EX-13 3 a2182799zex-13.htm EXHIBIT 13

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EXHIBIT 13


EXHIBIT 13


GENZYME CORPORATION AND SUBSIDIARIES
FINANCIAL STATEMENTS

 
  Page No.
Consolidated Selected Financial Data   F-2

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

 

F-6

Report of Independent Registered Public Accounting Firm

 

F-65

Consolidated Statements of Operations and Comprehensive Income for the Years Ended December 31, 2007, 2006 and 2005

 

F-67

Consolidated Balance Sheets as of December 31, 2007 and 2006

 

F-68

Consolidated Statements of Cash Flows for the Years Ended December 31, 2007, 2006
and 2005

 

F-69

Consolidated Statements of Stockholders' Equity for the Years Ended December 31, 2007, 2006 and 2005

 

F-71

Notes to Consolidated Financial Statements

 

F-73

F-1



GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Selected Financial Data

        The following financial data should be read in conjunction with our audited, consolidated financial statements and related notes contained elsewhere in this Annual Report on Form 10-K. These selected financial data may not be indicative of our future financial condition due to the risks and uncertainties associated with operating our business, including those described under the caption "Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations—Risk Factors" included in this Annual Report on Form 10-K.

CONSOLIDATED STATEMENTS OF OPERATIONS DATA

 
  For the Years Ended December 31,
 
 
  2007
  2006
  2005
  2004
  2003
 
 
  (Amounts in thousands)

 
Revenues:                                
  Net product sales   $ 3,457,778   $ 2,887,409   $ 2,453,303   $ 1,976,191   $ 1,563,509  
  Net service sales     326,326     282,118     261,379     212,392     130,984  
  Research and development revenue     29,415     17,486     20,160     12,562     19,378  
   
 
 
 
 
 
    Total revenues     3,813,519     3,187,013     2,734,842     2,201,145     1,713,871  
   
 
 
 
 
 
Operating costs and expenses:                                
  Cost of products sold(1,2)     715,504     536,388     462,177     448,442     399,961  
  Cost of services sold(1)     211,826     199,283     170,475     140,144     75,683  
  Selling, general and administrative(1,3)     1,187,184     1,010,400     787,839     599,388     519,977  
  Research and development(1,4)     737,685     649,951     502,657     391,802     335,256  
  Amortization of intangibles     201,105     209,355     181,632     109,473     80,257  
  Purchase of in-process research and development(5)     106,350     552,900     29,200     254,520     158,000  
  Charges for impaired goodwill(6)         219,245             102,792  
  Charges for impaired assets                 4,463     10,894  
   
 
 
 
 
 
    Total operating costs and expenses     3,159,654     3,377,522     2,133,980     1,948,232     1,682,820  
   
 
 
 
 
 
Operating income (loss)     653,865     (190,509 )   600,862     252,913     31,051  
   
 
 
 
 
 
Other income (expenses):                                
  Equity in income (loss) of equity method investments(7)     7,398     15,705     151     (15,624 )   (16,743 )
  Minority interest     3,932     10,418     11,952     5,999     2,232  
  Gains (losses) on investments in equity securities, net(8)     13,067     73,230     5,698     (1,252 )   (1,201 )
  Loss on sale of product line(9)                     (27,658 )
  Other     (637 )   (2,045 )   (1,535 )   (357 )   959  
  Investment income     70,196     56,001     31,429     24,244     43,015  
  Interest expense     (12,147 )   (15,478 )   (19,638 )   (38,227 )   (26,600 )
   
 
 
 
 
 
    Total other income (expenses)     81,809     137,831     28,057     (25,217 )   (25,996 )
   
 
 
 
 
 
Income (loss) before income taxes(1)     735,674     (52,678 )   628,919     227,696     5,055  
(Provision for) benefit from income taxes(1,6)     (255,481 )   35,881     (187,430 )   (141,169 )   (72,647 )
   
 
 
 
 
 
Net income (loss)(1)   $ 480,193   $ (16,797 ) $ 441,489   $ 86,527   $ (67,592 )
   
 
 
 
 
 

F-2


GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Selected Financial Data (Continued)

CONSOLIDATED STATEMENTS OF OPERATIONS DATA (Continued)

 
  For the Years Ended December 31,
 
 
  2007
  2006
  2005
  2004
  2003
 
 
  (Amounts in thousands, except per share amounts)

 
Net income (loss) per share:                                
Allocated to Genzyme Stock(10):                                
Net income (loss) allocated to Genzyme Stock   $ 480,193   $ (16,797 ) $ 441,489   $ 86,527   $ 94,283  
   
 
 
 
 
 
Net income (loss) per share of Genzyme Stock:                                
  Basic(1)   $ 1.82   $ (0.06 ) $ 1.73   $ 0.38   $ 0.43  
   
 
 
 
 
 
  Diluted(1)   $ 1.74   $ (0.06 ) $ 1.65   $ 0.37   $ 0.42  
   
 
 
 
 
 
Allocated to Biosurgery Stock(10):                                
Net loss allocated to Biosurgery Stock                           $ (152,651 )
                           
 
Net loss per share of Biosurgery Stock—basic and diluted                           $ (3.76 )
                           
 
Weighted average shares outstanding                             40,630  
                           
 
Allocated to Molecular Oncology Stock(10):                                
Net loss allocated to Molecular Oncology Stock                           $ (9,224 )
                           
 
Net loss per share of Molecular Oncology Stock—basic and diluted                           $ (0.54 )
                           
 
Weighted average shares outstanding                             16,958  
                           
 

F-3


GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Selected Financial Data (Continued)

CONSOLIDATED BALANCE SHEET DATA

 
  December 31,
 
  2007
  2006
  2005
  2004
  2003
 
  (Amounts in thousands)

Cash and investments(11)   $ 1,460,394   $ 1,285,604   $ 1,089,102   $ 1,079,454   $ 1,227,460
Working capital     1,106,791     1,338,062     1,114,976     1,009,231     930,951
Total assets     8,301,741     7,191,188     6,878,865     6,069,421     5,004,528
Long-term debt, capital lease obligations and convertible debt, including current portion     810,373     816,029     820,113     940,494     1,435,759
Stockholders' equity     6,612,937     5,660,711     5,149,867     4,380,156     2,936,412

There were no cash dividends paid.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1)
Effective January 1, 2006, we adopted the provisions of FAS 123R, "Share-Based Payment, an amendment of FASB Statement Nos. 123 and 95." For the years ended December 31, 2007 and 2006, we recorded pre-tax stock-based compensation expense, which was allocated based on the functional cost center of each employee as follows (amounts in thousands, except per share amounts):

 
  For the Years Ended December 31,
 
 
  2007
  2006
 
Cost of products and services sold   $ (25,677 ) $ (21,430 )
Selling, general and administrative     (106,172 )   (121,822 )
Research and development     (58,101 )   (65,248 )
   
 
 
  Total     (189,950 )   (208,500 )
Less: tax benefit of stock options     58,148     66,331  
   
 
 
Stock-based compensation expense, net of tax   $ (131,802 ) $ (142,169 )
   
 
 
Net loss per share—basic and diluted   $ (0.50 ) $ (0.54 )
   
 
 
(2)
Includes a charge of $20.9 million recorded in 2007 to write off finished lots and record reserves against other lots of our Thymoglobulin inventory which did not meet our specifications for saleable product.

