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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 September 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 ý    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 October 23, 2009: 265,382,892April 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.

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™ is a trademark,and 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 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, SEPTEMBER 30, 2009MARCH 31, 2010

TABLE OF CONTENTS

 
  
 PAGE NO. 

PART I.

 

FINANCIAL INFORMATION

  
67
 

ITEM 1.

 

Financial Statements

  
67
 

 

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


6

Unaudited, Consolidated Balance Sheets as of September 30, 2009 and December 31, 2008

  
7
 

 

Unaudited, Consolidated StatementsBalance Sheets as of Cash Flows for the Nine Months Ended September 30,March 31, 2010 and December 31, 2009 and 2008

  
8

Unaudited, Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2010 and 2009


9
 

 

Notes to Unaudited, Consolidated Financial Statements

  
910
 

ITEM 2.

 

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

  
3437
 

ITEM 3.

 

Quantitative and Qualitative Disclosures About Market Risk

  
8183
 

ITEM 4.

 

Controls and Procedures

  
8183
 

PART II.

 

OTHER INFORMATION

  
8284
 

ITEM 1.

 

Legal Proceedings

  
8284
 

ITEM 1A.

 

Risk Factors

  
8385
 

ITEM 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

  
8385
 

ITEM 6.

 

Exhibits

  
8385
 

Signatures

  
8486
 

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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
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Revenues:

             
 

Net product sales

 $953,686 $1,058,296 $3,106,355 $3,136,365 
 

Net service sales

  102,436  92,586  309,628  269,072 
 

Research and development revenue

  1,392  9,402  18,912  26,042 
          
  

Total revenues

  1,057,514  1,160,284  3,434,895  3,431,479 
          

Operating costs and expenses:

             
 

Cost of products sold

  296,881  225,691  821,342  683,773 
 

Cost of services sold

  62,526  59,517  184,400  174,078 
 

Selling, general and administrative

  367,347  331,170  1,039,436  996,861 
 

Research and development

  219,275  305,242  636,722  949,900 
 

Amortization of intangibles

  71,280  55,295  192,823  166,558 
 

Contingent consideration expense

  28,197    37,287   
          
  

Total operating costs and expenses

  1,045,506  976,915  2,912,010  2,971,170 
          

Operating income

  12,008  183,369  522,885  460,309 
          

Other income (expenses):

             
 

Losses on investments in equity securities, net

  (651) (14,129) (1,332) (4,201)
 

Gain on acquisition of business

      24,159   
 

Other

  616  (133) (2,419) 940 
 

Investment income

  4,544  11,793  14,038  40,015 
 

Interest expense

    (792)   (3,596)
          
  

Total other income (expenses)

  4,509  (3,261) 34,446  33,158 
          

Income before income taxes

  16,517  180,108  557,331  493,467 

Provision for income taxes

  (522) (60,512) (158,276) (159,036)
          

Net income

 $15,995 $119,596 $399,055 $334,431 
          

Net income per share:

             
 

Basic

 $0.06 $0.44 $1.48 $1.25 
          
 

Diluted

 $0.06 $0.42 $1.45 $1.19 
          

Weighted average shares outstanding:

             
 

Basic

  268,957  269,176  269,923  267,767 
          
 

Diluted

  273,741  288,179  275,375  286,003 
          
 
 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)



 September 30,
2009
 December 31,
2008
 
 March 31,
2010
 December 31,
2009
 

ASSETS

ASSETS

 

ASSETS

 

Current assets:

Current assets:

 

Current assets:

 

Cash and cash equivalents

 $679,559 $572,106 

Cash and cash equivalents

 $643,337 $742,246 

Short-term investments

 169,153 57,507 

Short-term investments

 162,011 163,630 

Accounts receivable, net

 993,206 1,036,940 

Accounts receivable, net

 904,102 899,731 

Inventories

 601,939 453,437 

Inventories

 608,642 608,022 

Other current assets

 164,362 208,040 

Other current assets

 310,626 210,747 

Deferred tax assets

 188,329 188,105 

Deferred tax assets

 181,318 178,427 
           
 

Total current assets

 2,796,548 2,516,135  

Total current assets

 2,810,036 2,802,803 

Property, plant and equipment, net

Property, plant and equipment, net

 2,695,231 2,306,567 

Property, plant and equipment, net

 2,824,099 2,809,349 

Long-term investments

Long-term investments

 140,160 344,078 

Long-term investments

 156,351 143,824 

Goodwill

Goodwill

 1,402,926 1,401,074 

Goodwill

 1,404,153 1,403,363 

Other intangible assets, net

Other intangible assets, net

 2,377,025 1,654,698 

Other intangible assets, net

 2,032,449 2,313,262 

Deferred tax assets-noncurrent

Deferred tax assets-noncurrent

 386,142 269,237 

Deferred tax assets-noncurrent

 401,370 376,815 

Investments in equity securities

Investments in equity securities

 75,872 83,325 

Investments in equity securities

 79,881 74,438 

Other noncurrent assets

Other noncurrent assets

 96,384 96,162 

Other noncurrent assets

 146,456 136,870 
           
 

Total assets

 $9,970,288 $8,671,276  

Total assets

 $9,854,795 $10,060,724 
           

LIABILITIES AND STOCKHOLDERS' EQUITY

LIABILITIES AND STOCKHOLDERS' EQUITY

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

Current liabilities:

Current liabilities:

 

Current liabilities:

 

Accounts payable

 $164,879 $127,869 

Accounts payable

 $175,764 $189,629 

Accrued expenses

 735,446 765,386 

Accrued expenses

 870,460 696,223 

Deferred revenue

 18,046 13,462 

Deferred revenue

 32,585 24,747 

Current portion of contingent consideration obligations

 170,478  

Current portion of contingent consideration obligations

 158,493 161,365 

Current portion of long-term debt and capital lease obligations

 7,988 7,566 

Current portion of long-term debt and capital lease obligations

 8,407 8,166 
           
 

Total current liabilities

 1,096,837 914,283  

Total current liabilities

 1,245,709 1,080,130 

Long-term debt and capital lease obligations

Long-term debt and capital lease obligations

 118,154 124,341 

Long-term debt and capital lease obligations

 113,389 116,434 

Deferred revenue-noncurrent

Deferred revenue-noncurrent

 11,769 13,175 

Deferred revenue-noncurrent

 12,870 13,385 

Long-term contingent consideration obligations

Long-term contingent consideration obligations

 834,188  

Long-term contingent consideration obligations

 875,184 853,871 

Other noncurrent liabilities

Other noncurrent liabilities

 294,009 313,484 

Other noncurrent liabilities

 80,415 313,252 
           
 

Total liabilities

 2,354,957 1,365,283  

Total liabilities

 2,327,567 2,377,072 
           

Commitments and contingencies

Commitments and contingencies

 

Commitments and contingencies

 

Stockholders' equity:

Stockholders' equity:

 

Stockholders' equity:

 

Preferred stock, $0.01 par value

   

Preferred stock, $0.01 par value

   

Common stock, $0.01 par value

 2,652 2,707 

Common stock, $0.01 par value

 2,665 2,657 

Additional paid-in capital

 5,612,569 5,779,279 

Additional paid-in capital

 5,770,283 5,688,741 

Accumulated earnings

 1,646,851 1,247,796 

Accumulated earnings

 1,555,148 1,670,096 

Accumulated other comprehensive income

 353,259 276,211 

Accumulated other comprehensive income

 199,132 322,158 
           
 

Total stockholders' equity

 7,615,331 7,305,993  

Total stockholders' equity

 7,527,228 7,683,652 
           
 

Total liabilities and stockholders' equity

 $9,970,288 $8,671,276  

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)



 Nine Months Ended
September 30,
 
 Three Months Ended
March 31,
 


 2009 2008 
 2010 2009 

Cash Flows from Operating Activities:

Cash Flows from Operating Activities:

 

Cash Flows from Operating Activities:

 

Net income

 $399,055 $334,431 

Reconciliation of net income to cash flows from operating activities:

 

Net income (loss)

 $(114,948)$195,486 
 

Depreciation and amortization

 329,359 276,042 

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

 
 

Stock-based compensation

 156,141 143,141  

Depreciation and amortization

 122,688 98,958 
 

Provision for bad debts

 14,700 9,065  

Stock-based compensation

 47,671 44,560 
 

Contingent consideration expense

 37,287   

Provision for bad debts

 2,449 5,762 
 

Losses on investments in equity securities, net

 1,332 4,201  

Contingent consideration expense

 62,549  
 

Gain on acquisition of business

 (24,159)   

Equity in loss of equity method investments

 697  
 

Deferred income tax benefits

 (74,949) (236,307) 

Deferred income tax benefit

 (32,679) (24,376)
 

Tax benefits from employee stock-based compensation

 10,956 57,149  

Tax benefit from employee stock-based compensation

 3,624 6,549 
 

Excess tax benefits from stock-based compensation

 (3,309) (17,470) 

Excess tax benefit from stock-based compensation

 480 (3,492)
 

Other

 8,517 2,936  

Other

 2,663 2,814 
 

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

  

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

 
 

Accounts receivable

 53,044 (99,579) 

Accounts receivable

 (31,463) (59,210)
 

Inventories

 20,539 (12,651) 

Inventories

 (28,225) 818 
 

Other current assets

 (12,301) (7,107) 

Other current assets

 (48,640) (22,659)
 

Accounts payable, accrued expenses and deferred revenue

 40,369 (19,786) 

Accounts payable, accrued expenses and deferred revenue

 139,598 12,565 
           
 

Cash flows from operating activities

 956,581 434,065  

Cash flows from operating activities

 126,464 257,775 
           

Cash Flows from Investing Activities:

Cash Flows from Investing Activities:

 

Cash Flows from Investing Activities:

 

Purchases of investments

 (244,208) (382,954)

Purchases of investments

 (120,119) (13,292)

Sales and maturities of investments

 336,918 412,690 

Sales and maturities of investments

 105,796 75,058 

Purchases of equity securities

 (7,548) (87,695)

Purchases of equity securities

 (3,302) (4,870)

Proceeds from sales of investments in equity securities

 2,365 16,519 

Proceeds from sales of investments in equity securities

 3,077 1,264 

Purchases of property, plant and equipment

 (480,436) (433,987)

Purchases of property, plant and equipment

 (152,220) (161,561)

Distributions from equity method investments

  5,995 

Investments in equity method investment

 (1,466)  

Acquisitions

 (57,238) (16,561)

Purchases of other intangible assets

 (5,885) (8,056)

Purchases of other intangible assets

 (29,838) (82,898)

Other

 (10,547) (47)

Other

 (7,096) 5,161       
      

Cash flows from investing activities

 (184,666) (111,504)
 

Cash flows from investing activities

 (487,081) (563,730)      

Cash Flows from Financing Activities:

Cash Flows from Financing Activities:

 
     

Proceeds from issuance of common stock

 30,075 34,526 

Cash Flows from Financing Activities:

 

Proceeds from the issuance of our common stock

 76,125 294,603 

Repurchases of our common stock

  (107,134)

Repurchases of our common stock

 (413,874) (143,012)

Excess tax benefits from stock-based compensation

 (480) 3,492 

Excess tax benefits from stock-based compensation

 3,309 17,470 

Payments of debt and capital lease obligations

 (3,092) (2,653)

Payments of debt and capital lease obligations

 (5,908) (5,281)

Decrease in bank overdrafts

 (20,728) (3,392)

Increase (decrease) in bank overdrafts

 (17,552) 20,889 

Payment of contingent consideration obligation

 (31,600)  

Other

 (5,237) 2,854 

Other

 116 1,995 
           
 

Cash flows from financing activities

 (363,137) 187,523  

Cash flows from financing activities

 (25,709) (73,166)
           

Effect of exchange rate changes on cash

Effect of exchange rate changes on cash

 1,090 (6,134)

Effect of exchange rate changes on cash

 (14,998) (1,773)
           

Increase in cash and cash equivalents

 107,453 51,724 

Increase (decrease) in cash and cash equivalents

Increase (decrease) in cash and cash equivalents

 (98,909) 71,332 

Cash and cash equivalents at beginning of period

Cash and cash equivalents at beginning of period

 572,106 867,012 

Cash and cash equivalents at beginning of period

 742,246 572,106 
           

Cash and cash equivalents at end of period

Cash and cash equivalents at end of period

 $679,559 $918,736 

Cash and cash equivalents at end of period

 $643,337 $643,438 
           

Supplemental disclosures of non-cash transactions:

Supplemental disclosures of non-cash transactions:

 

Supplemental disclosures of non-cash transactions:

 

Strategic Transactions—Note 6.

 

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 genetic diseaseinherited 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:

        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:

        Formerly, we included our MSWelchol product line, which previously was reported as part of our bulk pharmaceuticals business unit under the caption "Other."Other;" As a result of

our recent acquisition of certain productsformer Cardiometabolic and development programs from Bayer,Renal reporting segment is now referred to as described under the heading "Acquisition from Bayer" in Note 6., "Strategic Transactions," to these consolidated financial statements,"Renal and Endocrinology" and now includes our MSimmune-mediated diseases business unit, is now material. We have aggregated our Hematologic Oncology and MS reportable segments and now report the activities of these two segmentswhich previously was reported under the caption "Hematologic Oncology."Other," Our transplantbut no longer includes our cardiovascular business unit, which develops, manufacturesunit; and distributes therapeutic products that address pre-transplantation, prevention and treatment of graft rejection in organ transplantation and other hematologic and auto-immune disorders, and our genetics 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 include our transplant and genetics business units under the caption "Other." We also report the activities of our diagnostic products, bulk pharmaceuticals and immune mediated disease business units under the caption "Other." 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."


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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 $317 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, commonly referred to asor U.S. GAAP.

        In June 2009, the Financial Accounting Standards Board, or FASB, issued Statement of Financial Accounting Standards No., or FAS, 168,"The FASB Accounting Standards Codification™ and the Hierarchy of Generally Accepted Accounting Principles." FAS 168 identifies the FASB Accounting Standards Codification™, or ASC, as the authoritative source of U.S. GAAP. Rules and interpretive releases of the SEC under federal securities laws are also sources of authoritative U.S. GAAP for SEC registrants. FAS 168 is effective for financial statements issued for interim reporting periods ending after September 15, 2009. The ASC does not change or alter existing U.S. GAAP and, therefore, it does not have an impact on our financial position, results of operations or cash flows.

