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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 March 31,June 30, 2008

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 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 filer ý Accelerated filer o Non-accelerated filer o
(Do not check if a smaller reporting company)
 Smaller reporting company o

        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 April 30,July 31, 2008: 267,313,161268,653,485




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NOTE REGARDING REFERENCES TO OUR COMMON STOCK

        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. We have one outstanding series of common stock, which we refer to as "Genzyme Stock."

NOTE REGARDING FORWARD-LOOKING STATEMENTS

        This Form 10-Q contains forward-looking statements, including 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 have included more detailed descriptions of these and other risks and uncertainties 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. We encourage you to read those descriptions carefully. We caution investors not to place substantial reliance on the forward-looking statements contained in 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 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®, Ceredase®, Fabrazyme®, Thyrogen®, Myozyme®, Renagel®, Renvela®, Campath®, Clolar®, Evoltra®, Thymoglobulin®, Synvisc®, Synvisc-One®, Sepra®, Seprafilm®, Carticel®, Epicel®, MACI®, Lymphoglobuline®, Hylaform®, Cholestagel® and Hectorol® are registered trademarks, and Mozobil™ is a trademark,, Lymphoglobuline™ and Synvisc-One™ are trademarks, of Genzyme or its subsidiaries. WelChol® is a registered trademark of Sankyo Pharma, Inc. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC. All rights reserved.


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GENZYME CORPORATION AND SUBSIDIARIES

FORM 10-Q, MARCH 31,JUNE 30, 2008

TABLE OF CONTENTS

 
  
 PAGE NO.

PART I.

 

FINANCIAL INFORMATION

 6

ITEM 1.

 

Financial Statements

 6

 

Unaudited, Consolidated Statements of Operations and Comprehensive Income for the Three and Six Months Ended March 31,June 30, 2008 and 2007

 6

 

Unaudited, Consolidated Balance Sheets as of March 31,June 30, 2008 and December 31, 2007

 7

 

Unaudited, Consolidated Statements of Cash Flows for the ThreeSix Months Ended March 31,June 30, 2008 and 2007

 8

 

Notes to Unaudited, Consolidated Financial Statements

 9

ITEM 2.

 

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

 2930

ITEM 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 6570

ITEM 4.

 

Controls and Procedures

 6671

PART II.

 

OTHER INFORMATION

 6771

ITEM 1.

 

Legal Proceedings

 6771

ITEM 1A.

 

Risk Factors

 6772

ITEM 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 6772

ITEM 6.4.

 Exhibits

Submission of Matters to a Vote of Security Holders

 6772
Signatures

ITEM 6.

 68

Exhibits

73

Signatures

74

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PART I.    FINANCIAL INFORMATION

ITEM 1.    FINANCIAL STATEMENTS


GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Statements of Operations and Comprehensive Income

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



 Three Months Ended March 31,
 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 


 2008
 2007
 
 2008 2007 2008 2007 
Revenues:Revenues:     

Revenues:

 
Net product sales $1,006,268 $798,190 

Net product sales

 $1,071,801 $845,482 $2,078,069 $1,643,672 
Net service sales 85,864 75,881 

Net service sales

 90,622 82,475 176,486 158,356 
Research and development revenue 7,929 9,112 

Research and development revenue

 8,711 5,462 16,640 14,574 
 
 
           
 Total revenues 1,100,061 883,183  

Total revenues

 1,171,134 933,419 2,271,195 1,816,602 
 
 
           
Operating costs and expenses:Operating costs and expenses:     

Operating costs and expenses:

 
Cost of products sold 216,739 154,724 

Cost of products sold

 241,343 163,252 458,082 317,976 
Cost of services sold 55,574 47,739 

Cost of services sold

 58,987 54,346 114,561 102,085 
Selling, general and administrative 318,386 269,021 

Selling, general and administrative

 347,305 339,480 665,691 608,501 
Research and development 262,797 166,120 

Research and development

 381,861 198,442 644,658 364,562 
Amortization of intangibles 55,658 50,017 

Amortization of intangibles

 55,605 49,465 111,263 99,482 
 
 
           
 Total operating costs and expenses 909,154 687,621  

Total operating costs and expenses

 1,085,101 804,985 1,994,255 1,492,606 
 
 
           
Operating incomeOperating income 190,907 195,562 

Operating income

 86,033 128,434 276,940 323,996 
 
 
           
Other income (expenses):Other income (expenses):     

Other income (expenses):

 
Equity in income of equity method investments 188 5,612 

Equity in income of equity method investments

  5,945 188 11,557 
Minority interest 463 3,912 

Minority interest

 563 15 1,026 3,927 
Gains on investments in equity securities, net 775 12,788 

Gains on investments in equity securities, net

 9,153 143 9,928 12,931 
Other (160) (525)

Other

 19 (278) (141) (803)
Investment income 14,870 16,219 

Investment income

 13,352 17,246 28,222 33,465 
Interest expense (1,655) (4,188)

Interest expense

 (1,149) (3,621) (2,804) (7,809)
 
 
           
 Total other income 14,481 33,818  

Total other income

 21,938 19,450 36,419 53,268 
 
 
           
Income before income taxesIncome before income taxes 205,388 229,380 

Income before income taxes

 107,971 147,884 313,359 377,264 
Provision for income taxesProvision for income taxes (60,117) (71,193)

Provision for income taxes

 (38,407) (64,090) (98,524) (135,283)
 
 
           
Net incomeNet income $145,271 $158,187 

Net income

 $69,564 $83,794 $214,835 $241,981 
 
 
           
Net income per share:Net income per share:     

Net income per share:

 
Basic $0.54 $0.60 

Basic

 $0.26 $0.32 $0.80 $0.92 
 
 
           
Diluted $0.52 $0.57 

Diluted

 $0.25 $0.31 $0.77 $0.88 
 
 
           
Weighted average shares outstanding:Weighted average shares outstanding:     

Weighted average shares outstanding:

 
Basic 267,276 263,476 

Basic

 266,904 263,911 267,127 263,693 
 
 
           
Diluted 285,208 279,924 

Diluted

 284,262 280,564 285,028 280,244 
 
 
           

Comprehensive income, net of tax:

Comprehensive income, net of tax:

 

 

 

 

 

Comprehensive income, net of tax:

 
Net incomeNet income $145,271 $158,187 

Net income

 $69,564 $83,794 $214,835 $241,981 
 
 
           
Other comprehensive income:     

Other comprehensive income (loss):

Other comprehensive income (loss):

 
Foreign currency translation adjustments 109,654 12,610 

Foreign currency translation adjustments

 (3,981) 8,636 105,673 21,246 
 
 
           
Pension liability adjustments, net of tax 78 198 

Pension liability adjustments, net of tax

 (7) (464) 71 (266)
 
 
           
Unrealized gains on securities, net of tax:     

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

 
 Unrealized gains arising during the period, net of tax 3,905 9,878  

Unrealized gains (losses) arising during the period

 806 (4,601) 4,711 (2,732)
 Reclassification adjustment for gains included in net income, net of tax (270) (8,161) 

Reclassification adjustments for gains (losses) included in net income

 (5,628) 398 (5,898) 246 
 
 
           
 Unrealized gains on securities, net of tax 3,635 1,717  

Unrealized losses on securities, net of tax

 (4,822) (4,203) (1,187) (2,486)
 
 
           
Other comprehensive income 113,367 14,525 

Other comprehensive income (loss)

 (8,810) 3,969 104,557 18,494 
 
 
           
Comprehensive incomeComprehensive income $258,638 $172,712 

Comprehensive income

 $60,754 $87,763 $319,392 $260,475 
 
 
           

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)



 March 31,
2008

 December 31,
2007

 
 June 30,
2008
 December 31,
2007
 
ASSETSASSETS     

ASSETS

 
Current assets:Current assets:     

Current assets:

 
Cash and cash equivalents $882,798 $867,012 

Cash and cash equivalents

 $693,687 $867,012 
Short-term investments 79,050 80,445 

Short-term investments

 67,688 80,445 
Accounts receivable, net 1,031,095 904,101 

Accounts receivable, net

 1,066,478 904,101 
Inventories 468,824 439,115 

Inventories

 472,538 439,115 
Prepaid expenses and other current assets 160,029 154,183 

Prepaid expenses and other current assets

 170,711 154,183 
Deferred tax assets 158,593 164,341 

Deferred tax assets

 158,728 164,341 
 
 
       
 Total current assets 2,780,389 2,609,197  

Total current assets

 2,629,830 2,609,197 

Property, plant and equipment, net

Property, plant and equipment, net

 

2,118,960

 

1,968,402

 

Property, plant and equipment, net

 2,212,044 1,968,402 
Long-term investmentsLong-term investments 486,135 512,937 

Long-term investments

 493,119 512,937 
GoodwillGoodwill 1,403,716 1,403,828 

Goodwill

 1,404,070 1,403,828 
Other intangible assets, netOther intangible assets, net 1,982,735 1,555,652 

Other intangible assets, net

 1,990,162 1,555,652 
Deferred tax assetsDeferred tax assets 120,707 95,664 

Deferred tax assets

 270,750 95,664 
Investments in equity securitiesInvestments in equity securities 168,301 89,181 

Investments in equity securities

 162,930 89,181 
Other noncurrent assetsOther noncurrent assets 22,110 66,880 

Other noncurrent assets

 19,947 66,880 
 
 
       
 Total assets $9,083,053 $8,301,741  

Total assets

 $9,182,852 $8,301,741 
 
 
       
LIABILITIES AND STOCKHOLDERS' EQUITYLIABILITIES AND STOCKHOLDERS' EQUITY     

LIABILITIES AND STOCKHOLDERS' EQUITY

 
Current liabilities:Current liabilities:     

