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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



FORM 10-Q

(Mark One)  

ý

 

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

For the quarterly period ended June 30, 2009March 31, 2010

Or

o

 

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

For the transition period from                             to                             

Commission File No. 0-14680

GENZYME CORPORATION
(Exact name of registrant as specified in its charter)

Massachusetts

(State or other jurisdiction of
incorporation or organization)
 06-1047163

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

500 Kendall Street
Cambridge, Massachusetts

(Address of principal executive offices)

 

02142

(Zip Code)

(617) 252-7500

(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 ý    No o

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

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

Large accelerated filerý Accelerated filero Non-accelerated filero
(Do not check if a smaller reporting company)
 Smaller reporting companyo

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

        Number of shares of Genzyme Stock outstanding as of July 31, 2009: 270,308,386April 30, 2010: 266,868,620


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NOTE REGARDING REFERENCES TO GENZYME

        Throughout this Form 10-Q, the words "we," "us," "our" and "Genzyme" refer to Genzyme Corporation as a whole, and "our board of directors" refers to the board of directors of Genzyme Corporation.

NOTE REGARDING FORWARD-LOOKING STATEMENTS

        This Form 10-Q contains forward-looking statements. These forward-looking statements include, among others, statements regarding:


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        These statements are subject to risks and uncertainties, and our actual results may differ materially from those that are described in this report. These risks and uncertainties include:


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        We refer to more detailed descriptions of these and other risks and uncertainties under the heading "Risk Factors" in Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations in Part I,I., Item 22. of this Form 10-Q. We encourage you to read those descriptions carefully. We caution investors not to place substantial reliance on the forward-looking statements contained in this Form 10-Q. These statements, like all statements in this Form 10-Q, speak only as of the date of this report (unless another date is indicated), and we undertake no obligation to update or revise the statements in light of future developments.

NOTE REGARDING INCORPORATION BY REFERENCE

        The United States Securities and Exchange Commission, commonly referred to as the SEC, allows us to disclose important information to you by referring you to other documents we have filed with them. The information that we refer you to is "incorporated by reference" into this Form 10-Q. Please read that information.


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NOTE REGARDING TRADEMARKS

        Genzyme®, Cerezyme®, Fabrazyme®, Thyrogen®, Myozyme®, Renagel®, Renvela®, Campath®, Clolar®, Evoltra®, Mozobil®, Thymoglobulin®, Cholestagel®, Synvisc®, Synvisc-One®, Sepra®,


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Seprafilm®, Carticel®, Epicel®, MACI® and Hectorol® are registered trademarks, and Lumizyme™ and Synvisc-One™Jonexa™ are trademarks, of Genzyme or its subsidiaries. WelChol®Welchol® is a registered trademark of Sankyo Pharma, Inc. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC. Elaprase® is a registered trademark of Shire Human Genetic Therapies, Inc. Prochymal® and Chondrogen® are registered trademarks of Osiris Therapeutics, Inc. Fludara® and Leukine® are registered trademarks of Bayer Schering Pharma A.G., and licensed to Genzyme. All other trademarks referred to in this Form 10-Q are the property of their respective owners. All rights reserved.


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GENZYME CORPORATION AND SUBSIDIARIES

FORM 10-Q, JUNE 30, 2009MARCH 31, 2010

TABLE OF CONTENTS

 
  
 PAGE NO. 

PART I.

 

FINANCIAL INFORMATION

  
7
 

ITEM 1.

 

Financial Statements

  
7
 

 

Unaudited, Consolidated Statements of Operations for the Three and Six Months Ended June 30,March 31, 2010 and 2009 and 2008

  
7
 

 

Unaudited, Consolidated Balance Sheets as of June 30, 2009March 31, 2010 and December 31, 20082009

  
8
 

 

Unaudited, Consolidated Statements of Cash Flows for the SixThree Months Ended June 30,March 31, 2010 and 2009 and 2008

  
9
 

 

Notes to Unaudited, Consolidated Financial Statements

  
10
 

ITEM 2.

 

Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations

  35
37
 

ITEM 3.

 

Quantitative and Qualitative Disclosures About Market Risk

  81
83
 

ITEM 4.

 

Controls and Procedures

  82
83
 

PART II.

 

OTHER INFORMATION

  
8384
 

ITEM 1.

 

Legal Proceedings

  83
84
 

ITEM 1A.

 

Risk Factors

  84
85
 

ITEM 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

  85

ITEM 4.

Submission of Matters to a Vote of Security Holders


85
 

ITEM 6.

 

Exhibits

  86
85
 

Signatures

  87
86
 

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PART I.    FINANCIAL INFORMATION

ITEM 1.    FINANCIAL STATEMENTS

        


GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Statements of Operations

(Unaudited, amounts in thousands, except per share amounts)

 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
 
 2009 2008 2009 2008 

Revenues:

             
 

Net product sales

 $1,115,425 $1,071,801 $2,152,669 $2,078,069 
 

Net service sales

  105,693  90,622  207,192  176,486 
 

Research and development revenue

  7,392  8,711  17,520  16,640 
          
  

Total revenues

  1,228,510  1,171,134  2,377,381  2,271,195 
          

Operating costs and expenses:

             
 

Cost of products sold

  288,899  241,343  524,461  458,082 
 

Cost of services sold

  61,624  58,987  121,874  114,561 
 

Selling, general and administrative

  354,128  347,305  672,089  665,691 
 

Research and development

  210,522  381,861  417,447  644,658 
 

Amortization of intangibles

  63,945  55,605  121,543  111,263 
 

Contingent consideration expense

  9,090    9,090   
          
  

Total operating costs and expenses

  988,208  1,085,101  1,866,504  1,994,255 
          

Operating income

  240,302  86,033  510,877  276,940 
          

Other income (expenses):

             
 

Gains (losses) on investments in equity securities, net

  (105) 9,153  (681) 9,928 
 

Gain on acquisition of business

  24,159    24,159   
 

Other

  (2,056) 582  (3,035) 1,073 
 

Investment income

  4,144  13,352  9,494  28,222 
 

Interest expense

    (1,149)   (2,804)
          
  

Total other income (expenses)

  26,142  21,938  29,937  36,419 
          

Income before income taxes

  266,444  107,971  540,814  313,359 

Provision for income taxes

  (78,870) (38,407) (157,754) (98,524)
          

Net income

 $187,574 $69,564 $383,060 $214,835 
          

Net income per share:

             
 

Basic

 $0.69 $0.26 $1.42 $0.80 
          
 

Diluted

 $0.68 $0.25 $1.39 $0.77 
          

Weighted average shares outstanding:

             
 

Basic

  269,958  266,904  270,406  267,127 
          
 

Diluted

  274,852  284,262  276,225  285,028 
          

 
 Three Months Ended
March 31,
 
 
 2010 2009 

Revenues:

       
 

Net product revenue

 $971,625 $1,037,244 
 

Net service revenue

  101,915  101,499 
 

Research and development revenue

  933  10,128 
      
  

Total revenues

  1,074,473  1,148,871 
      

Operating costs and expenses:

       
 

Cost of products sold

  279,739  235,562 
 

Cost of services sold

  65,872  60,250 
 

Selling, general and administrative

  553,310  317,961 
 

Research and development

  220,930  206,925 
 

Amortization of intangibles

  70,984  57,598 
 

Contingent consideration expense

  62,549   
      
  

Total operating costs and expenses

  1,253,384  878,296 
      

Operating income (loss)

  (178,911) 270,575 
      

Other income (expenses):

       
 

Equity in loss of equity method investments

  (697)  
 

Other

  (439) (1,555)
 

Investment income

  3,300  5,350 
      
  

Total other income

  2,164  3,795 
      

Income (loss) before income taxes

  (176,747) 274,370 

Benefit from (provision for) income taxes

  61,799  (78,884)
      

Net income (loss)

 $(114,948)$195,486 
      

Net income (loss) per share:

       
 

Basic

 $(0.43)$0.72 
      
 

Diluted

 $(0.43)$0.70 
      

Weighted average shares outstanding:

       
 

Basic

  266,251  270,854 
      
 

Diluted

  266,251  277,628 
      

The accompanying notes are an integral part of these unaudited, consolidated financial statements.


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GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Balance Sheets

(Unaudited, amounts in thousands, except par value amounts)

 
 June 30,
2009
 December 31,
2008
 

ASSETS

       

Current assets:

       
 

Cash and cash equivalents

 $731,930 $572,106 
 

Short-term investments

  74,504  57,507 
 

Accounts receivable, net

  1,138,828  1,036,940 
 

Inventories

  586,686  453,437 
 

Prepaid expenses and other current assets

  138,763  208,040 
 

Due from Bayer

  74,647   
 

Deferred tax assets

  187,954  188,105 
      
  

Total current assets

  2,933,312  2,516,135 

Property, plant and equipment, net

  2,550,269  2,306,567 

Long-term investments

  242,949  344,078 

Goodwill

  1,402,073  1,401,074 

Other intangible assets, net

  2,438,124  1,654,698 

Deferred tax assets-noncurrent

  362,043  269,237 

Investments in equity securities

  67,386  83,325 

Other noncurrent assets

  98,930  96,162 
      
  

Total assets

 $10,095,086 $8,671,276 
      

LIABILITIES AND STOCKHOLDERS' EQUITY

       

Current liabilities:

       
 

Accounts payable

 $160,271 $127,869 
 

Accrued expenses

  714,974  765,386 
 

Deferred revenue

  20,710  13,462 
 

Current portion of contingent consideration obligations

  212,196   
 

Current portion of long-term debt and capital lease obligations

  7,850  7,566 
      
  

Total current liabilities

  1,116,001  914,283 

Long-term debt and capital lease obligations

  119,850  124,341 

Deferred revenue-noncurrent

  12,237  13,175 

Long-term contingent consideration obligations

  760,994   

Other noncurrent liabilities

  305,535  313,484 
      
  

Total liabilities

  2,314,617  1,365,283 
      

Commitments and contingencies

       

Stockholders' equity:

       
 

Preferred stock, $0.01 par value

     
 

Common stock, $0.01 par value

  2,701  2,707 
 

Additional paid-in capital

  5,848,179  5,779,279 
 

Accumulated earnings

  1,630,856  1,247,796 
 

Accumulated other comprehensive income

  298,733  276,211 
      
  

Total stockholders' equity

  7,780,469  7,305,993 
      
  

Total liabilities and stockholders' equity

 $10,095,086 $8,671,276 
      

 
 March 31,
2010
 December 31,
2009
 

ASSETS

       

Current assets:

       
 

Cash and cash equivalents

 $643,337 $742,246 
 

Short-term investments

  162,011  163,630 
 

Accounts receivable, net

  904,102  899,731 
 

Inventories

  608,642  608,022 
 

Other current assets

  310,626  210,747 
 

Deferred tax assets

  181,318  178,427 
      
  

Total current assets

  2,810,036  2,802,803 

Property, plant and equipment, net

  2,824,099  2,809,349 

Long-term investments

  156,351  143,824 

Goodwill

  1,404,153  1,403,363 

Other intangible assets, net

  2,032,449  2,313,262 

Deferred tax assets-noncurrent

  401,370  376,815 

Investments in equity securities

  79,881  74,438 

Other noncurrent assets

  146,456  136,870 
      
  

Total assets

 $9,854,795 $10,060,724 
      

LIABILITIES AND STOCKHOLDERS' EQUITY

       

Current liabilities:

       
 

Accounts payable

 $175,764 $189,629 
 

Accrued expenses

  870,460  696,223 
 

Deferred revenue

  32,585  24,747 
 

Current portion of contingent consideration obligations

  158,493  161,365 
 

Current portion of long-term debt and capital lease obligations

  8,407  8,166 
      
  

Total current liabilities

  1,245,709  1,080,130 

Long-term debt and capital lease obligations

  113,389  116,434 

Deferred revenue-noncurrent

  12,870  13,385 

Long-term contingent consideration obligations

  875,184  853,871 

Other noncurrent liabilities

  80,415  313,252 
      
  

Total liabilities

  2,327,567  2,377,072 
      

Commitments and contingencies

       

Stockholders' equity:

       
 

Preferred stock, $0.01 par value

     
 

Common stock, $0.01 par value

  2,665  2,657 
 

Additional paid-in capital

  5,770,283  5,688,741 
 

Accumulated earnings

  1,555,148  1,670,096 
 

Accumulated other comprehensive income

  199,132  322,158 
      
  

Total stockholders' equity

  7,527,228  7,683,652 
      
  

Total liabilities and stockholders' equity

 $9,854,795 $10,060,724 
      

The accompanying notes are an integral part of these unaudited, consolidated financial statements.


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GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Statements of Cash Flows

(Unaudited, amounts in thousands)

 
 Six Months Ended
June 30,
 
 
 2009 2008 

Cash Flows from Operating Activities:

       
 

Net income

 $383,060 $214,835 
 

Reconciliation of net income to cash flows from operating activities:

       
  

Depreciation and amortization

  208,515  183,119 
  

Stock-based compensation

  109,831  96,952 
  

Provision for bad debts

  10,808  5,844 
  

Contingent consideration expense

  9,090   
  

Gain on acquisition of business

  (24,159)  
  

(Gains) losses on investments in equity securities, net

  681  (9,928)
  

Deferred income tax benefit

  (50,632) (172,813)
  

Tax benefit from employee stock-based compensation

  9,239  25,645 
  

Excess tax benefits from stock-based compensation

  (4,424) (8,647)
  

Other

  4,068  1,987 
  

Increase (decrease) in cash from working capital changes (excluding impact of acquired assets and assumed liabilities):

       
   

Accounts receivable

  (106,901) (98,174)
   

Inventories

  21,795  (4,812)
   

Prepaid expenses and other current assets

  (903) (15,295)
   

Income taxes payable

  32,958  13,288 
   

Accounts payable, accrued expenses and deferred revenue

  (2,680) (52,692)
      
    

Cash flows from operating activities

  600,346  179,309 
      

Cash Flows from Investing Activities:

       
 

Purchases of investments

  (64,394) (289,129)
 

Sales and maturities of investments

  150,739  319,758 
 

Purchases of equity securities

  (7,363) (81,472)
 

Proceeds from sales of investments in equity securities

  1,473  16,169 
 

Purchases of property, plant and equipment

  (318,324) (251,785)
 

Distributions from equity method investments

    6,595 
 

Acquisitions

  (117,073)  
 

Purchases of other intangible assets

  (18,345) (75,400)
 

Other

  (5,198) 2,571 
      
    

Cash flows from investing activities

  (378,485) (352,693)
      

Cash Flows from Financing Activities:

       
 

Proceeds from the issuance of our common stock

  53,508  127,008 
 

Repurchases of our common stock

  (107,134) (143,012)
 

Excess tax benefits from stock-based compensation

  4,424  8,647 
 

Payments of debt and capital lease obligations

  (4,305) (3,886)
 

Increase (decrease) in bank overdrafts

  (14,303) 29,309 
 

Other

  3,660  2,804 
      
    

Cash flows from financing activities

  (64,150) 20,870 
      

Effect of exchange rate changes on cash

  2,113  (20,811)
      

Increase (decrease) in cash and cash equivalents

  159,824  (173,325)

Cash and cash equivalents at beginning of period

  572,106  867,012 
      

Cash and cash equivalents at end of period

 $731,930 $693,687 
      

Supplemental disclosures of non-cash transactions:

       
 

Strategic Transactions—Note 6.

       

 
 Three Months Ended
March 31,
 
 
 2010 2009 

Cash Flows from Operating Activities:

       
 

Net income (loss)

 $(114,948)$195,486 
 

Reconciliation of net income (loss) to cash flows from operating activities:

       
  

Depreciation and amortization

  122,688  98,958 
  

Stock-based compensation

  47,671  44,560 
  

Provision for bad debts

  2,449  5,762 
  

Contingent consideration expense

  62,549   
  

Equity in loss of equity method investments

  697   
  

Deferred income tax benefit

  (32,679) (24,376)
  

Tax benefit from employee stock-based compensation

  3,624  6,549 
  

Excess tax benefit from stock-based compensation

  480  (3,492)
  

Other

  2,663  2,814 
  

Increase (decrease) in cash from working capital changes (excluding impact of acquired assets and assumed liabilities):

       
   

Accounts receivable

  (31,463) (59,210)
   

Inventories

  (28,225) 818 
   

Other current assets

  (48,640) (22,659)
   

Accounts payable, accrued expenses and deferred revenue

  139,598  12,565 
      
    

Cash flows from operating activities

  126,464  257,775 
      

Cash Flows from Investing Activities:

       
 

Purchases of investments

  (120,119) (13,292)
 

Sales and maturities of investments

  105,796  75,058 
 

Purchases of equity securities

  (3,302) (4,870)
 

Proceeds from sales of investments in equity securities

  3,077  1,264 
 

Purchases of property, plant and equipment

  (152,220) (161,561)
 

Investments in equity method investment

  (1,466)  
 

Purchases of other intangible assets

  (5,885) (8,056)
 

Other

  (10,547) (47)
      
    

Cash flows from investing activities

  (184,666) (111,504)
      

Cash Flows from Financing Activities:

       
 

Proceeds from issuance of common stock

  30,075  34,526 
 

Repurchases of our common stock

    (107,134)
 

Excess tax benefits from stock-based compensation

  (480) 3,492 
 

Payments of debt and capital lease obligations

  (3,092) (2,653)
 

Decrease in bank overdrafts

  (20,728) (3,392)
 

Payment of contingent consideration obligation

  (31,600)  
 

Other

  116  1,995 
      
    

Cash flows from financing activities

  (25,709) (73,166)
      

Effect of exchange rate changes on cash

  (14,998) (1,773)
      

Increase (decrease) in cash and cash equivalents

  (98,909) 71,332 

Cash and cash equivalents at beginning of period

  742,246  572,106 
      

Cash and cash equivalents at end of period

 $643,337 $643,438 
      

Supplemental disclosures of non-cash transactions:

       
 

Strategic Transactions—Note 6.

       
 

Goodwill and Other Intangible Assets—Note 8.

       

The accompanying notes are an integral part of these unaudited, consolidated financial statements.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements

1. Description of Business

        We are a global biotechnology company dedicated to making a major impact on the lives of people with serious diseases. Our broad productproducts and service portfolio isservices are focused on rare inherited disorders, renalkidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Our commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and predictive testing.other areas of unmet medical need.

        In the fourth quarter of 2008, we changed our segment reporting structure to better reflect the way we manage and measure the performance of our businesses. Under the new reporting structure, weWe are organized into fourfive financial reporting units, which we also consider to be our reporting segments:

        Our transplantEffective January 1, 2010, based on changes in how we review our business, we re-allocated certain of our business units among our segments and adopted new names for certain of our reporting segments. Specifically:


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

1. Description of Business (Continued)

        We report the activities of the following business units under the caption "Other": our genetic testing business unit, which provides testing services for the oncology, prenatal and reproductive markets; and our diagnostic products and pharmaceutical intermediates business units. These operating segments did not meet the quantitative threshold for separate segment reporting.

        We report our corporate, general and administrative operations and corporate science activities under the caption "Corporate."

        We have revised our 2009 segment disclosures to conform to our 2010 presentation.

        On May 6, 2010, we announced that we plan to pursue strategic alternatives for our genetic testing, diagnostic products and pharmaceutical intermediates business units. Options could include divestiture, spin-out or management buy-out. In 2009, our genetic testing business unit had revenue of approximately $371 million and revenue for our diagnostic products business unit was approximately $167 million. We expect these transactions to be completed in 2010.

2. Basis of Presentation and Significant Accounting Policies

Basis of Presentation

        Our unaudited, consolidated financial statements for each period include the statements of operations, balance sheets and statements of cash flows for our operations taken as a whole. We have eliminated all intercompany items and transactions in consolidation. We have reclassified certain 20082009 data to conform to our 20092010 presentation. We prepare our unaudited, consolidated financial statements following the requirements of the SEC for interim reporting. As permitted under these rules, we condense or omit certain footnotes and other financial information that are normally required by accounting principles generally accepted in the United States.States, or U.S. GAAP.

        These financial statements include all normal and recurring adjustments that we consider necessary for the fair presentation of our financial position and results of operations. Since these are interim financial statements, you should also read our audited, consolidated financial statements and notes included in Exhibit 13Part II., Item 8. to our 20082009 Form 10-K. Revenues, expenses, assets and liabilities can vary from quarter to quarter. Therefore, the results and trends in these interim financial statements may not be indicative of results for future periods. The balance sheet data as of December 31, 20082009 that is included in this Form 10-Q was derived from our audited financial statements.statements but does not include all disclosures required by U.S. GAAP.

        Our unaudited, consolidated financial statements for each period include the accounts of our wholly owned and majority owned subsidiaries. As a result of our adoption of Financial Accounting Standards Board, or FASB, Interpretation No., or FIN, 46R, "Consolidation of Variable Interest Entities," we also consolidate certain variable interest entities for which we are the primary beneficiary. For consolidated subsidiaries in which we have less than a 100% ownership interest, we record minority interest expense in "Other" in our consolidated statements of operations (representing the ownership interest of the minority owner) because the amount was immaterial for all periods presented. We use the equity method of accounting to account for our investments in entities in whichnot subject to consolidation using the equity method of accounting if we have a substantial ownership interest (20% to 50%) which do not fall in the scope of FIN 46R, or over which we exercise significant influence.influence over the entity. Our consolidated net income (loss) includes our share of the earnings or losses of these entities.

        Any material subsequent events All intercompany accounts and transactions have been considered for disclosure through the filing date of this Form 10-Q.

Recent Accounting Pronouncements

        Periodically, accounting pronouncements and related information on the adoption, interpretation and application of accounting principles generally acceptedeliminated in the United States are issued or amended by the various U.S. financial accounting regulatory groups. The following table provides a description of the types of accounting pronouncements that are frequently issued or amended:consolidation.

Accounting Regulatory Group
Type of Pronouncement Issued or Amended

Accounting Principles Board

APB Opinion No., or APB

FASB

FASB Statement of Financial Accounting Standards No., or FAS

FASB Statement of Position No., or FSP

Emerging Issues Task Force Issue No., or EITF

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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

2. Basis of Presentation and Significant Accounting Policies (Continued)

Revenue Recognition—Recent Healthcare Reform Legislation

        In March 2010, healthcare reform legislation was enacted in the United States, which contains several provisions that impact our business. Although many provisions of the new legislation do not take effect immediately, several provisions became effective in the first quarter of 2010. These include:

These provisions did not have a significant impact on our results of operations or financial position for the first quarter of 2010.

        Effective October 1, 2010, the new legislation re-defines the Medicaid average manufacturer price, or AMP, such that the AMP and, consequently, the Medicaid rebate are expected to increase for some of our drugs, in particular those that offer discounted pricing to customers.

        Beginning in 2011, the new law requires that drug manufacturers provide a 50% discount to Medicare beneficiaries whose prescription drug costs cause them to be subject to the Medicare Part D coverage gap, which is known as the "donut hole." Also beginning in 2011, clinical laboratory fee schedule payments will be reduced by 1.75% over a period of five years and we will be required to pay our share of a new fee assessed on all branded prescription drug manufacturers and importers. This fee will be calculated based upon each organization's percentage share of total branded prescription drug sales to U.S. government programs (such as Medicare and Medicaid, the Department of Veterans Affairs, or VA, the Department of Defense, or DOD, and the TriCare retail pharmacy discount programs) made during the previous year. Sales of orphan drugs, however, are not included in the fee calculation. Final guidance relating to how we will be required to account for this fee is still pending, however, it is expected that the fee will be classified as either a reduction to net sales or an operating expense. The aggregated industry wide fee is expected to total approximately $28 billion through 2019, ranging from $2.5 billion to $4.1 billion annually. Beginning in 2013, a 2.3% excise tax will be imposed on sales of all medical devices except retail purchases by the public intended for individual use.

        Presently, uncertainty exists as many of the specific determinations necessary to implement this new legislation have yet to be decided and communicated to industry participants. We are still assessing the full extent that the U.S. healthcare reform legislation may have on our business.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

2. Basis of Presentation and Significant Accounting Policies (Continued)

Stock-Based Compensation

        All stock-based awards to non-employees are accounted for at their fair value. We periodically grant awards, including time vesting stock options, time vesting restricted stock units, or RSUs, and performance vesting restricted stock units, or PSUs, under our employee and director equity plans. Beginning in 2010, our long-term incentive program for senior executives includes a combination of:

Approximately half of each senior executive's grant consists of time vesting stock options with the remainder in PSUs. Grants under our former long-term incentive program were comprised of time vesting stock options and time vesting RSUs.

        We record the estimated fair value of awards granted as stock-based compensation expense in our consolidated statements of operations over the requisite service period, which is generally the vesting period. Where awards are made with non-substantive vesting periods, such as where a portion of the award vests upon retirement eligibility, we estimate and recognize expense based on the period from the grant date to the date on which the employee is retirement eligible.

        The fair values of our:


Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

2. Basis of Presentation and Significant Accounting Policies (Continued)

Recent Accounting Pronouncements

        Periodically, accounting pronouncements and related information on the adoption, interpretation and application of U.S. GAAP are issued or amended by the Financial Accounting Standards Board, or FASB, or other standard setting bodies. Changes to the FASB Accounting Standards Codification™, or ASC, are communicated through Accounting Standards Updates, or ASUs. The following table shows FASB ASUs recently issued accounting pronouncementsthat could affect our disclosures and our position for adoption:

PronouncementsASU Number
 Relevant Requirements of ASU Issued Date/Our
Effective Dates
 Status

FAS 165, "Subsequent Events.2009-13 "Multiple-Deliverable Revenue Arrangements—a consensus of the FASB Emerging Issues Task Force."

 Establishes general standardsthe accounting and reporting guidance for arrangements under which a vendor will perform multiple revenue-generating activities. Specifically, the provisions of accounting forthis update address how to separate deliverables and disclosurehow to measure and allocate arrangement consideration to one or more units of events that occur after the balance sheet date but before financial statements are issued or are available to be issued. It requires the disclosure of the date through which an entity has evaluated subsequent events and whether that date represents the date the financial statements were issued or were available to be issued.accounting. Issued MayOctober 2009. Effective prospectively for periods endingrevenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2009.2010. Early adoption is permitted. Since FAS 165 at most requires additional disclosures,We will adopt the adoptionprovisions of this pronouncement did not have a material impact on our consolidated financial statements.

FAS 166, "Accounting for Transfers of Financial Assets—an amendment of FASB Statement No. 140."


Improves the relevance, representational faithfulness, and comparability of the information that a reporting entity provides in its financial statements about a transfer of financial assets; the effects of a transfer on its financial position, financial performance and cash flows; and a transferor's continuing involvement, if any, in transferred financial assets.


Issued June 2009. Effectiveupdate for the first annual reporting period that begins after November 15, 2009.


quarter of 2011. We do not expectare currently assessing the adoptionimpact the provisions of this pronouncement to have any affect on our consolidated financial statements.

FAS 167, "Amendments to FASB Interpretation No. 46(R)."


Improves financial reporting by enterprises involved with variable interest entities and to provide more relevant and reliable information to users of financial statements.


Issued June 2009. Effective for the first annual reporting period that begins after November 15, 2009.


We are evaluating the impact this pronouncementupdate will have, if any, on our consolidated financial statements.

FAS 168, "The FASB Accounting Standards Codification™ and the Hierarchy of Generally Accepted Accounting Principles a replacement of FASB Statement No. 162.2009-17 "Improvements to Financial Reporting by Enterprises Involved with Variable Interest Entities."


 

Establishes Consists of amendments to ASC 810, "Consolidation," which change how a company determines when an entity that is insufficiently capitalized or is not controlled through voting should be consolidated. This is based on, among other things, an entity's purpose and design and a company's ability to direct the FASB Accounting Standards Codification (Codification) asactivities of the sourceentity that most significantly impact the entity's economic performance.

Issued December 2009. Effective for the first interim or annual reporting period after December 15, 2009.

We adopted the provisions of authoritative accounting principles recognized by the FASB to be applied by nongovernmental entities that are presented in conformity with generally accepted accounting principles (GAAP)this update in the United States (the GAAP hierarchy).



Issued June 2009 to replace FAS 162, "first quarter of 2010. The Hierarchy of Generally Accepted Accounting Principles." Effective for financial statements issued for interim and annual periods ending after September 15, 2009.


We do not expect the adoptionprovisions of this pronouncement toupdate did not have a materialany impact on our consolidated financial statements.statements, other than for our interest in BioMarin/Genzyme LLC, as discussed in Note 9., "Investment in BioMarin/Genzyme LLC," below.


Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

2. Basis of Presentation and Significant Accounting Policies (Continued)

PronouncementsASU Number
 Relevant Requirements of ASU Issued Date/Our
Effective Dates
 Status

FSP FAS 107-1 and APB 28-1, "Interim2010-06 "Improving Disclosures about Fair Value of Financial Instruments.Measurements."

 Amends guidance on

Requires new disclosures and clarifies some existing disclosure requirements about fair value measurements codified within ASC 820, "Fair Value Measurements and interim financial reporting to require disclosure aboutDisclosures," including significant transfers into and out of Level 1 and Level 2 investments of the fair value hierarchy. Also requires additional information in the roll forward of financial instruments whenever summarized financialLevel 3 investments including presentation of purchases, sales, issuances, and settlements on a gross basis. Further clarification for existing disclosure requirements provides for the disaggregation of assets and liabilities presented, and the enhancement of disclosures around inputs and valuation techniques.

Issued January 2010. Effective for the first interim or annual reporting period beginning after December 15, 2009, except for the additional information is issuedin the roll forward of Level 3 investments. Those disclosures are effective for fiscal years beginning after December 15, 2010, and for interim reporting periods.periods within those fiscal years.

 Issued April 2009. Effective

We adopted the applicable provisions of this update, except for periods ending after June 15, 2009.

Thethe additional information in the roll forward of Level 3 investments (as previously noted), in the first quarter of 2010. Besides a change in disclosure, the adoption of this pronouncement didupdate does not have a material impact on our consolidated financial statements forstatements. During the periods presented.three months ended March 31, 2010, none of our instruments were reclassified between Level 1, Level 2 or Level 3.


FSP FAS 115-2, FAS 124-2, and EITF 99-20-2, "Recognition and Presentation of Other-Than-Temporary Impairments.2010-11, "Scope Exception Related to Embedded Credit Derivatives."


 

Amends Update provides amendments to Subtopic 815-15,"Derivatives and Hedging—Embedded Derivatives, " to clarify the other-than-temporary impairment guidancescope exception for debt securitiesembedded credit derivative features related to make the guidance more operational and to improve the presentation and disclosuretransfer of other- than-temporary impairmentscredit risk in the form of subordination of one financial statements.instrument to another.


 

Issued April 2009.March 2010. Effective for periods endingat the beginning of each reporting entity's first fiscal quarter beginning after June 15, 2009.



The2010. Early adoption is permitted at the beginning of each reporting entity's first fiscal quarter beginning after issuance of this pronouncement did notupdate.

We will adopt the provisions of this update for the third quarter of 2010. We are currently assessing the impact the provisions of this update will have, a material impactif any, on our consolidated financial statements for the periods presented.statements.


FSP FAS 157-4, "Determining Fair Value When 2010-17, "Milestone Method of Revenue Recognition—a Market Is Not Active and a Transaction Is Not Distressed.consensus of the FASB Emerging Issues Task Force."


 

Provides guidelines Update provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition for making fair value measurements more consistent with the principles presented in FAS 157,research and development transactions."Fair Value Measurements,"

as well as additional authoritative guidance in determining whether a market is active or inactive, and whether a transaction is distressed. Applicable to all assets and liabilities (i.e. financial and nonfinancial) and will require enhanced disclosures.



Issued April 2009.2010. Effective on a prospective basis for milestones achieved in fiscal years, and interim periods endingwithin those years, beginning on or after June 15, 2009.2010. Early adoption is permitted.


 

The adoption We will adopt the provisions of this pronouncement did notupdate beginning January 1, 2011. We are currently assessing the impact the provisions of this update will have, a material impactif any, on our consolidated financial statements for the periods presented.statements.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3. Fair Value Measurements

        A significant number of our financial instrumentsassets and liabilities are carried at fair value. These assets and liabilities include:

Fair Value Measurement—Definition and Hierarchy

        FAS 157 provides a framework for measuring fairFair value and requires expanded disclosures regarding fair value measurements. FAS 157 defines fair valueis defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the "exit price") in an orderly transaction between market participants at the measurement date. In determining fair value, FAS 157 permits thewe are permitted to use of


Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3.    Fair Value Measurements (Continued)


various valuation approaches, including market, income and cost approaches. FAS 157 establishes aWe are required to follow an established fair value hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available.

        The fair value hierarchy is broken down into three levels based on the reliability of inputs. We have categorized our fixed income, equity securities, derivatives and contingent consideration obligations within the hierarchy as follows:

Valuation Techniques

        Fair value is a market-based measure considered from the perspective of a market participant who would buy the asset or assume the liability rather than our own specific measure. All of our fixed income securities are priced using a variety of daily data sources, largely readily-available market data and broker quotes. To validate these prices, we compare the fair market values of our fixed income investments using market data from observable and corroborated sources. We also perform the fair value calculations for our derivatives and equity securities using market data from observable and corroborated sources. We determine the fair value of the contingent consideration obligations based on


Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3. Fair Value Measurements (Continued)


a probability-weighted income approach. The measurement is based on significant inputs not observable in the market. In periods of market inactivity, the observability of prices and inputs may be reduced for certain instruments. This condition could cause an instrument to be reclassified from Level 1 to Level 2 or from Level 2 to Level 3. During the three months ended March 31, 2010, none of our instruments were reclassified between Level 1, Level 2 or Level 3.

        The following tables set forth our assets and liabilities that were accounted for at fair value on a recurring basis as of March 31, 2010 and December 31, 2009 (amounts in thousands):

Description Balance as of
March 31,
2010
 Level 1 Level 2 Level 3 

Fixed income investments(1):

 

Cash equivalents:

 Money market funds/other $534,143 $534,143 $ $ 
              

 

Short-term investments:

 U.S. Treasury notes  30,420  30,420     

   Non U.S. Governmental notes  7,229    7,229   

   U.S. agency notes  62,393    62,393   

   Corporate notes—global  60,969    60,969   

   Commercial paper  1,000    1,000   
              

   Total  162,011  30,420  131,591   
              

 

Long-term investments:

 U.S. Treasury notes  66,179  66,179     

   Non U.S. Governmental notes  1,624    1,624   

   U.S. agency notes  16,906    16,906   

   Corporate notes—global  71,642    71,642   
              

   Total  156,351  66,179  90,172   
              

 

Total fixed income investments

  852,505  630,742  221,763   
              

Equity holdings(1):

 

Publicly-traded equity securities

  44,255  44,255     
              

Derivatives:

 

Foreign exchange forward contracts

  701    701   
              

Contingent liabilities(2):

 

Contingent consideration obligations

  (1,033,677)     (1,033,677)
              

Total assets (liabilities) at fair value

 $(136,216)$674,997 $222,464 $(1,033,677)
              

Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3. Fair Value Measurements (Continued)

 The following tables set forth our assets and liabilities that were accounted for at

Description Balance as of
December 31,
2009
 Level 1 Level 2 Level 3 

Fixed income investments(1):

 

Cash equivalents:

 Money market funds/other $603,109 $603,109 $ $ 
              

 

Short-term investments:

 U.S. Treasury notes  41,040  41,040     

   Non U.S. Governmental notes  4,114    4,114   

   U.S. Government agency notes  56,810    56,810   

   Corporate notes—global  54,825    54,825   

   Commercial paper  6,841    6,841   
              

   Total  163,630  41,040  122,590   
              

 

Long-term investments:

 U.S. Treasury notes  29,793  29,793     

   Non U.S. Governmental notes  4,873    4,873   

   U.S. Government agency notes  28,015    28,015   

   Corporate notes—global  81,143    81,143   
              

   Total  143,824  29,793  114,031   
              

 

Total fixed income investments

  910,563  673,942  236,621   
              

Equity holdings(1):

 

Publicly-traded equity securities

  40,380  40,380     
              

Derivatives:

 

Foreign exchange forward contracts

  4,284    4,284   
              

Contingent liabilities(2):

 

Contingent consideration obligations

  (1,015,236)     (1,015,236)
              

Total assets (liabilities) at fair value

 $(60,009)$714,322 $240,905 $(1,015,236)
              

(1)
Changes in the fair value onof our fixed income investments and investments in publicly-traded equity securities are recorded in accumulated other comprehensive income, a recurring basiscomponent of stockholders' equity, in our consolidated balance sheets.