        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 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. 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 account for our investments in entities not subject to consolidation using the equity method of accounting if we have a substantial ownership interest (20% to 50%) in or exercise significant 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.eliminated in consolidation.


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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:


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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 SEC.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 166, "Accounting for Transfers 2009-13 "Multiple-Deliverable Revenue Arrangements—a consensus of Financial Assets—an amendment ofthe FASB Statement No. 140.Emerging Issues Task Force."

 ImprovesEstablishes the relevance, representational faithfulness,accounting and comparabilityreporting guidance for arrangements under which a vendor will perform multiple revenue-generating activities. Specifically, the provisions of the information that a reporting entity provides in its financial statements about a transferthis update address how to separate deliverables and how to measure and allocate arrangement consideration to one or more units 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.accounting. Issued JuneOctober 2009. Effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. Early adoption is permitted.We will adopt the provisions of this update for the first annual reporting period that begins after November 15, 2009.It is anticipated that FAS 166 will primarily be incorporated into ASC 860, "Transfers and Servicing."quarter of 2011. We do not expectare currently assessing the adoptionimpact the provisions of this pronouncement toupdate will have, if any, affect on our consolidated financial statements.

FAS 167, "Amendments2009-17 "Improvements to FASB Interpretation No. 46(R).Financial Reporting by Enterprises Involved with Variable Interest Entities."

 

Improves financial reporting by enterprises involved with variable interest entities 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 provide more relevant reliable information to usersdirect the activities of financial statements.the entity that most significantly impact the entity's economic performance.

 

Issued JuneDecember 2009. Effective for the first interim or annual reporting period that begins after NovemberDecember 15, 2009.

 

It We adopted the provisions of this update in the first quarter of 2010. The provisions of this update did not have any impact on our consolidated financial statements, other than for our interest in BioMarin/Genzyme LLC, as discussed in Note 9., "Investment in BioMarin/Genzyme LLC," below.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

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

ASU NumberRelevant Requirements of ASUIssued Date/Our Effective DatesStatus

2010-06 "Improving Disclosures about Fair Value Measurements."

Requires new disclosures and clarifies some existing disclosure requirements about fair value measurements codified within ASC 820, "Fair Value Measurements and Disclosures," 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 Level 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 in the roll forward of Level 3 investments. Those disclosures are effective for fiscal years beginning after December 15, 2010, and for interim reporting periods within those fiscal years.

We adopted the applicable provisions of this update, except for the 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 update does not have a material impact on our consolidated financial statements. During the three months ended March 31, 2010, none of our instruments were reclassified between Level 1, Level 2 or Level 3.

2010-11, "Scope Exception Related to Embedded Credit Derivatives."

Update provides amendments to Subtopic 815-15,"Derivatives and Hedging—Embedded Derivatives, " to clarify the scope exception for embedded credit derivative features related to the transfer of credit risk in the form of subordination of one financial instrument to another.

Issued March 2010. Effective at the beginning of each reporting entity's first fiscal quarter beginning after June 15, 2010. Early adoption is anticipated that FAS 167permitted at the beginning of each reporting entity's first fiscal quarter beginning after issuance of this update.

We will primarily be incorporated into ASC 810, "Consolidation."adopt the provisions of this update for the third quarter of 2010. We are evaluatingcurrently assessing the impact the provisions of this pronouncementupdate will have, if any, on our consolidated financial statements.

2010-17, "Milestone Method of Revenue Recognition—a consensus of the FASB Emerging Issues Task Force."

Update provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition for research and development transactions.

Issued April 2010. Effective on a prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. Early adoption is permitted.

We will adopt the provisions of this update beginning January 1, 2011. We are currently assessing the impact the provisions of this update will have, if any, on our consolidated financial 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 assets and liabilities are carried at fair value. These include:

Fair Value Measurement—Definition and Hierarchy

        Fair value is 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, we are permitted to use various valuation approaches, including market, income and cost approaches. We 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.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3. Fair Value Measurements (Continued)

        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


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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)
              

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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 September 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
September 30,
2009
 Level 1 Level 2 Level 3 

Fixed income investments(1):

 

Cash equivalents:

 Money market funds/other $540,412 $540,412 $ $ 
              

 

Short-term investments:

 U.S. Treasury notes  47,840  47,840     

   Non U.S. Governmental notes  4,100    4,100   

   U.S. agency notes  56,110    56,110   

   Corporate notes—global  58,014    58,014   

   Commercial paper  3,089    3,089   
              

   Total  169,153  47,840  121,313   
              

 

Long-term investments:

 U.S. Treasury notes  14,265  14,265     

   Non U.S. Governmental notes  3,232    3,232   

   U.S. agency notes  37,023    37,023   

   Corporate notes—global  85,640    85,640   
              

   Total  140,160  14,265  125,895   
              

 

Total fixed income investments

  849,725  602,517  247,208   
              

Equity holdings(1):

 

Publicly-traded equity securities

  48,893  48,893     
              

Derivatives:

 

Foreign exchange forward contracts

  (1,002)   (1,002)  
              

Contingent liabilities(2):

 

Contingent consideration obligations

  (1,004,666)     (1,004,666)
              

Total assets (liabilities) at fair value

 $(107,050)$651,410 $246,206 $(1,004,666)
              

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.

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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, we recorded contingent consideration obligations in connection with our acquisition from Bayer of the worldwide rights to Campath, Fludara, Leukine and alemtuzumab for 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 nine months ended September 30, 2009 were as follows (amounts in thousands):

Contingent consideration obligations related to acquisition from Bayer in May 2009

 $964,100 

Payments

  (9,187)

Contingent consideration expense

  37,287 

Effect of foreign currency adjustment

  12,466 
    

Fair value at September 30, 2009

 $1,004,666 
    

        The carrying amounts reflected in our consolidated balance sheets for cash, accounts receivable, 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.

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


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3. Fair Value Measurements (Continued)


which we do not apply hedge accounting treatment, 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, in our consolidated statements of operations. We do not have any derivatives designated as hedging instruments 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 September 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 other current assets and net liability derivatives are included in accrued expenses in our consolidated balance sheets.

        The following table summarizes the balance sheet classification of the fair value of these derivatives on both a gross and net basis as of September 30, 2009March 31, 2010 and December 31, 20082009 (amounts in thousands):

 
 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
 

September 30, 2009

 $1,770 $2,772 $ $1,002 

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 nine months ended September 30,March 31, 2010 and 2009 and 2008 was not significant.

        The following table summarizes the effect of the unrealized and realized lossesnet gains related to our foreign exchange forward contracts on our consolidated statements of operations for the three and nine months ended September 30,March 31, 2010 and 2009 and 2008 (amounts in thousands):

 
  
 Net (Gain)/Loss Reported 
 
  
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 Statement of
Operations Location
 
Derivative Instrument
 2009 2008 2009 2008 

Foreign exchange forward contracts

 SG&A $16,275 $(28,066)$24,173 $12,127 

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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

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
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Net income—basic

 $15,995 $119,596 $399,055 $334,431 

Effect of dilutive securities:

             
 

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

    1,885    5,658 
          

Net income—diluted

 $15,995 $121,481 $399,055 $340,089 
          

Shares used in computing net income per common share—basic

  268,957  269,176  269,923  267,767 

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)

  3,209  8,081  4,106  7,665 
 

Restricted stock units

  1,565  871  1,335  618 
 

Other

  10  365  11  267 
          
  

Dilutive potential common shares

  4,784  19,003  5,452  18,236 
          

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

  273,741  288,179  275,375  286,003 
          

Net income per common share:

             
 

Basic

 $0.06 $0.44 $1.48 $1.25 
          
 

Diluted

 $0.06 $0.42 $1.45 $1.19 
          

(1)
Prior to January 1, 2009, 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 the three and nine months ended September 30, 2009, because we redeemed these notes, primarily for cash, on December 1, 2008.

(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
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Shares issuable under our stock plans

  21,108  3,123  16,474  3,121 
          

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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

5. Comprehensive Income

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

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Net income

 $15,995 $119,596 $399,055 $334,431 
          

Other comprehensive income (loss):

             
 

Foreign currency translation adjustments

  48,546  (172,636) 82,178  (66,963)
          
 

Pension liability adjustments, net of tax(1)

    2,019    2,090 
          
 

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

             
  

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

  6,358  475  (4,592) 5,186 
  

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

  (378) (141) (538) (6,039)
          
  

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

  5,980  334  (5,130) (853)
          
 

Other comprehensive income (loss)

  54,526  (170,283) 77,048  (65,726)
          

Comprehensive income (loss)

 $70,521 $(50,687)$476,103 $268,705 
          

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

(2)
Net of $(3.4) million of tax for the three months ended and $2.9 million of tax for the nine months ended September 30, 2009, and $(0.2) million of tax for the three months ended and $0.5 million of tax for the nine months ended September 30, 2008.
 
  
 Three Months Ended
March 31,
 
 
 Statement of
Operations Location
 
Derivative Instrument
 2010 2009 

Foreign exchange forward contracts

 SG&A $(5,041)$(10,828)

Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

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

        Effective January 1, 2009, we account for business combinations completed on or after January 1, 2009The following table sets forth our computation of basic and diluted net income (loss) per common share (amounts in accordance withthousands, 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 revised guidance for accounting for business combinations, which modifiesthree months ended March 31, 2010, basic and diluted net loss per share are the criteria that must be met to qualify as a business combination and prescribes new accounting requirements. Among various other requirements and differences,same. We did not include the securities described in 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 prior to and on or after January 1, 2009:

the period (amounts in thousands):

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

Transaction costsStock options

 2,949

•       Capitalized as cost of acquisitionRestricted stock units

 

•       Expensed as incurred

2,534

Exit/Restructuring costsOther

 247

•       Capitalized as costTotal shares excluded from calculation of acquisition if certain criteria were metdiluted loss per share

 

•       Expensed as incurred at or subsequent to acquisition date

5,730

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

•       Amortized from date of completion over estimated useful life

Contingent consideration

•       Recorded at acquisition date only to the extent of negative goodwill

•       Capitalized as cost of acquisition when contingency was resolved

•       No subsequent re-measurement

•       Measured at fair value and recorded on acquisition date

•       Re-measured in subsequent periods with an adjustment to earnings

Negative goodwill (excess of the value of acquired assets over consideration transferred)

•       Offset other long-lived intangibles acquired

•       Recognized as a gain in earnings

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)

Acquisition of Assets from Targeted Genetics Corporation5. Comprehensive Income (Loss)

        On September 8, 2009, we entered into an agreement with Targeted Genetics Corporation to acquire certain gene therapy manufacturing assets for $7.0 million. We acquired intellectual property and materials used in manufacturing Adeno-Associated Virus, or AAV, vectors. We paid Targeted Genetics Corporation a nonrefundable upfront paymentThe components of $3.5 million in September 2009 and will also make additional payments totaling $3.5 million upon achievement of certain technology transfer-based milestones. We recorded a total of $7.0 million as a charge to research and development expenses for our Genetic Diseases reporting segment in our consolidated statements of operationscomprehensive income (loss) for the three and nine months ended September 30, 2009. The payment for the milestones and the transition of the technologyperiods presented are all expected to be completed by the first quarter of 2010.

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 the product's development while Bayer will continue to fund development at current levels and will participate in the development steering committee. We will have worldwide commercialization rights, with Bayer retaining an option to co-promote alemtuzumab for MS. In exchange 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 are using Bayer for certain transition services and are purchasing 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 and is included in our results of operations beginning on May 29, 2009, the date of acquisition. The results for the acquired products are included in our Hematologic Oncology reporting segment. 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 
    
 
 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 
      

        At closing, we paid a total


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

(2)
Net of $117.1 million to Bayer, of which $74.6 million was refundable. The remaining non-refundable amount of $42.4 million represents a payment for acquired inventory. A total of $59.8$(1.4) million of the refundable amount was received in July 2009 and $14.8 million remains due from Bayer as of September 30, 2009. The contingent consideration obligations are net of the continued funding expected to be received from Bayer for the development of alemtuzumab 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. 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.


Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

6. Strategic Transactions (Continued)

        As of September 30, 2009, the fair value of the total contingent consideration obligations was $1.0 billion primarily due to changes in discount periods and management estimates. Accordingly, we recorded contingent consideration expense in our consolidated statements of operations of $28.2 milliontax for the three months ended March 31, 2010 and $37.3 million for the nine months ended September 30, 2009. As of September 30, 2009, we have paid $9.2 million in contingent consideration payments to Bayer and have not received funding from Bayer for the development of alemtuzumab for MS since May 29, 2009.

        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. 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, we recognized a gain on acquisition of business of $24.2 million in our consolidated statements of operations for the nine months ended September 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 nine months ended September 30, 2009 includes approximately $4$11.9 million of acquisition-related costs, primarily legal fees, associated with the Bayer transaction. Acquisition-related coststax for the three months ended September 30, 2009 were not significant.March 31, 2009.

6. Strategic Transactions

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 genetics 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 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.under this agreement are not significant.


Table of Contents


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

6. Strategic Transactions (Continued)

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. Effective January 1, 2009, 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.

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

   217.3 alemtuzumab for MS—ex-US 16% 2013    174.2 alemtuzumab for MS—ex-US 16% 2013 
      

   $632.9(1)        $632.9(1)     
      

Bioenvision (2007)

 $349.9 $125.5(2)Clolar/Evoltra (clofarabine)(3) 17% 2009-2014(4)

Bioenvision, Inc., or Bioenvision (2007)

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

AnorMED (2006)

 $589.2 $526.8(2)Mozobil (stem cell transplant)(5) 15% 2009-2013(4)

AnorMED Inc., or AnorMED (2006)

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

(1)
Capitalized as an indefinite-lived intangible asset.

(2)
Expensed on acquisition 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. We are continuing to launch Clolar/Evoltra and Mozobil on a country-by-country basis as pricing and reimbursement approvals are obtained.

(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.tumor sensitization.