(3)
Includes a charge of $64.0 million recorded in 2007 to settle the litigation related to the consolidation of our former tracking stocks.

(4)
Includes a charge of $25.0 million recorded in 2007 for an upfront milestone payment paid to Ceregene Inc. for the development and commercialization of CERE-120, a gene therapy product candidate.

(5)
Includes charges for pre-tax IPR&D incurred in connection with the following acquisitions:

2007—Bioenvision;

2006—AnorMED;

2005—Avigen, Inc., or Avigen, Bone Care and Verigen;

F-4


GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Selected Financial Data (Continued)

    2004—ILEX Oncology Inc., or ILEX Oncology; and

    2003—SangStat.

(6)
Charges for impaired goodwill includes the following charges recorded in accordance with FAS 142, "Goodwill and Other Intangible Assets":

2006—a $219.2 million pre-tax impairment charge and $69.8 million of related tax benefits to write off the goodwill of our Genetics reporting unit; and

2003—a $102.8 million charge to write off the goodwill associated with our orthopaedics business unit.

(7)
For 2007, includes a charge of $19.1 million related to the completion of the first step of the two step acquisition process under which we acquired Bioenvision.

(8)
For 2007, includes a pre-tax gain of $10.8 million recorded on the sale of our entire investment in the common stock of Therapeutic Human Polyclonals Inc., or THP. For 2006, includes a $69.4 million gain on the sale of our entire investment in Cambridge Antibody Technology Group plc, or CAT.

(9)
Reflects a loss of $27.7 million related to the sale of substantially all of the tangible and intangible assets directly associated with our cardiac device business to Teleflex Inc in 2003.

(10)
Through June 30, 2003, we had three outstanding series of common stock—Genzyme General Stock, Genzyme Biosurgery Stock and Genzyme Molecular Oncology Stock, which we refer to as "tracking stock." Effective July 1, 2003, we eliminated our tracking stock capital structure and, as a result, ceased allocating earnings to Biosurgery Stock and Molecular Oncology Stock. Effective July 1, 2003, we have one outstanding series of common stock, which we refer to as Genzyme Stock, and as of that date, all of our earnings are allocated to Genzyme Stock.

(11)
Includes cash, cash equivalents, and short- and long-term investments in debt securities.

F-5



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 "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:

    Renal, which develops, manufactures and distributes products that treat patients suffering from renal diseases, including chronic renal failure. The unit derives substantially all of its revenue from sales of Renagel (including sales of bulk sevelamer) and Hectorol;

    Therapeutics, which develops, manufactures and distributes therapeutic products, with an expanding focus on products to treat patients suffering from genetic diseases and other chronic debilitating diseases, including a family of diseases known as LSDs, and other specialty therapeutics, such as Thyrogen. The unit derives substantially all of its revenue from sales of Cerezyme, Fabrazyme, Myozyme and Thyrogen;

    Transplant, which develops, manufactures and distributes therapeutic products that address pre-transplantation, prevention and treatment of graft rejection in organ transplantation and other hematologic and auto-immune disorders. The unit derives substantially all of its revenue from sales of Thymoglobulin;

    Biosurgery, which develops, manufactures and distributes biotherapeutics and biomaterial-based products, with an emphasis on products that meet medical needs in the orthopaedics and broader surgical areas. The unit derives substantially all of its revenue from sales of Synvisc, the Sepra line of products, Carticel and MACI;

    Genetics, which provides testing services for the oncology, prenatal and reproductive markets; and

    Oncology, which develops, manufactures and distributes products for the treatment of cancer, with a focus on antibody- and small molecule-based therapies. The unit derives substantially all of its revenue from sales and royalties received on sales of Campath and Clolar and from the reimbursement of Campath development expenses.

        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."

F-6


MERGERS AND ACQUISITIONS

2007 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 its diagnostics operations in Prince Edward Island, Canada and Connecticut. We paid gross consideration of $53.3 million Canadian dollars, or $53.8 million U.S. dollars (based on the December 3, 2007 spot rate for the Canadian dollar), in cash. We closed the transaction on December 3, 2007.

Bioenvision

        On May 29, 2007, we entered into an agreement and plan of merger with Bioenvision, a publicly-traded biopharmaceutical company based in New York City and Edinburgh, Scotland, and Wichita Bio Corporation, one of our wholly-owned subsidiaries, to acquire Bioenvision in an all-cash transaction valued at $11.20 per outstanding share of Bioenvision Series A Preferred Stock (plus accrued but unpaid dividends) and $5.60 per outstanding share of Bioenvision Common Stock. 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. Effective October 23, 2007, we completed the 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.

        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. We currently market clofarabine in the United States and Canada under the brand name Clolar for relapsed and refractory pediatric acute lymphoblastic leukemia, or ALL, patients. In Europe, we co-developed clofarabine with Bioenvision and Bioenvision has 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 acute myeloid leukemia, or AML. Clofarabine has been granted orphan drug status for ALL and AML in both the United States and European Union.

    Tender Offer—Step One

        On July 10, 2007, we completed the tender offer and purchased 2,250,000 shares of Bioenvision Series A Preferred Stock for $25.2 million, which we recorded as a component of investments in equity securities, and 8,398,098 shares of Bioenvision Common Stock for $47.0 million, which we recorded as a component of other noncurrent assets in our consolidated balance sheet. As a result of the tender offer, we acquired approximately 22% of the then outstanding shares of Bioenvision Common Stock on an as-converted basis, including 100% of the outstanding Bioenvision Series A Preferred Stock.

