Quarterly Report on Form 10-Q
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

 

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

For the quarterly period ended June 30, 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 000-30713

LOGO

Intuitive Surgical, Inc.

(Exact name of Registrant as specified in its Charter)

 

Delaware   77-0416458
(State or Other Jurisdiction of Incorporation or Organization)   (I.R.S. Employer Identification Number)

1266 Kifer Road

Sunnyvale, California 94086

(Address of Principal Executive Offices) (Zip Code)

(408) 523-2100

(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 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 definition of “large accelerated filer,” “accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer  x   Accelerated filer  ¨   Non-accelerated filer  ¨   Smaller Reporting company  ¨
      (Do not check if a smaller reporting company)

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

The Registrant had 39,083,127 shares of Common Stock, $0.001 par value per share, outstanding as of July 14, 2011.

 

 

 

 


Table of Contents

INTUITIVE SURGICAL, INC.

TABLE OF CONTENTS

 

          Page No.  

PART I. FINANCIAL INFORMATION

  

Item 1.

  

Condensed Consolidated Financial Statements (Unaudited):

     3   
  

Condensed consolidated balance sheets as of June 30, 2011 and December 31, 2010

     3   
  

Condensed consolidated statements of income for the three and six-month periods ended June  30, 2011 and June 30, 2010

     4   
  

Condensed consolidated statements of cash flows for the six-month periods ended June  30, 2011 and June 30, 2010

     5   
  

Notes to condensed consolidated financial statements

     6   

Item 2.

  

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

     16   

Item 3.

  

Quantitative and Qualitative Disclosures About Market Risk

     27   

Item 4.

  

Controls and Procedures

     27   

PART II. OTHER INFORMATION

  

Item 1.

  

Legal Proceedings

     27   

Item 1A.

  

Risk Factors

     28   

Item 2.

  

Unregistered Sales of Equity Securities and Use of Proceeds

     29   

Item 3.

  

Defaults Upon Senior Securities

     29   

Item 5.

  

Other Information

     29   

Item 6.

  

Exhibits

     30   
  

Signature

     31   

 

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Table of Contents

PART I — FINANCIAL INFORMATION

 

Item 1. Financial Statements

INTUITIVE SURGICAL, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN MILLIONS, EXCEPT PAR VALUE)

(UNAUDITED)

 

     June 30,      December 31,  
     2011      2010  

ASSETS

     

Current assets:

     

Cash and cash equivalents

   $ 382.0       $ 279.8   

Short-term investments

     611.9         630.6   

Accounts receivable, net

     250.3         246.8   

Inventory

     100.1         86.8   

Prepaids and other assets

     17.0         23.3   

Deferred tax assets

     4.0         8.5   
                 

Total current assets

     1,365.3         1,275.8   

Property, plant and equipment, net

     194.2         159.8   

Long-term investments

     828.1         698.5   

Long-term deferred tax assets

     77.3         73.3   

Intangible and other assets, net

     68.1         66.1   

Goodwill

     116.9         116.9   
                 

Total assets

   $ 2,649.9       $ 2,390.4   
                 

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities:

     

Accounts payable

   $ 37.5       $ 35.6   

Accrued compensation and employee benefits

     54.6         63.4   

Deferred revenue

     134.3         126.1   

Other accrued liabilities

     47.6         48.7   
                 

Total current liabilities

     274.0         273.8   

Long-term liabilities

     87.4         79.2   
                 

Total liabilities

     361.4         353.0   
                 

Commitments and contingencies

     

Stockholders’ equity:

     

Preferred stock, 2.5 shares authorized, $0.001 par value, issuable in series; no shares issued and outstanding as of June 30, 2011 and December 31, 2010

     —           —     

Common stock, 100.0 shares authorized, $0.001 par value, 39.1 and 38.9 shares issued and outstanding as of June 30, 2011 and December 31, 2010, respectively

     —           —     

Additional paid-in capital

     1,487.4         1,316.9   

Retained earnings

     798.5         718.9   

Accumulated other comprehensive income

     2.6         1.6   
                 

Total stockholders’ equity

     2,288.5         2,037.4   
                 

Total liabilities and stockholders’ equity

   $ 2,649.9       $ 2,390.4   
                 

See accompanying Notes to Condensed Consolidated Financial Statements.

 

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INTUITIVE SURGICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(IN MILLIONS, EXCEPT PER SHARE AMOUNTS)

(UNAUDITED)

 

     Three Months Ended      Six Months Ended  
     June 30,      June 30,  
     2011      2010      2011      2010  

Revenue:

           

Product

   $ 358.1       $ 295.3       $ 682.6       $ 573.3   

Service

     67.6         55.4         131.2         106.0   
                                   

Total revenue

     425.7         350.7         813.8         679.3   

Cost of revenue:

           

Product

     93.5         72.7         178.3         140.7   

Service

     25.6         21.2         50.1         41.3   
                                   

Total cost of revenue

     119.1         93.9         228.4         182.0   
                                   

Gross profit

     306.6         256.8         585.4         497.3   
                                   

Operating expenses:

           

Selling, general, and administrative

     106.5         88.6         205.6         171.4   

Research and development

     32.0         28.5         63.4         56.5   
                                   

Total operating expenses

     138.5         117.1         269.0         227.9   
                                   

Income from operations

     168.1         139.7         316.4         269.4   

Interest and other income, net

     4.1         4.5         9.4         8.6   
                                   

Income before taxes

     172.2         144.2         325.8         278.0   

Income tax expense

     54.8         55.5         104.3         104.0   
                                   

Net income

   $ 117.4       $ 88.7       $ 221.5       $ 174.0   
                                   

Earnings per share:

           

Basic

   $ 2.99       $ 2.26       $ 5.65       $ 4.45   
                                   

Diluted

   $ 2.91       $ 2.19       $ 5.51       $ 4.31   
                                   

Shares used in computing earnings per share:

           

Basic

     39.2         39.3         39.2         39.1   
                                   

Diluted

     40.3         40.5         40.2         40.4   
                                   

See accompanying Notes to Condensed Consolidated Financial Statements.

 

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INTUITIVE SURGICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(IN MILLIONS)

(UNAUDITED)

 

     Six Months Ended  
     June 30,  
     2011     2010  

Operating Activities:

    

Net income

   $ 221.5      $ 174.0   

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

    

Depreciation

     13.8        11.4   

Amortization of intangible assets

     8.7        7.9   

Deferred income taxes

     0.8        0.4   

Income tax benefits from employee stock option plans

     21.1        40.7   

Excess tax benefit from stock-based compensation

     (24.4     (46.9

Share-based compensation expense

     66.9        57.1   

Changes in operating assets and liabilities:

    

Accounts receivable

     (3.5     10.7   

Inventory

     (13.3     (16.4

Prepaids and other assets

     (3.1     0.8   

Accounts payable

     1.8        14.3   

Accrued compensation and employee benefits

     (9.0     (7.5

Deferred revenue

     8.5        8.3   

Accrued liabilities

     6.5        36.3   
                

Net cash provided by operating activities

     296.3        291.1   
                

Investing Activities:

    

Purchase of investments

     (725.9     (604.3

Proceeds from sales and maturities of investments

     619.3        386.6   

Purchase of property and equipment and acquisition of intellectual property

     (53.2     (36.5
                

Net cash used in investing activities

     (159.8     (254.2
                

Financing Activities:

    

Proceeds from issuance of common stock, net

     91.2        115.9   

Excess tax benefit from stock-based compensation

     24.4        46.9   

Repurchase and retirement of common stock

     (150.7     —     
                

Net cash provided by (used in) financing activities

     (35.1     162.8   
                

Effect of exchange rate changes on cash and cash equivalents

     0.8        (1.1
                

Net increase in cash and cash equivalents

     102.2        198.6   

Cash and cash equivalents, beginning of period

     279.8        221.4   
                

Cash and cash equivalents, end of period

   $ 382.0      $ 420.0   
                

See accompanying Notes to Condensed Consolidated Financial Statements.

 

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INTUITIVE SURGICAL, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

In this report, “Intuitive Surgical,” “Intuitive,” and the “Company” refer to Intuitive Surgical, Inc. and its wholly-owned subsidiaries.

NOTE 1. DESCRIPTION OF BUSINESS

Intuitive Surgical, Inc. designs, manufactures, and markets the da Vinci Surgical System, which is an advanced surgical system that the Company believes represents a new generation of surgery. The da Vinci Surgical System consists of a surgeon’s console or consoles, a patient-side cart, a high performance vision system and proprietary “wristed” instruments. The da Vinci Surgical System translates the surgeon’s natural hand movements on instrument controls at the console into corresponding micro-movements of instruments positioned inside the patient through small puncture incisions, or ports. The Company markets its products through sales representatives in the United States, and through a combination of sales representatives and distributors in its international markets.

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

In the opinion of management, the accompanying unaudited Condensed Consolidated Financial Statements (“financial statements”) of Intuitive Surgical, Inc. and its wholly-owned subsidiaries have been prepared on a consistent basis with the December 31, 2010 audited Consolidated Financial Statements and include all adjustments, consisting of only normal recurring adjustments, necessary to fairly state the information set forth herein. These financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”), and, therefore, omit certain information and footnote disclosure necessary to present the statements in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). These financial statements should be read in conjunction with the audited Consolidated Financial Statements and Notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010, which was filed on February 1, 2011. The results of operations for the first six months of fiscal 2011 are not indicative of the results to be expected for the entire fiscal year or any future periods.

New Accounting Standards Recently Adopted

No new accounting standards have been adopted since the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010 was filed.

Recent Accounting Pronouncements

In June 2011, the FASB issued new accounting guidance related to the presentation of comprehensive income that increases comparability between U.S. GAAP and IFRS. This guidance eliminates the current option to report other comprehensive income and its components in the statement of changes in equity and instead requires presenting in one continuous statement or two separate but consecutive statements. This guidance is effective for the Company’s interim and annual periods beginning January 1, 2012. The Company does not believe the adoption of this guidance will have a material impact on its consolidated financial statements, as it only requires a change in the format of presentation.

 

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NOTE 3. CASH, CASH EQUIVALENTS & INVESTMENTS

The following tables summarize the Company’s cash, cash equivalents and investments as of June 30, 2011 and December 31, 2010 (in millions):

 

     Amortized
Cost
     Gross
Unrealized
Gains
     Gross
Unrealized
Losses
    Fair
Value
 

June 30, 2011

          

Cash and cash equivalents:

          

Cash

   $ 20.3       $ —         $ —        $ 20.3   

Cash equivalents

     361.7         —           —          361.7   
                                  

Total cash and cash equivalents

   $ 382.0       $ —         $ —        $ 382.0   
                                  

Available for sale investments:

          

Short-term

          

Commercial paper

   $ 90.3       $ —         $ —        $ 90.3   

Municipal notes

     108.4         0.3         —          108.7   

U.S. corporate debt & equity securities

     170.0         1.4         —          171.4   

U.S. treasuries

     106.8         0.1         —          106.9   

U.S. government agencies

     134.4         0.2         —          134.6   
                                  

Total short-term

   $ 609.9       $ 2.0       $ —        $ 611.9   
                                  

Long-term

          

Municipal notes

   $ 142.8       $ 0.6       $ (3.9   $ 139.5   

U.S. corporate debt

     380.9         2.4         (0.3     383.0   

U.S. treasuries

     18.4         0.1         —          18.5   

U.S. government agencies

     253.2         0.9         —          254.1   

Non-U.S. government securities

     32.7         0.3         —          33.0   
                                  

Total long-term

   $ 828.0       $ 4.3       $ (4.2   $ 828.1   
                                  

Total cash, cash equivalents and available for sale investments

   $ 1,819.9       $ 6.3       $ (4.2   $ 1,822.0   
                                  

 

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     Amortized
Cost
     Gross
Unrealized
Gains
     Gross
Unrealized
Losses
    Fair
Value
 

December 31, 2010

          

Cash and cash equivalents:

          

Cash

   $ 20.1       $ —         $ —        $ 20.1   

Cash equivalents

     259.7         —           —          259.7   
                                  

Total cash and cash equivalents

   $ 279.8       $ —         $ —        $ 279.8   
                                  

Available for sale investments:

          

Short-term

          

Commercial paper

   $ 79.0       $ —         $ —        $ 79.0   

Municipal notes

     111.8         0.4         —          112.2   

U.S. corporate debt

     174.1         1.3         —          175.4   

U.S. treasuries

     76.3         —           —          76.3   

U.S. government agencies

     187.4         0.3         —          187.7   
                                  

Total short-term

   $ 628.6       $ 2.0       $ —        $ 630.6   
                                  

Long-term

          

Municipal notes

   $ 143.4       $ 0.3       $ (4.3   $ 139.4   

U.S. corporate debt

     300.4         1.8         (0.9     301.3   

U.S. treasuries

     39.9         0.1         —          40.0   

U.S. government agencies

     196.7         0.3         (0.4     196.6   

Non-U.S. government securities

     21.2         0.1         (0.1     21.2   
                                  

Total long-term

   $ 701.6       $ 2.6       $ (5.7   $ 698.5   
                                  

Total cash, cash equivalents and available for sale investments

   $ 1,610.0       $ 4.6       $ (5.7   $ 1,608.9   
                                  

The following table summarizes the maturities of the Company’s cash equivalents and available-for-sale investments, excluding equity securities, as of June 30, 2011 (in millions):

 

     Amortized
Cost
     Fair
Value
 

Mature in less than one year

   $ 970.9       $ 972.4   

Mature in one to five years

     805.5         809.4   

Mature in more than five years

     22.5         18.7   
                 

Total

   $ 1,798.9       $ 1,800.5   
                 

During the six months ended June 30, 2011, realized gains recognized on the sale of investments were approximately $2.4 million. Realized gains and losses recognized for three months ended June 30, 2011 and three and six months ended June 30, 2010 were not significant. As of June 30, 2011 and December 31, 2010, net unrealized gains on available-for-sale securities, net of tax, of $2.1 million and $1.3 million, respectively were included in accumulated other comprehensive income in the accompanying unaudited Condensed Consolidated Balance Sheets. At June 30, 2011, the Company evaluated its gross unrealized losses, the majority of which were from auction-rate securities (ARS). The Company determined these unrealized losses to be temporary, because the Company does not intend to sell the security and it is not more likely than not that the Company will be required to sell these securities before the recovery of their amortized cost basis.

