

Money market funds

   $ 36.4       $ —        $ —        $ 36.4   
  

 

 

    

 

 

   

 

 

   

 

 

 

Total assets measured at fair value

   $ 36.4       $ —        $ —        $ 36.4   
  

 

 

    

 

 

   

 

 

   

 

 

 

Liabilities at October 1, 2010:

         

Derivative liabilities

   $ —         $ (0.5   $ —        $ (0.5
  

 

 

    

 

 

   

 

 

   

 

 

 

Total liabilities measured at fair value

   $ —         $ (0.5   $ —        $ (0.5
  

 

 

    

 

 

   

 

 

   

 

 

 

 

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NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

     Fair Value Measurement Using  

Line Item in Consolidated Balance Sheet

   Quoted Prices in
Active Markets
for Identical
Instruments
(Level 1)
     Significant
Other
Observable
Inputs

(Level 2)
    Significant
Unobservable
Inputs

(Level 3)
    Total
Balance
 
(In millions)                          

Assets at July 1, 2011:

         

Cash and cash equivalents

   $ 3.0       $ —        $ —        $ 3.0   

Other assets

     1.1         —          —          1.1   
  

 

 

    

 

 

   

 

 

   

 

 

 

Total assets measured at fair value

   $ 4.1       $ —        $ —        $ 4.1   
  

 

 

    

 

 

   

 

 

   

 

 

 

Liabilities at July 1, 2011:

         

Accrued liabilities

   $ —         $ (0.2   $ (0.4   $ (0.6

Other long-term liabilities

     —           —          (0.1     (0.1
  

 

 

    

 

 

   

 

 

   

 

 

 

Total liabilities measured at fair value

   $ —         $ (0.2   $ (0.5   $ (0.7
  

 

 

    

 

 

   

 

 

   

 

 

 

Assets at October 1, 2010:

         

Cash and cash equivalents

   $ 35.3       $ —        $ —        $ 35.3   

Other assets

     1.1         —          —          1.1   
  

 

 

    

 

 

   

 

 

   

 

 

 

Total assets measured at fair value

   $ 36.4       $ —        $ —        $ 36.4   
  

 

 

    

 

 

   

 

 

   

 

 

 

Liabilities at October 1, 2010:

         

Accrued liabilities

   $ —         $ (0.5   $ —        $ (0.5
  

 

 

    

 

 

   

 

 

   

 

 

 

Total liabilities measured at fair value

   $ —         $ (0.5   $ —        $ (0.5
  

 

 

    

 

 

   

 

 

   

 

 

 

The following table present the reconciliation for all liabilities measured and recorded at fair value on a recurring basis using significant unobservable inputs (Level 3):

 

(In millions)    Contingent
Consideration
 

Balance at October 1, 2010

   $ 0.0   

Additions due to acquisition

     (0.5
  

 

 

 

Balance at July 1, 2011

   $ (0.5
  

 

 

 

 

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NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

4. FINANCING RECEIVABLES AND ALLOWANCE FOR CREDIT LOSSES

A financing receivable is a contractual right to receive money, on demand or on fixed or determinable dates, that is recognized as an asset in the creditor’s balance sheet. The Company’s financing receivables, consisting of its notes receivable and accounts receivable with contractual maturities of more than one year, and the related allowance for doubtful accounts are presented in the following table:

 

(In millions)    July 1,
2011
 

Accounts receivable with contractual maturities of more than one year:

  

Gross amount

   $ 16.4   

Allowance for doubtful accounts

     —     
  

 

 

 

Net amount

   $ 16.4   
  

 

 

 

Amount past due

   $ 1.7   
  

 

 

 

Notes receivable:

  

Note receivable from related party

   $ 8.8   

Note receivable from customer1

     8.0   
  

 

 

 

Total note receivable

   $ 16.8   
  

 

 

 

Amount past due

   $ —     
  

 

 

 

 

1 

Represents a bridge loan to a customer that will mature no later than December 2011.

During the three months ended July 1, 2011, the Company sold $3 million of accounts receivable with contractual maturities of more than one year. There was no activity in the allowance for doubtful financing receivable accounts during the three months ended July 1, 2011.

5. GOODWILL AND INTANGIBLE ASSETS

The following table reflects the gross carrying amount and accumulated amortization of the Company’s intangible assets included in “Other assets” in the Condensed Consolidated Balance Sheets as follows:

 

(In millions)    July 1,
2011
    October 1,
2010
 

Intangible Assets:

    

Acquired existing technology

   $ 26.3      $ 20.7   

Patents, licenses and other

     19.4        18.9   

Customer contracts and supplier relationship

     10.4        10.4   

Accumulated amortization

     (43.3     (40.8
  

 

 

   

 

 

 

Net carrying amount

   $ 12.8      $ 9.2   
  

 

 

   

 

 

 

Amortization expense for intangible assets was $0.7 million and $0.8 million for the three months ended July 1, 2011 and July 2, 2010, and $2.3 million and $2.6 million for the nine months ended July 1, 2011 and July 2, 2010, respectively. The Company estimates amortization expense on a straight-line basis for the remaining three months of fiscal year 2011, fiscal years 2012 through 2015 and thereafter, to be as follows (in millions): $0.7, $2.4, $2.0, $1.2 and $6.5, respectively.

 

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NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

The following table reflects goodwill activity by reportable operating segment:

 

(In millions)    Oncology
Systems
     X-ray Products      Other      Total  

Balance at October 1, 2010

   $ 126.7       $ 4.5       $ 77.3       $ 208.5   

Acquisition of businesses

     3.4         —           —           3.4   

Payment or accrual of contingent consideration

     —           0.9         —           0.9   

Foreign currency translation adjustments

     —           —           3.3         3.3   
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance at July 1, 2011

   $ 130.1       $ 5.4       $ 80.6       $ 216.1   
  

 

 

    

 

 

    

 

 

    

 

 

 

6. RELATED PARTY TRANSACTIONS

VMS has a 40% ownership interest in dpiX Holding LLC (“dpiX Holding”), a two-member consortium which has a 100% ownership interest in dpiX LLC (“dpiX”), a supplier of amorphous silicon based thin-film transistor arrays (“flat panels”) for the Company’s X-ray Products’ digital image detectors and for its Oncology Systems’ On-Board Imager®, and PortalVisionTM imaging products. In accordance with the dpiX Holding agreement, net losses were to be allocated to the members, in succession, until their capital accounts equaled zero, then to the members in accordance with their ownership interests. The dpiX Holding agreement also provided that net profits were to be allocated to the members, in succession, until their capital accounts equaled the net losses previously allocated, then to the members in accordance with their ownership interests.

The investment in dpiX Holding is accounted for under the equity method of accounting. When VMS recognizes its share of net profits or losses of dpiX Holding, profits in inventory purchased from dpiX are eliminated until realized by VMS. VMS recorded income on the equity investment in dpiX Holding of $0.3 million in the three months ended July 1, 2011 and a loss of $1.7 million in the three months ended July 2, 2010. VMS recorded income from the equity investment in dpiX Holding of $4.5 million for the nine months ended July 1, 2011 and a loss of $0.4 million in the nine months ended July 2, 2010. Income and loss on the equity investment in dpiX Holding are included in “Selling, general and administrative” expenses in the Condensed Consolidated Statements of Earnings. The carrying value of the investment in dpiX Holding, which was included in “Other assets” in the Condensed Consolidated Balance Sheets, was $46.5 million at July 1, 2011 and $45.1 million at October 1, 2010.

In February 2009, VMS agreed to loan $14 million to dpiX in four separate installments. The loan bears interest at prime plus 1% per annum. The principal balance is due and payable to VMS in four installments beginning in December 2011; interest is payable in full according to a quarterly schedule that began in April 2009; and the entire principal balance, together with accrued and unpaid interest thereon and all other related amounts payable thereunder, is due and payable on September 10, 2012. As of July 1, 2011, VMS had loaned $8.8 million to dpiX under this loan agreement, which was included in “Prepaid expenses and other current assets” in the Condensed Consolidated Balance Sheets. As of October 1, 2010, VMS had loaned $8.8 million to dpiX under this loan agreement, with the current portion included in “Prepaid expenses and other current assets” and the long-term portion included in “Other assets” in the Condensed Consolidated Balance Sheets. The Company evaluates the collectability of its note receivable with dpiX at least on a quarterly basis, considering the timeliness of recurring payments as well as its financial position and cash flows, and would recognize an impairment loss for any amount the Company deemed uncollectible.

During the three months ended July 1, 2011 and July 2, 2010, the Company purchased glass transistor arrays from dpiX totaling approximately $6.4 million and $7.7 million, respectively. Glass transistor arrays purchased from dpiX totaled $18.7 million for the nine months ended July 1, 2011 and $27.2 million for the nine months ended July 2, 2010. These purchases of glass transistor arrays are included as a component of “Inventory” in the Condensed Consolidated Balance Sheets and “Cost of revenues - product” in the Condensed Consolidated Statements of Earnings for these periods.

 

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NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

7. PRODUCT WARRANTY

The following table reflects the changes in the Company’s accrued product warranty:

 

      Nine Months Ended  
(In millions)    July 1,
2011
    July 2,
2010
 

Accrued product warranty, at beginning of period

   $ 53.2      $ 50.8   

Charged to cost of revenues

     32.0        36.5   

Actual product warranty expenditures

     (33.2     (37.7
  

 

 

   

 

 

 

Accrued product warranty, at end of period

   $ 52.0      $ 49.6   
  

 

 

   

 

 

 

8. CREDIT FACILITIES

In July 2007, VMS entered into a credit agreement with Bank of America, N.A. (“BofA”), which was amended and restated on November 10, 2008, and then again amended July 14, 2009, August 11, 2010 and August 24, 2010. As amended to date, the credit agreement with BofA provides for a revolving credit facility that enables the Company to borrow and have outstanding at any given time a maximum of $225 million (the “Amended BofA Credit Facility”). A portion of the Amended BofA Credit Facility is collateralized with a pledge of stock of certain of VMS’s present and future subsidiaries that are deemed to be material subsidiaries. As of July 1, 2011, VMS has pledged to BofA 65% of the voting shares that it holds in Varian Medical Systems Nederland B.V., a wholly-owned subsidiary.

Under the Amended BofA Credit Facility, VMS’s Japanese subsidiary (“VMS KK”) can borrow up to 2.7 billion Japanese Yen as part of the overall credit facility (the “Japanese Line of Credit”). At any time amounts are outstanding under the Japanese Line of Credit, the full borrowing capacity is deemed committed for use in Japan and therefore the maximum amount VMS can otherwise borrow under the Amended BofA Credit Facility will be reduced by $35 million to $190 million. VMS guarantees the payment of the outstanding balance under the Japanese Line of Credit.

The Amended BofA Credit Facility may be used for working capital, capital expenditures, permitted VMS share repurchases, permitted acquisitions and other lawful corporate purposes. Borrowings under the Japanese Line of Credit can be used by VMS KK for refinancing certain intercompany debts, working capital, capital expenditures and other lawful corporate purposes. Borrowings under the Amended BofA Credit Facility (outside of the Japanese Line of Credit) accrue interest either (i) based on the London Interbank Offered Rate (“LIBOR”) plus a margin of 1.25% to 1.50% based on a leverage ratio involving funded indebtedness and earnings before interest, taxes, depreciation and amortization (“EBITDA”) or (ii) based upon a base rate of either the federal funds rate plus 0.5% or BofA’s announced prime rate, whichever is greater, minus a margin of 0.5% to 0% based on a leverage ratio involving funded indebtedness and EBITDA, depending upon the Company’s instructions to BofA. The Company may select borrowing periods of one, two, three or six months for advances based on the LIBOR rate. Interest rates on advances based on the base rate are adjustable daily. Under the Amended BofA Credit Facility, the Company pays commitment fees at an annual rate of 0.2% to 0.3% based on a leverage ratio involving funded indebtedness and EBITDA. Borrowings under the Japanese Line of Credit accrue interest at the basic loan rate announced by the Bank of Japan plus a margin of 1.25% to 1.50% based on a leverage ratio involving funded indebtedness and EBITDA. The Amended BofA Credit Facility, as well as the Japanese Line of Credit, will expire on November 10, 2011, if not extended by mutual agreement of VMS and BofA.

As of July 1, 2011, there was no outstanding balance under the Amended BofA Credit Facility. At October 1, 2010, $20 million was outstanding under the Amended BofA Credit Facility with a weighted average interest rate of 1.51%, none of which was outstanding under the Japanese Line of Credit. Up to $25 million of the Amended BofA Credit Facility can be used to support letters of credit issued on behalf of the Company, of which none were outstanding as of July 1, 2011 or October 1, 2010.

The Amended BofA Credit Facility contains customary affirmative and negative covenants for facilities of this type. The Company has also agreed to maintain certain financial covenants relating to (i) leverage ratios involving funded indebtedness and EBITDA, (ii) liquidity and (iii) consolidated assets. For all periods presented within these condensed consolidated financial statements, the Company was in compliance with all covenants.

 

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NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

In March 2011, VMS KK entered into an unsecured overdraft agreement with Sumitomo Mitsui Banking Corporation that enables VMS KK to borrow and have outstanding at any given time a maximum of 500 million Japanese Yen (the “Japanese Overdraft Facility”). Borrowings under the Japanese Overdraft Facility accrue interest at 0.81% per annum. The Japanese Overdraft Facility expired on June 30, 2011. As of July 1, 2011, there was no outstanding balance under the Japanese Overdraft Facility.

9. DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES

The Company measures all derivatives at fair value on the Condensed Consolidated Balance Sheets. The accounting for gains or losses resulting from changes in the fair value of those derivatives depends upon the use of the derivative and whether it qualifies for hedge accounting. Changes in the fair value of derivatives that do not qualify for hedge accounting treatment must be recognized in earnings, together with elements excluded from effectiveness testing and the ineffective portion of a particular hedge.

The fair values of derivative instruments reported on the Company’s Condensed Consolidated Balance Sheet were as follows:

 

      Asset Derivatives            Liability Derivatives  
     Balance Sheet
Location
   July 1,
2011
     October 1,
2010
           Balance Sheet
Location
     July 1,
2011
     October 1,
2010
 
(In millions)       Fair Value      Fair Value               Fair Value      Fair Value  

Derivative designated as hedging instruments:

                      

Foreign exchange forward contracts

   Prepaid expenses
and other current
assets
   $ —         $ —                Accrued liabilities       $ —         $ 0.5   

Derivative not designated as hedging instruments:

                      

Foreign exchange forward contracts

   Prepaid expenses
and other current
assets
     —           —                Accrued liabilities         0.2         —     
     

 

 

    

 

 

            

 

 

    

 

 

 

Total derivatives

      $ —         $ —                 $ 0.2       $ 0.5   
     

 

 

    

 

 

            

 

 

    

 

 

 

See Note 3, “Fair Value” and “Valuation of Derivative Instruments” under Critical Accounting Estimates in Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” regarding valuation of the Company’s derivative instruments. Also see Note 1, “Significant Accounting Policies” to the Consolidated Financial Statements of the 2010 Annual Report regarding credit risk associated with the Company’s derivative instruments.

Cash Flow Hedging Activities

The Company has many transactions denominated in foreign currencies and addresses certain of those financial exposures through a risk management program that includes the use of derivative financial instruments. The Company sells products throughout the world, often in the currency of the customer’s country, and may hedge certain of the larger foreign currency transactions when they are not denominated in the relevant subsidiary’s functional currency. These foreign currency sales transactions are hedged using foreign currency forward contracts. The Company may use other derivative instruments in the future. The Company enters into foreign currency forward contracts primarily to reduce the effects of fluctuating foreign currency exchange rates. The Company does not enter into foreign currency forward contracts for speculative or trading purposes. The foreign currency forward contracts range from one to twelve months in maturity. As of July 1, 2011, the Company did not have any foreign currency forward contracts with an original maturity greater than twelve months.

 

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NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

The hedges of foreign currency denominated forecasted revenues are accounted for in accordance with ASC 815, pursuant to which the Company has designated its hedges of forecasted foreign currency revenues as cash flow hedges. The Company’s designated cash flow hedges de-designate when the anticipated revenues associated with the transactions are recognized and the effective portion in “Accumulated other comprehensive income (loss)” is reclassified to revenues. Subsequent changes in fair value of the derivative instrument are recorded in “Selling, general and administrative expenses” to offset changes in fair value of the resulting non-functional currency receivables. For derivative instruments that are designated and qualified as cash flow hedges under ASC 815, the Company formally documents for each derivative instrument at the hedge’s inception the relationship between the hedging instrument (foreign currency forward contract) and hedged item (forecasted foreign currency revenues), the nature of the risk being hedged, as well as its risk management objective and strategy for undertaking the hedge. The Company records the effective portion of the gain or loss on the derivative instrument designated and qualified as cash flow hedges in “Accumulated other comprehensive income (loss)” and reclassifies these amounts into “Revenues” in the period during which the hedged transaction is recognized in earnings. The Company assesses hedge effectiveness both at the onset of the hedge and on an ongoing basis using regression analysis. The Company measures hedge ineffectiveness by comparing the cumulative change in the fair value of the effective component of the hedge contract with the cumulative change in the fair value of the hedged item. The Company recognizes any over performance of the derivative as ineffectiveness in “Revenues,” and amounts not included in the assessment of effectiveness in “Cost of revenues” in the Condensed Consolidated Statements of Earnings. During the three and nine months ended July 1, 2011 and July 2, 2010, the Company did not discontinue any cash flow hedges. At the inception of the hedge, the Company assesses whether the likelihood of meeting the forecasted cash flow is highly probable. As of October 1, 2010, net unrealized loss on derivative instruments of $0.5 million, before tax, was included in “Accumulated other comprehensive income (loss).” As of July 1, 2011, the Company did not have any outstanding foreign currency forward contracts designated as cash flow hedges and the Company did not have any unrealized gain or loss on derivative instruments included in “Accumulated other comprehensive income (loss).”

The following table presents the amounts, before tax, recognized in “Accumulated other comprehensive income (loss)” and in the Condensed Consolidated Statements of Earnings that are related to the effective portion of the foreign currency forward contracts designated as cash flow hedges:

 

     Gain (Loss) Recognized in Other
Comprehensive Income (Effective
Portion)
     Location of Gain (Loss)
Reclassified from
Accumulated Other
   Gain (Loss) Reclassified from
Accumulated Other
Comprehensive Income into Net
Earnings (Effective Portion)
 
     Three Months Ended     Nine Months Ended      Comprehensive Income    Three Months Ended      Nine Months Ended  
(In millions)    July 1,
2011
     July 2,
2010
    July 1,
2011
    July 2,
2010
     into Net Earnings
(Effective Portion)
   July 1,
2011
     July 2,
2010
     July 1,
2011
    July 2,
2010
 

Foreign exchange contracts

   $ —         $ (0.7   $ (0.5   $ 1.1       Revenues    $ —         $ 1.2       $ (1.0   $ 1.9   

The following table presents the amounts recognized in the Condensed Consolidated Statements of Earnings that are related to (i) the ineffective portion of the cash flow hedges and (ii) the amount excluded from effectiveness testing of the cash flow hedges:

 

          Three Months Ended      Nine Months Ended  
(In millions)    Location of gain (loss) recognized    July 1,
2011
     July 2,
2010
     July 1,
2011
     July 2,
2010
 

Ineffective portion of cash flow hedges - Gain (Loss)

   Revenues    $ —         $ —         $ —         $ —     

Amount excluded from assessment of effective of cash flow hedges - Gain (Loss)

   Cost of revenues    $ —         $ —         $ —         $ —     

 

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NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

Balance Sheet Hedging Activities

The Company also hedges balance sheet exposures from its various subsidiaries and business units where the U.S. dollar is the functional currency. The Company enters into foreign currency forward contracts to minimize the short-term impact of foreign currency fluctuations on monetary assets and liabilities denominated in currencies other than the U.S. dollar functional currency. The foreign currency forward contracts are short term in nature, typically with maturity of approximately one month, and are based on the net forecasted balance sheet exposure. These hedges of foreign-currency-denominated assets and liabilities do not qualify for hedge accounting treatment and are not designated as hedging instruments under ASC 815. For derivative instruments not designated as hedging instruments, changes in their fair values are recognized in “Selling, general and administrative expenses” in the Condensed Consolidated Statements of Earnings. Changes in the values of these hedging instruments are offset by changes in the values of foreign-currency-denominated assets and liabilities. Variations from the forecasted foreign currency assets or liabilities, coupled with a significant currency movement, may result in a material gain or loss if the hedges are not effectively offsetting the change in value of the foreign currency asset or liability. Other than foreign exchange hedging activities, the Company has no other free-standing or embedded derivative instruments.

The Company had the following outstanding foreign currency forward contracts that were either (i) entered into to hedge balance sheet exposures from its various foreign subsidiaries and business units or (ii) were originally designated as cash flow hedges (primarily in Euro and Japanese Yen) and were subsequently de-designated when the forecasted revenues were recognized:

 

     At July 1, 2011  
(In millions)    Notional
Value Sold
     Notional
Value
Purchased
 

Australian Dollar

   $ 24.7       $ —     

British Pound

     —           8.1   

Canadian Dollar

     4.3         —     

Danish Krone

     6.1         —     

Euro

     120.2         —     

Japanese Yen

     37.8         —     

Norwegian Krone

     3.4         —     

Swedish Krona

     1.8         2.3   

Swiss Franc

     —           43.6   
  

 

 

    

 

 

 

Totals

   $ 198.3       $ 54.0   
  

 

 

    

 

 

 

 

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NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

The following table presents the gains (losses) recognized in the Condensed Consolidated Statements of Earnings related to the foreign currency forward exchange contracts that are not designated as hedging instruments under ASC 815.

 

Location of Gain or (Loss) Recognized in Income on

Derivative

   Amount of Gain or (Loss)
Recognized in Net
Earnings on Derivative
 
     Three Months Ended      Nine Months Ended  
(In millions)    July 1,
2011
    July 2,
2010
     July 1,
2011
    July 2,
2010
 

Selling, general and administrative expenses

   $ (4.1   $ 7.4       $ (7.1   $ 19.8   

The gains (losses) on these derivative instruments were significantly offset by the gains (losses) resulting from the remeasurement of monetary assets and liabilities denominated in currencies other than the U.S. dollar functional currency.

Contingent Features

Certain of the Company’s derivative instruments are subject to a master netting agreement which contains provisions that require the Company, in the event of a default, to settle the outstanding contracts in net liability positions by making settlement payments in cash or by setting off amounts owed to the counterparty against any credit support or collateral held by the counterparty. The counterparty’s right of set-off is not limited to the derivative instruments and applies to other rights held by the counterparty. Pursuant to the master netting agreement, an event of default includes the Company’s failure to pay the counterparty under the derivative instruments, voluntary or involuntary bankruptcy, the Company’s failure to repay an aggregate of $25 million or more in debts, and deterioration of creditworthiness of the surviving entity when the Company merges or transfers its assets or liabilities to another entity. As of July 1, 2011 and October 1, 2010, the Company did not have significant outstanding derivative instruments with credit-risk-related contingent features that were in a net liability position.

10. COMMITMENTS AND CONTINGENCIES

Environmental Remediation Liabilities

The Company’s operations and facilities, past and present, are subject to environmental laws, including laws that regulate the handling, storage, transport and disposal of hazardous substances. Certain of those laws impose cleanup liabilities under certain circumstances. In connection with those laws and certain of the Company’s past and present operations and facilities, the Company oversees various environmental cleanup projects and also reimburses certain third parties for cleanup activities. Those include facilities sold as part of the Company’s electron devices business in 1995 and thin film systems business in 1997. In addition, the U.S. Environmental Protection Agency (“EPA”) or third parties have named the Company as a potentially responsible party under the amended Comprehensive Environmental Response Compensation and Liability Act of 1980 (“CERCLA”), at sites to which the Company or the facilities of the sold businesses were alleged to have shipped waste for recycling or disposal (the “CERCLA sites”). In connection with the CERCLA sites, the Company to date has been required to pay only modest amounts as its contributions to cleanup efforts. Under the agreement that governs the spin-offs of Varian, Inc. (“VI”), now a wholly owned subsidiary of Agilent Technologies Inc., and Varian Semiconductor Equipment Associates, Inc. (“VSEA”), VI and VSEA are each obligated to indemnify the Company for one-third of the environmental cleanup costs associated with corporate, discontinued or sold operations prior to the spin-offs (after adjusting for any insurance proceeds or tax benefits received by the Company), as well as fully indemnify the Company for other liabilities arising from the operations of the business transferred to it as part of the spin-offs.

The Company spent $0.5 million (net of amounts borne by VI and VSEA) during each of the three months ended July 1, 2011 and July 2, 2010, respectively, on environmental cleanup costs, third-party claim costs, project management costs and legal costs. The Company spent $0.9 million (net of amounts borne by VI and VSEA) during each of the nine months ended July 1, 2011 and July 2, 2010, respectively, on such costs.

 

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NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

Inherent uncertainties make it difficult to estimate the likelihood of the cost of future cleanup, third-party claims, project management and legal services for the CERCLA sites and one of the Company’s past facilities. Nonetheless, as of July 1, 2011, the Company estimated that, net of VI’s and VSEA’s indemnification obligations, future costs associated with the CERCLA sites and this facility would range in total from $2.3 million to $9.5 million. The time frames over which these cleanup project costs are estimated vary, ranging from one year up to thirty years as of July 1, 2011. Management believes that no amount in that range is more probable of being incurred than any other amount and therefore accrued $2.3 million for these cleanup projects as of July 1, 2011. The accrued amount has not been discounted to present value due to the uncertainties that make it difficult to develop a single best estimate.

The Company believes it has gained sufficient knowledge to better estimate the scope and cost of monitoring, cleanup and management activities for its other past and present facilities. This, in part, is based on agreements with other parties and also cleanup plans approved by or completed in accordance with the requirements of the governmental agencies having jurisdiction. As of July 1, 2011, the Company estimated that the Company’s future exposure, net of VI’s and VSEA’s indemnification obligations, for the costs at these facilities, and reimbursements of third party’s claims for these facilities, ranged in total from $6.5 million to $38.3 million. The time frames over which these costs are estimated to be incurred vary, ranging from one year to thirty years as of July 1, 2011. As to each of these facilities, management determined that a particular amount within the range of estimated costs was a better estimate than any other amount within the range, and that the amount and timing of these future costs were reliably determinable. The best estimate within that range was $14.5 million at July 1, 2011. Accordingly, the Company has accrued $10.8 million for these costs, which represents the best estimate discounted at 4%, net of inflation. This accrual is in addition to the $2.3 million described in the preceding paragraph.