Pro Forma Financial Summary

        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 those dates,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)


forma financial summaries for the periods presented (amounts in thousands, except per share amounts):

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2008 2009 2008 

Total revenues

 $1,230,149 $3,535,044 $3,639,597 
        

Net income

 $88,472 $326,590 $227,777 
        

Net income per share:

          
 

Basic

 $0.33 $1.21 $0.85 
        
 

Diluted

 $0.31 $1.19 $0.82 
        

Weighted average shares outstanding:

          
 

Basic

  269,176  269,923  267,767 
        
 

Diluted

  288,179  275,375  286,003 
        

7. Inventories



 September 30,
2009
 December 31,
2008
 
 March 31,
2010
 December 31,
2009
 


 (Amounts in thousands)
 
 (Amounts in thousands)
 

Raw materials

Raw materials

 $112,691 $96,986 

Raw materials

 $113,567 $123,434 

Work-in-process

Work-in-process

 287,331 141,094 

Work-in-process

 298,235 288,653 

Finished goods

Finished goods

 201,917 215,357 

Finished goods

 196,840 195,935 
           

Total

 $601,939 $453,437 

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 $23.7 million for the three months ended and $37.9 million for the nine months ended September 30, 2009charge to cost of products sold in our consolidated statements of operations in the second quarter of 2010.

        We capitalize inventory produced for costs relatedcommercial sale, which may result in the capitalization of inventory prior to the remediationregulatory approval of this facility, including the sanitization of the facility, idle capacity and overhead expenses anda product. If a product is not approved for sale, it would result in the write off of certainthe inventory and a charge to earnings. 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, materials.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

        When we suspended production at our Allston facility, we had significant Cerezyme work-in-process material. We decided not to processmanufacture 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 work-in-process material becausefacility, which damaged some of the material either had expired orequipment used to produce these active ingredients as well as the building in which the equipment was located. As a result, we were not sufficiently assuredhave 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 material wasfacility will resume production of sevelamer carbonate in the fourth quarter of 2010. We believe that we have adequate supply levels to meet the current demand for both Renagel and Renvela and do not contaminated with Vesivirus 2117 and incurredanticipate there will be any supply constraints for either product while the facility undergoes repairs. During the first quarter of 2010, we recorded a write offtotal of approximately $8$7.5 million for the nine months ended September 30, 2009. In August 2009, the FDA communicatedof expenses, net of $3.0 million of insurance reimbursements, to us steps it recommends we take prior to forward processing the remaining Cerezyme work-in-process. The steps recommendedcost 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)


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 mid-2010. If we decide not to process this remaining material or if we process the materialremediation cost of our Haverhill, England manufacturing facility, including repairs and the FDA or another regulatory authority does not allow us to release it, we will incur a write off of approximately $3 million for the inventory value of this remaining material. We had two lots of Cerezyme in inventory that were finished before production was suspended at our Allston facility. Both lots were released during the third quarter of 2009.idle capacity expenses.

8. Goodwill and Other Intangible Assets

Goodwill

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

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

Genetic Diseases

 $339,563 $ $339,563 

Cardiometabolic and Renal

  319,882    319,882 

Biosurgery

  7,585    7,585 

Hematologic Oncology

  640,137    640,137 

Other(1)

  93,907  1,852  95,759 
        

Goodwill

 $1,401,074 $1,852 $1,402,926 
        
 
 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)
The adjustmentsAccumulated 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 September 30, 2009 As of December 31, 2008 
 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
 
 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:

Finite-lived other intangible assets:

 

Finite-lived other intangible assets:

 

Technology(1)

 $2,180,620 $(824,819)$1,355,801 $1,919,074 $(692,235)$1,226,839 

Distribution rights(2)

 428,478 (213,451) 215,027 399,768 (170,892) 228,876 

Technology(1)

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

Patents

 188,651 (128,307) 60,344 194,560 (121,763) 72,797 

Distribution rights(2)

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

License fees

 98,833 (45,422) 53,411 98,123 (39,824) 58,299 

Patents

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

Customer lists

 86,526 (41,328) 45,198 83,729 (34,271) 49,458 

License fees

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

Trademarks

 60,596 (46,264) 14,332 60,556 (42,194) 18,362 

Customer lists

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

Other

    2,039 (1,972) 67 

Trademarks

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

Total finite-lived other intangible assets

 3,043,704 (1,299,591) 1,744,113 2,757,849 (1,103,151) 1,654,698 

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:

Indefinite-lived other intangible assets:

 

Indefinite-lived other intangible assets:

 

IPR&D(3)

 632,912  632,912    

IPR&D

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

Total other intangible assets

 $3,676,616 $(1,299,591)$2,377,025 $2,757,849 $(1,103,151)$1,654,698 

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 $29.8$5.9 million for the ninethree months ended September 30, 2009March 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 additional contingent royalty payments to Wyeth based on the volume of Synvisc sales in the covered territories. To date, $275.4 million of the maximum amount payable under the agreement has been paid. We anticipate completingMarch 31, 2010, the contingent royalty payments to Wyeth bypayable under the agreement are substantially complete. We completed the contingent royalty payments to Wyeth related to North American sales of Synvisc in the first quarter of 2010.

(3)
Includes capitalized IPR&D totaling $632.9 million2010 and anticipate completing the remaining contingent royalty payments to Wyeth related to our acquisitionsales 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 September 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)
  Estimated
Revenue-
Based
Amortization
Expense(1)
 Estimated
Other
Amortization
Expense
 Total
Estimated
Amortization
Expense(1)
 

2009 (remaining three months)

 $74,587 

2010

 319,597 

2010 (remaining nine months)

 $82,704 $137,218 $219,922 

2011

 319,968  119,184 175,081 294,265 

2012

 224,474  87,705 148,272 235,977 

2013

 162,750  28,970 131,432 160,402 

2014

 23,696 109,116 132,812 

Thereafter

 658,545  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

the technology intangible assets resulting from our acquisition of the worldwide rights to the oncology products Campath, Leukine and Fludara, of which:

the assets related to Campath and Leukine are being amortized on a straight-line basis; and

the asset related to Fludara is being amortized based on the forecasted future sales of Fludara.

(2)
Excludes future amortization expense

9. Investment in BioMarin/Genzyme LLC

        We and BioMarin Pharmaceutical Inc., or BioMarin, have entered into agreements to develop and commercialize Aldurazyme, a recombinant form of the 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 $240.2 millionmanufacturing 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 technology recorded effectiveworldwide net product sales of Aldurazyme.

        Prior to January 1, 2008 related to our consolidation of2010, we determined that we were the resultsprimary beneficiary of BioMarin/Genzyme LLC because such amortization is entirely offset byand, as a result, we:


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Notes to Unaudited, Consolidated Financial Statements (Continued)

9. InvestmentsInvestment in Equity SecuritiesBioMarin/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. Investment in Isis Pharmaceuticals, Inc. Common Stock

        We recorded the following losses on investmentsAs of March 31, 2010, our investment in equity securities, netIsis common stock had a carrying value of charges for impairment$80.1 million, or $16.02 per share, and a fair market value of investments, for the periods presented (amounts in thousands):

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Gross gains (losses) on investments in equity securities

 $(36)$(8,819)$422 $2,398 

Less: charges for impairment of investments

  (615) (5,310) (1,754) (6,599)
          

Losses on investments in equity securities, net

 $(651)$(14,129)$(1,332)$(4,201)
          

        Gross gains (losses) on investments in equity securities for both$54.7 million, or $10.93 per share. The closing price per share of Isis common stock exhibited volatility during 2009 and the three and nine months ended March 31, 2010 and has remained below our historical cost since September 30, 2008 includes1, 2009, with closing prices subsequent to that date ranging from a chargehigh of $10.0 million$15.69 per share to write offa low of $8.66 per share. We considered all available evidence in assessing the purchasedecline 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 of an exclusive option to acquire equity in a private company asestimate for Isis common stock among some analysts is approximately $16 per share. As a result of our terminationanalysis, as of March 31, 2010, we consider the option agreement prior$25.5 million unrealized loss on our investment in Isis common stock to be temporary. We will continue to review the exercise deadline. Gross gains (losses) for the nine months ended September 30, 2008 also includes a gain of $10.3 million recorded in the second quarter of 2008 resulting from the liquidationfair value of our investment in theIsis common stock of Sirtris for net cash proceeds of $14.8 million.

        Charges for impairment of investments for all periods presented representsin comparison to our historical cost and in the future, if the decline in value has become "other than temporary," we will write down of our investmentsinvestment in certain venture capital fundsIsis common stock to fairits then current market value at the end of each period.

        At September 30, 2009, our stockholders' equity includes $14.2 million of unrealized gains and $0.2 million of unrealized losses relatedrecord an impairment charge to our strategic investments in equity securities.

10. Revolving Credit Facility

        Asconsolidated statements of September 30, 2009, we had approximately $12 million of outstanding standby letters 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 September 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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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 repurchase 20,000,000 shares115%. For performance between 85% and 100% of our outstanding common stock overthe 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 three year periodcash payment that began in June 2007. The board authorized the expenditure ofwill be awarded based on performance achieved between target and maximum levels, up to $1.5 billiona 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 purchase those shares.100% of the senior executive's target PSU award associated with this performance measure. R-TSR performance between the target and maximum levels 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 the performance period because of death, disability or retirement, 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 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 based on a range of factors, including share price. The program does not obligate us to acquire any particular amount of common stockmet and the program mayassociated targeted payout level that is forecasted will be suspended at any time at our discretion.

        During the nine months ended September 30, 2009, we repurchased 7,500,000 sharesachieved, net of our common stock under this program at an average price of $55.16 per share for a total of $413.9 millionestimated


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Notes to Unaudited, Consolidated Financial Statements (Continued)

11. Stockholders' Equity (Continued)


inforfeitures. 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 including fees. Since June 2007, when we first began repurchasing sharesflow return on investment performance metric, which includes both performance and service conditions, is estimated based on the market value of our common stock under this program, we have repurchasedon the date of grant. We use a cumulative totallattice model with a Monte Carlo simulation to determine the fair value of 13,000,000 shares of our common stock at an average price of $60.63 per share for a total of $788.5 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, 2009

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%

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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
September 30,
 Nine Months Ended
September 30,
 
 Three Months Ended
March 31,
 


 2009 2008 2009 2008 
 2010 2009 

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

 

Cost of products and services sold(1)

 $(7,575)$(6,926)$(22,379)$(19,751)

Selling, general and administrative expense

 (24,648) (24,222) (86,301) (79,015)

Research and development expense

 (14,058) (14,645) (47,374) (43,322)
         
 

Total

 (46,281) (45,793) (156,054) (142,088)

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

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

 $(47,641)$(44,606)

Less: tax benefit from stock options

Less: tax benefit from stock options

 12,700 14,025 40,433 43,396 

Less: tax benefit from stock options

 13,072 12,589 
               

Total stock-based compensation expense, net of tax

 $(33,581)$(31,768)$(115,621)$(98,692)

Total stock-based compensation expense, net of tax

 $(34,569)$(32,017)
               

Effect per common share:

Effect per common share:

 

Effect per common share:

 

Basic

 $(0.12)$(0.12)$(0.43)$(0.37)

Basic and Diluted

 $(0.13)$(0.12)
               

Diluted

 $(0.12)$(0.11)$(0.42)$(0.35)
         

(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
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Stock-based compensation expense capitalized to inventory

 $3,623 $3,486 $12,764 $10,482 
 
 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 September 30, 2009,March 31, 2010, there was $278.6$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 2.01.6 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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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 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 these lawsuitsthis lawsuit vigorously. We are not able to predict the outcome of these lawsuits or estimate the amount or range of any possible loss we might incur if we do not prevail in final, non-appealable determinations of these matters. Therefore, we have not accrued any amounts in connection with these contingencies.

Shareholder Demand Letters

        Beginning inSince August 2009, we have received sixnine letters from alleged shareholders demanding that our board of directors take action on our 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 that we made materially false and misleadingregarding our disclosures and failed to disclose material information to shareholders with respect to manufacturing issues and compliance with GMP.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 our 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 determination that it was in our best interest to institute an action against any officers or directors, any monetary recovery would be to our benefit.

        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 1999 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 and in September 2009, Abbott agreed to pay Church & Dwight approximately $27 million to settle the lawsuit. 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. The supply agreement between Abbott and Wyntek provides for dispute resolution through an arbitration proceeding in the event that the parties are unable to reach agreement on the indemnification amount.


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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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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 the 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 determination of these matters. Therefore, we have not accrued any amounts in connection with the lawsuits and 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 currently evaluating whether to appealhave 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.

13. Provision forBenefit from (Provision for) Income Taxes


 Three Months Ended
September 30,
 Nine Months Ended
September 30,
  Three Months Ended
March 31,
 

 2009 2008 2009 2008  2010 2009 

 (Amounts in thousands)
  (Amounts in thousands)
 

Provision for income taxes

 $522 $60,512 $158,276 $159,036 

Benefit from (provision for) income taxes

 $61,799 $(78,884)

Effective tax rate

 3% 34% 28% 32% 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 includes income tax benefits of $2.6 million for the three months ended and $7.8 million for the nine months ended September 30, 2009. The income tax benefits result from the reversal of a portion of our U.S. tax reserves due to a remeasurement of our uncertain income tax position liabilities based on new information arising in the second and third quarter of 2009.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

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

        We are currently under IRS audit for the tax years 2006 to 2007 andby various states and foreign jurisdictions for various years. We believe that we have provided sufficiently for all audit exposures. We reasonably expect that our unrecognized tax benefits will decrease by approximately $15 million within the next twelve months as we receive clarification of certain tax issues as a result of the audit process. Settlement of these audits or the expiration of the statute of limitations on the assessment of income taxes for any tax year will 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

        We present segment information in a manner consistent with the method we use to report this information to our management. In the fourth quarter of 2008,Effective January 1, 2010, based on changes in 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. In addition, we now aggregate our MS and Hematologic Oncology reporting segments under the caption "Hematologic Oncology." The activities of our MS reporting unit were formerly reported under the caption "Other." 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
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Revenues:

             
 

Genetic Diseases(1)

 $354,288 $561,165 $1,459,491 $1,668,515 
 

Cardiometabolic and Renal

  261,160  243,599  752,122  714,722 
 

Biosurgery

  145,647  122,962  404,496  365,839 
 

Hematologic Oncology(2)

  87,989  34,054  192,183  96,506 
 

Other

  207,937  198,119  625,102  584,672 
 

Corporate

  493  385  1,501  1,225 
          
  

Total

 $1,057,514 $1,160,284 $3,434,895 $3,431,479 
          

Income (loss) before income taxes:

             
 

Genetic Diseases(1)

 $124,356 $259,392 $809,297 $982,569 
 

Cardiometabolic and Renal(3)

  114,123  98,670  323,053  48,520 
 

Biosurgery

  40,277  23,453  102,360  70,910 
 

Hematologic Oncology(2)

  (78,449) (33,798) (135,690) (109,211)
 

Other(4)

  30,227  6,993  66,854  30,374 
 

Corporate(5)

  (214,017) (174,602) (608,543) (529,695)
          
  

Total

 $16,517 $180,108 $557,331 $493,467 
          

(1)
Includes:

the impact of supply constraints for Cerezyme and Fabrazyme due to the temporary suspension of production at our Allston facility in June 2009; and
 
 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)


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)
Includes the impact of supply constraints for Cerezyme and 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 chargeportion of $100.0the 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 recorded in July 2008 for a nonrefundable upfront fee we paid to PTC Therapeutics, Inc., or PTC, related to our collaboration agreement with PTC to developHematology and commercialize atalurenOncology reporting segment and $41.1 million for our Multiple Sclerosis reporting segment for the treatmentthree months ended March 31, 2010 for which there were no comparable amounts for the same period of genetic diseases caused by nonsense mutations, including Duchenne muscular dystrophy, cystic fibrosis and hemophilia.