(2)
Changes in the fair value of the contingent consideration obligations are recorded as contingent consideration expense, a component of June 30, 2009operating expenses in our consolidated statements of operations. We recorded a total of $62.5 million of contingent consideration expense in our consolidated statements of operations for the three months ended March 31, 2010, including $21.4 million for our Hematology and DecemberOncology reporting segment and $41.1 million for our Multiple Sclerosis reporting segment, for which there were no comparable amounts in the same period of 2009.

        Changes in the fair value of our Level 3 contingent consideration obligations during the three months ended March 31, 20082010 were as follows (amounts in thousands):

Description Balance as of
June 30,
2009
 Level 1 Level 2 Level 3 

Fixed income investments(1):

 

Cash equivalents:

 Money market funds/other $548,247 $548,247 $ $ 
              

 

Short-term investments:

 

U.S. Treasury notes

  
7,357
  
7,357
  
  
 

   U.S. agency notes  13,463    13,463   

   Corporate notes—global  50,601    50,601   

   Commercial paper  3,083    3,083   
              

   Total  74,504  7,357  67,147   
              

 

Long-term investments:

 

U.S. Treasury notes

  
48,672
  
48,672
  
  
 

   Non U.S. Governmental notes  7,409    7,409   

   U.S. agency notes  91,038    91,038   

   Corporate notes—global  95,830    95,830   
              

   Total  242,949  48,672  194,277   
              

 

Total fixed income investments

  865,700  604,276  261,424   
              

Equity holdings(1):

 

Publicly-traded equity securities

  39,182  39,182     
         ��    

Derivatives:

 

Foreign exchange forward contracts

  (468)   (468)  
              

Contingent liabilities:

 

Contingent consideration obligations(2)

  (973,190)     (973,190)
              

Total assets (liabilities) at fair value

 $(68,776)$643,458 $260,956 $(973,190)
              

Balance as of December 31, 2009

 $(1,015,236)

Payments

  31,600 

Contingent consideration expense(1)

  (62,549)

Effect of foreign currency adjustments

  12,508 
    

Fair value at March 31, 2010

 $(1,033,677)
    

(1)
Includes $35.5 million of contingent consideration expense for the three months ended March 31, 2010 related to changes in estimates.

Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3. Fair Value Measurements (Continued)


Description Balance
as of
December 31,
2008
 Level 1 Level 2 Level 3 

Fixed income investments(1):

 

Cash equivalents:

 Money market funds/other $357,680 $357,680 $ $ 
              

 

Short-term investments:

 

U.S. Treasury notes

  
7,505
  
7,505
  
  
 

   U.S. agency notes  10,328    10,328   

   Corporate notes—global  39,674    39,674   
              

   Total  57,507  7,505  50,002   
              

 

Long-term investments:

 

U.S. Treasury notes

  
75,040
  
75,040
  
  
 

   Non U.S. Governmental notes  7,322    7,322   

   U.S. agency notes  121,707    121,707   

   Corporate notes—global  140,009    140,009   
              

   Total  344,078  75,040  269,038   
              

 

Total fixed income investments

  759,265  440,225  319,040   
              

Equity holdings(1):

 

Publicly-traded equity securities

  56,596  56,596     
              

Derivatives:

 

Foreign exchange forward contracts

  (1,434)   (1,434)  
              

Total assets (liabilities) at fair value

 $814,427 $496,821 $317,606 $ 
              

(1)
Changes in the fair value of our fixed income investments and investments in publicly-traded equity securities are recorded in accumulated other comprehensive income (loss), a component of stockholders' equity, in our consolidated balance sheets.

(2)
In May 2009, in connection with our acquisition from Bayer of the worldwide rights to Campath, Fludara, Leukine and alemtuzumab for the treatment of MS, changes in the fair value of these contingent consideration obligations are recorded as contingent consideration expense, a component of operating expenses in our consolidated statements of operations.

        Changes in the fair value of the our Level 3 contingent consideration obligations during the six months ended June 30, 2009 were as follows (amounts in thousands):

Contingent consideration obligations related to acquisition from Bayer in May 2009

 $(964,100)

Payments

   

Contingent consideration expense

  (9,090)
    

Fair value at June 30, 2009

 $(973,190)
    

        The carrying amounts reflected in our consolidated balance sheets for cash, accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses, current portion of contingent consideration obligations and current portion of long-term debt and capital lease obligations approximate fair value due to their short-term maturities.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3.    Fair Value Measurements (Continued)

Derivative Instruments

        As a result of our worldwide operations, we may face exposure to potential adverse movements in foreign currency exchange rates. Exposures to currency fluctuations that result from sales of our products in foreign markets are partially offset by the impact of currency fluctuations on our international expenses. We may also use derivatives, primarily foreign exchange forward contracts for which we do not apply hedge accounting treatment, under FAS 133, "Accounting for Derivative Instruments and Hedging Activities," to further reduce our exposure to changes in exchange rates, primarily to offset the earnings effect from short-term foreign currency assets and liabilities. We account for such derivatives at market value with the resulting gains and losses reflected within selling, general and administrative expenses, or SG&A, expense in our consolidated statements of operations. We do not have any derivatives designated as hedging instruments under FAS 133 and we do not use derivative instruments for trading or speculative purposes.

Foreign Exchange Forward Contracts

        Generally, we enter into foreign exchange forward contracts with maturities of not more than 15 months. All foreign exchange forward contracts in effect as of June 30, 2009March 31, 2010 and December 31, 20082009 had maturities of 1 to 2 months. We report these contracts on a net basis. Net asset derivatives are included in prepaid expenses and other current assets and net liability derivatives are included in accrued expenses in our consolidated balance sheets.

        In accordance with the provisions of FAS 161, "Disclosures about Derivative Instruments and Hedging Activities—an amendment of FASB Statement No. 133," theThe following table summarizes the balance sheet classification of the fair value of these derivatives on both a gross and net basis as of June 30, 2009March 31, 2010 and December 31, 20082009 (amounts in thousands):

 
 Foreign Exchange Forward Contracts 
 
  
  
 As Reported 
 
 Gross Net 
 
 Asset
Derivatives
 Liability
Derivatives
 Asset
Derivatives
 Liability
Derivatives
 
As of:
 Prepaid expenses
and other
current assets
 Accrued
expenses
 Prepaid expenses
and other
current assets
 Accrued
expenses
 
June 30, 2009 $87 $555 $ $468 
December 31, 2008 $2,758 $4,192 $ $1,434 

 
 Unrealized Gain/Loss on Foreign Exchange Forward Contracts 
 
  
  
 As Reported 
 
 Gross Net 
 
 Asset
Derivatives
 Liability
Derivatives
 Asset
Derivatives
 Liability
Derivatives
 
As of:
 Other
current assets
 Accrued
expenses
 Other
current assets
 Accrued
expenses
 

March 31, 2010

 $1,338 $637 $701 $ 

December 31, 2009

 $9,834 $5,550 $4,284 $ 

        Total foreign exchange (gains) and losses included in SG&A in our consolidated statements of operations includes unrealized and realized (gains) and losses related to both our foreign exchange forward contracts and our foreign currency assets and liabilities. The net impact of our overall unrealized and realized foreign exchange (gains) and losses for both the three and six months ended June 30,March 31, 2010 and 2009 and 2008 was not significant.

        In accordance with the provisions of FAS 161, theThe following table summarizes the effect of the unrealized and realized lossesnet gains related to our foreign exchange forward contracts on our consolidated


Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3.    Fair Value Measurements (Continued)


statements of operations for the three and six months ended June 30,March 31, 2010 and 2009 and 2008 (amounts in thousands):

 
  
 Net Loss Reported 
 
  
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
 
 Statement of
Operations
Location
 
Derivative Instrument
 2009 2008 2009 2008 

Foreign exchange forward contracts

 SG&A $18,728 $4,296 $7,898 $40,193 

4.    Net Income Per Share

        The following table sets forth our computation of basic and diluted net income per common share (amounts in thousands, except per share amounts):

 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
 
 2009 2008 2009 2008 

Net income—basic

 $187,574 $69,564 $383,060 $214,835 

Effect of dilutive securities:

             
 

Interest expense and debt fee amortization, net of tax, related to our 1.25% convertible senior notes(1)

    1,886    3,772 
          

Net income—diluted

 $187,574 $71,450 $383,060 $218,607 
          

Shares used in computing net income per common share—basic

  
269,958
  
266,904
  
270,406
  
267,127
 

Effect of dilutive securities:

             
 

Shares issuable upon the assumed conversion of our 1.25% convertible senior notes(1)

    9,686    9,686 
 

Stock options(2)

  3,555  7,123  4,554  7,712 
 

Restricted stock units

  1,303  538  1,221  491 
 

Other

  36  11  44  12 
          
  

Dilutive potential common shares

  4,894  17,358  5,819  17,901 
          

Shares used in computing net income per common share—diluted(1,2)

  274,852  284,262  276,225  285,028 
          

Net income per common share:

             
 

Basic

 $0.69 $0.26 $1.42 $0.80 
          
 

Diluted

 $0.68 $0.25 $1.39 $0.77 
          

(1)
Prior to January 1, 2009, in accordance with EITF 04-8, "The Effect of Contingently Convertible Debt on Diluted Earnings Per Share," the shares issuable upon redemption of $690.0 million in principal of our 1.25% convertible senior notes were included in diluted weighted average shares outstanding for purposes of computing diluted earnings per share, unless the effect was anti-dilutive. There are no similar adjustments to the computation of diluted earnings per share for

 
  
 Three Months Ended
March 31,
 
 
 Statement of
Operations Location
 
Derivative Instrument
 2010 2009 

Foreign exchange forward contracts

 SG&A $(5,041)$(10,828)

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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

4.    Net Income Per Share (Continued)

(2)
We did not include the securities described in the following table in the computation of diluted earnings per share because these securities were anti-dilutive during the corresponding period (amounts in thousands):
 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
 
 2009 2008 2009 2008 

Shares issuable upon exercise of outstanding options

  19,732  4,258  14,191  3,120 

5.    Comprehensive Income

        The components of comprehensive income for the periods presented are as follows (amounts in thousands):

 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
 
 2009 2008 2009 2008 

Comprehensive income, net of tax:

             

Net income

 $187,574 $69,564 $383,060 $214,835 
          

Other comprehensive income (loss):

             
 

Foreign currency translation adjustments

  153,780  (3,981) 33,632  105,673 
          
 

Pension liability adjustments, net of tax(1)

    (7)   71 
          
 

Unrealized gains (losses) on securities, net of tax:

             
  

Unrealized gains (losses) arising during the period, net of tax

  9,657  806  (10,950) 4,711 
  

Reclassification adjustment of (gains) losses included in net income, net of tax

  37  (5,628) (160) (5,898)
          
  

Unrealized gains (losses) on securities, net of tax(2)

  9,694  (4,822) (11,110) (1,187)
          
 

Other comprehensive income (loss)

  163,474  (8,810) 22,522  104,557 
          

Comprehensive income

 $351,048 $60,754 $405,582 $319,392 
          

(1)
Tax amounts for all periods were not significant.

(2)
Net of $(5.6) million of tax for the three months ended and $6.3 million of tax for the six months ended June 30, 2009 and $2.7 million of tax for the three months ended and $0.7 million of tax for the six months ended June 30, 2008.

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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

6.    Strategic Transactions4. Net Income (Loss) Per Share

        The following table sets forth our computation of basic and diluted net income (loss) per common share (amounts in thousands, except per share amounts):

 
 Three Months Ended
March 31,
 
 
 2010 2009 

Net income (loss)—basic and diluted

 $(114,948)$195,486 
      

Shares used in computing net income (loss) per common share—basic

  266,251  270,854 

Effect of dilutive securities(1):

       
 

Stock options(2)

    5,553 
 

Restricted stock units

    1,138 
 

Other

    83 
      
  

Dilutive potential common shares

    6,774 
      

Shares used in computing net income (loss) per common share—diluted(1,2)

  266,251  277,628 
      

Net income (loss) per common share:

       
 

Basic

 $(0.43)$0.72 
      
 

Diluted

 $(0.43)$0.70 
      

(1)
For the three months ended March 31, 2010, basic and diluted net loss per share are the same. We account for business combinations completed prior to January 1, 2009did not include the securities described in accordance with FAS 141 and business combinations completed on or after January 1, 2009 in accordance with FAS 141R. FAS 141R modifies the criteria that must be met to qualify as a business combination and prescribes new accounting requirements that differ significantly from FAS 141. Among various other requirements and differences, the following table illustrates how we accountin the computation of diluted net loss per share because these securities would have an anti-dilutive effect due to our net loss for specific elements of our business combinations under FAS 141 and FAS 141R:the period (amounts in thousands):

Element
 Prior toThree Months Ended
January 1, 2009,
FAS 141March 31, 2010
 On or after
January 1, 2009,
FAS 141R

Transaction costsStock options

Capitalized as cost of acquisitionExpensed as incurred

Exit/Restructuring costs

Capitalized as cost of acquisition if certain criteria were met

Expensed as incurred at or subsequent to acquisition date

IPR&D

Measured at fair value and expensed on acquisition date, or capitalized as an intangible asset if certain criteria were met

Measured at fair value and capitalized as an intangible asset and tested for impairment until completion of program

  2,949

Restricted stock units

  2,534

Other

 

Amortized from date of completion over estimated useful life

Contingent consideration

247
 

Recorded at acquisition date only to the extent of negative goodwill

Measured at fair value and recorded on acquisition date

Capitalized as cost of acquisition when contingency was resolved

Re-measured in subsequent periods with an adjustment to earnings

No subsequent re-measurement

    

Negative goodwill (excessTotal shares excluded from calculation of the value of acquired assets over consideration transferred)diluted loss per share

 

5,730
 

Offset other long-lived intangibles acquired

 

Recognized as a gain in our consolidated statements of operations

Changes in deferred tax assets and valuation allowances

Recorded as adjustments to goodwill

Recorded as tax expense

Adjustments to acquisition accounting

Recorded in the current period financial statements

Recorded as adjustments to prior period financial statements

(2)
We did not include the securities described in the following table in the computation of diluted earnings (loss) per share because these securities were anti-dilutive during the corresponding period (amounts in thousands):

 
 Three Months Ended
March 31,
 
 
 2010 2009 

Shares issuable upon exercise of outstanding options

  20,648  8,650 
      

Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

6.    Strategic Transactions (Continued)

Strategic Alliance with Osiris Therapeutics, Inc.5. Comprehensive Income (Loss)

        In October 2008, we entered into a strategic alliance with Osiris Therapeutics, Inc., or Osiris, whereby we obtained an exclusive license to develop and commercialize Prochymal and Chondrogen, mesenchymal stem cell products, outsideThe components of the United States and Canada. Osiris will commercialize Prochymal and Chondrogen in the United States and Canada. We paid Osiris a nonrefundable upfront payment of $75.0 million in November 2008 and an additional $55.0 million nonrefundable upfront license fee in July 2009, both of which were recorded as charges to research and development expense in our consolidated statement of operations in the fourth quarter of 2008. The results of these programs are included under the category "Other" in our segment disclosures. The full description of our strategic alliance with Osiris is provided in Note C., "Mergers, Acquisitions and Strategic Transactions—Strategic Alliance with Osiris," to our consolidated financial statements included in Exhibit 13 to our 2008 Form 10-K.

Acquisition from Bayer

        On May 29, 2009, we completed a transaction with Bayer to:

        Prior to this transaction, we shared with Bayer the development and certain commercial rights to alemtuzumab for MS and Campath and received two-thirds of Campath net profits on U.S. sales and a royalty on foreign sales. Under our new arrangement with Bayer, prior to regulatory approval of alemtuzumab for MS, we will have primary responsibility for its development while Bayer will continue to fund that development at current levels and will participate on the development steering committee. We will have worldwide commercialization rights, with Bayer retaining an option to co-promote the product as a treatment for MS. In exchangecomprehensive income (loss) for the above, Bayer is eligible to receive the following contingent purchase price payments:


Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

6.    Strategic Transactions (Continued)

        We will utilize Bayer for certain transition services and purchase commercial supply of Fludara and Leukine from Bayer. We have employed certain members of Bayer's commercial teams for all three products and have an opportunity to employ certain members of Bayer's manufacturing team if we acquire the Leukine facility. The transaction has been accounted for as a business combination under FAS 141R and is included in our results of operations beginning on May 29, 2009, the date of acquisition. The results for Campath, Fludara and Leukine are included in our Hematologic Oncology reporting segment and the development costs of alemtuzumab for MS are included in our MS business unit, which is reported under the caption "Other." The fair value of the consideration and acquired assets at the date of acquisition consisted of the followingfollows (amounts in thousands):

Cash, net of refundable cash deposits

 $42,425 

Contingent consideration obligations

  964,100 
    
 

Total fair value of total consideration

 $1,006,525 
    

Inventory

 
$

136,400
 

Developed technology:

    
  

Fludara (to be amortized over 5 years)

  182,100 
  

Campath (to be amortized over 10 years)

  71,000 
  

Leukine (to be amortized over 12 years)

  8,272 

IPR&D—alemtuzumab for MS

  632,912 
    
 

Total fair value of assets acquired

  1,030,684 
    

Gain on acquisition of business

 $24,159 
    

        At closing, we paid a total

 
 Three Months Ended March 31, 
 
 2010 2009 

Net income (loss)

 $(114,948)$195,486 
      

Other comprehensive income (loss):

       
 

Foreign currency translation adjustments

  (125,477) (120,148)
      
 

Pension liability adjustments, net of tax(1)

  (9)  
      
 

Unrealized gains (losses) on securities, net of tax:

       
  

Unrealized gains (losses) arising during the period, net of tax

  3,638  (20,607)
  

Reclassification adjustment of gains included in net income (loss), net of tax

  (1,178) (197)
      
  

Unrealized gains (losses) on securities, net of tax(2)

  2,460  (20,804)
      
 

Other comprehensive loss

  (123,026) (140,952)
      

Comprehensive income (loss)

 $(237,974)$54,534 
      

(1)
Tax amounts for all periods were not significant.

(2)
Net of $117.1$(1.4) million to Bayer, of which $74.6 million is refundable and a majority of which was received in July 2009. The remaining non-refundable amount of $42.4 million represents a payment for acquired inventory. The contingent consideration obligations are net of the continued funding expected to be received from Bayertax for the developmentthree months ended March 31, 2010 and $11.9 million of alemtuzumabtax for MS. We determined the fair value of the contingent consideration obligations based on a probability-weighted income approach derived from revenue estimates and probability assessment with respect to regulatory approval of alemtuzumab for MS. The fair value measurement is based on significant inputs not observable in the market and thus represents a Level 3 measurement as defined in FAS 157. The resultant probability-weighted cash flows were then discounted using discount rates of 11% for Campath, Fludara and Leukine and 13% for alemtuzumab for MS.

        Of the $964.1 million total contingent consideration obligations recorded as of the acquisition date, $529.1 million related to Campath, Fludara and Leukine, and $435.0 million related to alemtuzumab for MS. Each period we revalue the contingent consideration obligations to their then fair value and record increases in the fair value as contingent consideration expense and decreases in the fair value as a reduction of contingent consideration expense. Increases or decreases in the fair value of the contingent consideration obligations can result from changes in discount periods and rates, changes in the timing and amount of revenue estimates and changes in probability adjustments with respect to regulatory approval of alemtuzumab for MS. As of June 30, 2009, the fair value of the contingent consideration obligations was $973.2 million. Accordingly, we recorded contingent consideration


three months ended March 31, 2009.

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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

6. Strategic Transactions (Continued)


expense of $9.1 million in our consolidated statements of operations for the three and six months ended June 30, 2009. As of June 30, 2009, we have not made any contingent consideration payments to, or received any research and development funding from, Bayer or adjusted any of the assumptions used in determining the fair value of the contingent consideration obligations.

        At the date of acquisition, alemtuzumab for MS had not reached technological feasibility nor had an alternative future use and is therefore considered to be IPR&D. In accordance with FAS 141R, we recorded the fair value of the purchase price attributable to IPR&D as an indefinite-lived intangible asset. We will test the asset annually for impairment, or earlier if conditions warrant. Amortization of this asset will begin upon regulatory approval based on the then estimated useful life of the asset.

        The fair value assigned to purchased IPR&D was estimated by discounting, to present value, the cash flows expected to result from the project once it has reached technological feasibility. We used a discount rate of 16% and cash flows that have been probability-adjusted to reflect the risks of advancement through the product approval process, which we believe are appropriate and representative of market participant assumptions. In estimating future cash flows, we also considered other tangible and intangible assets required for successful exploitation of the technology resulting from the purchased IPR&D project and adjusted future cash flows for a charge reflecting the contribution to value these assets.

        The fair value of the identifiable assets acquired in this transaction of $1.03 billion exceeded the fair value of the purchase price of $1.01 billion. As a result, in accordance with FAS 141R, we recognized a gain on acquisition of business of $24.2 million in our consolidated statements of operations for the three and six months ended June 30, 2009. The fair value of the consideration and assets remain subject to potential adjustments.

        SG&A in our consolidated statements of operations for the three and six months ended June 30, 2009 includes $4.0 million of acquisition-related costs, primarily legal fees, associated with the Bayer transaction.

Purchase of Intellectual Property from EXACT Sciences Corporation

        On January 27, 2009, we purchased certain intellectual property in the fields of prenatal testing and reproductive health from EXACT Sciences Corporation, or EXACT Sciences, for our diagnostic testing servicesgenetics business unit and 3,000,000 shares of EXACT Sciences common stock. We paid EXACT Sciences total cash consideration of $22.7 million.million at that time. Of this amount, we allocated $4.5 million to the acquired shares of EXACT Sciences common stock based on the fair value of the stock on the date of acquisition, which we recorded as an increase to investments in equity securities in our consolidated balance sheet as of March 31, 2009. As the purchased assets did not qualify as a business combination under FAS 141R and have not reached technological feasibility nor have alternative future use, we allocated the remaining $18.2 million to the acquired intellectual property, which we recorded as a charge to research and development expenses in our consolidated statementstatements of operations forin March 2009. Additional amounts we paid during the three months ended March 31, 2009. Wefirst quarter of 2010 and will pay in the future to EXACT Sciences an additional $1.9 million by July 2010, unless such amount is required to satisfy certain of EXACT Sciences' indemnification obligations.

Purchase of In-Process Research and Development

        Prior to January 1, 2009, IPR&D acquired through a business combination was expensed on the acquisition date in our consolidated financial statements. In accordance with our adoption ofunder this agreement are not significant.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

6. Strategic Transactions (Continued)


FAS 141R, all IPR&D we acquire through business combinations on or after January 1, 2009 will be capitalized as an intangible asset on our consolidated balance sheetsPurchase of In-Process Research and periodically tested for impairment.Development

        The following table sets forth the significant in-process research and development, or IPR&D, projects for the companies and assets we acquired between January 1, 2006 and June 30, 2009March 31, 2010 (amounts in millions):

Company/Assets Acquired
 Purchase
Price
 IPR&D Programs Acquired Discount
Rate
Used in
Estimating
Cash Flows
 Year of
Expected
Launch
 

Bayer (2009)

 $1,006.5 $415.6 alemtuzumab for MS—US  16% 2012 

     217.3 alemtuzumab for MS—ex-US  16% 2013 
               

    $632.9(1)        
               

Bioenvision (2007)

 $349.9 $125.5(2)Clolar/Evoltra (clofarabine)(3)  17% 2009-2013 
               

AnorMED (2006)

 $589.2 $526.8 Mozobil (stem cell transplant)(4)  15% 2009-2014 

     26.1 AMD070(5)  15%  
               

    $552.9(2)        
               

Company/Assets Acquired
 Purchase
Price
 IPR&D Programs Acquired Discount Rate
Used in
Estimating
Cash Flows
 Year of
Expected
Launch
 

Bayer (2009)

 $1,006.5 $458.7 alemtuzumab for MS—US  16% 2012 

     174.2 alemtuzumab for MS—ex-US  16% 2013 
               

    $632.9(1)        
               

Bioenvision, Inc., or Bioenvision (2007)

 $349.9 $125.5(2)Clolar(3)  17% 2010-2016(4)
               

AnorMED Inc., or AnorMED (2006)

 $589.2 $526.8(2)Mozobil(5)  15% 2016 
               

(1)
Capitalized as an indefinite-lived intangible asset in accordance with FAS 141R.asset.

(2)
Expensed on acquisition date in accordance with FAS 141.date.

(3)
Clofarabine, whichClolar is approved for the treatment of relapsed and refractory pediatric acute lymphoblastic leukemia, or ALL, is marketed under the names Clolar and Evoltra.ALL. The IPR&D projects for clofarabineClolar are related to the development of the product for the treatment of other medical issues.

(4)
Year of expected launch reflects both the ongoing launch of products for currently approved indications and the anticipated launch of the products in the future for new indications.

(5)
Mozobil received marketing approval for use in stem cell transplants in the United States in December 2008 and in Europe in July 2009. Mozobil is also being developed for chemosensitization.

(5)
Year of expected launch is not provided for AMD070 at this time because we are assessing our future plans for this program.tumor sensitization.

Pro Forma Financial Summary (Unaudited)

        The following pro forma financial summary is presented as if the acquisition from Bayer was completed as of January 1, 2009 and 2008.2009. The pro forma combined results are not necessarily indicative of the actual results that would have occurred had the acquisition been consummated on that date, or of the future operations of the combined entities. Material nonrecurring charges related to this acquisition, such as a gain on acquisition of business of $24.2 million, are included in the pro forma financial summaries for the period presented (amounts in thousands, except per share amounts):

 
 Three Months Ended
March 31, 2009
 

Total revenues

 $1,197,060 
    

Net income

 $175,262 
    

Net income per share:

    
 

Basic

 $0.65 
    
 

Diluted

 $0.63 
    

Weighted average shares outstanding:

    
 

Basic

  270,854 
    
 

Diluted

  277,628 
    

Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

6.    Strategic Transactions (Continued)


financial summaries for the three and six months ended June 30, 2009 and 2008 (amounts in thousands, except per share amounts):

 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
 
 2009 2008 2009 2008 

Total revenues

 $1,280,470 $1,239,487 $2,477,530 $2,409,448 
          

Net income

 $158,488 $25,295 $307,138 $139,305 
          

Net income per share:

             
 

Basic

 $0.59 $0.09 $1.14 $0.52 
          
 

Diluted

 $0.58 $0.09 $1.11 $0.50 
          

Weighted average shares outstanding:

             
 

Basic

  269,958  266,904  270,406  267,127 
          
 

Diluted

  274,852  274,576  276,225  285,028 
          

7. Inventories

 
 June 30,
2009
 December 31,
2008
 
 
 (Amounts in thousands)
 

Raw materials

 $109,211 $96,986 

Work-in-process

  256,870  141,094 

Finished goods

  220,605  215,357 
      
 

Total

 $586,686 $453,437 
      

 
 March 31,
2010
 December 31,
2009
 
 
 (Amounts in thousands)
 

Raw materials

 $113,567 $123,434 

Work-in-process

  298,235  288,653 

Finished goods

  196,840  195,935 
      
 

Total

 $608,642 $608,022 
      

        In May 2009,order to build a small inventory buffer to help us more consistently manage the resupply of Cerezyme to patients in connection with our acquisition ofapproximately 100 countries and reduce interruptions in shipping that occur in the worldwide rights to the oncology products Campath, Fludara and Leukine from Bayer, we acquired a total of $136.4 millionabsence of inventory, including $15.3 millionwe began shipping 50% of CampathCerezyme demand at the end of February 2010. Although we achieved our goal of building a small inventory $22.9 millionbuffer for Cerezyme during the first quarter of Fludara inventory and $98.2 million of Leukine inventory.

        In June 2009,2010, we announced in April 2010 that the 50% shipping allocation will be extended due to an interruption in operations at our Allston facility at the end of March 2010. The interruption resulted from an unexpected city electrical power failure that compounded issues with the plant's water system. The issues have been corrected and the facility is operational. We estimate that we had interrupted productionwill need to continue the 50% shipping allocation for two to three months. We are currently assessing whether approximately $7 million in the aggregate of Cerezyme and Fabrazyme work-in-process material, the majority of which is Cerezyme, that was unfinished when the interruption occurred can be finished and shipments ofexpect to complete our assessment over the next month. If we determine that this Cerezyme at our Allston facilityand/or Fabrazyme material cannot be finished, we will have to sanitize the facility after identifyingwrite off that inventory as a virus, Vesivirus 2117, in a bioreactor used for Cerezyme production. We recorded charges totaling $14.2 millioncharge to cost of products sold in our consolidated statements of operations in the second quarter of 2010.

        We capitalize inventory produced for commercial sale, which may result in the three and six months ended June 30, 2009capitalization of inventory prior to regulatory approval of a product. If a product is not approved for the initial costs related to the remediation of this facility, including the sanitization of the facility, idle capacity and overhead expenses while production at the plant was suspended andsale, it would result in the write off of certain production materials.

        When we suspended production at Allston, we had significant Cerezyme work-in-process material.the inventory and a charge to earnings. We have decided notbeen working to increase the productivity of the Fabrazyme manufacturing process, approximately 80% of this work-in-process material becausewhich has performed at the material either had expired or we were not sufficiently assured that the material was not contaminated with Vesivirus 2117 and, accordingly, have incurred a write off of $8.4 million for the second quarter of 2009. At thelow end of the business day on Friday, August 7,historical range since the re-start of production, and have developed a new working cell bank for Fabrazyme that is in its second run. Regulatory approval of the new working cell bank is required. As of March 31, 2010, the amount of inventory for Fabrazyme related to the new working cell bank that has not yet been approved for sale was not significant.

Manufacturing-Related Charges

        We manufacture the majority of our supply requirements for sevelamer hydrochloride (the active ingredient in Renagel) and sevelamer carbonate (the active ingredient in Renvela) at our manufacturing facility in Haverhill, England. In December 2009, equipment failure caused an explosion and fire at this facility, which damaged some of the FDA communicatedequipment used to us steps it recommendsproduce these active ingredients as well as the building in which the equipment was located. As a result, we take priorhave temporarily suspended production of sevelamer hydrochloride and sevelamer carbonate at this facility while repairs are made. We resumed production of sevelamer hydrochloride in May 2010. We anticipate that the facility will resume production of sevelamer carbonate in the fourth quarter of 2010. We believe that we have adequate supply levels to forward processingmeet the current demand for both Renagel and Renvela and do not anticipate there will be any Cerezyme work-in-process. The stepssupply constraints for either product while the facility undergoes repairs. During the first quarter of 2010, we recorded a total of $7.5 million of expenses, net of $3.0 million of insurance reimbursements, to cost of products sold in our consolidated statements of operations for


Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

7. Inventories (Continued)


recommended byRenagel and Renvela related to the FDA were consistent with the steps that we independently had planned to implement. The remaining Cerezyme work-in-process material expires in June 2010. If we decide not to process this remaining material or if we process the material and the FDA or another regulatory authority does not allow us to release it, we will incur a write offremediation cost of approximately $2.7 million for the inventory value of this remaining material. In addition, we have two lots of finished Cerezyme product in inventory. If the FDA or another regulatory authority does not allow us to release both of these finished lots, we will incur an additional write off of $3.1 million.

        We capitalize inventory produced for commercial sale, which may result in the capitalization of inventory prior to regulatory approval. If a product is not approved for sale, it would result in the write off of the inventory and a charge to earnings. Our total inventories at June 30, 2009 included $3.6 million of Campath inventory, produced at our Haverhill, England manufacturing facility, in Belgium that has not yet been approved for sale because the facility has not yet received approval to manufacture Campath.including repairs and idle capacity expenses.

8. Goodwill and Other Intangible Assets

Goodwill

        The following table contains the change in our goodwill during the sixthree months ended June 30, 2009March 31, 2010 (amounts in thousands):

 
 As of
December 31,
2008
 Adjustments As of
June 30,
2009
 

Genetic Diseases

 $339,563 $ $339,563 

Cardiometabolic and Renal

  319,882    319,882 

Biosurgery

  7,585    7,585 

Hematologic Oncology

  322,078    322,078 

Other

  411,966  999  412,965 
        

Goodwill

 $1,401,074 $999 $1,402,073 
        

 
 Personalized
Genetic
Health
 Renal and
Endocrinology
 Biosurgery Hematology
and
Oncology
 Multiple
Sclerosis
 Other Total 

Goodwill

 $339,563 $319,882 $110,376 $375,889 $318,059 $261,631 $1,725,400 

Accumulated impairment losses(1)

      (102,792)     (219,245) (322,037)
                

Balance as of December 31, 2009

  339,563  319,882  7,584  375,889  318,059  42,386  1,403,363 

Net exchange differences arising during the period

            494  494 

Other changes in carrying amounts during the period

            296  296 
                

Balance as of March 31, 2010

 $339,563 $319,882 $7,584 $375,889 $318,059 $43,176 $1,404,153 
                

Goodwill

 
$

339,563
 
$

319,882
 
$

110,376
 
$

375,889
 
$

318,059
 
$

262,421
 
$

1,726,190
 

Accumulated impairment losses(1)

      (102,792)     (219,245) (322,037)
                

Balance as of March 31, 2010

 $339,563 $319,882 $7,584 $375,889 $318,059 $43,176 $1,404,153 
                

(1)
Accumulated impairment losses include:

Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

8. Goodwill and Other Intangible Assets (Continued)

Other Intangible Assets

        The following table contains information about our other intangible assets for the periods presented (amounts in thousands):

 
 As of June 30, 2009 As of December 31, 2008 
 
 Gross
Other
Intangible
Assets
 Accumulated
Amortization
 Net
Other
Intangible
Assets
 Gross
Other
Intangible
Assets
 Accumulated
Amortization
 Net
Other
Intangible
Assets
 

Finite-lived other intangible assets:

                   
 

Technology(1)

 $2,180,455 $(774,865)$1,405,590 $1,919,074 $(692,235)$1,226,839 
 

Distribution rights(2)

  416,968  (198,730) 218,238  399,768  (170,892) 228,876 
 

Patents

  188,651  (124,156) 64,495  194,560  (121,763) 72,797 
 

License fees

  98,660  (43,517) 55,143  98,123  (39,824) 58,299 
 

Customer lists

  84,843  (38,767) 46,076  83,729  (34,271) 49,458 
 

Trademarks

  60,573  (44,903) 15,670  60,556  (42,194) 18,362 
 

Other

        2,039  (1,972) 67 
              
 

Total finite-lived other intangible assets

  3,030,150  (1,224,938) 1,805,212  2,757,849  (1,103,151) 1,654,698 

Indefinite-lived other intangible assets:

                   
 

IPR&D(3)

  632,912    632,912       
              
 

Total other intangible assets

 $3,663,062 $(1,224,938)$2,438,124 $2,757,849 $(1,103,151)$1,654,698 
              

 
 As of March 31, 2010 As of December 31, 2009 
 
 Gross
Other
Intangible
Assets
 Accumulated
Amortization
 Net
Other
Intangible
Assets
 Gross
Other
Intangible
Assets
 Accumulated
Amortization
 Net
Other
Intangible
Assets
 

Finite-lived other intangible assets:

                   
 

Technology(1)

 $1,939,700 $(896,937)$1,042,763 $2,180,232 $(877,611)$1,302,621 
 

Distribution rights(2)

  446,374  (246,832) 199,542  440,521  (227,726) 212,795 
 

Patents

  188,652  (135,209) 53,443  188,651  (131,898) 56,753 
 

License fees

  98,586  (48,576) 50,010  98,647  (47,052) 51,595 
 

Customer lists

  88,448  (46,306) 42,142  87,423  (43,822) 43,601 
 

Trademarks

  60,621  (48,984) 11,637  60,608  (47,623) 12,985 
              
 

Total finite-lived other intangible assets

  2,822,381  (1,422,844) 1,399,537  3,056,082  (1,375,732) 1,680,350 

Indefinite-lived other intangible assets:

                   
 

IPR&D

  632,912    632,912  632,912    632,912 
              
 

Total other intangible assets

 $3,455,293 $(1,422,844)$2,032,449 $3,688,994 $(1,375,732)$2,313,262 
              

(1)
Includes an additional $261.4 million ofFor the year ended December 31, 2009, includes a gross technology intangible assets resulting fromasset of $240.3 million and related accumulated amortization of $(24.0) million related to our acquisitionconsolidation of the worldwide rights toresults of BioMarin/Genzyme LLC. Effective January 1, 2010, under new guidance we adopted for consolidating variable interest entities, we no longer consolidate the oncology products Campath, Fludararesults of this joint venture and Leukine from Bayerno longer include this gross technology asset and the related accumulated amortization or a related other noncurrent liability in May 2009. Of this amount:our consolidated balance sheets.