These amounts are only estimates of anticipated future costs. The amounts the Company will actually spend may be greater or less than these estimates, even as the Company believes the degree of uncertainty will narrow as cleanup activities progress. While the Company believes its reserve is adequate, as the scope of the Company’s obligations becomes more clearly defined, the Company may modify the reserve, and charge or credit future earnings accordingly. Nevertheless, based on information currently known to management, and assuming VI and VSEA satisfy their indemnification obligations, management believes the costs of these environmental-related matters are not reasonably likely to have a material adverse effect on the consolidated financial statements of the Company in any one fiscal year.

The Company evaluates its liability for investigation and cleanup costs in light of the obligations and apparent financial strength of potentially responsible parties and insurance companies with respect to which the Company believes it has rights to indemnity or reimbursement. The Company has asserted claims for recovery of environmental investigation and cleanup costs already incurred, and to be incurred in the future against various insurance companies and other third parties. The Company receives certain cash payments in the form of settlements and judgments from defendants, insurers and other third parties from time to time. The Company has also reached an agreement with an insurance company under which that insurer has agreed to pay a portion of the Company’s past and future environmental-related expenditures. The Company recorded receivables from that insurer of $3.3 million at July 1, 2011 and $3.0 million at October 1, 2010, with the current portion included in “Prepaid expenses and other current assets” and the noncurrent portion included in “Other assets” in the Condensed Consolidated Balance Sheets. The Company believes that this receivable is recoverable because it is based on a binding, written settlement agreement with what appears to be a financially viable insurance company, and the insurance company has paid the Company’s claims in the past.

The availability of the indemnities of VI and VSEA will depend upon the future financial strength of VI and VSEA. Given the long-term nature of some of the liabilities, VI and VSEA may be unable to fund the indemnities in the future. It is also possible that a court would disregard this contractual allocation among the parties and require the Company to assume responsibility for obligations allocated to another party, particularly if the other party were to refuse or was unable to pay any of its allocated share. The agreement governing the spin-offs generally provides that if a court prohibits a company from satisfying its shared indemnification obligations, the indemnification obligations will be shared equally by the two other companies.

 

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VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

Acquisition-Related Commitments/Obligations

When the Company acquired ACCEL in January 2007, ACCEL was involved in a contract-related lawsuit, which the Company settled by agreeing to perform certain services for a fixed price contract (the “Fixed Price Contract”). As of October 2, 2009, the Company had a loss accrual of €7.6 million related to the Fixed Price Contract. In the first quarter of fiscal year 2010, the Company entered into a new contract (the “New Contract”) to perform certain services for a fixed price and the Company recorded a loss accrual of €0.9 million in connection with the New Contract. As of July 1, 2011, the balance of the loss accrual related to this contingency (the New Contract) was €1.0 million. If the actual costs related to the contingency exceed the estimated amount or if the estimated loss increases, the variances will be recognized in the Consolidated Statements of Earnings in the periods in which these variances arise.

Other Matters

From time to time, the Company is a party to or otherwise involved in legal proceedings, claims and government inspections or investigations and other legal matters, both in and outside the United States, arising in the ordinary course of its business or otherwise. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. The Company accrues amounts, to the extent they can be reasonably estimated, that it believes are adequate to address any liabilities related to legal proceedings and other loss contingencies that the Company believes will result in a probable loss. While there can be no assurances as to the ultimate outcome of any legal proceeding or other loss contingency involving the Company, management does not believe any pending matter will be resolved in a manner that would have a material adverse effect on the Company’s consolidated financial position, results of operations or cash flows.

11. RETIREMENT PLANS

The Company’s net defined benefit and post-retirement benefit costs were composed of the following:

 

     Three Months Ended     Nine Months Ended  
(In thousands)    July 1,
2011
    July 2,
2010
    July 1,
2011
    July 2,
2010
 

Defined Benefit Plans

        

Service cost

   $ 945      $ 588      $ 2,713      $ 1,816   

Interest cost

     1,283        1,169        3,710        3,650   

Expected return on plan assets

     (1,251     (1,156     (3,622     (3,605

Amortization of prior service cost

     38        37        113        111   

Recognized actuarial loss

     512        418        1,538        1,255   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net periodic benefit cost

   $ 1,527      $ 1,056      $ 4,452      $ 3,227   
  

 

 

   

 

 

   

 

 

   

 

 

 

Post-Retirement Benefit Plans

        

Interest cost

   $ 62      $ 79      $ 186      $ 237   

Amortization of transition amount

     —          18        —          54   

Amortization of prior service cost

     1        1        3        3   

Recognized actuarial loss

     13        16        39        48   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net periodic benefit cost

   $ 76      $ 114      $ 228      $ 342   
  

 

 

   

 

 

   

 

 

   

 

 

 

The Company made contributions to the defined benefit plans of $5.8 million during the nine months ended July 1, 2011. The Company currently expects total contributions to the defined benefit plans for fiscal year 2011 will be approximately $7.3 million. The Company made contributions to the post-retirement benefit plans of $0.4 million during the nine months ended July 1, 2011. The Company currently expects total contributions to the post-retirement benefit plans for fiscal year 2011 will be approximately $0.5 million.

 

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VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

12. INCOME TAXES

The Company’s effective tax rate on earnings from continuing operations was 29.9% for the three months ended July 1, 2011, compared to 29.2% in the same period of fiscal year 2010. The increase in the Company’s effective tax rate was primarily due to a shift in the geographic mix of earnings, partially offset by a net benefit for discrete items, primarily the release of certain liabilities for uncertain tax positions, including the expiration of the statutes of limitation in various jurisdictions and the favorable resolution of several income tax audits. For the nine months ended July 1, 2011, the Company’s effective tax rate on earnings from continuing operations was 30.5%, compared to 31.8% in the same period of fiscal year 2010. The decrease was primarily due to a net benefit for discrete items, primarily the release of certain liabilities for uncertain tax positions, including the expiration of the statutes of limitation in various jurisdictions and the favorable resolution of several income tax audits, and the benefit of the retroactive reinstatement of the federal research and development credit, partially offset by a shift in the geographic mix of earnings.

The Company’s effective income tax rate differs from the U.S. federal statutory rate primarily because the Company’s foreign earnings are taxed at rates that are, on average, lower than the U.S. federal rate, and because the Company’s domestic earnings are subject to state income taxes.

The total amount of unrecognized tax benefits did not change by a significant amount during the nine months ended July 1, 2011; however, the amount of unrecognized tax benefits has increased as a result of positions taken during the current and prior years, and has decreased as a result of expirations of the statutes of limitation and audit settlements in various jurisdictions.

13. STOCKHOLDERS’ EQUITY

Stock Repurchase Program

During the three months ended April 1, 2011, the Company settled an accelerated share repurchase agreement executed on August 24, 2010 with BofA (the “August 2010 Repurchase Agreement”). Pursuant to the August 2010 Repurchase Agreement, the Company initially paid to BofA $225 million and BofA delivered 3,888,249 shares of VMS common stock, representing approximately 90% of the shares expected to be repurchased based on the closing price of VMS common stock of $52.08 on August 24, 2010. Under the terms of the August 2010 Repurchase Agreement, the specific number of shares that the Company ultimately repurchased was to be based on the volume weighted average share price of VMS common stock during the repurchase period, less a discount, such that the Company might be entitled to receive additional shares of VMS common stock from BofA or the Company might be required to deliver VMS shares or, at its option, make a cash payment to BofA. The repurchase period ended on February 23, 2011 and the Company made a cash payment of $26.1 million to settle this contract without receiving or delivering additional VMS shares in March 2011. This cash payment upon settlement, together with $22.5 million, representing approximately 10% of the initial cash payment to BofA, was recorded as an equity forward contract, which was included in “Capital in excess of par value” in the Condensed Consolidated Balance Sheet as of July 1, 2011.

On February 23, 2011, the Company entered into another accelerated share repurchase agreement with BofA (the “February 2011 Repurchase Agreement”). Pursuant to the February 2011 Repurchase Agreement, the Company paid to BofA $280 million and BofA delivered 3,547,474 shares of VMS common stock, representing approximately 85% of the shares expected to be repurchased based on the closing price of VMS common stock of $67.09 on February 23, 2011. The remaining $42 million, representing approximately 15% of the cash payment to BofA, was recorded as an equity forward contract, which was included in “Capital in excess of par value” in the Condensed Consolidated Balance Sheet as of July 1, 2011. Under the terms of the February 2011 Repurchase Agreement, the specific number of shares that the Company ultimately repurchased was to be based on the volume weighted average share price of VMS common stock during the repurchase period, less a discount. In June 2011, BofA accelerated the end of the repurchase period and the Company received additional 630,921 shares of VMS common stock upon the settlement of the February 2011 Repurchase Agreement. The market value of the shares received of $41.3 million was recorded as a reduction to “Capital in excess of par value” in the Condensed Consolidated Balance Sheet as of July 1, 2011.

 

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VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

During the nine months ended July 1, 2011, the Company repurchased 4,178,395 shares of VMS common stock (all of which was purchased under the February 2011 Repurchase Agreement), of which 630,921 shares were repurchased for no additional consideration during the three months ended July 1, 2011 in connection with the settlement of the February 2011 Repurchase Agreement. During the nine months ended July 2, 2010, the Company paid $242.6 million to repurchase 4,950,000 shares of VMS common stock, of which $115.9 million was paid during the three months ended July 2, 2010 to repurchase 2,250,000 shares. All shares that were repurchased have been retired. In February 2011, the VMS Board of Directors authorized the repurchase of an additional 12 million shares of VMS common stock through the end of fiscal year 2012. As of July 1, 2011, 12,283,356 shares of VMS common stock remained available for repurchase under this and a prior repurchase authorization. Shares may be repurchased in the open market, in privately negotiated transactions or under Rule 10b5-1 share repurchase plans, and may be made from time to time or in one or more large blocks, including accelerated share repurchase arrangements.

Comprehensive Earnings

The components of comprehensive earnings are as follows:

 

     Three Months Ended     Nine Months Ended  
(In thousands)    July 1,
2011
     July 2,
2010
    July 1,
2011
    July 2,
2010
 

Net earnings

   $ 98,605       $  85,494      $  298,173      $  255,383   

Other comprehensive income (loss), net of tax:

         

Defined benefit pension and post-retirement benefit plans:

         

Amortization of transition obligation included in net periodic benefit cost

     —           11        —          33   

Amortization of prior service cost included in net periodic benefit cost

     35         34        103        100   

Amortization of net actuarial loss included in net periodic benefit cost

     415         330        1,242        992   
  

 

 

    

 

 

   

 

 

   

 

 

 
     450         375        1,345        1,125   

Unrealized gain (loss) on derivatives:

         

Increase (decrease) in unrealized gain

     —           (434     (318     678   

Reclassification adjustments

     —           (769     625        (1,189
  

 

 

    

 

 

   

 

 

   

 

 

 
     —           (1,203     307        (511

Currency translation adjustment

     3,194         (7,221     7,714        (14,298
  

 

 

    

 

 

   

 

 

   

 

 

 

Other comprehensive income (loss)

     3,644         (8,049     9,366        (13,684
  

 

 

    

 

 

   

 

 

   

 

 

 

Total comprehensive earnings

   $ 102,249       $ 77,445      $ 307,539      $ 241,699   
  

 

 

    

 

 

   

 

 

   

 

 

 

Because amounts related to Research Instruments, which is classified as a discontinued operation, were not material for any period presented, the Company has not segregated them from continuing operations in this note. See Note 18 “Discontinued Operations” for a detailed discussion.

 

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VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

14. EMPLOYEE STOCK PLANS

The table below summarizes the share-based compensation expense under ASC 718:

 

     Three Months Ended     Nine Months Ended  
(In thousands, except per share amounts)    July 1,
2011
    July 2,
2010
    July 1,
2011
    July 2,
2010
 

Cost of revenues - Product

   $ 1,055      $ 956      $ 3,013      $ 2,557   

Cost of revenues - Service contracts and other

     392        638        1,610        1,815   

Research and development

     1,174        1,354        4,485        3,271   

Selling, general and administrative

     6,186        7,747        25,803        19,299   

Taxes on earnings

     (2,942     (3,849     (11,827     (9,627
  

 

 

   

 

 

   

 

 

   

 

 

 

Net decrease in net earnings

   $ 5,865      $ 6,846      $ 23,084      $ 17,315   
  

 

 

   

 

 

   

 

 

   

 

 

 

Increase (decrease) on:

        

Cash flows from operating activities (1)

   $ (4,282   $ (3,506   $ (21,768   $ (8,972

Cash flows from financing activities (1)

   $ 4,282      $ 3,506      $ 21,768      $ 8,972   

 

(1) Amounts represent excess tax benefits from share-based compensation.

During the three and nine months ended July 1, 2011, total share-based compensation expense recognized in earnings before taxes was $8.8 million and $34.9 million, respectively, and the total related recognized tax benefit was $2.9 million and $11.8 million, respectively. During the three and nine months ended July 2, 2010, total share-based compensation expense recognized in earnings before taxes was $10.7 million and $26.9 million, respectively, and the total related recognized tax benefit was $3.8 million and $9.6 million, respectively.

Total share-based compensation expense capitalized as part of inventory for the three and nine months ended July 1, 2011 was $0.6 million and $2.3 million, respectively. Total share-based compensation expense capitalized as part of inventory for the three and nine months ended July 2, 2010 was $84,000 and $0.3 million, respectively.

The fair value of options granted was estimated at the date of grant using the Black-Scholes model with the following weighted average assumptions:

 

     Three Months Ended     Nine Months Ended  
     July 1,
2011
    July 2,
2010
    July 1,
2011
    July 2,
2010
 

Employee Stock Option Plans

        

Expected term (in years)

     5.19        4.73        4.75        4.72   

Risk-free interest rate

     1.8     2.0     2.0     2.0

Expected volatility

     34.5     37.3     35.5     37.3

Expected dividend

     —          —          —          —     

Weighted average fair value at grant date

   $ 23.23      $ 18.28      $ 23.26      $ 18.17   

 

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VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

In May 2009, as part of a broader set of cost control initiatives, VMS’s Board of Directors authorized the suspension of the Company’s employee stock purchase plan in fiscal year 2010. A new employee stock purchase plan was introduced in the three months ended December 31, 2010. The option component of employee stock purchase plan shares for the three and nine months ended July 1, 2011 was estimated at the date of grant using the Black-Scholes model with the following weighted average assumptions:

 

     Three Months Ended      Nine Months Ended  
     July 1,
2011
    July 2,
2010
     July 1,
2011
    July 2,
2010
 

Employee Stock Purchase Plan

         

Expected term (in years)

     0.50        —           0.50        —     

Risk-free interest rate

     0.1     —           0.2     —     

Expected volatility

     12.6     —           11.9     —     

Expected dividend

     —          —           —          —     

Weighted average fair value at grant date

   $ 13.09        —         $ 11.91        —     

Activity under the Company’s employee stock plans is presented below:

 

           Options Outstanding  
(In thousands, except per share amounts)    Shares
Available

for  Grant
    Number of
Shares
    Weighted
Average Exercise
Price
     Weighted-
Average
Remaining
Contractual
Term (in years)
     Aggregate
Intrinsic Value
(3)
 

Balance at October 1, 2010

     8,407        10,174      $ 44.03         

Granted (1)

     (106     48        69.67         

Cancelled or expired (2)

     106        (39     48.32         

Exercised

     —          (3,127     40.44         
  

 

 

   

 

 

         

Balance at July 1, 2011

     8,407        7,056      $ 45.77         4.3       $ 177,096   
  

 

 

   

 

 

         

Exercisable at July 1, 2011

       6,150      $ 45.29         4.1       $ 157,341   
    

 

 

         

 

(1) The difference between the number of shares granted listed in the column headed “Shares Available for Grant” and the number of shares granted listed in the column headed “Options Outstanding—Number of Shares” represents the awards of restricted stock units and deferred stock units. Restricted stock unit awards and deferred stock unit awards were counted against the shares available for grant limit as 2.5 shares for every one awarded.
(2) The difference between the number of cancelled or expired shares listed in the column headed “Shares Available for Grant” and the number of cancelled or expired shares listed in the column headed “Options Outstanding—Number of Shares” represents the cancellation of shares of restricted common stock and restricted stock units due to employee terminations.
(3) The aggregate intrinsic value represents the total pre-tax intrinsic value, which is computed based on the difference between the exercise price and VMS’s closing common stock price of $70.87 as of July 1, 2011, the last trading date of the second quarter of fiscal year 2011, and which would have been received by the option holders had all option holders exercised and sold their options as of that date.

As of July 1, 2011, there was $9.1 million of total unrecognized compensation expense related to outstanding stock options. This unrecognized compensation expense is expected to be recognized over a weighted average period of 1.7 years.

 

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VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

The activity for restricted stock, restricted stock units and deferred stock units is summarized as follows:

 

(In thousands, except per share amounts)    Shares     Weighted Average
Grant-Date Fair
Value
 

Balance at October 1, 2010

     1,333      $ 46.91   

Granted

     23        69.38   

Vested

     (557     47.52   

Cancelled or expired

     (27     46.62   
  

 

 

   

Balance at July 1, 2011

     772      $ 47.16   
  

 

 

   

As of July 1, 2011, unrecognized compensation expense totaling $23.1 million was related to restricted stock, restricted stock units and deferred stock units. This unrecognized compensation expense is expected to be recognized over a weighted average period of 1.9 years.

15. EARNINGS PER SHARE

Basic net earnings per share is computed by dividing net earnings by the weighted average number of shares of VMS common stock outstanding for the period. Diluted net earnings per share is computed by dividing net earnings by the sum of the weighted average number of common shares outstanding and dilutive common shares under the treasury method.

The following table sets forth the computation of net basic and diluted earnings per share:

 

     Three Months Ended     Nine Months Ended  
(In thousands, except per share amounts)    July 1,
2011
     July 2,
2010
    July 1,
2011
     July 2,
2010
 

Earnings from continuing operations

   $ 98,605       $ 91,944      $ 298,173       $ 261,833   

Loss from discontinued operations, net of taxes

     —           (6,450     —           (6,450
  

 

 

    

 

 

   

 

 

    

 

 

 

Net earnings

   $ 98,605       $ 85,494      $ 298,173       $ 255,383   
  

 

 

    

 

 

   

 

 

    

 

 

 

Basic weighted average shares outstanding

     116,874         122,072        117,614         122,871   

Dilutive effect of potential common shares

     2,190         2,439        2,217         1,660   
  

 

 

    

 

 

   

 

 

    

 

 

 

Diluted weighted average shares outstanding

     119,064         124,511        119,831         124,531   
  

 

 

    

 

 

   

 

 

    

 

 

 

Net earnings (loss) per share - basic:

          

Continuing operations

   $ 0.84       $ 0.75      $ 2.54       $ 2.13   

Discontinued operations

     —           (0.05     —           (0.05
  

 

 

    

 

 

   

 

 

    

 

 

 

Net earnings per share

   $ 0.84       $ 0.70      $ 2.54       $ 2.08   
  

 

 

    

 

 

   

 

 

    

 

 

 

Net earnings (loss) per share - diluted:

          

Continuing operations

   $ 0.83       $ 0.74      $ 2.49       $ 2.10   

Discontinued operations

     —           (0.05     —           (0.05
  

 

 

    

 

 

   

 

 

    

 

 

 

Net earnings per share

   $ 0.83       $ 0.69      $ 2.49       $ 2.05   
  

 

 

    

 

 

   

 

 

    

 

 

 

The Company excludes shares underlying stock options from the computation of diluted weighted average shares outstanding if the per share value, either the exercise price of the options or the sum of (a) the exercise price of the options and (b) the amount of the compensation cost attributed to future services and not yet recognized and (c) the amount of tax benefit or shortfall that would be recorded in additional paid-in capital when the award becomes deductible, is greater than the average market price of the shares, because the inclusion of the shares underlying these stock options would be antidilutive to earnings per share.

 

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VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

Based on this calculation, stock options to purchase 47,750 shares at an average exercise price of $69.67 per share and 1,326,128 shares at an average exercise price of $53.16 per share were excluded from the computation of diluted weighted average shares outstanding for the three months ended July 1, 2011 and July 2, 2010, respectively. Stock options to purchase 41,000 shares at an average exercise price of $70.60 and 6,188,386 shares at an average exercise price of $51.27 per share were excluded from the computation of diluted weighted average shares outstanding for the nine months ended July 1, 2011 and July 2, 2010, respectively.

16. BUSINESS COMBINATIONS

On March 4, 2011, the Company acquired all of the outstanding equity of a company, which will be integrated into the Company’s Oncology Systems business. This acquisition was accounted for as a business combination. The total purchase price of $8.0 million consisted of $7.5 million of cash consideration and $0.5 million of contingent consideration at fair value. Of the purchase price, $3.4 million was preliminarily allocated to goodwill, $5.7 million to amortizable intangible assets, and $(1.1) million to net assumed liabilities. Goodwill represents the excess of the purchase price over the fair value of the net tangible and intangible assets acquired and in this case is not deductible for income tax purposes.

The business combination completed during the nine months ended July 1, 2011 did not have a material impact on the Company’s condensed consolidated financial statements, and therefore pro forma disclosures have not been presented.

17. SEGMENT INFORMATION

The Company’s operations are grouped into two reportable operating segments: Oncology Systems and X-ray Products. These reportable operating segments were determined based on how the Company’s Chief Executive Officer, its Chief Operating Decision Maker (“CODM”), views and evaluates the Company’s operations. The Company’s Ginzton Technology Center (“GTC”), SIP business and VPT (previously known as ACCEL Proton Therapy) are reflected in the “Other” category because these operating segments do not meet the criteria of a reportable operating segment. The CODM allocates resources to and evaluates the financial performance of each operating segment primarily based on operating earnings.

The following table summarizes selected operating results information for each business segment:

 

     Three Months Ended     Nine Months Ended  
(In millions)    July 1,
2011
    July 2,
2010
    July 1,
2011
    July 2,
2010
 

Revenues

        

Oncology Systems

   $ 513      $ 456      $ 1,473      $ 1,351   

X-ray Products

     121        103        350        296   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total reportable segments

   $ 634      $ 559      $ 1,823      $ 1,647   

Other

     16        20        55        58   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total company

   $ 650      $ 579      $ 1,878      $ 1,705   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating Earnings (Loss)

        

Oncology Systems

   $ 120      $ 113      $ 368      $ 335   

X-ray Products

     30        26        88        72   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total reportable segments

   $ 150      $ 139      $ 456      $ 407   

Other

     (8     (7     (21     (26

Corporate

     (1     (2     (6     4   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total company

   $ 141      $ 130      $ 429      $ 385   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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VARIAN MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (CONTINUED)

(Unaudited)

 

18. DISCONTINUED OPERATIONS

In September 2008, the Company approved a plan to sell Research Instruments, which developed, manufactured and serviced highly customized scientific instrument components and systems for fundamental and applied physics research primarily for national research laboratories worldwide. Research Instruments was part of the January 2007 ACCEL acquisition and was previously included in the “Other” category in the Company’s Condensed Consolidated Financial Statements. The Company decided to sell Research Instruments in order to focus exclusively on the development of VPT. In the second quarter of fiscal year 2009, the Company completed the sale of Research Instruments for total cash proceeds of $0.4 million. In connection with the sale of Research Instruments, the Company entered into a non-binding supply agreement with the buyer to supply certain inventory parts for VPT. The supply agreement can be terminated by either party upon six months’ notice after December 31, 2011. The inventory purchases under this supply agreement are not expected to have a significant impact on the cash flows of Research Instruments.

The Company classified the operating results of Research Instruments as a discontinued operation in the Condensed Consolidated Statements of Earnings for all periods presented. Because the amounts related to Research Instruments are not material in the Condensed Consolidated Balance Sheet and the Condensed, Consolidated Statements of Cash Flows for all periods presented, the Company has not segregated them from continuing operations.

The Company did not record any profit or loss and did not recognize any revenues in discontinued operations for the three and nine months ended July 1, 2011. For the three months ended July 2, 2010, the Company accrued an additional loss of $6.5 million related to the estimated costs to complete and settle two customer contracts, which were related to the sale of Research Instruments. These contracts had been accounted for under the percentage-of-completion method, under which revenues and costs of sales are adjusted to reflect changes in estimated costs to complete the contracts. Including the additional loss recognized for the two contracts, total losses of Research Instruments for the three and nine months ended July 2, 2010 were both $6.5 million, less applicable income tax of zero. Total revenues of Research Instruments, reported in discontinued operations, for the three and nine months ended July 2, 2010, were $(3.8) million and $(3.6) million, respectively.

As of July 1, 2011, the Company retained one Research Instruments customer contract. If the estimated loss to complete or settle the remaining contract increases, the variance will be recognized in the periods these variances arise.

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and

Stockholders of Varian Medical Systems, Inc.:

We have reviewed the accompanying condensed consolidated balance sheet of Varian Medical Systems, Inc. and its subsidiaries (the “Company”) as of July 1, 2011 and the related condensed consolidated statements of earnings for the three and nine-month periods ended July 1, 2011 and July 2, 2010, and the condensed consolidated statement of cash flows for the nine-month periods ended July 1, 2011 and July 2, 2010. These interim financial statements are the responsibility of the Company’s management.

We conducted our review in accordance with the standards of the Public Company Accounting Oversight Board (United States). A review of interim financial information consists principally of applying analytical procedures and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with the standards of the Public Company Accounting Oversight Board (United States), the objective of which is the expression of an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion.

Based on our review, we are not aware of any material modifications that should be made to the accompanying condensed consolidated interim financial statements for them to be in conformity with accounting principles generally accepted in the United States of America.

We previously audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheet as of October 1, 2010, and the related consolidated statements of earnings, of stockholders’ equity and of cash flows for the year then ended (not presented herein), and in our report dated November 23, 2010, we expressed an unqualified opinion on those consolidated financial statements. In our opinion, the information set forth in the accompanying condensed consolidated balance sheet as of October 1, 2010, is fairly stated in all material respects in relation to the consolidated balance sheet from which it has been derived.

 

/S/    PRICEWATERHOUSECOOPERS LLP
San Jose, CA
August 10, 2011

 

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

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 which provides a “safe harbor” for statements about future events, products and future financial performance that are based on the beliefs of, estimates made by and information currently available to the management of Varian Medical Systems, Inc. (“VMS”) and its subsidiaries (collectively “we,” “our” or the “Company”). The outcome of the events described in these forward-looking statements is subject to risks and uncertainties. Actual results and the outcome or timing of certain events may differ significantly from those projected in these forward-looking statements or management’s current expectations due to the factors cited in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” (“MD&A”), the Risk Factors listed under Part II, Item 1A of this Quarterly Report on Form 10-Q, and other factors described from time to time in our other filings with the Securities and Exchange Commission (“SEC”), or other reasons. For this purpose, statements concerning: industry or market segment outlook; market acceptance of or transition to new products or technology such as fixed field intensity-modulated radiation therapy (“IMRT”), image-guided radiation therapy (“IGRT”), volumetric modulated arc therapy (“VMAT”), stereotactic radiotherapy, stereotactic radiosurgery, brachytherapy, software, treatment techniques, proton therapy (including intensity modulated proton therapy (“IMPT”)) , and advanced x-ray products; growth drivers; future orders, revenues, backlog, earnings or other financial results; and any statements using the terms “believe,” “expect,” “expectation,” “anticipate,” “can,” “should,” “will,” “would,” “could,” “estimate,” “continue,” “grow,” “may,” “intended,” “potential,” “ongoing,” “likely,” and “possible” or similar statements are forward-looking statements. By making forward-looking statements, we have not assumed any obligation to, and you should not expect us to, update or revise those statements because of new information, future events or otherwise.