        We accounted for our investment in Bioenvision Common Stock under the equity method of accounting from July 10, 2007 through October 22, 2007. We recorded our initial $47.0 million investment in Bioenvision Common Stock as a single amount in other noncurrent assets in our consolidated balance sheet. The purchase price of our initial investment in Bioenvision Common Stock

F-7



was attributed to the fair value of our 15% proportional share of the tangible assets and liabilities of Bioenvision as of July 10, 2007. The excess of the purchase price over our proportional share of the net assets of Bioenvision as of that date was attributed to the underlying intangible assets and IPR&D, net of tax, and goodwill. The following table sets forth the purchase price allocation for our initial investment in Bioenvision Common Stock and the components of the $21.1 million of charges we recorded to equity in income of equity method investments for the period from July 10, 2007 through October 22, 2007 related to our initial investment in Bioenvision Common Stock (amounts in thousands):

 
  Investment in
Bioenvision
Common
Stock

  Equity in
Income (Loss) of
Equity Method
Investments

 
Our 15% proportional share of the tangible assets and liabilities of Bioenvision   $ 7,062   $  
Goodwill     4,008      
Other intangible assets     26,531      
IPR&D     19,150      
Deferred tax liabilities     (9,722 )    
   
 
 
Initial investment in Bioenvision Common Stock     47,029      
Effect of equity method of accounting:              
  IPR&D     (19,150 )   (19,150 )
  Our 15% proportional share of the losses of Bioenvision(1)     (1,424 )   (1,424 )
  Amortization expense(1)     (829 )   (829 )
  Deferred tax benefits(1)     302     302  
   
 
 
Total   $ 25,928   $ (21,101 )
   
 
 

(1)
Represents charges for the period from July 10, 2007 through October 22, 2007.

    The Merger—Step Two

        On October 22, 2007, holders of a majority of the issued and outstanding shares of Bioenvision Common Stock and Bioenvision Series A Preferred Stock, voting together as a single class on an as-converted basis, approved the merger. On October 23, 2007, we paid approximately $245 million in cash consideration to the former Bioenvision stockholders and Bioenvision Common Stock ceased trading and was delisted from The Nasdaq Stock Market, Inc., or NASDAQ. In December 2007, we paid approximately $12 million in cash for the outstanding options to purchase shares of Bioenvision Common Stock. We accounted for the acquisition as a business combination and, accordingly, included its results of operations in our consolidated statements of operations from October 23, 2007, the date of acquisition.

2006 Acquisition:

    AnorMED

        In November 2006, we acquired AnorMED, a publicly-traded chemical-based biopharmaceutical company based in Langley, British Columbia, Canada with a focus on the discovery, development and commercialization of new therapeutic products in the area of hematology, oncology and human immunodeficiency virus, or HIV. We paid gross consideration of $589.2 million in cash, including $584.2 million for the shares of AnorMED's common stock outstanding on the date of acquisition and approximately $5 million for acquisition costs. Net consideration was $569.0 million as we acquired AnorMED's cash and short-term investments totaling $20.2 million. As part of the transaction, we acquired Mozobil, a late-stage product candidate in development for hematopoietic stem cell

F-8


transplantation, which we have added to our Transplant business. Multiple earlier studies showed that Mozobil rapidly increases the number of stem cells that move out of the bone marrow and into a patient's blood, which is an important step in preparing a patient for a stem cell transplant.

2005 Acquisitions:

    On July 1, 2005, we acquired Bone Care, a publicly-traded specialty pharmaceutical company based in Middleton, Wisconsin with a focus on nephrology. As part of the transaction, we acquired Hectorol, a line of vitamin D2 pro-hormone products used to treat secondary hyperparathyroidism in patients on dialysis and those with earlier stage CKD, which product we have added to our Renal business.

    Other 2005 acquisitions:

    On July 15, 2005, we acquired Equal Diagnostics, a privately-held diagnostics company based in Exton, Pennsylvania that formerly served as a distributor for our clinical chemistry reagents.

    On February 8, 2005, we acquired Verigen, a private company based in Leverkusen, Germany with a proprietary cell therapy product for cartilage repair (referred to as MACI) that is currently sold in Europe and Australia.

CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES

        The significant accounting policies and methods used in the preparation of our consolidated financial statements are described in Note A., "Summary of Significant Accounting Policies." The preparation of consolidated financial statements under accounting principles generally accepted in the United States of America requires us to make certain estimates and judgments that affect reported amounts of assets, liabilities, revenues, expenses, and disclosure of contingent assets and liabilities in our financial statements. Our actual results could differ from these estimates under different assumptions and conditions. We believe that the following critical accounting policies affect the more significant judgments and estimates used in the preparation of our consolidated financial statements:

    Revenue Recognition;

    Stock-Based Compensation;

    Income Taxes;

    Inventories;

    Long-Lived and Intangible Assets;

    Asset Impairments;

    IPR&D; and

    Investments in Marketable Securities and Equity Investments

Revenue Recognition

Product Sales

        The timing of product shipments and receipts by the customer can have a significant impact on the amount of revenue recognized in a particular period. A significant portion of our products are sold at least in part through wholesalers and specialty distributors, along with direct sales to hospitals, homecare providers, government agencies and physicians. Consequently, our net sales and quarterly growth comparisons may be affected by fluctuations in the buying patterns of our major distributors and other trade buyers, which may result from seasonality, pricing, wholesaler buying decisions or other factors. Inventory in the distribution channel consists of inventory held by wholesalers and specialty

F-9



distributors, who are our customers, and inventory held by their retail customers, such as pharmacies and hospitals. Our revenue in a particular period can be impacted by increases or decreases in channel inventories. Significant increases in wholesaler or retail inventories could result in reduced purchases in subsequent periods, or product returns from the distribution channel due to overstocking, low end-user demand or product expiration.

        We use a variety of data sources to determine the amount of inventory in the distribution channel. For most product lines, we receive data on sales and inventory levels directly from our primary customers. For key product lines in our Renal and Therapeutics areas, our data sources also include prescription and wholesaler data purchased from external data providers. As part of our efforts to limit the amount of Renal and Therapeutics inventory held by distributors and to gain improved visibility into the distribution channel, we have executed agreements to limit the amounts of inventory they carry and to provide us ongoing reports to verify distributor inventory levels and sales data.