$71.0 million is related to Campath and will be amortized over ten years;

$182.1 million is related to Fludara and will be amortized over five years; and

$8.3 million is related to Leukine and will be amortized over twelve years.

(2)
Includes an additional $18.3$5.9 million infor the first half of 2009three months ended March 31, 2010 for additional payments made or accrued in connection with the reacquisition of the Synvisc sales and marketing rights from Wyeth in January 2005. In addition, we will make a seriesAs of additionalMarch 31, 2010, the contingent royalty payments to Wyeth based onpayable under the volume of Synvisc sales inagreement are substantially complete. We completed the covered territories. These contingent royalty payments could extend out to June 2012, or could total a maximumWyeth related to North American sales of $293.7 million, whichever comes first. To date, $263.9 millionSynvisc in the first quarter of 2010 and anticipate completing the remaining contingent royalty payments to Wyeth related to sales of the $293.7 million has been paid.

(3)
Includes capitalized IPR&D totaling $632.9 million related to our acquisition of the worldwide rights to alemtuzumab for MS from Bayer in May 2009, including $415.6 million related to the development of the product for sale in the United States and $217.3 million for the development of the product for sale outside of the United States.States by the end of 2010, the amount of which is not significant.

        All of our finite-lived other intangible assets are amortized over their estimated useful lives.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

8. Goodwill and Other Intangible Assets (Continued)

        All of our finite-lived other intangible assets are amortized over their estimated useful lives.

As of June 30, 2009,March 31, 2010, the estimated future amortization expense for our finite-lived other intangible assets for the remainder of fiscal year 2009,2010, the four succeeding fiscal years and thereafter is as follows (amounts in thousands):

Year Ended December 31,
 Estimated
Amortization
Expense(1,2)
 

2009 (remaining six months)

 $152,274 

2010

  320,412 

2011

  299,923 

2012

  226,557 

2013

  147,463 

Thereafter

  492,286 

Year Ended December 31,
 Estimated
Revenue-
Based
Amortization
Expense(1)
 Estimated
Other
Amortization
Expense
 Total
Estimated
Amortization
Expense(1)
 

2010 (remaining nine months)

 $82,704 $137,218 $219,922 

2011

  119,184  175,081  294,265 

2012

  87,705  148,272  235,977 

2013

  28,970  131,432  160,402 

2014

  23,696  109,116  132,812 

Thereafter

  19,992  352,984  372,976 

(1)
Includes estimated future amortization expense for:

the Synvisc distribution rights based on the forecasted respective future sales of Synvisc and the resulting future contingent payments we may be required to make to Wyeth and the Myozyme patent and technology rights pursuant to a license agreement with Synpac based on forecasted future sales of Myozyme and the milestone payments we may be required to make to Synpac. These contingent payments will be recorded as intangible assets when the payments are accrued; and

other arrangements involving contingent payments.

(2)
Excludes future amortization expense related to:the technology intangible assets resulting from our acquisition of the worldwide rights to the oncology products Campath, Leukine and Fludara, of which:

the $240.2 million of technology recorded effective January 1, 2008assets related to our consolidation of the results of BioMarin/Genzyme LLC, because such amortization is entirely offset by the corresponding amortization ofCampath and Leukine are being amortized on a noncurrent liability related to the consolidation of BioMarin/Genzyme LLC;straight-line basis; and

the $632.9 million of indefinite-lived IPR&Dasset related to alemtuzumab for MS, as described above.Fludara is being amortized based on the forecasted future sales of Fludara.

9. InvestmentsInvestment in Equity SecuritiesBioMarin/Genzyme LLC

        In the second quarter of 2008, we recorded a $10.3 million gain resulting from the liquidation of our investment in the common stock of Sirtris Pharmaceuticals,We and BioMarin Pharmaceutical Inc., or Sirtris, for net cash proceedsBioMarin, have entered into agreements to develop and commercialize Aldurazyme, a recombinant form of $14.8 million.

        At June 30, 2009, our stockholders' equity includes $11.7 million of unrealized gains and $7.4 million of unrealized lossesthe human enzyme alpha-L-iduronidase, used to treat an LSD known as mucopolysaccharidosis, or MPS, I. Under the relationship, an entity we formed with BioMarin in 1998 called BioMarin/Genzyme LLC has licensed all intellectual property related to Aldurazyme and other collaboration products on a royalty-free basis to BioMarin and us. BioMarin holds the manufacturing rights and we hold the global marketing rights. We are required to pay BioMarin a tiered royalty payment ranging from 39.5% to 50% of worldwide net product sales of Aldurazyme.

        Prior to January 1, 2010, we determined that we were the primary beneficiary of BioMarin/Genzyme LLC and, as a result, we:


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

9. Investment in BioMarin/Genzyme LLC (Continued)

        Effective January 1, 2010, in accordance with new guidance we adopted for consolidating variable interest entities, we were required to reassess our designation as primary beneficiary of BioMarin/Genzyme LLC. Under the new guidance, the entity with the power to direct the activities that most significantly impact a variable interest entity's economic performance is the primary beneficiary. We have concluded that BioMarin/Genzyme LLC is a variable interest entity, but does not have a primary beneficiary because the power to direct the activities of BioMarin/Genzyme LLC that most significantly impact its performance, is, in fact, shared equally between us and BioMarin through our commercialization rights and BioMarin's manufacturing rights. Effective January 1, 2010, we no longer consolidate the results of BioMarin/Genzyme LLC and instead record our portion of the results of BioMarin/Genzyme LLC in equity in loss of equity method investments in our consolidated statements of operations. For the three months ended March 31, 2010, the results of BioMarin/Genzyme LLC and our portion of the results of BioMarin/Genzyme LLC were not significant.

10. Revolving Credit FacilityInvestment in Isis Pharmaceuticals, Inc. Common Stock

        As of June 30,March 31, 2010, our investment in Isis common stock had a carrying value of $80.1 million, or $16.02 per share, and a fair market value of $54.7 million, or $10.93 per share. The closing price per share of Isis common stock exhibited volatility during 2009 and the three months ended March 31, 2010 and has remained below our historical cost since September 1, 2009, with closing prices subsequent to that date ranging from a high of $15.69 per share to a low of $8.66 per share. We considered all available evidence in assessing the decline in value of our investment in Isis common stock, including investment analyst reports and Isis's expected results and future outlook, none of which suggests that the decline would be "other than temporary." Currently, the average 12-month price estimate for Isis common stock among some analysts is approximately $16 per share. As a result of our analysis, as of March 31, 2010, we had approximately $12consider the $25.5 million unrealized loss on our investment in Isis common stock to be temporary. We will continue to review the fair value of outstanding standby lettersour investment in Isis common stock in comparison to our historical cost and in the future, if the decline in value has become "other than temporary," we will write down our investment in Isis common stock to its then current market value and record an impairment charge to our consolidated statements of credit and no borrowings, resulting in approximately $338 million of available credit under our five-year $350.0 million senior unsecured revolving credit facility, which matures July 14, 2011. The terms of this credit facility include various covenants, including financial covenants that require us to meet minimum interest coverage ratios and maximum leverage ratios. As of June 30, 2009, we were in compliance with these covenants.operations.

11. Stockholders' Equity

Stock RepurchaseLong-Term Incentive Program for Senior Executives

        From 2007 through 2009, our long-term incentive program for senior executives was comprised of equity awards in the form of time vesting stock options and time vesting RSUs. Beginning with 2010, the equity vehicles for our long-term incentive program for senior executives includes a combination of:

Approximately half of each senior executive's grant consists of time vesting stock options with the remainder in PSUs.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

11. Stockholders' Equity (Continued)

        For the 2010 through 2012 performance period, the performance metrics are:

        Each metric is weighted equally. For both metrics, performance between the threshold level and the target level will be awarded in PSUs. The PSUs will be paid out in shares of our stock at the end of the three-year period if performance between the threshold level and target level is achieved. If performance above the target level is achieved, the portion of the award above the target level will be paid out in cash up to a predetermined maximum cash award. Since it is possible that the PSUs may not pay out at all, it is completely "at risk" compensation.

In May 2007,January 2010, the compensation committee of our board of directors authorizedapproved a stock repurchase programrange for the three-year cash flow return on invested capital metric of 85% to repurchase115%. For performance between 85% and 100% of the cash flow return on invested capital target, the payout range is 50% to 100% of the senior executive's target PSU award associated with this performance measure. Performance between 101% and 115% of the cash flow return on invested capital target will result in a cash payment that will be awarded based on performance achieved between target and maximum levels, up to an aggregatea predetermined maximum.

        The committee also approved the following performance levels for R-TSR:

Performance Level
Percentile Rank

Threshold

40th

Target

65th

Maximum

75th

        For performance between the R-TSR threshold and target levels, the payout range is 35% to 100% of the senior executive's target PSU award associated with this performance measure. R-TSR performance between the target and maximum amountlevels will result in a cash payment that will be awarded based on performance achieved between target and maximum levels, up to a predetermined maximum.

        If a participating senior executive's employment is terminated before the end of $1.50 billionthe performance period because of death, disability or 20,000,000 sharesretirement, payment of the PSU will be pro-rated to the date of termination based upon the company's actual achievement of performance levels at the end of the performance period. Upon a change in control, payment of a PSU will be paid out at the target performance level and pro-rated to the date of the change of control.

PSUs

        During February and March 2010, we granted a total of 214,386 PSUs with a weighted average grant date fair value of $50.10 per share to senior executives under our outstanding common stock over a three year period that began in June 2007.2004 Equity Plan. The repurchasesPSUs are being made from time to time and can be effectuated through open market purchases, privately negotiated transactions, transactions structured through investment banking institutions, or by other means, subject to management's discretion and as permitted by securities laws and other legal requirements. The mannerthe attainment of certain performance criteria established at the beginning of the purchase,performance period, as described above, and cliff vest at the amount that we spend andend of the performance period, which ends December 31, 2012. Compensation expense associated with our PSUs is initially based upon the number of shares we ultimately purchaseexpected to vest after assessing the probability that certain performance criteria will be met and the associated targeted payout level that is forecasted will be achieved, net of estimated


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

11. Stockholders' Equity (Continued)


forfeitures. Compensation expense for our PSUs is recognized over the applicable performance period, adjusted for the effect of estimated forfeitures.

        The fair value of PSUs subject to the cash flow return on investment performance metric, which includes both performance and service conditions, is estimated based on a range of factors, including share price. The program does not obligate us to acquire any particular amount of common stock and the program may be suspended at any time at our discretion.

        During the six months ended June 30, 2009, we repurchased 2,000,000 sharesmarket value of our common stock under this program at an average priceon the date of $53.55 per share forgrant. We use a totallattice model with a Monte Carlo simulation to determine the fair value of $107.1 million in cash, including fees. Since June 2007, when we first began repurchasing shares of our common stock under this program, we have repurchased a cumulative total of 7,500,000 shares of our common stock at an average price of $64.21 per share for a total of $481.7 million in cash, including fees. We recordedPSUs subject to the repurchases in our consolidated balance sheets as a reductionR-TSR performance metric, which includes both market and service conditions. The lattice model requires various highly judgmental assumptions to our common stock account fordetermine the parfair value of the repurchased sharesawards. This model samples paths of our stock price and the stock prices of a group of peer companies in the S&P 500 Health Care Index, which we refer to as the Peer Group, and calculates the resulting change in cash flow multiple at the end of the forecasted performance period. This model iterates these randomly forecasted results until the distribution of results converge on a reductionmean or estimated fair value.

        We used the following assumptions to our additional paid-in capital account.determine the fair value of these awards:


For the Three Months Ended
March 31, 2010

Expected dividend yield

0%

Range of risk free rate of return

1.33%-1.45%

Range of our expected stock price volatility

35.11%-36.06%

Range of Peer Group expected stock price volatility

21.27%-60.32%

Range of our average closing stock prices on the grant dates

$51.83-$56.50    

Range of Peer Group average closing stock prices on the grant dates

$7.22-$348.13    

Range of our historical total shareholder return on the grant dates

5.75%-15.28%

Range of historical total shareholder return for the Peer Group on the grant dates

(19.78)%-23.22%

Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

11. Stockholders' Equity (Continued)

Stock-Based Compensation Expense, Net of Estimated Forfeitures

        We allocated pre-tax stock-based compensation expense, net of estimated forfeitures, based on the functional cost center of each employee as follows (amounts in thousands, except per share amounts):

 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
 
 2009 2008 2009 2008 

Pre-tax stock-based compensation expense, net of estimated forfeitures, charged to:

             
 

Cost of products and services sold(1)

 $(7,570)$(6,311)$(14,804)$(12,825)
 

Selling, general and administrative expense

  (37,817) (31,904) (61,653) (54,793)
 

Research and development expense

  (19,780) (16,092) (33,316) (28,677)
          
  

Total

  (65,167) (54,307) (109,773) (96,295)

Less: tax benefit from stock options

  15,144  16,834  27,733  29,371 
          
  

Total stock-based compensation expense, net of tax

 $(50,023)$(37,473)$(82,040)$(66,924)
          

Effect per common share:

             
 

Basic

 $(0.19)$(0.14)$(0.30)$(0.26)
          
 

Diluted

 $(0.18)$(0.13)$(0.30)$(0.23)
          

 
 Three Months Ended
March 31,
 
 
 2010 2009 

Pre-tax stock-based compensation, net of estimated forfeitures

 $(47,641)$(44,606)

Less: tax benefit from stock options

  13,072  12,589 
      
 

Total stock-based compensation expense, net of tax

 $(34,569)$(32,017)
      

Effect per common share:

       
 

Basic and Diluted

 $(0.13)$(0.12)
      

(1)
We also capitalized the following amounts of stock-based compensation expense to inventory, all of which is attributable to participating employees that support our manufacturing operations (amounts in thousands):
  
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
  
 2009 2008 2009 2008 
 

Stock-based compensation expense capitalized to inventory

 $5,729 $3,875 $9,141 $6,996 

 
 Three Months Ended
March 31,
 
 
 2010 2009 

Stock-based compensation expense capitalized to inventory

 $3,802 $3,412 

        We amortize stock-based compensation expense capitalized to inventory based on inventory turns.

At June 30, 2009,March 31, 2010, there was $320.4$209.5 million of pre-tax stock-based compensation expense, net of estimated forfeitures, related to unvested awards not yet recognized which is expected to be recognized over a weighted average period of 2.31.6 years.

12. Commitments and Contingencies

Pending FDA Consent Decree

        In March 2010, the FDA notified us that it intended to take enforcement action to ensure that products manufactured at our Allston facility are made in compliance with good manufacturing practice, or GMP, regulations. We have received a draft consent decree from the FDA that provides for a potential up-front disgorgement of past profits of $175.0 million, which we have recorded as a charge to SG&A in our consolidated statements of operations for the first quarter of 2010 and as an increase to accrued expenses on our consolidated balance sheet as of March 31, 2010. We recorded this charge during the first quarter of 2010 because it is probable that we will have to pay this amount to the FDA and we can reasonably estimate the amount that will be paid. In addition, if the fill-finish operations at our Allston facility are still operating after deadlines for domestic and exported products, the draft provides for disgorgement of 18.5% of revenues from sales of products manufactured and distributed from our Allston facility after those deadlines. We and the FDA are having discussions regarding appropriate deadlines for moving fill-finish operations, as well as the details of the disgorgement provisions. Finally, if fill-finish operations are moved from our Allston facility but certain remediation


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

12. Commitments and Contingencies (Continued)


actions relating to overall GMP compliance are not met by deadlines over the coming years in a remediation plan to be approved by the FDA, the draft provides for payment of $15,000 per day per violation until the compliance milestones are met.

        We expect that the FDA will allow us to continue to ship our Cerezyme, Fabrazyme and Myozyme products that are produced or fill-finished at our Allston facility because the FDA has determined that these products meet the definition of "medical necessity" that would justify continued production of these products at Allston during the enforcement period. The FDA, however, has made a preliminary determination that Thyrogen, which is fill-finished at our Allston facility, does not meet the FDA's definition and may require us to cease fill-finishing the product at Allston when we enter into the consent decree. We are actively negotiating with the FDA the terms of the consent decree and presenting our view that there is also patient need for uninterrupted supply of Thyrogen. We expect that the negotiations will be completed during the second quarter of 2010.

Legal Proceedings

        OnFederal Securities Litigation

        In July 29, 2009 and August 3, 2009, two purported securities class action lawsuits were filed in the U.S. District Court for the District of Massachusetts against us and our President and Chief Executive Officer. The lawsuits were filed on behalf of those who purchased our common stock during the period from June 26, 2008 through July 21, 2009 and allege violations of Section 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. Each of the suitslawsuits is premised upon allegations that we made materially false and misleading statements and omissions by


Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

12.    Commitments and Contingencies (Continued)


failing to disclose instances of viral contamination at two of our manufacturing facilities and our receipt of a list of inspection observations from the FDA related to one of the facilities, which detailed observations of practices that the FDA considered to be deviations from "Good Manufacturing Practices," or GMP. The plaintiffs seek unspecified damages and reimbursement of costs, including attorneys' and experts' fees. In November 2009, the lawsuits were consolidated inIn Re Genzyme Corp. Securities Litigation and a lead plaintiff was appointed. In March 2010, the plaintiffs filed a consolidated amended complaint that extended the class period from October 24, 2007 through November 13, 2009. We intend to defend this lawsuit vigorously.

Shareholder Demand Letters

        Since August 2009, we have received nine letters from shareholders demanding that our board of directors take action on behalf of Genzyme Corporation to remedy alleged breaches of fiduciary duty by our directors and certain executive officers. The demand letters are primarily premised on allegations regarding our disclosures to shareholders with respect to manufacturing issues and compliance with GMP and our processes and decisions related to manufacturing at our Allston facility. Several of the letters also assert that certain of our executive officers and directors took advantage of their knowledge of material non-public information about Genzyme to illegally sell stock they personally held in Genzyme. Our board of directors has designated a special committee of three independent directors to oversee the investigation of the allegations made in the demand letters and to recommend to the independent directors of the board whether any action should be instituted on behalf of Genzyme Corporation against any officer or director. The committee has retained independent legal counsel. If the independent members of our board of directors were to make a


Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

12. Commitments and Contingencies (Continued)


determination that it was in our best interest to institute an action against any officers or directors, any monetary recovery would be to the benefit of Genzyme Corporation. The special committee's investigation is ongoing.

Shareholder Derivative Actions

        In December 2009, two actions were filed by shareholders derivatively for Genzyme's benefit in the U.S. District Court for the District of Massachusetts against our board of directors and certain of our executive officers after a ninety day period following their respective demand letters had elapsed (the "District Court Actions"). In January 2010, a derivative action was filed in Massachusetts Superior Court (Middlesex County) by a shareholder who has not issued a demand letter and in February and March 2010, two additional derivative actions were filed in Massachusetts Superior Court (Suffolk County and Middlesex County, respectively) by two separate shareholders after the lapse of a ninety day period following the shareholders' respective demand letters (collectively, the "State Court Actions").

        The derivative actions in general are based on allegations that our board of directors and certain executive officers breached their fiduciary duties by causing Genzyme to make purportedly false and misleading or inadequate disclosures of information regarding manufacturing issues, compliance with GMP, ability to meet product demand, expected revenue growth, and approval of Lumizyme. The actions also allege that certain of our directors and executive officers took advantage of their knowledge of material non-public information about Genzyme to illegally sell stock they personally held in Genzyme. The plaintiffs generally seek, among other things, judgment in favor of Genzyme for the amount of damages sustained by Genzyme as a result of the alleged breaches of fiduciary duty, disgorgement to Genzyme of proceeds that certain of our directors and executive officers received from sales of Genzyme stock and all proceeds derived from their service as directors or executives of Genzyme, and reimbursement of plaintiffs' costs, including attorneys' and experts' fees. The District Court Actions have been consolidated inIn Re Genzyme Derivative Litigation and the plaintiffs have agreed to a joint stipulation staying these cases until our board of directors has had sufficient time to exercise its duties and complete an appropriate investigation, which is ongoing. In the State Court Actions, the parties are working to consolidate all three lawsuits. We intend to defend these lawsuits vigorously.

Fabrazyme Patent Litigation

        In October 2009, Shelbyzyme LLC filed a complaint against us in the U.S. District Court for the District of Delaware alleging infringement of U.S. patent 7,011,831 by "making, using, selling and promoting a method for the treatment of" Fabry disease. The '831 patent, which is directed to a method for treating Fabry disease, was issued in March 2006 and expired in March 2009. The plaintiffs seek damages for past infringement, including treble damages for alleged willful infringement and reimbursement of costs, including attorney's fees. We intend to defend this lawsuit vigorously.

Other Matters

        We are party to a legal action brought by Kayat pending before the District Court in Nicosia, Cyprus. Kayat alleges that we breached a 1996 distribution agreement under which we granted Kayat the right to distribute melatonin tablets in the Ukraine, primarily by not providing products or by


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

12. Commitments and Contingencies (Continued)


providing non-conforming products. Kayat further claims that due to the alleged breach, it suffered lost profits that Kayat claims it would have received under agreements it alleges it had entered into with subdistributors. Kayat also alleges common law fraud and violations of Mass. Gen. L. c. 93A and the Racketeer Influenced and Corrupt Organizations Act. Kayat filed its suit on August 8, 2002 and a trial began in Cyprus in December 2009. Kayat seeks damages for its legal claims and for expenses it claims it has incurred, including legal fees and advertising, promotion and other out-of-pocket expenses. We believe we acted appropriately in all regards, including properly terminating the agreement when we decided to exit the melatonin business, and we intend to defend this lawsuit vigorously.

        We are not able to predict the outcome of thesethe lawsuits and matters described above or estimate the amount or range of any possible loss we might incur if we do not prevail in final, non-appealable determinationsdetermination of these matters. Therefore, we have not accrued any amounts in connection with these contingencies.

        In April 2005, Church & Dwight Co., Inc., or Church & Dwight, filed a suit in U.S. District Court for the District of New Jersey against Abbott Laboratories, or Abbott, claiming that certain over-the-counter pregnancy tests distributed by Abbott between 1999lawsuits and 2003 infringed upon patents owned by Church & Dwight. During part of this period, a portion of the test kits distributed by Abbott were manufactured by Wyntek Diagnostics, Inc., or Wyntek, which had agreed to indemnify Abbott for patent infringement related costs and damages for these products. In 2002, we acquired Wyntek and assumed the obligations under this agreement. In June 2008, the court issued a ruling awarding Church & Dwight approximately $29 million in damages based on a jury finding of willful infringement by Abbott. This award has been entered as a final ruling and Abbott has filed an appeal. Because multiple parties, including Abbott, manufactured infringing product for Abbott during this period, any responsibility that we may have for indemnifying Abbott is only for a portion of its costs and damages related to this case. We currently are disputing with Abbott the percentage of infringing product that was supplied by us and may in the future assert additional claims that, if successful, would reduce or relieve us of any liability.matters described above.

        Through June 30, 2003, we had three outstanding series of common stock, which we referred to as tracking stocks: Genzyme General Stock (which we now refer to as Genzyme Stock); Biosurgery Stock; and Molecular Oncology Stock. On August 6, 2007, we reached an agreement in principle to settle for $64.0 million the lawsuits related to our 2003 exchange of Genzyme Stock for Biosurgery Stock. We recorded a liability for the settlement payment of $64.0 million as a charge to SG&A in our consolidated statements of operations for the three months ended June 30, 2007. We paid the settlement in August 2007. The court approved the settlement in October 2007. We have submitted claims to our insurers for reimbursement of portions of the expenses incurred in connection with these cases; the insurers have denied coverage, and therefore, we have not recorded a receivable for any potential recovery from our insurers. In our lawsuit against our primary insurer, the court granted the insurer's motion to dismiss the suit in October 2009. We are vigorously pursuing our rights with respect to insurance coverage. To the extent we are successful, we will record the recovery in our consolidated statements of operations.have appealed this judgment.

        We periodically becomealso are subject to other legal proceedings and claims arising in connection with our business. Although we cannot predict the outcome of these additional proceedings and claims, we do not believe the ultimate resolution of any of these existing matters would have a material adverse affecteffect on our consolidated financial position or results of operations.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

13. Provision forBenefit from (Provision for) Income Taxes

 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
 
 2009 2008 2009 2008 
 
 (Amounts in thousands)
 

Provision for income taxes

 $78,870 $38,407 $157,754 $98,524 

Effective tax rate

  30% 36% 29% 31%

 
 Three Months Ended
March 31,
 
 
 2010 2009 
 
 (Amounts in thousands)
 

Benefit from (provision for) income taxes

 $61,799 $(78,884)

Effective tax rate

  35% 29%

        Our effective tax rate for allboth periods presented varies from the U.S. statutory tax rate as a result of:


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

13. Benefit from (Provision for) Income Taxes (Continued)

In addition, our provision for income taxes for both the three and six months ended June 30, 2009 includes $5.3 million of income tax benefits resulting from the reversal of a portion of our U.S. tax reserves due to a remeasurement, in accordance with the provisions of FIN 48, "Accounting for Uncertainty in Income Taxes—an Interpretation of FASB Statement No. 109," based on new information discovered during the second quarter of 2009.

        We are currently under IRS audit by various states and foreign jurisdictions for the tax years 2006 to 2007.various years. We believe that we have provided sufficiently for all audit exposures. We expect to settle the 2006 to 2007 IRS audit within the next twelve months and do not expect that the settlement will have a material impact on our financial position or results of operations. Settlement of these audits or the expiration of the statute of limitations on the assessment of income taxes for any tax year maywill likely result in a reduction of future tax provisions. Any such benefit would be recorded upon final resolution of the audit or expiration of the applicable statute of limitations.

14. Segment Information

        In accordance with FAS 131, "Disclosures about Segments of an Enterprise and Related Information," weWe present segment information in a manner consistent with the method we use to report this information to our management. Applying FAS 131,Effective January 1, 2010, based on changes in the fourth quarter of 2008,how we changedreview our segment reporting structure to better reflect the waybusiness, we manage and measure the performancere-allocated certain of our businesses.business units amongst our segments and adopted new names for certain of our reporting segments. Under the new reporting structure, we are organized into fourfive reporting segments as described above in Note 1., "Description of Business," to these consolidated financial statements. We have revised our 20082009 segment disclosures to conform to our 20092010 presentation.

        We have provided information concerning the operations of these reportable segments in the following tables (amounts in thousands):

 
 Three Months Ended March 31, 
 
 2010 2009 

Revenues:

       
 

Personalized Genetic Health(1)

 $392,504 $549,960 
 

Renal and Endocrinology

  252,423  242,468 
 

Biosurgery

  137,366  119,522 
 

Hematology and Oncology(2)

  156,310  88,573 
 

Multiple Sclerosis(2)

    7,291 
 

Other

  135,859  140,603 
 

Corporate

  11  454 
      
  

Total

 $1,074,473 $1,148,871 
      

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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

14. Segment Information (Continued)

 We have provided information concerning the operations of these reportable segments in the following tables (amounts in thousands):

 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
 
 2009 2008 2009 2008 

Revenues:

             
 

Genetic Diseases

 $568,153 $572,461 $1,105,203 $1,107,350 
 

Cardiometabolic and Renal

  248,000  239,285  490,962  471,123 
 

Biosurgery

  139,327  131,215  258,849  242,877 
 

Hematologic Oncology(1)

  55,930  28,346  91,837  52,226 
 

Other

  216,546  199,370  429,522  396,779 
 

Corporate

  554  457  1,008  840 
          
  

Total

 $1,228,510 $1,171,134 $2,377,381 $2,271,195 
          

Income (loss) before income taxes:

             
 

Genetic Diseases

 $332,967 $366,456 $684,941 $723,177 
 

Cardiometabolic and Renal(2)

  106,711  (78,981) 208,929  (50,150)
 

Biosurgery

  33,750  28,670  62,083  47,457 
 

Hematologic Oncology(1)

  (29,752) (26,606) (43,394) (52,567)
 

Other(3)

  29,702  (4,642) 22,780  535 
 

Corporate(4)

  (206,934) (176,926) (394,525) (355,093)
          
  

Total

 $266,444 $107,971 $540,814 $313,359 
          

Income (loss) before income taxes:

       
 

Personalized Genetic Health(1,3)

 $(27,024)$351,795 
 

Renal and Endocrinology

  114,542  106,062 
 

Biosurgery

  28,993  28,332 
 

Hematology and Oncology(2)

  8,388  (2,985)
 

Multiple Sclerosis(2)

  (89,925) (16,445)
 

Other(4)

  4,228  (4,798)
 

Corporate(5)

  (215,949) (187,591)
      
  

Total

 $(176,747)$274,370 
      

(1)
The resultsIncludes the impact of operations of acquired companiessupply constraints for Cerezyme and assets and the amortization expense related to acquired intangible assets are included in segment results beginning on the date of acquisition.Fabrazyme.

(2)
On May 29, 2009, we acquired the worldwide rights to the oncology products Campath, Fludara and Leukine and alemtuzumab for MS from Bayer. As of that date, we ceased recognizing research and development revenue for Bayer's reimbursement of a portion of the development costs for alemtuzumab for MS. The fair value of the research and development costs for alemtuzumab for MS that will be reimbursed by Bayer is accounted for as an offset to the contingent consideration obligations for alemtuzumab for MS.

Includes contingent consideration expense of $21.4 million for our Hematology and Oncology reporting segment and $41.1 million for our Multiple Sclerosis reporting segment for the three months ended March 31, 2010 for which there were no comparable amounts for the same period of 2009.

(3)
Includes a charge of $175.0 million recorded to SG&A for the three months ended March 31, 2010 for the potential up-front disgorgement of past profits provided for in June 2008the draft consent decree we received from the FDA. We recorded this charge because it is probable that we will have to pay this amount to the FDA and a charge of $69.9 million recorded in February 2008 as license fees payments to Isis Pharmaceuticals, Inc., or Isis, for exclusive, worldwide rights to mipomersen.we can reasonably estimate the amount that will be paid.

(3)(4)
Includes a charge of $18.2 million recorded to research and development expense in our consolidated statements of operations in Januaryfor the three months ended March 31, 2009, for intellectual property we acquired from EXACT Sciences.Sciences in January 2009.

(4)(5)
Loss before income taxes for Corporate includes our corporate, general and administrative and corporate science activities, all of our stock-based compensation expenses, as well as net gains on our investments in equity securities, investment income, interest expense and other income and expense items that we do not specifically allocate to a particular reporting segment.

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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

14. Segment Information (Continued)

Segment Assets

        We provide information concerning the assets of our reportable segments in the following table (amounts in thousands):

 
 June 30,
2009
 December 31,
2008
 

Segment Assets(1):

       
 

Genetic Diseases

 $1,670,943 $1,520,586 
 

Cardiometabolic and Renal

  1,326,750  1,366,970 
 

Biosurgery

  500,895  497,813 
 

Hematologic Oncology(2)

  1,126,895  700,563 
 

Other(2)

  1,788,066  1,097,169 
 

Corporate(3)

  3,681,537  3,488,175 
      
  

Total

 $10,095,086 $8,671,276 
      

 
 March 31, 2010 December 31, 2009 

Segment Assets(1):

       
 

Personalized Genetic Health(2)

 $1,356,806 $1,525,602 
 

Renal and Endocrinology

  1,230,601  1,283,731 
 

Biosurgery

  482,487  509,064 
 

Hematology and Oncology

  1,388,832  1,406,684 
 

Multiple Sclerosis

  951,327  956,448 
 

Other

  460,917  462,978 
 

Corporate(3)

  3,983,825  3,916,217 
      
  

Total

 $9,854,795 $10,060,724 
      

(1)
Assets for our fourfive reporting segments and Other include primarily accounts receivable, inventory and certain fixed and intangible assets, including goodwill.

(2)
In MayFor the year ended December 31, 2009, includes a gross technology intangible asset of $240.3 million and related accumulated amortization of $(24.0) million related to our consolidation of the results of BioMarin/Genzyme LLC. Effective January 1, 2010, under new guidance we acquiredadopted for consolidating variable interest entities, we no longer consolidate the worldwide rights toresults of this joint venture and no longer include this gross technology asset and the oncology products Campath, Fludara and Leukine and alemtuzumab for MS from Bayer for $42.4 million of cash, net of refundable deposits, and $964.1 million of contingent consideration obligations. Total assets for the acquisition as of May 29, 2009, the date of acquisition, include (amountsrelated accumulated amortization or a related other noncurrent liability in millions):our consolidated balance sheet.

 
 Amount Business
Segment

Inventory

 $136.4 Hematologic Oncology

Developed technology

  261.4 Hematologic Oncology

IPR&D

  632.9 Other
     
 

Total

 $1,030.7  
     
(3)
Includes the assets related to our corporate, general and administrative operations, and corporate science activities that we do not allocate to a particular segment. Segment assets for Corporate consist of the following (amounts in thousands):
 
 June 30,
2009
 December 31,
2008
 

Cash, cash equivalents, short- and long-term investments in debt securities

 $1,049,383 $973,691 

Deferred tax assets, net

  549,997  457,342 

Property, plant & equipment, net

  1,622,764  1,524,442 

Investments in equity securities

  67,386  83,325 

Other

  392,007  449,375 
      
 

Total

 $3,681,537 $3,488,175 
      

 
 March 31, 2010 December 31, 2009 

Cash, cash equivalents, short- and long-term investments in debt securities

 $961,699 $1,049,700 

Deferred tax assets, net

  582,688  555,242 

Property, plant & equipment, net

  1,813,697  1,787,054 

Investments in equity securities

  79,881  74,438 

Other

  545,860  449,783 
      
 

Total

 $3,983,825 $3,916,217 
      

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

        When reviewing the discussion below, you should keep in mind the substantial risks and uncertainties that characterize our business. In particular, we encourage you to review the risks and uncertainties described under the heading "Risk Factors" below. These risks and uncertainties could cause actual results to differ materially from those forecasted in forward-looking statements or implied by past results and trends. Forward-looking statements are statements that attempt to project or anticipate future developments in our business; we encourage you to review the examples of forward looking statements under "Note Regarding Forward-Looking Statements" at the beginning of this report. These statements, like all statements in this report, speak only as of the date of this report (unless another date is indicated), and we undertake no obligation to update or revise the statements in light of future developments.

        Note: All references to increases or decreases for the three months ended June 30, 2009March 31, 2010 are as compared to the three months ended June 30, 2008. All references to increases or decreases for the six months ended June 30, 2009 are as compared to the six months ended June 30, 2008, unless otherwise noted.March 31, 2009.