(2)
The results of operations of acquired companies and assets and the amortization expense related to acquired intangible assets are included in segment results beginning on the date of acquisition.

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.

(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.

(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.

Segment Assets

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

 
 September 30,
2009
 December 31,
2008
 

Segment Assets(1):

       
 

Genetic Diseases

 $1,543,651 $1,520,586 
 

Cardiometabolic and Renal

  1,305,361  1,366,970 
 

Biosurgery

  493,586  497,813 
 

Hematologic Oncology(2)

  1,998,962  1,024,674 
 

Other

  871,767  773,058 
 

Corporate(3)

  3,756,961  3,488,175 
      
  

Total

 $9,970,288 $8,671,276 
      

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

(2)
In May 2009, we acquired the worldwide rights to the oncology products Campath, Fludara and Leukine and alemtuzumab for MS from Bayer for $42.4 million of cash, net of refundable

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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

14. Segment Information (Continued)

 
 Amount Business Segment

Inventory

 $136.4 Hematologic Oncology

Developed technology

  261.4 Hematologic Oncology

IPR&D

  632.9 Hematologic Oncology
     
 

Total

 $1,030.7  
     
 
 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 five reporting segments and Other include primarily accounts receivable, inventory and certain fixed and intangible assets, including goodwill.

(2)
For 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 adopted for consolidating variable interest entities, we no longer consolidate the results of this joint venture and no longer include this gross technology asset and the related accumulated amortization or a related other noncurrent liability in our consolidated balance sheet.

(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):



 September 30,
2009
 December 31,
2008
 
 March 31, 2010 December 31, 2009 

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

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

 $988,872 $973,691 

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

 $961,699 $1,049,700 

Deferred tax assets, net

Deferred tax assets, net

 574,471 457,342 

Deferred tax assets, net

 582,688 555,242 

Property, plant & equipment, net

Property, plant & equipment, net

 1,721,787 1,524,442 

Property, plant & equipment, net

 1,813,697 1,787,054 

Investments in equity securities

Investments in equity securities

 75,872 83,325 

Investments in equity securities

 79,881 74,438 

Other

Other

 395,959 449,375 

Other

 545,860 449,783 
           

Total

 $3,756,961 $3,488,175 

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 September 30, 2009March 31, 2010 are as compared to the three months ended September 30, 2008. All references to increases or decreases for the nine months ended September 30, 2009 are as compared to the nine months ended September 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 genetic diseaseinherited 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:

        Formerly, we included our MS business unit under the caption "Other." As a result of our recent acquisition of certain products and development programs from Bayer, as described under the heading "Strategic Transactions—Acquisition from Bayer," below, our MS business unit is now material. We have aggregated our Hematologic Oncology and MS reporting segments and now report the activities


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

        We report the activities of graft rejection in organ transplantation and other hematologic and auto-immune disorders, andthe following business units under the caption "Other": our geneticsgenetic 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 include our transplantmarkets; and genetics business units under the caption "Other." We also report the activities of our 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."

STRATEGIC TRANSACTIONS

Acquisition of Assets from Targeted Genetics Corporation        We have revised our 2009 segment disclosures to conform to our 2010 presentation.

        On September 8,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 entered into an agreement with Targeted Genetics Corporation to acquire certain gene therapy manufacturing assetsour genetic testing business unit had revenue of approximately $317 million and revenue for $7.0our diagnostic products business unit was approximately $167 million. We acquired intellectual property and materials used in manufacturing AAV vectors. We paid Targeted Genetics Corporation a nonrefundable upfront payment of $3.5 million in September 2009 and will also make additional payments totaling $3.5 million upon achievement of certain technology transfer-based milestones. We recorded a total of $7.0 million as a charge to research and development expenses for our Genetic Diseases reporting segment in our consolidated statements of operations for the three and nine months ended September 30, 2009. The payment for the milestones and the transition of the technology are all expectedexpect these transactions to be completed by the first quarter ofin 2010.

STRATEGIC TRANSACTIONS

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 the product's development while Bayer will continuecontinues to fund development at currentthe levels specified under the previous agreement and will participateparticipates in the


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


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        Wethese contingent purchase price payments are using Bayer fordescribed 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 are purchasing 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 and is included in our results of operations beginning on May 29, 2009, the date of acquisition. The results for the acquired productsCampath, Fludara and Leukine are included in our HematologicHematology and Oncology reporting segment and the results for alemtuzumab for MS are included in our Multiple 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 assets atin this transaction based on their estimated fair values as of the date of acquisition, consisted of the following (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 of $117.1 million to Bayer, of which $74.6$136.4 million was refundable. The remaining non-refundable amountallocated to inventory and $894.3 million was allocated to intangible assets. We recognized a gain on acquisition of $42.4business of $24.2 million represents a payment for acquired inventory. A totalin our consolidated statements of $59.8 million of the refundable amount was received in July 2009 and $14.8 million remains due from Bayer as of September 30, 2009. The contingent consideration obligations are net of the continued funding expected to be received from Bayeroperations for the developmentsecond quarter of alemtuzumab for MS. We determined2009 representing the amount by which 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 approvalacquired assets of alemtuzumab for MS. The$1.03 billion exceeded the fair value measurement is based on significant inputs not observable in the market and thus represents a Level 3 measurement. 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.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.


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        As of September 30,December 31, 2009, the fair value of the total contingent consideration obligations was $1.0$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 discount periodsthe assumed timing and managementamount of revenue and expense estimates. Accordingly, we recorded a total of $62.5 million of contingent consideration expense, of which $35.5 million is related to changes in estimates, in our consolidated statements of operations of $28.2 million for the three months ended and $37.3March 31, 2010 to reflect the increase in fair value, including $21.4 million for the nine months ended September 30, 2009. Asour Hematology and Oncology reporting segment and $41.1 million for our Multiple Sclerosis reporting segment. In April 2010, we received $7.6 million of September 30, 2009, we have paid $9.2 million in contingent consideration payments to Bayer and have not received funding from Bayer for the development of alemtuzumab for MS since May 29, 2009.

        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. 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, we recognized a gain on acquisition of business of $24.2 million in our consolidated statements of operations for the nine months ended September 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 nine months ended September 30, 2009 includes approximately $4 million of acquisition-related costs, primarily legal fees, associated with the Bayer transaction. Acquisition-related costs for the three months ended September 30, 2009 were not significant.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 genetics 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 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


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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.

        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
September 30,
  
  
 Nine Months Ended
September 30,
  
  
 
 Three Months Ended
March 31,
  
  
 


 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 


 2009 2008 2009 2008 
 2010 2009 

Product sales allowances:

Product sales allowances:

 

Product sales allowances:

 

Contractual adjustments

 $160,132 $153,800 $6,332 4%$445,362 $362,813 $82,549 23%

Contractual adjustments

 $180,296 $136,180 $44,116 32%

Discounts

 6,628 5,655 973 17% 19,668 16,663 3,005 18%

Discounts

 6,630 6,275 355 6%

Sales returns

 7,019 8,434 (1,415) (17)% 22,917 20,103 2,814 14%

Sales returns

 7,809 6,523 1,286 20%
                           
 

Total product sales allowances

 $173,779 $167,889 $5,890 4%$487,947 $399,579 $88,368 22% 

Total product sales allowances

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

Total gross product sales

Total gross product sales

 $1,127,466 $1,226,184 $(98,718) (8)%$3,594,302 $3,535,943 $58,359 2%

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

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

 15% 14% (6)%   14% 11% >100%   

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

 17% 13%     

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

        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 supply 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 17%9% to approximately $246$257 million as of September 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 and approximately $10 million of additional contractual fees in the third quarter of 2009.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 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

        Cash 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:


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        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
September 30,
  
  
 Nine Months Ended
September 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

 $4,211 $3,437 $774  23%$11,224 $9,723 $1,501  15%
 

Charged to SG&A

  3,371  3,519  (148) (4)% 10,400  10,039  361  4%
                    
  

Total distributor fees

 $7,582 $6,956 $626  9%$21,624 $19,762 $1,862  9%
                    
 
 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%
           

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:

        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


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future cash flows for a charge reflectingStock-Based Compensation

        We use the contributionBlack-Scholes model to value of these assets. Such contributory tangibleboth service condition and intangible assets may include, but are not limited to, working capital, fixed assets, assembled workforce, customer relationships, patents, trademarks,performance condition option awards. For awards with only service conditions 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 thatgraded-vesting features, we will be able to successfully develop and completerecognize compensation cost on a straight-line basis over 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, thenrequisite service period. For awards with performance conditions, we may not realize the value we have estimated and recorded in our financial statementsrecognize stock-based compensation expense based on the acquisition date,graded-vesting method. Determining the appropriate fair value model and we may also not recoverrelated assumptions requires judgment, including estimating stock price volatility, forfeiture rates, and expected terms. The expected volatility rates are estimated based on historical and implied volatilities of our common stock. The expected term represents the research and development investment made since the acquisition dateaverage time that options that vest are expected 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. Effective January 1, 2009, all IPR&D acquired through business combinations on or after January 1, 2009 will be capitalized as an intangible assetoutstanding based on the balance sheetvesting provisions and periodically tested for impairment. Amortization of such capitalized IPR&D will commenceour 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 assumptions are warranted.

        We issue PSUs to our senior 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 September 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 geographic 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. We will test our capitalized IPR&D assets annually for potential impairment, or earlier if conditions warrant.

Contingent Consideration Expense

        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.


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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 September 30,  
  
 Nine Months Ended September 30,  
  
 
 Three Months Ended
March 31,
  
  
 


 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 


 2009 2008 2009 2008 
 2010 2009 

Product revenue

Product revenue

 $953,686 $1,058,296 $(104,610) (10)%$3,106,355 $3,136,365 $(30,010) (1)%

Product revenue

 $971,625 $1,037,244 $(65,619) (6)%

Service revenue

Service revenue

 102,436 92,586 9,850 11% 309,628 269,072 40,556 15%

Service revenue

 101,915 101,499 416  
                           

Total product and service revenue

 1,056,122 1,150,882 (94,760) (8)% 3,415,983 3,405,437 10,546  

Total product and service revenue

 $1,073,540 $1,138,743 $(65,203) (6)%

Research and development revenue

Research and development revenue

 1,392 9,402 (8,010) (85)% 18,912 26,042 (7,130) (27)%

Research and development revenue

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

Total revenues

 $1,057,514 $1,160,284 $(102,770) (9)%$3,434,895 $3,431,479 $3,416  

Total revenues

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

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Product Revenue

        We derive product revenue from sales of:

their related indications:

Reporting SegmentsProductsApproved Indications
Personalized Genetic HealthCerezymeGaucher disease



Fabrazyme


Fabry disease



Myozyme


Pompe disease



Aldurazyme


MPS I



Elaprase


MPS II



Royalties earned on sales of Welchol


Reduction of LDL in patients with hypercholesterolemia


Renal and Endocrinology




Renagel/Renvela and bulk sevelamer




Control of serum phosphorus in patients with chronic kidney disease, or CKD, on dialysis and in Europe in CKD patients both on and not on dialysis with serum phosphorus above a certain level



Hectorol


Secondary hyperparathyroidism in CKD patients



Thyrogen


An adjunctive diagnostic agent used in the follow-up treatment of patients with well-differentiated thyroid cancer and an adjunctive therapy in the ablation of remnant thyroid tissue in patients that have undergone thyroid removal

Biosurgery


Synvisc/Synvisc-One


Treatment of pain associated with osteoarthritis



Sepra products


Prevention of adhesions following various surgical procedures in the abdomen and pelvis

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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 September 30,  
  
 Nine Months Ended September 30,  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Genetic Diseases

 $354,288 $561,165 $(206,877) (37)%$1,459,466 $1,668,172 $(208,706) (13)%

Cardiometabolic and Renal

  260,999  243,511  17,488  7% 751,885  714,502  37,383  5%

Biosurgery

  134,557  112,373  22,184  20% 370,798  331,799  38,999  12%

Hematologic Oncology

  87,982  25,904  62,078  >100% 176,746  74,204  102,542  >100%

Other product revenue

  115,860  115,343  517    347,460  347,688  (228)  
                    
 

Total product revenue

 $953,686 $1,058,296 $(104,610) (10)%$3,106,355 $3,136,365 $(30,010) (1)%
                    
 
 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

Regulatory and Manufacturing

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

Cerezyme

 $93,599 $309,280 $(215,681) (70)%$687,656 $932,943 $(245,287) (26)%

Fabrazyme

  115,161  125,619  (10,458) (8)% 371,664  368,702  2,962  1%

Myozyme

  85,980  76,663  9,317  12% 232,645  221,209  11,436  5%

Aldurazyme

  40,331  38,236  2,095  5% 116,358  113,742  2,616  2%

Other Genetic Diseases

  19,217  11,367  7,850  69% 51,143  31,576  19,567  62%
                    
 

Total Genetic Diseases

 $354,288 $561,165 $(206,877) (37)%$1,459,466 $1,668,172 $(208,706) (13)%
                    

        Genetic Diseases product revenue decreased forIn March 2010, the three and nine months ended September 30, 2009 primarily dueFDA notified us that it intended to the temporary suspension of productiontake enforcement action to ensure that products manufactured at our Allston facility are made in June 2009, resultingcompliance 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 supply constraints for Cerezyme and Fabrazyme, and unfavorable exchange rate fluctuations, offset in part by continued growth in sales volume for Myozyme, Aldurazyme and Elaprase.