Current liabilities:

 
Accounts payable $121,192 $128,380 

Accounts payable

 $117,180 $128,380 
Accrued expenses 616,592 645,645 

Accrued expenses

 636,205 645,645 
Income taxes payable 19,567 18,479 

Income taxes payable

 23,166 18,479 
Deferred revenue and other income 21,569 13,277 

Deferred revenue

 18,732 13,277 
Current portion of long-term debt and capital lease obligations 696,743 696,625 

Current portion of long-term debt and capital lease obligations

 696,860 696,625 
 
 
       
 Total current liabilities 1,475,663 1,502,406  

Total current liabilities

 1,492,143 1,502,406 

Long-term debt and capital lease obligations

Long-term debt and capital lease obligations

 

111,144

 

113,748

 

Long-term debt and capital lease obligations

 109,157 113,748 
Deferred revenue—noncurrentDeferred revenue—noncurrent 15,536 16,662 

Deferred revenue—noncurrent

 14,783 16,662 
Other noncurrent liabilitiesOther noncurrent liabilities 532,719 55,988 

Other noncurrent liabilities

 525,365 55,988 
 
 
       
 Total liabilities 2,135,062 1,688,804  

Total liabilities

 2,141,448 1,688,804 
 
 
       

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 2,670 2,660 

Common stock, $0.01 par value

 2,670 2,660 
Additional paid-in capital 5,461,714 5,385,154 

Additional paid-in capital

 5,491,727 5,385,154 
Notes receivable from stockholders (15,824) (15,670)

Notes receivable from stockholders

 (13,178) (15,670)
Accumulated earnings 971,986 826,715 

Accumulated earnings

 1,041,550 826,715 
Accumulated other comprehensive income 527,445 414,078 

Accumulated other comprehensive income

 518,635 414,078 
 
 
       
 Total stockholders' equity 6,947,991 6,612,937  

Total stockholders' equity

 7,041,404 6,612,937 
 
 
       
 Total liabilities and stockholders' equity $9,083,053 $8,301,741  

Total liabilities and stockholders' equity

 $9,182,852 $8,301,741 
 
 
       

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)



 Three Months Ended
March 31,

 
 Six Months Ended
June 30,
 


 2008
 2007
 
 2008 2007 
Cash Flows from Operating Activities:Cash Flows from Operating Activities:     

Cash Flows from Operating Activities:

 
Net income $145,271 $158,187 

Net income

 $214,835 $241,981 
Reconciliation of net income to cash flows from operating activities:     

Reconciliation of net income to cash flows from operating activities:

 
 Depreciation and amortization 91,039 81,919  

Depreciation and amortization

 183,119 162,827 
 Stock-based compensation 42,346 40,737  

Stock-based compensation

 96,952 102,023 
 Provision for bad debts 2,862 2,041  

Provision for bad debts

 5,844 4,569 
 Equity in income of equity method investments (188) (5,612) 

Equity in income of equity method investments

 (188) (11,557)
 Minority interest (463) (3,912) 

Minority interest

  (3,927)
 Gains on investments in equity securities, net (775) (12,788) 

Gains on investments in equity securities, net

 (9,928) (12,931)
 Deferred income tax benefit (24,712) (24,328) 

Deferred income tax benefit

 (172,813) (55,026)
 Tax benefit from employee stock-based compensation 17,599 3,715  

Tax benefit from employee stock-based compensation

 25,645 8,349 
 Excess tax benefits from stock-based compensation (5,790) (264) 

Excess tax benefits from stock-based compensation

 (8,647) (565)
 Other 2,233 1,049  

Other

 2,175 3,048 
 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 (57,928) (37,806) 

Accounts receivable

 (98,174) (71,660)
 Inventories (1,239) (25,048) 

Inventories

 (4,812) (47,312)
 Prepaid expenses and other current assets (6,326) (15) 

Prepaid expenses and other current assets

 (15,295) (1,589)
 Income taxes payable 9,229 29,734  

Income taxes payable

 13,288 (11,496)
 Accounts payable, accrued expenses and deferred revenue (53,625) (9,803) 

Accounts payable, accrued expenses and deferred revenue

 (52,692) 69,434 
 
 
       
 Cash flows from operating activities 159,533 197,806  

Cash flows from operating activities

 179,309 376,168 
 
 
       

Cash Flows from Investing Activities:

Cash Flows from Investing Activities:

 

 

 

 

 

Cash Flows from Investing Activities:

 
Purchases of investments (146,862) (187,380)

Purchases of investments

 (289,129) (412,067)
Sales and maturities of investments 180,037 219,440 

Sales and maturities of investments

 319,758 496,986 
Purchases of equity securities (80,699) (17,518)

Purchases of equity securities

 (81,472) (19,945)
Proceeds from sales of investments in equity securities 1,148 16,121 

Proceeds from sales of investments in equity securities

 16,169 19,277 
Purchases of property, plant and equipment (121,967) (82,982)

Purchases of property, plant and equipment

 (251,785) (180,041)
Distributions from equity method investments 6,595 6,000 

Distributions from equity method investments

 6,595 10,900 
Purchases of other intangible assets (7,046) (12,207)

Purchases of other intangible assets

 (75,400) (27,618)
Other 3,107 603 

Other

 2,571 891 
 
 
       
 Cash flows from investing activities (165,687) (57,923) 

Cash flows from investing activities

 (352,693) (111,617)
 
 
       

Cash Flows from Financing Activities:

Cash Flows from Financing Activities:

 

 

 

 

 

Cash Flows from Financing Activities:

 
Proceeds from issuance of common stock 90,243 27,765 

Proceeds from issuance of our common stock

 127,008 68,174 
Repurchases of our common stock (73,218)  

Repurchases of our common stock

 (143,012) (63,430)
Excess tax benefits from stock-based compensation 5,790 264 

Excess tax benefits from stock-based compensation

 8,647 565 
Payments of debt and capital lease obligations (2,554) (2,117)

Payments of debt and capital lease obligations

 (3,886) (3,356)
Increase in bank overdrafts 18,549 29,528 

Increase in bank overdrafts

 29,309 15,935 
Minority interest contributions  4,136 

Payments of notes receivable from stockholders

 2,770  
Other 959 2,482 

Minority interest contributions

  4,136 
 
 
 

Other

 34 2,474 
 Cash flows from financing activities 39,769 62,058       
 
 
  

Cash flows from financing activities

 20,870 24,498 
     

Effect of exchange rate changes on cash

Effect of exchange rate changes on cash

 

(17,829

)

 

(6,346

)

Effect of exchange rate changes on cash

 
(20,811

)
 
10,222
 
 
 
       
Increase in cash and cash equivalents 15,786 195,595 

Increase (decrease) in cash and cash equivalents

Increase (decrease) in cash and cash equivalents

 (173,325) 299,271 
Cash and cash equivalents at beginning of periodCash and cash equivalents at beginning of period 867,012 492,170 

Cash and cash equivalents at beginning of period

 867,012 492,170 
 
 
       
Cash and cash equivalents at end of periodCash and cash equivalents at end of period $882,798 $687,765 

Cash and cash equivalents at end of period

 $693,687 $791,441 
 
 
       

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 product and service portfolio is focused on rare disorders, renal diseases, orthopaedics, organ transplant, diagnostic and predictive testing, and cancer. We are organized into six financial reporting units, which we also consider to be our reporting segments:

        We report the activities of our diagnostic products, bulk pharmaceuticals and cardiovascular business units under the caption "Other." We report our corporate, general and administrative operations and corporate science activities under the caption "Corporate."

        Effective January 1, 2008, as a result of changes in how we review our business, certain general and administrative expenses, which were formerly allocated amongst our reporting segments and Other, are now allocated to Corporate.

        As a result of our acquisition of Bioenvision in October 2007, our Oncology business unit, which was formerly reported combined with "Other," now meets the criteria for disclosure as a separate reporting segment. We have revised our 2007 segment disclosures to conform to our 2008 presentation.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

2.    Basis of Presentation and Significant Accounting Policies

Basis of Presentation

        Our unaudited, consolidated financial statements for each period include the statements of operations and comprehensive income, 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 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.

        These financial statements include all normal and recurring adjustments that we consider necessary for the fair presentation of our financial positioncondition and results of operations. Since these are interim financial statements, you should also read our audited, consolidated financial statements and notes included in our 2007 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.

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

Recent Accounting Pronouncements

         FAS 159, "The Fair Value Option for Financial Assets and Financial Liabilities, Including an Amendment of FASB Statement No. 115."    Effective January 1, 2008, we adopted FAS 159, "The Fair Value Option for Financial Assets and Financial Liabilities, Including an Amendment of FASB Statement No. 115," which permits, but does not require, entities to measure certain financial instruments and other assets and liabilities at fair value on an instrument-by-instrument basis. Unrealized gains and losses on items for which the fair value option has been elected should be recognized in earnings at each subsequent reporting date. In adopting FAS 159, we did not elect to measure any new assets or liabilities at their respective fair values and, therefore, the adoption of FAS 159 did not have an impact on our results of operations and financial position.

         EITF Issue No. 07-1, "Accounting for Collaborative Arrangements."    In December 2007, the Emerging Issues Task Force, or EITF, of the FASB reached a consensus on Issue No. 07-1, "Accounting for Collaborative Arrangements." The EITF concluded on the definition of a collaborative arrangement and that revenues and costs incurred with third parties in connection with collaborative arrangements would be presented gross or net based on the criteria in EITF 99-19 and other accounting literature. Companies are also required to disclose the nature and purpose of collaborative arrangements along with the accounting policies and the classification and amounts of significant financial-statement amountsattributable to transactions related to the arrangements. EITF 07-1 will becomeis effective for us January 1, 2009 and we will be appliedapply it retrospectively to all periods presented for all collaborative arrangements existing as of the


Table of Contents

GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

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


periods presented for all collaborative arrangements existing as of the effective date. We are evaluating the impact, if any, this standardthat EITF 07-1 will have on our consolidated financial statements.