Overview

In the third quarter of fiscal year 2011, net earnings per diluted share from continuing operations increased 12% and revenues from continuing operations increased 12%, or 9% on a constant currency basis, over the year-ago quarter. Gross margin in the third quarter of fiscal year 2011 declined 0.9 percentage points over the year-ago quarter with declines in the gross margins of Oncology Systems and businesses in the “Other” category, partially offset by an improvement in the gross margin of X-ray Products.

In the third quarter of fiscal year 2011, Oncology Systems net orders grew 9% and X-ray Products net orders grew 17% over the year-ago quarter. Our backlog at the end of the third quarter of fiscal year 2011 was 10% higher than at the end of the year-ago quarter. We ended the third quarter of fiscal year 2011 with $568 million of cash and cash equivalents and $18 million of debt.

Effective in the fourth quarter of fiscal year 2008, we classified our scientific research instruments business (“Research Instruments”) as a discontinued operation for all periods presented in our Condensed Consolidated Statements of Earnings. Research Instruments was previously included in the “Other” category. Unless otherwise stated, the discussion in this MD&A pertains to our continuing operations. Research Instruments did not have revenues and earnings in the third quarter and first nine months of fiscal year 2011.

Oncology Systems. Our largest business segment is Oncology Systems, which designs, manufacturers, sells and services hardware and software products for radiation treatment of cancer with conventional radiotherapy, IMRT, IGRT, VMAT (an advanced form of IMRT), stereotactic radiotherapy, stereotactic radiosurgery and brachytherapy.

In our view, the fundamental market forces that drive long-term growth in our Oncology Systems business are the rising cancer incidence; technological advances and product developments that are leading to improvements in patient care; customer demand for more advanced and effective cancer treatments, such as fixed field IMRT, IGRT, stereotactic radiosurgery, brachytherapy and VMAT; competitive conditions among hospitals and clinics to offer such advanced treatments; continued improvement in safety and cost efficiency in delivering radiation therapy; and underserved medical needs outside of the United States. Our primary goal in the Oncology Systems business is to promote the adoption of more advanced and effective cancer treatments. We do not know what impact the Affordable Health Care for America Act and similar state proposals will have on long-term growth or demand for our products and services in our Oncology Systems business.

 

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In the second quarter of fiscal year 2010, we introduced the TrueBeamTM system for image-guided radiotherapy and radiosurgery. TrueBeam is a fully-integrated system designed from the ground up to treat a moving target with higher speed and accuracy, and complements, at the high end, our accelerator product line portfolio, including UNIQUETM, Clinac® and Trilogy®. Through July 1, 2011 we had received orders for almost 300 TrueBeam systems since its introduction, a majority of which came from North America. A minority of these orders represented upgrades from other linear accelerators already in our backlog. We believe TrueBeam will be a valuable tool for clinicians in the fight against cancer and we expect it will continue to stimulate faster replacement of older systems in our installed base. In April 2011, we received approval by the State Food & Drug Administration in China to market and sell our TrueBeam system in China. In the third quarter of fiscal year 2011, we received Shonin approval from the Japanese Ministry of Health, Labor and Welfare to market the TrueBeam system in Japan.

Oncology Systems net orders increased 9%, or 5% on a constant currency basis, in the third quarter of fiscal year 2011 over the third quarter of fiscal year 2010 primarily due to increased net orders in the international region while North American net orders remained relatively flat. Growth in demand for our service contracts and for our high energy linear accelerators, particularly for the new TrueBeam system, contributed to the growth in total Oncology Systems net orders during the quarter.

In the third quarter of 2011, Oncology Systems total revenues rose 12% over the third quarter of 2010, with a 25% increase in North America and a 2% increase in the international region. Continuing growth in demand for our Oncology Systems products depends in part on the strength and sustainability of an economic recovery in the United States. Oncology Systems gross margin decreased 1.2 percentage points in the third quarter of fiscal year 2011 over the year-ago quarter primarily due to product retrofits and product mix shift towards lower margin products.

In May 2011, we signed an agreement with Augmenix, Inc. (“Augmenix”), a privately-held company that is developing hydrogel products to improve outcomes in radiation oncology, under which we paid $15 million to Augmenix for a minority equity interest plus an exclusive option to purchase the remaining equity interest of Augmenix provided certain agreed-upon milestones have been met.

X-ray Products. Our X-ray Products business segment designs, manufactures and sells: (i) x-ray tubes for use in a range of applications including computed tomography (“CT”) scanning, radiographic or fluoroscopic imaging, mammography, special procedures and industrial applications; and (ii) flat panel detectors for filmless x-ray imaging. We continue to view the long-term fundamental growth driver for this business to be the ongoing success of key x-ray imaging original equipment manufacturers (“OEMs”) that incorporate our x-ray tube products and flat panel detectors into their medical diagnostic, dental, veterinary and industrial imaging systems.

Compared to the third quarter of fiscal year 2010, X-ray Products net orders increased 17% and revenues increased 18% in the third quarter of fiscal year 2011, with both the flat panel detector and x-ray tubes product lines contributing to the net orders and revenue growth. X-ray Products gross margin for the third quarter of fiscal year 2011 increased 0.9 percentage points over the third quarter of fiscal year 2010 as a result of higher sales volumes, product mix shift towards flat panel products (which carry higher gross margins), as well as lower costs of quality. We have been notified by one of our larger customers in Japan that it will be shutting down production for two weeks during the fourth quarter of fiscal year 2011 due to a power shortage stemming from the March 2011 natural disasters in Japan. The financial performance in X-ray Products may potentially be impacted if this customer is unable to compensate for any loss in production or if more of our Japanese customers are similarly impacted.

Our success in our X-ray Products business depends upon our ability to anticipate changes in our markets, the direction of technological innovation and the demands of our customers. In addition, changes in access to diagnostic radiology or the reimbursement rates associated with diagnostic radiology as a result of the Affordable Health Care for America Act and similar state proposals will likely affect demand for our products in our X-ray Products business.

Other. The “Other” category is comprised of Security and Inspections Products (“SIP”), Varian Particle Therapy (“VPT”), and the operations of the Ginzton Technology Center (“GTC”). (Please refer to Note 17, “Segment Information” to the Condensed Consolidated Financial Statements within this Quarterly Report on Form 10-Q) .

SIP designs, manufactures, sells and services Linatron® x-ray accelerators, imaging processing software and image detection products (including IntellXTM) for cargo screening and border protection needs. Orders and revenues for our SIP products have been and may continue to be unpredictable as governmental agencies may place large orders in a short time period, such as the $21.0 million order for five of our IntellX cargo screening systems received from U.S. Customs and Border Protection in the second quarter of fiscal year 2011, and then may not place any orders for a long time period thereafter.

 

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VPT develops, designs, manufactures, sells and services products and systems for delivering proton therapy, another form of external beam radiotherapy using proton beams, for the treatment of cancer. Although proton therapy has been in clinical use for more than four decades, it has not been widely deployed due to high capital cost. We are investing substantial resources to commercialize this technology and to build this new business. We currently have a Conformité Européenne (“CE”) mark to market our proton therapy systems within the European Economic Area (“EEA”). In January 2011, we received 510(k) clearance in the United States for our proton therapy system, which is capable of delivering precise IMPT using pencil beam scanning technology.

GTC, our scientific research facility, continues to invest in developing technologies that enhance our current businesses or may lead to new business areas, including next generation digital x-ray imaging technology, volumetric and functional imaging, and improved x-ray sources and technology for security and cargo screening applications. In addition, GTC is developing technologies and products that are designed to improve disease management by more precise targeting of radiation, as well as by employing targeted energy and molecular agents to enhance the effectiveness and broaden the application of radiation therapy.

In the third quarter of fiscal year 2011, net orders in the “Other” category decreased $2 million and revenues decreased $4 million from the third quarter of fiscal year 2010.

This discussion and analysis of our financial condition and results of operations is based upon and should be read in conjunction with the Condensed Consolidated Financial Statements and the notes included elsewhere in this Quarterly Report on Form 10-Q and the Consolidated Financial Statements and the Notes to the Consolidated Financial Statements and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the fiscal year ended October 1, 2010 (the “2010 Annual Report”), as well as the Risk Factors contained in Part II, Item 1A of this Quarterly Report on Form 10-Q, and other information provided from time to time in our other filings with the SEC.

Critical Accounting Estimates

The preparation of our financial statements and related disclosures in conformity with accounting principles generally accepted in the United States (“GAAP”) requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. These estimates and assumptions are based on historical experience and on various other factors that we believe are reasonable under the circumstances. We periodically review our accounting policies, estimates and assumptions and make adjustments when facts and circumstances dictate. In addition to the accounting policies that are more fully described in the Notes to the Consolidated Financial Statements included in our 2010 Annual Report, we consider the critical accounting policies described below to be affected by critical accounting estimates. Our critical accounting policies that are affected by accounting estimates include revenue recognition, share-based compensation expense, valuation of allowance for doubtful accounts, valuation of inventories, assessment of recoverability of goodwill and intangible assets, valuation of warranty obligations, assessment of environmental remediation liabilities, valuation of defined benefit pension and post-retirement benefit plans, valuation of derivative instruments and taxes on earnings. Such accounting policies require us to use judgments, often as a result of the need to make estimates and assumptions regarding matters that are inherently uncertain; and actual results could differ materially from these estimates. For a discussion of how these estimates and other factors may affect our business, see Part II, Item 1A, “Risk Factors.”

Revenue Recognition

We frequently enter into sales arrangements with customers that contain multiple elements or deliverables such as hardware, software and services. Judgments as to the allocation of consideration from an arrangement to the multiple elements of the arrangement, and the appropriate timing of revenue recognition are critical with respect to these arrangements to ensure compliance with GAAP.

At the beginning of the second quarter of fiscal year 2010, we elected to early adopt the amended software revenue guidance and amended multiple deliverable revenue arrangement guidance on a prospective basis as of the beginning of fiscal year 2010 and have applied the amended guidance for revenue arrangements originating or materially modified after October 2, 2009. Under the amended guidance, the allocation of consideration in a multiple element arrangement is affected by the determination of whether any software deliverables that function together with other hardware components to deliver the

 

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hardware products’ essential functionality are considered non-software products for the purpose of revenue recognition. The allocation of consideration to each non-software deliverable is based on the assumptions we use to establish its selling price, which are based on vendor-specific objective evidence (“VSOE”) of selling price, if it exists, otherwise, third-party evidence of selling price, if it exists, and if not on estimated selling prices. In addition, the allocation of consideration to each software deliverable in a multiple element arrangement is affected by our judgment as to whether VSOE of its fair value exists in these arrangements.

Under the prior authoritative guidance, the allocation of consideration to each deliverable in a multiple deliverable arrangement was affected by our judgment as to whether objective and reliable evidence of fair value existed for hardware deliverables and VSOE of the fair value existed for software deliverables in these arrangements.

Changes to the elements in an arrangement and the amounts allocated to each element could affect the timing and amount of revenue recognition. Revenue recognition also depends on the timing of shipment and is subject to customer acceptance and the readiness of customers’ facilities. If shipments are not made on scheduled timelines or if the products are not accepted by the customer in a timely manner, our reported revenues may differ materially from expectations.

In addition, revenues related to certain proton therapy commissioning service contracts and highly customized image detection systems are recognized under the percentage-of-completion method of accounting. Under the percentage-of-completion method of accounting, sales and gross profit are recognized as work is performed, based on the relationship between actual costs incurred and total estimated costs at the completion of the contract. Because the percentage-of-completion method involves considerable use of estimates in determining revenues, costs and profits and in assigning the dollar amounts to relevant accounting periods, and because the estimates must be periodically reviewed and appropriately adjusted, if our estimates prove to be inaccurate or circumstances change over time, we may be forced to adjust revenues or even record a contract loss in later periods. If a loss is expected on a contract under the percentage-of-completion method or completed contract method, the estimated loss would be charged to cost of sales in the period the loss is identified.

Share-based Compensation Expense

We value our stock options granted and the option component of the shares purchased under the Employee Stock Purchase Plan using the Black-Scholes option-pricing model. The determination of fair value of share-based payment awards on the date of grant using the Black-Scholes option-pricing model is affected by VMS’s stock price, as well as the input of other subjective assumptions, including the expected term of stock awards and the expected price volatility of VMS stock over the expected term of the awards.

The expected term is based on the observed and expected time to post-vesting exercise and post-vesting cancellations of stock options by our employees. We determined the expected term of stock options based on the demographic grouping of employees and retirement eligibility. We used a combination of historical and implied volatility, or blended volatility, in deriving the expected volatility assumption. Blended volatility represents the weighted average of implied volatility and historical volatility. Implied volatility is derived based on traded options on VMS common stock. Implied volatility is weighted in the calculation of blended volatility based on the ratio of the term of the exchange-traded options to the expected terms of the employee stock options. Historical volatility represents the remainder of the weighting. Our decision to incorporate implied volatility was based on our assessment that implied volatility of publicly traded options on VMS 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. After considering the above factors, we determined that we could not rely exclusively on implied volatility based on the fact that the term of VMS exchange-traded options is less than one year and that it is different from the expected terms of the stock options we grant. Therefore, we believe a combination of the historical volatility over the expected terms of the stock options we grant and the implied volatility of exchange-traded options best reflects the expected volatility of VMS common stock. The risk-free interest rate assumption is based upon observed interest rates appropriate for the term of our stock options. The dividend yield assumption is based on our history and expectation of no dividend payouts. If factors change and we employ different assumptions in future periods, the compensation expense that we record may differ significantly from what we have recorded in the current period. In addition, we are required to estimate the expected forfeiture rate and recognize expense only for those shares expected to vest. If our actual forfeiture rate is materially different from our estimate, the stock-based compensation expense could be significantly different from what we have recorded in the current period.

 

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Allowance for Doubtful Accounts

We evaluate the creditworthiness of our customers prior to authorizing shipment for all major sale transactions. Except for government tenders, group purchases and orders with letters of credit in Oncology Systems, SIP and VPT, and orders in our X-ray Products business, our payment terms usually require payment of a small portion of the total amount due when the customer signs the purchase order, a significant amount upon transfer of risk of loss to the customer and the remaining amount upon completion of the installation. On a quarterly basis, we evaluate aged items in the accounts receivable aging report and provide an allowance in an amount we deem adequate for doubtful accounts. If our evaluation of our customers’ financial conditions does not reflect our future ability to collect outstanding receivables, additional provisions may be needed and our operating results could be negatively affected.

Inventories

Our inventories include high technology parts and components that are highly specialized in nature and that are subject to rapid technological obsolescence. We have programs to minimize the required inventories on hand and we regularly review inventory quantities on hand and on order and adjust for excess and obsolete inventory based primarily on historical usage rates and our estimates of product demand and production. Actual demand may differ from our estimates, in which case we may have understated or overstated the provision required for obsolete and excess inventory, which would have an impact on our operating results.

Goodwill and Intangible Assets

Goodwill is initially recorded when the purchase price paid for a business acquisition exceeds the estimated fair value of the net identified tangible and intangible assets acquired. The majority of businesses that we have acquired have not had significant identified tangible assets and, as a result, we have typically allocated a significant portion of the purchase price to intangible assets and goodwill. Our future operating performance will be impacted by the future amortization of these acquired intangible assets and potential impairment charges related to these intangibles or to goodwill if indicators of impairment exist. The allocation of the purchase price from business acquisitions to goodwill and intangible assets could have a significant impact on our future operating results. In addition, the allocation of the purchase price of the acquired businesses to goodwill and intangible assets requires us to make significant estimates and assumptions, including estimates of future cash flows expected to be generated by the acquired assets and the appropriate discount rate for those cash flows. Should conditions differ from management’s estimates at the time of the acquisition, material write-downs of intangible assets and/or goodwill may be required, which would adversely affect our operating results.

In accordance with Accounting Standard Codification (“ASC”) 350, we evaluate goodwill for impairment at least annually or whenever an event occurs or circumstances change that would more likely than not reduce the fair value of a reporting unit below its carrying amount. The impairment test for goodwill is a two-step process. Step one consists of a comparison of the fair value of a reporting unit against its carrying amount, including the goodwill allocated to each reporting unit. We determine the fair value of our reporting units based on the present value of estimated future cash flows of the reporting units. If the carrying amount of the reporting unit is in excess of its fair value, step two requires the comparison of the implied fair value of the reporting unit’s goodwill against the carrying amount of the reporting unit’s goodwill. Any excess of the carrying value of the reporting unit’s goodwill over the implied fair value of the reporting unit’s goodwill is recorded as an impairment loss. The impairment test for intangible assets with indefinite useful lives, if any, consists of a comparison of fair value to carrying value, with any excess of carrying value over fair value being recorded as an impairment loss. Based on the most recent annual goodwill impairment testing that we performed in the fourth quarter of fiscal year 2010 for each of our four reporting units with goodwill (Oncology Systems, X-ray Products, SIP and VPT), the fair value of each such reporting unit was substantially in excess of its carrying value. We will continue to make assessments of impairment on an annual basis in the fourth quarter of our fiscal years or more frequently if indicators of potential impairment arise.

Warranty Obligations

We warrant most of our products for a specific period of time, usually twelve months, against material defects. We provide for the estimated future costs of warranty obligations in cost of revenues when the related revenues are recognized. The accrued warranty costs represent our best estimate at the time of sale of the total costs that we will incur to repair or replace product parts that fail while still under warranty. The amount of accrued estimated warranty costs obligation for established products is primarily based on historical experience as to product failures adjusted for current information on repair costs.

 

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For new products, estimates will include historical experience of similar products, as well as a reasonable allowance for start-up expenses. Actual warranty costs could differ from the estimated amounts. On a quarterly basis, we review the accrued balances of our warranty obligations and update the historical warranty cost trends, if required. If we were required to accrue additional warranty costs in the future, it would have a negative effect on our operating results.

Environmental Matters

We are subject to a variety of environmental laws around the world. Those laws regulate multiple aspects of our operations, including the handling, storage, transport and disposal of hazardous substances. They impose costs on our operations and in connection with past operations. We record environmental remediation liabilities when we conclude that environmental assessments or remediation efforts are probable and we believe we can reasonably estimate the costs of those efforts. Our accrued environmental costs represent our best estimate of the total costs of assessments and remediation and the time period over which we expect to incur those costs. We review these accrued balances quarterly. Were we required to increase or decrease the accrued environmental costs in the future, it would adversely or favorably impact our operating results.

Defined Benefit Pension and Post-Retirement Benefit Plans

We sponsor five defined benefit pension plans in Germany, Japan, Switzerland and the United Kingdom covering employees who meet the applicable eligibility requirements in these countries. Since July 2007, the accrual of additional benefits for existing participants has been terminated and the enrollment of new participants has been suspended under the defined benefit pension plan in the United Kingdom. Although we do not have any defined benefit pension plans in the United States, we sponsor a post-retirement benefit plan that provides healthcare benefits to certain eligible retirees. Several statistical and other factors that attempt to anticipate future events are used in calculating the expenses and liabilities related to those plans for which the benefits are actuarially determined, such as our defined benefit pension and post-retirement benefit plans. These factors include assumptions about the discount rate, expected return on plan assets, rate of future compensation increases and rate of healthcare cost increases, all of which we determine within certain guidelines. In addition, we also use assumptions, such as withdrawal and mortality rates, to calculate the expenses and liabilities. The actuarial assumptions we use are long-term assumptions and may differ materially from actual experience particularly in the short term due to changing market and economic conditions and changing participant demographics. These differences may have a significant impact on the amount of defined benefit pension and post-retirement benefit plan expense we record.

The expected rates of return on the various defined benefit pension plans’ assets are based on the asset allocation of each plan and the long-term projected return on those assets. The discount rate enables us to state expected future cash flows at a present value on the measurement date. The discount rates used for defined benefit plans in all countries are based primarily on the yields of a universe of high quality corporate bonds in each country or the spot rate of high quality AA-rated corporate bonds, with durations corresponding to the expected durations of the benefit obligations. In countries where the corporate bond market is not sufficiently representative of the time period at longer durations, the discount rate also takes into account the yield of long-term government bonds corresponding to the duration of the benefit obligations and the difference between the yield curve on high quality corporate fixed-income investments and government fixed-income investments. A change in the discount rate will cause the present value of benefit obligations to change in the opposite direction.

Valuation of Derivative Instruments

We use foreign currency forward contracts to reduce the effects of currency fluctuations on sales transactions denominated in foreign currencies and on assets and liabilities denominated in foreign currencies. These foreign currency forward contracts are derivative instruments and are measured at fair value. ASC 820 establishes three levels of inputs that may be used to measure fair value (see Note 3, “Fair Value Measurements” of the Notes to the Condensed Consolidated Financial Statements). Each level of input has different levels of subjectivity and difficulty involved in determining fair value. The fair value of foreign currency forward contracts are calculated primarily using Level 2 inputs, which include currency spot and forward rates, interest rate and credit or non-performance risk. The spot rate for each currency is the same spot rate used for all balance sheet translations at the measurement date and sourced from our major trading banks. The forward point values for each currency and the London Interbank Offered Rate (“LIBOR”) to discount assets and liabilities are interpolated from commonly quoted broker services. One year credit default swap spreads of the counterparty at the measurement date are used to adjust derivative assets, all of which mature in less than 12 months, for non-performance risk. We are required to adjust derivative liabilities to reflect the potential non-performance risk to lenders based on our incremental borrowing rate. Each contract is individually adjusted using the counterparty’s discount rate (for net asset) or our discount rate (for net liability). The use of Level 2 inputs in determining fair values requires certain management judgment and subjectivity. Changes to these Level 2 inputs could have a material impact on the valuation of our derivative instruments, as well as on our results of operations.

 

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Taxes on Earnings

We are subject to taxes on earnings in both the United States and numerous foreign jurisdictions. As a global taxpayer, significant judgments and estimates are required in evaluating our tax positions and determining our provision for taxes on earnings.

The provisions in ASC 740 related to accounting for uncertainty in income taxes contain a two-step approach to recognizing, derecognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining whether the weight of available evidence indicates that it is more likely than not that, based on the technical merits, the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. Recognition, derecognition and measurement are based on management’s best judgment given the facts, circumstances and information available at the end of the accounting period. A tax benefit should be recognized in the first period in which it meets the more likely than not recognition threshold, and conversely, a tax benefit previously recognized should be derecognized in the first period in which new information results in a change in judgment in which the position fails to meet the recognition threshold. A benefit not previously recognized would be recognized when the tax position is effectively settled through examination, negotiation or litigation with tax authorities, or when the statute of limitations for the relevant taxing authority to examine and challenge the position has expired. Our policy is to include interest and penalties related to unrecognized tax benefits within the provision for taxes on earnings.

Generally, the carrying value of our net deferred tax assets assumes that we will be able to generate sufficient future taxable earnings in the applicable tax jurisdictions to utilize these deferred tax assets. Should we conclude it is more likely than not that we will be unable to recover our net deferred tax assets in these tax jurisdictions, we would increase our valuation allowance and our tax provision would increase in the period in which we make such a determination.

Earnings derived from our international region are generally taxed at rates lower than U.S. rates. Our effective tax rate is impacted by existing tax laws in both the United States and in the respective countries in which our international subsidiaries do business. In addition, a change in the percentage of our total earnings from our international region, or a change in the mix of particular tax jurisdictions within the international region could cause our effective tax rate to increase or decrease. Also, our current effective tax rate does not assume U.S. taxes on certain undistributed profits of certain foreign subsidiaries. These earnings could become subject to incremental foreign withholding or U.S. federal and state taxes should they either be deemed or actually remitted to the United States.

Results of Operations

Fiscal Year

Our fiscal year is the 52- or 53-week period ending on the Friday nearest September 30. Fiscal year 2011 is the 52-week period ending September 30, 2011, and fiscal year 2010 was the 52-week period ended October 1, 2010. The fiscal quarters ended July 1, 2011 and July 2, 2010 were both 13-week periods.

 

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Discussion of Results of Operations for the Third Quarter and First Nine Months of Fiscal Year 2011 Compared to the Third Quarter and First Nine Months of Fiscal Year 2010

Total Revenues

 

Revenues by sales classification    Three Months Ended     Nine Months Ended  
(Dollars in millions)    July 1,
2011
    July 2,
2010
    Percent
Change
    July 1,
2011
    July 2,
2010
    Percent
Change
 

Product

   $ 490.4      $ 440.8        11   $ 1,420.9      $ 1,305.4        9

Service Contracts and Other

     159.0        137.2        16     456.8        399.1        14
  

 

 

   

 

 

     

 

 

   

 

 

   

Total Revenues

   $ 649.4      $ 578.0        12   $ 1,877.7      $ 1,704.5        10
  

 

 

   

 

 

     

 

 

   

 

 

   

Product as a percentage of total revenues

     76     76       76     77  

Service Contracts and Other as a percentage of total revenues

     24     24       24     23  

Revenues by region

            

North America

   $ 301.6      $ 242.4        24   $ 824.5      $ 725.2        14
  

 

 

   

 

 

     

 

 

   

 

 

   

Europe

     197.3        175.9        12     575.5        538.2        7

Asia

     124.2        142.5        (13 %)      401.7        386.0        4

Rest of world

     26.3        17.2        53     76.0        55.1        38
  

 

 

   

 

 

     

 

 

   

 

 

   

Total International (1)

     347.8        335.6        4     1,053.2        979.3        8
  

 

 

   

 

 

     

 

 

   

 

 

   

Total

   $ 649.4      $ 578.0        12   $ 1,877.7      $ 1,704.5        10
  

 

 

   

 

 

     

 

 

   

 

 

   

North America as a percentage of total revenues

     46     42       44     43  

International as a percentage of total revenues

     54     58       56     57  

 

(1) We consider international revenues to be revenues outside of North America.

The increase in revenues in the third quarter of fiscal year 2011 over the year-ago quarter was due to revenue growth in Oncology Systems and X-ray Products, partially offset by declines in SIP and VPT revenues. For the first nine months of fiscal year 2011, the increase in revenues over the first nine months of fiscal year 2010 was due to revenue growth in Oncology Systems, X-ray Products and SIP, partially offset by a decrease in VPT revenues. For the third quarter and the first nine months of fiscal year 2011, Oncology Systems and X-ray Products contributed to the growth in product revenues over the respective year-ago periods, partially offset by declines in SIP product revenues.