INTRODUCTION

        We are a global biotechnology company dedicated to making a major impact on the lives of people with serious diseases. Our broad productproducts and service portfolio isservices are focused on rare inherited disorders, renalkidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Our commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and predictive testing.other areas of unmet medical need.

        In the fourth quarter of 2008, we changed our segment reporting structure to better reflect the way we manage and measure the performance of our businesses. Under the new reporting structure, weWe are organized into fourfive financial reporting units, which we also consider to be our reporting segments:

        Our transplant business unit,

Multiple Sclerosis, which develops, manufactures and distributes therapeutic products that address pre-transplantation, prevention andis developing a product for the treatment of graft rejection in organ transplantation and other hematologic and auto-immune disorders, and our genetics business unit, which provides

MS.

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        Effective January 1, 2010, based on changes in how we review our business, we re-allocated certain of our business units among our segments and adopted new names for certain of our reporting segments. Specifically:

        We report the activities of the following business units under the caption "Other": our genetic testing business unit, which provides testing services for the oncology, prenatal and reproductive markets, were formerly reported as separate reporting segments. Effective as of the fourth quarter of 2008, we includemarkets; and our transplant and genetics business units under the caption "Other." We also report the activities of our MS, diagnostic products bulk pharmaceuticals and immune mediated diseasepharmaceutical intermediates business units under the caption "Other."units. These operating segments did not meet the quantitative threshold for separate segment reporting. We have revised our 2008 segment disclosures to conform to our 2009 presentation.

        We report our corporate, general and administrative operations and corporate science activities under the caption "Corporate."

Update        We have revised our 2009 segment disclosures to Second Quarter Earnings Releaseconform to our 2010 presentation.

        On July 22,May 6, 2010, we announced that we plan to pursue strategic alternatives for our genetic testing, diagnostic products and pharmaceutical intermediates business units. Options could include divestiture, spin-out or management buy-out. In 2009, we issued a press release containing our resultsgenetic testing business unit had revenue of operations and financial condition for the three month period ended June 30, 2009, which we furnished as an exhibit under Form 8-K prior to hosting a conference call to discuss our second quarter financial results. Subsequent to July 22, 2009, two events occurred which have caused us to update our second quarter financial results in this Form 10-Q. Specifically, we:

2010.

STRATEGIC TRANSACTIONS

Strategic Alliance with Osiris

        In October 2008, we entered into a strategic alliance with Osiris whereby we obtained an exclusive license to develop and commercialize Prochymal and Chondrogen, mesenchymal stem cell products, outside of the United States and Canada. Osiris will commercialize Prochymal and Chondrogen in the United States and Canada. We paid Osiris a nonrefundable upfront payment of $75.0 million in November 2008 and an additional $55.0 million nonrefundable upfront license fee in July 2009, both of which were recorded as charges to research and development expense in our consolidated statement of operations in the fourth quarter of 2008. The results of these programs are included under the category "Other" in our segment disclosures. The full description of our strategic alliance with Osiris is provided in Note C., "Mergers, Acquisitions and Strategic Transactions—Strategic Alliance with Osiris," to our consolidated financial statements included in Exhibit 13 to our 2008 Form 10-K.

Acquisition from Bayer

        On May 29, 2009, we paid $42.4 million of net cash tocompleted a transaction with Bayer for inventory and recorded contingent consideration obligations totaling $964.1 million to:


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Of the $964.1 million total contingent consideration obligations recorded as of the acquisition date, $529.1 million related to Campath, Fludara and Leukine, and $435.0 million related to alemtuzumab for MS. The contingent consideration obligations are net of the continued funding expected to be received from Bayer for the development of alemtuzumab for MS.

        Prior to this transaction, we shared with Bayer the development and certain commercial rights to alemtuzumab for MS and Campath and received two-thirds of Campath net profits on U.S. sales and a royalty on foreign sales. Under our new arrangement with Bayer, prior to regulatory approval of alemtuzumab for MS, we will have primary responsibility for itsthe product's development while Bayer will continuecontinues to fund that development at currentthe levels specified under the previous agreement and will participate on theparticipates in


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a development steering committee. We will have worldwide commercialization rights, with Bayer retaining an option to co-promote the product as a treatmentalemtuzumab for MS. In exchange for the above, Bayer is eligible to receive the following contingent purchase price payments:

        We will utilize Bayer forthese contingent purchase price payments are described in more detail in our 2009 Form 10-K. These contingent purchase price payments could amount to over $2.9 billion in total and extend, in certain transition services and purchase commercial supply of Fludara and Leukine from Bayer. We have employed certain members of Bayer's commercial teams for all three products and have an opportunity to employ certain members of Bayer's manufacturing team if we acquire the Leukine facility.circumstances, over more than ten years.

        The transaction has beenwas accounted for as a business combination under FAS 141R and is included in our results of operations beginning on May 29, 2009, the date of acquisition. The results for Campath, Fludara and Leukine are included in our HematologicHematology and Oncology reporting segment and the development costs ofresults for alemtuzumab for MS are included in our MSMultiple Sclerosis reporting segment. The fair value of the total consideration for this transaction was $1.01 billion, consisting of $42.4 million of cash payments net of refundable cash deposits, and $964.1 million of contingent consideration obligations. We allocated the purchase price to the identifiable assets acquired in this transaction based on their estimated fair values as of the date of acquisition, of which $136.4 million was allocated to inventory and $894.3 million was allocated to intangible assets. We recognized a gain on acquisition of business unit,of $24.2 million in our consolidated statements of operations for the second quarter of 2009 representing the amount by which is reported under the caption "Other."fair value of the acquired assets of $1.03 billion exceeded the fair value of the purchase price of $1.01 billion.

        Each period we revalue the contingent consideration obligations to their then fair value and record increases in the fair value as contingent consideration expense and decreases in the fair value as a reduction of contingent consideration expense. Increases or decreases in the fair value of the contingent consideration obligations can result from changes in discount periods and rates, changes in the timing and amount of revenue estimates and changes in probability adjustments with respect to regulatory approval of alemtuzumab for MS.

        As of June 30,December 31, 2009, the fair value of the total contingent consideration obligations was $973.2$1.02 billion. During the three months ended March 31, 2010:

As of March 31, 2010, the fair value of the total contingent consideration obligations increased to $1.03 billion primarily due to changes in the assumed timing and amount of revenue and expense estimates. Accordingly, we recorded a total of $62.5 million of contingent consideration expense, of $9.1which $35.5 million is related to changes in estimates, in our consolidated statements of operations for the three and six months ended June 30, 2009. AsMarch 31, 2010 to reflect the increase in fair value, including $21.4 million for our Hematology and Oncology reporting segment and $41.1 million for our Multiple Sclerosis reporting segment. In April 2010, we received $7.6 million of June 30, 2009, we have not made any contingent consideration payments to, or received


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any research and development funding from Bayer or adjusted any of the assumptions used in determining the fair value of the contingent consideration obligations.

        The fair value of the identifiable assets acquired in this transaction of $1.03 billion exceeded the fair value of the purchase price of $1.01 billion. As a result, in accordance with FAS 141R, we recognized a gain on acquisition of business of $24.2 million in our consolidated statements of operations for the three and six months ended June 30, 2009. The fair valuedevelopment of the consideration and assets remain subject to potential adjustments.alemtuzumab for MS.

Purchase of Intellectual Property from EXACT Sciences Corporation

        On January 27, 2009, we purchased certain intellectual property in the fields of prenatal testing and reproductive health from EXACT Sciences for our diagnostic testing servicesgenetics business unit and 3,000,000 shares of EXACT Sciences common stock. We paid EXACT Sciences total cash consideration of $22.7 million.million at that time. Of this amount, we allocated $4.5 million to the acquired shares of EXACT Sciences common stock based on the fair value of the stock on the date of acquisition, which we recorded as an increase to investments in equity securities in our consolidated balance sheet as of March 31, 2009. As the purchased assets did not qualify as a business combination under FAS 141R and have not reached technological


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feasibility nor have alternative future use, we allocated the remaining $18.2 million to the acquired intellectual property, which we recorded as a charge to research and development expenses in our consolidated statementstatements of operations forin March 2009. Additional amounts we paid during the three months ended March 31, 2009. Wefirst quarter of 2010 and amounts we will pay in the future to EXACT Sciences an additional $1.9 million by July 2010, unless such amount is required to satisfy certain of EXACT Sciences' indemnification obligations.under this agreement are not significant.

CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES

        Our critical accounting policies and significant judgments and estimates are set forth under the heading "Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates" in Exhibit 13Part II., Item 7. to our 20082009 Form 10-K. Excluding the addition of our policy for contingent consideration expense,PSUs to our stock-based compensation policy, there have been no significant changes to our critical accounting policies or significant judgments and estimates since December 31, 2008.2009. Additional information regarding our provisions and estimates for our product sales allowances, sales allowance reserves and accruals, and distributor fees and IPR&D and our revised stock-based compensation policy for accounting for contingent consideration expense are included below.

Revenue Recognition

Product Sales Allowances

        Sales of many biotechnology products in the United States are subject to increased pricing pressure from managed care groups, institutions, government agencies and other groups seeking discounts. We and other biotechnology companies in the U.S. market are also required to provide statutorily defined rebates and discounts to various U.S. government agencies in order to participate in the Medicaid program and other government-funded programs. In most international markets, we operate in an environment where governments may and have mandated cost-containment programs, placed restrictions on physician prescription levels and patient reimbursements, emphasized greater use of generic drugs and enacted across-the-board price cuts as methods to control costs. In some cases, we have estimated the potential impact of these allowances. The sensitivity of our estimates can vary by program, type of customer and geographic location. Estimates associated with Medicaid and other government allowances may become subject to adjustment in a subsequent period.


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        We record product sales net of the following significant categories of product sales allowances:


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        Our provisions for product sales allowances reduced gross product sales as follows (amounts in thousands):

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Product sales allowances:

                         
 

Contractual adjustments

 $149,049 $107,012 $42,037  39%$285,229 $209,014 $76,215  36%
 

Discounts

  6,764  5,503  1,261  23% 13,040  11,008  2,032  18%
 

Sales returns

  9,375  4,917  4,458  91% 15,898  11,668  4,230  36%
                    
  

Total product sales allowances

 $165,188 $117,432 $47,756  41%$314,167 $231,690 $82,477  36%
                    

Total gross product sales

 $1,280,614 $1,189,234 $91,380  8%$2,466,836 $2,309,759 $157,077  7%
                    

Total product sales allowances as a percent of total gross product sales

  13% 10%       13% 10%      

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 

Product sales allowances:

             
 

Contractual adjustments

 $180,296 $136,180 $44,116  32%
 

Discounts

  6,630  6,275  355  6%
 

Sales returns

  7,809  6,523  1,286  20%
           
  

Total product sales allowances

 $194,735 $148,978 $45,757  31%
           

Total gross product sales

 $1,166,360 $1,186,222 $(19,862) (2)%
           

Total product sales allowances as a percent of total gross product sales

  17% 13%      

        Total product sales allowances increased for the three and six months ended June 30, 2009March 31, 2010, primarily due to the impact of price increases implemented after the second quarter of 2008, primarilyto:

Table        These increases were offset, in part, by a $11.2 million decrease in the aggregate product sales allowances for Cerezyme and Fabrazyme as a result of Contentssupply constraints. Total product sales allowances as a percentage of total gross product sales increased for the three months ended March 31, 2010, primarily due to decreased sales volumes for Cerezyme and Fabrazyme as a result of the supply constraints for which there was not a proportionate decrease in product sales allowances because these products generally have lower sales allowances.

        Total estimated product sales allowance reserves and accruals in our consolidated balance sheets increased approximately 3%9% to approximately $217$257 million as of June 30, 2009,March 31, 2010, as compared to approximately $210$236 million as of December 31, 2008,2009, primarily due to increased contractual adjustments for or Renal and Endocrinology reporting segment and changes in the timing of certain payments. Our actual results have not differed materially from amounts recorded. The annual variation has been less than 0.5% of total product sales for each of the last three years.


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Accounts Receivable Related to Sales in Greece

        Total accounts receivable in our consolidated balance sheets as of March 31, 2010 and December 31, 2009 include sales to government-owned or supported healthcare facilities in Greece. These sales are subject to significant payment delays due to government funding and reimbursement practices. We believe that this is an industry-wide issue for suppliers to these facilities. The outstanding accounts receivable balances, net of reserves, held by our subsidiary in Greece related to such sales were approximately $57 million as of both March 31, 2010 and December 31, 2009. If significant changes occur in the availability of government funding, we may not be able to collect on amounts due from these customers. We do not expect this concentration of credit risk to have a material adverse impact on our financial position or liquidity.

Healthcare Reform Legislation

        In March 2010, healthcare reform legislation was enacted in the United States. Although many provisions of the new legislation do not take effect immediately, several provisions became effective in the first quarter of 2010. These include:

These provisions did not have a significant impact on our results of operations or financial position for the first quarter of 2010.

        Effective October 1, 2010, the new legislation re-defines the Medicaid AMP such that the AMP and, consequently, the Medicaid rebate are expected to increase for some of our drugs, in particular those that offer discounted pricing to customers.

        Beginning in 2011, the new law requires drug manufacturers to provide a 50% discount to Medicare beneficiaries whose prescription drug costs cause them to be subject to the Medicare Part D coverage gap, which is known as the "donut hole". Also beginning in 2011, clinical laboratory fee schedule payments will be reduced 1.75% over a period of five years and we will be required to pay our share of a new fee assessed on all branded prescription drug manufacturers and importers. This fee will be calculated based upon each organization's percentage share of total branded prescription drug sales to U.S. government programs (such as Medicare and Medicaid and VA, DOD and TriCare retail pharmacy discount programs) made during the previous year. Sales of orphan drugs, however, are not included in the fee calculation. Final guidance relating to how we will be required to account for this fee is still pending, however, it is expected that the fee will be classified as either a reduction of net sales or an operating expense. The aggregated industry wide fee is expected to total approximately $28 billion through 2019, ranging from $2.5 billion to $4.1 billion annually. Beginning in 2013, a 2.3%


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excise tax will be imposed on sales of all medical devices except retail purchases by the public intended for individual use.

        Presently, uncertainty exists as many of the specific determinations necessary to implement this new legislation have yet to be decided and communicated to industry participants. We have made several estimates with regard to important assumptions relevant to determining the financial impact of this legislation on our business due to the lack of availability of both certain information and complete understanding of how the process of applying the legislation will be implemented. Although we are still assessing the full extent that the U.S. healthcare reform legislation may have on our business, we currently estimate that our revenues in the United States will be adversely impacted by less than approximately $20 million in 2010, with most of the impact occurring in the third and fourth quarters, and by approximately $30 million to $40 million in 2011.

        We expect that the United States Congress and state legislatures will continue to review and assess healthcare proposals, and public debate of these issues will likely continue. We cannot predict which, if any, of such reform proposals will be adopted and when they might be adopted. In addition, we anticipate seeing continued efforts to reduce healthcare costs in many other countries outside the United States. For example, in May 2010, the Greek health ministry imposed a flat mandatory discount of 27% on medicinal products above a certain price level. This discount, however, does not apply to our orphan drugs or Thymoglobulin. The Greek health ministry has stated that this newly imposed pricing is temporary and in two months the ministry will issue new pricing for most medicinal products based on the average of the three lowest prices in the European Union, and at that time, also determine the pricing for orphan products. As another example, the German government is expected to implement measures during the second half of 2010 that, among other things, increase mandatory discounts and impose a three-year price freeze on pharmaceutical prices, based on August 2009 pricing. We expect that our revenues would be negatively impacted if these or similar measures are implemented or maintained.

Distributor Fees

        EITF Issue No. 01-9, "Accounting for Consideration given by a Vendor to a Customer (including a Reseller of a Vendor's Products)" specifies that cashCash consideration (including a sales incentive) given by a vendor to a customer is presumed to be a reduction of the selling prices of the vendor's products or services and, therefore, should beis appropriately characterized as a reduction ofin revenue. We include such fees in contractual adjustments, which are recorded as a reduction to product sales. That presumption is overcome and the consideration should be characterized as a cost incurred if, and to the extent that, both of the following conditions are met:

        We record service fees paid to our distributors as a charge to SG&A, a component of operating expenses, only if the criteria set forth above are met. The following table sets forth the distributor fees recorded as a reduction to product sales and charged to SG&A (amounts in thousands):

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Distributor fees:

                         
 

Included in contractual adjustments and recorded as a reduction to product sales

 $3,534 $1,590 $1,944  >100%$7,013 $6,286 $727  12%
 

Charged to SG&A

  3,481  3,569  (88) (2)% 7,028  6,520  508  8%
                    
  

Total distributor fees

 $7,015 $5,159 $1,856  36%$14,041 $12,806 $1,235  10%
                    

In-Process Research and Development

        IPR&D represents the fair value assigned to incomplete technologies that we acquire, which at the time of acquisition have not reached technological feasibility and have no alternative future use. A technology is considered to have an alternative future use if it is probable that the acquirer will use the asset in its incomplete state as it exists at the acquisition date, in another research and development project that has not yet commenced, and economic benefit is anticipated from that use.

        Substantial additional research and development will be required before any of our acquired programs reach technological feasibility. In addition, once research is completed, each underlying product candidate will need to complete a series of clinical trials and receive regulatory approvals prior to commercialization. Management assumes responsibility for determining the valuation of the acquired IPR&D programs. The fair value assigned to IPR&D for each acquisition is estimated by discounting, to present value, the future cash flows expected from the programs since the date of our acquisition. Accordingly, such cash flows reflect our estimates of revenues, costs of sales, operating expenses and income taxes from the acquired IPR&D programs based on the following factors:

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 

Distributor fees:

             
 

Included in contractual adjustments and recorded as a reduction to product sales

 $6,060 $4,247 $1,813  43%
 

Charged to SG&A

  3,346  3,547  (201) (6)%
           
  

Total distributor fees

 $9,406 $7,794 $1,612  21%
           

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        The discount rates used are commensurate with the uncertainties associated with the economic estimates described above. The resulting discounted future cash flows are then probability-adjusted to reflect the different stages of development, the time and resources needed to complete the development of the product and the risks of advancement through the product approval process. In estimating the future cash flows, we also consider the tangible and intangible assets required for successful exploitation of the technology resulting from the purchased IPR&D programs and adjust future cash flows for a charge reflecting the contribution to value of these assets. Such contributory tangible and intangible assets may include, but are not limited to, working capital, fixed assets, assembled workforce, customer relationships, patents, trademarks, and core technology.

        Use of different estimates and judgments could yield materially different results in our analysis and could result in materially different asset values or expense. There can be no assurance that we will be able to successfully develop and complete the acquired IPR&D programs and profitably commercialize the underlying product candidates before our competitors develop and commercialize products for the same indications, or at all. Moreover, if certain of the acquired IPR&D programs fail, are abandoned during development, or do not receive regulatory approval, then we may not realize the value we have estimated and recorded in our financial statementsoutstanding based on the acquisition date,vesting provisions and we may also not recoverour historical exercise, cancellation and expiration patterns. We estimate pre-vesting forfeitures when recognizing stock-based compensation expense based on historical rates and forward-looking factors. We update these assumptions at least on an annual basis and on an interim basis if significant changes to the research and development investment made since the acquisition dateassumptions are warranted.

        We issue PSUs to further develop that program. If such circumstances were to occur, our future operating results could be materially adversely impacted.

        Prior to January 1, 2009, IPR&D acquired through a business combination was expensed. In accordance with the adoption of FAS 141R, IPR&D acquired through business combinations on or after January 1, 2009 will be capitalized as an intangible asset on the balance sheet and periodically tested for impairment. Amortization of such capitalized IPR&D will commencesenior executives, which vest upon the successful completionachievement of the programcertain financial performance goals, including cash flow return on investment and continue for the then estimated useful life of the asset.

        None of the incomplete technology programs we have acquired through our business combinations prior to January 1, 2009 had reached technological feasibility nor had an alternative future use and, therefore, theR-TSR. The fair value of those programs was expensedPSUs subject to the cash flow return on investment performance metric, which includes both performance and service conditions, is based on the acquisition date and classified inmarket value of our consolidated statements of operations within the line item Purchase of In-Process Research and Development. In May 2009, we acquired the worldwide rights to the oncology products Campath, Fludara and Leukine and alemtuzumab for MS. The transaction was accounted for as a business combination. Atstock on the date of acquisition, alemtuzumabgrant. We use a lattice model with a Monte Carlo simulation to value PSUs subject to the R-TSR performance metric, which is a market condition. We recognize compensation cost for MS had not reached technological feasibility nor had an alternative future use and is therefore consideredour PSUs on a straight-lined basis over the requisite performance period. Determining the appropriate amount to be IPR&D. Accordingly, we capitalizedexpense based on the $632.9 million fair valueanticipated achievement of the IPR&D for alemtuzumab for MS, whichstated goals requires judgment, including forecasting future financial results. The estimate of expense is includedrevised periodically based on the probability of achieving the required performance targets and adjustments are made as appropriate. The cumulative impact of any revision is reflected in Other intangible assets, net in our consolidated balance sheet asthe period of June 30, 2009. Of this amount, $415.6 million is relatedchange. In the case of PSUs subject to the development ofR-TSR performance metric, if the product for salefinancial performance goals are not met, the award does not vest, no compensation cost is recognized and any previously recognized stock-based compensation expense is reversed.

        We review our valuation assumptions periodically and, as a result, we may change our valuation assumptions used to value share-based awards granted in future periods. Such changes may lead to a significant change in the United States and $217.3 million is related to the development of the product for sales outside of the United States. Amortization of these capitalized IPR&D assets will commence upon our receipt of the necessary approvals to sell alemtuzumab for MS in each area. We currently anticipate receiving approval for alemtuzumab for MS in the United States in 2012 and outside of the United States starting in 2013.


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We will test our capitalized IPR&D assets annually for potential impairment, or earlier if conditions warrant.

Contingent Consideration Expense

        In accordance with FAS 141R, each period we revalue the contingent consideration obligations associated with certain acquisitions to their then fair value and record increases in the fair value as contingent consideration expense and record decreases in the fair value as a reduction of contingent consideration expense. Increases or decreases in the fair value of the contingent consideration obligations can result from changes in assumed discount periods and rates, changes in the assumed timing and amount of revenue estimates and changes in assumed probability adjustments with respect to regulatory approval. Significant judgment is employed in determining the appropriateness of these assumptions as of the acquisition date and for each subsequent period. Accordingly, future business and economic conditions, as well as changes in any of the assumptions described above, can materially impact the amount of contingent consideration expense we recordrecognize in any given period.connection with share-based payments.

RESULTS OF OPERATIONS

        The following discussion summarizes the key factors our management believes are necessary for an understanding of our consolidated financial statements.

REVENUES

        The components of our total revenues are described in the following table (amounts in thousands):

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Product revenue

 $1,115,425 $1,071,801 $43,624  4%$2,152,669 $2,078,069 $74,600  4%

Service revenue

  105,693  90,622  15,071  17% 207,192  176,486  30,706  17%
                    
 

Total product and service revenue

  1,221,118  1,162,423  58,695  5% 2,359,861  2,254,555  105,306  5%

Research and development revenue

  7,392  8,711  (1,319) (15)% 17,520  16,640  880  5%
                    
 

Total revenues

 $1,228,510 $1,171,134 $57,376  5%$2,377,381 $2,271,195 $106,186  5%
                    

Product Revenue

        We derive product revenue from sales of:

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 

Product revenue

 $971,625 $1,037,244 $(65,619) (6)%

Service revenue

  101,915  101,499  416   
           
 

Total product and service revenue

 $1,073,540 $1,138,743 $(65,203) (6)%

Research and development revenue

  933  10,128  (9,195) (91)%
           
 

Total revenues

 $1,074,473 $1,148,871 $(74,398) (6)%
           

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Reporting SegmentsProductsApproved Indications

Hematology and Oncology


Mozobil


Mobilization of hematopoietic stem cells



Thymoglobulin


Immunosuppression of certain types of cells responsible for organ rejection in transplant patients and treatment of aplastic anemia



Clolar


Acute leukemia



Campath


Leukemia



Fludara


Leukemia and lymphoma



Leukine


Reduction of the incidence of severe and life-threatening infections in older adult patients with AML following chemotherapy and certain other uses


Other




Diagnostic products




Infectious disease and cholesterol testing products



Pharmaceutical intermediates products


Pharmaceutical intermediates

        The following table sets forth our product revenue on a reporting segment basis (amounts in thousands):

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Genetic Diseases

 $568,153 $572,294 $(4,141) (1)%$1,105,178 $1,107,007 $(1,829)  

Cardiometabolic and Renal

  247,949  239,199  8,750  4% 490,886  470,991  19,895  4%

Biosurgery

  127,113  119,099  8,014  7% 236,241  219,426  16,815  8%

Hematologic Oncology

  54,786  26,019  28,767  >100% 88,764  48,300  40,464  84%

Other product revenue

  117,424  115,190  2,234  2% 231,600  232,345  (745)  
                    
 

Total product revenue

 $1,115,425 $1,071,801 $43,624  4%$2,152,669 $2,078,069 $74,600  4%
                    

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 

Personalized Genetic Health

 $392,484 $549,923 $(157,439) (29)%

Renal and Endocrinology

  252,257  242,455  9,802  4%

Biosurgery

  126,261  109,128  17,133  16%

Hematology and Oncology

  156,291  86,644  69,647  80%

Other product revenue

  44,332  49,094  (4,762) (10)%
           
 

Total product revenue

 $971,625 $1,037,244 $(65,619) (6)%
           

Personalized Genetic DiseasesHealth

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 
 
 (Amounts in thousands)
 

Cerezyme

 $298,087 $319,360 $(21,273) (7)%$594,057 $623,663 $(29,606) (5)%

Fabrazyme

  134,302  126,608  7,694  6% 256,503  243,083  13,420  6%

Myozyme

  79,273  77,222  2,051  3% 146,665  144,546  2,119  1%

Aldurazyme

  39,190  38,667  523  1% 76,027  75,506  521  1%

Other Genetic Diseases

  17,301  10,437  6,864  66% 31,926  20,209  11,717  58%
                    
 

Total Genetic Diseases

 $568,153 $572,294 $(4,141) (1)%$1,105,178 $1,107,007 $(1,829)  
                    

Regulatory and Manufacturing

        Genetic Diseases product revenue decreased slightlyIn March 2010, the FDA notified us that it intended to take enforcement action to ensure that products manufactured at our Allston facility are made in compliance with GMP regulations. We have received a draft consent decree from the FDA that provides for an up-front disgorgement of past profits of $175.0 million, which we have recorded as a charge to SG&A in our consolidated statements of operations for the three and six months ended June 30, 2009 primarily due to unfavorable exchange rate fluctuations, which offset continued growth in sales volume for Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Elaprase. Elaprase was developed by Shire Human Genetic Therapies Inc., or Shire and we have the rights to commercialize the product in Japan and other Asia-Pacific countries under an agreement with Shire. We launched Elaprase in Japan in the fourthfirst quarter of 2007. Sales2010 and as an increase to accrued expenses in our consolidated balance sheets as of ElapraseMarch 31, 2010. In addition, if the fill-finish operations at our Allston facility is still operating after deadlines for domestic and exported products, the draft provides for disgorgement of 18.5% of revenues from sales of products manufactured and distributed from our Allston facility after those deadlines. We and the FDA are includedhaving discussions regarding appropriate deadlines for moving fill-finish operations, as well as the details of the disgorgement provisions. Finally, if fill-finish operations are moved from our Allston facility but certain remediation actions relating to overall GMP compliance are not met by deadlines over the coming years in Other Genetic Diseases product revenue.

        The decreases in Cerezyme revenue for the three and six months ended June 30, 2009 are primarily duea remediation plan to the weakening of foreign currencies against the U.S. dollar, which adversely impacted revenuebe approved by $21.9 million for the three months ended June 30, 2009 and by $44.5 million for the six months ended June 30, 2009. These decreases were offset, in part, by increases in sales volume due to continued identification of Gaucher disease patients, particularly in international markets.


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        The increases in Fabrazyme revenuethe FDA, the draft provides for payment of $15,000 per day per violation until the three and six months ended June 30, 2009compliance milestones are primarily attributable to increased patient identification worldwide as Fabrazyme is introduced into new markets. The increases in the sales volume of Fabrazyme were offset, in part, by decreases of $8.2 million for the three months ended June 30, 2009 and $14.9 million for the six months ended June 30, 2009 attributable to the weakening of foreign currencies against the U.S. dollar.met.

        OnWe expect that the FDA will allow us to continue to ship our Cerezyme, Fabrazyme and Myozyme products that are produced or fill-finished at our Allston facility because the FDA has determined that these products meet the definition of "medical necessity" that would justify continued production of these products at Allston during the enforcement period. The FDA, however, has made a preliminary determination that Thyrogen, which is fill-finished at our Allston facility, does not meet the FDA's definition and may require us to cease fill-finishing the product at Allston when we enter into the consent decree. We are actively negotiating with the FDA the terms of the consent decree and presenting our view that there is also patient need for uninterrupted supply of Thyrogen. We expect that the negotiations will be completed during the second quarter of 2010.

        In June 16, 2009, we announced that we had interrupted production of Cerezyme and Fabrazyme and shipments of Cerezyme, at our Allston facility after identifying a virus, Vesivirus 2117, in a bioreactor used for Cerezyme production. The virus we identified impairs the viability of cells used in the manufacturing process and is not known to cause infection in humans. We have completed sanitization of the facility. The first new releases of Cerezymefacility and Fabrazyme are expected beforeresumed production there in the endthird quarter of 2009. Cerezyme and Fabrazyme inventories arewere not sufficient to avoid shortagesshortages.

        We resumed Cerezyme shipments in the fourth quarter of 2009. In order to build a small inventory buffer to help us more consistently manage the resupply of Cerezyme to patients in approximately 100 countries and reduce interruptions in shipping that occur in the absence of inventory, we began shipping 50% of Cerezyme demand at the end of February 2010. Although we achieved our goal of building a small inventory buffer during the periodfirst quarter of suspended2010, we announced in April 2010 that the 50% shipping allocation will be extended due to an interruption in operations at our Allston facility at the end of March 2010. The interruption resulted from an unexpected city electrical power failure that compounded issues with the plant's water system. The issues have been corrected and the facility is operational.

        We resumed shipments of vials of Fabrazyme at the beginning of the first quarter of 2010 and have been shipping Fabrazyme to meet approximately 30% of global demand. We have been working to increase the productivity of the Fabrazyme manufacturing process, which has performed at the low end of the historical range since the re-start of production, and recovery.have developed a new working cell bank for Fabrazyme that is in its second run.

        On April 21, 2010, we announced our estimate that we would need to continue the 50% shipping allocation for Cerezyme for two to three months and the 30% shipping allocation for Fabrazyme through the third quarter of 2010. At that time, we also announced that we expect to provide more precise supply updates for Cerezyme and Fabrazyme within a month, once additional information is available about whether we are able to finish approximately $7 million in the aggregate of Cerezyme and Fabrazyme work-in-process material, the majority of which is Cerezyme, that was unfinished when the interruption of operations occurred at our Allston facility, the productivity and timing for regulatory clearance of the new Fabrazyme working cell bank, the impact of the pending consent decree on product release timelines and our assessment for global demand.

        We will continue to work with minimal levels of inventory for Cerezyme and Fabrazyme until our new Framingham manufacturing facility is approved, which is anticipated to take place in late 2011. Any additional manufacturing delays will likely impact supply of these products. We are also working closely with treating physicians, other health care providers, patient communitiesto transition fill-finish operations out of our Allston facility to our Waterford, Ireland plant and regulatory officials worldwide to support patients with Gauchera contract manufacturer. The fill-finish area of the Waterford facility is being expanded to accommodate the long-term growth of our PGH products, and Fabry diseases duringwe currently anticipate receiving approval of this new capacity in 2011.


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        We are pursuing FDA approval of alglucosidase alfa produced using a larger bioreactor scale process, which we refer to as Lumizyme in the periodUnited States. Since 2008, we had been seeking approval of supply constraint,the product in the United States using a 2000L scale process, but we stopped manufacturing the product at this scale in 2009. In November 2009, we received a complete response letter from the FDA regarding our application to produce at the 2000L scale stating that satisfactory resolution of deficiencies related to our Allston facility were required before the Lumizyme application could be approved. Based on subsequent conversations with the goalFDA, we decided to seek approval of conserving supplythe product produced at our Geel, Belgium facility using a 4000L scale process, which will also be known as Lumizyme in the United States. We submitted an amendment to the 2000L BLA to the FDA in December 2009, which the FDA has assigned a June 17, 2010 action date under the Prescription Drug User Fee Act, or PDUFA. Production of alglucosidase alfa at the larger 4000L scale is required to fulfill global demand. In Europe, we received approval for the most vulnerable patients.4000L scale process in February 2009 and, as of the first quarter of 2010, the majority of markets outside of the United States have transitioned to the 4000L scale product. At our Geel, Belgium facility, we are adding a third bioreactor for the production of Myozyme and approval is anticipated in mid-2011.

        ThePersonalized Genetic Health Product Revenue

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 
 
 (Amounts in thousands)
  
 

Cerezyme

 $179,147 $295,970 $(116,823) (39)%

Fabrazyme

  53,241  122,201  (68,960) (56)%

Myozyme

  86,059  67,392  18,667  28%

Aldurazyme

  39,897  36,837  3,060  8%

Other Personalized Genetic Health

  34,140  27,523  6,617  24%
           
 

Total Personalized Genetic Health

 $392,484 $549,923 $(157,439) (29)%
           

        PGH product revenue decreased for the three months ended March 31, 2010, primarily due to:

Cerezyme and Fabrazyme

        The supply constraint for Cerezyme adversely impacted Cerezyme revenue by $126.5 million for the three months ended March 31, 2010. The strengthening of foreign currencies, primarily the Euro, against the U.S. dollar, positively impacted Cerezyme revenue by $7.4 million for the three months ended March 31, 2010. Our results of operations are dependent on sales of Cerezyme and any reduction in revenue from sales of this product adversely affects our results of operations. Sales of Cerezyme were approximately 24%17% of our total revenue for the three months ended June 30, 2009 and approximately 25%March 31, 2010, which reflect periods of our total revenue for the six months ended June 30, 2009,supply constraint, as compared to approximately 27%26% for the three months ended June 30, 2008 and approximately 27% for the six months ended June 30, 2008.same period in 2009.

        The Cerezyme supply constraints caused Cerezyme revenue to be approximately $13 million lower than anticipated for both the three and six months ended June 30, 2009. We expect Cerezyme revenue for the second half of 2009 to be significantly adversely affected by the supply constraint and, therefore, expect that total Cerezyme revenue for 2009 will be significantly lower than in 2008.

        When we suspended production at Allston, we had significant Cerezyme work-in-process material. We have decided not to process approximately 80% of this work-in-process material because the material either had expired or we were not sufficiently assured that the material was not contaminated with Vesivirus 2117 and, accordingly, have incurred a write off of $8.4 million for the second quarter of 2009. At the end of the business day on Friday, August 7, 2009, the FDA communicated to us steps it recommends we take prior to forward processing any Cerezyme work-in-process. The steps recommended by the FDA were consistent with the steps that we independently had planned to implement. The remaining Cerezyme work-in-process material expires in June 2010. If we decide not to process this remaining material or if we process the material and the FDA or another regulatory authority does not allow us to release it, we will incur a write off of approximately $2.7 million for the inventory value of this remaining material. In addition, we have two lots of finished Cerezyme product in inventory. If the FDA or another regulatory authority does not allow us to release both of these finished lots, we will incur an additional write off of $3.1 million.

        We are constructing additional manufacturing capacity for Cerezyme and Fabrazyme in Framingham, Massachusetts to support the growth of these two products. The plant, which will include four 2000L bioreactors, is expected to be mechanically complete by the end of 2009 and FDA approval for commercial production is anticipated in mid-2011 for Fabrazyme and in 2012 for Cerezyme.