         EITF Issue No. 07-3, "Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities."    In June 2007, the FASB ratified the EITF consensus reached in EITF Issue No. 07-3, "Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities," which provides guidance for nonrefundable prepayments for goods or services that will be used or rendered for future research and development activities and directs that such payments should be deferred and capitalized. Such amounts should be recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered. EITF 07-3 was effective for us beginning January 1, 2008 and we applied it prospectively to new contracts we entered into on or after that date. The implementation of this standardEITF 07-3 did not have a material impact on our financial position, results of operations or cash flows.

         FAS 141 (revised 2007), "Business Combinations."    In December 2007, the FASB issued FAS 141 (revised 2007), "Business Combinations," or FAS 141R, which replaces FAS 141, "Business Combinations." FAS 141R retains the underlying concepts of FAS 141 in that all business combinations are still required to be accounted for at fair value under the acquisition method of accounting but changes a number of significant aspects of applying this method. Acquisition costs will generally be expensed as incurred; noncontrolling interests will be valued at fair value at the acquisition date; in-process research and development, or IPR&D, will be recorded at fair value as an indefinite-lived intangible asset at the acquisition date; restructuring costs associated with a business combination will generally be expensed subsequent to the acquisition date; and changes in deferred tax asset valuation allowances and income tax uncertainties after the acquisition date generally will affect income tax expense. FAS 141R is effective for us on a prospective basis for all business combinations for which the acquisition date is on or after January 1, 2009. Early adoption is not permitted. We are currently evaluating the effects, if any, that FAS 141R will have on our consolidated financial statements.

         FAS No. 160, "Noncontrolling Interests in Consolidated Financial Statements—an amendment of ARB No. 51."    In December 2007, the FASB issued FAS 160, "Noncontrolling Interests in Consolidated Financial Statements—an amendment of ARB No. 51," which establishes new accounting and reporting standards that require the ownership interests in subsidiaries not held by the parent to be clearly identified, labeled and presented in the consolidated statement of financial position within equity, but separate from the parent's equity. FAS 160 also requires the amount of consolidated net income attributable to the parent and to the non-controllingnoncontrolling interest, commonly referred to as the minority interest, to be clearly identified and presented on the face of the consolidated statement of income. Changes in a parent's ownership interest while the parent retains its controlling financial interest must be accounted for consistently, and when a subsidiary is deconsolidated, any retained non-controllingnoncontrolling equity investment in the former subsidiary must be initially measured at fair value. The gain or loss on the deconsolidation of the subsidiary is measured using the fair value of any non-controllingnoncontrolling equity investment. FAS 160 also requires entities to provide sufficient disclosures that clearly identify and distinguish between the interests of the parent and the interests of the non-controllingnoncontrolling owners. FAS 160 is effective for us January 1, 2009 and adoption is prospective only; however,only. However, upon adoption, presentation and disclosure requirements described above must be applied retrospectively for all


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

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


periods presented in our consolidated financial statements. We are currently evaluating the effects, if any, that FAS 160 will have on our consolidated financial statements.


GENZYME CORPORATION AND SUBSIDIARIES

NotesFASB Staff Position, or FSP, No. 157-2, "Effective Date of FASB Statement No. 157."    In accordance with the provisions of FSP No. 157-2, "Effective Date of FASB Statement No. 157," we elected to Unaudited, Consolidated Financial Statements (Continued)

2.    Basisdefer implementation of PresentationFAS 157, as it relates to our non-financial assets and Significant Accounting Policies (Continued)non-financial liabilities that are recognized and disclosed at fair value in our consolidated financial statements on a nonrecurring basis, until January 1, 2009. We are evaluating the impact, if any, the adoption of FAS 157, for those assets and liabilities within the scope of FSP No. FAS 157-2, will have on our financial position, results of operations and liquidity. We did not have any non-financial assets or non-financial liabilities that would be recognized or disclosed on a recurring basis as of June 30, 2008.

         FAS No. 161, "Disclosures About Derivative Instruments and Hedging Activities—an amendment of FASB Statement No. 133."    In March 2008, the FASB issued FAS 161, "Disclosures about Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133," which amends and expands the disclosure requirements of FAS 133, "Accounting for Derivative Instruments and Hedging Activities." FAS 161 requires qualitative disclosures about objectives and strategies for using derivatives, quantitative disclosures about fair value amounts of gains and losses on derivative instruments, and disclosures about credit-risk-related contingent features in derivative agreements. FAS 161 is effective prospectively for financial statements issued for fiscal years and interim periods beginning after November 15, 2008, with early application encouraged. We are currently evaluating the effects, if any, that FAS 161 will have on our consolidated financial statements.

         FSP No. 142-3, "Determination of the Useful Life of Intangible Assets."    In April 2008, the FASB issued FSP No. 142-3, "Determination of the Useful Life of Intangible Assets." FSP No. 142-3 amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under FAS 142, "Goodwill and Other Intangible Assets". FSP No. 142-3 is effective for fiscal years beginning after December 15, 2008. We are currently evaluating the effects, if any, that FSP No. 142-3 will have on our consolidated financial statements.

         FAS No. 162, "The Hierarchy of Generally Accepted Accounting Principles."    In May 2008, the FASB issued FAS 162, "The Hierarchy of Generally Accepted Accounting Principles." FAS 162 identifies the sources of accounting principles and the framework for selecting the principles used in the preparation of financial statements. FAS 162 is effective 60 days following the SEC's approval of the Public Company Accounting Oversight Board amendments to AU Section 411, "The Meaning of Present Fairly in Conformity with Generally Accepted Accounting Principles." The implementation of this standard will not have a material impact on our consolidated financial position and results of operations.

3.    Fair Value Measurements

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



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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3.    Fair Value Measurements (Continued)


Fair Value Measurement—Definition and Hierarchy

        Effective January 1, 2008, we implemented FAS 157, "Fair Value Measurements," for our financial assets and liabilities that are re-measured and reported at fair value at each reporting period. The adoption of FAS 157 to our financial assets and liabilities did not have a material impact on our financial position and results of operations.

        FAS 157 provides a framework for measuring fair value and requires expanded disclosures regarding fair value measurements. FAS 157 defines fair value as the price that would be received to sell an asset or paid to transfer a liability (i.e., the "exit price") in an orderly transaction between market participants at the measurement date. In determining fair value, FAS 157 permits the use of various valuation approaches, including market, income and cost approaches. FAS 157 establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available.

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


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3.    Fair Value Measurements (Continued)

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 by our custodial agent and nationally known pricing vendors, 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 derivative and equity securities using market data from observable and corroborated sources. In periods of market inactivity, the observability of prices and inputs may be reduced for many instruments. This condition could cause an instrument to be reclassified from Level 1 to Level 2 or from Level 2 to Level 3.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3.    Fair Value Measurements (Continued)

        The following table sets forth our financial assets and liabilities that were accounted for at fair value on a recurring basis as of March 31,June 30, 2008 (amounts in thousands):

Description
Description
 Total
 Level 1
 Level 2
 Level 3
Description Total Level 1 Level 2 Level 3 
Fixed income investments(1): Cash equivalents: Money market funds $552,031 $552,031 $ $ Cash equivalents: Money market funds $498,111 $498,111 $ $ 
     
 
 
 


 

Short-term investments:

 

U.S. Treasury notes

 

 


 

 


 

 


 

 

   U.S. agency notes  15,821    15,821            
   Corporate notes—global  53,274    53,274   

Short-term investments:

 

U.S. agency notes

 
8,388
 
 
8,388
 
 
   Corporate commercial paper  9,955    9,955   Corporate notes—global 59,300  59,300  
     
 
 
 
          
   Total  79,050    79,050   Total 67,688  67,688  
     
 
 
 
          


 

Long-term investments:

 

U.S. Treasury notes

 

 

117,267

 

 

117,267

 

 


 

 

 

Long-term investments:

 

U.S. Treasury notes

 
105,243
 
105,243
 
 
 
   U.S. agency notes  156,829    156,829   U.S. agency notes 170,613  170,613  
   Corporate notes—global  212,039    212,039   Corporate notes—global 217,263  217,263  
     
 
 
 
          
   Total  486,135  117,267  368,868   Total 493,119 105,243 387,876  
     
 
 
 
          
 Total fixed
income
investments
  1,117,216  669,298  447,918   Total fixed
income
investments
  1,058,918 603,354 455,564  
     
 
 
 
          

Derivatives:

 

Foreign exchange contracts(2)

 

 

(28,894

)

 


 

 

(28,894

)

 

 

Foreign exchange contracts(2)

  
(4,824

)
 
 
(4,824

)
 
 
     
 
 
 
          

Equity holdings:

 

Publicly-traded equity securities(1)

 

 

63,296

 

 

63,296

 

 


 

 

 

Publicly-traded equity securities(1)

  
57,224
 
57,224
 
 
 
     
 
 
 
          
Total assets and (liabilities) at fair valueTotal assets and (liabilities) at fair value $1,151,618 $732,594 $419,024 $

Total assets and (liabilities) at fair value

 $1,111,318 $660,578 $450,740 $ 
     
 
 
 
          

(1)
Changes in 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; andsheets.