 

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NOTE 4. FAIR VALUE MEASUREMENTS

The Company measures certain financial assets, including cash equivalents, available-for-sale securities and foreign currency derivatives at their fair value. The fair value of these financial assets was determined based on three levels of inputs, of which the first two are considered observable and the last unobservable, as follows:

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

Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

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.

The following tables represent the Company’s fair value hierarchy for its financial assets and liabilities as of June 30, 2011 and December 31, 2010 (in millions):

 

     Fair Value Measurements at June 30, 2011 Using  

Assets

   Level 1      Level 2      Level 3      Total  

Available-for-sale securities

           

Money Market funds

   $ 337.9       $ —         $ —         $ 337.9   

U.S. treasuries

     125.4         —           —           125.4   

Commercial paper

     —           114.1         —           114.1   

Corporate debt & equity securities

     1.2         553.2         —           554.4   

U.S. government agencies

     —           388.7         —           388.7   

Non-U.S. government securities

     —           33.0         —           33.0   

Municipal notes

     —           229.5         18.7         248.2   
                                   

Total available-for-sale securities

     464.5         1,318.5         18.7         1,801.7   
                                   

Total assets measured at fair value

   $ 464.5       $ 1,318.5       $ 18.7       $ 1,801.7   
                                   

Liabilities

                           

Foreign Currency Derivatives

   $ —         $ 2.2       $ —         $ 2.2   
                                   

Total liabilities measured at fair value

   $ —         $ 2.2       $ —         $ 2.2   
                                   

 

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     Fair Value Measurements at December 31, 2010 Using  

Assets

   Level 1      Level 2      Level 3      Total  

Available-for-sale securities

           

Money Market funds

   $ 211.2       $ —         $ —         $ 211.2   

U.S. treasuries

     116.3         —           —           116.3   

Commercial paper

     —           122.5         —           122.5   

Corporate debt

     —           476.8         —           476.8   

U.S. government agencies

     —           389.2         —           389.2   

Non-U.S. government securities

     —           21.1         —           21.1   

Municipal notes

     —           233.1         18.6         251.7   
                                   

Total available-for-sale securities

     327.5         1,242.7         18.6         1,588.8   
                                   

Foreign Currency Derivatives

     —           0.2         —           0.2   
                                   

Total assets measured at fair value

   $ 327.5       $ 1,242.9       $ 18.6       $ 1,589.0   
                                   

Liabilities

                           

Foreign Currency Derivatives

   $ —         $ 2.1       $ —         $ 2.1   
                                   

Total liabilities measured at fair value

   $ —         $ 2.1       $ —         $ 2.1   
                                   

Level 2 securities are priced using quoted market prices for similar instruments, nonbinding market prices that are corroborated by observable market data, or discounted cash flow techniques. The Company’s derivative instruments are primarily classified as Level 2 as they are not actively traded and are valued using pricing models that use observable market inputs. There have been no transfers between Level 1 and Level 2 measurements during the three and six months ended June 30, 2011. Level 3 assets consist of municipal bonds with an auction reset feature (ARS) whose underlying assets are student loans which are substantially backed by the federal government. Since the auctions for these securities have continued to fail since February 2008, these investments are not currently trading and therefore do not have a readily determinable fair value. The Company has valued the ARS using a discounted cash flow model based on Level 3 assumptions, including estimates of, based on data available as of June 30, 2011, interest rates, timing and amount of cash flows, credit and liquidity premiums and expected holding periods of the ARS.

Foreign currency derivative

Cash Flow Hedges

The Company enters into currency forward contracts as cash flow hedges to hedge certain forecasted revenue transactions denominated in currencies other than the U.S. dollar, primarily the Euro and GBP.

As of June 30, 2011 and December 31, 2010, the Company had notional amounts of €24.5 million and €21.0 million, respectively, of outstanding currency forward contracts entered into to hedge Euro dominated sales. The net gains (losses) reclassified to revenue related to hedged revenue transactions for the three and six months ended June 30, 2011 were $(1.0) million and $(1.6) million, respectively, compared with $1.9 million and $2.5 million, respectively, for the same periods in 2010.

Other Derivatives Not Designated as Hedging Instruments

Other derivatives not designated as hedging instruments consist primarily of forward contracts that the Company uses to hedge intercompany balances and other monetary assets or liabilities denominated in currencies other than the U.S. dollar, primarily the Euro and GBP.

As of June 30, 2011, the Company had notional amounts of €22.5 million and £2.7 million outstanding currency forward contracts that were entered into to hedge non-functional currency denominated net monetary assets, compared to €26.0 million and £2.2 million at December 31, 2010. For the three months ended June 30, 2011 and 2010, the Company had recognized gains (losses) of approximately $(1.0) million and $1.9 million, respectively, in interest and other income, net, related to derivative instruments used to hedge against balance sheet foreign currency exposures. These were offset by net foreign exchange gains (losses) of approximately $1.0 million and $(2.2) million during the three months ended June 30, 2011 and 2010, respectively, primarily related to the re-measurement of non-functional currency denominated net monetary assets. For the six months ended June 30, 2011 and 2010, the Company had recognized gains (losses) of approximately $(3.2) million and $4.1 million, respectively, in interest and other income, net, related to derivative instruments used to hedge against balance sheet foreign currency exposures. These were offset by net foreign exchange gains (losses) of approximately $3.3 million and $(4.9) million during the six months ended June 30, 2011 and 2010, respectively, primarily related to the re-measurement of non-functional currency denominated net monetary assets.

 

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NOTE 5. BALANCE SHEET DETAILS

The following table provides details of selected balance sheet items (in millions):

 

     June 30,
2011
     December 31,
2010
 

Inventory

     

Raw materials

   $ 26.8       $ 25.6   

Work-in-process

     2.6         2.5   

Finished goods

     70.7         58.7   
                 

Total

   $ 100.1       $ 86.8   
                 

During the three month period ended June 30, 2011, the Company purchased land and buildings in Sunnyvale, California for approximately $33.1 million.

NOTE 6. CONTINGENCIES

On August 6, 2010, a purported class action lawsuit entitled Perlmutter v. Intuitive Surgical et al., No. CV10-3451, was filed against the Company and seven of the Company’s current and former officers and directors in the United States District Court for the Northern District of California. The lawsuit seeks unspecified damages on behalf of a putative class of persons who purchased or otherwise acquired the Company’s common stock between February 1, 2008 and January 7, 2009. The complaint alleges that the defendants violated federal securities laws by making allegedly false and misleading statements and omitting certain material facts in the Company’s filings with the Securities and Exchange Commission. On February 15, 2011, the Police Retirement System of St. Louis was appointed Lead Plaintiff in the case pursuant to the Private Securities Litigation Reform Act of 1995. An amended complaint was filed on April 15, 2011, making allegations substantially similar to the allegations described above. On May 23, 2011 the Company filed a motion to dismiss the amended complaint; that motion is scheduled to be heard on August 11, 2011.

On August 19, 2010, an alleged stockholder caused a purported stockholder’s derivative lawsuit entitled Himmel v. Smith et al., No. 1-10-CV-180416, to be filed in the Superior Court of California for the County of Santa Clara naming the Company as a nominal defendant, and naming 14 of the Company’s current and former officers and directors as defendants. The lawsuit seeks to recover, for the Company’s benefit, unspecified damages purportedly sustained by the Company in connection with allegedly misleading statements and/or omissions made in connection with the Company’s financial reporting for the period between February 1, 2008 and January 7, 2009. It also seeks a series of changes to the Company’s corporate governance policies and an award of attorneys’ fees. On September 15, 2010, another purported stockholder filed an essentially identical lawsuit entitled Applbaum v. Guthart et al., No. 1-10-CV-182645, in the same court against 15 of the Company’s current and former officers and directors. On October 5, 2010 the court ordered that the two cases be consolidated for all purposes. By agreement with the plaintiffs, formal discovery has been stayed in the case.

Due to the uncertainty surrounding the litigation process, the Company is unable to reasonably estimate the ultimate outcome of the above cases at this time, and therefore no amounts have been accrued related to the outcome of the cases above. Based on currently available information, the Company believes that it has meritorious defenses to the above actions and that the resolution of these cases is not likely to have a material adverse effect on the Company’s business, financial position or future results of operations.

The Company is also a party to various other legal actions that arose in the ordinary course of its business. The Company does not believe that any of these other legal actions will have a material adverse impact on its business, financial position or results of operations.

 

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NOTE 7. STOCKHOLDERS’ EQUITY

Stock Repurchase Program

During the year ended December 31, 2010, the Company repurchased and retired approximately 0.7 million shares of its common stock at an average purchase price of $267.81 per share, for an aggregate purchase price of $198.6 million, through open market transactions. On February 3, 2011, the Board increased its authorization for stock repurchases to $400 million. During the three months ended June 30, 2011, the Company repurchased and retired approximately 401,000 shares of its common stock at an average purchase price of $347.12 per share, for an aggregate purchase price of $139.1 million, through open market transactions. During the six months ended June 30, 2011, the Company repurchased and retired approximately 437,000 shares of its common stock at an average purchase price of $345.15 per share, for an aggregate purchase price of $150.7 million, through open market transactions. As of June 30, 2011, the remaining authorized amount of stock repurchases under the Board-authorized stock repurchase program was approximately $249.3 million.

Comprehensive Income

The components of other comprehensive income, net of tax, are as follows (in millions):

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2011     2010     2011     2010  

Net income

   $ 117.4      $ 88.7      $ 221.5      $ 174.0   

Foreign currency translation gains (losses)

     —          (0.4     0.3        (0.6

Unrealized gains (losses) on derivative instruments, net of tax:

        

Unrealized gains (losses) on derivative instruments

     (0.1     1.1        (1.7     3.1   

Reclassification adjustment for (gains) losses on derivative instruments recognized during the period

     1.0        (2.2     1.6        (3.1

Unrealized gains on available-for-sale securities, net of tax

     2.4        —          0.8        —     
                                

Total other comprehensive income

   $ 120.7      $ 87.2      $ 222.5      $ 173.4   
                                

The components of accumulated other comprehensive income are as follows (in millions):

 

     June 30,
2011
     December 31,
2010
 

Foreign currency translation gains

   $ 0.4       $ 0.1   

Accumulated net realized gains on derivatives, net of tax

     0.1         0.2   

Accumulated net unrealized gains on available-for-sale securities, net of tax

     2.1         1.3   
                 

Total accumulated other comprehensive income

   $ 2.6       $ 1.6   
                 

NOTE 8. STOCK-BASED COMPENSATION

Stock Option Plans

2010 Incentive Award Plan

In April 2011, the Company’s stockholders approved the amended and restated 2010 Incentive Award Plan (“2010 Plan”) to provide for an increase in the number of shares of common stock authorized for issuance pursuant to awards granted under the 2010 Plan from 1,250,000 to 2,450,000.

2009 Employment Commencement Incentive Plan

In July 2011, the Company’s Board of Directors amended and restated the 2009 Employment Commencement Incentive Plan (“2009 Plan”) to provide for an increase in the number of shares of common stock authorized for issuance pursuant to awards granted under the 2009 Plan from 350,000 to 530,000.

 

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A summary of stock option activity under all stock plans for the six months ended June 30, 2011 is presented as follows (in millions, except per share amounts):

 

           Stock Options Outstanding  
     Shares
Available
for Grant
    Number
Outstanding
    Weighted Average
Exercise Price

Per Share
 

Balance at December 31, 2010

     1.4        4.8      $ 209.03   

Options authorized

     1.3        —          —     

Options granted

     (1.2     1.2        339.76   

Options exercised

     —          (0.5     142.81   

Options forfeited/expired

     —          (0.1     274.47   
                  

Balance at June 30, 2011

     1.5        5.4      $ 244.66   
                  

As of June 30, 2011, 2.5 million shares of options were exercisable at a weighted-average price of $194.58 per share.

Employee Stock Purchase Plan

Under the Employee Stock Purchase Plan (“ESPP”), employees purchased 92,072 shares for $10.4 million and 82,948 shares for $7.7 million during the six months ended June 30, 2011 and 2010, respectively.