        Sales of Myozyme increased slightly for the three and six months ended June 30, 2009 due to the identification of new patients and expanded supply following European approval in February 2009 of product produced at our Belgium facility at the 4000L scale. Sales of Myozyme were adversely impacted Fabrazyme revenue by decreases of $9.1$72.6 million for the three months ended June 30, 2009 and $17.9 million for


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the six months ended June 30, 2009 attributable to the weakeningMarch 31, 2010. The strengthening of foreign currencies, againstprimarily the U.S. dollar.

        We have approval to sell Myozyme (alglucosidase alfa) that is manufactured using a 160L scale process in the United States. The product produced using the 160L scale process is reserved for infants and children because the smaller scale produces a limited supply of FDA-approved product for the U.S. market. Myozyme produced using a 2000L scale process has been approved for sale in many countries outside of the United States. In Europe we also had approval to sell Myozyme produced using a 2000L scale process and recently received approval for a 4000L scale process.

        In May 2008, we submitted a biologics license application, or BLA, to the FDA seeking approval of alglucosidase alfa produced using the 2000L scale process, which we refer to as Lumizyme. In February 2009, we received a complete response letter, or CR Letter, from the FDA regarding our 2000L application. In the CR Letter, the FDA outlined items that need to be addressed before our application could be approved. These items included finalizing agreement with the FDA on the design of a post-approval verification study to demonstrate the clinical benefit of Lumizyme, as required under the FDA's accelerated approval process, as well as a Risk Evaluation and Mitigation Strategy, or REMS, for the product; finalizing label discussions with the FDA; and providing the FDA with information regarding specific chemistry, manufacturing and controls questions and with a safety update. In May 2009, we submitted documentation to address the items in the CR Letter. The submission included the REMS, the final label, and clinical data requested by the FDA from our Pompe Registry. The FDA has agreed that our Pompe Registry data can fulfill the requirements for a verification study to demonstrate the clinical benefit of Lumizyme.

        In addition, the FDA's CR Letter stated that before the FDA would approve Lumizyme, we would need to resolve issues identified in a Warning Letter related to our Allston facility that we received in February 2009, on the same day as the CR Letter. An FDA inspector inspected the plant in May 2009 as a follow up to the Warning Letter. At the end of July 2009, the FDA informed us that it will re-inspect our Allston facility to verify that all corrective and preventative actions identified in the February Warning Letter have been implemented. The FDA indicated that all promised actions had not been either fully or adequately implemented at the time of the May inspection, such as identifying measures to prevent column rouging; inspection and preventative maintenance, or PM, of remaining chromatography columns; revision of PM scheduled inspection to every six months for Chromaflow columns and an annual inspection for all other column types; revision of column packing records to include internal inspection; development of on the job training for preventative maintenance and division of maintenance responsibility; and implementation of the revised transfer/transport procedures for cryoshippers. In addition, recent remediation of the Allston facility in response to the Vesivirus 2117 contamination employed cleaning procedures using sodium hypochlorite and vaporized hydrogen peroxide treatment of columns. The cleaning validation will be reviewed during the next inspection along with our investigation and other remediation efforts related to the identification of the virus at our Allston facility. We will work with the FDA to schedule the re-inspection as soon as possible.

        In order to provide more capacity in our Allston facility for Cerezyme and Fabrazyme, we have transitioned all Myozyme/Lumizyme production to our 4000L Belgium facility and are no longer manufacturing the product at the 2000L scale. FDA approval of the 4000L process will be necessary to expand supply and support an increase in U.S. sales. We will begin to transition U.S. patients in the Myozyme Temporary Access Program from the product produced at the 2000L scale to that produced at the 4000L scale and will provide 4000L data to the FDA to support this transition. The FDA's target action date under the Prescription Drug User Fee Act, or PDUFA, for Lumizyme is November 14, 2009. We expect to submit a supplemental BLA for the 4000L process upon approval of Lumizyme. We anticipate a four-month FDA review of the supplemental BLA, and if the FDA acts by the PDUFA date, a potential approval for the 4000L product by the end of March 2010.Euro,


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against the U.S. dollar, positively impacted Fabrazyme revenue by $2.1 million for the three months ended March 31, 2010.

        The Cerezyme and Fabrazyme supply constraints resulting from the suspension of production at our Allston facility have created opportunities for our competitors and our future sales may be negatively affected by competitive products that are being developed by Shire Human Genetic Therapies Inc., or Shire, and Protalix Biotherapeutics Ltd., or Protalix. After our products experienced supply constraints, Shire and Protalix were able to offer their developmental therapies for the treatment of Gaucher disease to patients in the United States through an FDA-approved treatment investigational new drug application, or IND, protocol and to patients in the European Union and other countries through pre-approval access programs. Shire submitted a new drug application, or NDA, to the FDA for its therapy in August 2009 and a Market Authorization Application, or MAA, to the European Medicines Agency, or EMA, in November 2009. Shire received marketing approval for its therapy from the FDA in late February 2010 and announced that it will price this therapy at a 15% savings over Cerezyme. Protalix submitted its NDA to the FDA in December 2009. Outside of the United States, Fabrazyme currently competes with Replagal, a product marketed by Shire. The FDA, however, has approved a treatment IND for Replagal and Shire has submitted a biologics license application, or BLA, with the FDA for this product and been granted "fast track" designation.

        We expectare aware that some Gaucher and Fabry patients have switched to one of our competitors' therapies during the period of supply constraint and there is a risk that they may not switch back to our products, which would result in the loss of additional revenue for us. In April 2010, the EMA advised physicians to consider switching Fabry disease patients from Fabrazyme to Replagal based on its concerns that certain patients were not tolerating reduced dosages of Fabrazyme. We also have encouraged patients to switch to competitors products during the period of supply constraint. These actions may result in additional patients switching to our competitors' therapies. In addition, the institution of treatment guidelines and dose conservation measures during the supply constraint present the risk that physicians and patients will not resume prior treatment or dosage levels after the supply constraint has ended, potentially resulting in further loss of revenue for us.

Myozyme/Lumizyme

        Myozyme salesrevenue increased for the three months ended March 31, 2010 due to increased patient identification outside of the United States following the European approval in Europe to continue to increase throughoutFebruary 2009 of the second half of 2009. We have begun preparations to add a third 4000L bioreactor toproduct produced at our Belgium facility using the 4000L scale process. The strengthening of foreign currencies, primarily the Euro, against the U.S. dollar, positively impacted Myozyme revenue by $3.8 million for the three months ended March 31, 2010.

        We have provided alglucosidase alfa free of charge since 2007 under a temporary access program, and in December 2009 we agreed with the FDA to help support Myozyme's growth overwork with the longer term.81 active study sites in the United States to enroll additional patients into this program. We anticipate that this bioreactor will be approvedplan to keep open the temporary access program until commercial approval of Lumizyme produced using the 4000L scale process in the United States. We are currently providing therapy free of charge to more than 200 patients in the United States. We have received a June 17, 2010 PDUFA date in connection with our supplemental BLA for commercial productionLumizyme produced at the 4000L scale. If the FDA approves Lumizyme, we would expect revenues for the product to increase in mid-2011.2011.

Aldurazyme

        Aldurazyme revenue increased slightly for the three and six months ended June 30, 2009March 31, 2010 due to increased patient identification worldwide as Aldurazyme was introduced into new markets. The weakeningstrengthening of foreign currencies, primarily the Euro, against the U.S. dollar, adverselypositively impacted Aldurazyme revenue by $3.6$1.7 million for the three months ended June 30, 2009 and $7.2 million for the six months ended June 30, 2009.March 31, 2010.


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Other Personalized Genetic Health

        Other Genetic DiseasesPGH product revenue increased for the three and six months ended June 30, 2009March 31, 2010, primarily due to an increase inincreased sales of Elaprase driven byattributable to the continued identification of new patients and thein our territories. The strengthening of foreign currencies, primarily the Japanese yenEuro, against the U.S. dollar, which positively impactedhad no significant impact on Other PGH product revenue by $0.7 million for the three months ended June 30, 2009 and $1.8 million for the six months ended June 30, 2009.March 31, 2010.

CardiometabolicRenal and RenalEndocrinology

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 
 
 (Amounts in thousands)
 

Renagel/Renvela (including sales of bulk sevelamer)

 $175,398 $168,567 $6,831  4%$345,997 $337,261 $8,736  3%

Hectorol

  28,981  30,852  (1,871) (6)% 62,011  59,928  2,083  3%

Thyrogen

  42,860  39,448  3,412  9% 81,686  73,233  8,453  12%

Other Cardiometabolic and Renal

  710  332  378  >100% 1,192  569  623  >100%
                    
 

Total Cardiometabolic and Renal

 $247,949 $239,199 $8,750  4%$490,886 $470,991 $19,895  4%
                    

        In October 2007, the FDA granted marketing approval for Renvela, a second generation buffered form of Renagel, for the control of serum phosphorus in patients with CKD on dialysis. In March 2008, we launched Renvela tablets in the United States.

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 
 
 (Amounts in thousands)
  
 

Renagel/Renvela (including sales of bulk sevelamer)

 $164,607 $170,599 $(5,992) (4)%

Hectorol

  42,025  33,030  8,995  27%

Thyrogen

  45,625  38,826  6,799  18%
           
 

Total Renal and Endocrinology

 $252,257 $242,455 $9,802  4%
           

        Sales of Renagel/Renvela, including sales of bulk sevelamer, increaseddecreased for the three and six months ended June 30, 2009March 31, 2010, primarily due to increased end-user demandthe effect of Renagel pricing in Brazil and Renagel price increasesthe conversion of patients to Renvela in the United States after the second quarter of 2008,States. These effects were offset, in part, by increased end-user demand. In 2009, we decreased the price decreases outside of Renagel in Brazil in connection with successfully negotiating a government tender in the face of competition from two similar products that had been approved in that country. Total revenue for Renagel/Renvela, including sales of bulk sevelamer, reflects the increasing percentage of Renvela sales within the United States which adversely impacted revenue.States. The weakeningstrengthening of foreign currencies, primarily the Euro, against the U.S. dollar, adverselypositively impacted Renagel revenue by $11.3$6.4 million for the three months ended June 30,March 31, 2010.

        We manufacture the majority of our supply requirements for sevelamer hydrochloride (the active ingredient in Renagel) and sevelamer carbonate (the active ingredient in Renvela) at our manufacturing facility in Haverhill, England. In December 2009, equipment failure caused an explosion and $24.2 million forfire at this facility, which damaged some of the six months ended June 30, 2009equipment used to produce these active ingredients as well as the building in which the equipment was located. As a result, we have temporarily suspended production of sevelamer hydrochloride and had no impact on salessevelamer carbonate at this facility while repairs are made. We resumed production of Renvela.

        In June 2009, the European Commission approved Renvela for the control of serum phosphorussevelamer hydrochloride in patients with CKD. The approval includes patients not on dialysis with serum phosphorus levels³1.78 mmol/L (5.5mg/dL) and covers both the tablet and powder formulations.

        In October 2007, an FDA advisory committee voted to recommendMay 2010. We anticipate that the agency extend the indications for phosphate binders to include patients with hyperphosphatemia who have not progressed to dialysis. In June 2008, we and two other companies submitted a position paper to the FDA regarding the expanded usefacility will resume production of phosphate binders and we have been in discussions with the FDA regarding the treatment of hyperphosphatemic CKD patients not on dialysis. There is no PDUFA date associated with this process and we cannot provide an anticipated timeframe for the FDA's decision on this indication. We expect FDA approval of a powder formulation of Renvela for CKD patients on dialysis during the second half of 2009.


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        Sales of Hectorol decreased for the three months ended June 30, 2009 primarily due to an increase in the returns reserve for Hectorol based on our recent experience with returns for the product, offset in part by an increase in revenue due to a price increasesevelamer carbonate in the fourth quarter of 2008.2010. We believe that we have adequate supply levels to meet the current demand for both Renagel and Renvela and do not anticipate there will be any supply constraints for either product while the facility undergoes repairs. During the first quarter of 2010, we recorded a total of $7.5 million of expenses, net of $3.0 million of insurance reimbursements, to cost of products sold in our consolidated statements of operations for Renagel and Renvela related to the remediation cost of our Haverhill, England manufacturing facility, including repairs and idle capacity expenses.

        Sales of Hectorol increased for the sixthree months ended June 30, 2009March 31, 2010, primarily due to a price increase in the fourth quarter of 2008. We implemented a 9% price increase in June 2009, which did not have a significant impact on Hectorol revenue for the three and six months ended June 30, 2009.

        We expect sales of Renagel/Renvela to continue to increase. Adoption rates for Renagel/Renvela are expected to trend favorably as a result of the introduction of Renvela globally, including in Europe for hyperphosphatemic patients who are not on dialysis and in a powder formulation, the potential label expansion in the United States to include hyperphosphatemic patients who are not on dialysis, and the introduction of a powder formulation in the United States expectedincreases in the second halfand fourth quarters of 2009. Sales of Hectorol also include an increase in sales volume due to the addition of the Hectorol 1mcg capsule formulation in August 2009.

        Renagel/Renvela and Hectorol currently compete with several other marketed products and our future sales may be impactedwill have additional competitors in the future. Competitive products, especially if they are lower cost generic or follow-on products, will negatively by these products. Renagel, impact the revenues we recognize from Renagel/Renvela and Hectorol are also subjects of Abbreviated New Drug Applications, or ANDAs, containing "Paragraph IV certifications," which is the filing a generic drug manufacturer uses to challenge the applicability of one or more Orange Book-listed patents in order to seek U.S. regulatory approval to market a generic version of a drug prior to the expiration date of those patents.Hectorol. See "Some of our products may face competition from lower cost generic or follow-on products," under the heading "Risk Factors" below. If any


Table of the ANDA filers or any other generic drug manufacturer were to receive approval to sell a generic version of Renagel/Renvela or Hectorol, our revenues from those products would be adversely affected.Contents

        In addition, our ability to maintain sales of Renagel/Renvela and Hectorol will depend on many other factors, including the ability of health care providers to improve patients' compliance with their prescribed doses and the availability of coverage and reimbursement under patients' health insurance and prescription drug plans including underand the Medicare Part D program in the United States.ability of health care providers to improve patients' compliance with their prescribed doses. Also, the accuracy of our estimates of fluctuations in the payor mix and our ability to effectively manage wholesaler inventories and the levels of compliance with the inventory management programs we implemented for Renagel/Renvela and Hectorol with our wholesalers could impact the revenue from our CardiometabolicRenal and RenalEndocrinology reporting segment that we record from period to period.

        The Medicare Improvements for Patients and Providers Act of 2008, or MIPPA, directs the Centers for Medicare and Medicaid Services, or CMS, to establish a bundled payment system to reimburse dialysis providers treating patients with end stage renal disease, or ESRD. In September 2009, CMS proposed changes to the prospective payment system that would include drugs and biologicals used to treat ESRD in the bundled payment amount for dialysis treatments. The bundled rate is proposed to include drugs and biologicals that are currently reimbursed separately by Medicare, including intravenous Vitamin D analogs and their oral equivalents such as Hectorol, and oral phosphate binders such as Renagel/Renvela. CMS will issue a final rule in 2010 with an anticipated implementation date of January 2011. We are in the process of evaluating the potential impact of the proposed bundling on our business. We cannot predict whether CMS's final rule would include phosphate binders in the bundled payment.

Sales of Thyrogen increased for the three and six months ended June 30, 2009March 31, 2010, primarily due to worldwide volume growth, driven by a significantan increase in the use of the product in thyroid remnant ablation procedures.procedures and a price increase in July 2009. The weakeningstrengthening of foreign currencies, primarily the Euro, against the U.S. dollar, adverselypositively impacted Thyrogen revenue by $2.6$1.5 million for the three months ended June 30,March 31, 2010. As described above, we are negotiating a consent decree with the FDA with respect to our Allston facility, where Thyrogen is fill-finished. The FDA has made a preliminary determination that Thyrogen does not meet the FDA's definition of "medical necessity" that would justify continued production at Allston during the enforcement period, and may require us to cease fill-finishing the product when we enter into the consent decree. During our negotiations with the FDA, we are presenting our view that there is patient need for uninterrupted supply of Thyrogen. In October 2009, we initiated a process to transfer Thyrogen fill-finish operations to a contract manufacturer. Depending on the timing and $5.1 millionterms of the final consent decree and the time required to receive FDA approval for the six months ended June 30, 2009.our contract manufacturer, we could experience supply constraints for Thyrogen.

Biosurgery

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 
 
 (Amounts in thousands)
 

Synvisc/Synvisc-One

 $82,417 $70,927 $11,490  16%$145,588 $127,069 $18,519  15%

Sepra products

  36,038  34,780  1,258  4% 70,342  65,384  4,958  8%

Other Biosurgery

  8,658  13,392  (4,734) (35)% 20,311  26,973  (6,662) (25)%
                    
 

Total Biosurgery

 $127,113 $119,099 $8,014  7%$236,241 $219,426 $16,815  8%
                    

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 
 
 (Amounts in thousands)
  
 

Synvisc/Synvisc-One

 $79,507 $63,171 $16,336  26%

Sepra products

  37,177  34,304  2,873  8%

Other Biosurgery

  9,577  11,653  (2,076) (18)%
           
 

Total Biosurgery

 $126,261 $109,128 $17,133  16%
           

        Biosurgery product revenue increased for the three and six months ended June 30, 2009. Revenue fromMarch 31, 2010, primarily due to increased sales for Synvisc/Synvisc-One increased for the three and six months ended June 30, 2009 primarily due to the addition of Synvisc-One sales in the United States. We received marketing approval for Synvisc-One in the United States in February 2009.


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        Sepra products revenue increased for the three and six months ended June 30, 2009 primarily due to greater penetration of Seprafilm into the United States, Japan and Europe and the expanded use of Seprafilm in C-sections and gynecological procedures.

        Other Biosurgery product revenue decreased for the three and six months ended June 30, 2009 primarily due to a decrease in milestone revenue associated with the development and commercialization of dermal filler products with Mentor Corporation.

The weakeningstrengthening of foreign currencies, primarily the Euro, against the U.S. dollar, adverselypositively impacted Biosurgery product revenue by $1.9$1.6 million for the three months ended June 30, 2009March 31, 2010. Sales of Synvisc/Synvisc-One are subject to seasonality in demand and $3.2 million for the six months ended June 30, 2009.

Hematologic Oncology

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 
 
 (Amounts in thousands)
 

Hematologic Oncology

 $54,786 $26,019 $28,767  >100%$88,764 $48,300 $40,464  84%
                    

        Hematologic Oncology product revenue increased for the three and six months ended June 30, 2009 primarily due to the addition of sales of Mozobiltypically decline in the United States, increased demand for Clolar in the United States, and the addition of sales of Fludara and Leukine in the second quarter of 2009. The weakening of foreign currencies against the U.S. dollar adversely impacted Hematologic Oncology product revenue by $1.1 million for the three months ended June 30, 2009 and $2.2 million for the six months ended June 30, 2009.first quarter.

        We are developing the intravenous formulation of clofarabine for new indications, including first-line and relapsed or refractory adult AML. In November 2008, we filed a supplemental New Drug Application, or NDA, with the FDA for the use of Clolar to treat previously untreated adults age 60 years or older with AML who have at least one unfavorable prognostic factor. FDA action is expected in the second half of 2009. We have discussed our adult AML development plans with the European Medicines Agency's Committee for Human Medicinal Products, or CHMP, and based on the CHMP's feedback, await the availability of additional data before seeking approval for this indication in Europe. We are also developing an oral formulation of clofarabine and have initiated clinical trials for the treatment of myelodysplastic syndrome, or MDS. Clofarabine has been granted orphan drug status for the treatment of ALL and AML in both the United States and the European Union.

        Mozobil was approved in the United States by the FDA in December 2008 for stem cell mobilization in patients with non-Hodgkin's lymphoma and multiple myeloma for autologous stem cell transplants. On July 31, 2009, the European Commission approved our marketing authorization application for Mozobil in Europe. In Europe, Mozobil is indicated to enhance stem cell mobilization in preparation for autologous stem cell transplants in patients with lymphoma and multiple myeloma whose cells mobilize poorly.

Other Product Revenue

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 
 
 (Amounts in thousands)
 

    

                         
 

Total Other product revenue

 $117,424 $115,190 $2,234  2%$231,600 $232,345 $(745)  
                    

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        OtherHematology and Oncology

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 
 
 (Amounts in thousands)
  
 

Mozobil

 $18,966 $10,837 $8,129  75%

Thymoglobulin

  52,910  50,655  2,255  4%

Clolar

  24,688  18,160  6,528  36%

Other Hematology and Oncology

  59,727  6,992  52,735  >100%
           

    Total Hematology and Oncology

 $156,291 $86,644 $69,647  80%
           

        Hematology and Oncology product revenue increased for the three months ended June 30, 2009March 31, 2010, primarily due to:

The strengthening of foreign currencies, primarily due to an increase in Thymoglobulin sales, partially offsetthe Euro, against the U.S. dollar, positively impacted Hematology and Oncology revenue by a decrease in demand for pharmaceutical products. Sales of Thymoglobulin increased by $8.4$2.2 million for the three months ended June 30, 2009 primarily due to an increase in sales volume resulting from increased utilization of Thymoglobulin in transplant procedures worldwide and a constraint in supply for the three months ended June 30, 2008.March 31, 2010.

Other Product Revenue

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 
 
 (Amounts in thousands)
  
 

Total Other product revenue

 $44,332 $49,094 $(4,762) (10)%
           

        Other product revenue decreased for the sixthree months ended June 30, 2009March 31, 2010, primarily due to a decrease indecreased demand for pharmaceutical intermediates products, partially offset, in part, by an increase in sales of transplant products primarily due to an increase in Thymoglobulin sales. Sales of Thymoglobulin increased by $15.7 milliondemand for the six months ended June 30, 2009 primarily due to an increase in sales volume resulting from increased utilization of Thymoglobulin in transplant procedures worldwide and a constraint in supply for the six months ended June 30, 2008.diagnostic products.

Service Revenue

        We derive service revenues primarily from the following sources:


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        The following table sets forth our service revenue on a segment basis (amounts in thousands):

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Genetic Diseases

 $ $167 $(167) (100)%$25 $343 $(318) (93)%

Cardiometabolic and Renal

  43  1  42  >100% 55  15  40  >100%

Biosurgery

  11,344  11,298  46    21,176  22,030  (854) (4)%

Hematologic Oncology

  292  424  (132) (31)% 737  834  (97) (12)%

Other service revenue

  94,014  78,732  15,282  19% 185,199  153,264  31,935  21%
                    
 

Total service revenue

 $105,693 $90,622 $15,071  17%$207,192 $176,486 $30,706  17%
                    

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 

Personalized Genetic Health

 $20 $37 $(17) (46)%

Biosurgery

  10,546  9,832  714  7%

Hematology and Oncology

    445  (445) (100)%

Other service revenue

  91,349  91,185  164   
           
 

Total service revenue

 $101,915 $101,499 $416   
           

        Other serviceService revenue increasedwas relatively consistent for the three and six months ended June 30, 2009March 31, 2010 as compared to the same period of 2009. The strengthening of foreign currencies, primarily due to continued growth in sales of genetic testing and prenatal screening services as well as higher demandthe Euro, against the U.S. dollar, had no significant impact on service revenue for certain testing services for patients diagnosed with cancer.


Table of Contentsthe three months ended March 31, 2010.

International Product and Service Revenue

        A substantial portion of our revenue is generated outside of the United States. The following table provides information regarding the change in international product and service revenue as a percentage of total product and service revenue during the periods presented (amounts in thousands):

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

International product and service revenue

 $606,988 $623,237 $(16,249) (3)%$1,158,100 $1,187,364 $(29,264) (2)%

% of total product and service revenue

  50% 54%       49% 53%      

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 

International product and service revenue

 $513,459 $551,111 $(37,652) (7)%

% of total product and service revenue

  48% 48%      

        International product and service revenue decreased for the three and six months ended June 30, 2009March 31, 2010, primarily due to a decrease in international sales volume for Cerezyme and Fabrazyme for the weakeningthree months ended March 31, 2010 due to supply constraints.

        This decrease was offset, in part, by:


Table of Cerezyme, Fabrazyme, Myozyme, Aldurazyme, Elaprase, Synvisc, Campath, Clolar/Evoltra, Thymoglobulin and the addition of sales of Fludara.Contents

Research and Development Revenue

        The following table sets forth our research and development revenue on a segment basis (amounts in thousands):

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Cardiometabolic and Renal

 $8 $85 $(77) (91)%$21 $117 $(96) (82)%

Biosurgery

  870  818  52  6% 1,432  1,421  11  1%

Hematologic Oncology

  852  1,903  (1,051) (55)% 2,336  3,092  (756) (24)%

Other research and development revenue

  5,165  5,463  (298) (5)% 12,738  11,185  1,553  14%

Corporate

  497  442  55  12% 993  825  168  20%
                    
 

Total research and development revenue

 $7,392 $8,711 $(1,319) (15)%$17,520 $16,640 $880  5%
                    

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 

Renal and Endocrinology

 $166 $13 $153  >100%

Biosurgery

  559  562  (3) (1)%

Hematology and Oncology

  19  1,484  (1,465) (99)%

Multiple Sclerosis

    7,291  (7,291) (100)%

Other

  189  282  (93) (33)%

Corporate

    496  (496) (100)%
           
 

Total research and development revenue

 $933 $10,128 $(9,195) (91)%
           

        Total research and development revenue decreased for the three months ended June 30, 2009March 31, 2010, primarily due to a decrease in revenue recognized by our Hematologic Oncology reporting segment and Other research and development revenue. Hematologic OncologyMultiple Sclerosis research and development revenue decreased due toas a result of our acquisition from Bayer and termination of the Campath profit share arrangement. Other research and development revenue decreased for the three months ended June 30, 2009 primarily due to our acquisition from Bayer. As of May 29, 2009, the effective date of our acquisition from Bayer, we ceased recognizing research and development revenue for Bayer's reimbursement of a portion of the development costs for alemtuzumab for MS. In accordance with the provisions of FAS 141R, theThe fair value of the research and development costs to be reimbursed by Bayer is accounted for as an offset to the contingent consideration obligations for alemtuzumab for MS.

        Total research and development revenue increased for the six months ended June 30, 2009 primarily due to an increase in Other research and development revenue resulting from an increase in spending for the development of alemtuzumab for MS under our collaboration with Bayer, and Bayer's reimbursement of a portion of these development expenses, particularly in the MS development program prior to May 29, 2009, the effective date of our acquisition from Bayer.


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GROSS PROFIT AND MARGINS

        The components of our total margins are described in the following table (amounts in thousands):

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Gross product profit

 $826,526 $830,458 $(3,932)  $1,628,208 $1,619,987 $8,221  1%

Product margin

  74% 77%       76% 78%      

Gross service profit

 $44,069 $31,635 $12,434  39%$85,318 $61,925 $23,393  38%

Service margin

  42% 35%       41% 35%      

Total gross product and service profit

 $870,595 $862,093 $8,502  1%$1,713,526 $1,681,912 $31,614  2%

Total product and service margin

  71% 74%       73% 75%      

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 

Gross product profit

 $691,886 $801,682 $(109,796) (14)%

Product margin

  71% 77%      

Gross service profit

 $36,043 $41,249 $(5,206) (13)%

Service margin

  35% 41%      

Total gross product and service profit

 $727,929 $842,931 $(115,002) (14)%

Total product and service margin

  68% 74%      

Gross Product Profit and Product Margin

        Our overall gross product profit decreased for the three months ended June 30, 2009 primarily due to $14.2 million of charges for the initial costs related to the remediation of our Allston facility, including the sanitization of the facility, idle capacity and overhead expenses while production at the plant was suspended and the write off of certain production materials, and $8.4 million of charges for the write off of 80% of the Cerezyme work-in-process material in inventory when production at the facility was suspended.

        Our overall gross product profit increased for the six months ended June 30, 2009March 31, 2010, primarily due to:


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These decreases were offset, in part, by:

        These increases were offset, in part, by the $14.2 million of charges for the initial costs related to the remediation of our Allston facility and the $8.4 million of charges for the write off of the Cerezyme work-in-process material recorded in June 2009.

        ProductOur product margin decreased for the three and six months ended June 30, 2009March 31, 2010, primarily due to:

        Our gross product profit and product margin for the three months ended March 31, 2010 were also impacted by the favorable effect of foreign exchange rates on product sales outside of the United States, offset, in part, by the unfavorable effect of such rates on the cost of those products.

        Our gross product profit and product margin for both the three months ended March 31, 2010 and 2009 includes the effect of manufacturing-related charges of:


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        For purposes of this discussion, the amortization of product related intangible assets is included in amortization expense and, as a result, is excluded from cost of products sold and the determination of product margins described above.

Gross Service Profit and Service Margin

        Our overall gross service profit increasedand total service margin decreased for the three and six months ended June 30, 2009March 31, 2010, primarily due to increases in Carticel revenueincreased employee, rent and revenue fromdepreciation expenses for our genetic testing and prenatal screening services in the area of molecular diagnostics.

        Total service margin increasedbusiness unit. Service revenue for our genetic testing business unit remained relatively consistent for the three and six months ended June 30, 2009 primarily due to the increase in revenue from our molecular diagnostics testing which is a higher margin product.March 31, 2010.

OPERATING EXPENSES

Selling, General and Administrative Expenses

        The following table provides information regarding the change in SG&A during the periods presented (amounts in thousands):

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Selling, general and administrative expenses

 $354,128 $347,305 $6,823  2%$672,089 $665,691 $6,398  1%

% of total revenue

  29% 30%       28% 29%      

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 

Selling, general and administrative expenses

 $553,310 $317,961 $235,349  74%

% of total revenue

  51% 28%      

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        SG&A increased for the three and six months ended June 30, 2009March 31, 2010, primarily due to spending increases of:

SG&A increased by $8.3 million for the three months ended June 30, 2009 and $9.0 million for the six months ended June 30, 2009 for Other, primarilyMarch 31, 2010 due to personnel additions and maintenance costs related to an internally developed enterprise software system in our genetics business unit; and

$3.3 million for the three months ended June 30, 2009 and $3.1 million forunfavorable impact of the six months ended June 30, 2009 for Corporate, primarily due to an increase in stock-based compensation expense.

        These increases were partially offset by decreases of $15.7 million for the three months ended June 30, 2009 and $30.7 million for the six months ended June 30, 2009 attributable to the weakeningstrengthening of foreign currencies, primarily the Euro, against the U.S. dollar.


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Research and Development Expenses

        The following table provides information regarding the change in research and development expenses during the periods presented (amounts in thousands):

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Research and development expenses

 $210,522 $381,861 $(171,339) (45)%$417,447 $644,658 $(227,211) (35)%

% of total revenue

  17% 33%       18% 28%      

 
 Three Months Ended March 31,  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 

Research and development expenses

 $220,930 $206,925 $14,005  7%

% of total revenue

  21% 18%      

        Research and development expenses decreased for the three and six months ended June 30, 2009 including a decrease of $5.3 millionincreased for the three months ended June 30, 2009 and a decrease of $10.2 million for the six months ended June 30, 2009March 31, 2010, primarily due to the weakening of foreign currencies against the U.S. dollar, as well as:to:

        These decreases were partially offset by spending increases of:

Research and development expense increased by $2.8 million for the three months ended June 30, 2009 and $29.1March 31, 2010 due to the unfavorable impact of the strengthening of foreign currencies, primarily the Euro, against the U.S. dollar.

        These increases were partially offset by a spending decrease of $17.2 million for the six months ended June 30, 2009 on research and development programs included under the category "Other," primarily due to a $9.9 million increase in spending for the development of alemtuzumab for MS for the three months ended June 30, 2009 and an $18.0 million increase in spending for the development of alemtuzumab for MS and a payment of $18.2 million to EXACT Sciences for the purchase of intellectual property in January 2009 for the six months ended June 30, 2009. These increases were partially offset by decreases in spending for our immune mediated disease business unit for the three and six months ended June 30, 2009; and

$5.4 millionwhich there was no comparable amount for the three months ended June 30, 2009 and $6.1 million for the six months ended June 30, 2009 for Corporate primarily due to an increase in stock-based compensation expense.
March 31, 2010.


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Amortization of Intangibles

        The following table provides information regarding the change in amortization of intangibles expense during the periods presented (amounts in thousands):

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Amortization of intangibles

 $63,945 $55,605 $8,340  15%$121,543 $111,263 $10,280  9%

% of total revenue

  5% 5%       5% 5%      

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease) % Change
 
 
 2010 2009 

Amortization of intangibles

 $70,984 $57,598 $13,386  23%

% of total revenue

  7% 5%      

        Amortization of intangibles expense increased for the three and six months ended June 30, 2009March 31, 2010, primarily due to the acquisition of the worldwide marketing and distribution rights to the oncology


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products Campath, Fludara and Leukine from Bayer and to additional amortization expense for the Synvisc sales and marketing rights we reacquired from Wyeth.

        As discussed in Note 8., "Goodwill and Other Intangible Assets," to our consolidated financial statements included in this report,Form 10-Q, we calculate amortization expense for the Synvisc sales and marketing rights we reacquired from Wyeth and the Myozyme patent and technology rights pursuant to a licensing agreement with Synpac by taking into account forecasted future sales of the products, and the resulting estimated future contingent payments we will be required to make. In addition, we also calculate amortization for the technology intangible assets for Fludara based on forecasted future sales of Fludara. We completed the contingent royalty payments to Wyeth related to North American sales of Synvisc in the first quarter of 2010 and anticipate completing the remaining contingent royalty payments to Wyeth related to sales of the product outside of the United States by the end of 2010, the amount of which is not significant. As a result, we expect amortization of intangibles expense to fluctuate over the next five years based on thesethe future contingent payments.payments to Synpac, as well as changes in the forecasted revenue for Fludara.

Contingent Consideration Expense

        The following table provides information regarding the change in contingent consideration expense during the periods presented (amounts in thousands):

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Contingent consideration expense

 $9,090 $ $9,090  N/A $9,090 $ $9,090  N/A 

% of total revenue

  1%                  

 
 Three Months Ended
March 31,
  
  
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 2010 2009

Contingent consideration expense

 $62,549 $ $62,549 N/A

% of total revenue

  6% N/A     

        During the three months endedIn June 30, 2009, in accordance with FAS 141R, we recorded contingent consideration obligations totaling $964.1 million for the estimated acquisition date fair value of the contingent royalty and milestone payments due to Bayer based on future sales and the successful achievement of certain sales volumes for Campath, Fludara and Leukine and for alemtuzumab for MS.

        Any change in the fair value of the contingent consideration obligations subsequent to the acquisition date, including changes from events after the acquisition date, such as changes in our estimates of the sales volume for these products, will be recognized in earnings in the period the estimated fair value changes. The fair value estimates are based on the probability weighted sales volumes to be achieved for Campath, Fludara, Leukine and for alemtuzumab for MS over the earn-out period for each product. A change in the fair value of the acquisition-related contingent consideration obligations could have a material affect on our statementconsolidated statements of operations and financial position in the period of the change in estimate.

        As of June 30, 2009,March 31, 2010, the fair value of the total contingent consideration obligations was $973.2 million. Accordingly, we recorded contingent consideration expenses totaling $9.1 million in our consolidated statements of operations for the three and six months ended June 30, 2009$1.03 billion primarily due to reflect the increasechanges in the fair value,assumed timing and amount of which $4.3 million was related to Campath, Fludararevenue and Leukine, and $4.8 million was related to alemtuzumab for MS.

Purchase of In-Process Research and Development

        Prior to January 1, 2009, IPR&D acquired through a business combination was expensed on the acquisition date in our consolidated financial statements. In accordance with our adoption of FAS 141R, all IPR&D we acquire through business combinations on or after January 1, 2009 will be capitalized as an intangible asset on our consolidated balance sheets and periodically tested for impairment.