(2)
As of March 31,June 30, 2008, the aggregate fair value of our foreign exchange contracts was an unrealized loss of $28.9$4.8 million, which we recorded as an increase to accrued expenses in our consolidated balance sheetsheets as of that date. Changes in fair value of our forward foreign exchange contracts are recorded in unrealized foreign exchange gains and losses, a component of selling, general and administrative expenses, or SG&A, in our consolidated statements of operations.

        In accordance with the provisions of FASB Staff Position, or FSP, No. FAS 157-2, "Effective Date of FASB Statement No. 157," we elected to defer implementation of FAS 157, as it relates to our non-financial assets and non-financial liabilities that are recognized and disclosed at fair value in our consolidated financial statements on a nonrecurring basis, until January 1, 2009. We are evaluating the impact, if any, the adoption of FAS 157, for those assets and liabilities within the scope of FSP No. FAS 157-2, will have on our financial position, results of operations or liquidity. We did not have any non-financial assets or non-financial liabilities that would be recognized or disclosed on a recurring basis as of March 31, 2008.


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

3.    Fair Value Measurements (Continued)

        The carrying amounts reflected in our consolidated balance sheets for cash, accounts receivable, other current assets, accounts payable and accrued expenses approximate fair value due to their short-term maturities.


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



 Three Months Ended
March 31,


 Three Months Ended
June 30,
 Six Months Ended
June 30,
 


 2008
 2007

 2008 2007 2008 2007 
Net income—basicNet income—basic $145,271 $158,187

Net income—basic

 $69,564 $83,794 $214,835 $241,981 
Effect of dilutive securities:Effect of dilutive securities:    

Effect of dilutive securities:

 
Interest expense and debt fee amortization, net of tax, related to our 1.25% convertible senior notes 1,886 1,886

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

 1,886 1,887 3,772 3,772 
 
 
         
Net income—dilutedNet income—diluted $147,157 $160,073

Net income—diluted

 $71,450 $85,681 $218,607 $245,753 
 
 
         

Shares used in computing net income per common share—basic

Shares used in computing net income per common share—basic

 

267,276

 

263,476

Shares used in computing net income per common share—basic

 
266,904
 
263,911
 
267,127
 
263,693
 
Effect of dilutive securities:Effect of dilutive securities:    

Effect of dilutive securities:

 
Shares issuable upon the assumed conversion of our 1.25% convertible senior notes 9,686 9,686

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

 9,686 9,686 9,686 9,686 
Stock options(1) 7,791 6,751

Stock options(1)

 7,123 6,906 7,712 6,829 
Restricted stock units(2) 443 

Restricted stock units(2)

 538 50 491 25 
Warrants and stock purchase rights 12 11

Warrants and stock purchase rights

 11 11 12 11 
 
 
         
 Dilutive potential common shares 17,932 16,448 

Dilutive potential common shares

 17,358 16,653 17,901 16,551 
 
 
         
Shares used in computing net income per common share—diluted(1,2)Shares used in computing net income per common share—diluted(1,2) 285,208 279,924

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

 284,262 280,564 285,028 280,244 
 
 
         

Net income per common share:

Net income per common share:

 

 

 

 

Net income per common share:

 
 Basic $0.54 $0.60

Basic

 $0.26 $0.32 $0.80 $0.92 
 
 
         
 Diluted $0.52 $0.57

Diluted

 $0.25 $0.31 $0.77 $0.88 
 
 
         

(1)
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
March 31,

 
 2008
 2007
Shares issuable upon exercise of outstanding options 1,982 13,483
  
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
  
 2008 2007 2008 2007 
 

Shares issuable upon exercise of outstanding options

  4,258  15,053  3,120  14,268 
(2)
We began issuing restricted stock units, or RSUs, under our 2004 Equity Incentive Plan in May 2007, in connection with our general grant program.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

5.    Mergers and Acquisitions

Bioenvision

        Effective October 23, 2007, we completed our acquisition of Bioenvision through the culmination of a two step process consisting of a tender offer completed in July 2007, and a merger approved in October 2007. We paid gross consideration of $349.9 million in cash, including $345.4 million for the outstanding shares of Bioenvision Common and Series A Preferred Stock and options to purchase shares of Bioenvision Common Stock, and approximately $5 million for acquisition costs.

        Bioenvision was focused on the acquisition, development and marketing of compounds and technologies for the treatment of cancer, autoimmune disease and infection. The acquisition of Bioenvision providesprovided us with the exclusive, worldwide rights to clofarabine.clofarabine outside North America.

        In connection with the merger, holders of 2,880,000 shares of Bioenvision Common Stock, representing less than 5% of the outstanding shares of Bioenvision Common Stock on an as-converted basis immediately before the merger became effective, submitted written demands for appraisal of their shares and elected not to accept the $5.60 per share merger consideration. We refer to these stockholders as dissenting stockholders. We obtained ownership of the dissenting shares and accounted for the merger based on 100% ownership of Bioenvision. In October 2007, we accrued $16.1 million in our consolidated balance sheets, which represented our estimate of the price to be paid to the dissenting shareholders upon resolution of their appraisal demand.

        The purchase price was allocated to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values at the date of acquisition. The excess of the purchase price over the estimated fair value of the assets acquired and liabilities assumed amounted to $85.3 million, which was allocated to goodwill. We expect that substantially all of the amount allocated to goodwill will be deductible for tax purposes.

        The allocation of purchase price remains subject to potential adjustments, including adjustments for liabilities associated with certain exit and tax restructuring activities. We recorded immaterial adjustments to the purchase price in the first quarterhalf of 2008.

Purchase of In-Process Research and Development

        We did not complete any acquisitions in the six months ended June 30, 2008. In connection with certain of our acquisitions that we completed between January 1, 2006 and December 31, 2007, we have acquired various IPR&D projects. Substantial additional research and development will be required prior to any of our acquired IPR&D programs and technology platforms reaching technological feasibility. In addition, once research is completed, each product candidate acquired will need to complete a series of clinical trials and receive FDA or other regulatory approvals prior to commercialization. Our current estimates of the time and investment required to develop these products and technologies may change depending on the different applications that we may choose to pursue. We cannot give assurances that these programs will ever reach technological feasibility or develop into products that can be marketed profitably. In addition, we cannot guarantee that we will be able to develop and commercialize products before our competitors develop and commercialize products for the same indications. If products based on our acquired IPR&D programs and technology platforms do not become commercially viable, our results of operations could be materially adversely affected. We did not complete any acquisitions in the three months ended March 31, 2008.


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

5.    Mergers and Acquisitions (Continued)

The following table sets forth the significant IPR&D projects for companies and certain assets we have acquired between January 1, 2006 and MarchDecember 31, 20082007 (amounts in millions):

Company/Assets Acquired
 Purchase
Price

 IPR&D(1)
 Programs Acquired
 Discount Rate
Used in
Estimating
Cash Flows(1)

 Year of
Expected
Launch

 Purchase
Price
 IPR&D Programs Acquired Discount Rate
Used in
Estimating
Cash Flows
 Year of
Expected
Launch
 
Bioenvision (2007) $349.9 $125.5 Clofarabine (rights outside North America)(2,3) 17%2008-2010 $349.9 $125.5 Evoltra (clofarabine)(1,2) 17% 2008-2010 
    
         

AnorMED Inc. (2006)

 

$

589.2

 

$

526.8
26.1

 

Mozobil (stem cell transplant)
AMD070 (HIV)(4)

 

15
15

%
%

2009-2014
 
$

589.2
 
$

526.8
26.1
 

Mozobil (stem cell transplant)(3)
AMD070 (HIV)(4)

 
15
15

%
%
 
2009-2014
 
    
         
    $552.9         $552.9     
    
         

(1)
Management assumes responsibility for determining the valuation of the acquired IPR&D projects. The fair value assigned to IPR&D for each acquisition is estimated by discounting, to present value, the cash flows expected once the acquired projects have reached technological feasibility. The cash flows are probability-adjusted to reflect the risks of advancement through the product approval process. In estimating the future cash flows, we also considered the tangible and intangible assets required for successful exploitation of the technology resulting from the purchased IPR&D projects and adjusted future cash flows for a charge reflecting the contribution to value of these assets.

(2)
IPR&D charges totaled $125.5 million related to the acquisition of Bioenvision, of which $106.4 million was charged to IPR&D and $19.1 million was charged to equity in income of equity method investments.


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

5.    Mergers and Acquisitions (Continued)

(3)(2)
ClolarClofarabine, which is marketedapproved for the treatment of relapsed and refractory pediatric acute lymphoblastic leukemia, or ALL.ALL, is marketed under the name Clolar in North America and as Evoltra elsewhere in the world. The IPR&D projects for Clolar are related to the development of the product for the treatment of other medical issues.diseases.

(3)
In June 2008, we submitted marketing applications for Mozobil in the United States and Europe. We expect to launch Mozobil in these regions during the first half of 2009, following regulatory approval.

(4)
Year of expected launch is not provided for AMD070 at this time because we are assessing our future plans for this program.