        The decreases in Cerezyme revenueour consolidated statements of operations for the threefirst quarter of 2010 and nine months ended September 30, 2009 are primarily dueas an increase to accrued expenses in our consolidated balance sheets as of March 31, 2010. In addition, if the temporary suspension of productionfill-finish operations at our Allston facility is still operating after deadlines for domestic and exported products, the resulting supply constraintdraft provides for Cerezymedisgorgement of 18.5% of revenues from sales of products manufactured and contractual fees, which adversely impacted revenue by approximately $209 million for the three months ended September 30, 2009 and by approximately $222 million for the nine months ended September 30, 2009. The weakening of foreign currencies against the U.S. dollar adversely impacted Cerezyme revenue by $5.3 million for the three months ended September 30, 2009 and by $49.8 million for the nine months ended September 30, 2009.

        The decrease in Fabrazyme revenue for the three months ended September 30, 2009 is primarily due to the temporary suspension of production atdistributed from our Allston facility after those deadlines. We and the resulting supply constraintFDA are having discussions regarding appropriate deadlines for Fabrazyme, which adversely impacted Fabrazyme revenuemoving 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 approximately $25 million fordeadlines over the three months ended September 30, 2009. The weakening of foreign currencies against the U.S. dollar adversely impacted Fabrazyme revenuecoming years in a remediation plan to be approved by $1.6 million for the three months ended September 30, 2009.

        The increase in Fabrazyme revenue for the nine months ended September 30, 2009 is primarily due to increased patient identification worldwide as Fabrazyme was introduced to new markets prior to the supply constraint. The increase in the sales volume of Fabrazyme was offset, in part, by a decrease of $16.6 million for the nine months ended September 30, 2009 attributable to the weakening of foreign currencies against the U.S. dollar.


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the FDA, the draft provides for payment of $15,000 per day per violation until the compliance milestones are 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 completed sanitization of the facility and resumed production there in the third quarter of 2009. Cerezyme and Fabrazyme inventories were not sufficient to avoid shortages.

        WhenWe 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 suspendedbegan shipping 50% of Cerezyme demand at the end of February 2010. Although we achieved our goal of building a small inventory buffer during the first quarter of 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 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 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 to transition fill-finish operations out of our Allston facility to our Waterford, Ireland plant and to a contract manufacturer. The fill-finish area of the Waterford facility is being expanded to accommodate the long-term growth of our PGH products, and we 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 United States. Since 2008, we had been seeking approval of 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 FDA, we decided to seek approval of the 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 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.

Personalized 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 inventory valuethree months ended March 31, 2010. The strengthening of this material inforeign currencies, primarily the second quarter of 2009. We also had two lots ofEuro, against the U.S. dollar, positively impacted Cerezyme in inventory that were finished before production was suspended at our Allston facility. Both lots were released during the third quarter of 2009.

        In August 2009, the FDA communicated to us steps it recommends we take prior to forward processing the remaining Cerezyme work-in-process. The steps recommendedrevenue by the FDA were consistent with the steps that we independently had planned to implement. The remaining Cerezyme work-in-process material expires in mid-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 $3$7.4 million for the inventory value of this remaining material.

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. Cerezyme and Fabrazyme inventories have not been sufficient to avoid shortages during the period of suspended production and recovery. The temporary suspension of production at our Allston facility has and will continue to adversely affect our Cerezyme and Fabrazyme revenues for 2009. Sales of Cerezyme were approximately 9%17% of our total revenue for the three months ended September 30, 2009 and approximately 20% for the nine months ended September 30, 2009,March 31, 2010, which reflect periods of supply constraint, as compared to approximately 27% for both the three and nine months ended September 30, 2008. We expect Cerezyme revenue26% for the fourth quarter of 2009 also to be significantly adversely affected by thesame period in 2009.

        The supply constraint and, therefore, expect that total Cerezyme revenue for 2009 will be significantly lower than 2008.

        We expect that newly produced Cerezyme will be available for shipment at the end of November and that the first shipments of new Fabrazyme will occur in late December. We expect that we will be able to meet anticipated demand for these therapies in the first quarter of 2010. We are constructing additional manufacturing capacity for Cerezyme and Fabrazyme in Framingham, Massachusetts to support the anticipated future 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 2011 for Fabrazyme and in 2012 for Cerezyme.

        Sales of Myozyme increased for the three and nine months ended September 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 $3.5$72.6 million for the three months ended September 30, 2009 and $21.4 million for the nine months ended September 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 in February 2009 received approval for a 4000L scale process.Euro,


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        In May 2008, weagainst 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 BLAnew drug application, or NDA, to the FDA seeking marketing 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 nine 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. The FDA is currently inspecting the facility.

        Inspectors visited our Allston facilityits therapy in August 2009 on behalf ofand a Market Authorization Application, or MAA, to the European Medicines Agency, or EMEA. We recentlyEMA, in November 2009. Shire received correspondencemarketing approval for its therapy from the EMEA confirmingFDA 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 are 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 inspection,certain patients were not tolerating reduced dosages of Fabrazyme. We also have encouraged patients to switch to competitors products during the operationsperiod of supply constraint. These actions may result in our Allston facility are in general compliance with the principles and guidelines of good manufacturing practice as laid down in Commission Directive 2003/94/EC.

        In order to provide more capacity in our Allston facility for Cerezyme and Fabrazyme, we have transitioned all Myozyme/Lumizyme productionadditional patients switching to our 4000L Belgium facility, where we are adding a third 4000L bioreactor,competitors' therapies. In addition, the institution of treatment guidelines and are no longer manufacturingdose conservation measures during the product atsupply constraint present the 2000L scale. FDA approvalrisk 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 revenue increased for the three months ended March 31, 2010 due to increased patient identification outside of the 4000L process will be necessary to expand supply and support an increaseUnited States following the European approval in U.S. sales. We have received FDA approval to transition U.S. patients in the Myozyme Temporary Access Program fromFebruary 2009 of the product produced at our Belgium facility using the 2000L4000L 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 thatwork with the 81 active study sites in the United States to enroll additional patients into this program. We plan 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 Lumizyme produced at the 4000L scale. The FDA's target action date underIf the Prescription Drug User Fee Act, or PDUFA, forFDA approves Lumizyme, is November 14, 2009. Wewe would expect to submit a supplemental BLArevenues for the 4000L process upon approval of Lumizyme. A standard review period is four months, which would mean an FDA action date by the end of March 2010. We expect Myozyme sales in Europe to continueproduct to increase in the fourth quarter of 2009.2011.

Aldurazyme

        Aldurazyme revenue increased for the three and nine months ended September 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 $1.5$1.7 million for the three months ended September 30, 2009 and $8.7 million for the nine months ended September 30, 2009.March 31, 2010.


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Other Personalized Genetic DiseasesHealth

        Other PGH product revenue increased for the three and nine months ended September 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 $1.6 million for the three months ended September 30, 2009 and $3.4 million for the nine months ended September 30, 2009.March 31, 2010.

CardiometabolicRenal and RenalEndocrinology



 Three Months Ended September 30,  
  
 Nine Months Ended September 30,  
  
 
 Three Months Ended
March 31,
  
  
 


 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 


 2009 2008 2009 2008 
 2010 2009 


 (Amounts in thousands)
 
 (Amounts in thousands)
  
 

Renagel/Renvela (including sales of bulk sevelamer)

Renagel/Renvela (including sales of bulk sevelamer)

 $181,702 $170,992 $10,710 6%$527,699 $508,253 $19,446 4%

Renagel/Renvela (including sales of bulk sevelamer)

 $164,607 $170,599 $(5,992) (4)%

Hectorol

Hectorol

 36,869 33,825 3,044 9% 98,880 93,753 5,127 5%

Hectorol

 42,025 33,030 8,995 27%

Thyrogen

Thyrogen

 41,691 38,153 3,538 9% 123,377 111,386 11,991 11%

Thyrogen

 45,625 38,826 6,799 18%

Other Cardiometabolic and Renal

 737 541 196 36% 1,929 1,110 819 74%
                           

Total Cardiometabolic and Renal

 $260,999 $243,511 $17,488 7%$751,885 $714,502 $37,383 5%

Total Renal and Endocrinology

 $252,257 $242,455 $9,802 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 and a powder form of Renvela was approved in the United States in August 2009. In June 2009, the European Commission approved Renvela for the control of serum phosphorus 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.

        Sales of Renagel/Renvela, including sales of bulk sevelamer, increaseddecreased for the three and nine months ended September 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 $5.4$6.4 million for the three months ended September 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 $29.6 million forfire at this facility, which damaged some of the nine months ended September 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 October 2007, an FDA advisory committee voted to recommendsevelamer hydrochloride in May 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 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 expectedsevelamer carbonate in the fourth quarter of 2009.2010. 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 three and nine months ended September 30, 2009March 31, 2010, primarily due to price increases in the second and fourth quarterquarters of 2008 and the second quarter2009. Sales of 2009 andHectorol also include an increase in sales volume due to the launchaddition of the Hectorol 1mcg capsule formulation in August 2009.


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        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.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 availability of coverage and reimbursement under patients' health insurance and prescription drug plans and the 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 includeestablish a bundled payment for drugs and biologicals that are usedsystem to treatreimburse dialysis providers treating patients with end stage renal disease, or ESRD, in the prospective payment system used to reimburse dialysis providers.ESRD. In September 2009, CMS proposed changes to the prospective payment system that would in accordance with MIPPA, 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 is accepting comments on the proposed rule through November 16, 2009 and will issue a final rule in 2010 with an anticipated implementation date of January 2011. There is controversy around the inclusion of drugs and biologicals that do not have an intravenous counterpart in the bundled payment amount because some observers have interpreted MIPPA to apply only to those oral drugs and biologicals that have an intravenous counterpart such as oral Hectorol. In response to this controversy, one of the healthcare reform bills being considered by Congress calls for the inclusion of certain oral drugs such as Renagel/Renvela as part of the ESRD bundled payment beginning in 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 or the final bill on healthcare reform would include Renagel/Renvelaphosphate binders in the bundled payment.

        Sales of Thyrogen increased for the three months ended September 30, 2009March 31, 2010, primarily due to worldwide volume growth, driven by an increase in the use of the product in thyroid remnant ablation procedures and a price increase in July 2009. Sales of Thyrogen increased for the nine months ended September 30, 2009 primarily due to worldwide volume growth, driven by a significant increase in the use of the product in thyroid remnant ablation procedures. The weakeningstrengthening of foreign currencies, primarily the Euro, against the U.S. dollar, adverselypositively impacted Thyrogen revenue by $0.9$1.5 million for the three months ended September 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 $6.0 millionterms of the final consent decree and the time required to receive FDA approval for the nine months ended September 30, 2009.our contract manufacturer, we could experience supply constraints for Thyrogen.

Biosurgery



 Three Months Ended
September 30,
  
  
 Nine Months Ended
September 30,
  
  
 
 Three Months Ended
March 31,
  
  
 


 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 


 2009 2008 2009 2008 
 2010 2009 


 (Amounts in thousands)
 
 (Amounts in thousands)
  
 

Synvisc/Synvisc-One

Synvisc/Synvisc-One

 $87,526 $67,513 $20,013 30%$233,114 $194,582 $38,532 20%

Synvisc/Synvisc-One

 $79,507 $63,171 $16,336 26%

Sepra products

Sepra products

 37,831 33,001 4,830 15% 108,173 98,385 9,788 10%

Sepra products

 37,177 34,304 2,873 8%

Other Biosurgery

Other Biosurgery

 9,200 11,859 (2,659) (22)% 29,511 38,832 (9,321) (24)%

Other Biosurgery

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

Total Biosurgery

 $134,557 $112,373 22,184 20%$370,798 $331,799 38,999 12%

Total Biosurgery

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

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        Biosurgery product revenue increased for the three and nine months ended September 30, 2009. Revenue fromMarch 31, 2010, primarily due to increased sales for Synvisc/Synvisc-One increased for the three and nine months ended September 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.

        Sepra products revenue increased for the three and nine months ended September 30, 2009 primarily due to greater penetration of Seprafilm into Japan and other international markets, the expanded use of Seprafilm in C-sections and gynecological procedures and a price increase we implemented in the first quarter of 2009.

        Other Biosurgery product revenue decreased for the three and nine months ended September 30, 2009 primarily due to a decrease in 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 $2.7$1.6 million for the nine months ended September 30, 2009. The weakening of foreign currencies against the U.S. dollar had no significant impact on revenue for the three months ended September 30, 2009.March 31, 2010. Sales of Synvisc/Synvisc-One are subject to seasonality in demand and typically decline in the first quarter.


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HematologicHematology and Oncology

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

Hematologic Oncology

 $87,982 $25,904 $62,078  >100%$176,746 $74,204 $102,542  >100%
                    
 
 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%
           

        HematologicHematology and Oncology product revenue increased for the three and nine months ended September 30, 2009March 31, 2010, primarily due to the addition ofto:

The weakeningstrengthening of foreign currencies, primarily the Euro, against the U.S. dollar, adverselypositively impacted HematologicHematology and Oncology product revenue by $0.6$2.2 million for the three months ended September 30, 2009 and $2.8 million for the nine months ended September 30, 2009.