Stock-based Compensation

The following table summarizes stock-based compensation charges (in millions):

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2011      2010      2011      2010  

Cost of sales - products

   $ 3.2       $ 2.4       $ 6.0       $ 4.5   

Cost of sales - services

     2.8         2.2         5.3         4.1   
                                   

Total cost of sales

     6.0         4.6         11.3         8.6   

Selling, general and administrative

     21.4         20.0         41.6         37.8   

Research and development

     7.4         5.7         14.0         10.7   
                                   

Stock-based compensation expense before income taxes

     34.8         30.3         66.9         57.1   

Income tax effect

     11.2         8.3         21.7         15.9   
                                   

Stock-based compensation expense after income tax effect

   $ 23.6       $ 22.0       $ 45.2       $ 41.2   
                                   

 

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The fair value of each option grant and the fair value of the option component of the ESPP shares were estimated at the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions, assuming no expected dividends:

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2011     2010     2011     2010  
Stock Options         

Average risk free interest rate

     1.95     2.33     2.30     2.33

Average expected term (years)

     4.6        4.6        4.8        4.8   

Average expected volatility

     35     37     35     35

Weighted average fair value at grant date

   $ 113.55      $ 115.53      $ 114.67      $ 111.69   

Total stock-based compensation expense (in millions)

   $ 32.8      $ 28.3      $ 62.8      $ 53.2   
ESPP         

Average risk free interest rate

         0.37     0.49

Average expected term (years)

         1.3        1.3   

Average expected volatility

         35     35

Weighted average fair value at grant date

       $ 97.07      $ 99.34   

Total stock-based compensation expense (in millions)

   $ 2.0      $ 2.0      $ 4.1      $ 3.9   

There were no new ESPP offerings during the three months ended June 30, 2011 and 2010.

NOTE 9. INCOME TAXES

Income tax expense for the three months ended June 30, 2011 was $54.8 million, or 31.8% of pre-tax income, compared with $55.5 million, or 38.5% of pre-tax income for the three months ended June 30, 2010. Income tax expense for the six months ended June 30, 2011 was $104.3 million, or 32.0% of pre-tax income, compared with $104.0 million, or 37.4% of pre-tax income for the six months ended June 30, 2010. The effective tax rate for the three and six months ended June 30, 2011 differs from the U.S. federal statutory rate of 35% primarily due to the effect of income earned by certain of the Company’s overseas entities being taxed at rates lower than the federal statutory rate and research & development credits (“R&D credits”), partially offset by state income taxes and non-deductible stock option expenses. The Company intends these foreign earnings to be indefinitely reinvested outside the United States. The effective tax rate for the three and six months ended June 30, 2010 differs from the federal statutory rate primarily due to state income taxes and non-deductible stock option expenses, partially offset by the effect of income earned by certain of the Company’s overseas entities being taxed at rates lower than the federal statutory rate. The decrease in effective tax rates for the three and six months ended June 30, 2011 compared with the three and six months ended June 30, 2010 is primarily related to R&D credits, the decrease in California tax after the adoption of single sales factor apportionment effective January 1, 2011, and an increase in foreign earnings taxed at lower rates relative to domestic income.

As of June 30, 2011, the Company has total gross unrecognized tax benefits of approximately $86.2 million compared with approximately $78.9 million as of December 31, 2010, representing an increase of approximately $7.3 million for the six months ended June 30, 2011. Of the total gross unrecognized tax benefits, $81.9 million and $74.7 million as of June 30, 2011 and December 31, 2010, respectively, if recognized, would reduce the Company’s effective tax rate in the period of recognition. Gross interest related to unrecognized tax benefit accrued was approximately $6.6 million and $5.5 million, respectively, as of June 30, 2011 and December 31, 2010.

The Company files federal, state and foreign income tax returns in many jurisdictions in the United States and abroad. For U.S. federal and California income tax purposes, the statutes of limitations currently remain open for all years since inception due to utilization of net operating losses and R&D credits generated in prior years.

 

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NOTE 10. NET INCOME PER SHARE

The following table presents the computation of basic and diluted net income per share (in millions, except per share data):

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2011      2010      2011      2010  

Net income

   $ 117.4       $ 88.7       $ 221.5       $ 174.0   

Basic:

           

Weighted-average shares outstanding

     39.2         39.3         39.2         39.1   
                                   

Basic net income per share

   $ 2.99       $ 2.26       $ 5.65       $ 4.45   
                                   

Diluted:

           

Weighted-average shares outstanding used in basic calculation

     39.2         39.3         39.2         39.1   

Add common stock equivalents

     1.1         1.2         1.0         1.3   
                                   

Weighted-average shares used in computing diluted net income per share

     40.3         40.5         40.2         40.4   
                                   

Diluted net income per share

   $ 2.91       $ 2.19       $ 5.51       $ 4.31   
                                   

Employee stock options to purchase approximately 2.5 million and 1.4 million weighted shares for the three months ended June 30, 2011 and 2010, respectively, and 2.2 million and 1.1 million weighted shares for the six months ended June 30, 2011 and 2010, respectively, were outstanding, but were not included in the computation of diluted net income per share because the effect of including such shares would have been antidilutive in the periods presented.

 

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

In this report, “Intuitive Surgical”, “Intuitive”, the “Company”, “we”, “us”, and “our” refer to Intuitive Surgical, Inc and its wholly-owned subsidiaries.

This management’s discussion and analysis of financial condition as of June 30, 2011 and results of operations for the three and six months ended June 30, 2011 and 2010 should be read in conjunction with management’s discussion and analysis of financial condition and results of operations included in our Annual Report on Form 10-K for the year ended December 31, 2010.

This report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to expectations concerning matters that are not historical facts. Words such as “projects,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “may,” “will,” “could,” “should,” “would,” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements related to our expected business, new product introductions, procedures and procedure adoption, results of operations, future financial position, our ability to increase our revenues, the mix of our revenues between product and service revenues, our financing plans and capital requirements, our costs of revenue, our expenses, our potential tax assets or liabilities, the effect of recent accounting pronouncements, our investments, cash flows and our ability to finance operations from cash flows and similar matters and include statements based on current expectations, estimates, forecasts and projections about the economies and markets in which we operate and our beliefs and assumptions regarding these economies and markets. These forward-looking statements should be considered in light of various important factors, including the following: the impact of the global and regional economic conditions and related credit markets and related impact on health care spending; health care reform legislation in the United States and its implications on hospital spending, reimbursement and fees which will be levied on certain medical device revenues; timing and success of product development and market acceptance of developed products; procedure counts; regulatory approvals, clearances and restrictions; guidelines and recommendations in the health care and patient communities; intellectual property positions and litigation; competition in the medical device industry and in the specific markets of surgery in which we operate; unanticipated manufacturing disruptions; delays in regulatory approvals of new manufacturing facilities or the inability to meet demand for products; the results of the year-end audit and other risk factors. Readers are cautioned that these forward-looking statements are based on current expectations and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those risk factors described throughout this filing and detailed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and other periodic filings with the Securities and Exchange Commission, particularly in Part I, “Item 1A: Risk Factors”. Our actual results may differ materially and adversely from those expressed in any forward-looking statements. We undertake no obligation to revise or update any forward-looking statements for any reason.

Intuitive®, Intuitive Surgical®, da Vinci®, da Vinci S®, da Vinci® S HD Surgical System, da Vinci® Si, da Vinci® Si-e HD Surgical SystemTM, EndoWrist®, Single-SiteTM, DVSTATTM and InSite® are trademarks of Intuitive Surgical, Inc.

Overview

Products. We design, manufacture and market da Vinci Surgical Systems, which are advanced surgical systems that we believe represent a new generation of surgery. We believe that this new generation of surgery, which we call da Vinci surgery, is a significant advancement similar in scope to previous generations of surgery—open surgery and minimally invasive surgery, or conventional MIS. The da Vinci Surgical System consists of a surgeon’s console, or consoles, a patient-side cart and a high performance vision system. The da Vinci Surgical System translates the surgeon’s natural hand movements, which are performed on instrument controls at a console, into corresponding micro-movements of instruments positioned inside the patient through small incisions, or ports. We believe that the da Vinci Surgical System provides the surgeon with intuitive control, range of motion, fine tissue manipulation capability and high definition 3-D vision, while simultaneously allowing the surgeons to work through the small ports of MIS.

By placing computer-enhanced technology between the surgeon and the patient, we believe that the da Vinci Surgical System enables surgeons to deliver higher value minimally invasive surgical procedures to their patients. We model patient value as equal to: procedure efficacy / invasiveness. Here procedure efficacy is a measure of the success of the surgery in resolving the underlying disease and invasiveness is how disruptive and painful the treatment is itself. When the patient value of robotic surgery is significantly higher than competing treatment options, we have seen that patients will seek out surgeons and hospitals that offer da Vinci procedures, potentially resulting in a local shift of treatment approach and market share. The combination of these local adoptions can drive a disruptive change in the marketplace and can lead to the broad adoption of robotic surgery. These adoptions occur procedure by procedure, and are driven by the relative patient value of da Vinci procedures against alternatives for the same disease state.

 

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Business Model. In our business model, we generate revenue from both the initial capital sales of da Vinci Surgical Systems as well as recurring revenue, derived from sales of instruments, accessories, and service. The da Vinci Surgical System generally sells for between $1.0 million and $2.3 million, depending on configuration and geography, and represents a significant capital equipment investment for our customers. We then generate recurring revenue as our customers consume our EndoWrist instruments and accessory products for use in performing procedures with the da Vinci Surgical System. EndoWrist instruments and accessories have a limited life and will either expire or wear out as they are used in surgery, at which point they are replaced. We also generate recurring revenue from ongoing system service. We typically enter into service contracts at the time systems are sold. These service contracts have been generally renewable at the end of the service period, typically at an annual rate of approximately $100,000 to $170,000 per year, depending on the configuration of the underlying system.

Recurring revenue has grown at a rate equal to or faster than the rate of growth of system revenue. Recurring revenue increased from $419.6 million, or 48% of total revenue in 2008 to $561.7 million, or 53% of total revenue in 2009 to $752.7 million, or 53% of total revenue in 2010. Recurring revenue for the three months ended June 30, 2011 was $239.1 million or 56% of total revenue and for the six months ended June 30, 2011 was $460.1 million, or 57% of total revenue. The increase in recurring revenue relative to system revenue reflects continuing adoption of procedures on a growing base of installed da Vinci Surgical Systems. We expect recurring revenue to become a larger percentage of total revenue in the future. The installed base of da Vinci Surgical Systems has grown to 1,933 at June 30, 2011, compared with 1,840 at March 31, 2011 and 1,752 at December 31, 2010.

Regulatory Activities

We believe that we have obtained the clearances required to market our products to our targeted surgical specialties within the United States. As we make additions to target procedures, we will continue to seek the necessary clearances. The following table lists chronologically our U.S. Food & Drug Administration (“FDA”) clearances to date:

 

   

July 2000—General laparoscopic procedures

 

   

March 2001—Non-cardiac thoracoscopic procedures

 

   

May 2001—Prostatectomy procedures

 

   

November 2002—Cardiotomy procedures

 

   

July 2004—Cardiac revascularization procedures

 

   

March 2005—Urologic surgical procedures

 

   

April 2005—Gynecologic surgical procedures

 

   

June 2005—Pediatric surgical procedures

 

   

December 2009—Transoral Otolaryngologic surgical procedures

During the first quarter of 2009, we received clearance to market our da Vinci Si Surgical System in the United States and Europe.

In November 2009, we received regulatory (Shonin) approval from the Japanese Ministry of Health, Labor, and Welfare (MHLW) for our da Vinci S System in Japan. During the three and six months ended June 30, 2011 we sold 4 and 9 da Vinci S Systems, respectively, compared to 1 and 8 systems during the three and six months ended June 30, 2010, respectively, in Japan. These sales were primarily made to early adopters. We are currently focusing our efforts on obtaining specific reimbursement for da Vinci procedures in Japan. If we are not successful in obtaining the necessary reimbursement approvals or obtaining approvals for future products and procedures, then the demand for our products could be limited. We have partnered with the experienced regulatory team from Johnson & Johnson K.K. Medical Company (Japan) in our Japanese regulatory process and are continuing to work with them to meet government requirements. We have partnered with Adachi Co., LTD as our separate independent distribution partner in Japan who is responsible for marketing, selling, and servicing our products in Japan. The recent earthquake and tsunami in Japan and their aftermath have created significant economic uncertainty in that country. Sales to customers located in Japan represented approximately 1% of our product revenue in 2010. Since the earthquake, we have noticed a drop in commercial activity in Japan. We believe economic activity in the country may be disrupted for a substantial period of time, including a reduction in hospital spending. As a result, our sales in Japan may be adversely affected. Given the relatively small proportion of our total revenue coming from Japanese customers, we do not expect the overall impact on our revenues resulting from the earthquake and tsunami in Japan to be material. However, we do expect demand for our products in Japan through 2012 to be curtailed as health spending resources are redeployed into more immediately critical areas. At this time, we do not believe that we face any critical inventory supply issues related to Japanese sourced components.

 

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2011 Business Events and Trends

Economic Environment. During the first half of 2009, the world-wide economic recession curtailed capital purchases of our da Vinci Surgical Systems. Beginning in the second half of 2009 through the second quarter of 2011, the U.S. economy has been recovering slowly. Demand for da Vinci systems in Europe has recovered more slowly than in the U.S. European demand, driven by procedure growth, has been stronger and more consistent in the larger German, French, and Italian markets. Demand in the smaller European economies has been more sporadic. Demand for da Vinci systems fluctuates quarter to quarter based upon changing economic and geopolitical factors. The 129 and 249 total da Vinci Surgical Systems sold in the three and six months ended June 30, 2011 exceeded those sold during the same periods of 2010 by 21 and 37 systems, respectively.

da Vinci Si Surgical System Market Acceptance. In the second quarter of 2009 we launched our newest da Vinci model, the da Vinci Si. The da Vinci Si Surgical System was FDA approved and CE marked upon launch and is currently available in most countries in Europe and Asia, excluding Japan, among others. da Vinci Si Systems are available with an option to purchase a second console. Existing da Vinci S instruments and most da Vinci S accessories, excluding endoscopes and drapes, are compatible with the da Vinci Si system. The da Vinci S System can be upgraded to the da Vinci Si System; however, most customers have chosen to trade-out their da Vinci S Systems rather than receiving component level field upgrades. We will continue to sell, service and support the da Vinci S Surgical System. Our sales of the standard da Vinci Surgical System have substantially ended; however, we continue to service and support this product line as well.