Exit Activities

        In connection with several of our acquisitions, we initiated integration plans to consolidate and restructure certain functions and operations, including the relocation and termination of certain personnel of these acquired entities and the closure of certain of the acquired entities' leased facilities. These costs have been recognized as liabilities in accordance with EITF Issue No. 95-3, "Recognition of Liabilities in Connection with a Purchase or Business Combination," and are subject to potential


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

5.    Mergers and Acquisitions (Continued)


adjustments as certain exit activities are confirmed or refined. The following table summarizes the liabilities established for exit activities related to these acquisitions (amounts in thousands):

 
 Employee
Related
Benefits

 Closure of
Leased
Facilities

 Other
Exit
Activities

 Total
Exit
Activities

 
Balance at December 31, 2006(1) $6,105 $24 $ $6,129 
 Acquisition(2)  2,601    70  2,671 
 Revision of estimates(1)  (931) 2,593    1,662 
 Payments  (5,602) (453)   (6,055)
  
 
 
 
 
Balance at December 31, 2007  2,173  2,164  70  4,407 
 Payments  (1,416) (155) (70) (1,641)
  
 
 
 
 
Balance at March 31, 2008 $757 $2,009 $ $2,766 
  
 
 
 
 
 
 Employee
Related
Benefits
 Closure of
Leased
Facilities
 Other
Exit
Activities
 Total
Exit
Activities
 

Balance at December 31, 2006

 $6,105 $24 $ $6,129 
 

Acquisition(1)

  2,601    70  2,671 
 

Revision of estimates

  (931) 2,593    1,662 
 

Payments

  (5,602) (453)   (6,055)
          

Balance at December 31, 2007

  2,173  2,164  70  4,407 
 

Revision of estimates

  (182)     (182)
 

Payments

  (1,654) (384) (70) (2,108)
          

Balance at June 30, 2008(2)

 $337 $1,780 $ $2,117 
          

(1)
Represents amounts accrued for employee related benefits resulting from our acquisition of Bioenvision. We completed payment of these benefits in June 2008.

(2)
We expect to pay employee benefits related to our acquisition of AnorMED through 2008 and payments related to the closing of the leased facility through 2012.

(2)
We expect to pay employee-related benefits related to our acquisition of Bioenvision through June 2008.

Pro Forma Financial Summary

        The following pro forma financial summary is presented as if the acquisition of Bioenvision had been completed as of January 1, 2007. These pro forma combined results are not necessarily indicative of the actual results that would have occurred had the acquisition been consummated on that date, or of the future operations of the combined entities. Material nonrecurring charges related to the


Table of Contents

GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

5.    Mergers and Acquisitions (Continued)


acquisition of Bioenvision, such as IPR&D charges of $125.5 million, are included in the following pro forma financial summary as of January 1, 2007 (amounts in thousands, except per share amounts):



 Three Months Ended
March 31, 2007


 Three Months Ended
June 30, 2007
 Six Months Ended
June 30, 2007
 
Total revenuesTotal revenues $885,305

Total revenues

 $937,437 $1,822,742 
 
     
Net incomeNet income $40,773

Net income

 $76,192 $116,965 
 
     
Net income per share:Net income per share:  

Net income per share:

 
Basic $0.15

Basic

 $0.29 $0.44 
 
     
Diluted $0.15

Diluted

 $0.28 $0.43 
 
     
Weighted average shares outstanding:Weighted average shares outstanding:  

Weighted average shares outstanding:

 
Basic 263,476

Basic

 263,911 263,693 
 
     
Diluted 279,924

Diluted

 280,564 280,244 
 
     

6.    Strategic Transactions

Collaboration with PTC Therapeutics, Inc.

        On July 15, 2008, we entered into a collaboration agreement with PTC Therapeutics, Inc., or PTC, to develop and commercialize PTC124, PTC's novel oral therapy in late-stage development for the treatment of nonsense-mutation-mediated Duchenne muscular dystrophy, or DMD, and nonsense-mutation-mediated cystic fibrosis, or CF. Under the terms of the agreement, PTC will commercialize PTC124 in the United States and Canada, and we will commercialize the treatment in all other countries. In connection with the collaboration agreement, we paid PTC a nonrefundable upfront payment of $100.0 million, which we recorded as a charge to research and development expense in our consolidated statements of operations in July 2008. We classify nonrefundable fees paid outside of a business combination for the acquisition or licensing of products that have not received regulatory approval and have no future alternative use as research and development expense. PTC will conduct and be responsible for the phase 2b trial of PTC124 in DMD, the phase 2b trial in CF and two proof-of-concept studies in other indications to be determined. Once these four studies have been completed, we and PTC will share research and development costs for PTC124 equally. We and PTC will each bear the sales and marketing and other costs associated with the commercialization of PTC124 in our respective territories. PTC is eligible to receive up to $337.0 million in milestone payments as follows:

PTC is also eligible to receive tiered, double-digit royalties from sales of PTC124 outside of the United States and Canada.


Table of Contents

GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

6.    Strategic Transactions (Continued)

Strategic Alliance with Isis

        On January 7, 2008, we entered into a strategic alliance with Isis, whereby we obtained an exclusive license to develop and commercialize mipomersen, a lipid-lowering drug targeting apolipoprotein B-100, for the treatment of familial hypercholesterolemia, or FH, an inherited disorder that causes exceptionally high levels of LDL-cholesterol. In February 2008, we made a nonrefundable payment to Isis of $150.0 million, of which $80.1 million was recorded as an investment in equity securities in our consolidated balance sheets based on the fair value of the five million shares of Isis common stock we acquired in connection with the transaction, and the remaining $69.9 million was allocated to the mipomersen license, which had not reached technological feasibility and did not have alternative future use. We recorded the $69.9 million license fee as a charge to research and development expense in our consolidated statements of operations in the first quarter of 2008. We classify nonrefundable fees paid outside of a business combination for the acquisition or licensing of products that have not received regulatory approval and have no future alternative use as research and development expense.

        In June 2008, we finalized the terms of our license and collaboration agreement with Isis and paid Isis an additional $175.0 million upfront nonrefundable license fee, which we recorded as a charge to research and development expense in our consolidated statements of operations in June 2008. Under the terms of the agreement, Isis will contribute up to the first $125.0 million in funding for the development of mipomersen and, thereafter, we and Isis will share development costs for mipomersen equally. The initial funding commitment by Isis and shared development funding will end when the mipomersen program is profitable. In the event the research and development of mipomersen is terminated prior to Isis completing their funding obligation, we are not entitled to any refund of our $175.0 million upfront payment. Accordingly, the $175.0 million was recorded as research and development expense in June 2008. Isis is eligible to receive up to $750.0 million in commercial milestone payments and up to $825.0 million in development and regulatory milestone payments.

        We will be responsible for funding sales and marketing expenses until mipomersen revenues are sufficient to cover such costs. Profits on mipomersen initially will be allocated 70% to us and 30% to Isis. The profit ratio will be adjusted on a sliding scale as annual revenues for mipomersen ramp up to $2.0 billion, at which point we will share profits equally with Isis. The results of our mipomersen program are included in the results of our cardiovascular business unit, which are reported under the caption "Other" in our segment disclosures.

7.    Inventories



 March 31,
2008

 December 31,
2007


 June 30,
2008
 December 31,
2007
 


 (Amounts in thousands)


 (Amounts in thousands)
 
Raw materialsRaw materials $113,887 $120,409

Raw materials

 $105,931 $120,409 
Work-in-processWork-in-process 148,436 130,812

Work-in-process

 147,408 130,812 
Finished goodsFinished goods 206,501 187,894

Finished goods

 219,199 187,894 
 
 
     
Total $468,824 $439,115

Total

 $472,538 $439,115 
 
 
     

        During the three months ended March 31,In July 2008, we recalledwrote off one lot of Thymoglobulin, that failedvalued at approximately $5 million, due to meeta filter failure at our specifications for product appearance. In April, we recalled an additional three lots for the same reason. The value of the unused portion of these four lots was not significant.

7.    Goodwill and Other Intangible Assets

Goodwill

        The following tables contains the changefill-finish facility in our goodwill during the three months ended March 31, 2008 (amounts in thousands):Waterford, Ireland.

 
 As of
December 31,
2007

 Adjustments
 As of
March 31,
2008

Renal $303,951 $ $303,951
Therapeutics  355,494    355,494
Transplant  163,061    163,061
Biosurgery  7,585    7,585
Oncology  530,909  477  531,386
Other  42,828  (589) 42,239
  
 
 
Goodwill $1,403,828 $(112)$1,403,716
  
 
 

Table of Contents

GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

7.8.    Goodwill and Other Intangible Assets (Continued)

Goodwill

        The following table contains the change in our goodwill during the six months ended June 30, 2008 (amounts in thousands):

 
 As of
December 31,
2007
 Adjustments As of
June 30,
2008
 

Renal

 $303,951 $ $303,951 

Therapeutics

  355,494    355,494 

Transplant

  163,061    163,061 

Biosurgery

  7,585    7,585 

Oncology

  530,909  477  531,386 

Other

  42,828  (235) 42,593 
        

Goodwill

 $1,403,828 $242 $1,404,070 
        

Other Intangible Assets

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



 As of March 31, 2008
 As of December 31, 2007

 As of June 30, 2008 As of December 31, 2007 


 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
 
Technology(1)Technology(1) $2,162,032 $(586,396)$1,575,636 $1,680,190 $(545,817)$1,134,373

Technology(1)

 $2,162,028 $(626,643)$1,535,385 $1,680,190 $(545,817)$1,134,373 
PatentsPatents 194,560 (108,750) 85,810 194,560 (104,413) 90,147

Patents

 194,560 (113,088) 81,472 194,560 (104,413) 90,147 
TrademarksTrademarks 60,618 (38,142) 22,476 60,634 (36,787) 23,847

Trademarks

 60,623 (39,498) 21,125 60,634 (36,787) 23,847 
License feesLicense fees 91,229 (31,394) 59,835 90,237 (28,833) 61,404

License fees

 90,871 (33,410) 57,461 90,237 (28,833) 61,404 
Distribution rights(2)Distribution rights(2) 314,213 (136,630) 177,583 307,260 (125,678) 181,582

Distribution rights(2)

 382,976 (147,356) 235,620 307,260 (125,678) 181,582 
Customer lists(3)Customer lists(3) 88,483 (27,461) 61,022 97,031 (33,209) 63,822

Customer lists(3)

 88,754 (29,924) 58,830 97,031 (33,209) 63,822 
OtherOther 2,052 (1,679) 373 2,050 (1,573) 477

Other

 2,054 (1,785) 269 2,050 (1,573) 477 
 
 
 
 
 
 
             
Total $2,913,187 $(930,452)$1,982,735 $2,431,962 $(876,310)$1,555,652

Total

 $2,981,866 $(991,704)$1,990,162 $2,431,962 $(876,310)$1,555,652 
 
 
 
 
 
 
             

(1)
Effective January 1, 2008, reflects the consolidation of the results of BioMarin/Genzyme LLC at fair value in accordance with FIN 46R, including $480.5 million for the fair value of the manufacturing and commercialization rights to Aldurazyme, net of $6.0$12.0 million of related accumulated amortization. This intangible asset is being amortized on a straight-lined basis over a period of 20 years.