Service contract and other revenues increased during the third quarter and the first nine months of fiscal year 2011 over the respective year-ago periods due to increases in Oncology Systems service contract revenues and, to a lesser extent, increases in SIP service contract and other revenues, partially offset by declines in VPT service contract revenues.

The increases in North American revenues in the third quarter and the first nine months of fiscal year 2011 from the respective year-ago periods were due to increases in revenues in Oncology Systems, X-ray Products and SIP businesses. International revenues increased in the third quarter and the first nine months of fiscal year 2011 over the respective year-ago periods due to increases in international revenues in Oncology Systems and X-ray Products, which were partially offset by declines in international revenues in SIP and VPT. Overall, the U.S. dollar was weaker against foreign currencies in the third quarter and the first nine months of fiscal year 2011 compared to the respective year-ago periods, which favorably affected our international revenues when measured in U.S. dollars.

 

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Oncology Systems Revenues

 

Revenues by sales classification    Three Months Ended     Nine Months Ended  
(Dollars in millions)    July 1,
2011
    July 2,
2010
    Percent
Change
    July 1,
2011
    July 2,
2010
    Percent
Change
 

Product

   $ 358.5      $ 323.7        11   $ 1,030.9      $ 969.7        6

Service Contracts (1)

     154.0        132.2        16     441.9        380.8        16
  

 

 

   

 

 

     

 

 

   

 

 

   

Total Oncology Systems revenues

   $ 512.5      $ 455.9        12   $ 1,472.8      $ 1,350.5        9
  

 

 

   

 

 

     

 

 

   

 

 

   

Product as a percentage of total Oncology Systems revenues

     70     71       70     72  

Service Contracts as a percentage of Oncology Systems revenues

     30     29       30     28  

Oncology Systems revenues as a percentage of total revenues

     79     79       78     79  

 

(1) Revenues from service contracts represent revenues from fixed-term service contracts and labor cost services. These exclude revenues from spare parts sold by our service organization.

Oncology Systems product revenues increased in the third quarter and the first nine months of fiscal year 2011 over the year-ago periods primarily due to increases in revenues from sales of our linear accelerators and from sales of our software products. The increases in Oncology Systems service contract revenues in the third quarter and the first nine months of fiscal year 2011 over the year-ago periods were primarily driven by increased customer adoption of service contracts as our products become more sophisticated and by an increased number of customers as our installed base of our products continues to grow.

 

Revenues by region    Three Months Ended     Nine Months Ended  
(Dollars in millions)    July 2,
2011
    July 2,
2010
    Percent
Change
    July 2,
2011
    July 2,
2010
    Percent
Change
 

North America

   $ 259.4      $ 207.1        25   $ 705.0      $ 619.8        14
  

 

 

   

 

 

     

 

 

   

 

 

   

Europe

     167.3        139.7        20     470.0        445.2        6

Asia

     60.4        94.6        (36 %)      224.9        235.4        (4 %) 

Rest of world

     25.4        14.5        75     72.9        50.1        45
  

 

 

   

 

 

     

 

 

   

 

 

   

Total International

     253.1        248.8        2     767.8        730.7        5
  

 

 

   

 

 

     

 

 

   

 

 

   

Total Oncology Systems revenues

   $ 512.5      $ 455.9        12   $ 1,472.8      $ 1,350.5        9
  

 

 

   

 

 

     

 

 

   

 

 

   

North America as a percentage of Oncology Systems revenues

     51     45       48     46  

International as a percentage of Oncology Systems revenues

     49     55       52     54  

The increase in North American Oncology Systems revenues in the third quarter of fiscal year 2011 over the year-ago quarter was primarily due to increases in revenues from sales of our high energy linear accelerators and our software products, as well as an increase in service contract revenues. For the first nine months of fiscal year 2011, North American Oncology Systems revenues increased over the first nine months of fiscal year 2010 primarily due to increases in revenues from sales of our high energy linear accelerators and an increase in service contract revenues, partially offset by a decrease in revenues from sales of our software products.

In the third quarter of fiscal year 2011, the increase in Oncology Systems international revenues was primarily due to an increase in service contract revenues in all international regions, as well as increased product revenues from sales of our high energy linear accelerators and our software products in Europe and the rest of the world region, partially offset by decreases in revenues from sales of most of our products in Asia, where we had very high revenues in Japan in the year-ago quarter that were attributable to a supplemental government spending program. Overall, the U.S. dollar was weaker against foreign currencies in the third quarter of fiscal year 2011 compared to the third quarter of fiscal year 2011, which favorably affected our Oncology Systems international revenues when measured in U.S. dollars.

 

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For the first nine months of fiscal year 2011, the increase in Oncology Systems international revenues was primarily due to an increase in service contract revenues in all international regions, as well as an increase in product revenues from sales of our software products in the rest of the world region and Europe. Overall, the U.S. dollar was weaker against foreign currencies in the first nine months of fiscal year 2011 compared to the first nine months of fiscal year 2011, which favorably affected our Oncology Systems international revenues when measured in U.S. dollars.

Varying cycles of higher and lower revenues between the international and North American regions is a historical pattern reflecting regional influences such the effects of government economic stimulus programs, the effects of the recession and economic recovery, uncertainty created by healthcare reform and reductions in Medicare reimbursement rates for radiotherapy and radiosurgery in the United States, and different technology adoption cycles that are consistent with the net order patterns discussed more fully under “Net Orders.”

X-ray Products Revenues

 

Revenues by region    Three Months Ended     Nine Months Ended  
(Dollars in millions)    July 1,
2011
    July 2,
2010
    Percent
Change
    July 1,
2011
    July 2,
2010
    Percent
Change
 

North America

   $ 35.0      $ 32.1        9   $ 100.5      $ 93.8        7
  

 

 

   

 

 

     

 

 

   

 

 

   

Europe

     21.7        19.7        10     71.5        49.1        46

Asia

     63.2        47.8        32     175.2        148.0        18

Rest of world

     0.9        2.7        (67 %)      3.0        5.0        (39 %) 
  

 

 

   

 

 

     

 

 

   

 

 

   

Total International

     85.8        70.2        22     249.7        202.1        24
  

 

 

   

 

 

     

 

 

   

 

 

   

Total X-ray Products Revenues

   $ 120.8      $ 102.3        18   $ 350.2      $ 295.9        18
  

 

 

   

 

 

     

 

 

   

 

 

   

North America as a percentage of X-ray Products revenues

     29     31       29     32  

International as a percentage of X-ray Products revenues

     71     69       71     68  

X-ray Products revenues as a percentage of total revenues

     19     18       19     17  

In the third quarter of fiscal year 2011, the increase in total X-ray Products revenues over the third quarter of fiscal year 2010 was primarily due to an increase in international revenues and, to a lesser extent, an increase in North American revenues. The increase in international X-ray Products revenues for the third quarter of fiscal year 2011 over the third quarter of fiscal year 2010 resulted primarily from increased sales of our x-ray tube products in Asia and from increased sales of our flat panel products in Asia and Europe. The increase in revenues from increased sales of our flat panel products was the primary contributor of revenue growth in North America in the third quarter of fiscal year 2011 compared to the third quarter of fiscal year 2010.

For the first nine months of fiscal year 2011, the international region and North America also both contributed to the increase in X-ray Products revenues over the year-ago period. Increased sales of our flat panel products in all international regions and increased sales of our x-ray tube products in Asia and Europe contributed to the increase in the international X-ray Products for the first nine months of fiscal year 2011 over the year-ago period. In North America, an increase in revenues from increased sales of our flat panel products was partially offset by a decline in revenues from decreased sales of our x-ray tube products in the first nine months of fiscal year 2011 compared to the first nine months of fiscal year 2010.

The fluctuation of the U.S. dollar against foreign currencies did not have a material impact on X-ray Products international revenue growth because sales transactions in the X-ray Products business are primarily denominated in U.S. dollars.

 

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Other Revenues

 

Revenues by sales classification    Three Months Ended     Nine Months Ended  
(Dollars in millions)    July 1,
2011
    July 2,
2010
    Percent
Change
    July 1,
2011
    July 2,
2010
    Percent
Change
 

Product

   $ 11.2      $ 14.9        (25 %)    $ 39.8      $ 39.9        (0 %) 

Service Contracts and Other

     4.9        4.9        1     14.9        18.2        (18 %) 
  

 

 

   

 

 

     

 

 

   

 

 

   

Total Other revenues

   $ 16.1      $ 19.8        (18 %)    $ 54.7      $ 58.1        (6 %) 
  

 

 

   

 

 

     

 

 

   

 

 

   

Other revenues as a percentage of total revenues

     2     3       3     4  

Revenues in our “Other” category decreased in the third quarter of fiscal year 2011 from the third quarter of fiscal year 2010 primarily due to a decrease in SIP product revenues and a decrease in VPT service contract revenues related to the commissioning of a proton therapy system. For the first nine months of fiscal year 2011, revenues in the “Other” category decreased over the year-ago period primarily because of a decrease in VPT service contract revenues related to the commissioning of a proton therapy system partially offset by an increase in SIP service contract and other revenues.

Gross Margin

 

     Three Months Ended     Nine Months Ended  
(Dollars in millions)    July 1,
2011
    July 2,
2010
    Percent
Change
    July 1,
2011
    July 2,
2010
    Percent
Change
 

Dollars by segment

            

Oncology Systems

   $ 225.2      $ 205.8        9   $ 670.5      $ 615.7        9

X-ray Products

     49.7        41.2        21     144.4        118.1        22

Other

     4.9        7.4        (33 %)      20.7        15.6        33
  

 

 

   

 

 

     

 

 

   

 

 

   

Gross margin

   $ 279.8      $ 254.4        10   $ 835.6      $ 749.4        12
  

 

 

   

 

 

     

 

 

   

 

 

   

Percentage by segment

            

Oncology Systems

     43.9     45.1       45.5     45.6  

X-ray Products

     41.2     40.3       41.3     40.0  

Total Company

     43.1     44.0       44.5     44.0  

For the third quarter of fiscal year 2011, the decrease in total company gross margin percentage over the third quarter of fiscal year 2010 was primarily due to decreases in gross margins in Oncology Systems, SIP and VPT (resulting from an increase in estimated costs to commission a proton therapy system in Munich, Germany), partially offset by an increase in X-ray Products gross margin. For the first nine months of fiscal year 2011, the increase in total company gross margin percentage over the first nine months of fiscal year 2010 was primarily due to increases in gross margins in X-ray Products and SIP, partially offset by a slight decrease in Oncology Systems gross margin and a decrease in VPT gross margin.

In the third quarter of fiscal year 2011, Oncology Systems total gross margin decreased 1.2 percentage points over the year-ago quarter primarily due to product retrofits and product mix shift towards lower margin products. Oncology Systems service contract gross margin increased to 51.4% in the third quarter of fiscal year 2011 from 48.6% in the third quarter of fiscal year 2010 primarily due to higher service contract volume partially offset by higher product retrofit costs. The increase in Oncology Systems service contract gross margin was more than offset by a decrease in Oncology Systems product gross margin, which was 40.7% for the third quarter of fiscal year 2011, compared to 43.7% in the third quarter of fiscal year 2010, primarily due to product mix shift towards lower margin products.

For the first nine months of fiscal year 2011, Oncology Systems gross margin decreased slightly with a decline in product gross margin partially offset by an improvement in service contract gross margin. Oncology Systems product gross margin decreased to 43.0% in the first nine months of fiscal year 2011 from 43.6% in the first nine months of fiscal year 2010, primarily due to product mix shift towards lower margin products. Oncology Systems service contract gross margin was 51.4% in the first nine months of fiscal year 2011, compared to 50.7% in the first nine months of fiscal year 2010. The increase in service contract gross margin was primarily due to higher service contract volume.

 

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For the third quarter and the first nine months of fiscal year 2011, X-ray Products gross margin improved over the respective year-ago periods primarily due to higher sales volume, product mix shift towards flat panel products (which carry higher gross margins), as well as lower costs of quality for our x-ray tube products.

Research and Development

 

     Three Months Ended     Nine Months Ended  
(Dollars in millions)    July 1,
2011
    July 2,
2010
    Percent
Change
    July 1,
2011
    July 2,
2010
    Percent
Change
 

Research and development

   $ 44.4      $ 38.9        14   $ 126.8      $ 116.2        9

As a percentage of total revenues

     6.8     6.7       6.8     6.8  

For the third quarter of fiscal year 2011, the $5.5 million increase in research and development expenses was primarily driven by increases in expenses of $3.8 million in Oncology Systems, $1.3 million in X-ray Products and $0.3 million in the “Other” category. The increase in Oncology Systems was primarily due to a $2.1 million unfavorable currency translation impact, as foreign currency denominated research and development expenses for Oncology Systems were translated into weaker U.S. dollars, as well as an increase in material costs and consulting expenses for product development. The $1.3 million increase in X-ray Products was mainly due to higher development expenses for flat panel and x-ray tube products. The increase $0.3 million increase in the “Other” category was primarily due to an increase in expenses for development projects in VPT, partially offset by a decrease in product development expenses in SIP.

The $10.6 million increase in research and development expenses for the first nine months of fiscal year 2011 compared to the first nine months of fiscal year 2010 was primarily due to increases in expenses of $3.8 million in the “Other” category, $3.4 million in Oncology Systems and $3.2 million in X-ray Products. The $3.8 million increase in the “Other” category was primarily due to an increase in expenses for development projects in VPT, partially offset by a decrease in product development expenses in SIP. The $3.4 million increase in Oncology Systems was mainly due to a $2.7 million unfavorable currency translation impact, as foreign currency denominated research and development expenses for Oncology Systems were translated into weaker U.S. dollars, as well as an increase in material costs and consulting expenses for product development. The $3.2 million increase in X-ray Products was attributable primarily to higher development expenses for flat panel and x-ray tube products.

Selling, General and Administrative

 

     Three Months Ended     Nine Months Ended  
(Dollars in millions)    July 1,
2011
    July 2,
2010
    Percent
Change
    July 1,
2011
    July 2,
2010
    Percent
Change
 

Selling, general and administrative

   $ 94.9      $ 84.7        12   $ 280.1      $ 247.8        13

As a percentage of total revenues

     14.6     14.7       14.9     14.5  

The $10.2 million increase in selling, general and administrative expenses for the third quarter of fiscal year 2011 compared to the third quarter of fiscal year 2010 was primarily attributable to: (a) unfavorable foreign currency impact of $3.3 million as the foreign currency denominated selling, general and administrative expenses of our foreign operations were translated into weaker U.S. dollars; (b) a $2.8 million increase in employee-related costs and headcount to support our growing business activities; (c) a $2.1 million increase in product promotion expenses and fees for certain commission arrangements, which were primarily tied to growth in Oncology Systems revenue; (d) a $1.2 million increase in bad debt expense and (e) a $0.9 million increase in depreciation and facility expenses primarily related to a Palo Alto, California facility that was placed in service in the first quarter of fiscal year 2011 These increases were partially offset by income of $0.3 million, versus a loss of $1.7 million in the year-ago quarter, recognized on the equity investment in dpiX Holding LLC (“dpiX Holding”).

The $32.3 million increase in selling, general and administrative expenses for the first nine months of fiscal year 2011 compared to the first nine months of fiscal year 2010 was primarily attributable to: (a) a $17.5 million increase in employee-related costs and headcount to support our growing business activities; (b) an $8.7 million net increase in legal expenses and accruals for contingent legal liabilities; (c) unfavorable foreign currency impact of $3.7 million as the foreign currency denominated selling, general and administrative expenses of our foreign operations were translated into weaker U.S. dollars;

 

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(d) a $3.1 million increase in depreciation and facilities expenses primarily related to a Palo Alto, California facility that was placed in service in the first quarter of fiscal year 2011; and (e) a $2.7 million increase in product promotions and fees for certain commission arrangements, which were primarily tied to growth in Oncology Systems revenue. These increases were partially offset by: (i) income of $4.5 million, versus a loss of $0.4 million in the first nine months of fiscal year 2010, recognized on the equity investment in dpiX Holding and (ii) the inclusion in the year-ago period of $3.0 million related to an October 2009 reduction in force.

Interest Income (Expense), Net

 

     Three Months Ended      Nine Months Ended  
(Dollars in millions)    July 1,
2011
     July 2,
2010
    Percent
Change
     July 1,
2011
     July 2,
2010
    Percent
Change
 

Interest income (expense), net

   $ 0.1       $ (0.8     n/a       $ 0.2       $ (1.5     n/a   

For the third quarter and the first nine months of fiscal year 2011, the net increases in interest income, net, over the respective year-ago periods were primarily due to lower interest expenses associated with lower levels of long-term debt compared to the third quarter and the first nine months of fiscal year 2010.

Taxes on Earnings

 

     Three Months Ended     Nine Months Ended  
     July 1,
2011
    July 2,
2010
    Percent
Change
    July 1,
2011
    July 2,
2010
    Percent
Change
 

Effective tax rate

     29.9     29.2     0.7     30.5     31.8     (1.3 %) 

Our effective tax rate on earnings from continuing operations was 29.9% for the third quarter of fiscal year 2011, compared to 29.2% for the third quarter of fiscal year 2010. The increase in our effective tax rate was primarily due to a shift in the geographic mix of earnings, partially offset by a net benefit for discrete items, primarily the release of certain liabilities for uncertain tax positions, including the expiration of the statutes of limitation in various jurisdictions and the favorable resolution of several income tax audits.

For the first nine months of fiscal year 2011, our effective tax rate on continuing operations was 30.5%, compared to 31.8% in the first nine months of fiscal year 2010. The decrease was primarily due to a net benefit for discrete items, primarily the release of certain liabilities for uncertain tax positions, including the expiration of the statutes of limitation in various jurisdictions and the favorable resolution of several income tax audits, and the benefit of the retroactive reinstatement of the federal research and development credit, partially offset by a shift in the geographic mix of earnings.

In general, our effective income tax rate differs from the U.S. federal statutory rate primarily because our foreign earnings are taxed at rates that are, on average, lower than the U.S. federal rate, and our domestic earnings are subject to state income taxes. Our future effective tax rate could be adversely affected by having lower earnings than anticipated in countries where we have lower statutory rates and higher earnings than anticipated in countries where we have higher statutory rates, by changes in the valuation of our deferred tax assets or liabilities, and by changes in tax laws or interpretations of those laws. For example, recent proposals would make significant changes to U.S. taxation of U.S.-based multinational corporations. Although we cannot predict whether or in what form Congress would enact any such proposals, legislation of this type could have an adverse impact on our effective tax rate. We also expect that our effective tax rate may experience increased fluctuation from period to period under the provisions in ASC 740 related to accounting for uncertainty in income taxes. Please refer to discussion in Note 12, “Income Taxes” of the Notes to the Consolidated Financial Statements in our 2010 Annual Report.

 

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Net Earnings Per Diluted Share

 

     Three Months Ended     Nine Months Ended  
     July 1,
2011
     July 2,
2010
     Percent
Change
    July 1,
2011
     July 2,
2010
     Percent
Change
 

Net earnings per diluted share

   $ 0.83       $ 0.74         12   $ 2.49       $ 2.10         19

The increase in net earnings from continuing operations per diluted share in the third quarter of fiscal year 2011 over the third quarter of fiscal year 2010 resulted from (i) an increase in total revenues and (ii) a reduction in the number of diluted shares of common stock outstanding due mainly to the accelerated stock repurchase programs that were executed in the fourth quarter of 2010 and in the second quarter of fiscal year 2011, partially offset by (a) a decrease in gross margin and (b) an increase in effective tax rate.

The increase in net earnings from continuing operations per diluted share in the first nine months of fiscal year 2011 over the first nine months of fiscal year 2010 resulted from (i) an increase in total revenues, (ii) an improvement in gross margin, (iii) a decrease in effective tax rate and (iv) a reduction in the number of diluted shares of common stock outstanding due mainly to the accelerated stock repurchase programs that were executed in the fourth quarter of 2010 and in the second quarter of fiscal year 2011.

Net Orders

 

Total Net Orders (by segment and region)    Three Months Ended     Nine Months Ended  
(Dollars in millions)    July 1,
2011
     July 2,
2010
     Percent
Change
    July 1,
2011
     July 2,
2010
    Percent
Change
 

Oncology Systems:

               

North America

   $ 244.8       $ 245.4         (0 %)    $ 697.0       $ 635.4        10

Total International

     308.4         261.2         18     835.3         783.9        7
  

 

 

    

 

 

      

 

 

    

 

 

   

Total Oncology Systems

   $ 553.2       $ 506.6         9   $ 1,532.3       $ 1,419.3        8
  

 

 

    

 

 

      

 

 

    

 

 

   

X-ray Products:

               

North America

   $ 42.3       $ 39.2         8   $ 109.2       $ 85.5        28

Total International

     78.6         64.0         23     247.3         221.4        12
  

 

 

    

 

 

      

 

 

    

 

 

   

Total X-ray Products

   $ 120.9       $ 103.2         17   $ 356.5       $ 306.9        16
  

 

 

    

 

 

      

 

 

    

 

 

   

Other:

   $ 17.2       $ 19.5         (12 %)    $ 76.8       $ (8.1     1052
  

 

 

    

 

 

      

 

 

    

 

 

   

Total Net Orders:

   $ 691.3       $ 629.3         10   $ 1,965.6       $ 1,718.1        14
  

 

 

    

 

 

      

 

 

    

 

 

   

For the third quarter of fiscal year 2011, Oncology Systems net orders grew 9%, or 5% on a constant currency basis, over the third quarter of fiscal year 2010, due to increased net orders in the international region while North American Oncology Systems net orders remained flat.

The growth in international Oncology Systems net orders in the third quarter of fiscal year 2011 over the year-ago quarter was primarily due to growth in all international regions in demand for our high energy linear accelerators (including the TrueBeam system) and our service contracts. When measured in constant currency, international Oncology Systems net orders grew 9% in the third quarter of fiscal year 2011 over the third quarter of fiscal year 2010. In North America, the growth in Oncology Systems service contract net orders was offset by declines in Oncology Systems net orders across most product lines.

For the first nine months of fiscal year 2011, Oncology Systems grew 8%, or 6% on a constant currency basis, over the first nine months of fiscal year 2010, primarily due to increased net orders in both North America and the international region. The growth in North American Oncology Systems net orders in the first nine months of fiscal year 2011 over the year-ago period, helped in part by strong net orders growth in Canada, was primarily due to increased demand for our high energy

 

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linear accelerators (including the TrueBeam system) and software upgrades, as well as growth in demand for our service contracts. The growth in international Oncology Systems net orders in the first nine month of fiscal year 2011 over the year-ago period was primarily due to increased demand for our high energy linear accelerators (including the TrueBeam system) in Europe and the rest of the world region, partially offset by a decline in demand for our high energy linear accelerators in Asia, where a supplemental spending program in Japan contributed to very high orders levels in the first half of fiscal year 2010. Growth in demand for our service contracts and software upgrades in all international regions also contributed to the growth in international Oncology Systems net orders in the first nine months of fiscal year 2011 over the year-ago period. When measured in constant currency, international Oncology Systems net orders grew 4% in the first nine months of fiscal year 2011 over the first nine months of fiscal year 2010.

The trailing 12 months growth in net orders for Oncology Systems at the end of the third quarter of fiscal year 2011 and at the end of the previous three fiscal quarters were: a 10% total increase, with a 14% increase in North America and a 7% increase for the international region, as of July 1, 2011; a 10% total increase, with an 18% increase in North America and a 4% increase for the international region, as of April 1, 2011; a 10% total increase, with an 11% increase in North America and a 10% increase for the international region, as of December 31, 2010; a 10% total increase, with a 4% increase in North America and a 16% increase for the international region, as of October 1, 2010; Consistent with the historical pattern, we expect that Oncology Systems net orders will continue to experience regional fluctuations. In addition, the availability of government programs that stimulate the purchase of healthcare products, such as the one in place in 2010 in Japan, could affect the demand for our products from period to period, and could therefore make it difficult to compare our financial results.

In the third quarter of fiscal year 2011, both the international region and North America contributed to the increase in X-ray Products net orders over the year-ago quarter. The increase in international X-ray Products net orders was primarily due to an increase in net orders for flat panel products in Asia and Europe and an increase in net orders for x-ray tubes in Asia. The increase in North American X-ray Products net orders was primarily due to an increase in net orders for both our flat panel products and our x-ray tube products.

For the first nine months of fiscal year 2011, the increase in X-ray Products net orders was primarily due to an increase in both international and North American net orders. The increase in international X-ray Products net orders was primarily due to increased demand for flat panel products in Europe and increased demand for x-ray tube products in Asia, partially offset by a decline in net orders for flat panel products in Asia. Increased demand for both the x-ray tube products and the flat panel products contributed the increase in North American X-ray Products net orders.

Net orders in the “Other” category decreased $2 million in the third quarter of fiscal year 2011 from the third quarter of fiscal year 2010 primarily due to a decrease in net orders for SIP products. For the first nine months of fiscal year 2011, net orders in the “Other” category increased $85 million from the first nine months of fiscal year 2010 when we reversed a $62 million proton therapy system order from Skandion Kliniken in Sweden. Excluding the reversal of the proton therapy system order, net orders in the “Other” category increased $23 million in the first nine months of fiscal year 2011 compared to the year-ago period primarily because SIP booked a $21 million order from U.S. Customs and Border Protection for five of our IntellX cargo screening systems.

Orders in any period may not be directly correlated to the level of revenues in any particular future quarter or period since the timing of revenue recognition will vary significantly based on the delivery requirements of individual orders, acceptance schedules and the readiness of individual customer sites for installation of our products. Moreover, certain types of orders, such as software or newly introduced products in our Oncology Systems segment, typically take more time from order to completion of installation and acceptance than hardware or older products.

Discontinued Operations

We sold Research Instruments in the second quarter of fiscal year 2009. Research Instruments has been classified as a discontinued operation in our Condensed Consolidated Statements of Earnings for all periods presented. Research Instruments was previously included in the “Other” category. We did not have any profit or loss and did not recognize any revenues in discontinued operations for the three and nine months ended July 1, 2011. For the three months ended July 2, 2010, we accrued an additional loss of $6.5 million related to the estimated costs to complete and settle two customer contracts, which were related to the sale of Research Instruments. These contracts had been accounted for under the percentage-of-completion method, under which revenues and costs of sales are adjusted to reflect changes in estimated costs to complete the contracts. Including the additional loss recognized for the two contracts, total losses of Research Instruments

 

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for the third quarter and the first nine months of fiscal year 2010 were both $6.5 million, less applicable income tax of zero. Total revenues reported in discontinued operations for the third quarter and the first nine months of fiscal year 2010, were $(3.8) million and $(3.6) million, respectively.

As of July 1, 2011, we retained one Research Instruments customer contract. If the estimated loss to complete or settle the remaining contract increases, the variance will be recognized in the periods these variances arise. See Note 18, “Discontinued Operations” to the Condensed Consolidated Financial Statements for a detailed discussion.