        As a result of our acquisition from Bayer in May 2009, alemtuzumab for MS had not reached technological feasibility nor had an alternative future use and is therefore considered to be IPR&D. In accordance with FAS 141R, we recorded the fair value of the purchase price attributable to IPR&D as an indefinite-lived intangible asset on our consolidated balance sheet. We will test the asset annually forexpense


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impairment, or earlier if conditions warrant. Amortizationestimates. Accordingly, we recorded a total of this asset will begin upon regulatory approval based on$62.5 million of contingent consideration expenses, of which $35.5 million is related to changes in estimates, for the then estimated useful lifethree months ended March 31, 2010 in our consolidated statements of the asset.

        Management assumes responsibility for determining the IPR&D valuation. The fair value assigned to purchased IPR&D was estimated by discounting, to present value, the cash flows expected to result from the project once it has reached technological feasibility. We used a discount rate of 16% and cash flows that have been probability-adjustedoperations to reflect the risksincrease in the fair value, including $21.4 million for our Hematology and Oncology reporting segment and $41.1 million for our Multiple Sclerosis reporting segment.

Purchase of advancement through the product approval process, which we believe are appropriateIn-Process Research and representative of a market participant assumption. In estimating future cash flows, we also considered other tangible and intangible assets required for successful exploitation of the technology resulting from the purchased IPR&D project and adjusted future cash flows for a charge reflecting the contribution to value of these assets.Development

        The following table sets forth the significant IPR&D projects for the companies and assets we acquired between January 1, 2006 and June 30, 2009March 31, 2010 (amounts in millions):

Company/Assets Acquired
 Purchase
Price
 IPR&D Programs Acquired Discount Rate
Used in
Estimating
Cash Flows
 Year of
Expected
Launch
 Estimated
Cost to
Complete
 

Bayer (2009)

 $1,006.5 $415.6 alemtuzumab for MS—US  16% 2012 $349.5 

     217.3 alemtuzumab for MS—ex-US  16% 2013 $176.9 
                  

    $632.9(1)           
                  

Bioenvision (2007)

 $349.9 $125.5(2)Clolar/Evoltra (clofarabine)(3)  17% 2009-2013 $36.6 
                  

AnorMED (2006)

 $589.2 $526.8 Mozobil (stem cell transplant)(4)  15% 2009-2014 $26.6 

     26.1 AMD070(5)  15%  $ 
                  

    $552.9(2)           
                  

Company/Assets Acquired
 Purchase
Price
 IPR&D Programs Acquired Discount Rate
Used in
Estimating
Cash Flows
 Year of
Expected
Launch
 Estimated
Cost to
Complete
 

Bayer (2009)

 $1,006.5 $458.7 alemtuzumab for MS—US  16% 2012 $175.4(1)

     174.2 alemtuzumab for MS—ex-US  16% 2013 $88.8(2)
                  

    $632.9(3)           
                  

Bioenvision (2007)

 $349.9 $125.5(4)Clolar(5)  17% 2010-2016(6)$23.7 
                  

AnorMED (2006)

 $589.2 $526.8(4)Mozobil(7)  15% 2016 $18.3 
                  

(1)
Does not include anticipated reimbursements from Bayer totaling approximately $44 million.

(2)
Does not include anticipated reimbursements from Bayer totaling approximately $16 million.

(3)
Capitalized as an indefinite-lived intangible asset in accordance with FAS 141R.asset.

(2)(4)
Expensed on acquisition date in accordance with FAS 141.date.

(3)(5)
Clofarabine, whichClolar is approved for the treatment of relapsed and refractory pediatric ALL is marketed under the names Clolar and Evoltra.ALL. The IPR&D projects for clofarabineClolar are related to the development of the product for the treatment of other medical issues.

(4)(6)
Year of expected launch reflects both the ongoing launch of the products for currently approved indications and the anticipated launch of the products in the future for new indications.

(7)
Mozobil received marketing approval for use in stem cell transplants in the United States in December 2008 and in Europe in July 2009. Mozobil is also being developed for chemosensitization.

(5)
Year of expected launch is not provided for AMD070 at this time because we are assessing our future plans for this program.tumor sensitization.

OTHER INCOME AND EXPENSES

 
 Three Months Ended
June 30,
  
  
 Six Months Ended
June 30,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 
 
 (Amounts in thousands)
 

Gains (losses) on investments in equity securities, net

 $(105)$9,153 $(9,258) >(100)%$(681)$9,928 $(10,609) >(100)%

Gain on acquisition of business

  24,159    24,159  N/A  24,159    24,159  N/A 

Other

  (2,056) 582  (2,638) >(100)% (3,035) 1,073  (4,108) >(100)%

Investment income

  4,144  13,352  (9,208) (69)% 9,494  28,222  (18,728) (66)%

Interest expense

    (1,149) 1,149  100%   (2,804) 2,804  100%
                    
 

Total other income (expenses)

 $26,142 $21,938 $4,204  19%$29,937 $36,419 $(6,482) (18)%
                    

 
 Three Months Ended
March 31,
  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2010 2009 
 
 (Amounts in thousands)
  
 

Equity in loss of equity method investments

 $(697)  $(697) N/A 

Other

  (439) (1,555) 1,116  72%

Investment income

  3,300  5,350  (2,050) (38)%
           
 

Total other income

 $2,164 $3,795 $(1,631) (43)%
           

Equity in Loss of Equity Method Investments

        Effective January 1, 2010, in accordance with changes in the guidance related to how we account for variable interest entities, we were required to reassess our designation as primary beneficiary of BioMarin/Genzyme LLC based on a control-based approach. Under this approach, an entity must have the power to direct the activities that most significantly impact a variable interest entity's economic performance in order to meet the requirements of a primary beneficiary. We have concluded that


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Gains (Losses) on InvestmentsBioMarin/Genzyme LLC is a variable interest entity, but does not have a primary beneficiary because the power to direct the activities of BioMarin/Genzyme LLC that most significantly impact its performance, is, in Equity Securities, Net

        Infact, shared equally between us and BioMarin through our commercialization rights and BioMarin's manufacturing rights. Effective January 1, 2010, we no longer consolidate the second quarterresults of 2008, we recorded a $10.3 million gain resulting fromBioMarin/Genzyme LLC and instead record our portion of the liquidationresults of our investmentBioMarin/Genzyme LLC in the common stockequity in loss of Sirtris for net cash proceeds of $14.8 million.

        At June 30, 2009, our stockholders' equity includes $11.7 million of unrealized gains and $7.4 million of unrealized losses related to our strategicmethod investments in equity securities.

Gain on Acquisitionour consolidated statements of Business

        We recorded a gain on acquisition of business of $24.2 million for the three and six months ended June 30, 2009 related to our acquisition of the worldwide rights to the oncology products Campath, Fludara and Leukine and alemtuzumab for MS from Bayer. The fair value of the identifiable assets acquired of $1.03 billion exceeded the fair value of the purchase price for the transaction of $1.01 billion.operations.

Investment Income

        Our investment income decreased for the three and six months ended June 30, 2009March 31, 2010 primarily due to a decrease in our average portfolio yield and lower average cash and investment balances.

Interest Expense

        Our interest expense decreased to zero for the three and six months ended June 30, 2009 primarily due to the redemption of $690.0 million in principal of our 1.25% convertible senior notes on December 1, 2008.

PROVISION FORBENEFIT FROM (PROVISION FOR) INCOME TAXES

 
 Three Months Ended
June 30,
  
  
 Six Months Ended June 30,  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 
 
 (Amounts in thousands)
 

Provision for income taxes

 $78,870 $38,407 $40,463  >100%$157,754 $98,524 $59,230  60%

Effective tax rate

  30% 36%       29% 31%      

 
 Three Months Ended
March 31,
 
 
 2010 2009 
 
 (Amounts in thousands)
 

Benefit from (provision for) income taxes

 $61,799 $(78,884)

Effective tax rate

  35% 29%

        Our effective tax rate for allboth periods presented varies from the U.S. statutory tax rate as a result of:

In addition, our provision for income taxes for both the three and six months ended June 30, 2009 includes $5.3 million of income tax benefits resulting from the reversal of a portion of our U.S. tax reserves due to a remeasurement, in accordance with the provisions of FIN 48, based on new information discovered during the second quarter of 2009.

        We are currently under IRS audit by various states and foreign jurisdictions for the tax years 2006 to 2007.various years. We believe that we have provided sufficiently for all audit exposures. We expect to settle the 2006 to 2007 IRS audit within the next


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twelve months and do not expect that the settlement will have a material impact on our financial position or results of operations. Settlement of these audits or the expiration of the statute of limitations on the assessment of income taxes for any tax year maywill likely result in a reduction of future tax provisions. Any such benefit would be recorded upon final resolution of the audit or expiration of the applicable statute of limitations.

        On May 4, 2009, U.S. President Barack Obama proposed significant changes to the U.S. international tax laws that would limit U.S. deductions for expenses related to un-repatriated foreign-source income and modify the U.S foreign tax credit and "check-the-box" rules. We cannot determine whether these proposals will be enacted into law or what, if any, changes may be made to such proposals prior to their being enacted into law. If the U.S. tax laws change in a manner that increases our tax obligation, our results of operations could suffer.

LIQUIDITY AND CAPITAL RESOURCES

        We continue to generate cash from operations. We had cash, cash equivalents and short-and long-term investments of $961.7 million at March 31, 2010 and $1.05 billion at June 30, 2009 and $973.7 million at December 31, 2008.2009.


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        The following is a summary of our statements of cash flows for the sixthree months ended June 30, 2009March 31, 2010 and 2008:2009:

Cash Flows from Operating Activities

        Cash flows from operating activities are as follows (amounts in thousands):

 
 Six Months Ended
June 30,
 
 
 2009 2008 

Cash flows from operating activities:

       

Net income

 $383,060 $214,835 

Non-cash charges, net

  273,017  122,159 

Decrease in cash from working capital changes (excluding impact of acquired assets and assumed liabilities)

  (55,731) (157,685)
      
 

Cash flows from operating activities

 $600,346 $179,309 
      

 
 Three Months Ended
March 31,
 
 
 2010 2009 

Cash flows from operating activities:

       

Net income (loss)

 $(114,948)$195,486 

Non-cash charges, net

  210,142  130,775 
      

Net income, excluding net non-cash charges

  95,194  326,261 

Increase (decrease) in cash from working capital changes

  31,270  (68,486)
      
 

Cash flows from operating activities

 $126,464 $257,775 
      

        Cash provided by operating activities increaseddecreased $131.3 million for the sixthree months ended June 30, 2009, primarilyMarch 31, 2010, driven by a $168.2$231.1 million increasedecrease in net income, asexcluding net non-cash charges, offset, in part, by a result of$99.8 million decrease in working capital, primarily due to the Cerezyme and Fabrazyme supply constraints and a $244.9corresponding reduction in collection activities for these products.

        Non-cash charges, net, increased by $79.4 million charge to research and development expense infor the sixthree months ended June 30, 2008 for the license fee we paid to Isis in exchange for the exclusive worldwide rights to mipomersen, compared to an $18.2 million charge to research and development in the six months ended June 30, 2009 for the intellectual property we acquired from EXACT Sciences in January 2009. Operating activities were also impacted by a $102.0 million increase in cash used for working capital and a $150.9 million increase in non-cash charges, net. The increase in non-cash charges, net, for the six months ended June 30, 2009, as compared to the same period of 2008, isMarch 31, 2010, primarily attributable to:


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These increases were offset, in part, by a $24.2 million gain on acquisition of business recorded in June 2009 related to our acquisition of the worldwide rights to Campath, Fludara, Leukine and alemtuzumab for MS from Bayer.

Cash Flows from Investing Activities

        Cash flows from investing activities are as follows (amounts in thousands):

 
 Six Months Ended
June 30,
 
 
 2009 2008 

Cash flows from investing activities:

       

Net sales of investments, excluding investments in equity securities

 $86,345 $30,629 

Net purchases of investments in equity securities

  (5,890) (65,303)

Purchases of property, plant and equipment

  (318,324) (251,785)

Distributions from equity method investments

    6,595 

Acquisitions, net of acquired cash

  (117,073)  

Purchases of other intangible assets

  (18,345) (75,400)

Other investing activities

  (5,198) 2,571 
      
 

Cash flows from investing activities

 $(378,485)$(352,693)
      

 
 Three Months Ended
March 31,
 
 
 2010 2009 

Cash flows from investing activities:

       

Net sales (purchases) of investments, excluding investments in equity securities

 $(14,323)$61,766 

Net purchases of investments in equity securities

  (225) (3,606)

Purchases of property, plant and equipment

  (152,220) (161,561)

Investments in equity method investment

  (1,466)  

Purchases of other intangible assets

  (5,885) (8,056)

Other investing activities

  (10,547) (47)
      
 

Cash flows from investing activities

 $(184,666)$(111,504)
      

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        For the sixthree months ended June 30, 2009,March 31, 2010, net purchases of capital expenditures accounted for significant cash outlays for investing activities. During the sixthree months ended June 30, 2009,March 31, 2010, we used $318.3$152.2 million in cash to fund the purchase of property, plant and equipment, primarily related to the ongoing expansion of our manufacturing capacity in the Republic of Ireland, France and Belgium, planned improvements at our Allston facility, the additional manufacturing capacity we are constructing in Framingham, Massachusetts and capitalized costs of an internally developed enterprise software system. In addition, we used $117.1 million in connection with our acquisition of the worldwide rights to Campath, Fludara, Leukine and alemtuzumab for MS from Bayer, of which $74.6 million is refundable and a majority of which was received in July 2009. The remaining $42.4 million represents a payment for inventory.

        For the sixthree months ended June 30, 2008,March 31, 2009, investing activities used:

the Republic of Ireland and France, planned improvements at our Allston facility and capitalized costs of an internally developed enterprise software system.

Cash Flows from Financing Activities

        Cash flows from financing activities are as follows (amounts in thousands):

 
 Six Months Ended June 30, 
 
 2009 2008 

Cash flows from financing activities:

       

Proceeds from the issuance of our common stock

 $53,508 $127,008 

Repurchases of our common stock

  (107,134) (143,012)

Excess tax benefits from stock-based compensation

  4,424  8,647 

Payments of debt and capital lease obligations

  (4,305) (3,886)

Increase (decrease) in bank overdrafts

  (14,303) 29,309 

Other financing activities

  3,660  2,804 
      
 

Cash flows from financing activities

 $(64,150)$20,870 
      


 
 Three Months Ended
March 31,
 
 
 2010 2009 

Cash flows from financing activities:

       

Proceeds from the issuance of our common stock

 $30,075 $34,526 

Repurchases of our common stock

    (107,134)

Excess tax benefits from stock-based compensation

  (480) 3,492 

Payments of debt and capital lease obligations

  (3,092) (2,653)

Decrease in bank overdrafts

  (20,728) (3,392)

Payment of contingent consideration obligations

  (31,600)  

Other financing activities

  116  1,995 
      
 

Cash flows from financing activities

 $(25,709)$(73,166)
      

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        Cash providedused by financing activities decreased by $85.0$47.5 million for the sixthree months ended June 30,March 31, 2010, as compared to the same period of 2009, primarily driven by a $73.5 million decrease in proceeds from the issuance of our common stock due to fewer stock option exercises, offset by a $35.9$107.1 million decrease in cash used to repurchase shares of our common stock under theour stock repurchase program described below.

        In May 2007, our board of directors authorized a stock repurchase programoffset by $31.6 million in contingent consideration payments to repurchase up to an aggregate maximum amount of $1.50 billion or 20,000,000 shares of our outstanding common stock over aBayer in the three year period that began in June 2007. The repurchases are being made from time to time and can be effectuated through open market purchases, privately negotiated transactions, transactions structured through investment banking institutions, or by other means, subject to management's discretion and as permitted by securities laws and other legal requirements. During the six months ended June 30, 2009, we repurchased 2,000,000 sharesMarch 31, 2010, for which there were no comparable payments for the same period of our common stock under this program at an average price of $53.55 per share for a total of $107.1 million in cash, including fees. Since June 2007, when we first began repurchasing shares of our common stock under this program, we have repurchased a cumulative total of 7,500,000 shares of our common stock at an average price of $64.21 per share for a total of $481.7 million in cash, including fees.2009.

Revolving Credit Facility

        As of June 30, 2009,March 31, 2010, we had approximately $12$11 million of outstanding standby letters of credit issued against this facility and no borrowings, resulting in approximately $338$339 million of available credit under our five-year $350.0 million senior unsecured2006 revolving credit facility, which matures July 14, 2011. The terms of this credit facility include various covenants, including financial covenants that require us to meet minimum interest coverage ratios and maximum leverage ratios. As of June 30, 2009,March 31, 2010, we were in compliance with these covenants.

Contractual Obligations

        AsThe disclosure of June 30, 2009,payments we hadhave committed to make the following payments under our contractual obligations (amountsis set forth in millions):

 
 Payments Due by Period 
Contractual Obligations
 Total July 1, 2009
through
December 31, 2009
 2010 2011 2012 2013 After 2013 

Long-term debt obligations(1)

 $23.6 $0.2 $1.6 $1.6 $1.7 $1.8 $16.7 

Capital lease obligations(1)

  157.5  7.8  15.5  15.5  15.5  16.8  86.4 

Operating leases(1)

  267.0  33.8  53.8  39.1  29.1  16.5  94.7 

Contingent payments(2)

  1,951.2  143.7  236.8  148.5  97.5  287.8  1,036.9 

Interest obligations(3)

  9.4  0.5  1.1  1.1  1.0  0.9  4.8 

Defined pension benefit plans payments

  20.0  0.6  1.2  1.3  1.5  1.7  13.7 

Unconditional purchase obligations

  191.0  29.7  56.4  56.4  48.5     

Capital commitments(4)

  716.9  317.2  264.4  78.8  56.5     
                
 

Total contractual obligations

 $3,336.6 $533.5 $630.8 $342.3 $251.3 $325.5 $1,253.2 
                

(1)
See Note L., "Long-term DebtItem 7. "Management's Discussion and Leases"Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations—Liquidity and Capital Resources," to our consolidated financial statements included in Exhibit 13 to our 20082009 Form 10-K for additional information on long-term debt and lease obligations.

(2)
For all periods presented consists primarily10-K. Excluding the $175.0 million of a total of $1.88 billion of contingent royalty and milestone payments thatcash we are obligatedmay potentially be required to pay to Bayer based on future sales and the successful achievement of certain sales volumes for Campath, Fludara and Leukine and alemtuzumab for
FDA under a consent decree we are negotiating with the agency, as described above, there have been no material changes to our contractual obligations since December 31, 2009.


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(3)
Represents interest payment obligations related to the promissory notes to three former shareholders of Equal Diagnostics and the mortgage payable we assumed in connection with the purchase of land and a manufacturing facility we formerly leased in Framingham, Massachusetts.

(4)
Consists of contractual commitments to vendors that we have entered into as of June 30, 2009 related to our outstanding capital and internally developed software projects. Our estimated cost of completion for assets under construction as of June 30, 2009 is as follows (amounts in millions):
Location
 Cost to
Complete at
June 30, 2009
 

Framingham, Massachusetts, U.S (approximately 47% for software development). 

 $277.5 

Westborough, Massachusetts, U.S. (primarily software development)

  110.6 

Lyon, France

  48.0 

Geel, Belgium

  37.4 

Waterford, Ireland

  59.3 

Allston, Massachusetts, U.S. 

  122.0 

Ridgefield, New Jersey, U.S. 

  5.8 

Haverhill, United Kingdom

  7.5 

Other

  48.8 
    
 

Total estimated cost to complete

 $716.9 
    

Financial Position

        We believe that our available cash, investments and cash flows from operations, together with our revolving credit facility and other available debt financing will be sufficientadequate to fundmeet our planned operationsoperating, investing and capital requirements forfinancing needs in the foreseeableforseeable future. Although we currently


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have substantial cash resources and positive cash flow, we have used or intend to use substantial portions of our available cash and may make additional borrowings for:

        ��On May 6, 2010, we announced that we will initiate a $2.0 billion stock repurchase program, under which we plan to purchase $1.0 billion of our common stock in the near term and financed by debt. We plan to repurchase the additional $1.0 billion during the next twelve months.

        In addition, we have several outstanding legal proceedings. Involvement in investigations and litigation can be expensive and a court may also ultimately require that we pay expenses and damages. As a result of legal proceedings, we also may be required to pay fees to a holder of proprietary rights in order to continue certain operations.

        Recently, the general economic, global capital and credit market conditions in the United States and other parts of the world have deteriorated significantly and have adversely affected access to capital and increased the cost of capital. However, we continue to believe that our available cash, investments and cash flow from operations, together with our revolving credit facility and other available debt financing, will be adequate to meet our operating, investing and financing needs in the foreseeable future. We currently do not rely on short-term borrowing to fund our operations and, as a result, we do not believe that existing global capital and credit market conditions will have a significant impact on our near-term liquidity. We are closely monitoring our liquidity as well as the condition of these markets. If these conditions continue or become worse, our future cost of debt and equity capital and our future access to capital markets could be adversely affected. We may not be able to obtain any additional financing in the future or extend any existing financing arrangements on favorable terms, or at all.

Off-Balance Sheet Arrangements

        We do not use special purpose entities or other off-balance sheet financing arrangements. We enter into guarantees in the ordinary course of business related to the guarantee of our own performance and the performance of our subsidiaries. In addition, we have joint ventures and certain other arrangements that are focused on research, development, and the commercialization of products. Entities falling within the scope of FIN 46RASC 810 are included in our consolidated statements of operations if we qualify as the primary beneficiary. Entities not subject to consolidation under FIN 46RASC 810 are accounted for under the equity method of accounting if our ownership percent exceeds 20% or if we


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exercise significant influence over the entity. We account for our portion of the resultsincome (losses) of these entities in the line item "Other""Equity in loss of equity method investments" in our consolidated statements of operations because the amounts are not material for all periods presented.operations. We also acquire companies in which we agree to pay contingent consideration based on attaining certain thresholds.


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Recent Accounting Pronouncements

        Periodically, accounting pronouncements and related information on the adoption, interpretation and application of U.S. GAAP are issued or amended by the FASB or other standard setting bodies. Changes to the ASC are communicated through ASUs. The following table shows FASB ASUs recently issued accounting pronouncementsthat could affect our disclosures and our position for adoption:

PronouncementsASU Number
 Relevant Requirements of ASU Issued Date/Our
Effective Dates
 Status

FAS 165, "Subsequent Events.2009-13 "Multiple-Deliverable Revenue Arrangements—a consensus of the FASB Emerging Issues Task Force."

 Establishes general standardsthe accounting and reporting guidance for arrangements under which a vendor will perform multiple revenue-generating activities. Specifically, the provisions of accounting forthis update address how to separate deliverables and disclosurehow to measure and allocate arrangement consideration to one or more units of events that occur after the balance sheet date but before financial statements are issued or are available to be issued. It requires the disclosure of the date through which an entity has evaluated subsequent events and whether that date represents the date the financial statements were issued or were available to be issued.accounting. Issued MayOctober 2009. Effective prospectively for periods endingrevenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2009.2010. Early adoption is permitted. Since FAS 165 at most requires additional disclosures,We will adopt the adoptionprovisions of this pronouncement did not have a material impact on our consolidated financial statements.

FAS 166, "Accounting for Transfers of Financial Assets—an amendment of FASB Statement No. 140."


Improves the relevance, representational faithfulness, and comparability of the information that a reporting entity provides in its financial statements about a transfer of financial assets; the effects of a transfer on its financial position, financial performance and cash flows; and a transferor's continuing involvement, if any, in transferred financial assets.


Issued June 2009. Effectiveupdate for the first annual reporting period that begins after November 15, 2009.


quarter of 2011. We do not expectare currently assessing the adoptionimpact the provisions of this pronouncement to have any affect on our consolidated financial statements.

FAS 167, "Amendments to FASB Interpretation No. 46(R)."


Improves financial reporting by enterprises involved with variable interest entities and to provide more relevant and reliable information to users of financial statements.


Issued June 2009. Effective for the first annual reporting period that begins after November 15, 2009.


We are evaluating the impact this pronouncementupdate will have, if any, on our consolidated financial statements.

FAS 168, "The FASB Accounting Standards Codification™ and the Hierarchy of Generally Accepted Accounting Principles a replacement of FASB Statement No. 162.2009-17 "Improvements to Financial Reporting by Enterprises Involved with Variable Interest Entities."


 

Establishes Consists of amendments to ASC 810, "Consolidation," which change how a company determines when an entity that is insufficiently capitalized or is not controlled through voting should be consolidated. This is based on, among other things, an entity's purpose and design and a company's ability to direct the FASB Accounting Standards Codification (Codification) asactivities of the sourceentity that most significantly impact the entity's economic performance.

Issued December 2009. Effective the first interim or annual reporting period after December 15, 2009.

We adopted the provisions of authoritative accounting principles recognized by the FASB to be applied by nongovernmental entities that are presented in conformity with generally accepted accounting principles (GAAP)this update in the United States (the GAAP hierarchy).



Issued June 2009 to replace FAS 162, "first quarter of 2010. The Hierarchy of Generally Accepted Accounting Principles." Effective for financial statements issued for interim and annual periods ending after September 15, 2009.


We do not expect the adoptionprovisions of this pronouncement toupdate did not have a materialany impact on our consolidated financial statements.statements other than for our interests in BioMarin/Genzyme LLC, as described in Note 9., "Investment in BioMarin/Genzyme LLC," to our consolidated financial statements included in this Form 10-Q.


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PronouncementsASU Number
 Relevant Requirements of ASU Issued Date/Our
Effective Dates
 Status

FSP FAS 107-1 and APB 28-1, "Interim2010-06 "Improving Disclosures about Fair Value of Financial Instruments.Measurements."

 Amends guidance on

Requires new disclosures and clarifies some existing disclosure requirements about fair value measurements codified within ASC 820, "Fair Value Measurements and interim financial reporting to require disclosure aboutDisclosures," including significant transfers into and out of Level 1 and Level 2 investments of the fair value hierarchy. Also requires additional information in the roll forward of financial instruments whenever summarized financialLevel 3 investments including presentation of purchases, sales, issuances, and settlements on a gross basis. Further clarification for existing disclosure requirements provides for the disaggregation of assets and liabilities presented, and the enhancement of disclosures around inputs and valuation techniques.

Issued January 2010. Effective for the first interim or annual reporting period beginning after December 15, 2009, except for the additional information is issuedin the roll forward of Level 3 investments. Those disclosures are effective for fiscal years beginning after December 15, 2010, and for interim reporting periods.periods within those fiscal years.

 Issued April 2009. Effective

We adopted the applicable provisions of this update, except for periods ending after June 15, 2009.

Thethe additional information in the roll forward of Level 3 investments (as previously noted), in the first quarter of 2010. Besides a change in disclosure, the adoption of this pronouncement didupdate does not have a material impact on our consolidated financial statements forstatements. During the periods presented.three months ended March 31, 2010, none of our instruments were reclassified between Level 1, Level 2 or Level 3.


FSP FAS 115-2, FAS 124-2, and EITF 99-20-2, "Recognition and Presentation of Other-Than-Temporary Impairments.2010-11, "Scope Exception Related to Embedded Credit Derivatives."


 

Amends Update provides amendments to Subtopic 815-15,"Derivatives and Hedging—Embedded Derivatives, " to clarify the other-than-temporary impairment guidancescope exception for debt securitiesembedded credit derivative features related to make the guidance more operational and to improve the presentation and disclosuretransfer of other-than-temporary impairmentscredit risk in the form of subordination of one financial statements.instrument to another.


 

Issued April 2009.March 2010. Effective for periods endingat the beginning of each reporting entity's first fiscal quarter beginning after June 15, 2009.



The2010. Early adoption is permitted at the beginning of each reporting entity's first fiscal quarter beginning after issuance of this pronouncement did notupdate.

We will adopt the provisions of this update for the third quarter of 2010. We are currently assessing the impact the provisions of this update will have, a material impactif any, on our consolidated financial statements for the periods presented.statements.


FSP FAS 157-4, "Determining Fair Value When 2010-17, "Milestone Method of Revenue Recognition—a Market Is Not Active and a Transaction Is Not Distressed.consensus of the FASB Emerging Issues Task Force."


 

Provides guidelines Update provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition for making fair value measurements more consistent with the principles presented in FAS 157, as well as additional authoritative guidance in determining whether a market is active or inactive,research and whether a transaction is distressed. Applicable to all assets and liabilities (i.e. financial and nonfinancial) and will require enhanced disclosures.development transactions.


 

Issued April 2009.2010. Effective on a prospective basis for milestones achieved in fiscal years, and interim periods endingwithin those years, beginning on or after June 15, 2009.2010. Early adoption is permitted.


 

The adoption We will adopt the provisions of this pronouncement did notupdate beginning January 1, 2011. We are currently assessing the impact the provisions of this update will have, a material impactif any, on our consolidated financial statements for the periods presented.statements.


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RISK FACTORS

        Our future operating results could differ materially from the results described in this report due to the risks and uncertainties related to our business, including those discussed below. In addition, these factors represent risks and uncertainties that could cause actual results to differ materially from those implied by forward-looking statements. We refer you to our "Cautionary Note Regarding Forward-Looking Statements," which identifies forward-looking statements in this report. The risks described below are not the only risks we face. Additional risk and uncertainties not currently known to us or that we currently deem to be immaterial may also materially and adversely affect our business, financial condition or results of operations.

Manufacturing problems may cause product launch delays,have caused inventory shortages, recallsloss of revenues and unanticipated costs and create opportunities for our competitors.may do so in the future.

        In order to generate revenue from our approved products, we must be able to produce sufficient quantities of the products to satisfy demand. Many of our products are difficult to manufacture. Our products that are biologics, for example, require processing steps that are more difficult than those required for most chemical pharmaceuticals. Accordingly, we employ multiple steps to attempt to control the manufacturing processes. Problems with these manufacturing processes, even minor deviations from the normal process, could result in product defects or manufacturing failures that result in lot failures, product recalls, product liability claims and insufficient inventory. In the past, we have had to write off and incur other charges and expenses for products that failed to meet internal or external specifications, including Thymoglobulin, or for products that experience terminated production runs, including Myozyme produced at the 4000L scale. We also have had to write off work-in-process materials and incur other charges and expenses associated with a viral contamination, described below, at two of our facilities, which are described below.facilities. Similar charges could occur in the future.

        Certain of the raw materials required in the commercial manufacturing and the formulation of our products are derived from biological sources, including mammalian sourcesbovine serum and human plasma.serum albumin. Such raw materials may beare difficult to procure and may be subject to contamination or recall. Also, some countries in which we market our products may restrict the use of certain biologically derived substances in the manufacture of drugs. A material shortage, contamination, recall, or restriction on the use of certain biologically derived substances in the manufacture of our products could adversely impact or disrupt our commercial manufacturing of our products or could result in a withdrawal of our products from markets. This, too, in turn, could adversely affect our ability to satisfy demand for our products, which could materially and adversely affect our operating results.

        In addition, we may only be able to produce some of our products at a very limited number of facilities.facilities and, therefore, have limited or no redundant manufacturing capacity for these products. For example, we manufacture all of our bulk Cerezyme and most of our bulk Fabrazyme products at our Allston facility, and in 2009 transitioned all of our larger scale bulk Myozyme production toproduced at the 160L scale at our Framingham facility, and all of our bulk Myozyme produced at the 4000L scale at our Belgium facility. In some cases, we contract out the manufacturing of our products to third parties, of which there are only a limited number capable of executing the manufacturing processes we require. A number of factors could cause production interruptions at our facilities or the facilities of our third party providers, including equipment malfunctions, facility contamination, labor problems, raw material shortages or contamination, natural disasters, power outages, terrorist activities, or disruptions in the operations of our suppliers.

        In June 2009, we announced that we had detected a virus, Vesivirus 2117, that impairs cell growth in one of the bioreactors used at our Allston facility to produce Cerezyme. We believe the virus was likely introduced through a raw material used in the manufacturing process. We temporarily interrupted bulk production at the plant to sanitize the facility, which affected production of Cerezyme and


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Fabrazyme. Cerezyme and Fabrazyme inventories were not sufficient to meet global demand during the period of suspended production and restoration of operations.demand. In 2009, we confirmed that Vesivirus


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2117 was the cause of declines in cell productivity in one previous instance in 2008 at our Allston facility and one previous instance in 2008 at our Belgium facility. We were able to detect the virus in 2009 at our Allston facility using a highly specific assay we had developed after standard tests were unable to identify the cause of the productivity declines that occurred in 2008. We intend to addare in the process of adding steps to increase the robustness of our raw materials screening, process monitoring for viruses and viral removal processes, someprocesses. Some of whichthese steps could beare subject to regulatory approval. However, given the nature of biologics manufacturing, contamination issues could occur in the future from time to time at our facilities and some of these issues could materially and adversely affect our operating results.

        In connection with sanitizing our Allston facility and resuming production there, we were required to dismantle, reassemble and test all of our equipment in a short period of time. In addition, we are restarting production at Allston in more bioreactors and more quickly than is customary when we start production at a facility. The steps in successfully producing our biologic products are highly complex and in the normal course are subject to equipment failures and other production difficulties. IfFor example, since restarting Fabrazyme production at Allston, we experience such difficulties,have experienced cell growth at lower than expected levels. In addition, in March 2010, we may not be able to produce newexperienced an interruption in operations at our Allston facility resulting from an unexpected city electrical power failure that compounded issues with the plant's water system, which resulted in continued supply limitation for Cerezyme and Fabrazyme. We also have experienced other shipment interruptions since restarting Cerezyme and Fabrazyme withinproduction. We will continue to work with minimal levels of inventory for Cerezyme and Fabrazyme until our expected timeframes or innew Framingham manufacturing facility is approved and any additional manufacturing delays will likely impact supply of these products.

The Cerezyme and Fabrazyme supply constraints resulting from the expected quantities.

        The supply constraint also may providesuspension of production at our Allston facility have created opportunities for our competitors.

        Outside of the United States, Fabrazyme competes with Replagal,Replagal®, a product marketed by Shire plc. Shire has announced that the company is in talks with the FDA to bring Replagal to the United States. With respect to Cerezyme, theThe FDA has approved a treatment INDprotocol for Shire's enzyme replacement therapy in developmentReplagal and Shire has submitted a BLA with the FDA for Replagal and been granted "fast track" designation. For Cerezyme, Shire and Protalix were able to offer their developmental therapies for the treatment of Gaucher disease to patients in the United States through an FDA-approved treatment protocol and has grantedto patients in the European Union and other countries through pre-approval access programs. Shire received FDA approval of its NDA "fast track" designation.therapy to treat Gaucher disease in February 2010 and announced that it will price this therapy at a 15% savings over Cerezyme. Shire submitted a MAA to the EMA for its therapy in November 2009. Shire also has announced that it has begunaccelerated its rolling NDA submission in the United States. We believe that Shire is in discussions with at least one other regulatory authority outside the United States about treating patients with this therapy on an accelerated basis. Similarly, Protalix Biotherapeutics, Inc. has announced that, at the FDA's request, it submitted a treatment INDmanufacturing timeline for its enzyme therapy by almost 18 months. Protalix submitted its NDA to the FDA in developmentDecember 2009 and has been granted "fast track" designation. Also in December 2009, Protalix and Pfizer entered into an agreement to develop and commercialize Protalix's therapy. The FDA has granted orphan drug status to both Shire's and Protalix's therapies for the treatment of Gaucher disease. Both the Shire and Protalix therapies are in phase 3 development. We have submitted a treatment IND for Genz-112638, which is also in phase 3 development for Gaucher disease. If any of these treatment protocols are accepted by the FDA, physicians could treat Gaucher disease patients with the therapies ahead of commercial availability in the United States. In addition, ZavescaZavesca® is currently approved in the United States for patients with Gaucher disease for whom enzyme replacement therapy is unsuitable. If

        The approval of treatment protocols and access programs for Shire's and Protalix's therapies has allowed physicians to treat Fabry and Gaucher disease patients with the therapies ahead of their commercial availability. Some Gaucher and Fabry patients decide to use Replagal or Gaucher patients decide to use one ofhave used our competitors' developmental therapies or Zavesca during the period of supply constraint and there is a risk that they may not switch back to Genzyme'sour products, once inventories have stabilized, which would result in the loss of additional revenue for Genzyme.us. In April 2010, the EMA advised physicians to consider switching Fabry disease patients from Fabrazyme to Replagal based on its concerns that certain patients were not tolerating reduced dosages of Fabrazyme. We also have encouraged patients to switch to competitive products during the period of supply constraint. These actions may result in additional patients switching to our competitors' therapies. In addition, the institution of treatment guidelines and dose conservation formeasures during the products presentsupply constraint presents the risk that physicians and patients dowill not resume regular treatment levels after the supply constraint has ended.