(2)
Includes an additional $6.9$75.7 million of intangible assets resulting from additional payments made or accrued in the first quarterhalf of 2008 in connection with our reacquisition of the Synvisc sales and marketing rights from Wyeth.Wyeth, including a $60.0 million milestone payment recorded in May 2008.

(3)
Reflects the write off, during the first quarter of 2008, of $8.3 million of fully amortized customer lists assigned to our Genetics reporting unit.

        All of our other intangible assets are amortized over their estimated useful lives. Total amortization expense for our other intangible assets was:


Table of Contents

GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

7.8.    Goodwill and Other Intangible Assets (Continued)

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

        The estimated future amortization expense for other intangible assets for the remainder of fiscal year 2008, the four succeeding fiscal years and thereafter is as follows (amounts in thousands):

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

 Estimated
Amortization
Expense(1,2)
 
2008 (remaining nine months) $169,320

2008 (remaining six months)

 $113,413 
2009 228,795 228,835 
2010 241,970 242,005 
2011 259,691 259,820 
2012 200,681 200,754 
Thereafter 567,345 567,645 

(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 will be required to make to Wyeth, and for 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 will be required to make to Synpac related to future anticipated regulatory approvals. These contingent payments will be recorded as intangible assets when the payments are accrued. Estimated future amortization expense also includes estimated future amortization expense for other arrangements involving contingent payments.

(2)
EstimatedExcludes future amortization expense related to the $480.5 million of technology recorded effective January 1, 2008, related to our consolidation of the results of BioMarin/Genzyme LLC, because such amortization is entirely offset by the corresponding amortization of a noncurrent liability related to the consolidation of BioMarin/Genzyme LLC.

8.Table of Contents

GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

9.    Investments in Equity Securities

        We recorded the following net gains on investments in equity securities, duringnet of charges for impairment of investments, for the periods presented (amounts in thousands):

 
 Three Months Ended
March 31,

 
 2008
 2007
Therapeutic Human Polyclonals, Inc. (THP) $ $10,848
Other  775  1,940
  
 
 Gains on investments in equity securities, net $775 $12,788
  
 
 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
 
 2008 2007 2008 2007 

Gross gains on investments in equity securities:

             
 

Sirtris Pharmaceuticals, Inc. (Sirtris)

 $10,304 $ $10,304 $ 
 

Therapeutic Human Polyclonals, Inc. (THP)

        10,848 
 

Other

  138  143  913  2,083 
          
  

Total

  10,442  143  11,217  12,931 

Less: charge for impairment of investment

  (1,289)   (1,289)  
          

Gains on investments in equity securities, net

 $9,153 $143 $9,928 $12,931 
          

        In the second quarter of 2008, we recorded a $10.3 million gain resulting from the liquidation of our investment in the common stock of Sirtris for net cash proceeds of $14.8 million.

        In March 2007, we recorded a $10.8 million gain in connection with the sale of theour entire investment in the capital stock of THP, held by our wholly-owned subsidiary, SangStat Medical, LLC, which had a zero cost basis, for net cash proceeds of $10.8 million.

Unrealized Gains (Losses)

        At March 31,June 30, 2008, our stockholders' equity includes $27.6$28.8 million of unrealized gains and $1.2$2.6 million of unrealized losses related to our strategic investments in equity securities.


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

8.    Investments in Equity Securities (Continued)

Strategic Alliance with Isis

        On January 7, 2008, we entered into a strategic alliance with Isis, whereby we obtained an exclusive license to develop and commercialize mipomersen, a lipid-lowering drug targeting apolipoprotein B-100, for the treatment of familial hypercholesterolemia, or FH, an inherited disorder that causes exceptionally high levels of LDL-cholesterol. In February 2008, we paid Isis $150.0 million to purchase five million shares of Isis common stock for $30 per share, of which $80.1 million was recorded as an increase to investment in equity securities in our consolidated balance sheets based on the $16.02 closing price per share of Isis common stock on February 4, 2008, the date we acquired the shares, and $69.9 million was charged to research and development expense in our consolidated statements of operations for the premium we paid to purchase the stock. We are working with Isis to finalize the contracts under which we will develop and commercialize mipomersen.

9.10.    Joint Venture with BioMarin

        We and BioMarin Pharmaceutical Inc., or BioMarin, formed BioMarin/Genzyme LLC to develop and commercialize Aldurazyme, a recombinant form of the human enzyme alpha-L-iduronidase, used to treat an LSD known as mucopolysaccharidosis I, or MPS I. Prior to January 1, 2008, we recorded our portion of the results of BioMarin/Genzyme LLC in equity in income (loss) of equity method investments in our consolidated statements of operations. Our portion of BioMarin/Genzyme LLC's resultsnet income was $6.5 million for the three months ended March 31,June 30, 2007 was net incomeand $12.6 million for the six months ended June 30, 2007.

        Condensed financial information for BioMarin/Genzyme LLC is summarized below for the three and six months ended June 30, 2007 (amounts in thousands):

 
 Three Months Ended
June 30, 2007
 Six Months Ended
June 30, 2007
 

Revenue

 $29,127 $55,948 

Gross margin

  22,434  42,957 

Operating expenses

  (9,560) (18,034)

Net income

  13,016  25,237 

Table of $6.1 million.Contents

GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

10.    Joint Venture with BioMarin (Continued)

        Effective January 1, 2008, we restructured our relationship with BioMarin/Genzyme LLC regarding the manufacturing and commercialization of Aldurazyme by entering into several new agreements. BioMarin/Genzyme LLC will no longer engage in commercial activities related to Aldurazyme and will solely:

Under the restructured relationship, BioMarin/Genzyme LLC has licensed all intellectual property related to Aldurazyme and other collaboration products on a royalty-free basis to BioMarin and us. BioMarin holds the manufacturing rights and we hold the global marketing rights. We are required to pay BioMarin a tiered royalty payment ranging from 39.5% to 50% of worldwide net product sales of Aldurazyme.

        As a result of the restructuring of our relationship with BioMarin/Genzyme LLC, effective January 1, 2008, in accordance with the provisions of FIN 46R, we began consolidating the results of BioMarin/Genzyme LLC. Upon consolidation of BioMarin/Genzyme LLC, we recorded the assets and liabilities of the joint venture in our consolidated balance sheets at fair value. The value of the intellectual property of the joint venture of approximately $480.5 million was recorded as an intangible asset and will be amortized over a useful life of 20 years. As this intellectual property has been out-licensedoutlicensed from the joint venture to BioMarin and us for no consideration, a noncurrent liability was recorded for an amount equal to the negative value of these licenses. The noncurrent liability is being amortized over a period of 20 years. We recorded BioMarin's portion of the joint venture's losses, the


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

9.    Joint Venture with BioMarin (Continued)


amount of which was not significant for the three and six months ended March 31,June 30, 2008, as minority interest in our consolidated statements of operations.

        Condensed financial information for BioMarin/Genzyme LLC is summarized below for the three months ended March 31, 2007 (amounts in thousands):11.    Long-Term Debt

 
 Three Months Ended
March 31, 2007

 
Revenue $26,822 
Gross margin  20,523 
Operating expenses  (8,474)
Net income  12,220 

10.    Revolving Credit Facility

        As of March 31,June 30, 2008, no amounts were outstanding under our five-year $350.0 million senior unsecured revolving credit facility, which we refer to as our 2006 revolving credit facility. The terms of our 2006 revolvingthis credit facility include various covenants, including financial covenants, that require us to meet minimum interest coverage ratios and maximum leverage ratios. As of March 31,June 30, 2008, we were in compliance with these covenants.

11.Mortgage

        In July 2008, we purchased land and a manufacturing facility we formerly leased in Framingham, Massachusetts for an aggregate purchase price of $38.9 million, including fees. We paid $20.8 million of cash and assumed the remaining $18.1 million in principal outstanding under the existing mortgage for the facility, which bears interest at 5.57% annually and is due in May 2020. We will allocate the purchase price to the fair value of the acquired land and buildings in our consolidated balance sheets as of July 31, 2008.


Table of Contents

GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

12.    Stockholders' Equity

Stock Repurchase

        During the three months ended March 31,June 30, 2008, we repurchased and retired an additional 1,000,000 shares of our common stock at an average price of $73.20$69.78 per share for a total of $73.2$69.8 million in cash, including fees. Since June 2007, when we first began making repurchases,repurchasing shares of our common stock, we have repurchased a cumulative total of 4,500,0005,500,000 shares of our common stock at an average price of $67.71$68.09 per share for a total of $304.8$374.6 million in cash, including fees. As a result, weWe recorded the repurchases in our consolidated balance sheets as of March 31, 2008 and December 31, 2007, as a reduction to our common stock account for the par value of the repurchased shares and as a reduction to our additional paid-in capital account.