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:

    Contractual adjustments—We offer chargebacks and contractual discounts and rebates, which we collectively refer to as contractual adjustments, to certain private institutions and various government agencies in both the United States and international markets. We record chargebacks and contractual discounts as allowances against accounts receivable in our consolidated balance sheets. We account for rebates by establishing an accrual for the amounts payable by us to these agencies and institutions, which is included in accrued liabilities in our consolidated balance sheets. We estimate the allowances and accruals for our contractual adjustments based on historical experience and current contract prices, using both internal data as well as information obtained from external sources, such as independent market research agencies and data from wholesalers. We continually monitor the adequacy of these estimates and adjust the allowances and accruals periodically throughout each quarter to reflect our actual experience. In evaluating these allowances and accruals, we consider several factors, including significant changes in the sales performance of our products subject to contractual adjustments, inventory in the distribution channel, changes in U.S. and foreign healthcare legislation impacting rebate or allowance rates, changes in contractual discount rates and the estimated lag time between a sale and payment of the corresponding rebate;

    Discounts—In some countries, we offer cash discounts for certain products as an incentive for prompt payment, which are generally a stated percentage off the sales price. We account for cash discounts by reducing accounts receivable by the full amounts of the discounts. We consider payment performance and adjust the accrual to reflect actual experience; and

    Sales returns—We record allowances for product returns at the time product sales are recorded. The product returns reserve is estimated based on the returns policies for our individual products and our experience of returns for each of our products. If the price of a product

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      changes or if the history of product returns changes, the reserve is adjusted accordingly. We determine our estimates of the sales return accrual for new products primarily based on the historical sales returns experience of similar products, or those within the same or similar therapeutic category.

Our provisions for product sales allowances reduced gross product sales as follows:

 
  2007
  2006
  2005
  07/06 Increase/ (Decrease) % Change
  06/05 Increase/ (Decrease) % Change
 
 
  (Amounts in thousands)

   
   
 
Product sales allowances:                            
  Contractual adjustments   $ 377,418   $ 298,274   $ 169,181   27 % 76 %
  Discounts     20,037     17,541     14,098   14 % 24 %
  Sales returns     15,342     13,853     7,227   11 % 92 %
   
 
 
         
    Total product sales allowances   $ 412,797   $ 329,668   $ 190,506   25 % 73 %
   
 
 
         
Total gross product sales   $ 3,870,575   $ 3,217,077   $ 2,643,809   20 % 22 %
   
 
 
         
Total product sales allowances as a percent of total gross product sales     11 %   10 %   7 %        

        Product sales allowances for contractual adjustments and discounts increased for the year ended December 31, 2007, as compared to the same period of 2006, primarily due to an increase in overall gross product sales, and to a lesser extent, changes in rebate rates or product mix. Product sales allowances for contractual adjustments and discounts increased for the year ended December 31, 2006, as compared to the same period of 2005, primarily due to growth in overall gross product sales and a full year of discounts related to sales of Hectorol, which we acquired as a result of our acquisition of Bone Care in July 2005. In addition, Hectorol chargebacks in 2006 were significantly higher than chargebacks for the product in 2005, and were offset, in part, by contracts executed with major customers.

        Total estimated product sales allowance reserves and accruals in our consolidated balance sheets increased 31% to approximately $171 million as of December 31, 2007, as compared to approximately $129 million as of December 31, 2006, primarily due to increased product sales. Our actual results have not differed materially from amounts recorded. The annual variation has been less than 0.5% of total product sales for each of the last three years.

Distributor Fees

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

    the vendor receives, or will receive, an identifiable benefit (goods or services) in exchange for the consideration; and

    the vendor can reasonably estimate the fair value of the benefit received.

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

 
  Year Ended December 31,
 
  2007
  2006
  2005
 
  (Amounts in thousands)

Distributor fees:                  
  Included in contractual adjustments and recorded as a reduction to product sales   $ 12,445   $ 8,956   $ 325
  Charged to SG&A     13,190     10,550     14,504
   
 
 
    Total distributor fees   $ 25,635   $ 19,506   $ 14,829
   
 
 

Collaborations

        We evaluate revenue from agreements that have multiple elements to determine whether the components of the arrangement represent separate units of accounting as defined in EITF Issue No. 00-21, "Revenue Arrangements with Multiple Deliverables." To recognize revenue for a delivered item in a multiple element arrangement, EITF Issue No. 00-21 requires that:

    the delivered items have value to the customer on a stand-alone basis;

    there is objective and reliable evidence of fair value of the undelivered items; and

    delivery or performance is probable and within our control for any delivered items that have a right of return.

The determination that multiple elements in an arrangement meet the criteria for separate units of accounting requires us to exercise our judgment.

        We consider the factors or indicators set forth in EITF Issue No. 99-19, "Reporting Revenue Gross as a Principal versus Net as an Agent," in deciding whether to record revenue on a gross or net basis. The determination of whether we should recognize revenue on a gross or net basis involves judgment based on the relevant facts and circumstances which relate primarily to whether we act as a principal or agent in the process of generating revenues for the revenue transactions.

Stock-Based Compensation

        Effective January 1, 2006, we adopted the provisions of FAS 123R, "Share-Based Payment, an amendment of FASB Statement Nos. 123 and 95," which requires us to recognize stock-based compensation expense in our financial statements for all share-based payment awards, including stock options and restricted stock units, or RSUs, made to employees and directors based upon the grant date fair value of those awards.

        We adopted FAS 123R using the modified prospective transition method, which requires us to apply the standard to new equity awards and to equity awards modified, repurchased or canceled after January 1, 2006, our adoption date. The modified prospective transition method does not allow for the restatement of prior periods. Accordingly, our results of operations for the year ended December 31, 2006 and future periods will not be comparable to our results of operations prior to January 1, 2006 because our historical results prior to that date do not reflect the impact of expensing the fair value of share-based payment awards.

        We estimate the fair value of each stock option grant using the Black-Scholes option pricing model. Use of a valuation model requires management to make certain assumptions with respect to selected model inputs. The key assumptions in the Black-Scholes model are the risk-free interest rate, the dividend yield, the expected option life (in years) and the expected volatility of the price of

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Genzyme Stock. The risk-free interest rate is based on the U.S. Treasury yield curve in effect on the date of grant. The dividend yield percentage is zero because we do not currently pay dividends nor intend to do so during the expected option life. We use historical data on exercises of our stock options and other factors to estimate the expected option life (in years), or term, of the share-based payments granted. We estimate the expected volatility rate for our stock options based on historical volatility of our stock over the expected term of the equity award granted. We determine separate volatility rates for each enrollment under our ESPP based on the period from the commencement date of each enrollment to each applicable purchase date. Changes in these input variables would affect the amount of expense associated with stock-based compensation. The compensation expense recognized for all share-based awards is net of estimated forfeitures. We estimate forfeiture rates based on historical analysis of option forfeitures. If actual forfeitures should vary from estimated forfeitures, adjustments to stock-based compensation expense may be required in future periods.