Market acceptance of the da Vinci Si Surgical System has been positive since its market introduction in the first quarter of 2009. During the three and six months ended June 30, 2011, 121 out of 129 and 234 out of 249 systems sold, respectively, were da Vinci Si models, representing approximately 94% of system sales for the three and six months ended June 30, 2011.

In the third quarter of 2010, we introduced the new Si-e model of the da Vinci Surgical System. The 3-arm Si-e System is designed to deliver core da Vinci functionality, providing a flexible, capable and economical solution for many robotic-assisted procedures. The da Vinci Si-e system is fully upgradeable to the da Vinci Si model by adding a fourth arm (third instrument arm), and other enhancements. During the three and six months ended June 30, 2011, we sold 4 and 7 da Vinci Si-e systems, respectively.

da Vinci Skills Simulator. In the first quarter of 2011, we began shipping the da Vinci Skills Simulator. The simulator is a practice tool for the da Vinci Si Surgical System that gives a user the opportunity to practice in his or her facility with the surgeon console controls. The simulator incorporates three-dimensional, physics-based computer simulation technology to immerse the user within a virtual environment. The user navigates through the environment and completes exercises by controlling virtual instruments from the surgeon console. The suite of exercises includes novice, intermediate, and advanced levels. Upon completion of a skills exercise, the simulator provides a quantitative assessment of user performance based on a variety of task-specific metrics. The simulator is intended to augment, not replace, existing training programs for the da Vinci Si Surgical System. Most da Vinci Skills Simulators have been sold in conjunction with new da Vinci Si Surgical System sales. Demand for the da Vinci Skills Simulator product has been strong. We sold 115 and 162 da Vinci Skills Simulators in the three and six months ended June 30, 2011, respectively.

da Vinci Single-Site instruments. In February 2011 we received the CE mark for our da Vinci Single-Site instrument kit and began selling these new products into Europe. da Vinci Single-Site is a set of instruments and accessories that allow da Vinci Si systems to work through a single incision rather than three incisions. Single incision surgery is intended to minimize trauma to patients by reducing the number of ports required to enter the body. Single site surgery today is typically performed with modified laparoscopic instruments. Early clinical results with manual instruments have been encouraging, however, manual single incision surgery is challenging due to a difficult user interface and the requirement to manage collisions in a small space near the patient. da Vinci Single-Site instruments and accessories are designed to avoid collisions at the patient while the surgeon operates them from the surgeon’s console with intuitive control. The vast majority of da Vinci Single-Site procedures performed to date have been cholecystectomies. da Vinci Single-site instruments and accessories are not yet FDA cleared for sale in the U.S. The FDA has requested additional clinical information which we will submit once collected.

 

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da Vinci Fluorescence Imaging. In the first quarter of 2011, we launched our new da Vinci Fluorescence Imaging product in the U.S. This new accessory offering combines fluorescent dye with a specialized da Vinci endoscope and illuminator to allow surgeons to see vasculature in three dimensions beneath tissue surfaces to assess blood flow and other conditions that cannot be seen with direct imaging. The fluorescent images integrate into the da Vinci surgeon console, providing the surgeon with real time images. We believe that da Vinci Fluorescence Imaging will enable surgeons to work with more confidence and precision in several procedures, potentially including partial nephrectomy and rectal resections. Our phased roll-out of the da Vinci Fluorescence Imaging product is progressing, with its initial use targeted in partial nephrectomy procedures.

Other Product Introductions. In the second quarter of 2011, we released in the U.S. and Europe our new thoracic grasper and dissecting bipolar instruments. In the U.S. we also released a medium/large clip applier. We believe these new instruments are targeted to enhance the da Vinci System’s surgical capability in emerging lobectomy and other thoracic procedures. We also received the CE mark for our new suction-irrigation instrument and we have begun its roll-out in Europe. The suction irrigation instrument is also designed to facilitate thoracic as well as general surgery procedures. We have submitted our 510(k) for the suction irrigation instrument and are working through the approval process with the FDA.

Procedure Adoption

We believe the adoption of da Vinci surgery occurs surgical procedure by surgical procedure, and is being adopted for those procedures which offer significant patient value. The value of a surgical procedure to a patient is higher if it offers superior clinical outcomes, less surgical trauma, or both.

An increasing body of peer reviewed literature has indicated that many of our targeted procedures offer improved clinical outcomes compared to traditional open surgery. For example, it has been reported that da Vinci Prostatectomy (“dVP”) offers less surgical and post-surgical morbidity and da Vinci Hysterectomy (“dVH”) for cancerous conditions offers increased lymph node retrieval counts and a significant reduction in blood transfusions. We believe that for many patients, a minimally invasive approach using the da Vinci Surgical System offers reduced pain, less blood loss, shorter hospital stays, reduced post-operative complications and a quicker return to normal daily activities when compared to open surgery.

In 2010, approximately 278,000 surgical procedures were performed with the da Vinci Surgical System, up approximately 35% compared to 2009. The growth in our overall procedure volume was driven primarily by: dVH in the U.S., dVP outside the U.S. and follow-on procedures in the Urology and Gynecology categories (Partial Nephrectomy, Cystectomy, Pyeloplasty, Sacralcolpopexy, Myomectomy) in the U.S. Total da Vinci surgical procedures for the three and six months ended June 30, 2011 grew by approximately 30%, compared with 36% and 37% for the same periods in 2010.

During 2010, dVH became our highest volume procedure, surpassing dVP. dVH procedure volume grew from approximately 69,000 cases in 2009 to approximately 110,000 cases in 2010. The vast majority of our 2010 dVH volume came from the U.S. market, where we estimate the total annual addressable robotic market to be approximately 300,000 to 350,000 cases, of which about 50,000 are for cancer.

dVP procedure volume grew from approximately 90,000 cases in 2009 to approximately 98,000 cases worldwide in 2010. The large majority of the approximately 85,000 prostatectomies performed each year in the U.S. are done robotically with the da Vinci Surgical System. The majority of our 2010 worldwide dVP growth came from European markets, while our 2010 U.S. dVP volume was essentially flat.

Other procedures (non-dVH/dVP) grew over 50% in 2010. Growth in these other da Vinci procedures is comprised of follow-on procedures such as da Vinci Partial Nephrectomy in Urology and da Vinci Sacralcopopexy in Gynecology as well as other procedures, which we term emerging procedures. Emerging procedures are earlier in their development, such as da Vinci Transoral Robotic Surgery (“dVTORS”) in head and neck surgery. While early results in emerging procedures are encouraging and may point to significant patient value, their growth is off of a small absolute base and their future growth rates are uncertain.

As we increase our penetration into benign dVH and other benign conditions, our procedure volumes are likely to reflect more seasonality as patients have more short-term flexibility regarding when these procedures are performed. Historically, we have experienced relatively lower procedure counts in the first quarter, as insurance deductibles are reset, and the third quarter, attributable to vacation season, especially in Europe. The fourth quarter has historically been the seasonally strongest procedure quarter, as more insurance deductibles are met. Timing of procedures and changes in procedure growth directly affect the timing of instruments and accessory purchases and capital purchases.

 

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Technology Acquisitions

We make strategic acquisitions of intellectual property and related technologies from time to time. Total investments in intellectual property and related technologies during the three and six months ended June 30, 2011 were none and $5.0 million, respectively, compared to $3.0 million and $6.5 million, respectively, during the three and six months ended June 30, 2010. Amortization expense related to purchased intellectual property for the three and six months ended June 30, 2011 were $4.3 million and $8.7 million, respectively, compared to $3.8 million and $7.3 million, respectively, during the three and six months ended June 30, 2010.

Second Quarter 2011 Financial Highlights

 

   

Total revenue increased to $425.7 million, or 21%, during the three months ended June 30, 2011 from $350.7 million during the three months ended June 30, 2010.

 

   

da Vinci procedures performed during the three months ended June 30, 2011 were up approximately 30% compared to the three months ended June 30, 2010.

 

   

Instruments and accessories revenue increased to $171.5 million, or 35%, during the three months ended June 30, 2011 from $127.5 million during the three months ended June 30, 2010.

 

   

Recurring revenue increased to $239.1 million, or 31%, during the three months ended June 30, 2011, representing 56% of total revenue from $182.9 million during the three months ended June 30, 2010, representing 52% of total revenue.

 

   

We sold 129 da Vinci Surgical Systems during the three months ended June 30, 2011, compared with 108 during the three months ended June 30, 2010.

 

   

System revenue increased to $186.6 million, or 11%, during the three months ended June 30, 2011 from $167.8 million during the three months ended June 30, 2010.

 

   

As of June 30, 2011, we had a da Vinci Surgical System installed base of 1,933 systems; 1,411 in the United States, 342 in Europe, and 180 in the rest of the world.

 

   

We added 40 employees during the three months ended June 30, 2011, the majority of which were in field sales, service, training, and product operations, bringing our total headcount to 1,769 as of June 30, 2011.

 

   

Operating income increased to $168.1 million, or 20%, during the three months ended June 30, 2011 compared to $139.7 million during the three months ended June 30, 2010. Operating income included $34.8 million and $30.3 million during the three months ended June 30, 2011 and 2010, respectively, of stock-based compensation expense related to employee stock programs.

 

   

As of June 30, 2011, we had $1,822.0 million in cash, cash equivalents and investments. Cash, cash equivalents, and investments increased by $65.0 million during the three months ended June 30, 2011 driven by cash flow from operations and $31.7 million generated from employee stock programs, offset by $139.1 million of stock repurchases and the purchase of property of $33.1 million.

 

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RESULTS OF OPERATIONS

The following table sets forth, for the periods indicated, certain unaudited Condensed Consolidated Statements of Income information (in millions):

 

     Three months Ended June 30,     Six months Ended June 30,  
            % of total            % of total            % of total            % of total  
      2011      revenue     2010      revenue     2011      revenue     2010      revenue  

Revenue:

                    

Products

   $ 358.1         84   $ 295.3         84   $ 682.6         84   $ 573.3         84

Services

     67.6         16     55.4         16     131.2         16     106.0         16
                                                                    

Total revenue

     425.7         100     350.7         100     813.8         100     679.3         100
                                                                    

Cost of revenue:

                    

Products

     93.5         22     72.7         21     178.3         22     140.7         21

Services

     25.6         6     21.2         6     50.1         6     41.3         6
                                                                    

Total cost of revenue

     119.1         28     93.9         27     228.4         28     182.0         27
                                                                    

Products gross profit

     264.6         62     222.6         63     504.3         62     432.6         63

Services gross profit

     42.0         10     34.2         10     81.1         10     64.7         10
                                                                    

Gross profit

     306.6         72     256.8         73     585.4         72     497.3         73
                                                                    

Operating expenses:

                    

Selling, general, and administrative

     106.5         25     88.6         25     205.6         25     171.4         25

Research and development

     32.0         8     28.5         8     63.4         8     56.5         8
                                                                    

Total operating expenses

     138.5         33     117.1         33     269.0         33     227.9         34
                                                                    

Income from operations

     168.1         39     139.7         40     316.4         39     269.4         40

Interest and other income, net

     4.1         1     4.5         1     9.4         1     8.6         1
                                                                    

Income before taxes

     172.2         40     144.2         41     325.8         40     278.0         41

Income tax expense

     54.8         12     55.5         16     104.3         13     104.0         15
                                                                    

Net income

   $ 117.4         28   $ 88.7         25   $ 221.5         27   $ 174.0         26
                                                                    

Total Revenue

Total revenue was $425.7 million for the three months ended June 30, 2011 compared to $350.7 million for the three months ended June 30, 2010. For the six months ended June 30, 2011, revenue increased to $813.8 million from $679.3 million for the six months ended June 30, 2010. Revenue growth for the first half of 2011 was driven by the continued adoption of da Vinci surgery, driving higher system and recurring revenue. We believe that robotic surgery will be adopted surgical procedure by surgical procedure. Our revenue growth during the periods presented reflects adoption progress made in our target procedures. dVH and dVP are our two largest procedures, representing more than 70% of our total procedures over the past several years. An increasing body of peer reviewed literature has indicated that dVP offers superior surgical outcomes compared to traditional open prostatectomies in the critical categories of cancer removal, continence, and sexual potency. Favorable clinical results have been reported in hysterectomies for cancerous pathology, which include increased lymph node retrieval counts and significant reduction in blood transfusion. We believe that for many patients, a minimally invasive approach using the da Vinci Surgical System offers reduced pain, less blood loss, shorter hospital stays, reduced post-operative complications and a quicker return to normal daily activities.

Revenue within the United States accounted for 80% and 78% of total revenue for the three and six month ended June 30, 2011, and 82% and 81% of total revenue for the three and six month ended June 30, 2010, respectively. We believe domestic revenue has accounted for the large majority of total revenue primarily due to more rapid procedure adoption in the United States, driven by the ability of patients to choose their providers and methods of treatment. For the three and six months ended June 30, 2011, international revenue grew as percentage of total revenue compared to the same period last year, primarily due to higher European sales driven by increased dVP penetration in Europe.