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
March 31,

 


 2008
 2007
 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
Pre-tax stock-based compensation expense, net of estimated forfeitures charged to:     


 2008 2007 2008 2007 

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

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

 
Cost of products and services sold(1) $(6,514)$(5,896)

Cost of products and services sold(1)

 $(6,311)$(6,865)$(12,825)$(12,761)
Selling, general and administrative expense (22,889) (22,499)

Selling, general and administrative expense

 (31,904) (35,248) (54,793) (57,747)
Research and development expense (12,585) (12,312)

Research and development expense

 (16,092) (19,143) (28,677) (31,455)
 
 
           
 Total (41,988) (40,707) 

Total

 (54,307) (61,256) (96,295) (101,963)
Less: tax benefit from stock optionsLess: tax benefit from stock options 12,537 12,432 

Less: tax benefit from stock options

 16,834 18,703 29,371 31,135 
 
 
           
Total stock-based compensation expense, net of tax $(29,451)$(28,275) 

Total stock-based compensation expense, net of tax

 $(37,473)$(42,553)$(66,924)$(70,828)
 
 
           
Effect per common share:Effect per common share:     

Effect per common share:

 
Basic $(0.12)$(0.11)

Basic

 $(0.14)$(0.16)$(0.26)$(0.27)
 
 
           
Diluted $(0.10)$(0.10)

Diluted

 $(0.13)$(0.15)$(0.23)$(0.25)
 
 
           

(1)
We also capitalized the following amounts of stock-based compensation expense to inventory, of $3.1 million for the three months ended March 31, 2008 and $2.9 million for the three months ended March 31, 2007, all of which is attributable to participating employees that support our manufacturing operations.operations (amounts in thousands):

  
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
  
 2008 2007 2008 2007 
 

Stock-based compensation expense capitalized to inventory

 $3,875 $4,957 $6,996 $7,839 

Table of Contents

GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

12.    Stockholders' Equity (Continued)

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

        At March 31,June 30, 2008, there was $219.7$329.6 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 1.92.4 years.

Notes Receivable from Stockholders

        In connection with our acquisition of Biomatrix, we assumed notes receivable from five former employees, directors and consultants of Biomatrix, whichwho we refer to as the Makers of the notes. The notes are full-recourse promissory notes that accrue interest at rates ranging from 5.30% to 7.18% and mature at various dates from May 2007 through September 2009, at which point the outstanding principal and accrued interest for each note will become payable.2009. As of March 31,June 30, 2008, there iswas a total of $15.8$13.2 million outstanding for these notes, including $10.2$8.1 million of principal and $5.6$5.1 million of accrued interest. Of these amounts, a total of $8.0 million of principal and $4.6$4.7 million of accrued interest is attributable to one Maker. We record the amount of principal and interest outstanding under the notes in stockholders' equity because the notes were originally received in exchange for the issuance of Biomatrix common stock, which was subsequently converted into Genzyme Stock.

        On April 29,During the second quarter of 2008, we received $1.0a total of $2.8 million of cash and shares of Genzyme stock valued at $0.3 million from onethree of the Makers as payment in full upon maturity of that Maker's note,their notes, including accrued interest. A total of $2.8$11.5 million in principal and accrued interest has come due under the notes but has not yet been repaid, of which $1.9 million was


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

11.    Stockholders' Equity (Continued)


all due as of March 31, 2008 and an additional $0.8 million became due as of April 30, 2008.from one Maker. We are pursuing collection of thesethis past due amountsamount and the notes will continue to accrue interest until the outstanding principal and accrued interest have been repaid. A total of $0.7 million of the principal and accrued interest that was due but not repaid as of April 30, 2008 is attributable to the Maker that owes a total of $8.0 million in principal under the notes. In June 2008, an additional $6.7 million in principal will become due from this Maker plus accrued interest.

12.13.    Commitments and Contingencies

        We periodically become subject to legal proceedings and claims arising in connection with our business.

        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. This award has not yet been entered as a final ruling. Abbott will have 60 days from the final entry of this award to file an appeal. Because multiple parties, including Abbott, manufactured infringing product for Abbott during this period, any responsibility that we may have for indemnifying Abbott is only for a portion of its costs and damages related to this case. We currently are disputing with Abbott the percentage of infringing product that was supplied by us and may in the future assert additional claims that, if successful, would reduce or relieve us of any liability.

        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


Table of Contents

GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

13.    Commitments and Contingencies (Continued)


and Molecular Oncology Stock. On August 6, 2007, we reached an agreement in principle to settle for $64.0 million, lawsuits related to our 2003 repurchaseexchange of BiosurgeryGenzyme Stock for $64.0 million. The court entered an order approving the settlement on December 30, 2007.Biosurgery Stock. As a result, we recorded a liability for the settlement payment of $64.0 million as a charge to selling, general and administrative expenses, or SG&A in our consolidated statements of operations in June 2007, which we subsequently paid 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 insurer hasinsurers have purported to deny coverage, and therefore, we have not recorded a receivable for any potential recovery from our insurer.insurers. We intend to vigorously pursue our rights with respect to insurance coverage and to the extent we are successful, we will record the recovery in our consolidated statements of operations.

        We periodically become subject to 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 affect on our financial position or results of operations.

13.14.    Provision for Income Taxes


 Three Months Ended
March 31,

  Three Months Ended
June 30,
 Six Months Ended
June 30,
 

 2008
 2007
  2008 2007 2008 2007 

 (Amounts in thousands)

  (Amounts in thousands)
 
Provision for income taxes $60,117 $71,193  $38,407 $64,090 $98,524 $135,283 
Effective tax rate 29% 31% 36% 43% 31% 36%

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


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

13.    Provision for Income Taxes (Continued)

        Our effective tax rate for the three and six months ended June 30, 2008 was also impacted by the settlement of IRS audits for the tax years 2004 to 2005. We recorded a $4.3 million tax benefit to our income tax provision reflecting the settlement of various issues. In conjunction with those settlements, we reduced our tax reserves by $4.9 million and recorded current and deferred tax benefits for the remaining portion of the settlement amounts.

        We are currently under IRS audit for the tax years 20042006 to 20052007 and various states for the tax years 1999 to 2005. We believe that we have provided sufficiently for all audit exposures. We expect to settle the 2004 to 2005 IRS audit within the next twelve months and do not expect that the settlement will have a material impact on our financial position or results of operations. Settlement of these audits or the expiration of the statute of limitations on the assessment of income taxes for any tax


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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

14.    Provision for Income Taxes (Continued)


year may result in a reductionan adjustment of future tax provisions. Any such benefitadjustment would be recorded upon the effective settlement of the audit or expiration of the applicable statute of limitations.

14.15.    Segment Information

        In accordance with FAS 131, "Disclosures about Segments of an Enterprise and Related Information," we present segment information in a manner consistent with the method we use to report this information to our management. Applying FAS 131, we have six reporting segments as described above in Note 1., "Description of Business," to these consolidated financial statements. Effective January 1, 2008, as a result of changes in how we review our business, certain general and administrative expenses, which were formerly allocated amongst our reporting segments and Other, are now allocated to Corporate. We have revised our 2007 segment presentation to conform to our 2008 presentation.


GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

14.    Segment Information (Continued)

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

 
 Three Months Ended
March 31,

 
 
 2008
 2007
 
Revenues:       
 Renal $197,770 $165,677 
 Therapeutics(1)  568,693  429,517 
 Transplant  45,930  41,277 
 Biosurgery  111,662  98,393 
 Genetics  74,329  66,158 
 Oncology  29,048  22,449 
 Other  72,246  59,409 
 Corporate  383  303 
  
 
 
  Total $1,100,061 $883,183 
  
 
 

Income (loss) before income taxes:

 

 

 

 

 

 

 
 Renal $93,275 $65,004 
 Therapeutics(1)  365,210  297,973 
 Transplant  (7,914) (3,197)
 Biosurgery  18,787  12,866 
 Genetics  4,108  3,804 
 Oncology(2)  (24,985) (6,886)
 Other(2,3)  (64,979) 1,639 
 Corporate(4)  (178,114) (141,823)
  
 
 
  Total $205,388 $229,380 
  
 
 
 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
 
 2008 2007 2008 2007 

Revenues:

             
 

Renal

 $199,419 $172,249 $397,189 $337,926 
 

Therapeutics(1)

  611,935  464,749  1,180,628  894,266 
 

Transplant

  47,843  43,424  93,773  84,701 
 

Biosurgery

  131,215  107,889  242,877  206,282 
 

Genetics

  78,534  73,714  152,863  139,872 
 

Oncology

  33,324  17,430  62,372  39,879 
 

Other

  68,407  53,564  140,653  112,973 
 

Corporate

  457  400  840  703 
          
  

Total

 $1,171,134 $933,419 $2,271,195 $1,816,602 
          

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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

15.    Segment Information (Continued)

 
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 
 
 2008 2007 2008 2007 

Income (loss) before income taxes:

             
 

Renal

 $88,170 $72,757 $181,445 $137,760 
 

Therapeutics(1)

  378,199  292,025  743,409  589,999 
 

Transplant

  (11,496) (7,127) (19,410) (10,325)
 

Biosurgery

  28,670  18,968  47,456  31,835 
 

Genetics

  3,620  11,965  7,729  15,769 
 

Oncology(2)

  (26,666) (12,826) (51,651) (19,712)
 

Other(2,3)

  (175,599) (224) (240,578) 1,415 
 

Corporate(4)

  (176,927) (227,654) (355,041) (369,477)
          
  

Total

 $107,971 $147,884 $313,359 $377,264 
          

(1)
Effective January 1, 2008, as a result of our restructured relationship with BioMarin/Genzyme LLC, instead of sharing all costs and profits of Aldurazyme equally, we began to record all sales of, and SG&A related to Aldurazyme.

(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.