        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. In October 2009, the FDA provided a complete response letter regarding the company's supplemental NDA for Clolar to treat previously untreated adults age 60 years or older with AML who have at least one unfavorable prognostic factor recommending that a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication. In addition, we have discussed our adult AML development plans with the EMEA'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 conducting a randomized, placebo-controlled phase 3 trial comparing clofarabine in combination with cytarabine to cytarabine alone in relapsed and refractory adult AML patients 55 years old or older and results from this trial are expected in 2011. 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 subsequent autologous stem cell transplants. In July 2009, the European Commission approved our marketing authorization application for Mozobil in Europe. In Europe, Mozobil is indicated to enhance stem cell


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mobilization in preparation for autologous stem cell transplants in patients with lymphoma and multiple myeloma whose cells mobilize poorly.March 31, 2010.

Other Product Revenue

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

Total Other product revenue

 $115,860 $115,343 $517   $347,460 $347,688 $(228)  
                    
 
 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 increased slightlydecreased for the three months ended September 30, 2009March 31, 2010, primarily due to increases in sales of transplant products, primarily Thymoglobulin, and an increase in demand for certain diagnostic products, offset by a decrease indecreased demand for pharmaceutical products. Sales of Thymoglobulinintermediates products, offset, in part, by increased by $8.1 million for the three months ended September 30, 2009 primarily due to higher sales volume resulting from increased utilization of Thymoglobulin in transplant procedures worldwide.

        Other product revenue decreased slightly for the nine months ended September 30, 2009 primarily due to a decrease in demand for pharmaceutical products, offset by increases in sales of transplant products, primarily Thymoglobulin, and an increase in demand for certain diagnostic products. Sales of Thymoglobulin increased by $23.8 million for the nine months ended September 30, 2009 primarily due to higher sales volume resulting from increased utilization of Thymoglobulin in transplant procedures worldwide and a constraint in supply for the first half of 2008.

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 September 30,  
  
 Nine Months Ended September 30,  
  
 
 
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 
 
 2009 2008 2009 2008 

Genetic Diseases

 $ $ $   $25 $343 $(318) (93)%

Cardiometabolic and Renal

  5  32  (27) (84)% 60  47  13  28%

Biosurgery

  10,443  9,928  515  5% 31,619  31,958  (339) (1)%

Hematologic Oncology

    424  (424) (100)% 737  1,258  (521) (41)%

Other service revenue

  91,988  82,202  9,786  12% 277,187  235,466  41,721  18%
                    
 

Total service revenue

 $102,436 $92,586 $9,850  11%$309,628 $269,072 $40,556  15%
                    
 
 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 nine months ended September 30, 2009March 31, 2010 as compared to the same period of 2009. The strengthening of foreign currencies, primarily due to increased volume from existing and new clients in both reproductive and oncology diagnostic testing services.


Table of Contentsthe Euro, against the U.S. dollar, had no significant impact on service revenue for the 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 September 30,  
  
 Nine Months Ended September 30,  
  
  Three Months Ended
March 31,
  
  
 

 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
  Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 

 2009 2008 2009 2008  2010 2009 

International product and service revenue

 $493,664 $578,744 $(85,080) (15)%$1,651,764 $1,770,426 $(118,662) (7)% $513,459 $551,111 $(37,652) (7)%

% of total product and service revenue

 47% 50%     48% 52%      48% 48%     

        International product and service revenue decreased for the three and nine months ended September 30, 2009March 31, 2010, primarily due to decreasesa decrease in international sales volume for Cerezyme and Fabrazyme due to supply constraints and the weakening of foreign currencies against the U.S. dollar. The weakening of foreign currencies against the U.S. dollar adversely impacted total product and service revenue by $19.9 million for the three months ended September 30, 2009 and by $151.3 million for the nine months ended September 30, 2009. These decreases wereMarch 31, 2010 due to supply constraints.

        This decrease was offset, in part, by by:


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Research and Development Revenue

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

 
 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 March 31, 2010, primarily due to a decrease in Multiple Sclerosis research and development revenue as a result of our acquisition from Bayer and termination of the Campath profit share arrangement. 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. The 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.

GROSS PROFIT AND MARGINS

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


 Three Months Ended
September 30,
  
  
 Nine Months Ended
September 30,
  
  
  Three Months Ended
March 31,
  
  
 

 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
  Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 

 2009 2008 2009 2008  2010 2009 

Gross product profit

 $656,805 $832,605 $(175,800) (21)%$2,285,013 $2,452,592 $(167,579) (7)% $691,886 $801,682 $(109,796) (14)%

Product margin

 69% 79%     74% 78%      71% 77%     

Gross service profit

 $39,910 $33,069 $6,841 21%$125,228 $94,994 $30,234 32% $36,043 $41,249 $(5,206) (13)%

Service margin

 39% 36%     40% 35%      35% 41%     

Total gross product and service profit

 $696,715 $865,674 $(168,959) (20)%$2,410,241 $2,547,586 $(137,345) (5)% $727,929 $842,931 $(115,002) (14)%

Total product and service margin

 66% 75%     71% 75%      68% 74%     

Gross Product Profit and Product Margin

        Our overall gross product profit decreased for the three and nine months ended September 30, 2009March 31, 2010, primarily due to:


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These decreases were offset, in part, by:


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        Product margin decreased for the three and nine months ended September 30, 2009 primarily due to:

        Our product margin decreased for the three months ended March 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:

        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 nine months ended September 30, 2009March 31, 2010, primarily due to increases in Carticelincreased employee, rent and depreciation expenses for our genetic testing business unit. Service revenue and revenue fromfor our reproductive and oncology diagnosticgenetic testing services.

        Total service margin increasedbusiness unit remained relatively consistent for the three and nine months ended September 30, 2009 primarily due to efficiencies resulting from prior period investments in our testing services processes and increased sales volume, attributable to both existing and new clients, for our reproductive and oncology diagnostic testing services.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
September 30,
  
  
 Nine Months Ended
September 30,
  
  
  Three Months Ended
March 31,
  
  
 

 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
  Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 

 2009 2008 2009 2008  2010 2009 

Selling, general and administrative expenses

 $367,347 $331,170 $36,177 11%$1,039,436 $996,861 $42,575 4% $553,310 $317,961 $235,349 74%

% of total revenue

  35% 29%     30% 29%      51% 28%     

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

SG&A increased by $8.3 million for the three months ended September 30, 2009 and $20.6 million for the nine months ended September 30, 2009 for Corporate, primarilyMarch 31, 2010 due to an increase in litigation expense for the three months ended September 30, 2009 and increases in stock-based compensation and litigation expense forunfavorable impact of the nine months ended September 30, 2009.

        These increases were partially offset by decreases of $5.4 million for the three months ended September 30, 2009 and $36.1 million for the nine months ended September 30, 2009 attributable to the weakeningstrengthening of foreign currencies, primarily the Euro, against the U.S. dollar.

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
September 30,
  
  
 Nine Months Ended
September 30,
  
  
  Three Months Ended March 31,  
  
 

 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
  Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 

 2009 2008 2009 2008  2010 2009 

Research and development expenses

 $219,275 $305,242 $(85,967) (28)%$636,722 $949,900 $(313,178) (33)% $220,930 $206,925 $14,005 7%

% of total revenue

 21% 26%     19% 28%      21% 18%     

        Research and development expenses decreased for the three and nine months ended September 30, 2009 including a decrease of $1.9 millionincreased for the three months ended September 30, 2009 and a decrease of $12.1 million for the nine months ended September 30, 2009March 31, 2010, primarily due to the weakening of foreign currencies against the U.S. dollar, as well as:to:


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        These decreases were partially offset by spending increases of:

Research and development expense increased by $2.8 million for the three months ended and a $27.2 million increase in spending forMarch 31, 2010 due to the nine months ended September 30, 2009 forunfavorable impact of the developmentstrengthening of alemtuzumab for MS.foreign currencies, primarily the Euro, against the U.S. dollar.

        These increases were partially offset by decreases in expenses related to our Mozobil NDA submission for the three and nine months ended September 30, 2008, for which there were no comparable amounts for the same periodsa spending decrease of 2009; and

$8.6$17.2 million for the nine months ended September 30, 2009 on research and development programs included under the category "Other," primarily due to a payment of $18.2 million to EXACT Sciences for the purchase of intellectual property in January 2009. This increase2009 for which there was partially offset by a decrease in spending for our immune mediated disease business unitno comparable amount for the three and nine months ended September 30, 2009.
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
September 30,
  
  
 Nine Months Ended
September 30,
  
  
  Three Months Ended
March 31,
  
  
 

 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
  Increase/
(Decrease)
 Increase/
(Decrease) % Change
 

 2009 2008 2009 2008  2010 2009 

Amortization of intangibles

 $71,280 $55,295 $15,985 29%$192,823 $166,558 $26,265 16% $70,984 $57,598 $13,386 23%

% of total revenue

 7% 5%     6% 5%      7% 5%     

        Amortization of intangibles expense increased for the three and nine months ended September 30, 2009March 31, 2010, primarily due to the acquisition of the worldwide marketing and distribution rights to the oncology 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 the future contingent payments to Wyeth and Synpac, as well as changes in the forecasted revenue for Fludara.


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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
September 30,
  
  
 Nine Months Ended
September 30,
  
  
 Three Months Ended
March 31,
  
  

 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change

 2009 2008 2009 2008 2010 2009

Contingent consideration expense

 $28,197 $ $28,197 N/A $37,287 $ $37,287 N/A $62,549 $ $62,549 N/A

% of total revenue

 3%       1%       6% N/A    

        In June 2009, 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 September 30, 2009,March 31, 2010, the fair value of the total contingent consideration obligations was $1.0$1.03 billion primarily due to changes in discount periodsthe assumed timing and management amount of revenue and expense


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estimates. Accordingly, we recorded a total of $62.5 million of contingent consideration expenses, totaling $28.2of which $35.5 million is related to changes in estimates, for the three months ended and $37.3 million for the nine months ended September 30, 2009March 31, 2010 in our consolidated statements of operations to reflect the increase in the fair value.value, including $21.4 million for our Hematology and Oncology reporting segment and $41.1 million for our Multiple Sclerosis reporting segment.

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. Effective January 1, 2009, 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.

        At the time 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. 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 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.

        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-adjusted to reflect the risks of advancement through the product approval process, which we believe are appropriate 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.


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        The following table sets forth the significant IPR&D projects for the companies and assets we acquired between January 1, 2006 and September 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
  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  $1,006.5 $458.7 alemtuzumab for MS—US 16% 2012 $175.4(1)

   217.3 alemtuzumab for MS—ex-US 16% 2013 $176.9    174.2 alemtuzumab for MS—ex-US 16% 2013 $88.8(2)
      

   $632.9(1)          $632.9(3)       
      

Bioenvision (2007)

 $349.9 $125.5(2)Clolar/Evoltra (clofarabine)(3) 17% 2009-2014(4)$33.5  $349.9 $125.5(4)Clolar(5) 17% 2010-2016(6)$23.7 
      

AnorMED (2006)

 $589.2 $526.8(2)Mozobil (stem cell transplant)(5) 15% 2009-2013(4)$22.1  $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.

(2)(4)
Expensed on acquisition 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. We are continuing to launch Clolar/Evoltra and Mozobil on a country-by-country basis as pricing and reimbursement approvals are obtained.

(5)(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.tumor sensitization.

OTHER INCOME AND EXPENSES

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

Losses on investments in equity securities, net

 $(651)$(14,129)$13,478  95%$(1,332)$(4,201)$2,869  68%

Gain on acquisition of business

        N/A  24,159    24,159  N/A 

Other

  616  (133) 749  >100% (2,419) 940  (3,359) >(100)%

Investment income

  4,544  11,793  (7,249) (61)% 14,038  40,015  (25,977) (65)%

Interest expense

    (792) 792  100%   (3,596) 3,596  100%
                    
 

Total other income (expenses)

 $4,509 $(3,261)$7,770  >100%$34,446 $33,158 $1,288  4%
                    
 
 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)%
           

Losses onEquity in Loss of Equity Method Investments in Equity Securities, Net

        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 recorded the following losses on investments in equity securities, net of charges for impairment of investments, for the periods presented (amounts in thousands):have concluded that

 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
 
 2009 2008 2009 2008 

Gross gains (losses) on investments in equity securities

 $(36)$(8,819)$422 $2,398 

Less: charges for impairment of investments

  (615) (5,310) (1,754) (6,599)
          

Losses on investments in equity securities, net

 $(651)$(14,129)$(1,332)$(4,201)
          

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        Gross gains (losses) onBioMarin/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 equity securities for both the three and nine months ended September 30, 2008 includes a chargeour consolidated statements of $10.0 million to write off the purchase price of an exclusive option to acquire equity in a private company as a result of our termination of the option agreement prior to the exercise deadline. Gross gains (losses) for the nine months ended September 30, 2008 also includes a gain of $10.3 million recorded in the second quarter of 2008 resulting from the liquidation of our investment in the common stock of Sirtris for net cash proceeds of $14.8 million.

        Charges for impairment of investments for all periods presented represents the write down of our investments in certain venture capital funds to fair value at the end of each period.

        At September 30, 2009, our stockholders' equity includes $14.2 million of unrealized gains and $0.2 million of unrealized losses related to our strategic investments in equity securities.

Gain on Acquisition of Business

        We recorded a gain on acquisition of business of $24.2 million for the nine months ended September 30, 2009 related to our acquisition of the worldwide rights to the oncology products Campath, Fludara, 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 nine months ended September 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 for the three and nine months ended September 30, 2009 primarily due to the redemption of the $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
September 30,
  
  
 Nine Months Ended
September 30,
  
  
  Three Months Ended
March 31,
 

 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
 Increase/
(Decrease)
 Increase/
(Decrease)
% Change
  2010 2009 

 2009 2008 2009 2008  (Amounts in thousands)
 

 (Amounts in thousands)
 

Provision for income taxes

 $522 $60,512 $(59,990) (99)%$158,276 $159,036 $(760)  

Benefit from (provision for) income taxes

 $61,799 $(78,884)

Effective tax rate

 3% 34%     28% 32%      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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In addition, our provision for income taxes includes income tax benefits of $2.6 million for the three months ended and $7.8 million for the nine months ended September 30, 2009. The income tax benefits for 2009 result from the reversal of a portion of our U.S. tax reserves due to a remeasurement of our uncertain income tax position liabilities based on new information arising in the second and third quarter of 2009.