 

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The following table summarizes our revenue and da Vinci Surgical System unit sales for the three and six month ended June 30, 2011 and 2010 (in millions, except percentages and unit sales):

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
      2011     2010     2011     2010  

Revenue

        

Instruments and accessories

   $ 171.5      $ 127.5      $ 328.9      $ 250.2   

Systems

     186.6        167.8        353.7        323.1   
                                

Total product revenue

     358.1        295.3        682.6        573.3   

Services

     67.6        55.4        131.2        106.0   
                                

Total revenue

   $ 425.7      $ 350.7      $ 813.8      $ 679.3   
                                

Recurring revenue

   $ 239.1      $ 182.9      $ 460.1      $ 356.2   
                                

% of total revenue

     56     52     57     52

Domestic

   $ 338.9      $ 287.7      $ 636.1      $ 547.9   

International

     86.8        63.0        177.7        131.4   
                                

Total revenue

   $ 425.7      $ 350.7      $ 813.8      $ 679.3   
                                

% of Revenue – Domestic

     80     82     78     81

% of Revenue – International

     20     18     22     19

Domestic Unit Sales

     99        86        188        166   

International Unit Sales

     30        22        61        46   
                                

Total Unit Sales

     129        108        249        212   
                                

Product Revenue

Product revenue was $358.1 million for the three months ended June 30, 2011 compared with $295.3 million for the three months ended June 30, 2010.

Instruments and accessories revenue increased to $171.5 million for the three months ended June 30, 2011 compared with $127.5 million for the three months ended June 30, 2010. The 35% increase in revenue was driven by a 30% increase in procedures performed and higher stocking orders associated with increased system sales. Procedure growth was primarily driven by hysterectomy and, to a lesser extent, prostatectomy adoption, largely in Europe. Higher procedure volume in follow-on gynecologic procedures, including sacralcolpopexies and myomectomies, follow-on urologic procedures, including partial and full nephrectomies, and emerging procedures, including low anterior resection, lobectomy, and transoral surgeries also contributed to the 2011 procedure growth.

Systems revenue increased to $186.6 million during the three months ended June 30, 2011 from $167.8 million during the three months ended June 30, 2010 primarily due to higher da Vinci system unit sales, partially offset by a lower average selling price, or ASP. We sold 129 da Vinci Surgical Systems during the three months ended June 30, 2011, compared with 108 in the same period last year. 121 of the 129 systems sold during the three months ended June 30, 2011 were the da Vinci Si Surgical Systems. 15 standard and 21 da Vinci S Surgical Systems were traded in as part of da Vinci Si purchase transactions during the three months ended June 30, 2011, compared with 19 standard systems traded in during the same period last year. Systems revenue during the three months ended June 30, 2010 included $6.7 million of da Vinci S to da Vinci Si upgrade revenue. Prior to the fourth quarter 2010, transactions involving customers transitioning from da Vinci S to a da Vinci Si system were included in upgrade revenue and excluded from the system count. Our present treatment reflects the current nature of the higher-priced transactions where customers are now shipped completely new da Vinci Si systems in exchange for their used da Vinci S systems, rather than receiving component level field upgrades of their da Vinci S units. System upgrade revenue was $0.8 million during the three months ended June 30, 2011 compared to $7.6 million during the three months ended June 30, 2010. The da Vinci system ASP was $1.44 million during the three months ended June 30, 2011 compared to $1.48 million for the three months ended June 30, 2010. The lower 2011 system ASP resulted primarily from a higher proportion of system sales involving trade-ins, and the associated credits for the returned units, and product and customer mix. 115 simulators, largely in connection with new system sales, were sold during the three months ended June 30, 2011, including 33 units (and related $1.3 million of revenue) which were deferred ending the first quarter of 2011.

 

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Product revenue was $682.6 million for the six months ended June 30, 2011 compared with $573.3 million for the six months ended June 30, 2010.

Instruments and accessories revenue increased to $328.9 million for the six months ended June 30, 2011 compared with $250.2 million for the six months ended June 30, 2010. The 31% increase in revenue was driven by the same factors driving instruments and accessories revenue growth for the three months ended June 30, 2011 and 2010 as described above.

Systems revenue increased to $353.7 million during the six months ended June 30, 2011 from $323.1 million during the six months ended June 30, 2010 primarily due to higher da Vinci system unit sales, partially offset by a lower ASP. We sold 249 da Vinci Surgical Systems during the six months ended June 30, 2011, compared with 212 in the same period in 2010. 227 of the 249 systems sold during the six months ended June 30, 2011 were the da Vinci Si Surgical Systems. 28 standard and 40 da Vinci S Surgical Systems were traded in as part of da Vinci Si purchase transactions during the six months ended June 30, 2011, compared with 36 standard systems traded in during the same period last year. System revenue during the six months ended June 30, 2010 included $11.0 million of da Vinci S to da Vinci Si upgrade revenue. Prior to the fourth quarter 2010, transactions involving customers transitioning from da Vinci S to a da Vinci Si system were included in upgrade revenue and excluded from the system count. Our present treatment reflects the current nature of the higher-priced transactions where customers are now shipped completely new da Vinci Si systems in exchange for their used da Vinci S systems, rather than receiving component level field upgrades of their da Vinci S units. System upgrade revenue was $2.3 million during the six months ended June 30, 2011 compared to $12.6 million during the six months ended June 30, 2010. The da Vinci system ASP was $1.41 million during the six months ended June 30, 2011 compared to $1.47 million during the six months ended June 30, 2010. The lower 2011 ASP resulted primarily from a higher proportion of system sales involving trade-ins, and the associated credits for the returned units. During the six months ended June 30, 2011, we recognized revenue of approximately $7.8 million related to da Vinci Skills Simulators, sold largely in connection with new system sales. 162 simulators were sold during the six months ended June 30, 2011.

Service Revenue

Service revenue, comprised primarily of system service and customer training, increased 22% to $67.6 million for the three months ended June 30, 2011 compared with $55.4 million for the three months ended June 30, 2010. We typically enter into system service contracts at the time systems are sold. These service contracts have been generally renewed at the end of the service period. Higher service revenue for the three months ended June 30, 2011 was primarily driven by a larger base of da Vinci Surgical Systems producing contract service revenue.

Service revenue increased 24% to $131.2 million for the six months ended June 30, 2011 compared with $106.0 million for the six months ended June 30, 2010. Higher service revenue during the first six months of 2011 was primarily driven by a larger base of da Vinci Surgical Systems producing contract service revenue.

Gross Profit

Product gross profit for the three months ended June 30, 2011 increased 19% to $264.6 million, or 73.9% of product revenue, compared with $222.6 million, or 75.4% of product revenue, for the three months ended June 30, 2010. Product gross profit for the six months ended June 30, 2011 increased 17% to $504.3 million, or 73.9% of product revenue, compared with $432.6 million, or 75.5% of product revenue, for the six months ended June 30, 2010. The higher product gross profit was driven by higher 2011 product revenue, as described above. The lower product gross profit percentages for the three and six months ended June 30, 2011 reflect the lower ASP as previously described, the inclusion of lower margin da Vinci Skills Simulators in 2011, and higher reserves taken for excess inventory.

 

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Service gross profit for the three months ended June 30, 2011 increased 23% to $42.0 million, or 62.1% of service revenue, compared with $34.2 million, or 61.7% of service revenue, for the three months ended June 30, 2010. Service gross profit for the six months ended June 30, 2011 increased 25% to $81.1 million, or 61.8% of service revenue, compared with $64.7 million, or 61.0% of service revenue, for the six months ended June 30, 2010. The higher 2011 service gross profit was driven by higher service revenue, as described above. The slightly higher gross service profit percentages for the three and six months ended June 30, 2011 were primarily driven by decreased service costs per system.

Selling, General and Administrative Expenses

Selling, general and administrative expenses include costs for sales, marketing and administrative personnel, proctoring expenses, tradeshow expenses, legal expenses, regulatory fees and general corporate expenses.

Selling, general and administrative expenses for the three months ended June 30, 2011 increased 20% to $106.5 million compared with $88.6 million for the three months ended June 30, 2010. Selling, general and administrative expenses for the six months ended June 30, 2011 increased 20% to $205.6 million compared with $171.4 million for the six months ended June 30, 2010. The increases were due to organizational growth to support our expanding business, particularly in the clinical field sales function, higher commissions related to higher revenue levels, and increased stock-based compensation expenses. Stock-based compensation expenses charged to sales, general and administrative expenses were approximately $21.4 million and $41.6 million for the three and six months ended June 30, 2011, respectively, compared with $20.0 million and $37.8 million during the three and six months ended June 30, 2010, respectively.

Research and Development Expenses

Research and development costs are expensed as incurred. Research and development expenses include costs associated with the design, development, testing and enhancement of our products. These enhancements represent significant improvements to our products.

Research and development expenses for the three months ended June 30, 2011 increased 12% to $32.0 million compared with $28.5 million for the three months ended June 30, 2010. Research and development expenses for the six months ended June 30, 2011 increased 12% to $63.4 million compared with $56.5 million for the six months ended June 30, 2010. The increases were due to the growth in our research and development organization, higher stock-based compensation expenses, and higher prototype costs. Amortization expense related to purchased intellectual property during the three months ended June 30, 2011 and 2010 were $3.4 million and $3.7 million, respectively. Amortization expense related to purchased intellectual property during the six months ended June 30, 2011 was $7.0 million compared to $7.3 million during the six months ended June 30, 2010. Stock-based compensation expense during the three months ended June 30, 2011 and 2010 were approximately $7.4 million and $5.7 million, respectively. Stock-based compensation expenses during the six months ended June 30, 2011 and 2010 were approximately $14.0 million and $10.7 million, respectively. We expect to continue to make substantial investments in research and development and anticipate that research and development expense, including co-development arrangements with industry partners, will continue to increase in the future.

Interest and Other Income, Net

Interest and other income, net for the three months ended June 30, 2011 was $4.1 million compared with $4.5 million for the three months ended June 30, 2010. Slightly lower interest and other income, net for the three months ended June 30, 2011 was driven by lower interest income resulting from lower rates earned on higher cash and investment balances in the three months ended June 30, 2011.

Interest and other income, net for the six months ended June 30, 2011 was $9.4 million, which was $0.8 million more than the $8.6 million recorded for the six months ended June 30, 2010. Higher interest and other income, net for the six months ended June 30, 2011 was driven by $1.7 million of capital gains realized on the sale of equity securities, partially offset by lower interest income resulting from lower rates earned on cash and investment balances during the six months ended June 30, 2011.

 

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Income Tax Expense

Income tax expense for the three months ended June 30, 2011 was $54.8 million, or 31.8% of pre-tax income, compared with $55.5 million, or 38.5% of pre-tax income for the three months ended June 30, 2010. Income tax expense for the six months ended June 30, 2011 was $104.3 million, or 32.0% of pre-tax income, compared with $104.0 million, or 37.4% of pre-tax income for the six months ended June 30, 2010. The effective tax rate for the three and six months ended June 30, 2011 differs from the U.S. federal statutory rate of 35% primarily due to the effect of income earned by certain of our overseas entities being taxed at rates lower than the federal statutory rate and R&D credits, partially offset by state income taxes and non-deductible stock option expenses. We intend these foreign earnings to be indefinitely reinvested outside the United States. The effective tax rate for the three and six months ended June 30, 2010 differs from the federal statutory rate primarily due to state income taxes and non-deductible stock option expenses, partially offset by the effect of income earned by certain of our overseas entities being taxed at rates lower than the federal statutory rate. The decrease in effective tax rates for the three and six months ended June 30, 2011 compared with the three and six months ended June 30, 2010 is primarily related to R&D credits, the decrease in California tax after the adoption of single sales factor apportionment effective January 1, 2011, and an increase in foreign earnings taxed at lower rates relative to domestic income.

As of June 30, 2011, we had total gross unrecognized tax benefits of approximately $86.2 million compared with approximately $78.9 million as of December 31, 2010, representing an increase of approximately $7.3 million for the six months ended June 30, 2011. Of the total gross unrecognized tax benefits, $81.9 million and $74.7 million as of June 30, 2011 and December 31, 2010, respectively, if recognized, would reduce our effective tax rate in the period of recognition. Gross interest related to unrecognized tax benefit accrued was approximately $6.6 million and $5.5 million, respectively, as of June 30, 2011 and December 31, 2010.

We file federal, state and foreign income tax returns in many jurisdictions in the United States and abroad. For U.S. federal and California income tax purposes, the statute of limitations currently remain open for all years since inception due to utilization of net operating losses and R&D credits generated in prior years.

LIQUIDITY AND CAPITAL RESOURCES

Sources and Uses of Cash

Our principal source of liquidity is cash provided by operations and the exercise of stock options. Cash and cash equivalents plus short- and long-term investments increased from $1,609 million at December 31, 2010 to $1,822 million at June 30, 2011. Cash generation is one of our fundamental strengths and provides us with substantial financial flexibility in meeting our operating, investing and financing needs.

Consolidated Cash Flow Data (unaudited)

 

     Six Months Ended
June 30,
 
     2011     2010  
     (in millions)  

Net cash provided by (used in)

  

Operating activities

   $ 296.3      $ 291.1   

Investing activities

     (159.8     (254.2

Financing activities

     (35.1     162.8   

Effect of exchange rates on cash and cash equivalents

     0.8        (1.1
                

Net increase in cash and cash equivalents

   $ 102.2      $ 198.6   
                

 

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Operating Activities

For the six months ended June 30, 2011, cash flow from operating activities of $296.3 million exceeded our net income of $221.5 million for two primary reasons:

 

  1. Our net income included substantial non-cash charges in the form of stock-based compensation, amortization of intangible assets, taxes, and depreciation. These non-cash charges totaled $86.9 million during the six months ended June 30, 2011.