Backlog

At July 1, 2011, our backlog was $2.3 billion, which is an increase of 10% over the backlog at July 2, 2010. Our Oncology Systems backlog at July 1, 2011 was 11% higher than the backlog at July 2, 2010, which reflects an 8% increase for North America and a 16% increase for the international region.

Liquidity and Capital Resources

Liquidity is the measurement of our ability to meet potential cash requirements, including ongoing commitments to repay borrowings, acquire businesses, repurchase VMS stock, and fund continuing operations. Our sources of cash have included operations, borrowings, stock option exercises and employee stock purchases (although no purchases under our employee stock purchase plan were made during fiscal year 2010) and interest income. Our cash usage is actively managed on a daily basis to ensure the maintenance of sufficient funds to meet our needs. Because Research Instruments’ cash flows were not material for any period presented, we have not segregated them from continuing operations on our Consolidated Statements of Cash Flows and the discussion herein.

Cash and Cash Equivalents

The following table summarizes our cash and cash equivalents:

 

(In millions)    July 1,
2011
     October 1,
2010
     Increase/
(Decrease)
 

Cash and cash equivalents

   $ 568       $ 520       $ 48   

Our cash and cash equivalents increased $48 million from $520 million at October 1, 2010 to $568 million at July 1, 2011. The increase in cash and cash equivalents in the first nine months of fiscal year 2011 was due primarily to $327 million of cash generated from operating activities, $133 million of cash provided by stock option exercises and $22 million of cash provided by the excess tax benefits from share-based compensation. These increases were partially offset by $238 million used for the repurchase of VMS common stock and $68 million for related equity forward contracts, $52 million of capital expenditures, $20 million of cash used for net repayments under our credit facilities, $15 million used for investment in a minority equity interest plus an exclusive option to purchase the remaining equity interest of Augmenix, $14 million used to satisfy employee tax withholding requirements for employees who tendered VMS stock upon vesting of restricted common stock and restricted stock units, $8 million used for the acquisition of all of the outstanding capital stock of a company and $8 million for a loan to a customer. In addition, foreign currency exchange rate changes in the first nine months of fiscal year 2011 decreased cash and cash equivalents by $3 million.

At July 1, 2011, we had approximately $5 million, or 1%, of total cash and cash equivalents in the United States. Approximately $563 million, or 99%, of total cash and cash equivalents was held abroad and could be subject to additional taxation if it were repatriated to the United States. As of July 1, 2011, most of our cash and cash equivalents that were held abroad were in U.S. dollars. Because our cash levels in the United States are relatively low, we have used our credit facilities to meet our cash needs from time to time and expect to continue to do so in the future. Borrowings under our credit facilities may be used for working capital, capital expenditures, stock repurchases, acquisitions and other corporate purposes.

 

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Cash Flows

 

     Nine Months Ended  
(In millions)    July 1,
2011
    July 2,
2010
 

Net cash flow provided by (used in):

    

Operating activities

   $ 327      $ 293   

Investing activities

     (85     (56

Financing activities

     (191     (209

Effects of exchange rate changes on cash and cash equivalents

     (3     6   
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

   $ 48      $ 34   
  

 

 

   

 

 

 

Our primary cash inflows and outflows for the first nine months of fiscal year 2011, as compared to the first nine months of fiscal year 2010, were as follows:

 

   

In the first nine months of fiscal year 2011, we generated net cash from operating activities of $327 million, compared to $293 million for the first nine months of fiscal year 2010. The $34 million increase in net cash from operating activities during the first nine months of fiscal year 2011 compared to the first nine months of fiscal year 2010 was driven primarily by an increase of $43 million in net earnings and an increase in non-cash items of $19 million partially offset by a net decrease of $28 million as a result of changes to operating assets and liabilities (working capital items) between the two nine-month periods.

During the first nine months of fiscal year 2011, the major contributors to the net change in working capital items from fiscal year end 2010 were inventories, advance payments from customers, accounts receivable, deferred revenues, other long-term liabilities and prepaid expense and other current assets as follows:

 

   

Inventories increased by $68 million due to anticipated customer demand for products during fiscal year 2011.

 

   

Advance payments from customers increased $41 million due to increased orders.

 

   

Accounts receivable decreased $25 million due to strong collection performance in the first nine months of fiscal year 2011.

 

   

Deferred revenues decreased by $11 million primarily due to timing of revenue recognized based on customer acceptance of our Oncology Systems products.

 

   

Other long-term liabilities decreased by $10 million primarily due to a decrease in long-term income taxes payable as a result of the expiration of the statutes of limitation in various jurisdictions and the favorable resolution of several income tax audits.

 

   

Prepaid expenses and other current assets increased $25 million primarily due to timing of expense payments.

We expect that cash provided by operating activities may fluctuate in future periods as a result of a number of factors, including fluctuations in our operating results, timing of product shipments and customer acceptance, accounts receivable collections, inventory management, and the timing and amount of tax and other payments. For additional discussion, please refer to the “Risk Factors” in Item 1A.

 

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We used $85 million for investing activities in the first nine months of fiscal year 2011, compared to $56 million used in the first nine months of fiscal year 2010. Cash used for purchases of property, plant and equipment was $52 million for the first nine months of fiscal year 2011 and $50 million for the first nine months of fiscal year 2010. During the first nine months of fiscal year 2011, we paid $15 million to Augmenix for a minority equity interest plus an exclusive option to purchase the remaining equity interest of Augmenix, paid cash of $8 million for the acquisition of all of the outstanding capital stock of a company and used $8 million for a loan to a customer.

 

   

Net cash used in financing activities was $191 million in the first nine months of fiscal year 2011, compared to $209 million in the first nine months of fiscal year 2010. During the first nine months of fiscal year 2011, we used $238 million for the repurchase of VMS common stock and $68 million for related equity forward contracts, $20 million for net repayments under our line of credit agreements, $14 million to satisfy employee tax withholding requirements for employees who tendered VMS stock upon vesting of restricted common stock and restricted stock units and $5 million for repaying banking borrowings. These uses were partially offset by $133 million of proceeds from employee stock option exercises and employee stock purchases and $22 million in excess tax benefits from share-based compensation. During the first nine months of fiscal year 2010, we used $243 million to repurchase shares of VMS common stock, $9 million for repaying bank borrowings, $7 million for tendered VMS common stock to satisfy employee tax withholding requirements upon vesting of restricted common stock and restricted stock units and $4 million for net repayment under our credit facility. Partially offsetting these uses were proceeds of $46 million from employee stock option exercises and $9 million in excess tax benefits from share-based compensation.

We expect our capital expenditures, which typically represent construction and/or purchases of facilities, manufacturing equipment, office equipment and furniture and fixtures, as well as capitalized costs related to the implementation of software applications, will be approximately 3% of revenues in fiscal year 2011.

We have a $225 million credit facility with Bank of America, N.A. (“BofA”), which was amended and restated in November 2008 and then again amended in July 2009 and in August 2010. This credit facility, as amended to date, is referred to as the “Amended BofA Credit Facility.” A portion of the Amended BofA Credit Facility is collateralized with a pledge of stock of certain of VMS’s present and future subsidiaries that are deemed to be material subsidiaries. As of July 1, 2011, VMS has pledged to BofA 65% of the voting shares that it holds in Varian Medical Systems Nederland B.V., a wholly-owned subsidiary. Under the Amended BofA Credit Facility, VMS’s Japanese subsidiary (“VMS KK”) can borrow up to 2.7 billion Japanese Yen as part of the overall credit facility (the “Japanese Line of Credit”). At any time amounts are outstanding under the Japanese Line of Credit, the full borrowing capacity is deemed committed for use in Japan and therefore the maximum amount VMS can otherwise borrow under the Amended BofA Credit Facility will be reduced by $35 million to $190 million. VMS guarantees the payment of the outstanding balance under the Japanese Line of Credit.

The Amended BofA Credit Facility may be used for working capital, capital expenditures, permitted VMS share repurchases, permitted acquisitions and other lawful corporate purposes. Borrowings under the Japanese Line of Credit can be used by VMS KK for refinancing certain intercompany debts, working capital, capital expenditures and other lawful corporate purposes. Borrowings under the Amended BofA Credit Facility (outside of the Japanese Line of Credit) accrue interest either (i) based on the London Interbank Offered Rate (“LIBOR”) plus a margin of 1.25% to 1.50% based on a leverage ratio involving funded indebtedness and earnings before interest, taxes, depreciation and amortization (“EBITDA”) or (ii) based upon a base rate of either the federal funds rate plus 0.5% or BofA’s announced prime rate, whichever is greater, minus a margin of 0.5% to 0% based on a leverage ratio involving funded indebtedness and EBITDA (depending upon our instructions to BofA). We may select borrowing periods of one, two, three or six months for advances based on the LIBOR rate. Interest rates on advances based on the base rate are adjustable daily. Under the Amended BofA Credit Facility, we pay commitment fees at an annual rate of 0.2% to 0.3% based on a leverage ratio involving funded indebtedness and EBITDA. Borrowings under the Japanese Line of Credit accrue interest at the basic loan rate announced by the Bank of Japan plus a margin of 1.25% to 1.50% based on a leverage ratio involving funded indebtedness and EBITDA. The Amended BofA Credit Facility, as well as the Japanese Line of Credit, will expire on November 10, 2011, if not extended by mutual agreement of VMS and BofA.

As of July 1, 2011, there was no outstanding balance under the Amended BofA Credit Facility. Up to $25 million of the Amended BofA Credit Facility can be used to support letters of credit issued on our behalf, of which none were outstanding as of July 1, 2011.

The Amended BofA Credit Facility contains customary affirmative and negative covenants for facilities of this type. We have also agreed to maintain certain financial covenants relating to (i) leverage ratios involving funded indebtedness and EBITDA, (ii) liquidity and (iii) consolidated assets. As of July 1, 2011, we were in compliance with all covenants. See also Note 8 “Credit Facilities” to the Condensed Consolidated Financial Statements for a discussion regarding the Amended BofA Credit Facility.

 

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In March 2011, VMS KK entered into an unsecured overdraft agreement with Sumitomo Mitsui Banking Corporation which enable the VMS KK to borrow and have outstanding at any given time a maximum of 500 million Japanese Yen (the “Japanese Overdraft Facility”). Borrowings under the Japanese Overdraft Facility accrue interest at 0.81% per annum. The Japanese Overdraft Facility expired on June 30, 2011.

During the first nine months of fiscal year 2011, the amount outstanding under our credit facilities reached $119 million, which was primarily used to finance an accelerated share repurchase agreement executed in February 2011.

Our liquidity is affected by many factors, some of which result from the normal ongoing operations of our business, some of which arise from uncertainties and conditions in the United States and global economies and some of which result from strategic decisions, such as the acquisitions of businesses or the repurchase of VMS common stock. Although our cash requirements will fluctuate as a result of the shifting influences of these factors, we believe that existing cash and cash equivalents and cash to be generated from operations and current or future credit facilities will be sufficient to satisfy anticipated commitments for capital expenditures and other cash requirements for the next 12 months. We currently anticipate that we will continue to utilize our available liquidity and cash flows from operations, as well as borrowed funds, to make strategic acquisitions, invest in the growth of our business, invest in advancing our systems and processes and repurchase VMS common stock.

Total debt as a percentage of total capital decreased to 1.2% at July 1, 2011 from 3.3% at October 1, 2010 primarily due to the repayments under our credit facilities. The ratio of current assets to current liabilities increased to 1.97 to 1 at July 1, 2011 from 1.86 to 1 at October 1, 2010.

Days Sales Outstanding

Trade accounts receivable days sales outstanding (“DSO”) were 81 days at July 1, 2011 compared to 80 days at July 2, 2010. Our accounts receivable and DSO are impacted by a number of factors, primarily including: the timing of product shipments; collections performance; payment terms; and the mix of revenues from different regions. As of July 1, 2011, less than 2% of our accounts receivable balance was related to customer contracts with remaining terms of more than one year.

Stock Repurchase Program

During the three months ended April 1, 2011, we settled an accelerated share repurchase agreement executed on August 24, 2010 with BofA (the “August 2010 Repurchase Agreement”). Pursuant to the August 2010 Repurchase Agreement, we initially paid to BofA $225 million and BofA delivered 3,888,249 shares of VMS common stock, representing approximately 90% of the shares expected to be repurchased based on the closing price of VMS common stock of $52.08 on August 24, 2010. Under the terms of the August 2010 Repurchase Agreement, the specific number of shares that we ultimately repurchased was to be based on the volume weighted average share price of VMS common stock during the repurchase period, less a discount, such that we might be entitled to receive additional shares of VMS common stock from BofA or we might be required to deliver VMS shares or, at our option, make a cash payment to BofA. The repurchase period ended on February 23, 2011 and we made a cash payment of $26.1 million to settle this contract without receiving or delivering additional VMS shares in March 2011.

On February 23, 2011, we entered into another accelerated share repurchase agreement with BofA (the “February 2011 Repurchase Agreement”). Pursuant to the February 2011 Repurchase Agreement, we paid to BofA $280 million and BofA delivered 3,547,474 shares of VMS common stock, representing approximately 85% of the shares expected to be repurchased based on the closing price of VMS common stock of $67.09 on February 23, 2011. Under the terms of the February 2011 Repurchase Agreement, the specific number of shares that we ultimately repurchased was to be based on the volume weighted average share price of VMS common stock during the repurchase period, less a discount. In June 2011, BofA accelerated the end of the repurchase period and we received additional 630,921 shares of VMS common stock, with a then market value of approximately $41.3 million, upon the settlement of the February 2011 Repurchase Agreement.

During the nine months ended July 1, 2011, we repurchased 4,178,395 shares of VMS common stock (all of which was purchased under the February 2011 Repurchase Agreement), of which 630,921 shares were repurchased for no additional consideration during the three months ended July 1, 2011 in connection with the settlement of the February 2011 Repurchase Agreement. During the nine months ended July 2, 2010, we paid $242.6 million to repurchase 4,950,000 shares of VMS

 

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common stock, of which $115.9 million was paid during the three months ended July 2, 2010 to repurchase 2,250,000 shares. All shares that were repurchased have been retired. In February 2011, our Board of Directors authorized the repurchase of an additional 12 million shares of VMS common stock through the end of our fiscal year 2012. As of July 1, 2011, 12,283,356 shares of VMS common stock remained available for repurchase under this and a prior repurchase authorization. Shares may be repurchased in the open market, in privately negotiated transactions or under Rule 10b5-1 share repurchase plans, and may be made from time to time or in one or more large blocks, including accelerated share repurchase arrangements.

Contractual Obligations

Long-term income taxes payable includes the liability for uncertain tax positions (including interest and penalties) and may also include other long-term tax liabilities. As of July 1, 2011, our liability for uncertain tax positions was $48.9 million. We believe that existing cash and cash equivalents and cash to be generated from operations and current or future credit facilities will be sufficient to satisfy any payment obligations that may arise related to our liability for uncertain tax positions.

In February 2009, we agreed to loan up to $14 million to dpiX LLC (“dpiX”) in four separate installments over a period through the first half of fiscal year 2010, which period could be extended. As of July 1, 2011, we had loaned $8.8 million to dpiX under this loan agreement and we do not know the timing of the funding of the remaining $5.2 million. Please refer to the more detailed discussion in Note 6, “Related Party Transactions” to the Condensed Consolidated Financial Statements.

Except for the changes in the outstanding balance under our credit facilities and the other items discussed above, there has been no significant changes to the other contractual obligations we reported in our 2010 Annual Report.

Contingencies

Environmental Remediation Liabilities

For a discussion of environmental remediation liabilities, see Note 10, “Commitments and Contingencies - Environmental Remediation Liabilities” to the Condensed Consolidated Financial Statements, of which discussion is incorporated herein by reference.

Acquisition-Related Commitments/Obligations

When we acquired ACCEL Instruments GmbH (“ACCEL,” which has since changed its name to Varian Medical Systems Particle Therapy GmbH) in January 2007, ACCEL was involved in a contract-related lawsuit, which we settled by agreeing to perform certain services for a fixed price contract (the “Fixed Price Contract”). As of October 2, 2009, we had a loss accrual of €7.6 million related to the Fixed Price Contract. In the first quarter of fiscal year 2010, we entered into a new contract (the “New Contract”) to perform certain services for a fixed price and we recorded a loss accrual of €0.9 million in connection with the New Contract. As of July 1, 2011, the balance of the loss accrual related to this contingency was €1.0 million. If the actual costs related to the contingency (the New Contract) exceed the estimated amount or if the estimated loss increases, the variances will be recognized in the Condensed Consolidated Statement of Earnings in the periods in which these variances arise.

Other Matters

From time to time, we are a party to or otherwise involved in legal proceedings, claims and government inspections or investigations and other legal matters both in and outside the United States, arising in the ordinary course of our business or otherwise. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. We accrue amounts, to the extent they can be reasonably estimated, that we believe are adequate to address any liabilities related to legal proceedings and other loss contingencies that we believe will result in a probable loss. While we cannot assure you as to the ultimate outcome of any legal proceeding or other loss contingency involving us, management does not believe any pending matter will be resolved in a manner that would have a material adverse effect on our consolidated financial position, results of operations or cash flows. However, it is possible that a legal or other proceeding brought against us could have an impact of this nature.

 

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Off-Balance Sheet Arrangements

In conjunction with the sale of our products in the ordinary course of business, we provide standard indemnification of business partners and customers for losses suffered or incurred for property damages, death and injury and for patent, copyright or any other intellectual property infringement claims by any third parties with respect to our products. The terms of these indemnification arrangements are generally perpetual. Except for losses related to property damages, the maximum potential amount of future payments we could be required to make under these arrangements is unlimited. As of July 1, 2011, we have not incurred any significant costs since the spin-offs of Varian, Inc. and Varian Semiconductor Equipment Associates, Inc. to defend lawsuits or settle claims related to these indemnification arrangements. As a result, we believe the estimated fair value of these arrangements is minimal.

We have entered into indemnification agreements with our directors and officers and certain of our employees that serve as officers or directors of our foreign subsidiaries that may require us to indemnify our directors and officers and those certain employees against liabilities that may arise by reason of their status or service as directors or officers, and to advance their expenses incurred as a result of any legal proceeding against them as to which they could be indemnified.

Recent Accounting Pronouncements

In June 2011, the Financial Accounting Standards Board (“FASB”) amended ASC 220, “Presentation of Comprehensive Income.” This amendment will require companies to present the components of net income and other comprehensive income either as one continuous statement or as two consecutive statements. It eliminates the option to present components of other comprehensive income as part of the statement of changes in stockholders’ equity. The amended guidance, which must be applied retroactively, will be effective for us in the second quarter of fiscal year 2012. The adoption of this amendment concerns disclosure only and we do not expect it to have an impact on our consolidated financial position, results of operations or cash flows.

In May 2011, the FASB amended ASC 820, “Fair Value Measurement.” This amendment is intended to result in convergence between GAAP and International Financial Reporting Standards requirements for measurement of and disclosures about fair value. This guidance clarifies the application of existing fair value measurements and disclosures, and changes certain principles or requirements for fair value measurements and disclosures. The amendment will be effective for us in the second quarter of fiscal year 2012. We are currently assessing the potential impact, if any, this amendment may have on our consolidated financial position, results of operations and cash flows.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are exposed to three primary types of market risks: credit risk, foreign currency exchange rate risk and interest rate risk.

Credit Risk

We are exposed to credit loss in the event of nonperformance by counterparties on the foreign currency forward contracts used in hedging activities. These counterparties are large international and regional financial institutions and to date, no such counterparty has failed to meet its financial obligation to us under such contracts. In addition, cash and cash equivalents held with financial institutions may exceed the Federal Deposit Insurance Corporation insurance limits or similar limits in foreign jurisdictions. We also may need to rely on the credit facility described below under “Interest Rate Risk”. Our access to our cash and cash equivalents or ability to borrow could be reduced if one or more financial institutions with which we have deposits or from which we borrow should fail or otherwise be adversely impacted by conditions in the financial or credit markets. Conditions such as those we experienced as a result of the economic downturn of 2008 and 2009 and accompanying contraction in the credit markets heighten these risks.

Foreign Currency Exchange Rate Risk

As a global entity, we are exposed to movements in foreign currency exchange rates. These exposures may change over time as business practices evolve. Adverse movements could have a material negative impact on our financial results. Our primary exposures related to foreign currency denominated sales and purchases are in Europe, Asia, Australia and Canada.

We have many transactions denominated in foreign currencies and address certain of those financial exposures through a risk management program that includes the use of derivative financial instruments. We sell products throughout the world, often in the currency of the customer’s country, and may hedge certain of these larger foreign currency transactions when they are

 

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not transacted in the subsidiaries’ functional currency. The foreign currency sales transactions that fit our risk management policy criteria are hedged with forward contracts. We may use other derivative instruments in the future. We enter into foreign currency forward contracts primarily to reduce the effects of fluctuating foreign currency exchange rates. We do not enter into forward contracts for speculative or trading purposes. The forward contracts range from one to twelve months in maturity.

We also hedge the balance sheet exposures from our various foreign subsidiaries and business units. We enter into foreign currency forward contracts to minimize the short-term impact of currency fluctuations on assets and liabilities denominated in currencies other than the U.S. dollar functional currency.

The notional values of our sold and purchased foreign currency forward contracts outstanding as of July 1, 2011 were $198.3 million and $54.0 million, respectively. The notional amounts of forward contracts are not a measure of our exposure. The fair value of forward contracts generally reflects the estimated amounts that we would receive or pay to terminate the contracts at the reporting date, thereby taking into account and approximating the current unrealized and realized gains or losses of the open contracts. A move in foreign currency exchange rates would change the fair value of the contracts, and the fair value of the underlying exposures hedged by the contracts would change in a similar offsetting manner.

Interest Rate Risk

Our market risk exposure to changes in interest rates depends primarily on our investment portfolio and short-term borrowings. Our investment portfolio consisted of cash and cash equivalents as of July 1, 2011. The principal amount of cash and cash equivalents at July 1, 2011 totaled $568 million with a weighted average interest rate of 0.28%.

The Amended BofA Credit Facility (including the Japanese Line of Credit) allows us to borrow up to a maximum amount of $225 million. Borrowings under the Amended BofA Credit Facility (outside of the Japanese Line of Credit) accrue interest based on (a) LIBOR plus a margin, or (b) the federal funds rate plus 0.5% or BofA’s prime rate, whichever is greater, minus a margin. Borrowings under the Japanese Line of Credit accrue interest at the basic loan rate announced by the Bank of Japan plus a margin.

We are affected by market risk exposure primarily through the effect of changes in interest rates on amounts payable under the Amended BofA Credit Facility (including the Japanese Line of Credit). As of July 1, 2011, there was no outstanding balance under the Amended BofA Credit Facility. See a detailed discussion of our credit facilities under “Liquidity and Capital Resources” section in Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

In addition, we had $17.9 million of long-term debt (including the current maturities of long-term debt) outstanding as of July 1, 2011 that was carried at a weighted average fixed interest rate of 6.9%, with principal payments due in various installments over a three-year period. To date, we have not used derivative financial instruments to hedge the interest rate of our investment portfolio, short-term borrowings or long-term debt, but may consider the use of derivative instruments in the future.

The estimated fair value of our cash and cash equivalents (99% of which was held abroad at July 1, 2011 and could be subject to additional taxation if it were repatriated to the United States) and the estimated fair value of our short-term borrowings under the credit facility approximated the principal amounts reflected above based on the maturities of these financial instruments.

Although payments under certain of our operating leases for our facilities are tied to market indices, these operating leases do not expose us to material interest rate risk.

 

Item 4. Controls and Procedures

 

(a) Disclosure controls and procedures. Based on the evaluation of our disclosure controls and procedures (as defined in the Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) required by Exchange Act Rules 13a-15(b) or 15d-15(b), our principal executive officer and principal financial officer have concluded that as of the end of the period covered by this report, our disclosure controls and procedures were effective to ensure that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms, and include controls and procedures designed to ensure that information required to be disclosed by us in such reports is accumulated and communicated to our management, including the principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

 

(b) Changes in internal control over financial reporting. There were no changes in our internal control over financial reporting that occurred during the third quarter of fiscal year 2011 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II

OTHER INFORMATION

Item 1. Legal Proceedings

We are subject to various legal proceedings and claims that are discussed in Note 10, “Commitments and Contingencies” to the Condensed Consolidated Financial Statements, which discussion is incorporated by reference into this item.

Item 1A. Risk Factors

The following risk factors and other information included in this Quarterly Report on Form 10-Q and in our 2010 Annual Report should be carefully considered. Although the risk factors described below are the ones management deems significant, additional risks and uncertainties not presently known to us or that we presently deem less significant may also impair our business operations. If any of the following risks actually occur, our business, operating results, and financial condition could be adversely affected.

IF OUR PRODUCTS AND PRODUCT LINES FAIL TO CONTINUE TO MEET CUSTOMER DEMANDS, OUR PRODUCTS MAY BECOME LESS USEFUL OR OBSOLETE AND OUR OPERATING RESULTS WILL SUFFER

We believe that IMRT, including VMAT, and IGRT have become accepted standards for treatment in the radiation oncology market. Demand for our IMRT and IGRT products have been historical drivers for our net orders and revenues in Oncology Systems and, because of the significance of Oncology Systems, on our business in general. We recently introduced UNIQUE, a low-energy linear accelerator for more price sensitive markets in international regions, and TrueBeam, a new line of linear accelerators for radiotherapy and radiosurgery, to meet the evolving needs of our IMRT and IGRT customers. We believe TrueBeam will be a valuable tool for clinicians in the fight against cancer and we expect it will continue to stimulate faster replacement of older systems in our installed base. We also believe that our RapidArc products for VMAT, are a significant advance in IMRT treatments and can help drive longer term demand for our linear accelerators and IMRT- and IGRT-related products. Orders for these new products and products lines have contributed greatly to our recent orders growth and are keys to our future success. If our customers do not purchase these products or if future studies call into question the effectiveness of these or our other IMRT or IGRT products (including other VMAT products) or show negative side effects, or if other more effective technologies are introduced, our net orders, revenues and financial results could suffer. In addition, if third party information systems do not support our VMAT technology, customers that have third party information systems may not purchase our RapidArc products, which could negatively impact our net orders and revenues. As more institutions buy or upgrade to achieve these capabilities, the market for IMRT and IGRT products (including VMAT products) may become saturated. Alternatively, the marketplace may conclude that functions and features of our products should no longer be an element of a generally accepted diagnostic or treatment regimen. If this occurs, the market for our products may be adversely affected and they may become less useful or obsolete.

Our X-ray Products business sells products primarily to a small number of imaging system OEM customers who use our products in their medical diagnostic and industrial imaging systems. To succeed, we must provide x-ray tube and flat panel detector products that meet customer demands for lower cost, better product quality and superior technology and performance. If we are unable to continue to innovate our X-ray Products technology and anticipate our customers’ demands in the areas of cost, quality, technology and performance, then our customers may purchase from other tube or panel manufacturers (including the in-house operations of some of these customers), which would negatively impact this business.