        We are currently under IRS audit for the tax years 2006 to 2007 andby various states and foreign jurisdictions for various years. We believe that we have provided sufficiently for all audit exposures. We reasonably expect that our unrecognized tax benefits will decrease by approximately $15 million within the next twelve months as we receive clarification of certain tax issues as a result of the audit process. Settlement of these audits or the expiration of the statute of limitations on the assessment of income taxes for any tax year will 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 $988.9$961.7 million at September 30, 2009March 31, 2010 and $973.7 million$1.05 billion at December 31, 2008.2009.


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

Cash Flows from Operating Activities

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



 Nine Months Ended
September 30,
 
 Three Months Ended
March 31,
 


 2009 2008 
 2010 2009 

Cash flows from operating activities:

Cash flows from operating activities:

 

Cash flows from operating activities:

 

Net income

 $399,055 $334,431 

Net income (loss)

Net income (loss)

 $(114,948)$195,486 

Non-cash charges, net

Non-cash charges, net

 455,875 238,757 

Non-cash charges, net

 210,142 130,775 

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

 101,651 (139,123)
     

Net income, excluding net non-cash charges

Net income, excluding net non-cash charges

 95,194 326,261 

Increase (decrease) in cash from working capital changes

Increase (decrease) in cash from working capital changes

 31,270 (68,486)
           

Cash flows from operating activities

 $956,581 $434,065 

Cash flows from operating activities

 $126,464 $257,775 
           

        Cash provided by operating activities increased $522.5decreased $131.3 million for the ninethree months ended September 30, 2009,March 31, 2010, driven by a $64.6$231.1 million increasedecrease in net income, asexcluding net non-cash charges, offset, in part, by a result of a$99.8 million decrease of $277.3 million, net of tax, in payments for strategic transactions for the nine months ended September 30, 2009 as comparedworking capital, primarily due to the same period of 2008. Additionally, net income in the nine months ended September 30, 2009 was lower as a result of decreased Cerezyme and Fabrazyme revenue due to supply constraints following our temporary suspension of production at our Allston facility in June 2009.


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        Operating activities were also impacted by a $240.8 million decrease in cash used for working capital and a $217.1 million increasecorresponding reduction in non-cash charges, net. The increase in non-cashcollection activities for these products.

        Non-cash charges, net, increased by $79.4 million for the ninethree months ended September 30, 2009, as compared to the same period of 2008, isMarch 31, 2010, primarily attributable to:

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):



 Nine Months Ended
September 30,
 
 Three Months Ended
March 31,
 


 2009 2008 
 2010 2009 

Cash flows from investing activities:

Cash flows from investing activities:

 

Cash flows from investing activities:

 

Net sales of investments, excluding investments in equity securities

 $92,710 $29,736 

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

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

 $(14,323)$61,766 

Net purchases of investments in equity securities

Net purchases of investments in equity securities

 (5,183) (71,176)

Net purchases of investments in equity securities

 (225) (3,606)

Purchases of property, plant and equipment

Purchases of property, plant and equipment

 (480,436) (433,987)

Purchases of property, plant and equipment

 (152,220) (161,561)

Distributions from equity method investments

  5,995 

Acquisitions

 (57,238) (16,561)

Investments in equity method investment

Investments in equity method investment

 (1,466)  

Purchases of other intangible assets

Purchases of other intangible assets

 (29,838) (82.898)

Purchases of other intangible assets

 (5,885) (8,056)

Other investing activities

Other investing activities

 (7,096) 5,161 

Other investing activities

 (10,547) (47)
           

Cash flows from investing activities

 $(487,081)$(563,730)

Cash flows from investing activities

 $(184,666)$(111,504)
           

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        For the ninethree months ended September 30, 2009,March 31, 2010, net purchases of capital expenditures accounted for significant cash outlays for investing activities. During the ninethree months ended September 30, 2009,March 31, 2010, we used $480.4$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 $57.2 million in connection with our acquisition of the worldwide rights to Campath, Fludara, Leukine and alemtuzumab for MS from Bayer. At closing, we paid a total of $117.1 million to Bayer, of which $74.6 million was refundable. The remaining non-refundable amount of $42.4 million represents a payment for acquired inventory. A total of $59.8 million of the refundable amount was received in July 2009 and $14.8 million remains due from Bayer as of September 30, 2009.

        For the ninethree months ended September 30, 2008,March 31, 2009, investing activities used:


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Cash Flows from Financing Activities

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



 Nine Months Ended
September 30,
 
 Three Months Ended
March 31,
 


 2009 2008 
 2010 2009 

Cash flows from financing activities:

Cash flows from financing activities:

 

Cash flows from financing activities:

 

Proceeds from the issuance of our common stock

Proceeds from the issuance of our common stock

 $76,125 $294,603 

Proceeds from the issuance of our common stock

 $30,075 $34,526 

Repurchases of our common stock

Repurchases of our common stock

 (413,874) (143,012)

Repurchases of our common stock

  (107,134)

Excess tax benefits from stock-based compensation

Excess tax benefits from stock-based compensation

 3,309 17,470 

Excess tax benefits from stock-based compensation

 (480) 3,492 

Payments of debt and capital lease obligations

Payments of debt and capital lease obligations

 (5,908) (5,281)

Payments of debt and capital lease obligations

 (3,092) (2,653)

Increase (decrease) in bank overdrafts

 (17,552) 20,889 

Decrease in bank overdrafts

Decrease in bank overdrafts

 (20,728) (3,392)

Payment of contingent consideration obligations

Payment of contingent consideration obligations

 (31,600)  

Other financing activities

Other financing activities

 (5,237) 2,854 

Other financing activities

 116 1,995 
           

Cash flows from financing activities

 $(363,137)$187,523 

Cash flows from financing activities

 $(25,709)$(73,166)
           

        Cash providedused by financing activities decreased by $550.7$47.5 million for the ninethree months ended September 30,March 31, 2010, as compared to the same period of 2009, primarily driven by a $218.5$107.1 million decrease in proceeds from the issuance of our common stock due to fewer stock option exercises and a $270.9 million increase 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 20,000,000 shares of our outstanding common stock over aBayer in the three year period that began in June 2007. The board authorized the expenditure of up to $1.5 billion to purchase those shares. 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 nine months ended September 30, 2009, we repurchased 7,500,000 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 $55.16 per share for a total of $413.9 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 13,000,000 shares of our common stock at an average price of $60.63 per share for a total of $788.5 million in cash, including fees.2009.

Revolving Credit Facility

        As of September 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 September 30, 2009,March 31, 2010, we were in compliance with these covenants.

Contractual Obligations

        The disclosure of payments we have committed to make under our contractual obligations is set forth in Item 7. "Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations—Liquidity and Capital Resources," to our 2009 Form 10-K. Excluding the $175.0 million of cash we may potentially be required to pay to the 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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Contractual Obligations

        As of September 30, 2009, we had committed to make the following payments under contractual obligations (amounts in millions):

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

Long-term debt obligations(1)

 $23.5 $0.1 $1.6 $1.6 $1.7 $1.8 $16.7 

Capital lease obligations(1)

  153.6  3.9  15.5  15.5  15.5  16.8  86.4 

Operating leases(1)

  250.1  16.9  53.8  39.1  29.1  16.5  94.7 

Contingent payments(2)

  1,896.2  88.7  236.8  148.5  97.5  287.8  1,036.9 

Interest obligations(3)

  9.1  0.2  1.1  1.1  1.0  0.9  4.8 

Defined pension benefit plans payments

  19.7  0.3  1.2  1.3  1.5  1.7  13.7 

Unconditional purchase obligations

  175.9  14.6  56.4  56.4  48.5     

Capital commitments(4)

  1,092.8  194.5  537.0  246.8  114.5     
                
 

Total contractual obligations

 $3,620.9 $319.2 $903.4 $510.3 $309.3 $325.5 $1,253.2 
                

(1)
See Note L., "Long-term Debt and Leases" to our consolidated financial statements included in Exhibit 13 to our 2008 Form 10-K for additional information on long-term debt and lease obligations.

(2)
For all periods presented consists primarily of a total of $1.88 billion of contingent royalty and milestone payments that we are obligated to pay to Bayer based on future sales and the successful achievement of certain sales volumes for Campath, Fludara and Leukine and alemtuzumab for MS.

Bayer is also eligible to receive a payment between $75.0 million and $100.0 million for a new Leukine manufacturing facility located in Lynnwood, Washington upon the facility receiving FDA approval, which is expected in 2011. We have not included any amounts for the contingent payments for this facility because we cannot be certain that the FDA will approve the facility or do so in the anticipated timeframe.

From time to time, as a result of mergers, acquisitions or license arrangements, we may enter into agreements under which we may be obligated to make contingent payments upon the occurrence of certain events, and/or royalties on sales of acquired products or distribution rights. The actual amounts for and the timing of contingent payments may depend on numerous factors outside of our control, including the success of our preclinical and clinical development efforts with respect to the products being developed under these agreements, the content and timing of decisions made by the United States Patent and Trademark Office, the FDA and other regulatory authorities, the existence and scope of third party intellectual property, the reimbursement and competitive landscape around these products, the volume of sales or gross margin of a product in a specified territory and other factors described under the heading "Risk Factors" below. Because we cannot predict with certainty the amount or specific timing of contingent payments, we have included amounts for contingent payments that we believe are probable of being paid in our contractual obligations table. See Note 6., "Strategic Transactions," to our consolidated financial statements included in this Form 10-Q for additional information on our transaction with Bayer.

Contingent payments also exclude any liabilities pertaining to uncertain tax positions as we cannot make a reliable estimate of the period of cash settlement with the respective taxing authorities. Other noncurrent liabilities in our consolidated balance sheets includes approximately $29 million


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(3)
Represents interest payment obligations related to the promissory notes to three former shareholders of Equal Diagnostics, a company we acquired in 2005, 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 September 30, 2009 related to our outstanding capital and internally developed software projects. Our estimated cost of completion for assets under construction as of September 30, 2009 is as follows (amounts in millions):

Location
 Cost to
Complete at
September 30, 2009
 

Framingham, Massachusetts, U.S (approximately 35% for software development). 

 $520.5 

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

  128.6 

Lyon, France

  37.0 

Geel, Belgium

  57.9 

Waterford, Ireland

  42.3 

Allston, Massachusetts, U.S. 

  134.3 

Ridgefield, New Jersey, U.S. 

  5.5 

Haverhill, United Kingdom

  42.6 

Other

  124.1 
    
 

Total estimated cost to complete

 $1,092.8 
    

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 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:


TableBayer (for more information on these payments please read Note C., "Strategic Transactions," to our consolidated financial statements included in Item 8 of Contents

        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. Such entitiesEntities falling within the scope of ASC 810 are included in our consolidated statements of operations if we qualify as the primary beneficiary. Entities not subject to consolidation under ASC 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.

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 166, "Accounting for Transfers 2009-13 "Multiple-Deliverable Revenue Arrangements—a consensus of Financial Assets—an amendment ofthe FASB Statement No. 140.Emerging Issues Task Force."

 ImprovesEstablishes the relevance, representational faithfulness,accounting and comparabilityreporting guidance for arrangements under which a vendor will perform multiple revenue-generating activities. Specifically, the provisions of the information that a reporting entity provides in its financial statements about a transferthis update address how to separate deliverables and how to measure and allocate arrangement consideration to one or more units 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.accounting. Issued JuneOctober 2009. Effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. Early adoption is permitted.We will adopt the provisions of this update for the first annual reporting period that begins after November 15, 2009.It is anticipated that FAS 166 will primarily be incorporated into ASC 860, "Transfers and Servicing."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 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.


It is anticipated that FAS 167 will primarily be incorporated into ASC 810, "Consolidation." We are evaluating the impact this pronouncementupdate will have, if any, on our consolidated financial statements.

2009-17 "Improvements to Financial Reporting by Enterprises Involved with Variable Interest Entities."

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 activities of the entity 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 this update in the first quarter of 2010. The provisions of this update did not have any impact on our consolidated financial 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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ASU NumberRelevant Requirements of ASUIssued Date/Our Effective DatesStatus

2010-06 "Improving Disclosures about Fair Value Measurements."

Requires new disclosures and clarifies some existing disclosure requirements about fair value measurements codified within ASC 820, "Fair Value Measurements and Disclosures," 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 Level 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 in the roll forward of Level 3 investments. Those disclosures are effective for fiscal years beginning after December 15, 2010, and for interim reporting periods within those fiscal years.

We adopted the applicable provisions of this update, except for the 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 update does not have a material impact on our consolidated financial statements. During the three months ended March 31, 2010, none of our instruments were reclassified between Level 1, Level 2 or Level 3.

2010-11, "Scope Exception Related to Embedded Credit Derivatives."

Update provides amendments to Subtopic 815-15,"Derivatives and Hedging—Embedded Derivatives, " to clarify the scope exception for embedded credit derivative features related to the transfer of credit risk in the form of subordination of one financial instrument to another.

Issued March 2010. Effective at the beginning of each reporting entity's first fiscal quarter beginning after June 15, 2010. Early adoption is permitted at the beginning of each reporting entity's first fiscal quarter beginning after issuance of this update.

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, if any, on our consolidated financial statements.

2010-17, "Milestone Method of Revenue Recognition—a consensus of the FASB Emerging Issues Task Force."

Update provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition for research and development transactions.

Issued April 2010. Effective on a prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. Early adoption is permitted.

We will adopt the provisions of this update beginning January 1, 2011. We are currently assessing the impact the provisions of this update will have, if any, on our consolidated financial 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 have caused inventory shortages, loss of revenues and unanticipated costs and 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 are 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. We also restarted 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, such asdifficulties. For example, since restarting Fabrazyme production at Allston, we have experienced cell growth at lower than expected levels. IfIn addition, in March 2010, we experience such difficulties, 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 in the expected quantities. In addition, since resuming production at Allston, we have been processing bulk drug material in smaller batches, which leads to faster availabilitynew Framingham manufacturing facility is approved and any additional manufacturing delays will likely impact supply of final product but also leads to losses in process efficiency and lower overall volume.these products.

The Cerezyme and Fabrazyme supply constraints resulting from the suspension of production at our Allston facility have created opportunities for our competitors.