Income Taxes

        We use the asset and liability method of accounting for deferred income taxes. We are subject to income taxes in both the United States and numerous foreign jurisdictions; however, our most significant tax jurisdictions are the U.S. federal and states. Significant judgments, estimates and assumptions regarding future events, such as the amount, timing and character of income, deductions and tax credits, are required in the determination of our provision for income taxes and whether valuation allowances are required against deferred tax assets. These judgments, estimates and assumptions involve:

    interpreting the tax laws in various jurisdictions in which we operate;

    analyzing changes in tax laws, regulations, and treaties, foreign currency exchange restrictions; and

    estimating our levels of income, expenses and profits in each jurisdiction and the potential impact of that income on the tax liability in any given year.

        We operate in many jurisdictions where the tax laws relating to the pricing of transactions between related parties are open to interpretation, which could potentially result in tax authorities asserting additional tax liabilities with no offsetting tax recovery in other countries.

        Uncertainties exist with respect to the interpretation of complex tax regulations and the amount and timing of future taxable income. Given the wide range of international business relationships and the long-term nature and complexity of existing contractual agreements, differences arising between the actual results and the assumptions made, or future changes to such assumptions, could necessitate adjustments to tax income and expense in future periods. We establish what we believe to be reasonable provisions for possible consequences of audits by the tax authorities of the respective countries. The amount of such provisions is based on various factors, such as experience with previous tax audits and differing interpretations of tax regulations by the taxable entity and the responsible tax authority. Such differences in interpretation may arise on a wide variety of issues depending on the conditions prevailing in the respective domicile. We develop our cumulative probability assessment of the measurement of uncertain tax positions under FASB Interpretation No., or FIN, 48 "Accounting for Uncertainty in Income Taxes—an Interpretation of FASB Statement No. 109," using internal expertise, experience and judgment. Estimates are refined as additional information becomes known. Any outcome upon settlement that differs from our initial estimate may result in additional or lower tax expense in future periods. However, we do not believe it is possible to reasonably estimate the potential impact of changes to the assumptions, estimates and judgments identified because the resulting change to our tax liability, if any, is dependent on numerous factors, including among others: changes in tax law, the amount and nature of additional taxes potentially asserted by local tax authorities; the willingness of local tax authorities to negotiate a fair settlement through an

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administrative process; the impartiality of the local courts; and the potential for changes in the tax paid to one country to either produce, or fail to produce, an offsetting tax change in other countries.

        In accordance with FIN 48, adopted on January 1, 2007, we apply a two-step approach to recognize and measure uncertain tax positions (tax contingencies) accounted for under FAS No. 109. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount which is more than 50% likely to be realized upon ultimate settlement. We consider many factors, including the factors described above, when evaluating and estimating our tax positions and tax benefits, which requires periodic adjustments and may not accurately forecast actual outcomes.

Inventories

        We value inventories at cost or, if lower, fair value. We determine cost using the first-in, first-out method. We analyze our inventory levels quarterly and write down inventory, as a charge to cost of sales that has become obsolete due to anticipated product expiration, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. Expired inventory is disposed of and the related costs are written off. If actual market conditions are less favorable than those projected by management, additional inventory write-downs may be required.

        We capitalize inventory produced for commercial sale, which may result in the capitalization of inventory prior to regulatory approval of a product. In no event is inventory capitalized prior to the completion of a phase 3 clinical trial. If a product is not approved for sale, it would result in the write off of the inventory and a charge to earnings. Our inventories as of December 31, 2007 and 2006 do not include any inventory for products that have not yet been approved for sale.

        We periodically review our inventories for excess or obsolete inventory and write down obsolete or otherwise unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than the value we estimate, or if there are any further determinations that inventory will not be marketable based on estimates of demand, additional inventory write downs will be required. Additionally, our products are subject to strict quality control and monitoring throughout the manufacturing process. Periodically, certain lots of inventory may fail to meet our quality specifications during the manufacturing process or prior to sale, or may expire. For such lots, we consider the factors affecting the decline in quality of the lot and assess the likelihood that the lot can be reworked into saleable product, or whether the lot is unmarketable. We record a charge to cost of products sold in our consolidated statement of operations to write off the value of any unmarketable inventory in the period in which we determine that the product no longer meets our criteria for saleable product. The determination of what factors may cause a lot to fail to meet our quality standards, the assessment of whether we can rework the lot within the scope of the approved manufacturing process for the product and the likelihood that we can complete such rework in a timely fashion involve judgments that can affect the amount and timing of the charges we record to write off the value of unmarketable inventory.

Long-Lived and Intangible Assets

Property, Plant and Equipment

        As of December 31, 2007, there was $2.0 billion of net property, plant and equipment on our consolidated balance sheet. We generally depreciate property, plant and equipment using the straight-line method over its estimated economic life, which ranges from 3 to 40 years. Determining the economic lives of property, plant and equipment requires us to make significant judgments that can

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materially impact our operating results. There can be no assurance that our estimates are accurate. If our estimates require adjustment, it could have a material impact on our reported results.

        In the ordinary course of our business, we incur substantial costs to purchase and construct property, plant and equipment. The treatment of costs to purchase or construct these assets depends on the nature of the costs and the stage of construction. Costs incurred in the initial design and evaluation phase, such as the cost of performing feasibility studies and evaluating alternatives, are charged to expense. Qualifying costs incurred in the committed project planning and design phase, and in the construction and installation phase, are capitalized as part of the cost of the asset. We stop capitalizing costs when an asset is substantially complete and ready for its intended use. Determining the appropriate period during which to capitalize costs, and assessing whether particular costs qualify for capitalization, requires us to make significant judgments. These judgments can have a material impact on our reported results.

        Equipment and facilities used to manufacture products subject to FDA or other governmental regulation are required to comply with standards of those regulatory agencies. The activities necessary to obtain approval from these regulatory agencies are referred to as validation costs. We capitalize the cost of validating new equipment and facilities for the underlying manufacturing process. We begin capitalization when we consider the product and manufacturing process to have demonstrated technological feasibility, and end capitalization when the asset is substantially complete and ready for its intended use. Costs capitalized include incremental labor and direct material, and incremental fixed overhead. Determining whether to capitalize validation costs requires judgment, and can have a significant impact on our reported results. Also, if we were unable to successfully validate the manufacturing process for any future product, we would have to write off to current operating expense any validation costs that had been capitalized during the unsuccessful validation process. Costs to initiate new projects in an existing facility are treated as start-up costs and expensed as incurred. To date, all of our manufacturing process validation efforts have been successful. As of December 31, 2007, capitalized validation costs, net of accumulated depreciation, were $15.5 million.