(3)
Includes a charge of $175.0 million recorded in June 2008 and a charge of $69.9 million recorded in February 2008 representing license fees paid to Isis for the exclusive worldwide rights to mipomersen which we recorded to research and development expense in our consolidated statements of operations for the premium paid to purchase five million shares of Isis in February 2008.operations. These charges were incurred by our cardiovascular business unit which had minimal revenues and expenses excluding this charge.

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

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GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements (Continued)

14.15.    Segment Information (Continued)

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

 
 March 31,
2008

 December 31,
2007

Segment Assets(1):      
 Renal $1,476,506 $1,468,428
 Therapeutics(2)  1,821,712  1,230,128
 Transplant  420,802  415,903
 Biosurgery  447,503  458,412
 Genetics  157,489  148,787
 Oncology  944,830  940,097
 Other  235,055  246,496
 Corporate(3)  3,579,156  3,393,490
  
 
  Total $9,083,053 $8,301,741
  
 
 
 June 30,
2008
 December 31,
2007
 

Segment Assets(1):

       
 

Renal

 $1,462,292 $1,468,428 
 

Therapeutics(2)

  1,829,763  1,230,128 
 

Transplant

  435,234  415,903 
 

Biosurgery

  515,357  458,412 
 

Genetics

  172,853  148,787 
 

Oncology

  939,637  940,097 
 

Other

  238,972  246,496 
 

Corporate(3)

  3,588,744  3,393,490 
      
  

Total

 $9,182,852 $8,301,741 
      

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

(2)
Includes the consolidation of the results of BioMarin/Genzyme LLC at fair value, including $480.5 million of additional technology recorded in the first quarter of 2008 for the fair value of BioMarin/Genzyme LLC's manufacturing and commercialization rights to Aldurazyme, net of $6.0$12.0 million of related accumulated amortization.

(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):



 March 31,
2008

 December 31,
2007


 June 30,
2008
 December 31,
2007
 
Cash, cash equivalents, short- and long-term investments in debt securitiesCash, cash equivalents, short- and long-term investments in debt securities $1,447,983 $1,460,394

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

 $1,254,495 $1,460,394 
Deferred tax assets, netDeferred tax assets, net 279,300 260,005

Deferred tax assets, net

 429,478 260,005 
Property, plant & equipment, netProperty, plant & equipment, net 1,361,381 1,240,992

Property, plant & equipment, net

 1,407,459 1,240,992 
Investments in equity securitiesInvestments in equity securities 168,301 89,181

Investments in equity securities

 162,930 89,181 
Other 322,191 342,918

Other assets

Other assets

 334,382 342,918 
 
 
     
Total $3,579,156 $3,393,490

Total

 $3,588,744 $3,393,490 
 
 
     

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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.

INTRODUCTION

        We are a global biotechnology company dedicated to making a major impact on the lives of people with serious diseases. Our broad product and service portfolio is focused on rare disorders, renal diseases, orthopaedics, organ transplant, diagnostic and predictive testing, and cancer. We are organized into six financial reporting units, which we also consider to be our reporting segments:

        We report the activities of our diagnostic products, bulk pharmaceuticals and cardiovascular business units under the caption "Other." We report our corporate, general and administrative operations and corporate science activities under the caption "Corporate."

        Effective January 1, 2008, as a result of a change in how we review our business, certain general and administrative expenses which were formerly allocated amongst our reporting segments and Other, are now allocated to Corporate.


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        As a result of our acquisition of Bioenvision in October 2007, our Oncology business unit, which was formerly reported combined with "Other," now meets the criteria for disclosure as a separate reporting segment. We have revised our 2007 segment disclosures to conform to our 2008 presentation.

MERGERS AND ACQUISITIONS

        The following acquisitions were accounted for as business combinations and, accordingly, we have included their results of operations in our consolidated statements of operations from the date of acquisition.

Diagnostic Assets of Diagnostic Chemicals Limited

        On December 3, 2007, we acquired certain diagnostic assets from Diagnostic Chemicals Limited, or DCL, a privately-held diagnostics and biopharmaceutical company, based in Charlottetown, Prince Edward Island, Canada, including DCL's line of over 50 formulated clinical chemistry reagents and itstheir diagnostics operations in Prince Edward Island, Canada and Connecticut. We paid consideration of $53.8 million in cash.

Bioenvision

        Effective October 23, 2007, we completed our acquisition of Bioenvision through the culmination of a two step process consisting of a tender offer completed in July 2007, and a merger approved in October 2007. We paid gross consideration of $349.9 million in cash, including $345.4 million for the outstanding shares of Bioenvision Common and Series A Preferred Stock and options to purchase shares of Bioenvision Common Stock, and approximately $5 million for acquisition costs. Net consideration was $304.7 million as we acquired Bioenvision's cash and cash equivalents totaling $45.2 million.

        Bioenvision was focused on the acquisition, development and marketing of compounds and technologies for the treatment of cancer, autoimmune disease and infection. The acquisition of Bioenvision provides us with the exclusive, worldwide rights to clofarabine.clofarabine outside North America. We currently market clofarabine in the United States and Canada under the brand name Clolar for relapsed and refractory pediatric ALL patients. In Europe, we co-developed clofarabine with Bioenvision and, prior to the acquisition, Bioenvision had been marketing the product under the brand name Evoltra, also for the treatment of relapsed and refractory pediatric ALL patients. We are developing clofarabine for diseases with significantly larger patient populations, including use as a first-line therapy for the treatment of adult AML. Clofarabine has been granted orphan drug status for the treatment of ALL and AML in both the United States and European Union.

STRATEGIC TRANSACTIONTRANSACTIONS

Collaboration with PTC

        On July 15, 2008, we entered into a collaboration agreement with PTC to develop and commercialize PTC124, PTC's novel oral therapy in late-stage development for the treatment of nonsense-mutation-mediated DMD and nonsense-mutation-mediated CF. Under the terms of the agreement, PTC will commercialize PTC124 in the United States and Canada, and we will commercialize the treatment in all other countries. In connection with the collaboration agreement, we paid PTC a nonrefundable upfront payment of $100.0 million, which we recorded as a charge to research and development in our consolidated statements of operations in July 2008. We classify nonrefundable fees paid outside of a business combination for the acquisition or licensing of products that have not received regulatory approval and have no future alternative use as research and development expense. PTC will conduct and be responsible for the phase 2b trial of PTC124 in DMD, the phase 2b trial in CF and two proof-of-concept studies in other indications to be determined. Once these four studies have been completed, we and PTC will share research and development costs for


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PTC124 equally. We and PTC will each bear the sales and marketing and other costs associated with the commercialization of PTC124 in our respective territories. PTC is eligible to receive up to $337.0 million in milestone payments as follows:

PTC is also eligible to receive tiered, double-digit royalties from sales of PTC124 outside of the United States and Canada.

Strategic Alliance with Isis

        On January 7, 2008, we entered into a strategic alliance with Isis, whereby we obtained an exclusive license to develop and commercialize mipomersen, a lipid-lowering drug targeting apolipoprotein B-100, for the treatment of FH, an inherited disorder that causes exceptionally high levels of LDL-cholesterol. In February 2008, we paidmade a nonrefundable payment to Isis of $150.0 million, to purchase five million shares of Isis common stock for $30 per share, consisting of $69.9 million for the premium we paid to purchase the stock, which was charged to research and development expenses in our consolidated statements of operations, and $80.1 million for the fair value of the stock, which was recorded as an increase to investment in equity securities in our consolidated balance sheet.sheets based on the fair value of the five million shares of Isis common stock we acquired in connection with the transaction and the remaining $69.9 million was allocated to the mipomersen license, which had not reached technological feasibility and did not have alternative future use. We are workingrecorded the $69.9 million license fee as a charge to research and development expense in our consolidated statements of operations in the first quarter of 2008. We classify nonrefundable fees paid outside of a business combination for the acquisition or licensing of products that have not received regulatory approval and have no future alternative use as research and development expense.

        In June 2008, we finalized the terms of our license and collaboration agreement with Isis to finalize the contracts underand paid Isis an additional $175.0 million upfront nonrefundable license fee, which we recorded as a charge to research and development expense in our consolidated statements of operations in June 2008. Under the terms of the agreement, Isis will developcontribute up to the first $125.0 million in funding for the development of mipomersen and, commercialize mipomersen.thereafter, we and Isis will share development costs for mipomersen equally. The initial funding commitment by Isis and shared development funding will end when the mipomersen program is profitable. In the event the research and development of mipomersen is terminated prior to Isis completing their funding obligation, we are not entitled to any refund of our $175.0 million upfront payment. Accordingly, the $175.0 million was recorded as research and development expense in June 2008. Isis is eligible to receive up to $750.0 million in commercial milestone payments and up to $825.0 million in development and regulatory milestone payments.


        We will be responsible for funding sales and marketing expenses until mipomersen revenues are sufficient to cover such costs. Profits on mipomersen initially will be allocated 70% to us and 30% to Isis. The profit ratio will be adjusted on a sliding scale as annual revenues for mipomersen ramp up to $2.0 billion, at which point we will share profits equally with Isis. The results of our mipomersen program will be included in the results of our cardiovascular business unit, which are reported under the caption "Other" in our segment disclosures.

CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES

        Our critical accounting policies and significant judgments and estimates are set forth under the heading "Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates" in Exhibit 13 to our 2007 Form 10-K. Additional information regarding significant judgments and estimates related to sales reserves are included below. There have been no significant changes to our critical accounting policies or significant judgments and estimates since December 31, 2007. Additional


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information regarding our provisions and estimates for our product sales allowances, sales allowance reserves and accruals, and distributor fees, and the key assumptions we use to determine the fair value assigned to in-process research and development 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. 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: