UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

 

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

For the quarterly period ended JuneSeptember 30, 2010

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 39,352,49839,293,400 shares of Common Stock, $0.001 par value per share, outstanding as of July 12,October 8, 2010.

 

 

 


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 JuneSeptember 30, 2010 and December 31, 2009  3
 Condensed consolidated statements of income for the threethree- and six-monthnine-month periods ended JuneSeptember 30, 2010 and JuneSeptember 30, 2009  4
 Condensed consolidated statements of cash flows for the six-monthnine-month periods ended JuneSeptember 30, 2010 and JuneSeptember 30, 2009  5
 Notes to condensed consolidated financial statements  6

Item 2.

 

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

  1517

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

  2627

Item 4.

 

Controls and Procedures

  2627

PART II. OTHER INFORMATION

  

Item 1.

 

Legal Proceedings

  2627

Item 1A.

 

Risk Factors

  2628

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

  2730

Item 3.

 

Defaults Upon Senior Securities

  2730

Item 5.

 

Other Information

  2730

Item 6.

 

Exhibits

  2831
 

Signature

  2932

PART I — FINANCIAL INFORMATION

 

Item 1.Financial Statements

INTUITIVE SURGICAL, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN MILLIONS, EXCEPT PAR VALUE)

(UNAUDITED)

 

  June 30,
2010
  December 31,
2009
  September 30,
2010
   December 31,
2009
 

ASSETS

        

Current assets:

        

Cash and cash equivalents

  $420.0  $221.4  $382.0    $221.4  

Short-term investments

   547.9   334.0   598.9     334.0  

Accounts receivable, net

   194.7   205.4   207.9     205.4  

Inventory

   74.0   57.6   85.0     57.6  

Prepaids and other assets

   20.3   20.9   20.3     20.9  

Deferred tax assets

   7.2   7.3   7.4     7.3  
              

Total current assets

   1,264.1   846.6   1,301.5     846.6  

Property, plant and equipment, net

   144.4   125.7   156.6     125.7  

Long-term investments

   620.3   616.6   639.7     616.6  

Long-term deferred tax assets

   53.2   53.4   65.2     53.4  

Intangible assets, net

   49.8   56.2   70.6     56.2  

Goodwill

   110.7   110.7   116.9     110.7  

Other assets

   0.6   0.5   1.3     0.5  
              

Total assets

  $2,243.1  $1,809.7  $2,351.8    $1,809.7  
              

LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Current liabilities:

        

Accounts payable

  $41.6  $27.6  $35.7    $27.6  

Accrued compensation and employee benefits

   42.1   49.8   47.2     49.8  

Deferred revenue

   107.6   99.4   116.8     99.4  

Other accrued liabilities

   52.0   26.0   67.6     26.0  
              

Total current liabilities

   243.3   202.8   267.3     202.8  

Long-term liabilities

   75.4   69.6   76.2     69.6  
              

Total liabilities

   318.7   272.4   343.5     272.4  
              

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, 2010 and December 31, 2009

   —     —  

Common stock, 100.0 shares authorized, $0.001 par value, 39.4 and 38.5 shares issued and outstanding as of June 30, 2010 and December 31, 2009, respectively

   —     —  

Preferred stock, 2.5 shares authorized, $0.001 par value, issuable in series; no shares issued and outstanding as of September 30, 2010 and December 31, 2009

   —       —    

Common stock, 100.0 shares authorized, $0.001 par value, 39.3 and 38.5 shares issued and outstanding as of September 30, 2010 and December 31, 2009, respectively

   —       —    

Additional paid-in capital

   1,238.0   1,024.3   1,287.5     1,024.3  

Retained earnings

   685.7   511.7   720.1     511.7  

Accumulated other comprehensive income

   0.7   1.3   0.7     1.3  
              

Total stockholders’ equity

   1,924.4   1,537.3   2,008.3     1,537.3  
              

Total liabilities and stockholders’ equity

  $2,243.1  $1,809.7  $2,351.8    $1,809.7  
              

See accompanying Notes to Condensed Consolidated Financial Statements.

INTUITIVE SURGICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(IN MILLIONS, EXCEPT PER SHARE AMOUNTS)

(UNAUDITED)

 

  Three Months Ended
June 30,
  Six Months Ended
June 30,
  Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
  2010  2009  2010  2009  2010   2009   2010   2009 

Revenue:

                

Product

  $295.3  $219.3  $573.3  $368.4  $287.1    $236.3    $860.4    $604.7  

Service

   55.4   41.3   106.0   80.6   57.3     43.8     163.3     124.4  
                            

Total revenue

   350.7   260.6   679.3   449.0   344.4     280.1     1,023.7     729.1  

Cost of revenue:

                

Product

   72.7   55.5   140.7   100.8   72.8     65.3     213.5     166.1  

Service

   21.2   14.9   41.3   29.3   21.0     15.8     62.3     45.1  
                            

Total cost of revenue

   93.9   70.4   182.0   130.1   93.8     81.1     275.8     211.2  
                            

Gross profit

   256.8   190.2   497.3   318.9   250.6     199.0     747.9     517.9  
                            

Operating expenses:

                

Selling, general, and administrative

   88.6   67.3   171.4   129.7   91.6     69.9     263.0     199.6  

Research and development

   28.5   23.4   56.5   44.7   26.9     24.6     83.4     69.3  
                            

Total operating expenses

   117.1   90.7   227.9   174.4   118.5     94.5     346.4     268.9  
                            

Income from operations

   139.7   99.5   269.4   144.5   132.1     104.5     401.5     249.0  

Interest and other income, net

   4.5   5.2   8.6   10.2   5.0     4.3     13.6     14.5  
                            

Income before taxes

   144.2   104.7   278.0   154.7   137.1     108.8     415.1     263.5  

Income tax expense

   55.5   42.3   104.0   64.2   50.5     44.3     154.5     108.5  
                            

Net income

  $88.7  $62.4  $174.0  $90.5  $86.6    $64.5    $260.6    $155.0  
                            

Earnings per share:

                

Basic

  $2.26  $1.65  $4.45  $2.36  $2.20    $1.69    $6.65    $4.05  
                            

Diluted

  $2.19  $1.62  $4.31  $2.32  $2.14    $1.64    $6.45    $3.97  
                            

Shares used in computing earnings per share:

                

Basic

   39.3   37.9   39.1   38.4   39.4     38.1     39.2     38.3  
                            

Diluted

   40.5   38.6   40.4   38.9   40.5     39.2     40.4     39.0  
                            

See accompanying Notes to Condensed Consolidated Financial Statements.

INTUITIVE SURGICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(IN MILLIONS)

(UNAUDITED)

 

  Six Months Ended
June 30,
   Nine Months Ended
September 30,
 
  2010 2009   2010 2009 

Operating Activities:

      

Net income

  $174.0   $90.5    $260.6   $155.0  

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

      

Depreciation

   11.4    9.1     17.4    14.2  

Amortization of intangible assets

   7.9    7.9     12.2    11.7  

Deferred income taxes

   0.4    (8.4   (11.8  (15.5

Income tax benefits from employee stock option plans

   40.7    0.7     49.5    8.7  

Excess tax benefit from stock-based compensation

   (46.9  (1.0   (56.3  (9.2

Share-based compensation expense

   57.1    47.4     87.5    71.9  

Changes in operating assets and liabilities:

      

Accounts receivable

   10.7    (5.1   (2.4  (16.4

Inventory

   (16.4  4.2     (27.4  6.8  

Prepaids and other assets

   0.8    (4.0   (0.3  (6.9

Accounts payable

   14.3    6.0     8.2    4.4  

Accrued compensation and employee benefits

   (7.5  (7.6

Deferred revenue

   8.3    10.3     17.2    12.4  

Accrued liabilities

   36.3    23.1  

Other accrued liabilities

   49.7    32.3  
              

Net cash provided by operating activities

   291.1    173.1     404.1    269.4  
              

Investing Activities:

      

Purchase of investments

   (604.3  (303.2   (1,032.2  (523.2

Proceeds from sales and maturities of investments

   386.6    286.1     745.4    417.7  

Purchase of property and equipment and acquisition of intellectual property

   (36.5  (40.3   (86.6  (45.7
              

Net cash used in investing activities

   (254.2  (57.4   (373.4  (151.2
              

Financing Activities:

      

Proceeds from issuance of common stock, net

   115.9    12.0     132.9    33.7  

Excess tax benefit from stock-based compensation

   46.9    1.0     56.3    9.2  

Repurchase and retirement of common stock

   —      (150.0   (58.9  (150.0
              

Net cash provided by (used in) financing activities

   162.8    (137.0   130.3    (107.1
              

Effect of exchange rate changes on cash and cash equivalents

   (1.1  0.1     (0.4  0.4  
              

Net increase (decrease) in cash and cash equivalents

   198.6    (21.2

Net increase in cash and cash equivalents

   160.6    11.5  

Cash and cash equivalents, beginning of period

   221.4    194.6     221.4    194.6  
              

Cash and cash equivalents, end of period

  $420.0   $173.4    $382.0   $206.1  
              

See accompanying Notes to Condensed Consolidated Financial Statements.

INTUITIVE SURGICAL, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

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

NOTE 1. DESCRIPTION OF BUSINESS

Intuitive Surgical, Inc. designs, manufactures, and markets theda Vinci Surgical System, which is an advanced minimally invasive robotic assisted surgical system that the Company believes represents a new generation of surgery. Theda Vinci Surgical System consists of a surgeon’s console or consoles, a patient-side cart, a high performance vision system and proprietary “wristed” instruments. Theda Vinci Surgical System seamlessly 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. By placing computer-enhanced technology between the surgeon and the patient, theda VinciSurgical systemSystem enables higher value surgical procedures to patients through increased effectiveness and reduced invasiveness.

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, 2009 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, 2009, which was filed on January 29, 2010. The results of operations for the first sixnine months of fiscal 2010 are not indicative of the results to be expected for the entire fiscal year or any future periods.

New Accounting Standards Recently Adopted

Revenue Recognition for Arrangements with Multiple Deliverables

The Company’s revenue consists of product revenue resulting from the sales of systems, instruments and accessories, and service revenue. The Company recognizes revenue when all four revenue recognition criteria have been met: persuasive evidence of an arrangement exists; delivery has occurred or service has been rendered; the price is fixed or determinable; and collectibility is reasonably assured. The Company’s revenue recognition policy generally results in revenue recognition at the following points:

 

  

System sales.For system sales directly to end customers, revenue is recognized when acceptance occurs, which is deemed to have occurred upon the receipt by the Company of a form executed by the customer acknowledging delivery and/or installation. For system sales through distributors, revenue is recognized upon transfer of title and risk of loss, which is generally at the time of shipment. Distributors do not have price protection rights. The Company’s system contracts do not allow rights of return. The Company’s system revenue contains a software component. Since theda VinciSystem’s software and non-software elements function together to deliver the System’s essential functionality, they are considered to be one deliverable that is excluded from the software revenue recognition guidance.

 

  

Instruments and accessories. Revenue from sales of instruments and accessories is recognized when the product has been shipped. The Company records an allowance on instruments and accessories sales returns based on historical returns experience.