Goodwill and Other Intangible Assets

        As of December 31, 2007, there was approximately $1.4 billion of goodwill and $1.6 billion of net other intangible assets on our consolidated balance sheet. We amortize intangible assets using the straight-line method over their estimated economic lives, which range from 1 and 15 years, or using the economic use method if that method results in significantly greater amortization than the straight-line method. Determining the economic lives of acquired intangible assets requires us to make significant judgment and estimates, and can materially impact our operating results. For certain acquired intangible assets, we may be required to make additional payments contingent upon meeting certain sales targets. We record amortization expense for these intangibles based on estimated future sales of the related products and include in the determination of amortization all contingent payments that we believe are probable of being made. We apply this amortization model to our Synvisc distribution rights (acquired from Wyeth) and our license agreement with Synpac related to Myozyme patents. We review the sales forecasts of these products on a quarterly basis and assess the impact changes in the forecasts have on the rate of amortization and the likelihood that contingent payments will be made. Adjustments to amortization expense resulting from changes in estimated sales are reflected prospectively.

Asset Impairments

Impairment of Goodwill

        FAS 142 requires periodic tests of goodwill for impairment and that other intangible assets be amortized over their useful lives unless these lives are determined to be indefinite. FAS 142 requires goodwill be tested using a two-step process. The first step compares the fair value of the reporting unit

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with the unit's carrying value, including goodwill. When the carrying value of the reporting unit is greater than fair value, the unit's goodwill may be impaired, and the second step must be completed to measure the amount of the goodwill impairment charge, if any. In the second step, the implied fair value of the reporting unit's goodwill is compared with the carrying amount of the unit's goodwill. If the carrying amount is greater than the implied fair value, the carrying value of the goodwill must be written down to its implied fair value. We determine the implied fair value by discounting, to present value, the estimated future cash flow of the reporting unit, which includes various analyses, assumptions and estimates including discount rates, projected results and estimated cash flows.

        We are required to perform impairment tests under FAS 142 annually and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. For all of our acquisitions, various analyses, assumptions and estimates were made at the time of each acquisition specifically regarding product development, market conditions and cash flows that were used to determine the valuation of goodwill and intangibles. We perform our required annual impairment tests for our goodwill in the third quarter of each year. When we perform impairment tests in future years, the possibility exists that changes in forecasts and estimates from those used at the acquisition date could result in impairment charges.

Impairment of Tangible and Intangible Assets, Other Than Goodwill

        We periodically evaluate long-lived assets for potential impairment under FAS 144, "Accounting for the Impairment or Disposal of Long-Lived Assets." We perform these evaluations whenever events or changes in circumstances suggest that the carrying value of an asset or group of assets is not recoverable. If we believe an indicator of potential impairment exists, we test to determine whether the impairment recognition criteria in FAS 144 have been met. In evaluating long-lived assets for potential impairment, we make several significant estimates and judgments, including:

    determining the appropriate grouping of assets at the lowest level for which cash flows are available;

    estimating future cash flows associated with the asset or group of assets; and

    determining an appropriate discount rate to use in the analysis.

        Use of different estimates and judgments could yield significantly different results in this analysis and could result in materially different asset impairment charges.

In-Process Research and Development

        In accounting for acquisitions, we allocate the purchase price to the fair value of the acquired tangible and intangible assets, including acquired IPR&D. This allocation requires us to make several significant judgments and estimates. For example, we generally estimate the value of acquired intangible assets and IPR&D using a discounted cash flow model, which requires us to make assumptions and estimates about, among other things:

    the time and investment that will be required to develop products and technologies;

    our ability to develop and commercialize products before our competitors develop and commercialize products for the same indications;

    the amount of revenues that will be derived from the products; and

    the appropriate discount rates to use in the analysis.

        Use of different estimates and judgments could yield materially different results in our analysis, and could result in materially different asset values and IPR&D charges.

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Investments in Debt and Equity Securities

        We invest a portion of our excess cash balances in short-term and long-term marketable debt securities. The earnings on our investment portfolios may be adversely affected by changes in interest rates, credit ratings, collateral value, the overall strength of credit markets, and other factors that may result in other than temporary declines in the value of the securities.

        We also invest in equity securities as part of our strategy to align ourselves with technologies and companies that fit with our strategic direction. Most often we will collaborate on scientific programs and research with the issuers of the securities.

        On a quarterly basis, we review the fair market value of our debt and equity investments in comparison to historical cost. If the fair market value of a security is significantly less than our carrying value, we consider all available evidence in assessing when and if the value of the investment can be expected to recover to at least its historical cost. This evidence would include:

    the extent and duration to which fair value is less than cost;

    historical operating performance and financial condition of the issuer, including industry and sector performance;

    short- and long-term prospects of the issuer and its industry;

    specific events that occurred affecting the issuer;

    overall market conditions and trends; and

    our ability and intent to retain the investment for a period of time sufficient to allow for a recovery in value.

        For equity investments, this evidence would additionally include:

    continued positive progress in the issuer's scientific and business programs;

    ongoing activity in our collaborations with the issuer; and

    a lack of any other substantial company-specific adverse events causing declines in value.

        If our review indicates that the decline in value is "other than temporary" we write down our investment to the then current market value and record an impairment charge to our consolidated statements of operations. The determination of whether an unrealized loss is "other than temporary" requires significant judgment, and can have a material impact on our reported earnings.

RESULTS OF OPERATIONS

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

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REVENUES

        The components of our total revenues are described in the following table:

 
  2007
  2006
  2005
  07/06
Increase/
(Decrease)
% Change

  06/05
Increase/
(Decrease)
% Change

 
 
  (Amounts in thousands)

   
   
 
Product revenue   $ 3,457,778   $ 2,887,409   $ 2,453,303   20 % 18 %
Service revenue     326,326     282,118     261,379   16 % 8 %
   
 
 
         
  Total product and service revenue     3,784,104     3,169,527     2,714,682   19 % 17 %
Research and development revenue     29,415     17,486     20,160   68 % (13 )%
   
 
 
         
  Total revenues   $ 3,813,519   $ 3,187,013   $ 2,734,842   20 % 17 %
   
 
 
         

Product Revenue

        We derive product revenue from sales of:

    Renal products, including Renagel for the reduction of elevated serum phosphorus levels in end-stage renal disease patients on hemodialysis, Hectorol for the treatment of secondary hyperparathyroidism in patients on dialysis and those with CKD, and bulk sevelamer;

    Therapeutics products, including Cerezyme for the treatment of Gaucher disease, Fabrazyme for the treatment of Fabry disease, Myozyme for the treatment of Pompe disease and Thyrogen, which is an adjunctive diagnostic agent used in the follow-up treatment of patients with well-differentiated thyroid cancer and an adjunctive therapy in the ablation of remnant thyroid tissue;

    Transplant products for the treatment of immune-mediated diseases, primarily Thymoglobulin, which induces immunosuppression of certain types of cells responsible for organ rejection in transplant patients;

    Biosurgery products, including orthopaedic products, such as Synvisc, and the Sepra line of products, such as Seprafilm;

    Oncology products, including Campath for the treatment of B-CLL, and Clolar for the treatment of ALL after at least two prior regimens; and

    Other products, including:

    diagnostic products, including infectious disease and cholesterol testing products; and

    bulk pharmaceuticals, including WelChol, which is a therapy for the reduction of LDL cholesterol in patients with primary hypercholesterolemia.