In both the Oncology Systems and X-ray Products businesses, and in our other product lines, we may be unable to accurately anticipate changes in our markets and the direction of technological innovation and demands of our customers. Our competitors may develop products or processes that are superior to what we can then offer. If this occurs, the market for our products may be adversely affected and they may become less useful or obsolete. Any development adversely affecting the markets for our products would force us to reduce production volumes or to discontinue manufacturing one or more of our products or product lines and would reduce our revenues and earnings.

 

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OUR SUCCESS DEPENDS ON THE SUCCESSFUL DEVELOPMENT, INTRODUCTION AND COMMERCIALIZATION OF NEW GENERATIONS OF PRODUCTS AND ENHANCEMENTS TO EXISTING PRODUCT LINES

Rapid change and technological innovation characterize the Oncology Systems market. Our products often have long development and government approval cycles, so we must anticipate changes in the marketplace, in technology and in customer demands. Our success depends on the successful development, introduction and commercialization of new generations of products, treatment systems and enhancements to and/or simplification of existing product lines. Our Oncology Systems products, including new products such as TrueBeam and RapidArc, are technologically complex and must keep pace with, if not be superior to, the products of our competitors. Our X-ray Products business must also continually develop improved and lower cost products. We are making significant investments in long-term growth initiatives, such as development of our SIP and VPT businesses, and expect that we will need more investment to develop and commercialize the products and technology for these businesses. Accordingly, many of our products may require significant planning, design, development and testing, as well as significant capital commitments, involvement of senior management and other investments on our part. We may need to spend more time and money than we expect to develop and introduce new products or enhancements and, even if we succeed, they may not be sufficiently profitable that we are able to recover all or a meaningful part of our investment. Once introduced, new products may adversely impact orders and sales of our existing products, or make them less desirable or even obsolete, and could adversely impact our revenues and operating results. Compliance with regulations, competitive alternatives, and shifting market preferences may also impact our success with new products or enhancements.

Our ability to successfully develop and introduce new products and product enhancements and simplifications, and the revenues and costs associated with these efforts, are affected by our ability to:

 

   

properly identify customer needs;

 

   

prove the feasibility of new products;

 

   

limit the time required from proof of feasibility to routine production;

 

   

comply with internal quality assurance systems and processes timely and efficiently;

 

   

limit the timing and cost of regulatory approvals;

 

   

accurately predict and control costs associated with inventory overruns caused by phase-in of new products and phase-out of old products;

 

   

price our products competitively and profitably;

 

   

manufacture, deliver and install our products in sufficient volumes on time, and accurately predict and control costs associated with manufacturing, installation, warranty and maintenance of the products;

 

   

appropriately manage our supply chain;

 

   

manage customer acceptance and payment for products;

 

   

manage customer demands for retrofits of both new and old products; and

 

   

anticipate and compete successfully with competitors.

Furthermore, we cannot be sure that we will be able to successfully develop, manufacture or introduce new products, treatment systems or enhancements, the roll-out of which involves compliance with complex quality assurance processes, including the Quality System Regulation (“QSR”) of the Food and Drug Administration (“FDA”). Failure to complete these processes timely and efficiently could result in delays that could affect our ability to attract and retain customers, or could cause customers to delay or cancel orders, causing our revenues and operating results to suffer.

New products generally take longer to install than well-established products. Because a portion of a product’s revenue is generally tied to installation and acceptance of the product, our recognition of revenue associated with new products may be deferred longer than expected. In addition, even if we succeed in our product introductions, potential customers may not decide to upgrade their equipment, or customers may delay delivery of some of our more sophisticated products because of the longer preparation and renovation of treatment rooms required. As a result, our revenues and other financial results could be adversely affected.

 

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SLIGHTLY MORE THAN HALF OF OUR REVENUES ARE INTERNATIONAL, AND ECONOMIC, POLITICAL AND OTHER RISKS ASSOCIATED WITH INTERNATIONAL SALES AND OPERATIONS COULD ADVERSELY AFFECT OUR SALES OR MAKE THEM LESS PREDICTABLE

We conduct business globally. Our international revenues accounted for approximately 54% and 58% of revenues from continuing operations during the third quarter of fiscal years 2011 and 2010, respectively. As a result, we must provide significant service and support globally. We intend to continue to expand our presence in international markets and expect to expend significant resources in doing so, although we cannot be sure we will be able to meet our sales, service and support objectives or obligations, or recover our investments. Accordingly, our future results could be harmed by a variety of factors, including:

 

   

the difficulties in enforcing agreements and collecting receivables through many foreign country’s legal systems;

 

   

the longer payment cycles associated with many foreign customers;

 

   

the imposition by foreign countries of additional taxes, tariffs or other restrictions on foreign trade;

 

   

the lower sales prices and gross margins usually associated with sales of our products in international regions;

 

   

the longer period from shipment to revenue recognition that generally results in greater revenue recognition deferrals and higher backlog;

 

   

any inability to obtain export licenses and other required export or import licenses or approvals;

 

   

failure to comply with export laws and requirements which may result in civil or criminal penalties and restrictions on our ability to export our products, particularly our industrial linear accelerator products;

 

   

failure to obtain proper business licenses or other documentation, or to otherwise comply with local laws and requirements regarding marketing, sales, service or any other business we conduct in a foreign jurisdiction, which may result in civil or criminal penalties and restrictions on our ability to conduct business in a foreign jurisdiction;

 

   

changes in the political, regulatory, safety or economic conditions in a country or region; and

 

   

the possibility that it may be more difficult to protect our intellectual property in foreign countries.

Although our orders and sales fluctuate from period to period, in recent years our international region has represented a larger share of our business. The more we depend on sales in the international region, the more vulnerable we become to these factors.

As of July 1, 2011, 99% of our cash and cash equivalents were held abroad. If these funds were repatriated to the United States, they could be subject to additional taxation and our overall tax rate and our results of operations could suffer.

Our effective tax rate is impacted by tax laws in both the United States and in the respective countries in which our international subsidiaries do business. Earnings from our international region are generally taxed at rates lower than U.S. rates. A change in the percentage of our total earnings from the international region, or a change in the mix of particular tax jurisdictions within the international region could cause our effective tax rate to increase or decrease. Also, we are not currently taxed in the United States on certain undistributed earnings of certain foreign subsidiaries. These earnings could become subject to incremental foreign withholding or U.S. federal and state taxes should they either be deemed or actually remitted to the United States, or if tax laws change, in which case our financial results could be adversely affected. In addition, Congress has recently considered proposals that would significantly change U.S. taxation of U.S.-based multinational corporations. Although we cannot predict whether or in what form Congress would enact any such proposals, legislation of this type could negatively impact our effective tax rate and adversely affect our financial results.

 

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OUR RESULTS HAVE BEEN AND MAY CONTINUE TO BE AFFECTED BY THE WORLDWIDE ECONOMIC DOWNTURN

Since fiscal year 2008, the global economy has been impacted by the sequential effects of the subprime lending crisis; the credit market crisis; collateral effects on the finance and banking industries; volatile currency exchange rates and energy costs; concerns about inflation (deflation), slower economic activity, consumer confidence, corporate profits and capital spending, adverse business conditions, liquidity and unemployment. These conditions have shrunk capital equipment budgets, slowed decision-making, made financing for large equipment purchases more expensive and more time consuming to obtain, and made it difficult for our customers and our vendors to accurately forecast and plan future business activities. This, in turn, caused our customers to freeze or dramatically reduce purchases and capital project expenditures. Even with economic recovery, it has taken time for our customers to establish new budgets and may take more time for them to fully return to normal purchasing patterns. Weak economic recovery may also disrupt supply if vendors consolidate or go out of business. As with our customers and vendors, such conditions make it more difficult for us to accurately forecast and plan our future business activities. While we have seen some improvement, we cannot predict the strength or sustainability of an economic recovery, in general or specifically in the healthcare industry. Historically, our business has felt the effects of market trends later than other sectors in the healthcare industry, such as diagnostic radiology, and we may experience the effects of any economic recovery later than others in the healthcare industry. A continued weak or deteriorating healthcare market would inevitably adversely affect our business, financial conditions and results of operations. Also, while the economic downturn has primarily affected our business in North America, other economic turmoil, such as the banking and currency instability in certain European countries, may negatively affect our international business.

In addition, some countries, including Japan, have adopted government stimulus programs to revitalize their economies and improve healthcare and medical services. The availability of stimulus programs in the future could positively affect our results in one period and adversely affect our results in other periods, making it difficult for investors to compare our financial results between fiscal periods.

WE FACE SIGNIFICANT COSTS IN ORDER TO COMPLY WITH LAWS AND REGULATIONS APPLICABLE TO THE MANUFACTURE AND DISTRIBUTION OF OUR PRODUCTS, AND FAILURE OR DELAYS IN OBTAINING REGULATORY CLEARANCES OR APPROVALS, OR FAILURE TO COMPLY WITH APPLICABLE LAWS AND REGULATIONS COULD PREVENT US FROM DISTRIBUTING OUR PRODUCTS OR RESULT IN SIGNIFICANT PENALTIES

Our products and those of OEMs that incorporate our products are subject to extensive and rigorous government regulation in the United States. Compliance with these laws and regulations is expensive and time-consuming, and failure to comply with these laws and regulations could adversely affect our business. Furthermore, the public media reports on misadministrations and focus on the role of the FDA in regulating medical devices has led to increased scrutiny of medical device companies and an environment for a higher likelihood of enforcement actions.

U.S. laws governing marketing a medical device. In the United States, as a manufacturer and seller of medical devices and devices emitting radiation or utilizing radioactive by-product material, we and some of our suppliers and distributors are subject to extensive regulation by federal governmental authorities, such as the FDA, Nuclear Regulatory Commission (“NRC”) and state and local regulatory agencies, such as the State of California, to ensure the devices are safe and effective and comply with laws governing products which emit, produce or control radiation. Similar international regulations apply overseas. These regulations govern, among other things, the design, development, testing, manufacturing, packaging, labeling, distribution, import/export, sale and marketing and disposal of our products.

Unless an exception applies, the FDA requires that the manufacturer of a new medical device or a new indication for use of, or other significant change in, an existing medical device obtain either 510(k) pre-market notification clearance or pre-market approval (“PMA”) before we can market or sell those products in the United States. Modifications or enhancements to a product that could significantly affect its safety or effectiveness, or that would constitute a major change in the intended use of the device, technology, materials, labeling, packaging, or manufacturing process may also require a new 510(k) clearance. Obtaining clearances or approvals is time-consuming, expensive and uncertain. We may not be able to obtain the necessary clearances or approvals or may be unduly delayed in doing so, which could harm our business. Furthermore, even if we are granted regulatory clearances or approvals, they may include significant limitations on the indicated uses of the product, which may limit the market for those products. If we were unable to obtain required FDA clearance or approval for

 

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a product or unduly delayed in doing so, or the uses of that product were limited, our business would suffer. In the past, in the United States, our devices have generally been subject to 510(k) clearance or exempt from 510(k) clearance. The 510(k) clearance process is generally less time-consuming, expensive and uncertain than the PMA process. However, there are some in the regulatory field who believe that certain medical devices should be required to use the PMA approval process, or a special more time-consuming 510(k) clearance process, rather than the current 510(k) clearance process. If we were required to use either of these lengthy processes for future products or product modifications, it could delay or prevent release of the proposed products or modifications, which could harm our business. The FDA recently announced its 510(k) clearance reform plan. We are currently analyzing how this plan may affect us and our ability to obtain product clearances.

Further, as we enter new businesses or pursue new business opportunities, such as opportunities that require clinical trials, we may become subject to additional laws, rules and regulations, including FDA rules and regulations. Becoming familiar with and implementing the infrastructure necessary to comply with these laws, rules and regulations could be quite costly. In addition, failure to comply with these laws, rules and regulations could delay the introduction of new products and could adversely affect our business.

Quality systems, audits and failure to comply. Our manufacturing operations are required to comply with the FDA’s QSR, as well as other federal and state regulations for medical devices and radiation emitting products that address a company’s responsibility for complying with the quality systems regulations, which include the requirements for current good manufacturing practices. The FDA makes announced and unannounced inspections of medical device manufacturers to determine compliance with QSR and in connection with these inspections has issued, and in the future may issue, reports, known as Form FDA 483 reports (listing instances where the manufacturer has failed to comply with applicable regulations and/or procedures), and/or Warning Letters citing failure to comply with applicable regulations or procedures. If observations from FDA issued on Form FDA 483 reports are not addressed and/or corrective action taken in a timely manner to the FDA’s satisfaction, the FDA may issue a Warning Letter and/or proceed directly to enforcement action. Similarly, if a Warning Letter were issued, prompt corrective action to come into compliance is required. Failure to respond timely to Form FDA 483 observations, a Warning Letter or other notice of noncompliance and to come into compliance could result in the FDA bringing enforcement action against us, which could include the total shutdown of our production facilities, denial of importation rights to the U.S. for products manufactured in overseas locations and criminal and civil fines. The expense and costs of any corrective actions that we may take, which may include products recalls, correction and removal of products from customer sites and/or changes to our product manufacturing and quality systems, could adversely impact our financial results and may also divert management resources, attention and time. Additionally, if a Warning Letter were issued, customers could delay purchasing decisions or cancel orders, and we could face increased pressure from our competitors who could use the Warning Letter against us in competitive sales situations, either of which could adversely affect our reputation, business and stock price. Currently, we are responding to and working with the FDA to resolve Form FDA 483 observations issued in May 2011 related to the inspections of our Oncology Systems manufacturing facilities located in Helsinki, Finland and Haan, Germany. While in the past, we have received Form 483 observations that we successfully resolved with the FDA, we cannot be certain that we will have similar success resolving these observations.

In addition, we are required to timely file various reports with the FDA, including reports required by the medical device reporting regulations, that require that we report to regulatory authorities if our devices may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur. If these reports are not filed timely, regulators may impose sanctions and sales of our products may suffer, and we may be subject to product liability or regulatory enforcement actions, all of which could harm our business.

If we initiate a correction or removal of a device to reduce a risk to health posed by the device, we would be required to submit a Corrections and Removals report to the FDA and in many cases, similar reports to other regulatory agencies. This report could be classified by the FDA as a device recall which could lead to increased scrutiny by the FDA and other international regulatory agencies regarding the quality and safety of our devices. Furthermore, the filing of these reports have been and could be used by competitors against us in competitive situations with customers to delay purchase decisions, cancel orders or adversely affect our reputation.

Our medical devices utilizing radioactive material are subject to the NRC clearance and approval requirements, and the manufacture and sale of these products are subject to extensive international, federal and state regulation that varies from state to state and among countries or regions. Our manufacture, distribution, installation and service of medical devices utilizing radioactive material or emitting radiation also requires us to obtain a number of licenses and certifications

 

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for these devices and materials. Service of these products must also be in accordance with a specific radioactive materials license. Obtaining licenses and certifications may be time consuming, expensive and uncertain. In addition, we are subject to a variety of environmental laws regulating our manufacturing operations and the handling, storage, transport and disposal of hazardous materials, and which impose liability for the cleanup of any contamination from these materials. In particular, the handling and disposal of radioactive materials resulting from the manufacture, use or disposal of our products may impose significant costs and requirements. Disposal sites for the lawful disposal of materials generated by the manufacture, use or decommissioning of our products may no longer accept these materials in the future, or may accept them on unfavorable terms.

The FDA and the Federal Trade Commission (“FTC”) also regulate advertising and promotion of our products to ensure that the claims we make are consistent with our regulatory clearances, that there are scientific data to substantiate the claims and that our advertising is neither false nor misleading. If the FDA or FTC determines that any of our advertising or promotional claims are not permissible, we may be subject to enforcement actions and may be required to revise our promotional claims or make other corrections or restitutions.

If we or any of our suppliers, distributors or customers fail to comply with FDA, FTC and other applicable U.S. regulatory requirements or are perceived to potentially have failed to comply, we may face:

 

   

adverse publicity affecting both us and our customers;

 

   

increased pressures from our competitors;

 

   

investigations by governmental authorities or Warning Letters;

 

   

fines, injunctions, and civil penalties;

 

   

partial suspensions or total shutdown of production facilities, or the imposition of operating restrictions;

 

   

increased difficulty in obtaining required FDA clearances or approvals;

 

   

losses of clearances or approvals already granted;

 

   

seizures or recalls of our products or those of our customers;

 

   

delays in purchasing decisions by customers or cancellation of existing orders;

 

   

the inability to sell our products, or, where we have failed to comply with foreign regulations, to import our products to such countries;

 

   

difficulty in obtaining product liability or operating insurance at a reasonable cost, or at all; and

 

   

criminal prosecutions.

Other applicable U.S. regulations. As a participant in the healthcare industry, we are also subject to extensive laws and regulations protecting the privacy and integrity of patient medical information, including the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), “fraud and abuse” laws and regulations, including physician self-referral prohibitions, and false claims laws. From time to time, these laws and regulations may be revised or interpreted in ways that could make it more difficult for our customers to conduct their businesses, such as recent proposed revisions to the laws prohibiting physician self-referrals, and such revisions could have an adverse effect on the demand for our products, and therefore our business and results of operations. We also must comply with numerous federal, state and local laws of more general applicability relating to such matters as safe working conditions, manufacturing practices and fire hazard control.

The laws and regulations and their enforcement are constantly undergoing change, and we cannot predict what effect, if any, changes to these laws and regulations may have on our business. For example, HIPAA was amended by the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”), enacted as part of the American Recovery and Reinvestment Act of 2009. The HITECH Act significantly increases the civil money penalties for violations of patient privacy rights protected under HIPAA. Furthermore, business associates who have access to patient health information provided by hospitals and healthcare providers are now directly subject to HIPAA, including the new enforcement scheme and inspection requirements. Moreover, there has been a trend in recent years toward more stringent regulation and enforcement of requirements applicable to medical device manufacturers and requirements regarding protection and confidentiality of personal data.

 

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Government regulation also may cause considerable delay or even prevent the marketing and full commercialization of future products or services that we may develop, and/or may impose costly requirements on our business. Insurance coverage is not commercially available for violations of law, including the fines, penalties or investigatory costs that may flow to us as the consequence of regulatory violations; consequently, we do not have insurance that would cover this type of liability.

COMPLIANCE WITH FOREIGN LAWS AND REGULATIONS APPLICABLE TO THE MANUFACTURE AND DISTRIBUTION OF OUR PRODUCTS MAY BE COSTLY, AND FAILURE TO COMPLY MAY RESULT IN PENALTIES

Regulatory requirements affecting our operations and sales outside the United States vary from country to country, often differing significantly from those in the United States. In general, outside the United States, our products are regulated as medical devices by foreign governmental agencies similar to the FDA.

Marketing a medical device internationally. In order for us to market our products internationally, we must obtain clearances or approvals for products and product modifications. These processes (including for example in the European Union (“EU”), the European Economic Area (“EEA”), Switzerland, China, Japan and Canada) can be time consuming, expensive and uncertain, which can delay our ability to market products in those countries. Delays in receipt of or failure to receive regulatory approvals, the inclusion of significant limitations on the indicated uses of a product, the loss of previously obtained approvals or failure to comply with existing or future regulatory requirements could restrict or prevent us from doing business in a country or subject us to a variety of enforcement actions and civil or criminal penalties, which would adversely affect our business.

Within the EU/EEA/Switzerland, we must affix a CE mark, a European marking of conformity that indicates that a product meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe. This conformity to the applicable directives is done through self-declaration and may be verified by an independent certification body, called a “Notified Body”. Once clearance is obtained and the CE mark is affixed to the device, the Notified Body will regularly audit us to ensure that we remain in compliance with the applicable European laws or directives. CE marking demonstrates that our products comply with the laws and regulations required by the EU/EEA/Switzerland countries to allow free movement of trade within these countries. If we cannot support our performance claims and demonstrate compliance with the applicable European laws and directives, we lose our CE mark, which would prevent us from selling our products within the EU/EEA/Switzerland territory. Significant revisions to some of the applicable regulations governing requirements for medical devices in the EU/EEA/Switzerland went into effect in March 2010. These revisions have introduced additional uncertainty into the marketing authorization process for medical devices in Europe. Until medical device manufacturers and European regulatory agencies, including Notified Bodies and “competent authorities,” have greater experience with interpreting and applying the revised regulations, we may be subject to risks associated with additional testing, modification, certification or amendment of our existing market authorizations, or we may be required to modify installed products in order to comply with the official interpretations of these revised regulations.

In addition, we are required to timely file various reports with international regulatory authorities, including reports required by international adverse event reporting regulations, that require that we report to regulatory authorities if our devices may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur. If these reports are not filed timely, regulators may impose sanctions and sales of our products may suffer, and we may be subject to product liability or regulatory enforcement actions, all of which could harm our business.

Further, as we enter new businesses or pursue new business opportunities internationally, such as opportunities that require clinical trials, we may become subject to additional laws, rules and regulations. Becoming familiar with and implementing the infrastructure necessary to comply with these laws, rules and regulations could be quite costly. In addition, failure to comply with these laws, rules and regulations could delay the introduction of new products and could adversely affect our business.

Manufacturing and selling a device internationally. We are also subject to laws and regulations that apply to manufacturers of radiation emitting devices and products utilizing radioactive materials, as well as laws and regulations of general applicability relating to matters such as environmental protection, safe working conditions, manufacturing practices and other matters. These are often comparable to, if not more stringent than, the equivalent regulations in the United States. Sales overseas are also affected by regulation of matters such as product standards, packaging, labeling, environmental and product recycling requirements, import and export restrictions, tariffs, duties and taxes.

 

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In some countries, we rely on our foreign distributors to assist us in complying with foreign regulatory requirements, and we cannot be sure that they will always do so. If we or any of our suppliers, distributors or customers fail to comply with applicable international regulatory requirements or are perceived to potentially have failed to comply, we may face:

 

   

adverse publicity affecting both us and our customers;

 

   

investigations by governmental authorities;

 

   

fines, injunctions, civil penalties and criminal prosecutions;

 

   

increased difficulty in obtaining required approvals in foreign countries;

 

   

losses of clearances or approvals already granted;

 

   

seizures or recalls of our products or those of our customers;

 

   

delays in purchasing decisions by customers or cancellation of existing orders; and

 

   

the inability to sell our products in or to import our products into such countries.

Other applicable international regulations. In addition to the U.S. laws regarding the privacy and integrity of patient medical information, we are subject to similar laws and regulations in foreign countries covering data privacy and other protection of health and employee information. Particularly within the EU/EEA/Switzerland area, data protection legislation is comprehensive and complex and there has been a recent trend toward more stringent enforcement of requirements regarding protection and confidentiality of personal data. Data protection authorities from the different member states of the EU may interpret the legislation differently, which adds to this complexity, and data protection is a dynamic field where guidance is often revised. Fully understanding and implementing this legislation could be quite costly and timely, which could adversely affect our business. Additionally, in some instances, in order to fulfill the requirements of applicable U.S. law relating to data privacy, we may be faced with deciding whether to comply with EU/EEA/Switzerland data protection rules. Failure or partial failure to comply with data protection rules and regulations across the EU/EEA/Switzerland area could result in substantial monetary fines.

We are also subject to international “fraud and abuse” laws and regulations, as well as false claims and misleading advertisement laws. From time to time, these laws and regulations may be revised or interpreted in ways that could make it more difficult for our customers to conduct their businesses, which could have an adverse effect on the demand for our products, and therefore our business and results of operations. The laws and regulations and their enforcement are constantly undergoing change, and we cannot predict what effect, if any, changes to these laws and regulations may have on our business.

THE “AFFORDABLE HEALTHCARE FOR AMERICA ACT” INCLUDES PROVISIONS THAT MAY ADVERSELY AFFECT OUR BUSINESS AND RESULTS OF OPERATIONS, INCLUDING AN EXCISE TAX ON THE SALES OF MOST MEDICAL DEVICES

On March 23, 2010, President Obama signed into law the Affordable Health Care for America Act. While we are continuing to evaluate this legislation and its potential impact on our business, it may adversely affect the demand for our products and services, and therefore our financial position and results of operations, possibly materially.

Specifically, one of the components of the new law is a 2.3% excise tax on sales of most medical devices, which include our Oncology Systems products, starting in 2013. The Congressional Budget Office estimates that the total cost to the medical device industry could exceed $20 billion over ten years. This tax may put increased pressure on medical device manufacturers and purchasers, and may lead our customers to reduce their orders for products we produce or to request that we reduce the prices we charge for our products in order to offset the tax. Other elements of this new legislation, including comparative effectiveness research, an independent payment advisory board, payment system reforms (including shared savings pilots) and other provisions, could meaningfully change the way healthcare is developed and delivered, and may materially impact numerous aspects of our business, including the demand and availability of our products, the reimbursement available for our products from governmental and third-party payors, and reduced medical procedure volumes.

 

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Various healthcare reform proposals have also emerged at the state level, and we are unable to predict which, if any of these proposals will be enacted. We believe that the uncertainty created by healthcare reform in the United States has complicated our customers’ decision-making process and impacted our Oncology Systems business, and we expect that this uncertainty will persist until there is greater clarity on how the Affordable Health Care for America Act and state proposals will affect healthcare providers. We are unable to predict what effect ongoing uncertainty surrounding these matters will have on our customer’s purchasing decisions. However, an expansion in government’s role in the U.S. healthcare industry may adversely affect our business, possibly materially.

CHANGES TO RADIATION ONCOLOGY REIMBURSEMENTS MAY AFFECT DEMAND FOR OUR PRODUCTS

Sales of our healthcare products indirectly depend on whether adequate reimbursement is available to our customers from a variety of sources, such as government healthcare insurance programs, including the Medicare and Medicaid programs; private insurance plans; health maintenance organizations; and preferred provider organizations. In general, third-party payors in the United States are increasingly cost-conscious, and we cannot be sure that they will reimburse our customers at levels sufficient to enable us to achieve or maintain sales and price levels for our products in this market. Without adequate support from third-party payors, the market for our products may be limited. There is no uniform policy on reimbursement among third-party payors, nor can we be sure that procedures using our products will qualify for reimbursement from third-party payors. Once Medicare has made a decision to provide reimbursement for a given treatment, these reimbursement rates are generally reviewed and adjusted by Medicare annually. Private third-party payors, although independent from Medicare, sometimes use portions of Medicare reimbursement policies and payment amounts in making their own reimbursement decisions. As a result, decisions by the U.S. Centers for Medicare and Medicaid Services (“CMS”) to reimburse for a treatment, or changes to Medicare’s reimbursement policies or reductions in payment amounts with respect to a treatment sometimes extend to third-party payor reimbursement policies and amounts for that treatment. We have seen our customers’ decision-making process complicated by the uncertainty surrounding Medicare reimbursement rates for radiotherapy and radiosurgery in the United States. From time to time, CMS and third party payors may review and modify the factors upon which they rely to determine appropriate levels of reimbursement for cancer treatments. For example, CMS and third-party payors have begun to focus on the comparative effectiveness of radiation therapy versus other methods of cancer treatment, and could modify reimbursement rates based on the results of comparative effectiveness studies. If comparative effectiveness studies are not available, or if available studies show that other cancer treatments are more effective than radiotherapy or radiosurgery, reimbursement rates for radiotherapy or radiosurgery could be reduced. Any significant cuts in reimbursement rates for radiotherapy, radiosurgery, proton therapy or brachytherapy, or concerns or proposals regarding further cuts, could further increase uncertainty, influence our customers’ decisions, reduce demand for our products, cause customers to cancel orders and have a material adverse effect on our revenues and stock price.