 

  

Service.Service contract revenue is recognized ratably over the term of the service period. Revenue related to services performed on a time-and-materials basis is recognized when it is earned and billable.

The Company determined that its multiple-element arrangements are generally comprised of the following elements that would qualify as separate units of accounting: system sales, service contracts and instruments and accessories sales.

In September 2009, the Financial Accounting Standards Board (“FASB”) amended the accounting standards related to revenue recognition for arrangements with multiple deliverables and arrangements that include software elements (“new accounting principles”). The new accounting principles permit prospective or retrospective adoption, and the Company elected prospective adoption at the beginning of the first quarter of 2010.

For multiple-element arrangements (which are generally comprised of system sales and service contracts) entered into prior to January 1, 2010, revenue was allocated to each element based on the relative fair value of each element. Fair value is generally determined by vendor specific objective evidence (VSOE) which is based on the price charged when each element is sold separately. The Company’s systems sales generally include a first year service obligation. The Company typically does not sell the systems on a stand-alone basis and therefore does not have VSOE for its systems. The Company has established VSOE for services. When the fair value of a delivered element had not been established, but fair value existed for the undelivered elements, prior to January 1, 2010, the Company used the residual method to recognize revenue. Under the residual method, the fair value of the undelivered elements was deferred and the remaining portion of the arrangement fee was allocated to the delivered elements.

Subsequent to the adoption of the new revenue accounting principles, for multiple-element arrangements entered into on or after January 1, 2010, revenue is allocated to each element based on their relative selling prices. Relative selling prices are based first on VSOE, then on third-party evidence of selling price (TPE) when VSOE does not exist, and then on estimated selling price (ESP) when VSOE and TPE do not exist.

Because the Company has neither VSOE nor TPE for its systems, the allocation of revenue has been based on the Company’s ESPs. The objective of ESP is to determine the price at which the Company would transact a sale if the product was sold on a stand-alone basis. The Company determines ESP for its systems by considering multiple factors including, but not limited to, features and functionality of the system, geographies, type of customer, and market conditions. The Company regularly reviews ESP and maintains internal controls over the establishment and updates of these estimates.

Had the new accounting guidance been applied to revenue at the beginning of 2009, the resultant revenue for the year ended December 31, 2009 would have been substantially the same. However, primarily due to theda Vinci Si upgrade offers made to certain first quarter 2009 customers, hadHad the new accounting guidance been applied to the three and sixnine months ended JuneSeptember 30, 2009, system revenue for the three months ended JuneSeptember 30, 2009 would have been approximately $3.8$1.5 million lower, while system revenue for the sixnine months ended JuneSeptember 30, 2009 would have been approximately $3.1$1.6 million higher. Under the new accounting guidance, less of the discount associated with theda Vinci Siupgrades would have been allocated to the initial system sale.

Fair Value Measurements Disclosures

Effective January 1, 2010, the Company adopted revised guidance intended to improve disclosures related to fair value measurements, issued by FASB. This guidance requires us to separate information about significant transfers in and out of Level 1 and Level 2 and the reason for such transfers, and also requires information related to purchases, sales, issuances, and settlements information of Level 3 financial assets to be included in the rollforward of activity. The guidance also requires us to provide certain disaggregated information on the fair value of financial assets and requires us to disclose valuation techniques and inputs used for both recurring and nonrecurring fair value measurements of our Level 2 and Level 3 financial assets. We have providedThe Company’s policy is to recognize transfers into or out of levels as of the additional required disclosures effective January 1, 2010.actual date of the event or change in circumstances that caused the transfer.

NOTE 3. CASH, CASH EQUIVALENTS & INVESTMENTS

The following tables summarize the Company’s cash, cash equivalents and investments as of JuneSeptember 30, 2010 and December 31, 2009 (in millions):

 

  Amortized
Cost
  Gross
Unrealized
Gains
  Gross
Unrealized
Losses
 Fair
Value
  Amortized
Cost
   Gross
Unrealized
Gains
   Gross
Unrealized
Losses
 Fair
Value
 

June 30, 2010

       

September 30, 2010

       

Cash and cash equivalents:

              

Cash

  $34.9  $—    $—     $34.9  $35.0    $—      $—     $35.0  

Cash equivalents

   385.1   —     —      385.1   347.0     —       —      347.0  
                           

Total cash and cash equivalents

  $420.0  $—    $—     $420.0  $382.0    $—      $—     $382.0  
                           

Available for sale investments:

              

Short-term

              

Commercial paper

  $54.6  $—    $—     $54.6  $62.5    $—      $—     $62.5  

Municipal notes

   73.6   0.5   —      74.1   110.7     0.5     —      111.2  

U.S. corporate debt

   181.0   0.9   (0.1  181.8   164.9     0.8     —      165.7  

U.S. treasuries

   81.4   —     —      81.4   103.3     —       —      103.3  

U.S. government agencies

   121.3   0.3   —      121.6   155.9     0.3     —      156.2  
                           

Total short-term

  $511.9  $1.7  $(0.1 $513.5  $597.3    $1.6    $—     $598.9  
                           

Long-term

              

Municipal notes

  $132.0  $0.9  $(4.4 $128.5  $109.8    $0.6    $(4.3 $106.1  

U.S. corporate debt

   248.0   2.3   (0.1  250.2   327.8     4.1     —      331.9  

U.S. treasuries

   12.5   0.1   —      12.6   16.0     0.2     —      16.2  

U.S. government agencies

   228.3   0.7   —      229.0   169.0     0.6     —      169.6  

Non-U.S. government securities

   15.7     0.2     —      15.9  
                           

Total long-term

  $620.8  $4.0  $(4.5 $620.3  $638.3    $5.7    $(4.3 $639.7  
                           

Total cash, cash equivalents and available for sale investments

  $1,552.7  $5.7  $(4.6 $1,553.8

Other securities (included in short-term investments):

       

Trading securities, auction rate securities

  $30.4  $—    $—     $30.4

Put option

   4.0   —     —      4.0

Total cash, cash equivalents and available for sale investments:

  $1,617.6    $7.3    $(4.3 $1,620.6  
                           

Total cash, cash equivalents and investments:

  $1,587.1  $5.7  $(4.6 $1,588.2
            

 

  Amortized
Cost
  Gross
Unrealized
Gains
  Gross
Unrealized
Losses
 Fair
Value
  Amortized
Cost
   Gross
Unrealized
Gains
   Gross
Unrealized
Losses
 Fair
Value
 

December 31, 2009

              

Cash and cash equivalents:

              

Cash

  $28.6  $—    $—     $28.6  $28.6    $—      $—     $28.6  

Cash equivalents

   192.8   —     —      192.8   192.8     —       —      192.8  
                           

Total cash and cash equivalents

  $221.4  $—    $—     $221.4  $221.4    $—      $—     $221.4  
                           

Available for sale investments:

              

Short-term

              

Commercial paper

  $13.1  $—    $—     $13.1  $13.1    $—      $—     $13.1  

Municipal notes

   21.3   0.2   —      21.5   21.3     0.2     —      21.5  

U.S. corporate debt

   150.5   1.3   —      151.8   150.5     1.3     —      151.8  

U.S. treasuries

   31.6   0.2   —      31.8   31.6     0.2     —      31.8  

U.S. government agencies

   45.5   0.5   —      46.0   45.5     0.5     —      46.0  
                           

Total short-term

  $262.0  $2.2  $—     $264.2  $262.0    $2.2    $—     $264.2  
                           

Long-term

              

Municipal notes

  $161.0  $1.5  $(4.5 $158.0  $161.0    $1.5    $(4.5 $158.0  

U.S. corporate debt

   222.5   2.1   (0.1  224.5   222.5     2.1     (0.1  224.5  

U.S. treasuries

   29.5   —     (0.2  29.3   29.5     —       (0.2  29.3  

U.S. government agencies

   204.6   0.6   (0.4  204.8   204.6     0.6     (0.4  204.8  
                           

Total long-term

  $617.6  $4.2  $(5.2 $616.6  $617.6    $4.2    $(5.2 $616.6  
                           

Total cash, cash equivalents and available for sale investments

  $1,101.0  $6.4  $(5.2 $1,102.2  $1,101.0    $6.4    $(5.2 $1,102.2  

Other securities (included in short-term investments):

              

Trading securities, auction rate securities

  $62.2  $—    $—     $62.2  $62.2    $—      $—     $62.2  

Put option

   7.6   —     —      7.6   7.6     —       —      7.6  
                           

Total cash, cash equivalents and investments

  $1,170.8  $6.4  $(5.2 $1,172.0  $1,170.8    $6.4    $(5.2 $1,172.0  
                           

The following table summarizes the maturities of the Company’s cash equivalents and available-for-sale investments at JuneSeptember 30, 2010 (in millions):

 

  Amortized
Cost
  Fair
Value
  Amortized
Cost
   Fair
Value
 

Mature in less than one year

  $897.0  $898.6  $944.2    $945.9  

Mature in one to five years

   597.9   601.8   615.5     621.1  

Mature in more than five years

   22.9   18.5   22.9     18.6  
              

Total

  $1,517.8  $1,518.9  $1,582.6    $1,585.6  
              

During the three and sixnine months ended JuneSeptember 30, 2010 and 2009, realized gains or losses recognized on the sale of investments were not significant. As of JuneSeptember 30, 2010 and December 31, 2009, net unrealized gains on available-for-sale securities, net of tax, of $2.1 million and $0.9 million, respectively, were included in accumulated other comprehensive income in the accompanying unaudited Condensed Consolidated Balance Sheets. At JuneSeptember 30, 2010, the majority of the Company’s gross unrealized losses were from auction-rate securities (ARS). The Company determined these unrealized losses to be temporary.temporary and recorded no other-than-temporary impairments. Factors considered in determining whether a loss is temporary included the length

of time and extent to which the investment’sinvestments fair value has been less than the cost basis; the financial condition and near-term prospects of the investee; extent of the loss related to credit of the issuer; the expected cash flows from the security; the Company’s intent to sell the security;security and whether or not the Company will be required to sell the security before the recovery of its amortized cost.