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        The following table sets forth our product revenue on a reporting segment basis:

 
  2007
  2006
  2005
  07/06
Increase/
(Decrease)
% Change

  06/05
Increase/
(Decrease)
% Change

 
 
  (Amounts in thousands)

   
   
 
Renal:                            
  Renagel (including sales of bulk sevelamer)   $ 602,670   $ 515,119   $ 417,485   17 % 23 %
  Hectorol     115,708     93,360     34,515   24 % >100 %
   
 
 
         
    Total Renal     718,378     608,479     452,000   18 % 35 %
   
 
 
         
Therapeutics:                            
  Cerezyme     1,133,153     1,007,036     932,322   13 % 8 %
  Fabrazyme     424,284     359,274     305,064   18 % 18 %
  Thyrogen     113,587     93,687     77,740   21 % 21 %
  Myozyme     200,728     59,238     3,827   >100 % >100 %
  Other Therapeutics     8,314     410     2,292   >100 % (82 )%
   
 
 
         
    Total Therapeutics     1,880,066     1,519,645     1,321,245   24 % 15 %
   
 
 
         
Transplant:                            
  Thymoglobulin/Lymphoglobuline     165,886     149,541     127,739   11 % 17 %
  Other Transplant     8,940     6,425     18,143   39 % (65 )%
   
 
 
         
    Total Transplant     174,826     155,966     145,882   12 % 7 %
   
 
 
         
Biosurgery:                            
  Synvisc     242,319     233,860     218,906   4 % 7 %
  Sepra products     104,318     85,338     68,171   22 % 25 %
  Other Biosurgery     34,793     28,020     27,402   24 % 2 %
   
 
 
         
    Total Biosurgery     381,430     347,218     314,479   10 % 10 %
   
 
 
         
Oncology     68,947     48,077     34,098   43 % 41 %
   
 
 
         
Other product revenue     234,131     208,024     185,599   13 % 12 %
   
 
 
         
    Total product revenue   $ 3,457,778   $ 2,887,409   $ 2,453,303   20 % 18 %
   
 
 
         

2007 As Compared to 2006

Renal

        Sales of Renagel, including sales of bulk sevelamer, increased 17% to $602.7 million for 2007, as compared to 2006. Renagel price increases in the United States in December 2006 and April 2007 accounted for $36.4 million of the additional revenue, while increased end-user demand worldwide accounted for $51.2 million of additional revenue. The strengthening of foreign currencies, primarily the Euro and British pound sterling, against the U.S. dollar in 2007, as compared to 2006, positively impacted Renagel revenue by $16.7 million. Sales of Renagel, including sales of bulk sevelamer, were 16% of our total revenue for 2007 and 2006.

        Sales of Hectorol increased 24% to $115.7 million for 2007, as compared to $93.4 million for 2006, primarily due to price increases for the 0.5 and 2.5 microgram tablets in July and December 2006 and a price increase for Hectorol IV in April 2006, as well as higher end-user demand.

        We expect sales of Renagel and Hectorol to continue to increase, driven primarily by growing patient access to these products, including through the Medicare Part D program in the United States,

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and the continued adoption of the products by nephrologists worldwide. We expect adoption rates for Renagel to trend favorably as a result of our DCOR trial and the growing acceptance of the National Kidney Foundation's 2003 Kidney Disease Outcome Quality Initiative, or KDOQI, Guidelines for Bone Metabolism and Disease in CKD and the RIND study. Renagel and Hectorol compete with several other products and our future sales may be impacted negatively by these products. In addition, a generic manufacturer has filed an Abbreviated New Drug Application (ANDA) seeking to market a generic version of Hectorol prior to the expiration dates of our patents covering the product. If this or any other generic manufacturer were to receive approval to sell a generic version of Hectorol, our revenues from this product would be adversely affected. In addition, our ability to continue to increase sales of Renagel and Hectorol will depend on many other factors, including our ability to optimize dosing and improve patient compliance with Renagel dosing, the availability of reimbursement from third-party payors and the extent of coverage, including under the Medicare Part D program. Also, the accuracy of our estimates of fluctuations in the payor mix and our ability to effectively manage wholesaler inventories and the levels of compliance with the inventory management programs we implemented for Renagel and Hectorol with our wholesalers could impact the revenue from our Renal reporting segment that we record from period to period.

        On October 22, 2007, the FDA granted marketing approval for Renvela, a second-generation buffered form of Renagel for the control of serum phosphorus in patients with CKD on dialysis. We expect to launch Renvela for dialysis patients in the United States during the first quarter of 2008 and are pursuing regulatory approvals in Europe, South America and in other markets internationally. We will continue to make Renagel available, with the long-term goal of transitioning patients to Renvela.

        In October 2007, an FDA advisory committee voted to recommend that the agency extend the indications for phosphate binders to include pre-dialysis patients with hyperphosphatemia. We are engaged in discussions with the FDA regarding the expansion of the product's labeling to include CKD patients with hyperphosphatemia who have not progressed to dialysis. In addition, we expect to file for approval of a powder form of Renvela that may make it easier for patients to comply with their prescribed treatment program. While Renagel will remain available for a period of time, our long-term goal is to transition patients to Renvela.

Therapeutics

        Therapeutics product revenue increased 24% to $1.9 billion for 2007, as compared to 2006, due to continued growth in sales of Cerezyme, Fabrazyme and Thyrogen and to the launch of Myozyme in the European Union, the United States and Canada in 2006.

        The 13% growth in sales of Cerezyme to $1.1 billion for 2007, as compared to 2006, is attributable to our continued identification of new Gaucher disease patients, particularly in international markets. Through October 2007, our price for Cerezyme remained consistent from period to period. Effective November 1, 2007, we implemented a 3% price increase in the United States for Cerezyme. Although we expect Cerezyme to continue to be a substantial contributor to revenues in the future, it is a mature product, and as a result, we do not expect that the current new patient growth trend will continue. The strengthening of foreign currencies, primarily the Euro and British pound sterling, against the U.S. dollar positively impacted Cerezyme revenue by $38.5 million in 2007, as compared to 2006.