 

  2. Cash used in working capital and other assets during the six months ended June 30, 2011 was approximately $12.1 million.

Working capital is comprised primarily of accounts receivable, inventory, deferred revenue and other liabilities. Accounts receivable increased by $3.5 million or 1% during the six months ended June 30, 2011 reflecting timing of system sales. The increase in inventory by $13.3 million or 15% during the six months ended June 30, 2011 reflects steps taken to increase component inventory where supplies have tightened and a build of finished goods as we prepare to move our manufacturing operations to our new building in Sunnyvale. Deferred revenue increased $8.5 million, or 7%, due to the increase in the number of installed systems for which service contracts exist.

For the six months ended June 30, 2010, cash flow from operating activities of $291.1 million exceeded our net income of $174.0 million for two primary reasons:

 

  1. Our net income included substantial non-cash charges in the form of stock-based compensation, amortization of intangible assets, taxes, and depreciation. These non-cash charges totaled $70.6 million during the six months ended June 30, 2010.

 

  2. Cash used in working capital and other assets during the six months ended June 30, 2010 was approximately $46.5 million.

Accounts receivable decreased by $10.7 million or 5% during the six months ended June 30, 2010 reflecting timing of system sales. Inventory increased by $16.4 million or 28% during the six months ended June 30, 2010 reflecting below optimal quantities at December 31, 2009. Other liabilities including accounts payable, accrued compensation and employee benefits, and accrued liabilities increased by $43.1 million or approximately 25% during the six months ended June 30, 2010 primarily due to taxes payable and timing of vendor payments during the six months ended June 30, 2010.

Investing Activities

Net cash used in investing activities during the six months ended June 30, 2011 consisted of purchases of investments (net of proceeds from sales and maturities of investments) of $106.6 million and capital expenditures and acquisitions of intellectual property of $53.2 million. The $53.2 million of capital expenditures and acquisitions of intellectual property includes $33.1 million in cash used when we completed our purchase of land and buildings near our headquarters in Sunnyvale, California. Net cash used in investing activities during the six months ended June 30, 2010 consisted of purchases of investments (net of proceeds from sales and maturities of investments) of $217.7 million and capital expenditures and acquisitions of intellectual property of $36.5 million. We invest predominantly in high quality, fixed income securities. Our investment portfolio may at any time contain investments in U.S. Treasury and U.S. government agency securities, taxable and/or tax exempt municipal notes (some of which may have an auction reset feature), corporate notes and bonds, commercial paper, and money market funds. We are not a capital intensive business.

Financing Activities

Net cash used in financing activities during the six months ended June 30, 2011 consisted primarily of $150.7 million for the repurchase of approximately 437,000 shares of our common stock through open market transactions, offset by proceeds from stock option exercises and employee stock purchases of $91.2 million and excess tax benefits from stock-based compensation of $24.4 million. Net cash provided by financing activities during the six months ended June 30, 2010 consisted primarily of proceeds from stock option exercises and employee stock purchases of $115.9 million and excess tax benefits from stock-based compensation of $46.9 million.

Our cash requirements depend on numerous factors, including market acceptance of our products, the resources we devote to developing and supporting our products and other factors. We expect to continue to devote substantial resources to expand procedure adoption and acceptance of our products. Based upon our business model, we anticipate that we will continue to be able to fund future growth through cash provided from operations. We believe that our current cash, cash equivalents and investment balances, together with income to be derived from the sale of our products, will be sufficient to meet our liquidity requirements for the foreseeable future.

 

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CRITICAL ACCOUNTING POLICIES

The discussion and analysis of our financial condition and results of operations are based upon our unaudited Condensed Consolidated Financial Statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. There have been no material changes to our critical accounting policies and estimates discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2010.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no material changes in our market risk during the six months ended June 30, 2011 compared to the disclosures in Part II, Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2010.

 

ITEM 4. CONTROLS AND PROCEDURES

Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures

We maintain disclosure controls and procedures, as such term is defined in SEC Rule 13a-15(e), that are designed to ensure that information required to be disclosed in our Securities Exchange Act of 1934 reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control Over Financial Reporting

There has been no change in our internal controls over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

From time to time, we may be involved in a variety of claims, lawsuits, investigations and proceedings relating to securities laws, product liability, patent infringement, contract disputes and other matters relating to various claims that arise in the normal course of our business. Certain of these lawsuits are described in further detail below. We do not know whether we will prevail in these matters nor can we assure that any remedy could be reached on commercially reasonable terms, if at all. Based on currently available information, we believe that we have meritorious defenses to these actions and that the resolution of these cases is not likely to have a material adverse effect on our business, financial position or future results of operations. In accordance with U.S. GAAP, we record a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. These provisions are reviewed at least quarterly and adjusted to reflect the impacts of negotiations, settlements, rulings, advice of legal counsel, and other information and events pertaining to a particular case.

 

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Purported Stockholder Class Action Lawsuit filed August 6, 2010

On August 6, 2010, a purported class action lawsuit entitled Perlmutter v. Intuitive Surgical et al., No. CV10-3451, was filed against us and seven of our current and former officers and directors in the United States District Court for the Northern District of California. The lawsuit seeks unspecified damages on behalf of a putative class of persons who purchased or otherwise acquired our common stock between February 1, 2008 and January 7, 2009. The complaint alleges that the defendants violated federal securities laws by making allegedly false and misleading statements and omitting certain material facts in our filings with the Securities and Exchange Commission. On February 15, 2011, the Police Retirement System of St. Louis was appointed Lead Plaintiff in the case pursuant to the Private Securities Litigation Reform Act of 1995. An amended complaint was filed on April 15, 2011, making allegations substantially similar to the allegations described above. On May 23, 2011 we filed a motion to dismiss the amended complaint; that motion is scheduled to be heard on August 11, 2011.

Purported Derivative Actions

On August 19, 2010, an alleged stockholder caused a purported stockholder’s derivative lawsuit entitled Himmel v. Smith et al., No. 1-10-CV-180416, to be filed in the Superior Court of California for the County of Santa Clara naming us as a nominal defendant, and naming 14 of our current and former officers and directors as defendants. The lawsuit seeks to recover, for the company’s benefit, unspecified damages purportedly sustained by us in connection with allegedly misleading statements and/or omissions made in connection with our financial reporting for the period between February 1, 2008 and January 7, 2009. It also seeks a series of changes to our corporate governance policies and an award of attorneys’ fees. On September 15, 2010, another purported stockholder filed an essentially identical lawsuit entitled Applbaum v. Guthart et al., No. 1-10-CV-182645, in the same court against 15 of our current and former officers and directors. On October 5, 2010, the court ordered that the two cases be consolidated for all purposes. By agreement with the plaintiffs, formal discovery has been stayed in the case.

 

ITEM 1A. RISK FACTORS

There have been no changes to the Risk Factors discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2010, except for the following:

NATURAL OR OTHER DISASTERS COULD DISRUPT OUR BUSINESS AND RESULT IN LOSS OF REVENUE OR IN HIGHER EXPENSES.

Natural disasters, terrorist activities and other business disruptions could seriously harm our revenue and financial condition and increase our costs and expenses. For example, the recent earthquake and tsunami in Japan and their aftermath have created significant economic uncertainty in that country. Since the earthquake, we have noticed a drop in commercial activity in Japan. We believe economic activity in the country may be disrupted for a substantial period of time, including a reduction in hospital spending. As a result, our sales in Japan may be adversely affected. In addition, we expect demand for our products in Japan through 2012 to be further curtailed as health spending resources are redeployed into more immediately critical areas.

Our corporate headquarters and many of our operations are located in California, a seismically active region. A natural disaster in any of our major markets in North America or Europe could have a material adverse impact on our operations, operating results and financial condition. Further, any unanticipated business disruption caused by Internet security threats, damage to global communication networks or otherwise could have a material adverse impact on our operating results.

 

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

The table below summarizes our stock repurchase activity for the three months ended June 30, 2011:

 

Fiscal Period

   Total Number of
Shares Repurchased
     Average Price
Paid Per Share
     Total Number of Shares
Purchased As Part of a
Publicly Announced
Program
     Approximate Dollar
Value of Shares That
May Yet be Purchased
Under the Program
 

April 1, 2011 to April 30, 2011

     —         $         —         $ 388.4 million   

May 1, 2011 to May 31, 2011

     208,504       $ 350.38         208,504       $ 315.3 million   

June 1, 2011 to June 30, 2011

     192,252       $ 343.59         192,252       $ 249.3 million   
                                   

Total during quarter ended June 30, 2011

     400,756       $ 347.12         400,756       $ 249.3 million   
                                   

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

 

ITEM 5. OTHER INFORMATION

None.

 

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ITEM 6. EXHIBITS

 

Exhibit
Number

  

Description

  3.1    Amended and Restated Certificate of Incorporation of Intuitive Surgical, Inc. (incorporated by reference to Exhibit 3.1 on Form 10-K filed with the Securities and Exchange Commission on February 6, 2009).
  3.2    Certificate of Amendment to Amended and Restated Certificate of Incorporation of Intuitive Surgical, Inc. (incorporated by reference to Exhibit 3.2 on Form 10-K filed with the Securities and Exchange Commission on February 6, 2009).
  3.3    Amended and Restated Bylaws of Intuitive Surgical, Inc. (incorporated by reference to Exhibit 3.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on July 26, 2010).
10.1    Intuitive Surgical Inc. 2010 Incentive Award Plan (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on April 26, 2011).
10.2    Intuitive Surgical Inc. 2009 Employment Commencement Incentive Plan
31.1    Certification of the Company’s Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2    Certification of the Company’s Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1    Certification of the Company’s Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2    Certification of the Company’s Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101    The following materials from Intuitive Surgical, Inc.’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, formatted in XBRL (Extensible Business Reporting Language): (i) the unaudited Condensed Consolidated Balance Sheets, (ii) the unaudited Condensed Consolidated Statements of Income, (iii) the unaudited Condensed Consolidated Statements of Cash Flows, and (iv) Notes to Condensed Consolidated Financial Statements, tagged from Level I through IV.

 

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SIGNATURE

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

 

INTUITIVE SURGICAL, INC.
(Registrant)

By: 

 

/s/ MARSHALL L. MOHR

  Marshall L. Mohr
  Senior Vice President and Chief Financial Officer
  (Principal Financial Officer and duly authorized signatory)

Date: July 20, 2011

 

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Intuitive Surgical Inc. 2009 Employment Commencement Incentive Plan

Exhibit 10.2

INTUITIVE SURGICAL, INC.

2009 EMPLOYMENT COMMENCEMENT INCENTIVE PLAN

ADOPTED BY THE BOARD OF DIRECTORS OCTOBER 22, 2009

AMENDMENT AND RESTATEMENT ADOPTED BY THE BOARD OF DIRECTORS FEBRUARY 3, 2011

AMENDMENT AND RESTATEMENT ADOPTED BY THE BOARD OF DIRECTORS JULY 1, 2011

 

1. PURPOSES.

(a) Eligible Recipients. Only Eligible Participants may receive Options under the Plan.

(b) General Purpose. The purpose of the Plan is to provide a means by which Eligible Participants may be given an opportunity to benefit from increases in value of the Common Stock through the granting of Options, to secure and retain the services of new members of this group and to provide incentives for such persons to exert maximum efforts for the success of the Company and its Affiliates.

 

2. DEFINITIONS.

(a) “Administrator” means the entity that conducts the general administration of the Plan as provided herein. The term “Administrator” shall refer to the Committee unless the Board has elected to exercise any of the rights and duties of the Committee under the Plan generally, as provided in Section 3 herein.

(b) “Affiliate” means any parent corporation or subsidiary corporation of the Company, whether now or hereafter existing, as those terms are defined in Sections 424(e) and (f), respectively, of the Code.

(c) “Board” means the Board of Directors of the Company.

(d) “Code” means the Internal Revenue Code of 1986, as amended.

(e) “Committee” means the Compensation Committee of the Board, or another committee or subcommittee of the Board, appointed as provided in Section 3 herein.

(f) “Common Stock” means the common stock of the Company.

(g) “Company” means Intuitive Surgical, Inc., a Delaware corporation.

(h) “Consultant” means any consultant or adviser if: (a) the consultant or adviser renders bona fide services to the Company or an Affiliate, (b) the services rendered by the consultant or adviser are not in connection with the offer or sale of securities in a capital raising transaction and do not directly or indirectly promote or maintain a market for the Company’s securities, and (c) the consultant or adviser is a natural person who has contracted directly with the Company or an Affiliate to render such services.


(i) “Continuous Service” means that the Participant’s service with the Company or an Affiliate, whether as an Employee or Consultant, is not interrupted or terminated. The Participant’s Continuous Service shall not be deemed to have terminated merely because of a change in the capacity in which the Participant renders service to the Company or an Affiliate as an Employee or Consultant or a change in the entity for which the Participant renders such service, provided that there is no interruption or termination of the Participant’s service to the Company or an Affiliate. For example, a change in status without interruption from an Employee of the Company to a Consultant of an Affiliate will not constitute an interruption of Continuous Service. Unless otherwise determined by the Board or chief executive officer of the Company, in that party’s sole discretion, any bona fide leave of absence authorized by the Company in accordance with established policies shall not be considered to constitute an interruption or termination of Continuous Service.

(j) “Director” means a member of the Board of Directors of the Company.

(k) “Disability” means the permanent and total disability of a person within the meaning of Section 22(e)(3) of the Code.