NOTE 4. FAIR VALUE MEASUREMENTS

The Company measures certain financial assets including cash equivalents, available-for-sale securities, trading 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 JuneSeptember 30, 2010 and December 31, 2009 (in millions):

 

  Fair Value Measurements at June 30, 2010 Using  Fair Value Measurements at September 30, 2010  Using 

Assets

  Level 1  Level 2  Level 3  Total  Level 1   Level 2   Level 3   Total 

Municipal notes - trading security

  $—    $—    $30.4  $30.4

Put option

   —     —     4.0   4.0

Available-for-sale securities

                

Money Market funds

   313.6   —     —    ��313.6  $248.6    $—      $—      $248.6  

U.S. treasuries

   94.0   —     —     94.0   119.5     —       —       119.5  

Commercial paper

   —     122.7   —     122.7   —       150.8     —       150.8  

Corporate debt

   —     432.0   —     432.0   —       497.6     —       497.6  

U.S. government agencies

   —     354.0   —     354.0   —       335.9     —       335.9  

Non-U.S. government agencies

   —       15.9     —       15.9  

Municipal notes

   —     184.1   18.5   202.6   —       198.7     18.6     217.3  
            

Total available-for-sale securities

   407.6   1,092.8   18.5   1,518.9
            

Foreign Currency Derivatives

   —     2.4   —     2.4
                            

Total assets measured at fair value

  $407.6  $1,095.2  $52.9  $1,555.7  $368.1    $1,198.9    $18.6    $1,585.6  
                            

Liabilities

                

Foreign Currency Derivatives

  $—      $2.8    $—      $2.8  
                

Total liabilities measured at fair value

  $—      $2.8    $—      $2.8  
                
  Fair Value Measurements at December 31, 2009 Using  

 

Fair Value Measurements at December 31, 2009 Using

 

Assets

  Level 1  Level 2  Level 3  Total  Level 1   Level 2   Level 3   Total 

Municipal notes - trading security

  $—    $—    $62.2  $62.2  $—      $—      $62.2    $62.2  

Put option

   —     —     7.6   7.6   —       —       7.6     7.6  

Available-for-sale securities

                

Money Market funds

   175.7   —     —     175.7   175.7     —       —       175.7  

U.S. treasuries

   61.1   —     —     61.1   61.1     —       —       61.1  

Commercial paper

   —     27.4   —     27.4   —       27.4     —       27.4  

Corporate debt

   —     379.0   —     379.0   —       379.0     —       379.0  

U.S. government agencies

   —     250.9   —     250.9   —       250.9     —       250.9  

Municipal notes

   —     160.4   19.1   179.5   —       160.4     19.1     179.5  
                            

Total available-for-sale securities

   236.8   817.7   19.1   1,073.6   236.8     817.7     19.1     1,073.6  
                            

Total assets measured at fair value

  $236.8  $817.7  $88.9  $1,143.4  $236.8    $817.7    $88.9    $1,143.4  
                            

Liabilities

                            

Foreign Currency Derivatives

  $—    $0.4  $—    $0.4  $—      $0.4    $—      $0.4  
                            

Total liabilities measured at fair value

  $—    $0.4  $—    $0.4  $—      $0.4    $—      $0.4  
                            

The following table provides a reconciliation of the beginning and ending balances for the assets measured at fair value using significant unobservable inputs (Level 3) (in millions):

 

  Fair Value Measurements at
Reporting Date Using
Significant Unobservable Inputs
(Level 3)
   Fair Value Measurements at
Reporting Date Using
Significant Unobservable Inputs 
(Level 3)
 
  Put Option ARS Total   Put Option ARS Total 

Balance at January 1, 2010

  $7.6   81.3   88.9    $7.6   $81.3   $88.9  

Sales/Maturities

   —     (8.1 (8.1   —      (8.1  (8.1

Total gains or (losses):

        

Included in other comprehensive income (loss)

   —     0.2   0.2     —      0.2    0.2  

Included in earnings

   (0.4 0.4   —       (0.4  0.4    —    
                    

Balance at March 31, 2010

   7.2   73.8   81.0     7.2    73.8    81.0  

Sales/Maturities

   —     (28.0 (28.0   —      (28.0  (28.0

Total gains or (losses):

        

Included in other comprehensive income (loss)

   —     (0.1 (0.1   —      (0.1  (0.1

Included in earnings

   (3.2 3.2   —       (3.2  3.2    —    
                    

Balance at June 30, 2010

  $4.0   48.9   52.9    $4.0   $48.9   $52.9  

Sales/Maturities

   (4.0  (30.4  (34.4

Total gains or (losses):

    

Included in other comprehensive income (loss)

   —      0.1    0.1  
                    

Balance at September 30, 2010

  $—     $18.6   $18.6  
          

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 sixnine months ended JuneSeptember 30, 2010.2010, and there were no changes in the Company’s valuation technique. 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. TheSince the auctions for these securities have continued to fail since February 2008. These2008, these investments are not currently trading and therefore do not have a readily determinable fairmarket value. PursuantOn June 30, 2010, pursuant to the terms of the UBS Rights Offering, on June 30, 2010rights offering, the Company exercised its right to sell all ARS subject to the Rights Offeringrights offering to UBS at par value. As of June 30 2010, the Company had $34.4 million par value of ARS with UBS. Subsequently,$34.4 million. As a result on July 1, 2010, the Company received the full par value in cash from UBS.

The remainder of the Company’s ARS investment portfolio of $18.6 million, is reflected as long-term available-for-sale on July 1,the Company’s unaudited Condensed Consolidated Balance Sheet as of September 30, 2010. 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 September 30, 2010, interest rates, timing and amount of cash flows, credit and liquidity premiums and expected holding periods of the ARS.

Foreign currency derivative

The Company uses derivatives to partially offset its business exposure to foreign currency exchange risk. On a monthly basis, the Company enters into foreign currency forward contracts with one to seven month terms. It does not purchase derivatives for trading purposes. Asterms to offset some of June 30, 2010, the foreign exchange risk of expected future cash flows on certain forecasted revenue and on certain existing assets and liabilities. The Company had enteredtypically hedges portions of its forecasted foreign currency exposure associated with revenue. The Company may also enter into €18.5 million and £1.4 million of foreign currency forward contracts to offset the foreign currency exchange gains and losses generated by re-measurement of certain assets and liabilities denominated in non-functional currencies. The hedging program is not designated for trading or speculative purposes.

The Company’s accounting policies for these instruments are based on whether the instruments are designated as hedge non-functional currency net monetary assets.or non-hedge instruments. The Company records all derivatives on the unaudited Condensed Consolidated Balance Sheets at fair value. The effective portions of cash flow hedges are recorded in other comprehensive income (OCI) until the hedged item is recognized in earnings. Derivative instruments designated as cash flow hedges must be de-designated as hedges when it is probable the forecasted hedged transaction will not occur in the initially identified time period or within a subsequent two month time period. Deferred gains

and losses in OCI associated with such derivative instruments are reclassified immediately into earnings through interest and other income, net. Any subsequent changes in fair value of such derivative instruments also are reflected in current earnings unless they are re-designated as hedges of other transactions.

Derivatives that are not designated as hedging instruments and the ineffective portions of cash flow hedges are adjusted to fair value through earnings in interest and other income, net.

The fair value of derivative instruments in the unaudited Condensed Consolidated Balance Sheet as of JuneSeptember 30, 2010 wasand December 31, 2009 were approximately $2.4$2.8 million and $0.4 million in assets. For the three and six months ended June 30, 2010, $1.9 million and $2.5 million of accumulated hedging gains were reclassified from other comprehensive income to revenue related to the impact of derivative instruments designatedliabilities, respectively.

Cash Flow Hedges

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

As of September 30, 2010, the Company had the notional amount of €11.3 million and £0 outstanding currency forward contracts that were entered into to hedge Euro and GBP dominated sales, compared to €19.5 million and £3.9 million at December 31, 2009. The amounts reclassified to revenue as the related hedged transactions were recognized in revenue for the three and sixnine months ended JuneSeptember 30, 2010 and 2009 were not significant. Other impacts of derivative instruments designated as cash flow hedges were not significant for the three and sixnine months ended JuneSeptember 30, 2010. Interest2010 and 2009.

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 or GBP.

As of September 30, 2010, the Company had the notional amount of €18.7 million and £1.4 million outstanding currency forward contracts that were entered into to hedge non-functional currency denominated net monetary assets, compared to €22.0 million and £4.5 million at December 31, 2009. For the three and nine months ended September 30, 2010, the Company had recognized losses of approximately $2.3 million and gains of approximately $2.5 million, respectively, in interest and other income, net for the three and six months ended June 30, 2010 includes approximately $1.9 million and $4.1 million, respectively, of income related to derivative instruments including those used to hedge against balance sheet foreign currency exposures. These amounts were offset by approximately $2.2 million and $4.9$2.9 million of losses related to the remeasurementnet foreign exchange gains and $1.9 million of balance sheetnet foreign currency exposuresexchange losses for the three and sixnine months ended JuneSeptember 30, 2010, respectively. The Company recognized a loss of approximately $1.4 million for derivative instruments used to hedge against balance sheet foreign currency exposure during the three months ended June 30, 2009 and the recognized loss was not significant during the six months ended June 30, 2009. These amounts were offset by approximately $1.6 million of gainsprimarily related to the remeasurementre-measurement of balance sheet foreignnon-functional currency exposuresdenominated net monetary assets. Impacts of derivative instruments not designated as hedges were not significant for the three and nine months ended JuneSeptember 30, 2009 and the impact related to the six months ended June 30, 2009 was not significant.2009.

NOTE 5. INVENTORY

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

 

  June 30,
2010
  December 31,
2009
  September 30,
2010
   December 31,
2009
 

Inventory

        

Raw materials

  $17.2  $16.3  $27.4    $16.3  

Work-in-process

   4.8   2.5   2.4     2.5  

Finished goods

   52.0   38.8   55.2     38.8  
              

Total

  $74.0  $57.6  $85.0    $57.6  
              

NOTE 6. STOCKHOLDERS’ EQUITY

Comprehensive Income

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

 

  Three Months Ended June 30, Six Months Ended June 30,   Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
  2010 2009 2010 2009   2010 2009 2010 2009 

Net income

  $88.7   $62.4   $174.0   $90.5    $86.6   $64.5   $260.6   $155.0  

Foreign currency translation gains (losses)

   (0.4  0.3    (0.6  0.1     0.4    0.2    (0.2  0.3  

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

          

Unrealized gains (losses) on derivative instruments

   1.1    (1.1  3.1    (0.7   (2.5  (0.6  0.6    (1.3

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

   (2.2  0.6    (3.1  0.4     0.9    0.3    (2.2  0.7  

Unrealized gains (losses) on available-for-sale securities, net of tax:

          

Unrealized gains arising during the period

   —      1.9    —      3.9     1.2    0.6    1.2    4.5  
                          

Total other comprehensive income

  $87.2   $64.1   $173.4   $94.2    $86.6   $65.0   $260.0   $159.2  
                          

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

 

   June 30,
2010
  December 31,
2009

Foreign currency translation gains (losses)

  $(0.2 $0.4

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

   0.9    0.9
        

Total accumulated other comprehensive income

  $0.7   $1.3
        

   September 30,
2010
  December 31,
2009
 

Foreign currency translation gains

  $0.2   $0.4  

Accumulated net unrealized losses on derivatives, net of tax

   (1.6  —    

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

   2.1    0.9  
         

Total accumulated other comprehensive income

  $0.7   $1.3  
         

NOTE 7. STOCK-BASED COMPENSATION

Stock Option Plans

2010 Incentive Award Plan

In April 2010, the Company’s stockholders approved the 2010 Incentive Award Plan (“2010 Plan”), which authorized approximately 1.3 million shares of common stock for issuance. Under this plan, the Company issues nonqualified stock options (“NSOs”) to employees and certain consultants. The 2010 Plan generally permits NSOs to be granted at no less than the fair market value of the common stock on the date of grant, with terms of 10 years from the date of grant. Options generally vest 12.5% upon completion of 6 months service and 1/48th48th per month thereafter; however, options may have different vesting terms as determined by the Compensation Committee. The plan expires in 2020.

A summary of stock option activity under the 2000 Equity Incentive Plan, the 2000 Non-Employee Directors’ Plan, the 2009 Employment Commencement Incentive Plan and the 2010 Incentive Award Plan for the sixnine months ended JuneSeptember 30, 2010 is presented as follows (in millions, except per share amounts):

 

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

Per Share
 

Balance at December 31, 2009

  8.9   4.6   $157.25   8.9    4.6   $157.25  

Options authorized

  1.3   —      —     1.3    

Options granted

  (1.3 1.3    333.50   (1.3  1.3    331.87  

Options exercised

  —     (0.8  141.23   —      (0.9  138.28  

Options forfeited/expired (1)

  (7.3 (0.1  209.37   (7.4  (0.1  222.25  
                

Balance at June 30, 2010

  1.6   5.0   $202.91

Balance at September 30, 2010

   1.5    4.9   $205.99  
                

 

(1)Primarily related to the expiration of the 2000 Equity Incentive Plan.

As of JuneSeptember 30, 2010, 2.02.3 million shares of options were exercisable at a weighted-average price of $146.07$163.81 per share.

Employee Stock Purchase Plan

Under the Employee Stock Purchase Plan (“ESPP”), employees purchased 82,94861,958 shares for $7.7$6.6 million and 55,18537,248 shares for $4.7$3.3 million during the sixthree months ended JuneSeptember 30, 2010 and 2009, respectively and 144,906 shares for $14.3 million and 92,433 shares for $8.0 million during the nine months ended September 30, 2010 and 2009, respectively.

Stock-based Compensation

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

 

  Three Months Ended
June 30,
  Six Months Ended
June 30,
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
  2010  2009  2010  2009  2010  2009  2010  2009

Cost of sales - products

  $2.4  $1.9  $4.5  $3.7  $2.5  $2.0  $7.0  $5.7

Cost of sales - services

   2.2   1.7   4.1   3.2   2.2   1.7   6.3   4.9
                        

Total cost of sales

   4.6   3.6   8.6   6.9   4.7   3.7   13.3   10.6

Selling, general and administrative

   20.0   15.5   37.8   29.9   19.8   15.5   57.6   45.4

Research and development

   5.7   5.5   10.7   10.5   5.9   5.4   16.6   15.9
                        

Stock-based compensation expense before income taxes

   30.3   24.6   57.1   47.3   30.4   24.6   87.5   71.9

Income tax effect

   8.3   6.8   15.9   14.1   9.1   7.2   25.0   21.3
                        

Stock-based compensation expense after income tax effect

  $22.0  $17.8  $41.2  $33.2

Stock-based compensation expense after income taxes

  $21.3  $17.4  $62.5  $50.6
                        

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,
   Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
  2010 2009 2010 2009   2010 2009 2010 2009 

Stock Options

          

Average risk free interest rate

   2.33  2.10  2.33  1.68   1.61  2.47  2.28  1.73

Average expected term (years)

   4.6    5.1    4.8    5.3     4.8    4.8    4.8    5.3  

Average expected volatility

   37  51  35  56   44  46  35  56

Weighted average fair value at grant date

  $115.53   $62.26   $111.69   $55.18    $121.32   $87.92   $112.32   $57.11  

Total stock-based compensation expense (in millions)

  $28.3   $23.0   $53.2   $44.2    $28.1   $22.9   $81.3   $67.1  

ESPP

          

Average risk free interest rate

     0.49  0.58   0.37  0.69  0.43  0.63

Average expected term (years)

     1.3    1.3     1.3    1.3    1.3    1.3  

Average expected volatility

     35  65   43  47  39  56

Weighted average fair value at grant date

    $99.34   $43.94    $110.90   $79.89   $106.72   $51.23  

Total stock-based compensation expense (in millions)

  $2.0   $1.6   $3.9   $3.1    $2.3   $1.7   $6.2   $4.8  

There were no new ESPP offerings duringNOTE 8. SHARE REPURCHASE PROGRAMS

During the first quarter of fiscal 2009, the Company’s Board of Directors (the “Board”) authorized $300 million under a share repurchase program. In March 2009, the Company paid $150 million to repurchase and retire 1.4 million shares of the Company’s common stock.

In July 2010, the Board authorized an additional $150 million for share repurchase under the share repurchase program. During the three months ended JuneSeptember 30, 2010, the Company repurchased and 2009.retired approximately 212,000 shares of its common stock at an average purchase price of $277.92 per share, for an aggregate purchase price of $58.9 million, through open market transactions. As of September 30, 2010, the remaining authorized amount of share repurchases that may be made under the Board-authorized share repurchase program was approximately $241.1 million.

The Company uses the par value method of accounting for its share repurchases. As a result of the share repurchases during the three and nine months ended September 30, 2010, the Company reduced common stock and additional paid-in capital by an aggregate of $6.7 million and charged $52.2 million to retained earnings.

NOTE 8.9. CONTINGENCIES

On August 6, 2010, a purported class action lawsuit entitledPerlmutter 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 August 19, 2010, an alleged shareholder caused a purported shareholder’s derivative lawsuit entitledHimmel 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 shareholder filed an essentially identical lawsuit entitledApplbaum 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.

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.

NOTE 10. INCOME TAXES

As part of the process of preparing the unaudited Condensed Consolidated Financial Statements, the Company is required to estimate its income taxes in each of the jurisdictions in which it operates. This process involves estimating the current tax liability under the most recent tax laws and assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included in the accompanying unaudited Condensed Consolidated Balance Sheets.

Income tax expense for the three months ended JuneSeptember 30, 2010 was $55.5$50.5 million, or 38.5%36.8% of pre-tax income, compared with $42.3$44.3 million, or 40.4%40.7% of pre-tax income for the three months ended JuneSeptember 30, 2009. Income tax expense for the sixnine months ended JuneSeptember 30, 2010 was $104.0$154.5 million, or 37.4%37.2% of pre-tax income, compared with $64.2$108.5 million, or 41.5%41.2% of pre-tax income for the sixnine months ended JuneSeptember 30, 2009. The effective tax rate for the three and sixnine months ended JuneSeptember 30, 2010 differs from the U.S. federal statutory rate of 35% 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 Company intends these foreign earnings to be indefinitely reinvested outside the United States. The effective tax rate for the three and sixnine months ended JuneSeptember 30, 2009 differs from the U.S. federal statutory rate of 35% primarily due to state income taxes and non-deductible stock option expenses, partially offset by 2009 research and development (“R&D”) credits and domestic production deductions. The state income taxes for the six months ended June 30, 2009 included a discrete increase of approximately 1.0% resulting from re-measurement of long term deferred tax assets due to a California law change enacted in February 2009.

As of JuneSeptember 30, 2010, the Company has total gross unrecognized tax benefits of approximately $75.4$75.6 million compared with approximately $70.0 million as of December 31, 2009, representing an increase of approximately $5.4$5.6 million for the sixnine months ended JuneSeptember 30, 2010. Of the total gross unrecognized tax benefits, $71.1$71.3 million and $65.7 million as of JuneSeptember 30, 2010 and December 31, 2009, 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 $4.2$4.8 million and $3.3 million, respectively, as of JuneSeptember 30, 2010 and December 31, 2009.

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 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.

NOTE 9.11. 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,
  Three Months  Ended
September 30,
   Nine Months  Ended
September 30,
 
  2010  2009  2010  2009  2010   2009   2010   2009 

Net income

  $88.7  $62.4  $174.0  $90.5  $86.6    $64.5    $260.6    $155.0  

Basic:

                

Weighted-average shares outstanding

   39.3   37.9   39.1   38.4   39.4     38.1     39.2     38.3  
                            

Basic net income per share

   2.26   1.65   4.45  $2.36  $2.20    $1.69    $6.65    $4.05  
                            

Diluted:

                

Weighted-average shares outstanding used in basic calculation

   39.3   37.9   39.1   38.4   39.4     38.1     39.2     38.3  

Add common stock equivalents

   1.2   0.7   1.3   0.5   1.1     1.1     1.2     0.7  
                            

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

   40.5   38.6   40.4   38.9   40.5     39.2     40.4     39.0  
                            

Diluted net income per share

  $2.19  $1.62  $4.31  $2.32  $2.14    $1.64    $6.45    $3.97  
                            

Employee stock options to purchase approximately 1.41.7 million and 2.91.5 million weighted shares for the three months ended JuneSeptember 30, 2010 and 2009, respectively, and 1.11.2 million and 3.02.6 million weighted shares for the sixnine months ended JuneSeptember 30, 2010 and 2009, 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.

 

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 JuneSeptember 30, 2010 and results of operations for the three and sixnine months ended JuneSeptember 30, 2010 and 2009 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, 2009.

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 companies; 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 Intuitive Surgical operates; 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 expectation 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, 2009 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 Si™, da Vinci® Si-e HD Surgical System™,EndoWrist®, andInSite® 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. Hereprocedure efficacy is a measure of the success of the surgery in resolving the underlying disease andinvasiveness 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 offerda Vinci procedures, potentially resulting in a local shift of treatment approach and market share. The combination of these local adoptions drivescan drive a disruptive change in the marketplace and leadscan lead to the broad adoption of robotic surgery. These adoptions occur procedure by procedure, and are driven by the relative patient value ofda Vinci procedures against alternatives for the same disease state.

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 revenue. The da Vinci Surgical System generally sells for between $1.0 million toand $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 purchaseconsume 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, and will need to be replaced asat which point they are consumed.replaced. We generate additional recurring revenue from ongoing system service. We typically enter into service contracts at the time the system is 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 $180,000 per year, depending on the configuration of the underlying system.

Since the introduction of the da Vinci Surgical System in 1999, robotic surgery volume has increased and our established base of da Vinci Surgical Systems has grown. Recurring revenue has generally grown at an equal ora faster rate than system revenue. Recurring revenue increased from $276.4 million, or 46% of total revenue in 2007, to $419.6 million, or 48% of total revenue in 2008 to $561.7 million, or 53% of total revenue in 2009. Recurring revenue for the three months ended JuneSeptember 30, 2010 was $182.9$184.8 million or 52%54% of total revenue and for the sixnine months ended JuneSeptember 30, 2010 was $356.2$541.0 million, or 52%53% of total revenue. The increase in recurring revenue relative to system revenue reflects continuing adoption of procedures on a growing base of installedda Vinci Surgical Systems. We expect recurring revenue to become a larger percentage of total revenue in the future. The installed base ofda Vinci Surgical Systems has grown to 1,5711,661 at JuneSeptember 30, 2010, compared with 1,2421,308 at September 30, 2009 and 1,571 at June 30, 2009 and 1,482 at March 31, 2010.

Regulatory Activities

We believe that we have obtained the necessary clearances required to market our products to our currently targeted surgical specialties within the United States. As we make additions to the target procedures, we will continue to seekobtain the necessary clearances. The following table lists chronologically our FDA clearances to date:

 

July 2000 – 2000—General laparoscopic procedures

 

March 2001 – 2001—Non-cardiac thoracoscopic procedures

 

May 2001 – 2001—Prostatectomy procedures

 

November 2002 – 2002—Cardiotomy procedures

 

July 2004 – 2004—Cardiac revascularization procedures

 

March 2005 – 2005—Urologic surgical procedures

 

April 2005 – 2005—Gynecologic surgical procedures

 

June 2005 – 2005—Pediatric surgical procedures

 

December 2009 – 2009—Transoral Otolaryngologic surgical procedures

During the first quarter of 2009, we received clearance to market ourda 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 ourda Vinci S System in Japan. During the three and nine months ended March 31, 2010 and six months ended JuneSeptember 30, 2010, we sold seven4 and eight12da Vinci SSystems, respectively, in Japan. These sales were primarily made to early adopters in Japan who were anticipating our Shonin approval.adopters. We are currently focusing our efforts on obtaining the appropriatespecific reimbursement forda 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 of 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.

2010 Business Events and Trends

Economic Environment. During the first half of 2009, the world-wide economic recession curtailed hospital demand for capital purchases of ourda Vinci Surgical Systems. Driven by the U.S. market, demand for ourda Vinci Surgical Systems improved towards the end of 2009 and into 2010. The 212317 totalda Vinci Surgical Systems sold in the sixnine months ended JuneSeptember 30, 2010 exceeded those sold during the same period of 2009 by 70 systems. The increase was89 systems, driven primarily by sales growth in the United States. However, the macro-economic environment in Europe has constrained capital spending such that system sales in the six months ended June 30, 2010 were 25 compared with 30 for the six months ended June 30, 2009 despite significant procedure growth.

da Vinci Si Surgical System Product Launch. During the second quarter of 2009 we launched our newest da Vinci model, the da Vinci Si. The da Vinci Si brings to market three significant innovations. First, ourInSite™ imaging system has been substantially redesigned for increased visual acuity and improved ease-of-use. The HD imaging system’s increased performance is similar to the move from 720p to 1080i in commercial television. We believe that the increased visual performance will continue to enhance

surgeon precision and confidence and willmay contribute to improved patient outcomes and shorter procedure times. Secondly, theda Vinci Si surgeon console’s user interface was redesigned to allow simplified and integrated control ofda Vinci products and other operating room devices, such as electro-surgical units. The new user interface also includes a set of ergonomic controls for surgeon comfort. We believe the simplified interface will allow for easier surgeon training. The third significant improvement is the introduction of a dual surgeon’s console for use during surgery, which will allow new methods of trainingda Vinci surgeons and enable collaborativeda Vinci surgery. With theda Vinci Si, a surgeon sitting at a second console can view the same surgery as the primary surgeon and can be passed control of some or all of theda Vinci arms during a case. We believe this will both shorten the learning curve for new surgeons and will allow collaborative surgery in complex cases.

The da Vinci Si Surgical System was FDA approved and CE marked upon launch and is currently available in the United States, Europe, and certain other countries. da Vinci SiSystems are available with an option to purchase a second console. Existing da Vinci S instruments and most da Vinci S accessories are compatible with the da Vinci Si system. An upgrade from ada Vinci S SystemSurgical Systems are upgradable to theda Vinci Si System is available for our current customers.Surgical Systems. 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 will continue to service and support this product line.

We offered certain of ourMost customers who purchased da Vinci S Surgical Systems in the first quarter of 2009 were offered the opportunity to upgrade their recently purchased da Vinci S Surgical Systems to da Vinci Si Surgical Systems at a discount to the list price of our upgrade. The upgrade program also provided our customers the opportunity to return their recently purchased da Vinci S camera accessories and receive a credit towards the purchase of da Vinci Si camera or other accessories. These customers were given until June 30, 2009 to accept our offer. Total revenue in an amount equal to the discount, of approximately $20.1 million, was deferred in the first quarter of 2009. During the second quarter of 2009, we recognized $13.8 million of revenue from offers declined, upgrades completed or accessories delivered. In the third quarter of 2009, we completed all accepted da Vinci Si system upgrade offers and recognized the remaining $6.3 million of deferred revenue.

Market acceptance of theda Vinci Si Surgical System has been positive since its market introduction in the second quarter of 2009. In the secondthird quarter of 2010, 8990 out of 108105 systems sold wereda Vinci SiSurgical Systems, representing approximately 82%86% of system sales.

SecondIn the third quarter 2010, we introduced the newSi-e model of theda Vinci Surgical System. The 3-armSi-eSystem is designed to deliver all coreda Vincifunctionality, providing a flexible, capable and economical solution for many robotic-assisted procedures. Theda Vinci Si-e system is fully upgradeable to theda Vinci Si model by adding a fourth arm (third instrument arm), a touch screen monitor,TilePro™multi-image display capability, and other enhancements.

Third Quarter 2010 Financial Highlights

 

  

Second quarter 2010 surgical procedures performed with theda Vinci Surgical System grew by approximately 36% compared to the second quarter of 2009.

Second quarter 2010da VinciHysterectomy (dVH) procedure volume surpassedda VinciProstatectomy (dVP) volume, becoming the highest volumeda Vinci surgery procedure.

Total revenue increased to $350.7$344.4 million in the third quarter of 2010 from $260.6$280.1 million during the secondthird quarter of 2010. Second2009. Third quarter 2009 total revenue included recognition of $13.8$6.3 million of the $20.1 million of revenue deferred in the first quarter of 2009 related toda Vinci Si system upgrade offers made.

 

  

Recurring revenue increasedThird quarter 2010 surgical procedures performed with theda Vinci Surgical System grew by approximately 33% compared to $182.9 million from $137.1 million during the secondthird quarter of 2010. Second quarter 2009 recurring revenue included recognition of $1.4 million of $2.1 million of revenue deferred in the first quarter of 2009 related toda Vinci Si system upgrade offers made.2009.

 

Instruments and accessories revenue increased to $127.5 million from $95.8 million during the second quarter of 2010. Second quarter 2009 instruments and accessories revenue included recognition of $1.4 million of $2.1 million of revenue deferred in the first quarter of 2009 related toda Vinci Si system upgrade offers made.

Instruments and accessories revenue increased to $127.5 million in the third quarter of 2010 from $100.8 million during the third quarter of 2009.

Recurring revenue increased to $184.8 million in the third quarter of 2010 from $144.6 million during the third quarter of 2009.

 

  

We sold 108105 da Vinci Surgical Systems during the secondthird quarter of 2010, compared with 7686 in the secondthird quarter of 2009.

 

  

System revenue was $167.8$159.6 million in the third quarter of 2010 compared with $123.5$135.5 million during the secondthird quarter of 2009. SecondThird quarter 2009 system revenue included recognition of $12.4$5.6 million of $18.0 million of revenue deferred in the first quarter of 2009 related toda Vinci Si system upgrade offers made.

 

  

As of JuneSeptember 30, 2010, we had ada Vinci Surgical System installed base of 1,5711,661 systems, 1,1601,228 in the United States, 276292 in Europe, and 135141 in the rest of the world.

We added 11992 employees during the secondthird quarter of 2010, primarilyof which the majority were in field sales, service, and product operations functions,training organization, bringing our total headcount to 1,4761,568 at JuneSeptember 30, 2010.

 

  

Operating income was $139.7$132.1 million in the third quarter of 2010 compared to $99.5$104.5 million during the secondthird quarter of 2009. SecondThird quarter 2009 operating income included recognition of $13.8$6.3 million of $20.1 million related to revenue deferred in the first quarter of 2009 forda Vinci Si system upgrade revenue offers made. Operating income included $30.3$30.4 million and $24.6 million during the secondthird quarter of 2010 and 2009, respectively, of stock-based compensation expense for the estimated fair value of employee stock options and stock purchases.

 

We ended the secondthird quarter of 2010 with $1,588.2$1,620.6 million in cash and investments. Cash and investments increased by $192.7$32.4 million during the secondthird quarter of 2010.2010, net of $58.9 million used to repurchase and retire approximately 212,000 shares of our common stock.

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 significantgreater patient value. TheWe believe that the value of a surgical procedure to a patient is higher if it offers superior clinical outcomes, less surgical trauma, or both.

The procedures that have driven the most growth in our business recently are theda Vinci Hysterectomy (dVH) andda Vinci Prostatectomy (dVP). Other gynecologic procedures such asda VinciMyomectomy andda Vinci Sacral Colpopexy, other urologic procedures such asda Vinci Partial Nephrectomy,da VinciCystectomy andda Vinci Pyeloplasty, cardiothoracic procedures such asda Vinci Mitral Valve Repair andda Vinci Revascularization, andda Vinci colorectal procedures have also contributed to our growth. WeThe recent United States economic environment for surgical procedure volumes has been challenging as many hospitals have reported declining patient volumes. While the majority ofda Vinci procedures are non-elective, and therefore less impacted by the economic climate, we have felt, and may continue to feel, some negative effects from the economic environment. Within this challenging environment, driven by the growth projections of the previously listed procedures, we anticipate total 2010 procedures to grow approximately 35% from approximately 205,000 procedures performed in 2009.

Technology Acquisitions

We continue to make several strategic acquisitions of intellectual property and related technologies. Total investments in intellectual property and related technologies during the three months ended September 30, 2010 were $31.7 million, compared to none during the three months ended September 30, 2009. Total investments in intellectual property and related technologies during the nine months ended September 30, 2010 were $38.2 million, compared to $25.7 million during the nine months ended September 30, 2009. Amortization expense related to purchased intellectual property for the three months ended September 30, 2010 and 2009 were $4.3 million and $3.8 million, respectively. Amortization expense related to purchased intellectual property for the nine months ended September 30, 2010 and 2009 were $11.9 million and $11.4 million, respectively.

Building Acquisition

During the third quarter of 2010, we entered into an agreement to purchase 17.7 acres of land and buildings for $33.0 million in Sunnyvale, California by June 2011. Although we entered into the agreement to support our anticipated future growth in capacity, there is no guarantee that the planned growth and expansion will take place in the timeframe we expected, or at all.

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, 
   2010  % of total
revenue
  2009  % of total
revenue
  2010  % of total
revenue
  2009  % of total
revenue
 

Revenue:

             

Products

  $295.3  84 $219.3  84 $573.3  84 $368.4  82

Services

   55.4  16  41.3  16  106.0  16  80.6  18
                             

Total revenue

   350.7  100  260.6  100  679.3  100  449.0  100
                             

Cost of revenue:

             

Products

   72.7  21  55.5  21  140.7  21  100.8  22

Services

   21.2  6  14.9  6  41.3  6  29.3  7
                             

Total cost of revenue

   93.9  27  70.4  27  182.0  27  130.1  29
                             

Products gross profit

   222.6  63  163.8  63  432.6  63  267.6  60

Services gross profit

   34.2  10  26.4  10  64.7  10  51.3  11
                             

Gross profit

   256.8  73  190.2  73  497.3  73  318.9  71
                             

Operating expenses:

             

Selling, general, and administrative

   88.6  25  67.3  26  171.4  25  129.7  29

Research and development

   28.5  8  23.4  9  56.5  8  44.7  10
                             

Total operating expenses

   117.1  33  90.7  35  227.9  34  174.4  39
                             

Income from operations

   139.7  40  99.5  38  269.4  40  144.5  32

Interest and other income, net

   4.5  1  5.2  2  8.6  1  10.2  2
                             

Income before taxes

   144.2  41  104.7  40  278.0  41  154.7  34

Income tax expense

   55.5  16  42.3  16  104.0  15  64.2  14
                             

Net income

  $88.7  25 $62.4  24 $174.0  26 $90.5  20
                             

   Three Months Ended September 30,  Nine Months Ended September 30, 
   2010   % of total
revenue
  2009   % of total
revenue
  2010   % of total
revenue
  2009   % of total
revenue
 

Revenue:

             

Product

  $287.1     83 $236.3     84 $860.4     84 $604.7     83

Service

   57.3     17  43.8     16  163.3     16  124.4     17
                                     

Total revenue

   344.4     100  280.1     100  1,023.7     100  729.1     100
                                     

Cost of revenue:

             

Product

   72.8     21  65.3     23  213.5     21  166.1     23

Service

   21.0     6  15.8     6  62.3     6  45.1     6
                                     

Total cost of revenue

   93.8     27  81.1     29  275.8     27  211.2     29
                                     

Product gross profit

   214.3     62  171.0     61  646.9     63  438.6     60

Service gross profit

   36.3     11  28.0     10  101.0     10  79.3     11
                                     

Gross profit

   250.6     73  199.0     71  747.9     73  517.9     71
                                     

Operating expenses:

             

Selling, general, and administrative

   91.6     26  69.9     25  263.0     26  199.6     27

Research and development

   26.9     8  24.6     9  83.4     8  69.3     10
                                     

Total operating expenses

   118.5     34  94.5     34  346.4     34  268.9     37
                                     

Income from operations

   132.1     38  104.5     37  401.5     39  249.0     34

Interest and other income, net

   5.0     2  4.3     2  13.6     1  14.5     2
                                     

Income before taxes

   137.1     40  108.8     39  415.1     40  263.5     36

Income tax expense

   50.5     15  44.3     16  154.5     15  108.5     15
                                     

Net income

  $86.6     25 $64.5     23  260.6     25 $155.0     21
                                     

Total Revenue

Total revenue was $350.7$344.4 million for the three months ended JuneSeptember 30, 2010 compared to $260.6$280.1 million for the three months ended JuneSeptember 30, 2009. For the sixnine months ended JuneSeptember 30, 2010, revenue increased to $679.3$1,023.7 million from $449.0$729.1 million for the sixnine months ended JuneSeptember 30, 2009. SecondThird quarter 2009 total revenue was impacted by recognition of $13.8$6.3 million of the $20.1 million of revenue deferred in the first quarter of 2009 related toda Vinci Si system upgrade revenue offers made. TotalThe $20.1 million of revenue deferred in the first halfquarter of 2009 excludedwas recognized in full by the remaining unrecognized $6.3 millionend of revenuethe three months ended September 30, 2009, in connection with the upgrade offers described above. Revenue growth for the first half ofnine months ended September 30, 2010 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 review literature has indicated that dVP offers superiorimproved functional surgical outcomes compared to traditional open prostatectomy in the critical categories of cancer removal, continence,with less surgical and sexual potency.post-surgical morbidity. Favorable clinical resultsoutcomes have also been reported in hysterectomies for cancerous pathology, which includesinclude increased lymph node retrieval counts and significant reduction in blood transfusion. For most patients, a minimally invasive approach using theda 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 82%83% and 81% of total revenue for the three and sixnine month periods ended JuneSeptember 30, 2010, respectively, and 78%83% and 77%79% of total revenue for the three and sixnine month periods ended JuneSeptember 30, 2009, respectively. We believe domestic revenue accounts for the large majority of total revenue primarily due to the ability of patients to choose their provider and method of treatment. The increase in second quarter and first half 2010 revenue in the United States relative to the rest of the world reflects increased hospital capital spending in the United States and decreased spendingrelatively flat demand in Europe due to the economic environment, compared to 2009. Although revenue increased in Europe sequentially over the second quarterpast three quarters, the economic environment in Europe continues to prove challenging, and first half of 2009.there is no assurance that system sales will continue to increase in future periods.

The following table summarizes our revenue andda Vinci Surgical System unit sales for the three and sixnine month periods ended JuneSeptember 30, 2010 and 2009 (in millions, except percentages and unit sales):

 

   Three Months Ended
June 30,
  Six Months Ended
June 30,
 
   2010  2009  2010  2009 

Revenue

     

Instruments and accessories

  $127.5   $95.8   $250.2   $175.4  

Systems

   167.8    123.5    323.1    193.0  
                 

Total product revenue

   295.3    219.3    573.3    368.4  

Services

   55.4    41.3    106.0    80.6  
                 

Total revenue

  $350.7   $260.6   $679.3   $449.0  
                 

Recurring revenue

  $182.9   $137.1   $356.2   $256.0  
                 

% of total revenue

   52  53  52  57

Domestic

  $287.7   $202.8   $547.9   $344.7  

International

   63.0    57.8    131.4    104.3  
                 

Total revenue

  $350.7   $260.6   $679.3   $449.0  
                 

% of Revenue - Domestic

   82  78  81  77

% of Revenue - International

   18  22  19  23

Domestic Unit Sales

   86    56    166    100  

International Unit Sales

   22    20    46    42  
                 

Total Unit Sales

   108    76    212    142  
                 

   Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
   2010  2009  2010  2009 

Revenue

     

Instruments and accessories

  $127.5   $100.8   $377.7   $276.2  

Systems

   159.6    135.5    482.7    328.5  
                 

Total product revenue

   287.1    236.3    860.4    604.7  

Services

   57.3    43.8    163.3    124.4  
                 

Total revenue

  $344.4   $280.1   $1,023.7   $729.1  
                 

Recurring revenue

  $184.8   $144.6   $541.0   $400.6  
                 

% of total revenue

   54  52  53  55

Domestic

  $285.0   $231.1   $832.9   $575.8  

International

   59.4    49.0    190.8    153.3  
                 

Total revenue

  $344.4   $280.1   $1,023.7   $729.1  
                 

% of Revenue - Domestic

   83  83  81  79

% of Revenue - International

   17  17  19  21

Domestic Unit Sales

   83    72    249    172  

International Unit Sales

   22    14    68    56  
                 

Total Unit Sales

   105    86    317    228  
                 

Product Revenue

Product revenue was $295.3$287.1 million for the three months ended JuneSeptember 30, 2010 compared with $219.3$236.3 million for the three months ended JuneSeptember 30, 2009. SecondThird quarter 2009 product revenue included recognition of $13.8$6.3 million of $20.1 million of revenue deferred in the first quarter of 2009 associated withda Vinci Si launch described above.

Instruments and accessories revenue increased to $127.5 million for the three months ended JuneSeptember 30, 2010 compared with $95.8$100.8 million for the three months ended JuneSeptember 30, 2009. Instruments and accessories revenue for the three months ended JuneSeptember 30, 2009 included recognition of $1.4$0.7 million of $2.1 million of camera accessories revenue associated with theda Vinci Si launch described above. The increase in revenue was driven by an increase in procedures performedperformed. The timing and increasedmagnitude of stocking orders associated with increasedcan vary relative to system sales. Procedure growth was primarily driven by hysterectomy adoption.sales and customer mix.

Systems revenue increased to $167.8$159.6 million during the three months ended JuneSeptember 30, 2010 from $123.5$135.5 million during the three months ended JuneSeptember 30, 2009 primarily due to 3219 more systems sold. Third quarter 2009 systems revenue includes $5.6 million recognition of $18.0 million of system revenue deferred in the first quarter 2009 associated withda Vinci Si upgrade offers. We sold 105da VinciSurgical Systems during the three months ended September 30, 2010, compared with 86 in the same period last year. 90 of the 105 systems sold during the third quarter of 2010 were theda Vinci Si Surgical Systems, of which 22 systems were dual console configurations. We had 15 used standardda VinciSurgical Systems traded in forda Vinci SiSurgical Systems during the three months ended September 30, 2010, compared with 20 standard systems traded in during the same period last year.

Product revenue was $860.4 million for the nine months ended September 30, 2010 compared with $604.7 million for the nine months ended September 30, 2009. Product revenue for the nine months ended September 30, 2009 included all of the $20.1 million of revenue deferred in connection with theda Vinci SiSurgical launch described above.

Instruments and accessories revenue increased to $377.7 million for the nine months ended September 30, 2010 compared with $276.2 million for the nine months ended September 30, 2009. The increase for the nine months ended September 30, 2010 resulted from the same factors as the three months ended September 30, 2010.

Systems revenue was $482.7 million during the nine months ended September 30, 2010 compared with $328.5 million during the nine months ended September 30, 2009. The increase was primarily due to 89 more systems sold, more second quarter 2010 system upgrade revenue during the nine months ended September 30, 2010, and higher average selling prices (ASPs) resulting from a higher percentage of the higher-priced single and dual consoleda Vinci Si Surgical Systems in the systems product mix. Second quarter 2009 systems revenue includes $12.4 million recognition of $18.0 million of system revenue deferred in the first quarter 2009 system revenue associated withda Vinci Si upgrade offers. We sold 108317da VinciSurgical Systems during the threenine months ended JuneSeptember 30, 2010, compared with 76228 in the same period last year. 89259 of the 108317 systems sold during the second quarter ofnine months period ended September 30, 2010 were theda Vinci Si Surgical Systems, of which 1552 systems were dual console configurations. We had 1951 standardda VinciSurgical Systems traded in during the threenine months ended JuneSeptember 30, 2010, compared with 5 standard systems traded in during the same period last year.

Product revenue was $573.3 million for the six months ended June 30, 2010 compared with $368.4 million for the six months ended June 30, 2009. Product revenue in the first half of 2009 excluded the remaining unrecognized $6.3 million of revenue deferred in connection with theda Vinci SiSurgical launch described above.

Instruments and accessories revenue increased to $250.2 million for the six months ended June 30, 2010 compared with $175.4 million for the six months ended June 30, 2009. Instruments and accessories revenue for the first half of 2009 excluded the remaining unrecognized $0.7 million of revenue deferrals in connection with theda Vinci Si launch described above. The increase for the six months ended June 30, 2010 resulted from the same factors as the three months ended June 30, 2010.

Systems revenue was $323.1 million during the six months ended June 30, 2010 compared with $193.0 million during the six months ended June 30, 2009. The increase was primarily due to 70 more systems sold, more system upgrade revenue during the first half of 2010, and higher average selling prices (ASPs) resulting from a higher percentage of the higher-priced single and dual consoleda VinciSi Surgical Systems in the systems product mix. Systems revenue during the first half of 2009 excluded the remaining unrecognized $5.6 million of $18.0 million associated withda VinciSi upgrade offers. We sold 212da Vinci Surgical Systems during the first half of 2010, compared with 142 in the same period last year. 169 of the 212 systems sold during the first half of 2010 were theda Vinci Si Surgical Systems, of which 30 systems were dual console configurations. We had 36 standardda VinciSurgical Systems traded in during the six months ended June 30, 2010, compared with 1131 standard systems traded in during the same period last year.