        Outside of the United States, Fabrazyme competes with Replagal®, a product marketed by Shire plc. Shire has announced that theThe FDA has approved a treatment INDprotocol for Replagal and that it will support emergency IND requests. Shire also has announced its plans to file for U.S. approval of Replagal in the fourth quarter of 2009. With respect to Cerezyme,submitted a BLA with the FDA has approved a treatment IND for each of Protalix'sReplagal and Shire's enzyme replacementbeen granted "fast track" designation. For Cerezyme, Shire and Protalix were able to offer their developmental therapies in development for the treatment of Gaucher disease. Both therapies aredisease to patients in phase 3 development.the United States through an FDA-approved treatment protocol and to patients in the European Union and other countries through pre-approval access programs. Shire has announced positive results from the final two phase 3 studiesreceived FDA approval of its therapy to treat Gaucher disease in February 2010 and completed its submission of an NDAannounced that it will price this therapy at a 15% savings over Cerezyme. Shire submitted a MAA to the FDA. In addition,EMA for its therapy in November 2009. Shire also has announced that it is engaging with national and regional authorities outside the United States to seek pre-approval access to its Gaucher therapy and has accelerated its manufacturing timeline for its therapy by almost 18 months. Protalix alsosubmitted its NDA to the FDA in December 2009 and has announced positive results from a pivotal phase 3 study of itsbeen 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 "fast track" designation for both companies' NDAs and granted orphan drug status to both Shire's and Protalix's therapy. It is expected that Protalix will offer its therapy, if approved, at a significantly discounted price to Cerezyme.

        The FDA's approvaltherapies for the treatment of treatment protocols for Protalix's and Shire's therapies allows physicians to treat Fabry and Gaucher disease patients with the therapies ahead of commercial availability in the United States.disease. In addition, Zavesca® 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


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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 Fabrazyme or Myozyme, our competitors could have an


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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. The FDA is now in the process of re-inspecting our Allston facility. In addition to verifying that we have responded appropriately to issues identified in the Warning Letter, we expect that the FDA will also review our Vesivirus 2117 contamination investigation and follow-up actions.

        We have some Cerezyme material in inventory that was being processed at the time of suspension of production due to viral contamination at our Allston facility, although we have already discarded the majority of this Cerezyme work-in-process inventory. The FDA has communicated to us steps it recommends we take prior to forward processing any of the remaining Cerezyme work-in-process. The steps recommended by the FDA are consistent with the steps that we independently had planned to implement. The FDA also has 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 mid-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.


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

        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.


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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 our Cerezyme, Renagel/Renvela, Synvisc/Synvisc-One, Fabrazyme, Myozyme, Aldurazyme, 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:

        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 as well as our ability to file for FDA approval for alglucosidase alfa produced using a 4000L scale process. The FDA is currently inspecting our Allston facility where alglucosidase alfa produced using the 2000L scale process was produced. If the inspection process takes longer than anticipated or if the inspection results in observations that cannot be addressed before our November 14, 2009 PDUFA date for the 2000L scale product, we may experience further delays in gaining FDA approval of the 2000L and 4000L scale products.earnings. 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 recently received a complete response letter from the FDA in October 2009 for Clolar's use in adult AML. TheAML in which the agency recommended that a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication. We intend to request a meeting with the FDA to discuss the optimal path forward.


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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 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. The FDA has approved a treatment IND for each of Protalix's and Shire'sVPRIV is an enzyme replacement therapies fortherapy developed by Shire that received marketing approval in the treatment of Gaucher disease, which allows physiciansUnited States in February 2010. In addition, an enzyme replacement therapy in development by Protalix to treat Gaucher disease is available to patients with the therapies ahead of commercial availability in the United States. In addition, ShireStates under an FDA-approved treatment protocol and Protalix has submitted itsan NDA to the FDA for its therapy. Both the Shire and Protalix expectstherapies are available to complete its NDA submission beforepatients in the end of 2009.European Union and 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 Fabrazyme has received orphan drug designation, which provides us with seven years of market exclusivity expiring in April 2010 for the product in the United States, the FDA has approved a treatment INDprotocol for Replagal, which allows physicians to treat Fabry patients with the therapy ahead of commercial availability in the United States. 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.


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        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 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


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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. For example, the Medicare Improvements for Patients and Providers Act of 2008, or MIPPA directs CMS to includeestablish a bundled payment for drugs and biologicals that are used to treat ESRD in the prospective payment system used to reimburse dialysis providers.providers treating ESRD patients. In September 2009, CMS proposed changes to the prospective payment system that would in accordance with MIPPA, 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 accepting comments on the proposed rule through November 16, 2009 and willexpected to issue a final rule in 2010 with an anticipated implementation date of January 2011. In addition, one


Table of the healthcare reform bills being considered by Congress calls for the inclusion of certain oral drugs such as Renagel/Renvela as part of the ESRD bundled payment beginning in 2011.Contents

        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 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 during the period of suspended production and recovery.shortages. 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 contract manufacturer for a portion of our Fabrazyme, Cerezyme and 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


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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 cause similar fluctuations. In addition, some of our products, including Synvisc/Synvisc-One are subject to seasonal fluctuation in demand.

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:


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        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, fines and other penalties and could receive adverse publicity, all of 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


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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 $687.7$179.1 million for the ninethree months ended September 30, 2009,March 31, 2010, representing approximately 20%17% of our total revenue. Because our business is dependent on Cerezyme, negative trends in revenue from this product could have, and 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.further decline or fail to recover. In addition, we 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.

        In June 2009, we temporarily suspended See"The Cerezyme and Fabrazyme supply constraints resulting from the suspension of production of Cerezyme at our Allston facility after identifying a virus in a bioreactor usedhave created opportunities 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 approved treatment protocols submitted by two companies developing alternative treatments for Gaucher disease. Approval of these treatment protocols allows physicians to 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. 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.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.


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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.

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 nine months ofas compared to a net unfavorable effect for 2009. Although we cannot predict with certainty future changes in foreign exchange rates or their 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.


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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 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. In addition, we are the subject of twoa consolidated purported securities class action lawsuitslawsuit and have received letters from alleged shareholders demanding that our board of directors take action on our behalf to remedy breaches of fiduciary duty by our directors and officers.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 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.


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        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 stocks 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 48% of our consolidated product and service revenue for the ninethree months ended September 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.

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, Mozobil, CerezymeFludara and ThyrogenMozobil 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


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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/Renvela and Hectorol are subjects of ANDA'sANDAs containing Paragraph IV certifications. Renagel is the subject of ANDA'sANDAs submitted by four companies, and Renvela is the subject of ANDA'sANDAs submitted by twothree companies, containing Paragraph IV certifications. We have initiated patent litigation against thesethe four ANDA applicants.applicants with respect to Renagel and against two ANDA applicants with respect to Renvela. At issue in the lawsuits are patents protecting Renagel and Renvela that expireis U.S. Patent No. 5,667,775, which expires in 2014.2014 (the "'775 Patent"). See "Legal Proceedings" in Part I., Item 3. of our 2009 Form 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 ANDA's submitted by four companiesANDAs containing Paragraph IV certifications.certifications submitted by six companies. We have initiated patent litigation against threefour of these 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"). The fourth ANDA applicant submitted a paragraph IV certificationIn one of the 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 did not initiate patent infringement litigation. Our Hectorol .5 mg and 2.5 mg capsule products, are the subject of one ANDA containing a Paragraph IV certification with respect to our 2014 patent. This ANDA filer is seeking approval forof its generic ..5 mg0.5µg capsule only for use only in pre-dialysisthe treatment of patients thus avoidingwith CKD who are not on dialysis, thereby attempting to avoid our patent. We expect the FDA to approve the applicant's .5 mg product. We will continue to pursue patent litigation with respect to the applicant's generic 2.5 mg capsule product.'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 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 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 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,


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cost-effectiveness, and use of related therapies. Organizations like these have in the past made recommendations about our products and services 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 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.

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.

        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


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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 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 September 30, 2009,March 31, 2010, we had $988.9$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:

product development and marketing;


Tablestrategic business initiatives;

repurchasing shares of Contentsour common stock;

upgrading our information technology systems, including installation and implementation of a new enterprise resource planning system worldwide;

contingent payments under business combinations, license and other agreements, including a milestone payment to Synpac if sales of Myozyme reach $400.0 million, as well as payments related to our license of mipomersen from Isis, ataluren from PTC, and Prochymal and Chondrogen from Osiris, as well as contingent consideration obligations related to our acquisition of the worldwide rights to the oncology products Campath, Fludara, Leukine and alemtuzumab for MS from Bayer;

expanding staff; and

working capital and satisfaction of our obligations under capital and operating leases.

        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 September 30, 2009,March 31, 2010, we held a number of financial instruments, including investments in marketable securities and derivative contracts in the form of foreign exchange forward contracts. We do not hold derivatives or other financial instruments for speculative purposes. There have been no material changes in our market risks during the ninethree months ended September 30, 2009March 31, 2010 compared to the disclosures in Part II,II., Item 7A7A. of our Annual Report on2009 Form 10-K for the year ended December 31, 2008.10-K.

ITEM 4.    CONTROLS AND PROCEDURES

        As of September 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 September 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 September 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

Shareholder Demand LettersFederal Securities Litigation

        Beginning in        In July 2009 and August 2009, we have received six letterstwo 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 alleged shareholders demanding that our boardJune 26, 2008 through July 21, 2009 and allege violations of directors take action on our behalf to remedy breachesSection 10(b) and 20(a) of fiduciary duty by our directorsthe Securities Exchange Act of 1934 and officers. The demand letters are primarilyRule 10b-5 promulgated thereunder. Each of the lawsuits is premised onupon allegations that we made materially false and misleading disclosuresstatements and failedomissions by failing to disclose materialinstances 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 to shareholders with respect toregarding manufacturing issues, and compliance with GMP. SeveralGMP, ability to meet product demand, expected revenue growth, and approval of the lettersLumizyme. The actions also assertallege that certain of our officersdirectors and directorsexecutive officers took advantage of their knowledge of material non-public information about Genzyme to illegally sell stock they personally held in Genzyme. Our boardThe plaintiffs generally seek, among other things, judgment in favor of directors has designatedGenzyme for the amount of damages sustained by Genzyme as a special committee of three independent directors to oversee the investigationresult of the allegations made in the demand letters andalleged breaches of fiduciary duty, disgorgement to recommend to the independent directorsGenzyme of the board whether any action should be instituted on our behalf against any officer or director. The committee has retained independent legal counsel. If the independent membersproceeds that certain of our board of directors wereand 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 make a determination that it was injoint stipulation staying these cases until our best interestboard of directors has had sufficient time to instituteexercise its duties and complete an action against any officers or directors, any monetary recovery would beappropriate investigation, which is ongoing. In the State Court Actions, the parties are working to our benefit.consolidate all three lawsuits. We intend to defend these lawsuits vigorously.

Renagel and Renvela PatentANDA Litigation Updates

        As reporteddisclosed in our 2009 Form 10-Q for the quarter ended June 30, 2009,10-K, we received notices beginning in 2009 from Lupin Ltd. and Lupin Pharmaceuticals, collectively Lupin, and Impax Laboratories, Inc., or Impax,have initiated patent litigation against a number of companies that each had submitted to the FDA abbreviated new drug applications, or ANDAs containing Paragraph IV certifications seeking approval


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to market generic versions of Renagel, (sevelamer hydrochloride)Renvela and Renvela (sevelamer carbonate).

        Lupin had beenHectorol. One of the ANDA filers, Sandoz, Inc., is seeking approval to market generic 400 mg400mg and 800 mg800mg sevelamer hydrochloride tablets and generic 800 mg sevelamer carbonate tablets prior toafter the expiration of all of our Orange Book-listedthe patents protecting Renagel and Renvela.that expire in 2013. In MarchJuly 2009, we filed a complaint against LupinSandoz in the U.S. District Court for the District of Maryland. In the complaint, we allegeMaryland alleging that Lupin'sSandoz's proposed sevelamer hydrochloridegeneric 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"). LupinSandoz filed an answer and counterclaim,counterclaims alleging that our asserted patents are invalid and/or not infringed by Lupin's proposed generic sevelamer hydrochloride products. In May 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. In September 2009, Lupin dismissed without prejudice all of its claims relating to the patents protecting Renagel and Renvela that expire in 2013 and at this time is challenging only 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 in March 2009 and with respect to Renvela in April 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. 6,773,780,6,733,780, which expires in October 2020 (the "'780 Patent") are invalid and/or not infringed by Impax'sSandoz's proposed generic sevelamer hydrochloride products. In September 2009, Impax dismissed its claim relatingthe 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


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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.

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 September 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
 

July 1, 2009-July 31, 2009

       $1,018,427,338 

August 1, 2009-August 31, 2009

  500,000 $55.50  500,000 $990,679,488 

September 1, 2009-September 30, 2009

  5,000,000 $55.78  5,000,000 $711,797,363 
            
 

Total

  5,500,000(1)$55.75(2) 5,500,000    
            

(1)
In May 2007, our board of directors authorized a stock repurchase program to repurchase 20,000,000 shares of our outstanding common stock over a three year period that began in June 2007. The board authorized the expenditure of up to $1.5 billion toWe did not purchase those shares. During the third quarter of fiscal 2009, we repurchased 5,500,000any shares of our common stock under this program for $306.7 million of cash, including fees.

(2)
Representsduring the weighted average price paid per share for repurchasesfirst quarter of our common stock made during the third quarter of2010 fiscal 2009.
year.

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: November 2, 2009May 10, 2010

 

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, SEPTEMBER 30, 2009MARCH 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 2007 Director Equity Plan,Senior Executive Annual Incentive 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 amended. Filed herewith.Exhibit 99.1 to Genzyme's Form 8-K filed on April 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.
 101.INS101 XBRL Instance Document. Furnished herewith.
101.SCHXBRL Taxonomy Extension Schema. Furnished herewith.
101.CALXBRL Extension Calculation Linkbase. Furnished herewith.
101.LABXBRL Taxonomy Extension Label Linkbase. Furnished herewith.
101.PREXBRL Taxonomy Extension Presentation Linkbase. Furnished herewith.The 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 of Genzyme Corporation were filed under Commission File No. 0-14680.