(l) “Eligible Participantmeans any Employee who has not previously been an Employee or Director of the Company or an Affiliate, or following a bona fide period of non-employment by the Company or an Affiliate, if he or she is granted an Option in connection with his or her commencement of employment with the Company or an Affiliate and such grant is an inducement material to his or her entering into employment with the Company or an Affiliate. The Board may in its discretion adopt procedures from time to time to ensure that an Employee is eligible to participate in the Plan prior to the granting of any Options to such Employee under the Plan (including, without limitation, a requirement, if any, that each such Employee certify to the Company prior to the receipt of an Option under the Plan that he or she has not been previously employed by the Company or an Affiliates, or if previously employed, has had a bona fide period of non-employment, and that the grant of Options under the Plan is an inducement material to his or her agreement to enter into employment with the Company or an Affiliate).

(m) “Employee” means any person employed by the Company or an Affiliate. Mere service as a Director or payment of a director’s fee by the Company or an Affiliate shall not be sufficient to constitute “employment” by the Company or an Affiliate.

(n) “Exchange Act” means the Securities Exchange Act of 1934, as amended.

(o) “Fair Market Value” means, as of any date, the value of the Common Stock determined as follows:

(i) If the Common Stock is listed on any (i) established stock exchange (such as the New York Stock Exchange, the NASDAQ Global Market and the NASDAQ Global Select Market), (ii) national market system or (iii) automated quotation system on which the shares of Common Stock are listed, quoted or traded, its Fair Market Value shall be the closing sales price for a share of Common Stock as quoted on such exchange or system for such date or, if there is no closing sales price for a share of Common Stock on the date in question, the closing sales price for a share of Common Stock on the last preceding date for which such quotation exists, as reported in The Wall Street Journal or such other source as the Administrator deems reliable;

 

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(ii) If the Common Stock is not listed on an established securities exchange, national market system or automated quotation system, but the Common Stock is regularly quoted by a recognized securities dealer, its Fair Market Value shall be the mean of the high bid and low asked prices for such date or, if there are no high bid and low asked prices for a share of Common Stock on such date, the high bid and low asked prices for a share of Common Stock on the last preceding date for which such information exists, as reported in The Wall Street Journal or such other source as the Administrator deems reliable; or

(iii) If the Common Stock is neither listed on an established securities exchange, national market system or automated quotation system nor regularly quoted by a recognized securities dealer, its Fair Market Value shall be determined in good faith by the Administrator.

(p) “Incentive Stock Option” means an Option intended to qualify as an incentive stock option within the meaning of Section 422 of the Code and the regulations promulgated thereunder. Incentive Stock Options may not be granted under the Plan.

(q) “Independent Director” means a Director of the Company who is not an Employee and who qualifies as “independent” within the meaning of Nasdaq Stock Market Rule 5605(a)(2), if the Company’s securities are traded on the Nasdaq Global Market, or the requirements of any other established stock exchange on which the Company’s securities are traded, as such rules or requirements may be amended from time to time.

(r) “Nonstatutory Stock Option” means an Option not intended to qualify as an Incentive Stock Option.

(s) “Option” means a Nonstatutory Stock Option granted pursuant to the Plan.

(t) “Option Agreement” means a written or electronic agreement between the Company and a Participant evidencing certain terms and conditions of an individual Option grant. Each Option Agreement shall be subject to the terms and conditions of the Plan.

(u) Participant” means a person to whom an Option is granted pursuant to the Plan or, if applicable, such other person who holds an outstanding Option.

(v) “Plan” means this Intuitive Surgical, Inc. 2009 Employment Commencement Incentive Plan.

(w) “Rule 16b-3” means Rule 16b-3 promulgated under the Exchange Act or any successor to Rule 16b-3, as in effect from time to time.

 

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(x) “Securities Act” means the Securities Act of 1933, as amended.

 

3. ADMINISTRATION.

(a) Administration by Committee. The Plan will be administered by a Committee of two or more Independent Directors, and the term “Administrator” will apply to any person or persons to whom such authority has been delegated. As of the Effective Date, the Plan will be administered by the Compensation Committee of the Board. The Board may at any time re-vest in the Board the administration of the Plan and thereafter for purposes of the Plan the term “Administrator” as used in this Plan will be deemed to refer to the Board; provided, however, that any action taken by the Board in connection with the administration of the Plan shall not be deemed approved by the Board unless such action is approved by a majority of the Independent Directors. Appointment of Committee members shall be effective upon acceptance of appointment. Committee members may resign at any time by delivering written notice to the Board. Vacancies in the Committee may be filled by the Board. To the extent desirable to qualify transactions hereunder as exempt under Rule 16b-3 promulgated under the Exchange Act, Options under the Plan may be made by the entire Board (provided, however, that any action taken by the Board in connection with the administration of the Plan shall not be deemed approved by the Board unless such action is approved by a majority of the Independent Directors) or a Committee meeting the requirements set forth above and such other requirements as may be established from time to time by the Securities and Exchange Commission for Options intended to qualify for exemption under Rule 16b-3 promulgated under the Exchange Act.

(b) Powers of Administrator. The Administrator shall have the power, subject to, and within the limitations of, the express provisions of the Plan:

(i) To determine from time to time which of the persons eligible under the Plan shall be granted Options; when and how each Option shall be granted; the provisions of each Option granted (which need not be identical), including the time or times when a person shall be permitted to receive Common Stock pursuant to an Option; and the number of shares of Common Stock with respect to which an Option shall be granted to each such person.

(ii) To adopt procedures from time to time in the Administrator’s discretion to ensure that a person is eligible to participate in the Plan prior to the granting of any Options to such person under the Plan (including, without limitation, a requirement, if any, that each such person certify to the Company prior to the receipt of an Option under the Plan that he or she has not been previously employed by the Company or an Affiliate, or if previously employed, has had a bona fide period of non-employment, and that the grant of Options under the Plan is an inducement material to his or her agreement to enter into employment with the Company or an Affiliate).

(iii) To construe and interpret the Plan and Options granted under it, and to establish, amend and revoke rules and regulations for its administration. The Administrator, in the exercise of this power, may correct any defect, omission or inconsistency in the Plan or in any Option Agreement, in a manner and to the extent it shall deem necessary or expedient to make the Plan fully effective.

 

4


(iv) Generally, to exercise such powers and to perform such acts as the Board deems necessary or expedient to promote the best interests of the Company, which are not in conflict with the provisions of the Plan.

(c) Majority Rule; Unanimous Written Consent. The Committee shall act by a majority of its members in attendance at a meeting at which a quorum is present or by a memorandum or other written instrument signed by all members of the Committee.

(d) Compensation; Professional Assistance; Good Faith Actions. Members of the Committee shall receive such compensation, if any, for their services as members as may be determined by the Board. All expenses and liabilities which members of the Committee incur in connection with the administration of the Plan shall be borne by the Company. The Committee may, with the approval of the Board, employ attorneys, consultants, accountants, appraisers, brokers or other persons. The Committee, the Company and the Company’s officers and Directors shall be entitled to rely upon the advice, opinions or valuations of any such persons. All actions taken and all interpretations and determinations made by the Committee or the Board in good faith shall be final and binding upon all Participants, the Company and all other interested persons. No members of the Committee or Board shall be personally liable for any action, determination or interpretation made in good faith with respect to the Plan or Options, and all members of the Committee and the Board shall be fully protected by the Company in respect of any such action, determination or interpretation.

 

4. SHARES SUBJECT TO THE PLAN.

(a) Share Reserve. The shares of stock subject to Options shall be Common Stock, subject to adjustment as provided in Section 10. Subject to adjustment as provided in Section 10, the aggregate number of such shares which may be issued with respect to Options granted under the Plan shall not exceed 530,000.

(b) Reversion of Shares to the Share Reserve. If any Option shall for any reason expire or otherwise terminate, in whole or in part, without having been exercised in full, the shares of Common Stock not acquired under such Option shall revert to and again become available for issuance under the Plan.

(c) Source of Shares. The shares of Common Stock subject to the Plan may be unissued shares or reacquired shares, bought on the market or otherwise.

 

5. ELIGIBILITY.

Options may be granted only to Eligible Participants. All Options granted under the Plan shall be Nonstatutory Stock Options.

 

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6. OPTION PROVISIONS.

The Administrator may grant Options, the terms of which Options shall be set forth in an appropriate Option Agreement. Each Option shall be in such form and shall contain such terms and conditions as the Administrator shall deem appropriate. The provisions of separate Options need not be identical, but each Option shall include (through incorporation of provisions hereof by reference in the Option or otherwise) the substance of each of the following provisions:

(a) Option Exercise Price and Option Term. The exercise price of each Option shall be not less than the Fair Market Value of the Common Stock subject to the Option on the date the Option is granted. The term of an Option granted to an Eligible Participant shall be set by the Administrator in its discretion, but in no event shall the term of an Option exceed ten years from the date the Option is granted.

(b) Consideration. The purchase price of Common Stock acquired pursuant to an Option shall be paid, to the extent permitted by applicable statutes and regulations, either: (i) in cash at the time the Option is exercised, or (ii) at the discretion of the Administrator (A) by delivery to the Company of other Common Stock, (B) according to a deferred payment or other similar arrangement with the Participant or (C) in any other form of legal consideration that may be acceptable to the Administrator. Unless otherwise specifically provided in the Option, the purchase price of Common Stock acquired pursuant to an Option that is paid by delivery to the Company of other Common Stock acquired, directly or indirectly from the Company, shall be paid only by shares of the Common Stock of the Company that have been held for more than the period of time required to avoid a charge to earnings for financial accounting purposes. At any time that the Company is incorporated in Delaware, payment of the Common Stock’s “par value,” as defined in the Delaware General Corporation Law, shall not be made by deferred payment.

(c) Deferred Payment. In the case of any deferred payment arrangement, interest shall be compounded at least annually and shall be charged at the minimum rate of interest necessary to avoid the treatment as interest, under any applicable provisions of the Code, of any amounts other than amounts stated to be interest under the deferred payment arrangement.

(d) Transferability of Options. An Option shall be transferable to the extent provided in the Option Agreement. If the Option does not provide for transferability, then the Option shall not be transferable except by will or by the laws of descent and distribution and shall be exercisable during the lifetime of the Participant only by the Participant. Notwithstanding the foregoing, the Participant may, by delivering written notice to the Company, in a form satisfactory to the Company, designate a third party who, in the event of the death of the Participant, shall thereafter be entitled to exercise the Option.

(e) Vesting Generally. The total number of shares of Common Stock subject to an Option may, but need not, vest and therefore become exercisable in periodic installments that may, but need not, be equal. The Option may be subject to such other terms and conditions on the time or times when it may be exercised (which may be based on performance or other criteria) as the Administrator may deem appropriate. The vesting provisions of individual Options may vary. The provisions of this subsection 6(e) are subject to any Option provisions governing the minimum number of shares of Common Stock as to which an Option may be exercised.

 

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(f) Limitations on Exercise of Options Granted. Unless otherwise provided by the Administrator in the Option Agreement, no Option granted to an Eligible Participant may be exercised to any extent by anyone after the first to occur of the following events:

(i) The expiration of 18 months from the date of the Participant’s death;

(ii) The expiration of 12 months from the date of the Participant’s termination of Continuous Service by reason of his or her Disability;

(iii) The expiration of three months from the date of the Participant’s termination of Continuous Service for any reason other than such Participant’s termination by the Company or an Affiliate for “Cause” (as defined in the Participant’s employment or consulting agreement with the Company in effect on the grant date of the Option, or, if the Participant does not have an employment or consulting agreement with the Company or the Participant’s employment or consulting agreement does not include a definition of “Cause”, as defined in the Option Agreement), death or Disability, unless the Participant dies within said three-month period;

(iv) The Participant’s termination by the Company or an Affiliate for “Cause” (as defined in the Participant’s employment or consulting agreement with the Company in effect on the grant date of the Option, or, if the Participant does not have an employment or consulting agreement with the Company or the Participant’s employment or consulting agreement does not include a definition of “Cause”, as defined in the Option Agreement);

(v) The expiration of the term of the Option, as set forth in the Option Agreement; or

(vi) Ten years from the date the Option was granted.

(g) Conditions to Issuance of Stock Certificates. The Company shall not be required to issue or deliver any certificate or certificates for shares of stock purchased upon the exercise of any Option or portion thereof prior to fulfillment of all of the following conditions:

(i) The admission of such shares to listing on all stock exchanges on which such class of stock is then listed;

(ii) The completion of any registration or other qualification of such shares under any state or federal law, or under the rulings or regulations of the Securities and Exchange Commission or any other governmental regulatory body which the Administrator shall, in its absolute discretion, deem necessary or advisable;

 

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(iii) The obtaining of any approval or other clearance from any state or federal governmental agency which the Administrator shall, in its absolute discretion, determine to be necessary or advisable;

(iv) The lapse of such reasonable period of time following the exercise of the Option as the Administrator may establish from time to time for reasons of administrative convenience; and

(v) The receipt by the Company of full payment for such shares, including payment of any applicable withholding tax, which in the discretion of the Administrator may be in the form of consideration used by the Participant to pay for such shares under Section 6(b), subject to Section 9(e).

(h) Extension of Termination Date. A Participant’s Option Agreement may also provide that if the exercise of the Option following the termination of the Participant’s Continuous Service (other than upon the Participant’s death or Disability) would be prohibited at any time solely because the issuance of shares of Common Stock would violate the registration requirements under the Securities Act, then the Option shall terminate on the earlier of:

(i) the expiration of the term of the Option set forth in subsection (a);

(ii) ten years from the date the Option was granted; or

(iii) the expiration of a period of three months after the termination of the Participant’s Continuous Service during which the exercise of the Option would not be in violation of such registration requirements.