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Our activities, products and services are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply with the regulations or maintain the approvals.

        Products that have received regulatory approval for commercial sale are subject to extensive continuing regulations relating to, among other things, testing, manufacturing, quality control, labeling and promotion. For example, we and certain of our third party suppliers are required to maintain compliance with GMP requirements, and are subject to inspections by the FDA, the EMA and comparable agencies in other jurisdictions to confirm such compliance. Failure to comply with applicable regulatory requirements could result in regulatory authorities taking actions such as:

        In a Form 483 issued in October 2008, a follow up warning letter issued in February 2009, and a Form 483 issued in November 2009, the FDA has detailed observations from its 2008 and 2009 inspections of our Allston facility considered to be significant deviations from GMP compliance. In March 2010, the FDA notified us that it intended to take enforcement action to ensure that products manufactured at our Allston facility are made in compliance with GMP. We have received a draft consent decree from the FDA, which provides for an upfront disgorgement of past profits of $175.0 million, for disgorgement of 18.5% of revenues from future sales of products manufactured, filled and finished at our Allston facility if fill-finish operations are still conducted there for domestic and exported products after dates to be negotiated, and payment of $15,000 per day for products manufactured at the facility but filled and finished elsewhere if certain GMP remediation actions are not met by dates to be negotiated. We are actively negotiating with the FDA all of the terms of the consent decree. If we are unable to comply with the terms of the consent decree, we may incur substantial additional expenses and may not be able to produce some or all of our products.

        The FDA, the EMA and comparable regulatory agencies worldwide may require post-marketing clinical trials or patient outcome studies. We have agreed with the FDA, for example, to a number of post-marketing commitments as a condition to U.S. marketing approval for Fabrazyme, Aldurazyme, Myozyme, Clolar and Mozobil. In addition, holders of exclusivity for orphan drugs are expected to assure the availability of sufficient quantities of their orphan drugs to meet the needs of patients. Failure to do so could result in the withdrawal of marketing exclusivity for the drug. As a result of the Fabrazyme supply constraint, we received a request from the FDA's Office of Orphan Products Development in July 2009 to provide a detailed explanation of the measures being taken to assure the availability of sufficient quantities of Fabrazyme within a reasonable time to meet the needs of patients. We also received the same request from the FDA in July 2009 with respect to Myozyme because of the limited supply of product produced using the 160L scale process in the United States. We have responded to both of the FDA's requests, but have not received any determination from the agency for either product. Fabrazyme currently has marketing exclusivity in the United States until April 2010 andrequests. Myozyme has exclusivity in the United States until April 2013, in each case due to its orphan drug status. We believe that orphan drug exclusivity is only one factor in the commercial success of our products. For example, these products may be protected by patents and other means. However, if2013. If the FDA were to withdraw exclusive approval for Myozyme, our competitors could have an


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approval for Fabrazyme or Myozyme, our competitors could have an opportunity to receive marketing approval in the United States for their products earlier than April 2013.

        In recent years, several states, including California, Vermont, Maine, Minnesota, Massachusetts, New Mexico and West Virginia, in addition to the current exclusivity expiration dates for FabrazymeDistrict of Columbia, have enacted legislation requiring biotechnology, pharmaceutical and Myozyme.

If the FDA believesmedical device companies to establish marketing compliance programs and file periodic reports on sales, marketing, and other activities. Similar legislation is being considered in other states. Many of these requirements are new and uncertain, and available guidance is limited. We could face enforcement action, fines and other penalties and could receive adverse publicity, all of which could harm our business, if it is alleged that we have repeatedly violated GMP requirements, it could pursue enforcement action against us.

        In a Form FDA 483 issued in October 2008failed to fully comply with such laws and in a follow up Warning Letter issued in February 2009, the FDA has detailed observations from its 2008 inspection of our Allston facility considered to be significant deviations from GMP compliance. As a follow up to the February Warning Letter, the FDA conducted an inspection of the Allston plant in May 2009. At the end of July 2009, the FDA informed us that its May inspection at Allston found all promised actions had not yet been fully implemented and that some actions were inadequate. In that same letter, the FDA informed us that it will re-inspect our Allston facility to verify that all corrective and preventative actions have been implemented and to evaluate our compliance. During that re-inspection, the FDA will also review our Vesivirus 2117 contamination investigation and follow-up actions.

        We have been in discussions with the FDA about releasing Cerezyme material that was being processed at the time of suspension of production due to viral contamination at our Allston facility. We have written off approximately 80% of this Cerezyme work-in-process inventory. At the end of the business day on Friday, August 7, 2009, the FDA communicated to us steps it recommends we take prior to forward processing any Cerezyme work-in-process. The steps recommended by the FDA were consistent with the steps that we independently had planned to implement. The FDA also stated that any further processing of the Cerezyme work-in-process is at our own risk. The remaining Cerezyme work-in-process material expires in June 2010. If we decide to process the material, the FDA may not agree with our decision and could determine that processing of the material was not in compliance with GMP. In such case, the FDA could prevent us from releasing the material, require us to re-sanitize the Allston facility and/or pursue an enforcement action, including seeking a consent decree, if the FDA determines that we do not have adequate control over the manufacturing of our products due to our manufacturing issues.

        FDA consent decrees often include reimbursements to the government for inspection costs, due dates for specific actions, and penalties for noncompliance. In connection with a consent decree, the FDA may dictate which products we can produce and the quantities of those products. The FDA may also appoint a third party to oversee our manufacturing operations under a consent decree. Consent decrees usually remain in effect for five years or more. If a consent decree were imposed, we would incur substantial additional expenses and may not be able to produce some or all of our products.related regulations.

The development of new biotechnology products involves a lengthy and complex process, and we may be unable to commercialize any of the products we are currently developing.

        We have numerous products under development and devote considerable resources to research and development, including clinical trials.

        Before we can commercialize our product candidates, we need to:


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        This process involves a high degree of risk and takes many years. Our product development efforts with respect to a product candidate may fail for many reasons, including:

        Few research and development projects result in commercial products, and success in preclinical studies or early clinical trials often is not replicated in later studies. For example, in our phase 3 trial known as the Polymer Alternative for CDAD Treatment (PACT) study, tolevamer did not meet its primary endpoint. In our pivotal study of hylastan for treatment of patients with osteoarthritis of the knee, hylastan did not meet its primary endpoint. In November 2009, we discontinued development of an advanced phosphate binder because although the advanced phosphate binder met its primary endpoint in its phase 2/3 trial, it did not demonstrate significant improvement in phosphate lowering compared to Renvela. In September 2009,


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our collaboration partner Osiris, to whom we have made substantial nonrefundable upfront payments, announced that its two phase 3 trials evaluating Prochymal for the treatment of acute Graft-versus-Host Disease failed to meet their primary endpoints, drawing into question the size of the market that may benefit from use of the product.

        We may decide to abandon development of a product or service candidate at any time, or we may be required to expend considerable resources repeating clinical trials or conducting additional trials, either of which would increase costs of development and delay any revenue from those programs.

        In addition, a regulatory authority may deny or delay an approval because it was not satisfied with the structure or conduct of clinical trials or due to its assessment of the data we supply. A regulatory authority, for instance, may not believe that we have adequately addressed negative safety signals. Clinical data are subject to varied interpretations, and regulatory authorities may disagree with our assessments of data. In any such case, a regulatory authority could insist that we provide additional data, which could substantially delay or even prevent commercialization efforts, particularly if we are required to conduct additional pre-approval clinical studies.

        We are also developing new products, such as mipomersen Prochymal and ataluren, through strategic alliances and collaborations. If we are unable to manage these external opportunities successfully or if the product development process is unsuccessful, we will not be able to grow our business in the way that we currently expect.

If we fail to increase sales of several existing products and services or to commercialize new products and services in our pipeline, we will not meet our financial goals.

        Over the next few years, our success will depend substantially on our ability to increase revenue from our existing products and services. These products and services include Renagel/our Cerezyme, Renvela, Synvisc/Synvisc-One, Fabrazyme, Myozyme, Aldurazyme, Hectorol, Thymoglobulin, Thyrogen, Clolar/Evoltra, Campath, Fludara, Leukine,Clolar and Mozobil products, and diagnosticour genetic testing services.

        Our ability to increase sales depends on a number of factors, including:


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        We expect regulatory action regarding several of our existing products in the coming months. Regulatory authorities denying or delaying these approvals would adversely impact our projected revenue and income growth. For example, we have encountered several delays in receiving marketing


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approval in the United States for alglucosidase alfa produced using a 2000Llarger scale process, which has adversely impacted our revenues and earnings, and weearnings. We could face additional delays or supply constraints with this product or other products.

        Part of our growth strategy involves conducting additional clinical trials to support approval of expanded uses of some of our products, including Clolar/EvoltraMozobil, Clolar and alemtuzumab for MS, pursuing marketing approval for our products in new jurisdictions and developing next generation products, such as Genz-112638 and our advanced phosphate binder.eliglustat tartrate (formerly Genz-112638). The success of this component of our growth strategy will depend on the outcome of these additional clinical trials, the content and timing of our submissions to regulatory authorities and whether and when those authorities determine to grant approvals. Because the healthcare industry is extremely competitive and regulatory requirements are rigorous, we spend substantial funds marketing our products and attempting to expand approved uses for them. These expenditures depress near-term profitability with no assurance that the expenditures will generate future profits that justify the expenditures. For example, we received a complete response letter from the FDA in October 2009 for Clolar's use in adult AML in which the agency recommended that a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication.

Our future success will depend on our ability to effectively develop and market our products and services against those of our competitors.

        The human healthcare products and services industry is extremely competitive. Other organizations, including pharmaceutical, biotechnology, device and genetic and diagnostic testing companies, and generic and biosimilar manufacturers, have developed and are developing products and services to compete with our products, services and product candidates. If healthcare providers, patients or payors prefer these competitive products or services or these competitive products or services have superior safety, efficacy, pricing or reimbursement characteristics, we will have difficulty maintaining or increasing the sales of our products and services. As described under the heading "Manufacturing problems may cause product launch delays, inventory shortages, recallsThe Cerezyme and unanticipated costs and createFabrazyme supply constraints resulting from the suspension of production at our Allston facility have created opportunities for our competitors,", the virus at our Allston facility and associated production interruption as well as the delay in our receipt of FDA approval of alglucosidase alfa produced at the 2000L scale, hashave provided new opportunities for our competitors that we did not anticipate.competitors.

        Zavesca® is        There are currently the onlytwo other marketed productproducts aimed at treating Gaucher disease, the disease addressed by Cerezyme.Cerezyme: Zavesca® and VPRIVTM. Zavesca is a small molecule oral therapy that has been approved in approximately thirty-five countries, including the United States, European Union Israel and six other countriesIsrael, for use in patients with mild to moderate


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Type 1 Gaucher disease for whom enzyme replacement therapy is unsuitable. Zavesca has been sold in the European Union since 2003 and in the United States since 2004. VPRIV is an enzyme replacement therapy developed by Shire that received marketing approval in the United States in February 2010. In addition, wean enzyme replacement therapy in development by Protalix to treat Gaucher disease is available to patients in the United States under an FDA-approved treatment protocol and Protalix has submitted an NDA to the FDA for its therapy. Both the Shire and Protalix therapies are aware of two companies each conducting a phase 3 clinical trialavailable to patients in the European Union and one company conducting a phase 2 clinical trial to investigate alternative treatments for Gaucher disease.other countries through pre-approval access programs.

        Replagal® is a competitive enzyme replacement therapy for Fabry disease, the disease addressed by Fabrazyme, thatwhich is approved for sale outside of the United States. In addition, while Fabrazymethe FDA has received orphan drug designation,approved a treatment protocol for Replagal, which provides usallows physicians to treat Fabry patients with seven yearsthe therapy ahead of market exclusivity for the product in the United States, other companies may seek to overcome our market exclusivity and, if successful, compete with Fabrazymecommercial availability in the United States. This market exclusivity expires in April 2010.Shire has submitted its BLA for Replagal to the FDA. We also are aware of a company that initiated a phase 3 clinical trial in June 2009 of an oral chaperone medication to treat Fabry disease.


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        Myozyme has marketing exclusivity in the United States until 2013 and in the European Union until 2016 due to its orphan drug status, although companies may seek to overcome the associated marketing exclusivity. In addition, we are aware of one company pursuing phase 1 clinical studies (after putting a phase 2 study on hold) for a small molecule pharmacologic chaperone treatment for Pompe disease.

        Renagel/        Renagel and Renvela competescompete with several other products for the control of elevated phosphorus levels in patients with chronic kidney failureCKD on hemodialysis, including PhosLo®, a prescription calcium acetate preparation marketed in the United States and Fosrenol®, a prescription lanthanum carbonate marketed in the United States, Europe, Canada and Latin America. A generic formulationGeneric formulations of PhosLo waswere launched in the United States in October 2008. Renagel/2008 and 2009. Renagel and Renvela also competescompete with over-the-counter calcium carbonate products such as TUMS® and metal-based options such as aluminum and magnesium. Our core patents protecting Renagel and Renvela expire in 2014 in the United States and in Europe in 2015. However, our Renagel and Renvela patents are the subjects of Abbreviated New Drug Application, or ANDA, filings in the United States by generic drug manufacturers as described in more detail in this Risk Factors section under the heading,"Some of our products may face competition from lower cost generic or follow-on products."

        Current competition for Synvisc and Synvisc/Synvisc-One includes: Supartz®/Artz®; Hyalgan®; Orthovisc®; Euflexxa™; Monovisc™, which is marketed in Europe and Turkey; and Durolane®, which is marketed in Europe and Canada. Durolane and Euflexxa are produced by bacterial fermentation, which may provide these products a competitive advantage over avian-sourced Synvisc and Synvisc/Synvisc-One. We believe that single injection products will have a competitive advantage over multiple injection products. Synvisc-One is currently the only single injection viscosupplementation product approved in the United States, but competitors are seeking FDA approval for their single injection products. Furthermore, several companies market products that are not viscosupplementation products but which are designed to relieve the pain associated with osteoarthritis. Synvisc and Synvisc/Synvisc-One will have difficulty competing with any of thesecompetitive products to the extent the competitivethose products have a similar safety profile and are considered more efficacious, less burdensome to administer or more cost-effective.

        Competition for Campath for patients with relapsed or refractory B-CLL includes single agent and combination chemotherapy regimens; Rituxan®/MabThera®, which is marketed globally; Treanda®, which is marketed globally; and Treanda®Arzerra™, which is marketed in the United States.States and recently received a conditional approval recommendation by the EMA. There are also other therapies under clinical study for the treatment of B-CLL, including ofatumumab, lumiliximab and lenalidomide. Competition for Clolar/EvoltraClolar for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory ALL after at least two prior regimens includes cytarabine and mitoxantrone, which are available as generics with no significant commercial promotion, and Arranon® (nelarabine), which is indicated for the treatment of patients with T-cell ALL whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. T-cell ALL is estimated to represent less than 20% of pediatric ALL patients. In addition, there are anti-cancer agents in clinical trials for the treatment of relapsed pediatric ALL patients.ALL. Leukine primarily competes with two colony stimulating growth factors, Neupogen® and Neulasta®. The primary competition for Fludara is generic drugs.

        The examples above are illustrative and not exhaustive. Almost all of our products and services currently face competition. Furthermore, the field of biotechnology is characterized by significant and rapid technological change. Discoveries by others may make our products or services obsolete. For example, competitors may develop approaches to treating LSDs that are more effective, convenient or less expensive than our products and product candidates. Because a significant portion of our revenue is derived from products that address this class of diseases and a substantial portion of our expenditures


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is devoted to developing new therapies for this class of diseases, such a development would have a material negative impact on our results of operations.


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If we fail to obtain and maintain adequate levels of reimbursement for our products and services from third party payors, the commercial potential ofdemand for our products and services will be significantly limited.

        A substantial portionSales of our domesticproducts and international revenue comesservices are dependent, in large part, on the availability and extent of reimbursement from payments by third party payors, including government health administration authorities, and private health insurers. Governmentsinsurers and other third party payors. These third party payors may not provide adequate insurance coverage or reimbursement for our products and services, which could reduce demand for our products and services and impair our financial results.

        Third party payors are increasingly scrutinizing pharmaceutical budgets and healthcare expenses and are attempting to contain healthcare costs by:

        Efforts by third party payors to reduce costs could decrease demand for our products and services. In addition,March 2010, the U.S. Congress enacted healthcare reform legislation that imposes cost containment measures on the healthcare industry. Some states are also considering legislation that would control the prices of drugs. We believe that federal and state legislatures and health agencies will continue to focus on additional healthcare reform in the future.

        We encounter similar cost containment issues in countries outside the United States. In certain countries, including countries in the European Union and Canada, the coverage of prescription drugs, pricing and levels of reimbursement are subject to governmental control. Therefore, we may be unable to negotiate coverage, pricing or reimbursement on terms that are favorable to us. Moreover, certain countries reference the prices in other countries where our products are marketed. Thus, inability to secure adequate prices in a particular country may also impair our ability to maintain or obtain acceptable prices in existing and potential new markets. Government health administration authorities may also rely on analyses of the cost-effectiveness of certain therapeutic products in determining whether to provide reimbursement for such products. Our ability to obtain satisfactory pricing and reimbursement may depend in part on whether our products, the cost of some of which is high in comparison to other therapeutic products, are viewed as cost-effective. As in the United States, we expect to see continued efforts to reduce healthcare costs in our international markets. For example, the German government is expected to implement measures during the second half of 2010 that, among other things, increase mandatory discounts and impose a three-year price freeze on pharmaceutical pricing based on August 2009 pricing.

        Furthermore, governmental regulatory bodies, such as the Centers for Medicare and Medicaid Services (CMS)CMS in the United States, may from time-to-time make unilateral changes to reimbursement rates for our products and services. TheseFor example, MIPPA directs CMS to establish a bundled payment system to reimburse dialysis providers treating ESRD patients. In September 2009, CMS proposed changes to the prospective payment system that would include drugs and biologicals used to treat ESRD patients in the bundled payment amount for dialysis treatments. The bundled rate is proposed to include drugs and biologicals that are currently reimbursed separately by Medicare, including intravenous Vitamin D analogs and their oral equivalents such as Hectorol, and oral phosphate binders such as Renagel/Renvela. CMS is expected to issue a final rule in 2010 with an anticipated implementation date of January 2011.


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        Changes to reimbursement rates, including implementation of CMS's proposed bundling rule in the United States, could reduce our revenue by causing healthcare providers to be less willing to use our products and services. Although we actively seek to assureensure that any initiatives that are undertaken by regulatory agencies involving reimbursement for our products and services do not have an adverse impact on us, we may not always be successful in these efforts. In addition, when a new product is approved, the availability of government and private reimbursement for that product is uncertain as is the amount for which that product will be reimbursed. We cannot predict the availability or amount of reimbursement for our product candidates.

        The American Recovery and Reinvestment Act of 2009 provided significant funding for the federal government to conduct comparative effectiveness research. Although the U.S. Congress indicated that these studies are intended to improve the quality of health care, outcomes of such studies could


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influence reimbursement decisions. If, for example, any of our products or services were determined to be less cost-effective than alternatives, reimbursement for those products or services could be affected.

We may encounter substantial difficulties managing our growth.

        Several risks are inherent to our plans to grow our business. Achieving our goals will require substantial investments in research and development, sales and marketing, and facilities. For example, we are spending considerable resources building and seeking regulatory approvals for our manufacturing facilities. These facilities may not prove sufficient to meet demand for our products or we may not have excess capacity at these facilities. For example, we havehad been operating with lower than usual inventories for Cerezyme and Fabrazyme because we had allocated capacity for Myozyme production at theour Allston plantfacility to meet Myozyme's worldwide growth. When we interrupted production of Cerezyme and Fabrazyme at the facility in June 2009 in order to sanitize the facility after identifying a virus in a bioreactor used to produce Cerezyme, inventories of Cerezyme and Fabrazyme were not sufficient to avoid product shortages duringshortages. We are constructing a new manufacturing facility with capacity for Cerezyme and Fabrazyme in Framingham, Massachusetts, expanding our Allston facility, and adding an additional 4000L bioreactor to produce Myozyme at our Belgium facility. We are also expanding our fill-finish capacity in Waterford, Ireland and working with a third party contract manufacturer to transfer fill-finish activities to the periodcontract manufacturer for a portion of suspended productionour Fabrazyme, Cerezyme and recovery.Myozyme production. If we experience a delay in completing these capacity expansions or securing regulatory approval for the new internal capacity or the fill-finish capacity from the contract manufacturer, we will not be able to build inventories in our expected timeframe.

        Building our facilities is expensive, and our ability to recover these costs will depend on increased revenue from the products produced at the facilities. In addition, to maintain product supply and to adequately prepare to launch a number of our late-stage product candidates, we must successfully implement a number of manufacturing projects on schedule, operate our facilities at appropriate production capacity, optimize manufacturing asset utilization, continue our use of third-party contract manufacturers and maintain a state of regulatory compliance.

        We produce relatively small amounts of material for research and development activities and pre-clinical trials. Even if a product candidate receives all necessary approvals for commercialization, we may not be able to successfully scale-up production of the product material at a reasonable cost or at all and we may not receive additional approvals in sufficient time to meet product demand. For example, the FDA has concluded that alglucosidase alfa produced in our 2000Llarger scale bioreactors is a different product than alglucosidase alfa produced in our 160 liter160L bioreactors and required us to submit a separate BLA for the 2000Llarger scale product. This delay in receipt of FDA approval has had an adverse effect on our revenue and earnings, and will continue to have an adverse effect until we receive FDA approval of alglucosidase alfa produced in our 4000L bioreactors.

        If we are able to increase sales of our products, we may have difficulty managing inventory levels. Marketing new therapies is a complicated process, and gauging future demand is difficult. With


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Renagel, for example, we have encountered problems in the past managing inventory levels at wholesalers. Comparable problems may arise with any of our products, particularly during market introduction.

        Growth in our business may also contribute to fluctuations in our operating results, which may cause the price of our securities to decline. Our revenue may fluctuate due to many factors, including changes in:

        We may also experience fluctuations in our quarterly results due to price changes and sales incentives. For example, purchasers of our products, particularly wholesalers, may increase purchase orders in anticipation of a price increase and reduce order levels following the price increase. We occasionally offer sales incentives and promotional discounts on some of our products and services that could have acause similar impact.fluctuations. In addition, some of our products, including Synvisc/Synvisc-One are subject to seasonal fluctuation in demand.


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Our activities, products and services are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply with the regulations or maintain the approvals.

        Products that have received regulatory approval for commercial sale are subject to extensive continuing regulations relating to, among other things, testing, manufacturing, quality control, labeling and promotion. Failure to comply with applicable regulatory requirements could result in regulatory authorities taking actions such as:

        Furthermore, the FDA, the EMEA and comparable foreign regulatory agencies may require post-marketing clinical trials or patient outcome studies. We have agreed with the FDA, for example, to a number of post-marketing commitments as a condition to U.S. marketing approval for Fabrazyme, Aldurazyme, Myozyme, Clolar and Mozobil.

        In addition, regulatory agencies subject a marketed therapy, its manufacturer and the manufacturer's facilities to continual review and periodic inspections. The discovery of previously unknown problems with a therapy or the facility or process used to produce the therapy could prompt a regulatory authority to impose restrictions on us or delay approvals for new products or could cause us to voluntarily adopt restrictions, including withdrawal of one or more of our products or services from the market. In connection with a periodic facility inspection, we received a Warning Letter from the FDA in 2007 that addressed certain of our manufacturing procedures at our Thymoglobulin production facility in Lyon, France. The FDA accepted our response to that Warning Letter. In February 2009, we received a Warning Letter from the FDA related to inspectional observations by the FDA at our Allston facility considered to be significant deviations from GMP. An FDA inspector inspected the plant in May 2009 as a follow up to the Warning Letter. At the end of July 2009, the FDA informed us that it will re-inspect our Allston facility to verify that all corrective and preventative actions identified in the February Warning Letter have been implemented. In its July letter, the FDA indicated that all promised actions had not been either fully or adequately implemented at the time of the May inspection. During the re-inspection, the FDA will also review our remediation efforts related to the identification of a virus at our Allston facility that required us to temporarily halt production there. If the FDA were to identify issues during its re-inspection, the FDA could be prompted to delay Lumizyme approval or impose restrictions on our production of Cerezyme and Fabrazyme at the facility.

        In recent years, several states, including California, Vermont, Maine, Minnesota, Massachusetts, New Mexico and West Virginia, in addition to the District of Columbia, have enacted legislation requiring biotechnology and pharmaceutical companies to establish marketing compliance programs and file periodic reports on sales, marketing, and other activities. Similar legislation is being considered in other states. Many of these requirements are new and uncertain, and available guidance is limited. We could face enforcement action and fines and other penalties and could receive adverse publicity, all of


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which could harm our business, if it is alleged that we have failed to fully comply with such laws and related regulations.

We rely on third parties to provide us with materials and services in connection with the manufacture of our products and the performance of our services.

        Some materials necessary for commercial production of our products, including specialty chemicals and components necessary for manufacture, fill-finish and packaging, are provided by unaffiliated third party suppliers. In some cases, such materials are specifically cited in our marketing applications with regulatory authorities so that they must be obtained from that specific source unless and until the applicable authority approves another supplier. In addition, there may only be one available source for a particular chemical or component. For example, we acquire polyalylamine, (PAA), used in the manufacture of Renagel, Renvela, Cholestagel and WelChol,Welchol, from Cambrex Charles City, Inc., and N925, which is necessary to manufacture our LSD products, from Invitrogen Corporation. These suppliers are the only sources for these materials currently qualified in our FDA drug applications for these products. Our suppliers also may be subject to FDA regulations or the regulations of other governmental agencies outside the United States regarding manufacturing practices. We may be unable to manufacture our products or to perform our services in a timely manner or at all if these third party suppliers were to cease or interrupt production or otherwise fail to supply sufficient quantities of these materials or products to us for any reason, including due to regulatory requirements or actions, adverse financial developments at or affecting the supplier, labor shortages or disputes, or contamination of materials or equipment. For example, we believe that a virus that we detected in one of our bioreactors used at our Allston facility to produce Cerezyme was likely introduced through a raw material used in the manufacturing process.

        We also source some of our manufacturing, fill-finish, packaging and distribution operations to third party contractors. The manufacture of products, fill-finish, packaging and distribution of those products requires successful coordination among these third party providers and us. Our inability to coordinate these efforts, the inability of a third party contractor to secure sufficient source materials, the lack of capacity available at a third party contractor, problems with manufacturing services provided by a third party contractor or any other problems with the operations of a third party contractor could require us to delay shipment of saleable products, to recall products previously shipped or impair our ability to supply products at all. This could increase our costs, cause us to lose revenue or market share and damage our reputation. Furthermore, any third party we use to manufacture, fill-finish or package


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our products to be sold must also be licensed by the applicable regulatory authorities. As a result, alternative third party providers may not be available on a timely basis or at all.

Our financial results are dependent on sales of Cerezyme.

        Sales of Cerezyme, our enzyme-replacement product for patients with Gaucher disease, totaled $594.1$179.1 million for the sixthree months ended June 30, 2009,March 31, 2010, representing approximately 25%17% of our total revenue. Because our business is dependent on Cerezyme, negative trends in revenue from this product have had, and could continue to have, an adverse effect on our results of operations and cause the value of our common stock to decline. In June 2009, we temporarily suspended production of Cerezyme at our Allston facility after identifying a virus in a bioreactor used for producing Cerezyme, which has resulted in a period of supply constraint for the product. As a result of the supply constraint, the FDA has asked companies developing certain alternative treatments for Gaucher diseasefurther decline or fail to submit treatment protocols. If the treatment protocols are approved, physicians could treat Gaucher patients with these therapies ahead of commercial availability in the United States. There is a risk that if patients decide to use one of these developmental therapies, they may not switch back to Cerezyme when our inventories of the product have stabilized.recover. In addition, treatment guidelines developed for Cerezyme during the supply constraint recommend missing doses or infusing less product. There is a risk that physicians and patients do not resume regular treatment levels after the supply constraint has ended. In addition, we


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will lose revenue if alternative treatments for Gaucher disease gain commercial acceptance, if our marketing activities are restricted, or if coverage, pricing or reimbursement is limited. The patient population with Gaucher disease is not large. Because a significant percentage of that population already uses Cerezyme, opportunities for future sales growth are constrained. Furthermore, changes in the methods for treating patients with Gaucher disease, including treatment protocols that combine Cerezyme with other therapeutic products or reduce the amount of Cerezyme prescribed, could limit growth, or result in a decline, in Cerezyme sales. See"The Cerezyme and Fabrazyme supply constraints resulting from the suspension of production at our Allston facility have created opportunities for our competitors" above.

Our operating results and financial position may be negatively impacted when we attempt to grow through business combination transactions.

        We may encounter problems assimilating operations acquired in business combination transactions. These transactions often entail the assumption of unknown liabilities, the loss of key employees, and the diversion of management attention. Furthermore, in any business combination there is a substantial risk that we will fail to realize the benefits we anticipate when we decide to undertake the transaction. We have in the past taken significant charges for impaired goodwill and for impaired assets acquired in business combination transactions. We may be required to take similar charges in the future. We enter into most such transactions with an expectation that the acquired assets will enhance the long-term strength of our business. These transactions, however, often depress our earnings in the near-term and the expected long-term benefits may never be realized. Business combination transactions also either deplete cash resources, require us to issue substantial equity, or require us to incur significant debt.

If our strategic alliances are unsuccessful, our operating results will be adversely impacted.

        Several of our strategic initiatives involve alliances with other biotechnology and pharmaceutical companies. The success of these arrangements is largely dependent on technology and other intellectual property contributed by our strategic partners or the resources, efforts, and skills of our partners. Disputes and difficulties in such relationships are common, often due to conflicting priorities or conflicts of interest. Merger and acquisition activity may exacerbate these conflicts. The benefits of these alliances are reduced or eliminated when strategic partners:

        Furthermore, payments we make under these arrangements may exacerbate fluctuations in our financial results. In addition, under some of our strategic alliances, including Osiris, PTC and Isis, we make upfront and milestone payments well in advance of commercialization of products with no assurance that we will ever recoup these payments. We also may make equity investments in our strategic partners, as we did with EXACT Sciences in January 2009 and Isis in February 2008. Our strategic equity investments are subject to market fluctuations, access to capital and other business events, such as initial public offerings, the completion of clinical trials and regulatory approvals, which can impact the value of these investments. If any of our strategic equity investments decline in value and remain below cost for an extended duration, we may be required to write offdown our investment.

Our operating results and financial position may be negatively impacted when we attempt to grow through business combination transactions.

        We may encounter problems assimilating operations acquired in business combination transactions. These transactions often entail the assumption of unknown liabilities, the loss of key employees, and the diversion of management attention. Furthermore, in any business combination there is a substantial risk that we will fail to realize the benefits we anticipate when we decide to undertake the transaction.


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We have in the past taken significant charges for impaired goodwill and for impaired assets acquired in business combination transactions. We may be required to take similar charges in the future. We enter into most such transactions with an expectation that the acquired assets will enhance the long-term strength of our business. These transactions, however, often depress our earnings and our returns on capital in the near-term and the expected long-term benefits may never be realized. Business combination transactions also either deplete cash resources, require us to issue substantial equity, or require us to incur significant debt.

Our international sales and operating expenses are subject to fluctuations in currency exchange rates.

        A significant portion of our business is conducted in currencies other than our reporting currency, the U.S. dollar. We recognize foreign currency gains or losses arising from our operations in the period in which we incur those gains or losses. As a result, currency fluctuations among the U.S. dollar and the currencies in which we do business have caused foreign currency translation gains and losses in the past and will likely do so in the future. Because of the number of currencies involved, the variability of currency exposures and the potential volatility of currency exchange rates, we may suffer significant foreign currency translation losses in the future due to the effect of exchange rate fluctuations.

        In 2008, For the three months ended March 31, 2010, the change in foreign exchange rates had a net favorable impact on our revenue; however, this trend changed during the fourth quarter of 2008 and adversely impacted our revenue, during the first half of 2009. Although we cannot predict with certainty future changes in foreign exchange rates or theiras compared to a net unfavorable effect on our results, we do not expect the change in foreign exchange rates to have a positive impact on our revenue for the remainder of 2009.

The current credit and financial market conditions may exacerbate certain risk affecting our business.

        Sales of our products and services are dependent, in part, on the availability and extent of reimbursement from third party payers, including governments and private insurance plans. As a result of the current volatility in the financial markets, third-party payers may delay payment or be unable to satisfy their reimbursement obligations. A reduction in the availability or extent of reimbursement could negatively affect our product and service sales and revenue.

        In addition, we rely upon third parties for certain aspects of our business, including collaboration partners, wholesale distributors for our products, contract clinical trial providers, contract manufacturers, and third-party suppliers. Because of the recent tightening of global credit and the volatility in the financial markets, there may be a delay or disruption in the performance or satisfaction of commitments to us by these third parties, which could adversely affect our business.

We may incur substantial costs as a result of litigation or other proceedings.

        We are or may become a party to litigation or other proceedings in the ordinary course of our business. A third party may sue us or one of our strategic collaborators for infringing the third party's patent or other intellectual property rights. Likewise, we or one of our strategic collaborators may sue to enforce intellectual property rights or to determine the scope and validity of third party proprietary rights. If we do not prevail in this type of litigation, we or our strategic collaborators may be required to:

        We have several ongoing legal proceedings on which we will continue to expand substantial sums. For example, we have initiated patent infringement litigation against several generic manufacturers andmanufacturers. In addition, we are the subject of twoa consolidated purported securities class action lawsuits, described under the heading "Legal Proceedings" in Part II, Item 1 of this report.lawsuit and three purported shareholder derivative lawsuits. We are also currently involved in other litigation matters and investigations and may be subject to additional actions in the future. For example, the federal government, state governments and private payors are investigating and have filed actions against numerous pharmaceutical and biotechnology companies, including Genzyme, alleging that the companies may have overstated prices in order to inflate reimbursement rates. Domestic and international enforcement authorities also have instituted actions under healthcare "fraud and abuse" laws, including


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anti-kickback and false claims statutes. Moreover, individuals who use our products or services, including our diagnostic products and genetic testing services, sometimes bring product and professional liability claims, and third parties with whom we do business sometimes bring breach of contract claims against us or our subsidiaries.

        Some of our products are prescribed by healthcare providers for uses not approved by the FDA, the EMEAEMA or comparable regulatory agencies. Although healthcare providers may lawfully prescribe our products for off-label uses, any promotion by us of off-label uses would be unlawful. Some of our practices intended to make healthcare providers aware of off-label uses of our products without engaging in off-label promotion could nonetheless be construedmisconstrued as off-label promotion. Although we


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have policies and procedures in place designed to help assure ongoing compliance with regulatory requirements regarding off-label promotion, some non-compliant actions may nonetheless occur. Regulatory authorities could take enforcement action against us if they believe we are promoting, or have promoted, our products for off-label use.