Foreign governments also have their own healthcare reimbursement systems and we cannot be sure that adequate reimbursement will be made available with respect to our products under any foreign reimbursement system.

OUR RESULTS MAY BE IMPACTED BY CHANGES IN FOREIGN CURRENCY EXCHANGE RATES

Because our business is global and payments are generally made in local currency, fluctuations in foreign currency exchange rates can impact our results by affecting product demand or our expenses and/or the profitability in U.S. dollars of products and services that we provide in foreign markets.

While we use hedging strategies to help offset the effect of fluctuations in foreign currency exchange rates, the protection these strategies provide is affected by the timing of transactions, and the effectiveness of those strategies, the number of transactions that are hedged, forecast volatility and the extent to which exchange rates change. If our hedging strategies do not offset these fluctuations, our revenues and other operating results may be harmed. In addition, movement in foreign currency exchange rates could impact our financial results positively or negatively in one period and not another, making it more difficult to compare our financial results from period to period. Furthermore, on July 21, 2010, President Obama signed into law the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”). The Dodd-Frank Act contains provisions which may impact our existing hedging strategies, but we cannot predict those effects at this time.

In addition, long-term movements in foreign currency exchange rates can also affect the competitiveness of our products in the local currencies of our international customers. Even though our international sales are mostly in local currencies, our cost structure is weighted towards the U.S. dollar. The volatility of the U.S. dollar that we have experienced over the last several years has affected the competitiveness of our pricing against our foreign competitors, some of which may have cost structures based in other currencies, either helping or hindering our international order and revenue growth, thereby affecting

 

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our overall financial performance and results. Changes in monetary or other policies here and abroad, including as a result of the economic downturn or in reaction thereto, or in the United States as a result of a change in the U.S. laws or regulations, would also likely affect foreign currency exchange rates.

WE ARE SUBJECT TO FEDERAL, STATE AND FOREIGN LAWS GOVERNING OUR BUSINESS PRACTICES WHICH, IF VIOLATED, COULD RESULT IN SUBSTANTIAL PENALTIES. ADDITIONALLY, CHALLENGES TO OR INVESTIGATION INTO OUR PRACTICES COULD CAUSE ADVERSE PUBLICITY AND BE COSTLY TO RESPOND TO AND THUS COULD HARM OUR BUSINESS

Laws and ethical rules governing interactions with healthcare providers. The Medicare and Medicaid “anti-kickback” laws, and several similar state laws, prohibit payments or other remuneration that is intended to induce hospitals, physicians or others either to refer patients or to purchase, lease or order, or arrange for or recommend the purchase, lease or order of healthcare products or services for which payment may be made under federal and state healthcare programs, such as Medicare and Medicaid. These laws affect our sales, marketing and other promotional activities by limiting the kinds of financial arrangements we may have with hospitals, physicians or other potential purchasers of our products. They particularly impact how we structure our sales offerings, including discount practices, customer support, education and training programs, physician consulting, research grants and other service arrangements. These laws are broadly written, and it is often difficult to determine precisely how these laws will be applied to specific circumstances.

Federal and state “false claims” laws generally prohibit knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payors that are false or fraudulent, or for items or services that were not provided as claimed. Although we do not submit claims directly to payors, manufacturers can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by providing inaccurate billing or coding information to customers, or through certain other activities, including promoting products for uses not approved or cleared by the FDA, which is called off-label promotion. Violating “anti-kickback” and “false claims” laws can result in civil and criminal penalties, which can be substantial, and potential exclusion from healthcare programs for noncompliance. Even an unsuccessful challenge or investigation into our practices could cause adverse publicity, and be costly to defend, and thus could harm our business and results of operations. Additionally, several recently enacted state and federal laws, including the laws in Massachusetts and Vermont, and the federal Physician Payment Sunshine Act, now require, among other things, extensive tracking, maintenance of data bases regarding and disclosures of relationships and payments to physicians and healthcare providers. These laws require us to implement the necessary and costly infrastructure to track and report certain payments to healthcare providers. Failure to comply with these new tracking and reporting laws could subject us to significant civil monetary penalties.

We are subject to similar laws in foreign countries where we conduct business. For example, within the EU, the control of unlawful marketing activities is a matter of national law in each of the member states of the EU. The member states of the EU closely monitor perceived unlawful marketing activity by companies. We could face civil, criminal and administrative sanctions if any member state determines that we have breached our obligations under its national laws. Industry associations also closely monitor the activities of member companies. If these organizations or authorities name us as having breached our obligations under their regulations, rules or standards, our reputation would suffer and our business and financial condition could be adversely affected.

Anti-corruption laws and regulations. We are also subject to the U.S. Foreign Corrupt Practices Act and anti-corruption laws, and similar laws in foreign countries, such as the U.K. Bribery Act of 2010, which became effective on July 1, 2011. In general, there is a worldwide trend to strengthen anticorruption laws and their enforcement. Any violation of these laws could create a substantial liability for us, subject our officers and directors to personal liability and also cause a loss of reputation in the market. Transparency International’s 2010 Corruption Perceptions Index measured the degree to which public sector corruption is perceived to exist in 178 countries around the world, and found that nearly three quarters of the countries in the index, including many that we consider to be high growth areas, such as China, India, Russia and Brazil, scored below five, on a scale from 10 (very clean) to 0 (highly corrupt). We currently operate in many countries where the public sector is perceived as being more or highly corrupt. Our strategic business plans include expanding our business in regions and countries that are rated as higher risk for corruption activity by Transparency International. Becoming familiar with and implementing the infrastructure necessary to comply with laws, rules and regulations applicable to new business activities and mitigate and protect against corruption risks could be quite costly. In addition, failure to comply with these laws, rules and regulations could delay our expansion into high-growth markets and could adversely affect our business. This notwithstanding, we will inevitably do more business in countries where the public sector is perceived to be more or highly corrupt and be engaging in business in more countries perceived to be more or highly corrupt. Increased business in higher risk countries could subject us and our officers and directors to increased scrutiny and increased liability. In addition, from

 

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time to time, we may conduct internal investigations or face audits or investigations by one or more domestic or foreign government agencies, which could be costly and time-consuming, and could divert our management and key personnel from our business operations. An adverse outcome under any such investigation or audit could subject us to fines or criminal or other penalties, which could adversely affect our business and financial results.

PRODUCT DEFECTS OR MISUSE MAY RESULT IN MATERIAL PRODUCT LIABILITY OR PROFESSIONAL ERRORS AND OMISSIONS CLAIMS, LITIGATION, INVESTIGATION BY REGULATORY AUTHORITIES OR PRODUCT RECALLS THAT COULD HARM FUTURE REVENUES AND REQUIRE US TO PAY MATERIAL UNINSURED CLAIMS

Our business exposes us to potential product liability claims that are inherent in the manufacture, sale, installation, servicing and support of medical devices and other devices that deliver radiation. Because our products are involved in the intentional delivery of radiation to the human body; other situations where people may come in contact with radiation (for example, when our SIP products are being used to scan cargo); the collection and storage of patient treatment data for medical analysis and treatment delivery; the planning of radiation treatment and diagnostic imaging of the human body; and the diagnosing of medical problems, the possibility for significant injury and/or death exists. Our medical products operate within our customers’ facilities and network systems, and under quality assurance procedures established by the facility that ultimately result in the delivery of radiation to patients. Human and other errors or accidents may arise from the operation of our products in complex environments with products from other vendors, where interoperability or data sharing protocol may not be optimized even though the equipment or system operates according to specifications. As a result, we may face substantial liability to patients, our customers and others for damages resulting from the faulty, or allegedly faulty, design, manufacture, installation, servicing, support, testing or interoperability of our products, or their misuse or failure, as well as liability related to the loss or misuse of private patient data. We may also be subject to claims for property damages or economic loss related to or resulting from any errors or defects in our products, or the installation, servicing and support of our products. Any accident or mistreatment could subject us to legal costs, litigation, adverse publicity and damage to our reputation, whether or not our products or services were a factor. Litigation and other legal proceedings can be costly and can divert management’s time and resources. An unfavorable outcome in litigation or proceedings against us could adversely affect our financial results. Adverse publicity regarding any accidents or mistreatments, even ones that do not involve our products, could cause patients to be less receptive to radiotherapy treatments, causing them to question the efficacy of radiation therapy and seek other methods of treatment and adversely impacting our business. Adverse publicity could also result in additional regulation of radiation therapy, medical devices or the healthcare industry in general. Increased regulatory activities could adversely affect our ability to promote, manufacture and sell our products, and therefore negatively impact our business and results of operations.

In addition, if a product we design or manufacture were defective (whether due to design, labeling or manufacturing defects, improper use of the product or other reasons), we may be required to recall the product and notify regulatory authorities. The adverse publicity resulting from a recall could damage our reputation and cause customers to review and potentially terminate their relationships with us. A product recall could consume management time and have an adverse financial impact on our business, including incurring substantial costs, losing revenues and accruing losses under GAAP, any of which may cause our quarterly results to fluctuate.

We maintain limited product liability insurance coverage and currently self-insure professional liability/errors and omissions liability. Our product liability insurance policies are expensive and have high deductible amounts and self-insured retentions. Our insurance coverage may also prove to be inadequate, and future policies may not be available on acceptable terms or in sufficient amounts, if at all. If a material claim is successfully brought against us relating to a self-insured liability or a liability that is in excess of our insurance coverage, or for which insurance coverage is denied or limited, we could have to pay substantial damages, which could have a material adverse effect on our financial position and results of operation.

WE COMPETE IN HIGHLY COMPETITIVE MARKETS, AND WE MAY LOSE MARKET SHARE TO COMPANIES WITH GREATER RESOURCES OR THE ABILITY TO DEVELOP MORE EFFECTIVE TECHNOLOGIES, OR WE COULD BE FORCED TO REDUCE OUR PRICES

Rapidly evolving technology, intense competition and pricing pressure characterize the markets for radiation therapy equipment and software. Some of our competitors have greater financial, marketing and other resources than we have. Also, we believe that new competitors will enter our markets, as we have encountered new competitors as we enter new markets such as stereotactic radiosurgery, VMAT and proton therapy. To compete successfully, we must provide technically superior, clinically proven products that deliver more precise, cost-effective, high quality clinical outcomes, together in a complete

 

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package of products and services, and to do so ahead of our competitors. As our Oncology Systems products are generally sold on a basis of total value to the customer, our business may suffer when purchase decisions are based solely upon price, which can happen if hospitals and clinics give purchasing decision authority to group purchasing organizations. In addition, additional competitors may delay customer purchasing decisions as customers evaluate the products of these competitors along with ours, potentially extending our sales cycle and adversely affecting our net orders.

In x-ray imaging components and subsystems, we often compete with companies that have greater financial, marketing and other resources than we have. Some of the major diagnostic imaging systems companies, which are the primary OEM customers for our x-ray components, also manufacture x-ray components, including x-ray tubes, for use in their own imaging systems products. We must compete with these in-house manufacturing operations for business from their affiliated companies. In addition, we compete against other stand-alone, independent x-ray tube manufacturers who compete with us for both the OEM business of major diagnostic imaging equipment manufacturers and the independent servicing business for x-ray tubes. The market for flat panel detectors is also very competitive. As a result, we must have a competitive advantage in one or more significant areas, which may include lower product cost, better product quality and/or superior technology and/or performance.

In our SIP business, we compete with other OEM suppliers, primarily outside of the United States. The market for our SIP products used for nondestructive testing in industrial applications is small and highly fragmented.

The market for proton therapy products is still developing and is characterized by rapidly evolving technology, high competition and pricing pressure. Our ability to compete successfully depends, in part, on our ability to complete the development of our commercial proton therapy system, lower our product costs, develop and provide technically superior, clinically proven products that deliver more precise, cost-effective, high quality clinical outcomes, including integration of IGRT technologies such as our On-Board Imager (“OBI”).

In each of our business segments, existing competitors’ actions and new entrants may adversely affect our ability to compete. These competitors could develop technologies and products that are more effective than those we currently use or produce or that could render our products obsolete or noncompetitive. In addition, the timing of our competitors’ introduction of products into the market could affect the market acceptance and market share of our products. Some competitors offer specialized products that provide, or may be perceived by customers to provide, a marketing advantage over our mainstream cancer treatment products. Also, some of our competitors may not be subject to the same standards, regulatory and/or other legal requirements that we are, and therefore, they could have a competitive advantage in developing, manufacturing and marketing products and services. Any inability to develop, gain regulatory approval for and supply commercial quantities of competitive products to the market as quickly and effectively as our competitors could limit market acceptance of our products and reduce our sales. In addition, some of our smaller competitors could be acquired by larger companies that have greater financial strength, which could enable them to compete more aggressively. Our competitors could also acquire some of our suppliers or distributors, which could disrupt these supply or distribution arrangements and result in less predictable and reduced revenues in our businesses. Any of these competitive factors could negatively affect our pricing, sales, revenues, market share and gross margins and our ability to maintain or increase our operating margins.

OPEN ARCHITECTURE IS BECOMING INCREASINGLY IMPORTANT, AND SALES OF OUR PRODUCTS COULD FALL IF WE FAIL TO ACHIEVE THIS

As radiation oncology treatment becomes more complex, our customers are increasingly focusing on ease-of-use and interconnectivity. Our equipment and software is highly sophisticated and requires a high level of training and education to use them competently and safely, a requirement made even more important because they work together within integrated environments. We have directed substantial product development efforts into (i) greater interconnectivity of our products for more seamless operation within a system, (ii) enhancing the ease of use of our software products and (iii) reducing setup and treatment times and increasing patient throughput. We have emphasized maintaining an “open systems” approach that allows customers to “mix and match” our various individual products, incorporate products from other manufacturers, share information with other systems or products and use the equipment for offering various methods of radiation therapy treatment. We have done this based on our belief that such interconnectivity will increase the acceptance and adoption of IMRT, IGRT and VMAT and will stimulate demand for our products. We face competition though from “closed-ended” dedicated-use systems that place simplicity of use ahead of flexibility. If we have misjudged the importance to our customers of maintaining an “open systems” approach, or if we are unsuccessful in our efforts to enable greater interconnectivity, enhance ease-of-use and reduce setup and treatment times, our revenues could suffer.

 

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Obtaining and maintaining this interoperability and compatibility can be costly and time-consuming. While we try to use standard published protocols for communication with other widely used radiation oncology products manufactured by other companies, if this cannot be done, we may need to develop individual interfaces so that our products communicate correctly. When other companies modify the design or functionality of their products, this may affect their compatibility with our products. When we implement design improvements to our products, customers may be reluctant to adopt our new technology due to interoperability issues. For example, a clinic may be unwilling to implement one of our new technologies because its third-party software does not yet communicate correctly with our new product. Our ability to obtain compatibility with products of other companies may depend on our ability to obtain adequate information from them regarding their products. In many cases, these third parties are our competitors and may schedule their product changes and delay their release of relevant information to us to place us at a competitive disadvantage. When we modify our products to make them interoperable or compatible with third-party products, we may be required to obtain additional regulatory clearances. This process is costly and could delay our ability to release our products for commercial use. It is also possible that, despite our best efforts, we may not be able to make our products interoperable or compatible with widely used third-party products or may only be able to do so at a prohibitive expense, making our products less attractive or more costly to our customers.

PROTECTING OUR INTELLECTUAL PROPERTY CAN BE COSTLY AND WE MAY NOT BE ABLE TO MAINTAIN LICENSED RIGHTS, AND IN EITHER CASE OUR COMPETITIVE POSITION WOULD BE HARMED IF WE ARE NOT ABLE TO DO SO

We file applications as appropriate for patents covering new products and manufacturing processes. We cannot be sure, however, that our current patents, the claims allowed under our current patents, or patents for technologies licensed to us will be sufficiently broad to protect our technology position against competitors. Issued patents owned by, or licensed to, us may be challenged, invalidated or circumvented, or the rights granted under the patents may not provide us with competitive advantages. We also cannot be sure that patents will be issued from any of our pending or future patent applications. Asserting our patent rights against others in litigation or other legal proceedings is costly and diverts managerial resources. An unfavorable outcome in any such litigation or proceeding could harm us. In addition, we may not be able to detect patent infringement by others or may lose our competitive position in the market before we are able to do so.

We also rely on a combination of copyright, trade secret and other laws, and contractual restrictions on disclosure, copying and transferring title (including confidentiality agreements with vendors, strategic partners, co-developers, employees, consultants and other third parties), to protect our proprietary rights. These protections may prove inadequate, since agreements may still be breached and we may not have adequate remedies for a breach, and our trade secrets may otherwise become known to or be independently developed by others. We have trademarks, both registered and unregistered, that are maintained and enforced to provide customer recognition for our products in the marketplace, but unauthorized third parties may still use them. We also have agreements with third parties that license to us certain patented or proprietary technologies. In some cases products with substantial revenues may depend on these license rights. If we were to lose the rights to license these technologies, or our costs to license these technologies were to materially increase, our business would suffer.

THIRD PARTIES MAY CLAIM WE ARE INFRINGING THEIR INTELLECTUAL PROPERTY, AND WE COULD SUFFER SIGNIFICANT LITIGATION OR LICENSING EXPENSES OR BE PREVENTED FROM SELLING OUR PRODUCTS

The industries in which we compete are characterized by a substantial amount of litigation over patent and other intellectual property rights. Our competitors, like companies in many high technology businesses, continually review other companies’ activities for possible conflicts with their own intellectual property rights. In addition, non-practicing entities may review our activities for conflicts with their patent rights. Determining whether a product infringes a third party’s intellectual property rights involves complex legal and factual issues, and the outcome of this type of litigation is often uncertain. Third parties may claim that we are infringing their intellectual property rights, and we may be found to infringe those intellectual property rights. We may not be aware of intellectual property rights of others that relate to our products, services or technologies. From time to time, we have received notices from third parties asserting infringement and we have been subject to lawsuits alleging infringement of third-party patent or other intellectual property rights. Any dispute regarding patents or other intellectual property could be costly and time-consuming, and could divert our management and key personnel from our business operations, and we may not prevail in a dispute. We do not maintain insurance for intellectual property infringement, so that costs of defense, whether or not we are successful in defending an infringement claim, will be borne by us and could be significant. If we are unsuccessful in defending an infringement claim, we may be subject to significant damages. We may also be subject to injunctions against development and sale of our products, which could be material. If a third party rights holder is willing to license rights, we may be required to enter into costly royalty or license agreements.

 

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THE LOSS OF A SUPPLIER OR ANY INABILITY TO OBTAIN SUPPLIES OF IMPORTANT COMPONENTS COULD RESTRICT OUR ABILITY TO MANUFACTURE PRODUCTS, CAUSE DELAYS IN OUR ABILITY TO DELIVER PRODUCTS, OR SIGNIFICANTLY INCREASE OUR COSTS

We obtain some of the components included in our products from a limited group of suppliers or from a single-source supplier, such as the radioactive sources for high dose afterloaders, klystrons for linear accelerators, transistor arrays and cesium iodide coatings for flat panel detectors, and specialized integrated circuits, x-ray tube targets, housings, glassframes and various other x-ray tube components. If we lose any of these suppliers or if their operations were substantially interrupted, we would be required to obtain and qualify one or more replacement suppliers, which may then also require us to redesign or modify our products to incorporate new parts and/or further require us to obtain clearance, qualification or certification of such product by the FDA or other applicable regulatory approvals in other countries. Events like these could significantly increase costs for the affected product and likely cause material delays in delivery of that and other related products. Although we have insurance to protect against business interruption loss, this insurance coverage may not be adequate or continue to remain available on acceptable terms, if at all. Additionally, some of our single-source suppliers supply components for certain of our rapidly growing product lines. Manufacturing capacity limitations of any of our suppliers or other inability of these suppliers to meet increasing demand could adversely affect us, resulting in curtailed growth opportunities for any of our product lines. Shortage of, and greater demand for, components and subassemblies could also increase manufacturing costs by increasing prices. Disruptions or loss of any of our limited- or sole-source components or subassemblies or the capacity limitations of the suppliers for these components or subassemblies, including the ones referenced above, could adversely affect our business and financial results and could damage our customer relationships.

A SHORTAGE OF RAW MATERIALS COULD RESTRICT OUR ABILITY TO MANUFACTURE PRODUCTS, CAUSE DELAYS, OR SIGNIFICANTLY INCREASE OUR COST OF GOODS

We rely upon the supplies of certain raw materials such as tungsten, lead and copper for Oncology Systems and SIP; copper, lead, tungsten, rhenium, molybdenum zirconium, and various high grades of steel alloy for X-ray Products, and high-grade steel, high-grade copper and iron for VPT. Demand for these raw materials both within the United States and from foreign countries, such as China, has increased over the last few years, resulting in limited supplies and higher prices. Worldwide demand, availability and pricing of these raw materials have been volatile, and we expect that availability and pricing will continue to fluctuate in the future. If supplies are restricted and prices increase, this could constrain our manufacturing of affected products, reduce our profit margins or otherwise adversely affect our business.

CONSOLIDATION AMONG OUR ONCOLOGY SYSTEMS CUSTOMERS COULD ADVERSELY AFFECT OUR SALES OF ONCOLOGY PRODUCTS

We have seen and may continue to see some consolidation among our customers in our Oncology Systems business, as hospitals and clinics combine through mergers and acquisitions, and as they join group purchasing organizations or affiliated enterprises. As customers consolidate, the volume of product sales to these customers might decrease. Alternatively, order size may increase as what were previously more than one customer combine orders as one entity. As a result, the purchasing cycle for our Oncology Systems products could lengthen, as orders increase in size and require more customer approvals. Both increased order size and extended purchasing cycles could cause our net orders to be more volatile and less predictable. In addition, group purchasing organizations often focus on pricing as the determinant in making purchase decisions. A reduction in net orders could affect the level of future revenues, which would adversely affect our operating results, financial condition, and the price of VMS common stock.

WE SELL OUR X-RAY TUBES TO A LIMITED NUMBER OF OEM CUSTOMERS, MANY OF WHICH ARE ALSO OUR COMPETITORS, AND A REDUCTION IN BUSINESS BY ONE OR MORE OF THESE CUSTOMERS OR CONSOLIDATION OF CUSTOMERS COULD REDUCE OUR SALES

There has been a consolidation of diagnostic imaging systems manufacturers over the past few years, including the consolidation of these customers into companies that already manufacture x-ray tubes. If this continues, we could experience less predictable and reduced sales of our x-ray tube products. In addition, the economic downturn has made it difficult for our OEM customers to accurately forecast and plan future business activities, and we saw our x-ray business impacted in fiscal year 2009 by inventory reduction efforts at some of these customers. Our agreements for x-ray components may contain purchasing estimates that are based on our customers’ historical purchasing patterns, and actual purchasing volumes under the agreements may vary significantly from our estimates. In recent years, we have also seen dramatic reductions in Medicare reimbursements for diagnostic radiology. We believe reductions in these Medicare reimbursement rates have

 

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reduced demand for medical x-ray imaging equipment, such as CT scanners, which have negatively impacted demand for our x-ray tube products. Also, because we sell our x-ray tube products to a limited number of OEM customers and many of them are also our competitors with in-house x-ray tube manufacturing operations, we could experience the loss of, or reduction in purchasing volume by, one or more of these customers if they lower external sourcing costs. Such a loss or reduction could have a material adverse effect on our X-ray Products business. We have been notified by one of our larger customers in Japan that it will be shutting down production for two weeks during the fourth quarter of fiscal year 2011 due to a power shortage stemming from the March 2011 natural disasters in Japan. The financial performance in X-ray Products may potentially be impacted if this customer is unable to compensate for any loss in production or if more of our Japanese customers are similarly impacted.

ORDERS FOR OUR SECURITY AND INSPECTION PRODUCTS COULD BE UNPREDICTABLE

Our SIP business designs, manufactures, sells and services Linatron x-ray accelerators, imaging processing software and image detection products for security and inspection, such as cargo screening at ports and borders and nondestructive examination for a variety of applications. We generally sell SIP products to OEMs who incorporate our products into their inspection systems, which are then sold to customs and other government agencies, as well as to commercial organizations in the casting, power, aerospace, chemical, petro-chemical and automotive industries. We believe growth in the SIP business will be driven by security cargo screening and border protection needs, as well as by the needs of customs agencies to verify shipments for assessing duties and taxes. However, use of linear accelerator and imaging technology in security cargo screening and border protection is in its early stages. Orders for our SIP products have been and may continue to be unpredictable as governmental agencies may place large orders with us or our OEM customers in a short time period, and then may not place any orders for a long time period thereafter. Because it is difficult to predict our OEM customer delivery and acceptance schedules, the actual timing of sales and revenue recognition will vary significantly.

In addition, our SIP business is heavily influenced by U.S. and foreign governmental policies on national and homeland security, border protection and customs revenue activities, which depend upon government budgets and appropriations that are subject to political changes. We have seen customers freeze or dramatically reduce purchases and capital project expenditures, or act cautiously as governments around the world wrestle with spending priorities. Furthermore, bid awards in this business may be subject to challenge by third parties, as we have recently encountered with a large government project, which can make the certainty and timing of some SIP orders unpredictable. As a result, this business is subject to unpredictability in the timing of orders, sales and revenue that could cause volatility in our revenues and earnings, and therefore the price of VMS common stock.

IF WE ARE UNABLE TO PROVIDE THE SIGNIFICANT EDUCATION AND TRAINING REQUIRED FOR THE HEALTHCARE MARKET TO ACCEPT OUR PRODUCTS, OUR BUSINESS WILL SUFFER

In order to achieve market acceptance for our radiation therapy products, we often need to educate physicians about the use of a new treatment procedure such as IMRT, IGRT, VMAT, stereotactic radiosurgery or proton therapy, overcome physician objections to some of the effects of the product or its related treatment regimen, convince healthcare payors that the benefits of the product and its related treatment process outweigh its costs and help train qualified physicists in the skilled use of our products. For example, the complexity and dynamic nature of IMRT and IGRT requires significant education of hospital personnel and physicians regarding the benefits of IMRT and IGRT and the required departures from their customary practices. Further, the complexity and high cost of proton therapy requires similar significant education, as well as education regarding construction and facility requirements. We have expended and will continue to expend significant resources on marketing and educational efforts to create awareness of IMRT, IGRT, VMAT, stereotactic radiosurgery and proton therapy generally; to encourage the acceptance and adoption of our products for these technologies; and to promote the safe use of our products in compliance with their operating procedures. Future products may not gain significant market acceptance among physicians, patients and healthcare payors, even if we spend significant time and expense on their education.