(i) Additional Limitations on Exercise of Options. Participants may be required to comply with any timing or other restrictions with respect to the settlement or exercise of an Option, including a window-period limitation, as may be imposed in the discretion of the Administrator.

 

7. COVENANTS OF THE COMPANY.

(a) Availability of Shares. During the terms of the Options, the Company shall keep available at all times the number of shares of Common Stock required to satisfy such Options.

(b) Securities Law Compliance. The Company shall seek to obtain from each regulatory commission or agency having jurisdiction over the Plan such authority as may be required to grant Options and to issue and sell shares of Common Stock upon exercise or vesting of the Options; provided, however, that this undertaking shall not require the Company to register under the Securities Act the Plan, any Option or any Common Stock issued or issuable pursuant to any such Option. If, after reasonable efforts, the Company is unable to obtain from any such regulatory commission or agency the authority which counsel for the Company deems necessary for the lawful issuance and sale of Common Stock under the Plan, the Company shall be relieved from any liability for failure to issue and sell Common Stock upon exercise or vesting of such Options unless and until such authority is obtained.

 

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8. USE OF PROCEEDS FROM STOCK

Proceeds from the sale of Common Stock pursuant to Options shall constitute general funds of the Company.

 

9. MISCELLANEOUS.

(a) Acceleration of Exercisability and Vesting. The Administrator shall have the power to accelerate the time at which an Option may first vest and/or be exercised in accordance with the Plan, notwithstanding the provisions in the Option stating the time at which it may first be exercised or the time during which it will vest.

(b) Stockholder Rights. No Participant shall be deemed to be the holder of, or to have any of the rights of a holder with respect to, any shares of Common Stock subject to such Option unless and until such Participant has satisfied all requirements for exercise of the Option pursuant to its terms.

(c) No Employment or Other Service Rights. Nothing in the Plan or any instrument executed or Option granted pursuant thereto shall confer upon any Participant any right to continue to serve the Company or an Affiliate in the capacity in effect at the time the Option was granted or shall affect the right of the Company or an Affiliate to terminate: (i) the employment of an Employee with or without notice and with or without cause; or (ii) the service of a Consultant pursuant to the terms of such Consultant’s agreement with the Company or an Affiliate.

(d) Investment Assurances. The Company may require a Participant, as a condition of exercising or acquiring Common Stock under any Option: (i) to give written assurances satisfactory to the Company as to the Participant’s knowledge and experience in financial and business matters and/or to employ a purchaser representative reasonably satisfactory to the Company who is knowledgeable and experienced in financial and business matters and that he or she is capable of evaluating, alone or together with the purchaser representative, the merits and risks of exercising the Option; and (ii) to give written assurances satisfactory to the Company stating that the Participant is acquiring Common Stock subject to the Option for the Participant’s own account and not with any present intention of selling or otherwise distributing the Common Stock. The foregoing requirements, and any assurances given pursuant to such requirements, shall be inoperative if: (A) the issuance of the shares of Common Stock upon the exercise or acquisition of Common Stock under the Option has been registered under a then currently effective registration statement under the Securities Act; or (B) as to any particular requirement, a determination is made by counsel for the Company that such requirement need not be met in the circumstances under the then applicable securities laws. The Company may, upon advice of counsel to the Company, place legends on stock certificates issued under the Plan as such counsel deems necessary or appropriate in order to comply with applicable securities laws, including, but not limited to, legends restricting the transfer of the Common Stock.

 

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(e) Withholding Obligations. To the extent provided by the terms of an Option Agreement, the Participant may satisfy any federal, state or local tax withholding obligation relating to the exercise or acquisition of Common Stock under an Option by any of the following means (in addition to the Company’s right to withhold from any compensation paid to the Participant by the Company) or by a combination of such means: (i) tendering a cash payment; (ii) authorizing the Company to withhold shares of Common Stock from the shares of Common Stock otherwise issuable to the Participant as a result of the exercise or acquisition of Common Stock under the Option, provided, however, that no shares of Common Stock are withheld with a value exceeding the minimum amount of tax required to be withheld by law; or (iii) delivering to the Company owned and unencumbered shares of Common Stock.

 

10. ADJUSTMENTS UPON CHANGES IN STOCK.

(a) Capitalization Adjustments. If any change is made in the Common Stock subject to the Plan, or subject to any Option, without the receipt of consideration by the Company (through merger, consolidation, reorganization, recapitalization, reincorporation, stock dividend, dividend in property other than cash, stock split, liquidating dividend, combination of shares, exchange of shares, change in corporate structure or other transaction not involving the receipt of consideration by the Company), the Plan will be appropriately adjusted in the class(es) and maximum number of securities subject to the Plan pursuant to subsection 4(a) and the outstanding Options will be appropriately adjusted in the class(es) and number of securities and price per share of Common Stock subject to such outstanding Options. The Administrator shall make such adjustments, and its determination shall be final, binding and conclusive. The conversion of any convertible securities of the Company shall not be treated as a transaction “without receipt of consideration” by the Company.

(b) Dissolution or Liquidation. In the event of a dissolution or liquidation of the Company, then all outstanding Options shall terminate immediately prior to such event.

(c) Asset Sale, Merger, Consolidation or Reverse Merger. In the event of: (i) a sale, lease or other disposition of all or substantially all of the assets of the Company, (ii) a merger or consolidation in which the Company is not the surviving corporation, or (iii) a reverse merger in which the Company is the surviving corporation but the shares of Common Stock outstanding immediately preceding the merger are converted by virtue of the merger into other property, whether in the form of securities, cash or otherwise (collectively, a “change in control”), then any surviving corporation or acquiring corporation shall assume any Options outstanding under the Plan or shall substitute similar stock awards (including an award to acquire the same consideration paid to the stockholders in the change in control for those outstanding under the Plan). In the event any surviving corporation or acquiring corporation refuses to assume such Options or to substitute similar stock awards for those outstanding under the Plan, then with respect to Options held by Participants whose Continuous Service has not terminated, the vesting of such Options (and, if applicable, the time during which such Options may be exercised) shall be accelerated in full, and the Options shall terminate if not exercised (if applicable) at or prior to the change in control. With respect to any other Options outstanding under the Plan, such Options shall terminate if not exercised (if applicable) prior to the change in control.

 

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11. AMENDMENT OF THE PLAN AND OPTIONS.

(a) Amendment of Plan. Except as otherwise provided in this Section 11(a), the Plan may be wholly or partially amended or otherwise modified at any time or from time to time by the Board. No amendment, suspension or termination of the Plan shall, without the consent of the Participant, alter or impair any rights or obligations under any Option theretofore granted or awarded, unless the Option itself otherwise expressly so provides.

(b) Contemplated Amendments. It is expressly contemplated that the Board may amend the Plan in any respect the Board deems necessary or advisable to provide Eligible Participants with the maximum benefits provided or to be provided under the provisions of the Code.

(c) No Impairment of Rights. Rights under any Option granted before amendment of the Plan shall not be impaired by any amendment of the Plan unless: (i) the Company requests the consent of the Participant; and (ii) the Participant consents in writing.

(d) Amendment of Options. The Board at any time, and from time to time, may amend the terms of any one or more Options; provided, however, that the rights under any Option shall not be impaired by any such amendment unless: (i) the Company requests the consent of the Participant; and (ii) the Participant consents in writing. Notwithstanding the foregoing, the Board shall not, without the approval of the stockholders of the Company, authorize the amendment of any outstanding Option to reduce its exercise price. Furthermore, no Option shall be canceled and replaced with grants having a lower exercise price without the further approval of stockholders of the Company.

 

12. TERMINATION OR SUSPENSION OF THE PLAN.

(a) Plan Term. The Board may suspend or terminate the Plan at any time. Unless sooner terminated, the Plan shall terminate on the day before the tenth (10th) anniversary of the date the Plan is adopted by the Board. No Option may be granted under the Plan while the Plan is suspended or after it is terminated.

(b) No Impairment of Rights. Suspension or termination of the Plan shall not impair rights and obligations under any Option granted while the Plan is in effect except with the written consent of the Participant.

 

13. EFFECTIVE DATE OF PLAN

The Plan shall become effective upon its adoption by the Board.

 

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14. CHOICE OF LAW/INTERPRETATION.

The law of the State of Delaware shall govern all questions concerning the construction, validity and interpretation of this Plan, without regard to such state’s conflict of laws rules.

 

15. STOCKHOLDER APPROVAL NOT REQUIRED.

It is expressly intended that approval of the Company’s stockholders not be required as a condition of the effectiveness of the Plan, and the Plan’s provisions shall be interpreted in a manner consistent with such intent for all purposes. Specifically, Rule 5635(c) promulgated by The Nasdaq Stock Market generally requires stockholder approval for stock option plans or other equity compensation arrangements adopted by companies whose securities are listed on the Nasdaq Global Market pursuant to which stock awards or stock may be acquired by officers, directors, employees or consultants of such companies. Nasdaq Stock Market Rule 5635(c)(4) provides an exception to this requirement for issuances of securities to a person not previously an employee or director of the issuer, or following a bona fide period of non-employment, as an inducement material to the individual’s entering into employment with the issuer, provided such issuances are approved by either the issuer’s independent compensation committee or a majority of the issuer’s independent directors. Notwithstanding anything to the contrary herein, Options under the Plan may only be made to Employees who have not previously been an Employee or member of the Board of the Company or an Employee or director of an Affiliate, or following a bona fide period of non-employment by the Company or an Affiliate, as an inducement material to the Employee’s entering into employment with the Company or an Affiliate. Options under the Plan will be approved as set forth herein by: (i) the Committee, provided it is comprised solely of two or more Independent Directors, or (ii) a majority of the Company’s Independent Directors. Accordingly, pursuant to Nasdaq Stock Market Rule 5635(c)(4), the issuance of Options and the shares of Common Stock issuable upon exercise or vesting of such Options pursuant to this Plan are not subject to the approval of the Company’s stockholders.

 

16. SECTION 409A.

To the extent that the Administrator determines that any Option granted under the Plan is subject to Section 409A of the Code, the Option Agreement evidencing such Option shall incorporate the terms and conditions required by Section 409A of the Code. To the extent applicable, the Plan and Option Agreements shall be interpreted in accordance with Section 409A of the Code and Department of Treasury regulations and other interpretive guidance issued thereunder, including without limitation any such regulations or other guidance that may be issued after the adoption of the Plan. Notwithstanding any provision of the Plan to the contrary, in the event that following the adoption of the Plan the Administrator determines that any Option may be subject to Section 409A of the Code and related Department of Treasury guidance (including such Department of Treasury guidance as may be issued after the adoption of the Plan), the Administrator may adopt such amendments to the Plan and the applicable Option Agreement or adopt other policies and procedures (including amendments, policies and procedures with retroactive effect), or take any other actions, that the Administrator determines are necessary or appropriate to: (a) exempt the Option from Section 409A of the Code and/or preserve the intended tax treatment of the benefits provided with respect to the Option; or (b) comply with the requirements of Section 409A of the Code and related Department of Treasury guidance.

 

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17. UNFUNDED STATUS OF AWARDS.

The Plan is intended to be an “unfunded” plan for incentive compensation. With respect to any payments not yet made to a Participant pursuant to an Option, nothing contained in the Plan or any Option Agreement shall give the Participant any rights that are greater than those of a general creditor of the Company or any Affiliate.

 

18. PARTICIPANTS IN FOREIGN COUNTRIES.

The Board shall have the authority to adopt such modifications, procedures and subplans as may be necessary or desirable to comply with provisions of the laws of foreign countries in which the Company or any Affiliate may operate to assure the viability of Options granted under the Plan in such countries and to meet the objectives of the Plan.

 

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CERTIFICATION OF THE COMPANY'S CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 302

EXHIBIT 31.1

Certification of Chief Executive Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Gary S. Guthart, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Intuitive Surgical, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: July 20, 2011

/s/  Gary S. Guthart

Gary S. Guthart

President and Chief Executive Officer

(Principal Executive Officer)

CERTIFICATION OF THE COMPANY'S CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 302

EXHIBIT 31.2

Certification of Chief Financial Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Marshall L. Mohr, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Intuitive Surgical, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal controls over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: July 20, 2011

/s/  Marshall L. Mohr

Marshall L. Mohr

Senior Vice President and Chief Financial Officer

(Principal Financial Officer)

CERTIFICATION OF THE COMPANY'S CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 906

EXHIBIT 32.1

Certification of Chief Executive Officer

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Intuitive Surgical, Inc. (the “Company”) hereby certifies, to such officer’s knowledge, that:

(i) the accompanying Quarterly Report on Form 10-Q of the Company for the quarterly period ended June 30, 2011 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: July 20, 2011

 

/s/ Gary S. Guthart

Gary S. Guthart

President and Chief Executive Officer

(Principal Executive Officer)

CERTIFICATION OF THE COMPANY'S CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 906

EXHIBIT 32.2

Certification of Chief Financial Officer

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Intuitive Surgical, Inc. (the “Company”) hereby certifies, to such officer’s knowledge, that:

(i) the accompanying Quarterly Report on Form 10-Q of the Company for the quarterly period ended June 30, 2011 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: July 20, 2011

/s/  Marshall L. Mohr

Marshall L. Mohr

Senior Vice President and Chief Financial Officer

(Principal Financial Officer)