        We have only limited amounts of insurance, which may not provide coverage to offset a negative judgment or a settlement payment. We may be unable to obtain additional insurance in the future, or we may be unable to do so on favorable terms. Our insurers may dispute our claims for coverage. For example, we have submitted claimsare seeking from our insurers coverage amounting to our insurersapproximately $30 million for reimbursement of portions of the expensescosts incurred in connection with the litigation and settlement related to the consolidation of our tracking stock and are seeking coverage for the settlement. The insurers have purported to deny coverage.stocks. Any additional insurance we do obtain may not provide adequate coverage against any asserted claims.

        Regardless of merit or eventual outcome, investigations and litigation can result in:

Our international sales, clinical activities, manufacturing and other operations are subject to the economic, political, legal and business environments of the countries in which we do business, and our failure to operate successfully or adapt to changes in these environments could cause our international sales and operations to be limited or disrupted.

        Our international operations accounted for approximately 49%48% of our consolidated product and service revenue for the sixthree months ended June 30, 2009.March 31, 2010. We expect that international product and service sales will continue to account for a significant percentage of our revenue for the foreseeable future. In addition, we have direct investments in a number of subsidiaries outside of the United States. Our international sales and operations could be limited or disrupted, and the value of our direct investments may be diminished, by any of the following:


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        Our international operations and marketing practices are also subject to regulation and scrutiny by the governments of the countries in which we operate. In addition,operate as well as the United States government. The United States Foreign Corrupt Practices Act and similar anti-bribery laws in other jurisdictions generally prohibit companies and their representatives from offering, promising, authorizing or making payments to foreign officials for the purpose of obtaining or retaining business. We operate in many parts of the world that have experienced governmental corruption to some degree. Although we have policies and procedures designed to help ensure that we, our employees and our agents comply with the Foreign Corrupt Practices Act, or FCPA, and other anti-bribery laws, such policies and procedures may not protect us against liability under the FCPA or other laws for actions taken by our employees, agents and intermediaries with respect to our business. Failure to comply with domestic or foreigninternational laws could result in various adverse consequences, including possible delay in the approval or refusal to approve a product, recalls, seizures, withdrawal of an approved product from the market, or the imposition of criminal or civil or criminal sanctions.sanctions, including substantial monetary penalties.

We may fail to adequately protect our proprietary technology, which would allow competitors or others to take advantage of our research and development efforts.

        Our long-term success largely depends on our ability to market technologically competitive products. If we fail to obtain or maintain adequate intellectual property protection in the United States or abroad, we may not be able to prevent third parties from using our proprietary technologies. Our currently pending or future patent applications may not result in issued patents. Patent applications are typically confidential for 18 months following their earliest filing, and because third parties may have filed patent applications for technology covered by our pending patent applications without us being aware of those applications, our patent applications may not have priority over patent applications of others. In addition, our issued patents may not contain claims sufficiently broad to protect us against third parties with similar technologies or products, or provide us with any competitive advantage. If a third party initiates litigation regarding our patents our collaborators' patents, or those patents for which we have license rights, and is successful, a court could declare oursuch patents invalid or unenforceable or limit the scope of coverage of those patents. Governmental patent offices and courts have not always been consistent in their interpretation of the scope and patentability of the subject matter claimed in biotechnology patents. Any changes in, or unexpected interpretations of, the patent laws may adversely affect our ability to enforce our patent position.

        We also rely upon trade secrets, proprietary know-how, and continuing technological innovation to remain competitive. We attempt to protect this information with security measures, including the use of confidentiality agreements with employees, consultants, and collaborators. These individuals may breach these agreements and any remedies available to us may be insufficient to compensate for our damages. Furthermore, our trade secrets, know-how and other technology may otherwise become known or be independently discovered by our competitors.


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Some of our products may face competition from lower cost generic or follow-on products.

        Some of our drug products, for example Renagel, Renvela, Hectorol, Clolar, Fludara and Mozobil are approved under the provisions of the United States Food, Drug and Cosmetic Act, or FDCA, that render them susceptible to potential competition from generic manufacturers via the Abbreviated New Drug Application (ANDA)ANDA procedure. Generic manufacturers pursuing ANDA approval are not required to conduct costly and time-consuming clinical trials to establish the safety and efficacy of their products; rather, they are permitted to rely on the innovator's data regarding safety and efficacy. Thus, generic manufacturers can sell their products at prices much lower than those charged by the innovative pharmaceutical or biotechnology companies who have incurred substantial expenses associated with the research and development of the drug product.


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        The ANDA procedure includes provisions allowing generic manufacturers to challenge the effectiveness of the innovator's patent protection long priorby submitting "Paragraph IV" certifications to the generic manufacturer actually commercializing their product by submitting a "Paragraph IV" certificationFDA in which the applicantgeneric manufacturer claims that the innovator's patent is invalid or will not be infringed by the manufacture, use, or sale of the generic product. A patent owner who receives a Paragraph IV certification may choose to sue the generic applicant for patent infringement. If such patent infringement lawsuit is madebrought within a statutory 45-day period, then a 30-month stay of FDA approval for the ANDA is triggered. In recent years, generic manufacturers have used Paragraph IV certifications extensively to challenge the applicability of patents listed in the FDA's Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, on a wide array of innovative pharmaceuticals.therapeutic products. We expect this trend to continue and to implicate drug products with even relatively modest revenues.

        Renagel, Renagel/Renvela and Hectorol are subjects of ANDAs containing Paragraph IV certifications. Renagel is the subject of ANDAs submitted by four ANDAscompanies, and Renvela is the subject of two ANDAs submitted by three companies, containing Paragraph IV certifications. The first-filed Renagel ANDA contained a Paragraph IV certification that relates only to our Orange Book-listed patent that expires in 2020 and covers features of our tablet dosage form. We reviewed the Paragraph IV certification and did not initiate patent infringement litigation. Three applicants have filed ANDA applications containing Paragraph IV certifications challenging additional aspects of the Renagel and Renvela patent estate, including patents that expire in 2014 and 2013. We have initiated patent litigation against these threethe four ANDA applicants.applicants with respect to Renagel and against two ANDA applicants with respect to Renvela. At issue in the lawsuits is U.S. Patent No. 5,667,775, which expires in 2014 (the "'775 Patent"). See "Legal Proceedings" in Part II,I., Item 13. of thisour 2009 Form 10-Q.10-K. If we are unsuccessful in these lawsuits, a generic manufacturer may launch its generic product prior to the expiration of the '775 Patent, but not before the expiration in 2013 of our other Orange Book-listed patents covering Renagel and Renvela. We are currently evaluating the Paragraph IV notice received from the third ANDA applicant with respect to Renvela.

        Our Hectorol injection product is(doxercalciferol) products (vial and capsule) are collectively the subject of five ANDAs containing Paragraph IV certifications.certifications submitted by six companies. We have initiated patent litigation against four of thethese ANDA applicants andapplicants. See "Legal Proceedings" in Part I., Item 3. of our 2009 Form 10-K. In all four cases we are pursuing claims with respect to our patentU.S. Patent No. 5,602,116 related to the use of Hectorol to treat hyperparathyroidism secondary to end-stage renal disease,ESRD, which expires in 2014 (the "2014 patent""'116 Patent"). See "Legal Proceedings" in Part II, Item 1In one of this Form 10-Q. The fifth ANDA applicant submitted a paragraph IV certificationthe four cases, we are also pursuing claims with respect to only one patent, our patent that claims specific aspectsU.S. Patent No. 7,148,211 related to the formulation of our Hectorol vial formulation andproduct, which expires in 2023. We reviewed2023 (the "'211 Patent"). Our Hectorol capsule product is labeled for the Paragraph IV certification relatedtreatment of secondary hyperparathyroidism in patients with CKD on dialysis and for those patients not on dialysis. In one of the four cases relating to our vial formulation and didHectorol capsule products, the ANDA filer is seeking approval of its generic 0.5µg capsule only for the treatment of patients with CKD who are not initiate patent infringement litigation.on dialysis, thereby attempting to avoid our '116 Patent. If we are unsuccessful in ourthe patent infringement lawsuits that we have chosen to pursue against the ANDA filers, a generic manufacturer may launch its generic product prior to the expiration of our Orange-Book listed patents covering Hectorol.our Hectorol products.

        As for the two ANDA applicants against whom litigation was not initiated, they submitted Paragraph IV certifications with respect to only the '211 Patent. Because we did not initiate litigation, the FDA could approve the applicants' generic products upon the later of expiration or invalidation of the '116 Patent or expiration of the 180-day exclusivity, if any, accorded to the first ANDA filer. In April 2010, we received notice of another ANDA applicant seeking approval of generic versions of all three dosage strengths of our Hectorol capsules. This ANDA contained a Paragraph IV certification with respect to the '116 Patent. We are currently evaluating this notice.

        We also have two biologic products approved under the FDCA, Cerezyme and Thyrogen. This renders them susceptible to potential competition from follow-on or biosimilar manufacturers via the "505(b)2" pathway of the FDCA. As with an ANDA, the sponsor of a 505(b)2 application is permitted to rely, at least in part, on the safety and efficacy data of the innovator. For that reason, 505(b)(2) applicants may have a shorter time to approval than an applicant filing an NDA.


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        Other of our products, including Cerezyme, Fabrazyme, Aldurazyme, Myozyme, Campath and Leukine (so-called "biotech drugs") are not currently considered susceptible towere approved in the United States under the Public Health Service Act, or PHSA. The PHSA was amended by the March 2010 enactment of healthcare reform legislation, which, among other things, establishes an abbreviated approval procedure, either due to current United States law or FDA practicepathway for "biosimilar" products. This approval process differs from the ANDA approval process in approving biologic products. However,a number of significant ways. In particular, a biosimilar product could not be approved based on the United States Congress has been exploring since 2007 legislation that would establish a procedure for the FDA to accept ANDA-like abbreviated applications for thesafety and efficacy data of one of our products until 12 years after initial approval of "follow-on," "biosimilar" or "comparable" biotech drugs. Congress continues to be interested in the issue and the


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new U.S. presidential administrationour product. Biosimilar legislation has also expressed an interest in passing legislation regarding biosimilars. Such legislation has already been adopted in the European Union.

        If an ANDA filer or any other genericbiosimilar manufacturer were to receive approval to sell a generic or follow-onbiosimilar version of one of our products, that product would become subject to increased competition and our revenue for that product would be adversely affected.

Guidelines, recommendations and studies published by various organizations can reduce the use of our products.products and services.

        Professional societies, practice management groups, private health/science foundations, and organizations involved in various diseases may publish guidelines, recommendations or studies to the healthcare and patient communities from time to time. Recommendations of government agencies or these other groups/organizations may relate to such matters as usage, dosage, route of administration, cost-effectiveness, and use of related therapies. Organizations like these have in the past made recommendations about our products and productsservices and those of our competitors. Recommendations, guidelines or studies that are followed by patients and healthcare providers could result in decreased use of our products.products or services. The perception by the investment community or stockholdersshareholders that recommendations, guidelines or studies will result in decreased use of our products or services could adversely affect prevailing market price for our common stock. In addition, our success also depends on our ability to educate patients and healthcare providers about our products and services and their uses. If these education efforts are not effective, then we may not be able to increase the sales of our existing products and services or successfully introduce new products and services to the market.

Legislative or regulatory changes may adversely impact our business.

        New laws, regulations and judicial decisions, or new interpretations of existing laws, regulations and decisions, that relate to healthcare availability, methods of delivery or payment for products and services, or sales, marketing or pricing may cause our revenue to decline. In addition, we may need to revise our research and development plans if a program or programs no longer are commercially viable. Such changes could cause our stock price to decline or experience periods of volatility.

        The pricing and reimbursement environment for our products may change in the future and become more challenging due to among other reasons, new healthcare legislation or fiscal challenges faced by government health administration authorities. In the United States, enactment of health reform legislation in March 2010 is expected to adversely affect our revenues through, among other provisions, the imposition of fees on certain elements of our businesses and an increase in the Medicaid rebate.

        On September 27, 2007, the Food and Drug Administration Amendment Act of 2007 was enacted, giving the FDA enhanced authority over products already approved for sale, including the authority to require post-marketing studies and clinical trials, labeling changes based on new safety information, and compliance with risk evaluations and mitigation strategies approved by the FDA. The FDA's exercise of its new authority could result in delays or increased costs during the period of product development, clinical trials and regulatory review and approval, increased costs to assure compliance with new post-approval regulatory requirements, and potential restrictions on the sale or distribution of approved products.


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Credit and financial market conditions may exacerbate certain risk affecting our business.

        Sales of our products and services are dependent, in part, on the availability and extent of reimbursement from third party payors, including governments and private insurance plans. As a result of the current volatility in the financial markets, third-party payors may delay payment or be unable to satisfy their reimbursement obligations. A reduction in the availability or extent of reimbursement could negatively affect our product and service revenues.

        In addition, we rely upon third parties for certain aspects of our business, including collaboration partners, wholesale distributors for our products, contract clinical trial providers, contract manufacturers, and third-party suppliers. Because of the tightening of global credit and the volatility in the financial markets, there may be a delay or disruption in the performance or satisfaction of commitments to us by these third parties, which could adversely affect our business.

We may be required to license patents from competitors or others in order to develop and commercialize some of our products and services, and it is uncertain whether these licenses would be available.

        Third party patents may cover some of the products or services that we or our strategic partners are developing or producing. A patent is entitled to a presumption of validity, and accordingly, we face significant hurdles in any challenge to a patent. In addition, even if we are successful in challenging the validity of a patent, the challenge itself may be expensive and require significant management attention.

        To the extent valid third party patent rights cover our products or services, we or our strategic collaborators would be required to seek licenses from the holders of these patents in order to manufacture, use or sell these products and services, and payments under them would reduce our profits from these products and services. We may not be able to obtain these licenses on favorable terms, or at all. If we fail to obtain a required license or are unable to alter the design of our technology to fall outside the scope of a third party patent, we may be unable to market some of our products and services, which would limit our profitability.


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Legislative or regulatory changes may adversely impact our business.

        The United States government and other governments have shown significant interest in pursuing healthcare reform. Any government-adopted reform measures could adversely impact:

        New laws, regulations and judicial decisions, or new interpretations of existing laws, regulations and decisions, that relate to healthcare availability, methods of delivery or payment for products and services, or sales, marketing or pricing may cause our revenue to decline, and we may need to revise our research and development programs. In addition, such changes could cause our stock price to decline or experience periods of volatility. The pricing and reimbursement environment for our products may change in the future and become more challenging due to among other reasons, policies advanced by the new presidential administration in the United States, new healthcare legislation or fiscal challenges faced by government health administration authorities. For example, the Centers for Medicare & Medicaid Services and the U.S. House of Representatives have proposed that Medicare payment for phosphate binders and vitamin D analogs be bundled into the packaged composite rate paid by Medicare to dialysis clinics as reimbursement for most of the dialysis-related services provided to Medicare patients. If these product classes are bundled into the composite rate as proposed, separate Medicare reimbursement will no longer be available for Renagel/Renvela or Hectorol. It is too early to project the impact bundling may have on sales of Renagel/Renvela and Hectorol.

        On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 was enacted, giving the FDA enhanced post-market authority, including the authority to require post-marketing studies and clinical trials, labeling changes based on new safety information, and compliance with risk evaluations and mitigation strategies approved by the FDA. The FDA's exercise of its new authority could result in delays or increased costs during the period of product development, clinical trials and regulatory review and approval, increased costs to assure compliance with new post-approval regulatory requirements, and potential restrictions on the sale or distribution of approved products.

Importation of products may lower the prices we receive for our products.

        In the United States and abroad, many of our products are subject to competition from lower-priced versions of our products and competing products from other countries where government price controls or other market dynamics result in lower prices for such products. Our products that require a prescription in the United States may be available to consumers in markets such as Canada, Mexico, Taiwan and the Middle East without a prescription, which may cause consumers to seek out these products in these lower priced markets. The ability of patients and other customers to obtain these lower priced imports has grown significantly as a result of the Internet, an expansion of pharmacies in Canada and elsewhere that target American purchasers, an increase in U.S.-based businesses affiliated with these Canadian pharmacies and other factors. Most of these foreign imports are illegal under current United States law. However, the volume of imports continues to rise due to the limited enforcement resources of the FDA and the United States Customs Service, and there is increased political pressure to permit such imports as a mechanism for expanding access to lower-priced medicines. The importation of lower-priced versions of our products into the United States and other markets adversely affects our profitability. This impact could become more significant in the future.

Our investments in marketable securities are subject to market, interest and credit risk that may reduce their value.

        We maintain a significant portfolio of investments in marketable securities. Our earnings may be adversely affected by changes in the value of this portfolio. In particular, the value of our investments


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may be adversely affected by increases in interest rates, downgrades in the corporate bonds included in the portfolio, instability in the global financial markets that reduces the liquidity of securities included in


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the portfolio, and by other factors which may result in other than temporary declines in value of the investments. Each of these events may cause us to record charges to reduce the carrying value of our investment portfolio or sell investments for less than our acquisition cost.

We may require significant additional financing, which may not be available to us on favorable terms, if at all.

        As of June 30, 2009,March 31, 2010, we had $1.05 billion$961.7 million in cash, cash equivalents and short- and long-term investments, excluding our investments in equity securities.

        We intend to use substantial portions of our available cash for:

        On May 6, 2010, we announced that we will initiate a $2.0 billion stock repurchase program, under which we plan to purchase $1.0 billion of our common stock in the near term and financed by debt. We plan to repurchase the additional $1.0 billion during the next twelve months.

        In addition, we have several outstanding legal proceedings. Involvement in investigations and litigation can be expensive and a court may ultimately require that we pay expenses and damages. As a result of legal proceedings, we may also be required to pay fees to a holder of proprietary rights in order to continue certain operations.

        Recently, the general economic, global capital and credit market conditions in the United States and other parts of the world have deteriorated significantly and have adversely affected access to capital and increased the cost of capital. However, weWe continue to believe that our available cash, investments and cash flow from operations, together with our revolving credit facility and other available debt financing, will be adequate to meet our operating, investing and financing needs in the foreseeable future. We currently do not rely on short-term borrowing


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Our business could be negatively affected as a result of a proxy fight.

        Icahn Partners LP and certain of its affiliates have begun a proxy contest relating to fundour 2010 annual meeting of shareholders, nominating their own slate of four nominees for election to our board of directors. If the proxy contest continues, our business could be adversely affected because:

ITEM 3.    QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

        We are exposed to potential loss from exposure to market risks represented principally by changes in foreign exchange rates, interest rates and equity prices. At June 30, 2009,March 31, 2010, we held a number of financial instruments, including investments in marketable securities and derivative contracts in the


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form of foreign exchange forward contracts. We do not hold derivatives or other financial instruments for speculative purposes.

Foreign Exchange Risk

        As a result There have been no material changes in our market risks during the three months ended March 31, 2010 compared to the disclosures in Part II., Item 7A. of our worldwide operations, we face exposure to potential adverse movements in foreign currency exchange rates. Exposures to currency fluctuations that result from sales of our products in foreign markets are partially offset by the impact of currency fluctuations on our international expenses. We use foreign exchange forward contracts to further reduce our exposure to changes in exchange rates, primarily to offset the earnings effect from foreign currency assets and liabilities. We also hold a limited amount of foreign currency denominated equity securities.

        As of June 30, 2009 we estimate the potential loss in fair value of our foreign exchange forward contracts and foreign equity holdings that would result from a hypothetical 10% adverse change in exchange rates to be $27.4 million, as compared to $26.9 million as of December 31, 2008. Since the contracts hedge mainly transactional exchange exposures, any changes in the fair values of the contracts would be offset by changes in the underlying values of the hedged items.Form 10-K.

Interest Rate Risk

        We are exposed to potential loss due to changes in interest rates, principally changes in U.S. interest rates. Instruments with interest rate risk include short- and long-term investments in fixed income securities and a fixed rate capital lease. To estimate the potential loss due to changes in interest rates, we performed a sensitivity analysis using the instantaneous adverse change in interest rates of 100 basis points across the yield curve.

        On this basis, we estimate the potential loss in net fair value to be $7.0 million as of June 30, 2009, as compared to $6.2 million as of December 31, 2008. The increase is primarily a result of a decrease in the amount and duration of the fixed income investment portfolio, which provides less of an offset to the increase in the fair value of our capital lease.

Equity Price Risk

        We hold investments in a limited number of U.S. and European equity securities. We estimate the potential loss in fair value due to a 10% decrease in the equity prices of marketable securities held at June 30, 2009 to be $3.9 million, as compared to $5.7 million at December 31, 2008. This estimate assumes no change in foreign exchange rates from quarter-end spot rates and excludes any potential risk associated with securities that do not have a readily determinable market value.

ITEM 4.    CONTROLS AND PROCEDURES

        As of June 30, 2009,March 31, 2010, we evaluated, with the participation of our Chief Executive Officer and Chief Financial Officer, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act")). Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2009.March 31, 2010.

        There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended June 30, 2009,March 31, 2010 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.


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PART II. OTHER INFORMATION

ITEM 1.    LEGAL PROCEEDINGS

Renagel and Renvela Patent Litigation

        Beginning in January 2009, we received notices from Lupin Ltd. and Lupin Pharmaceuticals, collectively Lupin, and Impax Laboratories, Inc., or Impax, that each had submitted to the FDA abbreviated new drug applications, or ANDAs, containing Paragraph IV certifications seeking approval to market generic versions of Renagel (sevelamer hydrochloride) and Renvela (sevelamer carbonate).

        Lupin is seeking to market generic 400 mg and 800 mg sevelamer hydrochloride tablets and generic 800 mg sevelamer carbonate tablets prior to the expiration of all of our Orange Book-listed patents protecting Renagel and Renvela. On March 6, 2009, we filed a complaint against Lupin in the U.S. District Court for the District of Maryland. In the complaint, we allege that Lupin's proposed sevelamer hydrochloride products infringe U.S. Patent Nos. 5,496,545, 6,509,013, and 7,014,846, which expire in 2013, and U.S. Patent No. 5,667,775, which expires in 2014 (the "'775 Patent"). Lupin filed an answer and counterclaim, alleging that our asserted patents are invalid and/or not infringed by Lupin's proposed generic sevelamer hydrochloride products. On May 14, 2009, we filed a complaint against Lupin in the same court alleging that Lupin's proposed sevelamer carbonate product infringes U.S. Patent Nos. 5,496,545, 6,509,013, 6,858,203 and 7,014,846 and 7,459,151, which expire in 2013, and the '775 Patent.

        Impax is seeking to market generic 400 mg and 800 mg sevelamer hydrochloride tablets and generic 800 mg sevelamer carbonate tablets after the expiration of the patents protecting Renagel and Renvela that expire in 2013. We filed complaints against Impax in the U.S. District Court for the District of Maryland for patent infringement with respect to Renagel on March 13, 2009 and with respect to Renvela on April 3, 2009. In both complaints, we allege that Impax's proposed sevelamer products infringe the '775 patent. Impax filed an answer and counterclaim with respect to both suits. In its counterclaim, Impax alleges that the '775 Patent and U.S. Patent No. 6,773,780 (which expires in October 2020) are invalid and/or not infringed by Impax's proposed generic sevelamer products.

        In May 2009, we received notice that Sandoz, Inc., or Sandoz, had submitted to the FDA an ANDA containing a Paragraph IV certification seeking approval to market generic 400 mg and 800 mg sevelamer hydrochloride tablets after the expiration of the patents protecting Renagel that expire in 2013. On July 2, 2009, we filed a complaint against Sandoz in the U.S. District Court for the District of Maryland alleging that Sandoz's proposed generic products infringe the '775 patent.

Hectorol Patent Litigation

        In January 2008, we received notice that Pentech Pharmaceuticals, Inc., or Pentech, had submitted to the FDA an ANDA containing a Paragraph IV certification seeking approval to market a generic version of our Hectorol injection product prior to the expiration of the following Orange Book-listed patents: U.S. Patent No. 6,903,083, which expires in 2021 (the "'083 Patent") and U.S. Patent No. 5,602,116, which expires in 2014 (the "'116 Patent"). On February 21, 2008, we and our wholly-owned subsidiary Bone Care International, LLC, or Bone Care, filed a lawsuit in U.S. District Court for the Northern District of Illinois. In the complaint, we alleged that Pentech's proposed product infringed both patents. On April 10, 2009, we granted Pentech a covenant not to sue on the '083 Patent. We continue, however, to pursue our claims related to the '116 Patent. After we filed the lawsuit, Pentech assigned all interest in its ANDA to Cobrek Pharmaceuticals, Inc., or Cobrek. On June 13, 2009, we filed an amended complaint to add Cobrek as a defendant. A trial on the merits is scheduled for April 2010 with respect to the '116 Patent.

        In March 2009, we received notice that Eagle Pharmaceuticals, Inc., or Eagle, had submitted to the FDA an ANDA containing a Paragraph IV certification seeking approval to market a generic version of


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our Hectorol injection product prior to the expiration of our Orange Book-listed patents protecting the product. On April 23, 2009, we and Bone Care filed a complaint against Eagle in the U.S. District Court for the District of Delaware alleging that Eagle's proposed product infringes the '116 Patent. Eagle filed an answer and counterclaim alleging that the '116 Patent is invalid and/or not infringed and seeking declaratory judgment that two other patents related to Hectorol are invalid and/or not infringed by Eagle's proposed generic product.

        In June 2009, we received notice that Sandoz had submitted to the FDA an ANDA containing a Paragraph IV certification seeking approval to market a generic version of our Hectorol injection product prior to the expiration of our Orange Book-listed patents covering the product. On July 16, 2009, we and Bone Care filed a complaint against Sandoz in the U.S. District Court for the District of Delaware alleging that Sandoz's proposed product infringes the '116 Patent.

        In June 2009 we also received notice that Roxane Laboratories, Inc., or Roxane, had submitted to the FDA an ANDA containing a Paragraph IV certification seeking approval to market a generic version of our Hectorol capsule products prior to the expiration of our Orange Book-listed patents covering these products. On July 31, 2009, we filed a complaint against Roxane in the U.S. District Court for the District of Delaware alleging that Roxane's proposed products infringe the '116 Patent.

Federal Securities Litigation

        On        In July 29, 2009 and August 3, 2009, two purported securities class action lawsuits were filed in the U.S. District Court for the District of Massachusetts against us and our President and Chief Executive Officer. The lawsuits were filed on behalf of those who purchased our common stock during the period from June 26, 2008 through July 21, 2009 and allege violations of Section 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. Each of the lawsuits is premised upon allegations that we made materially false and misleading statements and omissions by failing to disclose instances of viral contamination at two of our manufacturing facilities and our receipt of a list of inspection observations from the FDA related to one of the facilities, which detailed observations of practices that the FDA considered to be deviations from GMP. The plaintiffs seek unspecified damages and reimbursement of costs, including attorneys' and experts' fees. In November 2009, the lawsuits were consolidated inIn Re Genzyme Corp. Securities Litigation and a lead plaintiff was appointed. In March 2010, the plaintiffs filed a consolidated amended complaint that extended the class period from October 24, 2007 through November 13, 2009. We intend to defend this lawsuit vigorously.

Shareholder Derivative Actions

        In December 2009, two actions were filed by shareholders derivatively for Genzyme's benefit in the U.S. District Court for the District of Massachusetts against our board of directors and certain of our executive officers after a ninety day period following their respective demand letters had elapsed (the "District Court Actions"). In January 2010, a derivative action was filed in Massachusetts Superior Court (Middlesex County) by a shareholder who has not issued a demand letter, and in February and March 2010, two derivative actions were filed in Massachusetts Superior Court (Suffolk County and Middlesex County, respectively) by two separate shareholders after the lapse of a ninety day period following the shareholders' respective demand letters (collectively, the "State Court Actions").

        The derivative actions in general are based on allegations that our board of directors and certain executive officers breached their fiduciary duties by causing Genzyme to make purportedly false and misleading or inadequate disclosures of information regarding manufacturing issues, compliance with GMP, ability to meet product demand, expected revenue growth, and approval of Lumizyme. The actions also allege that certain of our directors and executive officers took advantage of their knowledge of material non-public information about Genzyme to illegally sell stock they personally held in Genzyme. The plaintiffs generally seek, among other things, judgment in favor of Genzyme for the amount of damages sustained by Genzyme as a result of the alleged breaches of fiduciary duty, disgorgement to Genzyme of proceeds that certain of our board of directors and executive officers received from sales of Genzyme stock and all proceeds derived from their service as board of directors or executives of Genzyme, and reimbursement of plaintiffs' costs, including attorneys' and experts' fees.

        The District Court Actions have been consolidated inIn Re Genzyme Derivative Litigation and the plaintiffs have agreed to a joint stipulation staying these cases until our board of directors has had sufficient time to exercise its duties and complete an appropriate investigation, which is ongoing. In the State Court Actions, the parties are working to consolidate all three lawsuits. We intend to defend these lawsuits vigorously.

ANDA Litigation

        As disclosed in our 2009 Form 10-K, we have initiated patent litigation against a number of companies that submitted to the FDA ANDAs containing Paragraph IV certifications seeking approval


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to market generic versions of Renagel, Renvela and Hectorol. One of the ANDA filers, Sandoz, Inc., is seeking approval to market generic 400mg and 800mg sevelamer hydrochloride tablets after the expiration of the patents protecting Renagel that expire in 2013. In July 2009, we filed a complaint against Sandoz in the U.S. District Court for the District of Maryland alleging that Sandoz's proposed generic products infringe U.S. Patent No. 5,667,775, which expires in 2014 (the "'775 Patent"). Sandoz filed an answer and counterclaims alleging that the '775 Patent and U.S. Patent No. 6,733,780, which expires in 2020 (the "'780 Patent") are invalid and/or not infringed by Sandoz's proposed generic sevelamer hydrochloride products. In the first quarter of 2010, the court granted our motion to dismiss Sandoz's counterclaims with respect to the '780 Patent.

        We also are subject to other legal proceedings and claims arising in connection with our business. Although we cannot predict the outcome of these proceedings and claims, we do not believe that the ultimate resolution of any of these existing matters would have a material adverse effect on our consolidated financial position or results of operations.

ITEM 1A.    RISK FACTORS

        We incorporate by reference our disclosure related to risk factors which is set forth under the heading "Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations—Risk Factors" in Part I., Item 2. of this Quarterly Report on Form 10-Q.


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

        The following table provides information about our repurchases of our equity securities during the quarter ended June 30, 2009:

Period
 Total
Number of
Shares
Purchased
 Average
Price
Paid per
Share
 Total
Number of
Shares
Purchased
as Part of
Publicly
Announced
Plans or
Programs
 Approximate
Dollar Value
of Shares that
May Yet Be
Purchased
Under the
Plans or
Programs
 

April 1, 2009-April 30, 2009

       $1,018,427,338 

May 1, 2009-May 31, 2009

       $1,018,427,338 

June 1, 2009-June 30, 2009

       $1,018,427,338 
            
 

Total

  (1)$      
            

(1)
In May 2007, our board of directors authorized a stock repurchase program to repurchase up to an aggregate maximum amount of $1.50 billion or 20,000,000 shares of our outstanding common stock over a three year period that began in June 2007. During the second quarter of fiscal 2009, weWe did not repurchasepurchase any additional shares of our common stock under this program.

ITEM 4.    SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

        We heldduring the first quarter of our annual meeting of shareholders on May 21, 2009. We have set forth below the results of the voting on proposals submitted to our shareholders for a vote at the annual meeting. Abstentions and broker non-votes were counted for determining a quorum, but were not treated as votes cast on any of the proposals.2010 fiscal year.

        a.     A proposal to reelect eight directors, each for a one-year term:

 
 Number of Votes  
 
 
 Number of Broker Non-Votes 
Nominee
 For Against Abstain 

Douglas A. Berthiaume

  219,927,913  8,101,223  640,098  513,569 

Gail K. Boudreaux

  220,648,278  7,450,908  570,054  513,563 

Robert J. Carpenter

  225,653,097  2,382,741  633,395  513,570 

Charles L. Cooney

  225,649,427  2,388,023  631,786  513,567 

Victor J. Dzau

  223,600,643  4,430,772  637,823  513,565 

Senator Connie Mack

  223,686,743  4,253,118  729,375  513,567 

Richard F. Syron

  216,418,332  11,608,086  642,818  513,567 

Henri A. Termeer

  223,464,667  4,595,404  609,167  513,565 

        The number of votes cast in favor of each nominee exceeded the number of votes cast against each nominee and therefore each was reelected as a director of Genzyme.

        b.     A proposal to amend the 2004 Equity Incentive Plan by increasing the number of shares of common stock available for issuance under the plan by 2,500,000 shares;

Number of
Votes for
 Number of
Votes Against
 Number of
Votes Abstaining
 Number of
Broker Non-Votes
 

185,289,483

  25,215,257  289,492  18,388,571 

        The number of votes cast in favor of the proposal exceeded the number of votes cast against it, and therefore the proposal was adopted.


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        c.     A proposal to approve the 2009 Employee Stock Purchase Plan;

Number of
Votes for
 Number of
Votes Against
 Number of
Votes Abstaining
 Number of
Broker Non-Votes
 

201,479,765

  9,041,954  273,312  18,387,772 

        The number of votes cast in favor of the proposal exceeded the number of votes cast against it, and therefore the proposal was adopted.

        d.     A proposal to ratify the audit committee's selection of PricewaterhouseCoopers, LLP as our independent auditors for 2009;

Number of
Votes for
 Number of
Votes Against
 Number of
Votes Abstaining
 Number of
Broker Non-Votes
 

225,851,662

  2,578,146  239,427  513,568 

        The number of votes cast in favor of the proposal exceeded the number of votes cast against it, and therefore the proposal was adopted.

ITEM 6.    EXHIBITS

(a)
Exhibits

        See the Exhibit Index following the signature page to this report on Form 10-Q.


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SIGNATURES

        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.

  GENZYME CORPORATION

Dated: AugustMay 10, 20092010

 

By:

 

/s/ MICHAEL S. WYZGA

Michael S. Wyzga
Executive Vice President, Finance,
Chief Financial Officer

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GENZYME CORPORATION AND SUBSIDIARIES

FORM 10-Q, JUNE 30, 2009

MARCH 31, 2010

EXHIBIT INDEX

EXHIBIT NO. DESCRIPTION
 *3.1 Restated Articles of Organization of Genzyme, as amended. Filed as Exhibit 3.1 to Genzyme's Form 10-Q for the quarter ended June 30, 2006.
 *3.2 By-laws of Genzyme, as amended. Filed as Exhibit 3.1 to Genzyme's Form 8-K filed May 25, 2007.
 *10.1 2004 EquitySenior Executive Annual Incentive Plan, as amended.Plan. Filed herewith.
10.2Senior Executive Long-Term Incentive Plan. Filed herewith.
10.3Forms of Performance Restricted Stock Unit Award Agreements. Filed herewith.
10.4*Amended and Restated agreement dated April 14, 2010 between Genzyme, Relational Investors LLC, Ralph V. Whitworth and the other parties identified therein. Filed as Appendix BExhibit 99.1 to Genzyme's Proxy StatementForm 8-K filed on Schedule 14A for the 2009 Annual Meeting of Shareholders filed April 13, 2009.15, 2010.
 31.1 Certification of the Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith.
 31.2 Certification of the Chief Financial Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith.
 32.1 Certification of the Chief Executive Officer pursuant to section 906 of the Sarbanes-Oxley Act of 2002. Furnished herewith.
 32.2 Certification of the Chief Financial Officer pursuant to section 906 of the Sarbanes-Oxley Act of 2002. Furnished herewith.
101The following materials from Genzyme Corporation's Form 10-Q for the quarter ended March 31, 2010, formatted in eXtensible Business Reporting Language (XBRL): (i) Consolidated Statements of Operations, (ii) Consolidated Balance Sheets, (iii) Consolidated Statements of Cash Flows and (iv) Notes to Unaudited, Consolidated Financial Statements, tagged as blocks of text.

*
Indicates exhibit previously filed with the SEC and incorporated herein by reference. Exhibits filed with Forms 10-Q and 8-K or Schedule 14A of Genzyme Corporation were filed under Commission File No. 0-14680.