OUR BUSINESS MAY SUFFER IF WE ARE NOT ABLE TO HIRE AND RETAIN QUALIFIED PERSONNEL

Our future success depends, to a significant extent, on our ability to attract, expand, integrate, train and retain our management team, qualified engineering personnel, technical personnel and sales and marketing staff. We compete for key personnel with other medical equipment and software manufacturers and technology companies, as well as universities and research institutions. Because this competition is intense, costs related to compensation could increase significantly if supply decreases or demand increases. If we are unable to hire, train or retain qualified personnel, we will not be able to maintain and expand our business, and our business would suffer.

 

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IF WE ARE NOT ABLE TO MATCH OUR MANUFACTURING CAPACITY WITH DEMAND FOR OUR PRODUCTS, OUR FINANCIAL RESULTS MAY SUFFER

Our products have a long production cycle and we need to anticipate demand for our products in order to ensure adequate manufacturing or testing capacity. If we are unable to anticipate demand and our manufacturing or testing capacity does not keep pace with product demand, we will not be able to fulfill orders timely, which may negatively impact our financial results and overall business. Conversely, if demand for our products decreases, the fixed costs associated with excess manufacturing capacity may harm our financial results.

IF WE FAIL TO SUCCESSFULLY ACQUIRE OR INTEGRATE NEW BUSINESSES, PRODUCTS AND TECHNOLOGY, WE MAY NOT REALIZE EXPECTED BENEFITS OR MAY HARM OUR BUSINESS

We need to grow our businesses in response to changing technologies, customer demands and competitive pressures. In some circumstances, we may decide to grow our business through the acquisition of complementary businesses, products or technologies rather than through internal development. For example, in March 2011 we acquired all of the outstanding equity of a privately-held supplier of devices for delivery of brachtherapy treatment of cancer. Identifying suitable acquisition candidates can be difficult, time-consuming and costly, and we may not be able to identify suitable candidates or successfully complete identified acquisitions. In addition, completing an acquisition can divert our management and key personnel from our business operations, which could harm our business and affect our financial results. Even if we complete an acquisition, we may not be able to successfully integrate newly acquired organizations, products, technologies or employees into our operations, or may not fully realize some of the expected synergies.

Integrating an acquisition can also be expensive and time-consuming, and may strain our resources. It may cost us more to commercialize new products than we originally anticipated, as we are experiencing with our proton therapy systems, which could impact our results of operations. In many instances, integrating a new business will also involve implementing or improving internal controls appropriate for a public company at a business that lacks them. In addition, we may be unable to retain the employees of acquired companies, or the acquired company’s customers, suppliers, distributors or other partners for a variety of reasons, including the fact that these entities may be our competitors or may have close relationships with our competitors.

Further, we may find that we need to restructure or divest acquired businesses, or assets of those businesses. Even if we do so, an acquisition may not produce the full efficiencies, growth or benefits we expected. If we decide to sell assets or a business, as we did in fiscal year 2008 with Research Instruments, it may be difficult to identify buyers or alternative exit strategies on acceptable terms, in a timely manner, or at all, which could delay the accomplishment of our strategic objectives, or we may dispose of a business at a lower price or on less advantageous terms than we had anticipated.

We account for our acquisitions under the purchase method of accounting. Under this method, we allocate the total purchase price to the acquired businesses’ tangible assets and liabilities, identifiable intangible assets and in-process research and development costs based on their fair values as of the date of the acquisition, and record the excess of the purchase price over those fair values as goodwill. If we fail to achieve the anticipated growth from an acquisition, or if we decide to sell assets or a business, we may be required to recognize an impairment loss on the write down of our assets and goodwill, which could adversely affect our financial results. In addition, acquisitions can result in potentially dilutive issuances of equity securities or the incurrence of debt, contingent liabilities or expenses, or other charges, any of which could harm our business and affect our financial results.

WE MAY FACE ADDITIONAL RISKS FROM THE ACQUISITION OR DEVELOPMENT OF NEW LINES OF BUSINESS

From time to time, we may acquire or develop new lines of business, such as proton therapy. There are substantial risks and uncertainties associated with this, particularly in instances where the markets are not fully developed. Risks include developing knowledge of and experience in the new business, recruiting market professionals, increasing research and development expenditures, and developing and capitalizing on new relationships with experienced market participants. This may mean significant investment and involvement of our senior management to acquire or develop, then integrate, the business into our operations. Timelines for integration of new businesses may not be achieved and price and profitability targets may not prove feasible, as new products can carry lower gross margins. External factors, such as compliance with regulations, competitive alternatives, and shifting market preferences, may also impact whether implementation of a new business will be successful. Failure to manage these risks in the development and implementation of new businesses successfully could materially and adversely affect our business, results of operations and financial condition.

 

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WE MAY NOT BE ABLE TO SUCCESSFULLY RESOLVE RESIDUAL ISSUES RELATED TO THE SALE OF OUR RESEARCH INSTRUMENTS BUSINESS

In the second quarter of fiscal year 2009, we completed the sale of Research Instruments. We retained the responsibility for one contract as of the end of fiscal year 2010. We have incurred, and may continue to incur, additional costs beyond those expected with the remaining contract which could adversely affect our financial condition. Continued efforts related to managing the remaining contract have required, and may likely continue to require, a substantial amount of management, administrative, financial and operational resources, particularly as unanticipated difficulties with the fulfillment of this contract are encountered. These demands may distract our employees and management from the day-to-day operation of our other businesses. If we are not able to successfully resolve these residual retained responsibilities in a timely manner, we may be subject of lawsuits, financial penalties and costs and further management, administrative and operational distraction, all of which may adversely affect our business, results of operations and financial condition.

WE WORK WITH DISTRIBUTORS FOR SALES IN SOME TERRITORIES, AND LOSING THEM COULD HARM OUR REVENUES IN THAT TERRITORY

We have strategic relationships with a number of key distributors for sales and service of our products, principally in Europe and Asia. If these strategic relationships end and are not replaced, our revenues from product sales in these territories and/or ability to service our products in the territories serviced by these distributors could be adversely affected.

FLUCTUATIONS IN OUR OPERATING RESULTS, INCLUDING QUARTERLY NET ORDERS, REVENUES, AND MARGINS, MAY CAUSE OUR STOCK PRICE TO BE VOLATILE, WHICH COULD CAUSE LOSSES FOR OUR STOCKHOLDERS

We have experienced and expect in the future to experience fluctuations in our operating results, including net orders, revenues and margins. Drivers of orders include timing of announcement of and introduction of new products or product enhancements by us and our competitors, as well as changes or anticipated changes in third party reimbursement amounts or policies applicable to treatments using our products. The availability of economic stimulus packages or other government funding may also affect timing of customer purchases. Many of our products require significant capital expenditures by our customers. Accordingly, individual product orders can be quite large in dollar amounts, which can extend the customer purchasing cycle. We have experienced this with our IGRT products, and expect this to be even greater with our proton therapy products because of the high cost of the equipment and the complexity of project financing. In addition, the budgeting cycles of hospitals and clinics for capital equipment purchases are frequently fixed well in advance. As a result of the recent worldwide economic downturn and contraction in credit markets, as well as the uncertainty surrounding the impact of healthcare reform and changes to reimbursement rates, the purchasing cycle has extended and may extend even further as potential customers more closely scrutinize and prioritize their capital spending budgets, and analyze appropriate financing alternatives. In addition, some of our more sophisticated equipment, such as IGRT and proton therapy products, requires greater site preparation and longer construction cycles, which can delay customer decision cycles even further. The timing of when individual orders are placed, installation is accomplished and the revenues recognized affect our quarterly results.

Once orders are received, factors that may affect whether these orders become revenues and the timing include:

 

   

delay in shipment due, for example, to unanticipated construction delays at customer locations where our products are to be installed, cancellations or rescheduling by customers, extreme weather conditions, natural disasters or port strikes;

 

   

delay in the installation and/or acceptance of a product;

 

   

for proton therapy systems, failure to satisfy contingencies associated with an order;

 

   

the method of accounting used to recognize revenue;

 

   

a change in a customer’s financial condition or ability to obtain financing; or

 

   

timing of appropriate regulatory approvals or authorizations.

Our quarterly operating results, including our margins, may also be affected by a number of other factors, including:

 

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changes in our or our competitors’ pricing or discount levels;

 

   

changes in foreign currency exchange rates;

 

   

changes in the relative portion of our revenues represented by our various products, including the relative mix between higher margin and lower margin products;

 

   

changes in the relative portion of our revenues represented by the international region;

 

   

fluctuation in our effective tax rate, which may or may not be known to us in advance;

 

   

disruptions in the supply or changes in the costs of raw materials, labor, product components or transportation services;

 

   

disruptions in our operations, including our ability to manufacture products, caused by events such as earthquakes, fires, floods, terrorist attacks or the outbreak of epidemic diseases;

 

   

changes in the general economic conditions or tightening of credit available to our customers;

 

   

the impact of changing levels of sales on sole purchasers of certain of our x-ray products;

 

   

the unfavorable outcome of any litigation or administrative proceeding or inquiry; and

 

   

accounting changes and adoption of new accounting pronouncements.

Because many of our operating expenses are based on anticipated capacity levels and a high percentage of these expenses are fixed for the short term, a small variation in the timing of revenue recognition can cause significant variations in operating results from quarter to quarter. Our overall gross margin may also be impacted by the gross margin of our proton therapy products, which are presently below the gross margins for our traditional radiotherapy products. If our gross margins fall below the expectation of securities analysts and investors, the trading price of VMS common stock would almost certainly decline.

We report on a quarterly and annual basis our net orders and backlog. It is important to understand that, unlike revenues, net orders and backlog are not governed by GAAP, and are not within the scope of the audit or reviews conducted by our independent registered public accounting firm; therefore, investors should not interpret our net orders or backlog in such a manner. Also, for the reasons set forth above, our net orders and backlog cannot necessarily be relied upon as accurate predictors of future revenues. High levels of order cancellation or delays in customer purchase decisions or delivery dates will reduce the quarterly net orders and backlog and also affect the level of future revenues. Accordingly, we cannot be sure if or when orders will mature into revenues. Our net orders, backlog, revenues and net earnings in one or more future periods may fall below the expectations of securities analysts and investors. In that event, the trading price of VMS common stock would almost certainly decline.

THE FINANCIAL RESULTS OF OUR VARIAN PARTICLE THERAPY BUSINESS MAY FLUCTUATE AND BE UNPREDICTABLE

The development of the business we now call VPT should enable us to offer products for delivering image-guided, intensity-modulated proton therapy for the treatment of cancer. Our success in this area will depend upon the wide-spread awareness, acceptance and adoption by the oncology market of proton therapy systems for the treatment of cancer. However, this technology may not be accepted as quickly as others.

Since proton therapy projects are highly customized and are generally large and more complex, planning for these projects will take more time and use more resources than those in the radiotherapy business conducted in our Oncology Systems segment. Due to its relatively large scale, the construction of a proton therapy facility requires significant capital investment and may involve complex project financing. The worldwide economic downturn resulted in a contraction in credit markets. To the extent this persists, it may make it more difficult for potential customers of this business to find appropriate financing for large proton therapy projects, which could cause them to delay or cancel their projects, or request our participation in financing arrangements or payment concessions in their agreements with us, which could impact our operating results. In addition, due to their size and complexity, the sales and customer decision cycles for proton therapy projects may take several years. As a result, the timing of these projects, and therefore our operating results for this business, may vary significantly from period to period.

 

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We expect that a limited number of customers will account for a substantial portion of VPT’s business for the foreseeable future. Because an order for a proton therapy system can be relatively large, an order in one fiscal period will cause our net orders to vary significantly, making comparisons between fiscal periods more difficult. Further, the award of a proton therapy system orders may be subject to challenge by third parties, which can make these orders more unpredictable than other products. If a customer cancels an order for a proton therapy system, such as occurred with the order for a proton therapy system for Skandion Kliniken in Sweden, it would negatively impact our orders in the fiscal period in which the order is cancelled and we would lose the opportunity for the product and services revenues that the order represents.

In addition, many of the components used in proton therapy equipment require a long lead time, which may require an increase in our levels of inventory. This may cause fluctuations in the operating results of VPT that may make it difficult to predict our results and to compare our results from period to period.

Moreover, entrance into the proton therapy business may subject us to increased risk and potential liability. For example, because proton therapy projects are large in scale and require detailed project planning, failure to deliver on our commitments could result in greater than expected liabilities, as we could be required to indemnify business partners and customers for losses suffered or incurred if we are unable to deliver our products in accordance with the terms of customer contracts. Additionally, customers are requesting that the systems vendor, as the primary technology provider, provide guarantees for and suffer penalties in relation to the overall construction project, as well as in some situations participate in or provide project financing for the project. If we must establish special purpose entities to finance and manage a proton therapy project, we may be required to consolidate these special purpose entities in our financial statements. Since the cost of each proton therapy center project will generally exceed $100 million, the amount of potential liability and potential for financial loss may be higher than the levels historically assumed by us for our traditional radiation therapy business and may also exceed the project’s value. Insurance covering these contingencies may be unobtainable. If we cannot reasonably mitigate or eliminate these contingencies or risks, our ability to competitively bid upon proton center projects will be negatively impacted or we may be required to assume material amounts of potential liability, all of which may have adverse consequences to us. In addition, we have encountered and may encounter additional challenges in the commercialization of the proton therapy products, which may increase our research and development costs and delay the introduction of our products. This and other unanticipated events could adversely affect our business and make our results of operations unpredictable.

WE HAVE ENTERED INTO A CREDIT FACILITY AGREEMENT THAT RESTRICTS CERTAIN ACTIVITIES, AND FAILURE TO COMPLY WITH THIS AGREEMENT MAY HAVE AN ADVERSE EFFECT ON OUR BUSINESS, LIQUIDITY AND FINANCIAL POSITION

We maintain a revolving credit facility that contains restrictive financial covenants, including financial covenants that require us to comply with specified financial ratios. We may have to curtail some of our operations to comply with these covenants. In addition, our revolving credit facility contains other affirmative and negative covenants that could restrict our operating and financing activities. These provisions limit our ability to, among other things, incur future indebtedness, contingent obligations or liens, guarantee indebtedness, make certain investments and capital expenditures, sell stock or assets and pay dividends, and consummate certain mergers or acquisitions. Because of the restrictions on our ability to create or assume liens, we may find it difficult to secure additional indebtedness if required. Furthermore, if we fail to comply with the credit facility requirements, we may be in default. Upon an event of default if the credit agreement is not amended or the event of default is not waived, the lender could declare all amounts outstanding, together with accrued interest, to be immediately due and payable. If this happens, we may not be able to make those payments or borrow sufficient funds from alternative sources to make those payments. Even if we were to obtain additional financing, that financing may be on unfavorable terms.

CHANGES IN INTERPRETATION OR APPLICATION OF GENERALLY ACCEPTED ACCOUNTING PRINCIPLES MAY ADVERSELY AFFECT OUR OPERATING RESULTS

We prepare our financial statements to conform to GAAP. These principles are subject to interpretation by the FASB, American Institute of Certified Public Accountants, the Public Company Accounting Oversight Board, the Securities and Exchange Commission and various other regulatory or accounting bodies. A change in interpretations of, or our application of, these principles can have a significant effect on our reported results and may even affect our reporting of transactions completed before a change is announced. In addition, when we are required to adopt new accounting standards, our methods of accounting for certain items may change, which could cause our results of operations to fluctuate from period to period and make it more difficult to compare our financial results to prior periods.

 

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As our operations evolve over time, we may introduce new products or new technologies that require us to apply different accounting principles, including that regarding revenue recognition, than we have applied in past periods. Additionally, we recognize revenues for some of our proton therapy products and services and for certain highly customized image detection systems in our SIP business under the percentage-of-completion method or the completed-contract method, which affects the timing of revenue recognition. We could be required to apply these methods to other businesses in the future. The percentage-of-completion method involves considerable use of estimates in determining revenues, costs and profits and in assigning dollar amounts to relevant accounting periods which must be periodically reviewed and appropriately adjusted. If our estimates prove to be inaccurate or circumstances change over time, we would be required to adjust revenues or even record a contract loss in later periods, and our financial results could suffer. In addition, if a loss is expected on a contract under the percentage-of-completion method and completed contract method, the estimated loss would be charged to cost of sales in the period the loss is identified. The application of different types of accounting principles and related potential changes may make it more difficult to compare our financial results from quarter to quarter, and the trading price of VMS common stock could suffer or become more volatile as a result.

ENVIRONMENTAL LAWS IMPOSE COMPLIANCE COSTS ON OUR BUSINESS AND CAN ALSO RESULT IN LIABILITY

We are subject to environmental laws around the world. These laws regulate many aspects of our operations, including our handling, storage, transport and disposal of hazardous materials. They can also impose cleanup liabilities, including with respect to discontinued operations. As a consequence, we can incur significant environmental costs and liabilities, some recurring and reasonably predictable, and others not recurring or easily predicted. Although we follow procedures intended to comply with existing environmental laws, we, like other businesses, can never completely eliminate the risk of contamination or injury from certain materials that we use in our business and, therefore, the prospect of resulting claims and damage payments. We may also be assessed fines or penalties for failure to comply with environmental laws and regulations. Although insurance has provided coverage for portions of cleanup costs resulting from historical occurrences, we maintain only limited insurance coverage for costs or claims that might result from any future contamination.

Future changes in environmental laws could also increase our costs of doing business, perhaps significantly. Several countries, including some in the EU, now require medical equipment manufacturers to bear certain disposal costs, of products at the end of a product’s useful life, increasing our costs. The EU has also adopted a directive that may lead to restrictions on the use of certain hazardous substances in some of our products sold there. These directives, along with another that requires material disclosure information to be provided upon request, could increase our operating costs. All of these costs, and any future violations or liabilities under environmental laws or regulations, could have a material adverse effect on our business.

AS A STRATEGY TO ASSIST OUR SALES EFFORTS, WE MAY OFFER EXTENDED PAYMENT TERMS, WHICH MAY POTENTIALLY RESULT IN HIGHER DSO AND GREATER PAYMENT DEFAULTS

We offer longer or extended payment terms for qualified customers in some circumstances. Many of the areas where we offer such longer or extended payment terms have under-developed legal systems for securing debt and enforcing collection of debt. As of July 1, 2011, customer contracts with remaining terms of more than one year amounted to less than 2% of our accounts receivable balance. While we qualify customers to whom we offer longer or extended payment terms, their financial positions may change adversely over the longer time period given for payment. This may result in an increase in payment defaults and uncollectible accounts, which would affect our net earnings. In addition, longer or extended payment terms could impact the timing of our revenue recognition, and they have in the past and may in the future result in an increase in our days sales outstanding.

 

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DISRUPTION OF CRITICAL INFORMATION SYSTEMS COULD HARM OUR BUSINESS AND FINANCIAL CONDITION

Information technology helps us operate efficiently, interface with customers, maintain financial accuracy and efficiency, and accurately produce our financial statements. If we do not allocate and effectively manage the resources necessary to build and sustain the proper technology infrastructure, we could be subject to transaction errors, processing inefficiencies, the loss of customers, business disruptions, or the loss of or damage to intellectual property through security breach. If our data management systems do not effectively collect, store, process and report relevant data for the operation of our business, whether due to equipment malfunction or constraints, software deficiencies, or human error, our ability to effectively plan, forecast and execute our business plan and comply with applicable laws and regulations will be impaired, perhaps materially. Any such impairment could materially and adversely affect our financial condition, results of operations, cash flows and the timeliness with which we report our operating results internally and externally.

OUR OPERATIONS ARE VULNERABLE TO INTERRUPTION OR LOSS DUE TO NATURAL OR OTHER DISASTERS, POWER LOSS, STRIKES AND OTHER EVENTS BEYOND OUR CONTROL

We conduct a significant portion of our activities, including manufacturing, administration and data processing at facilities located in the State of California and other seismically active areas that have experienced major earthquakes and other natural disasters. We carry limited earthquake insurance that may not be adequate or continue to be available at commercially reasonable rates and terms. A major earthquake or other disaster (such as a major fire, flood, tsunami, volcanic eruption or terrorist attack) affecting our facilities, or those of our suppliers, could significantly disrupt our operations, and delay or prevent product manufacture and shipment during the time required to repair, rebuild or replace our or our suppliers’ damaged manufacturing facilities; these delays could be lengthy and costly. If any of our customers’ facilities are adversely affected by a disaster, shipments of our products could be delayed. Additionally, customers may delay purchases of our products until operations return to normal. Even if we are able to quickly respond to a disaster, the ongoing effects of the disaster could create some uncertainty in the operations of our businesses, such as the recent catastrophe in Japan has created. In addition, our facilities, particularly those located in the western states of the United States, may be subject to a shortage of available electrical power and other energy supplies. Any shortages may increase our costs for power and energy supplies or could result in blackouts, which could disrupt the operations of our affected facilities and harm our business. Further, our products are typically shipped from a limited number of ports, and any disaster, strike or other event blocking shipment from these ports could delay or prevent shipments and harm our business. In addition, concerns about terrorism, the effects of a terrorist attack, political turmoil or an outbreak of epidemic diseases, such as the swine flu, could have a negative effect on our business operations, those of our suppliers and customers, and the ability to travel, resulting in adverse consequences on our revenues and financial performance.

 

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

(a) Not applicable

(b) Not applicable

(c) The following table provides information with respect to the shares of common stock repurchased by us during the third quarter of fiscal year 2011.

 

Period

   Total Number of
Shares Purchased
    Average Price
Paid Per Share
    Total Number of
Shares Purchased as
Part of Publicly
Announced Plans or
Programs
     Maximum Number
of Shares that May
Yet Be Purchased
Under the Plans or
Programs (1)
 

April 2, 2011 - April 29, 2011

     —        $ —          —           12,914,277   

April 30, 2011 - May 27, 2011

     —        $ —          —           12,914,277   

May 28, 2011 - July 1, 2011

     701,668  (2)    $ 65.81  (3)      630,921         12,283,356   
  

 

 

     

 

 

    

Total

     701,668      $ —          630,921      
  

 

 

     

 

 

    

 

(1) On August 6, 2010, VMS’s Board of Directors authorized the repurchase of 8,000,000 shares of VMS common stock from August 7, 2010 through September 30, 2011. In February 2011, VMS’s Board of Directors authorized the repurchase of an additional 12,000,000 shares of VMS common stock through the end of our fiscal year 2012. We expect remaining repurchases under these authorization, if any, will be made in open market purchases, in privately negotiated transactions or under Rule 10b5-1 share repurchase plans, and may be made from time to time or in one or more large blocks, including accelerated share repurchase arrangements. Shares will be retired upon repurchase.
(2) Includes 70,747 shares of VMS common stock that were tendered to VMS in satisfaction of tax withholding obligations upon the vesting of restricted common stock and restricted stock units granted under the Company’s employee stock plans.

Also includes 630,921 shares of VMS common stock that were received from BofA upon settlement of the February 2011 Repurchase Agreement. See Note 13, “Stockholders’ Equity” of the Notes to the Condensed Consolidated Financial Statements.

 

(3) The calculation of average price paid per share includes $41.3 million, representing the then market value of the 630,921 shares of VMS common stock received upon settlement of the February 2011 Repurchase Agreement. See Note 13, “Stockholders’ Equity” of the Notes to the Condensed Consolidated Financial Statements.

 

Item 3. Defaults Upon Senior Securities

None.

 

Item 4. Removed and reserved

 

Item 5. Other Information

None.

 

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Item 6. Exhibits

 

(a) Exhibits required to be filed by Item 601 of Regulation S-K:

 

Exhibit No.

  

Description

15.1    Letter Regarding Unaudited Interim Financial Information.
31.1    Chief Executive Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act.
31.2    Chief Financial Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act.
32.1    Certification pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2    Certification pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS†    XBRL Instance Document
101.SCH†    XBRL Taxonomy Extension Schema Document
101.CAL†    XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF†    XBRL Taxonomy Extension Definition Linkbase Document
101.LAB†    XBRL Taxonomy Extension Label Linkbase Document
101.PRE†    XBRL Taxonomy Extension Presentation Linkbase Document

 

Attached as Exhibit 101 to this Quarterly Report on Form 10-Q are the following formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Statements of Earnings for the three and nine months ended July 1, 2011 and July 2, 2010; (ii) Condensed Consolidated Statements of Earnings for the three and nine months ended July 1, 2011 and July 2, 2010; (iii) Condensed Consolidated Balance Sheets at July 1, 2011 and October 1, 2010; (iv) Condensed Consolidated Statements of Cash Flows for the three and nine months ended July 1, 2011 and July 2, 2010; and (v) Notes to Condensed Consolidated Financial Statements for the three and nine months ended July 1, 2011 and July 2, 2010.

In accordance with Rule 406T of Regulation S-T, the XBRL related information in Exhibit 101 to this Quarterly Report on Form 10-Q shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, and shall not be part of any registration statement or other document filed under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

   

VARIAN MEDICAL SYSTEMS, INC.

    (Registrant)
Dated: August 10, 2011   By:  

/s/    ELISHA W. FINNEY        

    Elisha W. Finney
    Senior Vice President, Finance and
    Chief Financial Officer
    (Duly Authorized Officer and
    Principal Financial Officer)

 

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INDEX TO EXHIBITS

 

Exhibit No.

  

Description

15.1    Letter Regarding Unaudited Interim Financial Information.
31.1    Chief Executive Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act.
31.2    Chief Financial Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act.
32.1    Certification pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2    Certification pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS†    XBRL Instance Document
101.SCH†    XBRL Taxonomy Extension Schema Document
101.CAL†    XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF†    XBRL Taxonomy Extension Definition Linkbase Document
101.LAB†    XBRL Taxonomy Extension Label Linkbase Document
101.PRE†    XBRL Taxonomy Extension Presentation Linkbase Document

 

Attached as Exhibit 101 to this Quarterly Report on Form 10-Q are the following formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Statements of Earnings for the three and nine months ended July 1, 2011 and July 2, 2010; (ii) Condensed Consolidated Statements of Earnings for the three and nine months ended July 1, 2011 and July 2, 2010; (iii) Condensed Consolidated Balance Sheets at July 1, 2011 and October 1, 2010; (iv) Condensed Consolidated Statements of Cash Flows for the three and nine months ended July 1, 2011 and July 2, 2010; and (v) Notes to Condensed Consolidated Financial Statements for the three and nine months ended July 1, 2011 and July 2, 2010.

In accordance with Rule 406T of Regulation S-T, the XBRL related information in Exhibit 101 to this Quarterly Report on Form 10-Q shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, and shall not be part of any registration statement or other document filed under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

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