Service Revenue

Service revenue, comprised primarily of system service and customer training, increased 34%31% to $55.4$57.3 million for the three months ended JuneSeptember 30, 2010 compared with $41.3$43.8 million for the three months ended JuneSeptember 30, 2009. 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 secondthe third quarter of 2010 was primarily driven by a larger base of da Vinci Surgical Systems producing contract service revenue. There were approximately 1,482 and 1,171 systems installed, entering the second quarter of 2010 and 2009, respectively.Systems.

Service revenue increased 32%31% to $106.0$163.3 million for the sixnine months ended JuneSeptember 30, 2010 compared with $80.6$124.4 million for the sixnine months ended JuneSeptember 30, 2009. Higher service revenue during the first sixnine months of 2010 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 JuneSeptember 30, 2010 increased 36%25% to $222.6$214.3 million, or 75.4%74.6% of product revenue, compared with $163.8$171.0 million, or 74.7%72.4% of product revenue, for the three months ended JuneSeptember 30, 2009. The higher product gross profit was driven by higher 2010 product revenue, as described above. The higher gross profit percentage was driven by system and instrument material cost reductions and lower third quarter 2010 charges for excess and obsolete inventory.

Product gross profit for the sixnine months ended JuneSeptember 30, 2010 increased 62%48% to $432.6$646.9 million, or 75.4%75.2% of product revenue, compared with $267.6$438.6 million, or 72.6%72.5% of product revenue, for the sixnine months ended JuneSeptember 30, 2009. The higher product gross profit was driven by higher 2010 product revenue, as described above. The higher product gross profit percentage for the three and six months ended June 30, 2010 was driven by higher first and second quarter 2010 system ASPs, system and instrument material cost reductions, lower 2010 charges for excess and obsolete inventory, and leveraging manufacturing overhead across higher revenue.

Service gross profit for the three months ended JuneSeptember 30, 2010 increased 30% to $34.2$36.3 million, or 61.7%63.4% of service revenue, compared with $26.4$28.0 million, or 63.9% of service revenue, for the three months ended JuneSeptember 30, 2009. Service gross profit for the sixnine months ended JuneSeptember 30, 2010 increased 26%27% to $64.7$101.0 million, or 61.0%61.8% of service revenue, compared with $51.3$79.3 million, or 63.6%63.7% of service revenue, for the sixnine months ended JuneSeptember 30, 2009. The higher 2010 service gross profit was driven by higher service revenue as described above. The lower 2010 gross service profit percentage was primarily driven by increased 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 JuneSeptember 30, 2010 increased 32%31% to $88.6$91.6 million compared with $67.3$69.9 million for the three months ended JuneSeptember 30, 2009. Selling, general and administrative expenses for the sixnine months ended JuneSeptember 30, 2010 increased 32% to $171.4$263.0 million compared with $129.7$199.6 million for the sixnine months ended June

September 30, 2009. The increases were due to organizational growth to support our expanding business, higher commissions related to higher revenue levels, and increased stock-based compensation. Stock-based compensation expense charged to sales, general and administrative expenses were approximately $20.0$19.8 million and $37.8$57.6 million for the three and sixnine months ended JuneSeptember 30, 2010, respectively, compared with $15.5 million and $29.9$45.4 million during the three and sixnine months ended JuneSeptember 30, 2009, 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 JuneSeptember 30, 2010 increased 21%9% to $28.5$26.9 million compared with $23.4$24.6 million for the three months ended JuneSeptember 30, 2009. Research and development expenses for the sixnine months ended JuneSeptember 30, 2010 increased 26%20% to $56.5$83.4 million compared with $44.7$69.3 million for the sixnine months ended JuneSeptember 30, 2009. The increases were due todriven by the growth in our research and development organization and higher prototype costs.organization. Amortization expense related to purchased intellectual property during the quarterthree months ended JuneSeptember 30, 2010 was $3.7 million compared to $3.8$3.6 million during the quarterthree months ended JuneSeptember 30, 2009. Amortization expense related to purchased intellectual property during the sixnine months ended JuneSeptember 30, 2010 was $7.3 million compared to $7.2 million during the six months ended Juneand September 30, 2009.2009 were both $10.8 million. Stock-based compensation expense increased to approximately $5.7$5.9 million and $10.7$16.6 million for the three and sixnine months ended JuneSeptember 30, 2010, respectively, compared with $5.5$5.4 million and $10.5$15.9 million during the three and sixnine months ended JuneSeptember 30, 2009.2009, 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 JuneSeptember 30, 2010 was $4.5$5.0 million compared with $5.2$4.3 million for the three months ended JuneSeptember 30, 2009. Interest and other income, net for the sixnine months ended JuneSeptember 30, 2010 was $8.6$13.6 million, which was $1.6$0.9 million less than the $10.2$14.5 million recorded for the sixnine months ended JuneSeptember 30, 2009. The changeHigher interest and other income, net for the three months ended September 30, 2010 was primarily due todriven by higher foreign exchange gains. Lower interest and other income, net for the nine months ended September 30, 2010 was driven by lower interest rates earned on higher cash and investment balances in 2010, and partially offset by lowerfluctuations in foreign exchange losses for 2010.gains and losses.

Income Tax Expense

We record provision for income taxes during interim periods based on our estimate of the effective tax rate for the year. Discrete items and changes in our estimate of the annual effective tax rate are recorded in the period in which they occur. We recognize interest related to uncertain tax positions in income tax expense.

Income tax expense for the three months ended JuneSeptember 30, 2010 was $55.5$50.5 million, or 38.5%36.8% of pre-tax income, compared with $42.3$44.3 million, or 40.4%40.7% of pre-tax income for the three months ended JuneSeptember 30, 2009. Income tax expense for the sixnine months ended JuneSeptember 30, 2010 was $104.0$154.5 million, or 37.4%37.2% of pre-tax income, compared with $64.2$108.5 million, or 41.5%41.2% of pre-tax income for the sixnine months ended JuneSeptember 30, 2009. The effective tax rate for the three and sixnine months ended JuneSeptember 30, 2010 differs from the U.S. federal statutory rate of 35% 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. As a result of the macro-economic environment in Europe, we now estimate U.S. pretax income will represent a greater portion of our total pretax income than we estimated at the end of the first quarter. As a result, we are now estimating our annual effective tax rate for 2010 will be approximately 37% versus the 36% estimated at the end of the first quarter. We intend these foreign earnings to be indefinitely reinvested outside the United States. The effective tax rate for the three and sixnine months ended JuneSeptember 30, 2009 differs from the U.S. federal statutory rate of 35% primarily due to state income taxes and non-deductible stock option expenses, partially offset by 2009 research and development (“R&D”) credits and domestic production deductions. The state income taxes for the six month period ended June 30, 2009 included a discrete increase of approximately 1.0% resulting from re-measurement of long term deferred tax assets due to a California law change enacted in February 2009.

As of JuneSeptember 30, 2010, we had total gross unrecognized tax benefits of approximately $75.4$75.6 million compared with approximately $70.0 million as of December 31, 2009, representing an increase of approximately $5.4$5.6 million for the sixnine months ended JuneSeptember 30, 2010. Of the total gross unrecognized tax benefits, $71.1$71.3 million and $65.7 million as of JuneSeptember 30, 2010 and December 31, 2009, respectively, if recognized, would reduce our effective tax rate in the period of recognition. Gross interest related to unrecognized tax benefit accrued was approximately $4.2$4.8 million and $3.3 million respectively, as of JuneSeptember 30, 2010 and December 31, 2009.2009, respectively.

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 $1,172 million at December 31, 2009 to $1,588$1,621 million at JuneSeptember 30, 2010. 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,
   Nine Months Ended
September 30,
 
  2010 2009   2010 2009 
  (in millions)   (in millions) 

Net cash provided by (used in)

    

Operating activities

  $291.1   $173.1    $404.1   $269.4  

Investing activities

   (254.2  (57.4   (373.4  (151.2

Financing activities

   162.8    (137.0   130.3    (107.1

Effect of exchange rates on cash and cash equivalents

   (1.1  0.1     (0.4  0.4  
              

Net increase (decrease) in cash and cash equivalents

  $198.6   $(21.2

Net increase in cash and cash equivalents

  $160.6   $11.5  
              

Operating Activities

For the sixnine months ended JuneSeptember 30, 2010, cash flow from operating activities of $291.1$404.1 million exceeded our net income of $174.0$260.6 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$98.5 million during the sixnine months ended JuneSeptember 30, 2010.

 

 2.Cash used inprovided by working capital and other assets during the sixnine months ended JuneSeptember 30, 2010 was approximately $46.5$45.0 million.

Working capital is comprised primarily of accounts receivable, inventory, deferred revenue and other liabilities. 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$27.4 million or 28%48% during the sixnine months ended JuneSeptember 30, 2010. The growth in inventory reflects increased revenue, increases to ensure adequate supply of key components as December 31st quantities were below optimal levels and inventory associated with new product introductions. Deferred revenue increased by $17.2 million or 17% during the nine months ended September 30, 2010 reflecting below optimal quantities at December 31, 2009.related to the increase in the number of installed systems for which service contracts exist. Other liabilities including accounts payable, accrued compensation and employee benefits, and accrued liabilities increased by $43.1$57.9 million or approximately 25%34% during the sixnine months ended JuneSeptember 30, 2010 primarily due to taxes payable later this year and timing of vendortax payments and employee compensation during the sixnine months ended JuneSeptember 30, 2010.

For the sixnine months ended JuneSeptember 30, 2009, cash flow from operating activities of $173.1$269.4 million exceeded our net income of $90.5$155.0 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 $55.7$81.8 million during the sixnine months ended JuneSeptember 30, 2009.

 

 2.Cash provided by working capital and other assets during the sixnine months ended JuneSeptember 30, 2009 was approximately $26.9$32.6 million.

Working capital is comprised primarily of deferredAccounts receivable increased by $16.4 million or 10% during the nine months ended September 30, 2009 reflecting increased revenue and other current liabilities.the timing of system sales. Deferred revenue increased by $10.3$12.4 million or 13%16% during the sixnine months ended JuneSeptember 30, 2009 related to the increase in the number of installed systems for which service contracts exist and due to the deferral associated with theda Vinci Si upgrade offers.exist. Other liabilities including accounts payable, accrued compensation and employee benefits, and accrued liabilities increased by $21.5$36.7 million or 17%29% during the sixnine months ended JuneSeptember 30, 2009 primarily due to timing of vendor payments.

Investing Activities

Net cash used in investing activities during the sixnine months ended JuneSeptember 30, 2010 and 2009 consisted primarily of purchases of investments (net of proceeds from sales and maturities of investments) of $217.7$286.8 million and $17.1$105.5 million respectively, and capital expenditures and acquisitions of fixed assets and intellectual property of $36.5$86.6 million and $40.3$45.7 million respectively. 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 provided by financing activities during the sixnine months ended JuneSeptember 30, 2010 consisted primarily of proceeds from stock option exercises and employee stock purchases of $115.9 million.$132.9 million, offset by $58.9 million for the repurchase of approximately 212,000 shares of our common stock through open market transactions. Net cash used in financing activities during the sixnine months ended JuneSeptember 30, 2009 consisted primarily of payment of $150.0 million for the repurchase of 1.4 million shares of our common stock through an accelerated share repurchase program, offset by proceeds from stock option exercises and employee stock purchases of $12.0$33.7 million.

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. With the exception of the updates to the following critical accounting estimates, 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, 2009.

Revenue recognition.We frequently enter into revenue arrangements that contain multiple elements or deliverables such as system and services. Judgments as to the allocation of the proceeds received from an arrangement to the multiple elements of the arrangement, the determination of whether any undelivered elements are essential to the functionality of the delivered elements and the appropriate timing of revenue recognition are critical in respect to these arrangements to ensure compliance with U.S. GAAP. Changes to the elements in an arrangement and the ability to establish objective and reliable evidence of fair value for those elements could affect the timing of revenue recognition. Revenue recognition also depends on the timing of shipment and is subject to customer acceptance. If shipments are not made on scheduled timelines or if the products are not accepted by the customer in a timely manner, our reported revenues may differ materially from expectations.

In September 2009, the FASB amended the accounting standards related to revenue recognition for arrangements with multiple deliverables and arrangements that include software elements (“new accounting principles”). The new accounting principles permit prospective or retrospective adoption, and we elected prospective adoption at the beginning of the first quarter of 2010.

These new accounting principles do not generally change the units of accounting for our revenue transactions and we continue to have system and service as the different elements in our multiple element arrangements. For multiple element arrangements entered into on or after January 1, 2010, we allocate revenue to all deliverables based on their relative selling prices. Because we have neither VSOE nor TPE for our systems, the allocation of revenue has been based on ESPs. The objective of ESP is to determine the price at which

we would transact a sale if the product was sold on a stand-alone basis. We determine ESP for our systems by considering multiple factors including, but not limited to, features and functionality of the system, geographies, type of customer and market conditions. We expect to review ESP regularly and maintain internal controls over the establishment and updates of these estimates. We do not expect material changes to ESPs established as of January 1, 2010 in future periods. However, since we apply significant judgment in arriving at the ESPs, any material changes would significantly affect the allocation of the total consideration to the different elements of a multiple element arrangement.

ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no material changes in our market risk during the sixnine months ended JuneSeptember 30, 2010 compared to the disclosures in Part II, Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2009.

 

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

We areFrom 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 ordinary and routine legal proceedings and disputesclaims that arise in the normal course of our business. These matters include product liability actions, patent infringement actions, contract disputes, and other matters.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 remedyresolution 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.

Purported Shareholder Class Action Lawsuit filed August 6, 2010

On August 6, 2010, a purported class action lawsuit entitledPerlmutter 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.

Purported Derivative Actions

On August 19, 2010, an alleged shareholder caused a purported shareholder’s derivative lawsuit entitledHimmel 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 shareholder filed an essentially identical lawsuit entitledApplbaum 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.

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, 2009, except for the below.

HEALTHCARE POLICY CHANGES, INCLUDING RECENTLY ENACTED LEGISLATION REFORMING THE U.S. HEALTHCARE SYSTEM, MAY HAVE A MATERIAL ADVERSE EFFECT ON OUR FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

In March 2010, the President signed the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the “PPACA”), which makes changes that are expected to significantly impact the pharmaceutical and medical device industries. One of the principal aims of the PPACA as currently enacted is to expand health insurance coverage to approximately 32 million Americans who are currently uninsured. The consequences of these significant coverage expansions on the sales of the Company’s products are unknown and speculative at this point.

The PPACA contains a number of provisions designed to generate the revenues necessary to fund the coverage expansions among other things. This includes new fees or taxes on certain health-related industries, including medical device manufacturers. Beginning in 2013, each medical device manufacturer will have to pay an excise tax (or sales tax) in an amount equal to 2.3 percent of the price for which such manufacturer sells its medical devices. Though there are some exceptions to the excise tax, this excise tax does apply to all of the Company’s products and product candidates.

Other significant measures contained in the PPACA include, by way of example, coordination and promotion of research on comparative clinical effectiveness of different technologies and procedures, initiatives to revise Medicare payment methodologies, such as bundling of payments across the continuum of care by providers and physicians, and initiatives to promote quality indicators in payment methodologies. The PPACA also includes significant new fraud and abuse measures, lowering the government’s thresholds to find violations and increasing potential penalties for such violations.

In additionThe PPACA provisions on comparative clinical effectiveness research extend the initiatives of the American Recovery and Reinvestment Act of 2009, also known as the stimulus package, which included $1.1 billion in funding to study the comparative effectiveness of health care treatments and strategies. This stimulus funding was designated for, among other things, conducting, supporting or synthesizing research that compares and evaluates the risks and benefits, clinical outcomes, effectiveness and appropriateness of products. The PPACA discussed above,appropriates additional funding to comparative clinical effectiveness research. Although Congress has indicated that this funding is intended to improve the effectquality of which cannot presently be fully quantified given its recent enactment, various healthcare reform proposals have also emerged athealth care, it remains unclear how the state level.research will impact current Medicare coverage and reimbursement or how new information will influence other third-party payor policies. We cannot predict whether future healthcare initiatives will be implemented atexpect that the PPACA, as well as other federal or state level,health care reform measures that may be adopted in the future, could have a material adverse effect on our industry generally and our ability to successfully commercialize our products or the effect any future legislationcould limit or regulation will haveeliminate our spending on us.certain development projects. The taxes imposed by the new federal legislation and the expansion in the government’s role in the U.S. healthcare industry may result in decreased profits to us, lower reimbursementsreimbursement by payors for our products and/or reduced medical procedure volumes, all of which may adversely affect our business, financial condition and results of operations.

UNFAVORABLE RESULTS OF LEGAL PROCEEDINGS COULD MATERIALLY ADVERSELY AFFECT US.

We are and may become subject to various legal proceedings and claims that arise in or outside the ordinary course of business.

On August 6, 2010, a purported class action lawsuit was filed against us and several of our officers and directors in the United States District Court for the Northern District of California seeking 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 we 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. Two purported derivative actions making substantially similar allegations were filed in the Superior Court of California for the County of Santa Clara shortly thereafter. Those actions are described more fully under “Part II, Item 1, Legal Proceedings.”

The results of these lawsuits and other legal proceedings cannot be predicted with certainty. Accordingly, we cannot determine whether our insurance coverage would be sufficient to cover the costs or potential losses, if any. Regardless of merit, litigation may be both time-consuming and disruptive to our operations and cause significant expense and diversion of management attention. If we do not prevail in the purported class action lawsuit or other legal proceedings, we may be faced with significant monetary damages or injunctive relief against us that may adversely affect our business, financial condition and results of operations, possibly materially.

WE ARE SUBJECT TO SIGNIFICANT, UNINSURED LIABILITIES.

For certain risks, we do not maintain insurance coverage because of cost and/or availability. For example, we indemnify our directors and officers for third-party claims and do not insure for the underlying losses, and we do not carry earthquake insurance, among others. In addition, in the future, we may not continue to maintain certain existing insurance coverage or adequate levels of coverage. Premiums for many types of insurance have increased significantly over the years, and depending on market conditions and our circumstances, in the future, certain types of insurance such as directors’ and officers’ insurance or products liability insurance may not be available on acceptable terms or at all. Because we retain some portion of our insurable risks, and in some cases self-insure completely, unforeseen or catastrophic losses in excess of insurance coverage could require us to pay substantial amounts, which would materially adversely affect our financial condition and operating results.

WE USE ESTIMATES, MAKE JUDGMENTS AND APPLY CERTAIN METHODS IN MEASURING THE PROGRESS OF OUR BUSINESS. IN DETERMINING OUR FINANCIAL RESULTS AND IN APPLYING OUR ACCOUNTING POLICIES. AS THESE ESTIMATES, JUDGMENTS, AND METHODS CHANGE, OUR ASSESSMENT OF THE PROGRESS OF OUR BUSINESS AND OUR RESULTS OF OPERATIONS COULD VARY.

The methods, estimates, and judgments we use in applying our accounting policies have a significant impact on our results of operations. Such methods, estimates, and judgments are, by their nature, subject to substantial risks, uncertainties, and assumptions, and factors may arise over time that lead us to change our methods, estimates, and judgments. Changes in any of our assumptions may adversely affect our reported financial results.

In addition, we utilize methods for determining surgical market sizes andda Vinci procedures completed that involve estimates and judgments, which are, by their nature, subject to substantial risks, uncertainties, and assumptions. Our estimates of surgical market sizes orda Vinciprocedures performed do not have an impact on our results of operations but are used to estimate the progress of our business. Estimates and judgments for determining surgical market sizes andda Vinci procedures may vary over time with changes in treatment modalities, hospital reporting behavior, increases in procedures per field employee and other factors. In addition, over time, we may change the method for determining market sizes andda Vinci procedures, causing variation in our reporting.

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

None.(c) Stock repurchases

On March 4, 2009, we announced that our Board of Directors (the “Board”) had authorized the repurchase of up to $300.0 million of our common stock. In the first quarter ended March 31, 2009, we repurchased $150.0 million of our common stock, leaving $150.0 million remaining to be repurchased under the program. On July 23, 2010, we announced that the Board authorized an additional $150.0 million for share repurchase, increasing the remaining amount to be repurchased under the program to $300.0 million.

The table below summarizes our share repurchase activity for the three months ended September 30, 2010:

 

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
Amount of Shares That
May Yet be Purchased
Under the Program
 

July 1, 2010 to July 31, 2010

   —      $—       —      $300.0 million  

August 1, 2010 to August 31, 2010

   57,500    $279.75     57,500    $283.9 million  

September 1, 2010 to September 30, 2010

   154,296    $277.23     154,296    $241.1 million  
                    

Total during quarter ended September 30, 2010

   211,796    $277.92     211,796    $241.1 million  
                    

ITEM 3.DEFAULTS UPON SENIOR SECURITIES

None.

 

ITEM 5.OTHER INFORMATION

None.

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 March 6, 2009)July 26, 2010).
10.1  Third Amendment to Employment Agreement between Lonnie Smith and Intuitive Surgical, Inc. effective as of July 1, 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 23,July 26, 2010).
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 JuneSeptember 30, 2010, 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.

Users of the XBRL data are advised pursuant to Rule 406T of Regulation S-T that this interactive data file is deemed not filed or part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of section 18 of the Securities Exchange Act of 1934, and otherwise is not subject to liability under these sections.

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
 By:

  /s/ MARSHALL L. MOHR

Marshall L. Mohr
 

Senior Vice President and Chief Financial Officer

(Principal Financial Officer and duly authorized signatory)

Date: July 22,October 20, 2010

 

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