        Our results of operations are highly dependent on sales of Cerezyme and a reduction in revenue from sales of this product would adversely affect our results of operations. Sales of Cerezyme were approximately 30% of our total revenue in 2007, as compared to 32% in 2006. Revenue from Cerezyme would be impacted negatively if competitors developed alternative treatments for Gaucher disease which gained commercial acceptance, if our marketing activities are restricted, or if coverage, pricing or reimbursement is limited.

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        The 18% increase to $424.3 million for 2007 in sales of Fabrazyme, as compared to 2006, is primarily attributable to increased patient identification worldwide as Fabrazyme is introduced into new markets. We established a 3% price increase in the United States for Fabrazyme in November 2007 which did not have a significant impact on Fabrazyme revenue in 2007 as compared to 2006. The strengthening of foreign currencies, primarily the Euro and British pound sterling, against the U.S. dollar positively impacted Fabrazyme revenue by $13.0 million in 2007, as compared to 2006.

        Sales of Thyrogen increased 21% to $113.6 million for 2007, as compared to 2006. A Thyrogen price increase of approximately 10% in the United States in April 2007 accounted for $4.3 million of the additional revenue while worldwide volume growth impacted sales by $15.6 million. The strengthening of foreign currencies, primarily the Euro and British pound sterling, against the U.S. dollar positively impacted Thyrogen revenue by $3.2 million in 2007, as compared to 2006. In December 2007 we received FDA approval for the use on Thyrogen in thyroid cancer remnant ablation procedures.

        Sales of Myozyme were $200.7 million in 2007, as compared to $59.2 million in 2006. We launched Myozyme in the United States in May 2006, in Europe a month later and in Canada in September 2006. We are introducing Myozyme on a country-by-country basis in the European Union, as pricing and reimbursement approvals are obtained. Myozyme has received orphan drug designation in the United States, which provides seven years of market exclusivity, and in the European Union, which provides ten years of market exclusivity. In April 2007, Myozyme was approved for commercial sale in Japan and in June 2007 we launched the product after we received reimbursement approval. We expect to file for approval in several additional countries in 2008. The 9% increase in the Euro against the U.S. dollar in 2007, as compared to 2006, positively impacted Myozyme revenue by $4.3 million.

        We currently manufacture Myozyme in the United States and have begun Myozyme fill-finish at our facility in Waterford, Ireland. In addition, in October 2007, we submitted an application to the FDA seeking approval of a larger-scale (2000 liters) manufacturing process, based in Allston, Massachusetts, to enable us to meet the expected demand for Myozyme in the U.S. market going forward. We currently anticipate a decision from the FDA on the application for our larger-scale manufacturing process in the first half of 2008. In the meantime, we are continuing our efforts to optimize supply for the U.S. market, including temporarily transitioning some patients to a clinical access program. This has had an adverse effect on our Myozyme revenue and will continue to have an adverse effect until we receive FDA approval. In 2008, we are planning to produce validation lots of Myozyme at the 4000 liters scale in our protein manufacturing facility in Geel, Belgium, with approval anticipated in 2009.

        Effective January 1, 2008, we, BioMarin and BioMarin/Genzyme LLC restructured our relationship regarding the manufacturing, marketing and sale of Aldurazyme and entered into several restructuring agreements. BioMarin will continue to manufacture Aldurazyme. We will continue to purchase Aldurazyme exclusively from BioMarin and globally market and sell the product. Effective January 1, 2008, instead of sharing all costs and profits of Aldurazyme equally, we will record all sales of Aldurazyme and will pay BioMarin a tiered payment ranging from approximately 39.5% to 50% of worldwide net product sales of Aldurazyme.

Transplant

        Transplant product revenue increased 12% to $174.8 million for 2007, as compared to 2006. The increase is primarily due to a $18.0 million increase in sales of Thymoglobulin as a result of its increased utilization in transplant procedures worldwide.

        In the second quarter of 2007, we began experiencing certain manufacturing challenges with respect to the production of Thymoglobulin resulting in stability issues. We have worked closely with the FDA in addressing these challenges, and have implemented certain process changes at our

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Thymoglobulin manufacturing plant in Lyon, France to resolve these production issues. The FDA has accepted our responses to a warning letter issued last year regarding the production processes at our plant in Lyon, France. We will continue to closely monitor our Thymoglobulin inventory levels and intend to manage production in order to maintain adequate supply levels in 2008.

Biosurgery

        Biosurgery product revenue increased 10% to $381.4 million in 2007, as compared to 2006. Seprafilm revenue increased $20.2 million in 2007, as compared to 2006, primarily due to greater penetration into the United States, Japanese and European markets.

        Synvisc sales increased $8.5 million in 2007, as compared to 2006, primarily due to a $5.4 million increase in U.S. volume.

        We received approval to market Synvisc-One, a single injection regimen, in the European Union in December 2007. We expect regulatory action on a marketing application in the United States in the second half of 2008. We also plan on pursuing marketing approvals for Synvisc-One in Canada, Asia and Latin America.

Oncology

        Oncology product revenue increased 43% to $68.9 million in 2007, as compared to 2006, primarily due to a 39% increase to $64.9 million in the combined sales of Campath and Clolar.

        In September 2007, the FDA approved expanded labeling for Campath to include first-line treatment of patients with B-CLL, significantly increasing the number of patients eligible to receive the product. In December 2007 we received European approval for an expanded indication as well.

        We are developing the intravenous formulation of Clolar for significantly larger indications, including first-line and relapsed or refractory AML in adults. We are also developing an oral formulation of Clolar and have initiated clinical trials for the treatment of MDS. Clolar has been granted orphan drug status for ALL and AML in both the United States and European Union.

Other Product Revenue

        Other product revenue increased 13% to $234.1 million in 2007, as compared to 2006, primarily due to:

    a 9% increase in sales of diagnostic products to $125.8 million, due to increased demand; and

    a 44% increase in sales of WelChol to $58.0 million, due to bulk sales and royalties earned as a result of increased demand from our U.S. marketing partner, Sankyo Pharma, Inc., or Sankyo.

        In October 2007, we obtained European Union marketing approval for and subsequently launched Cholestagel in Europe. Cholestagel is a non-absorbed, cholesterol-lowering agent aimed at treating patients with primary hypercholesterolemia who cannot meet their targeted cholesterol levels with standard therapies alone.

2006 As Compared to 2005

Renal

        Sales of Renagel, including sales of bulk sevelamer, increased 23% to $515.1 million for 2006, as compared to 2005, primarily due to an $89.9 million increase in 2006 in sales related to increased customer volume, of which $68.0 million is primarily attributable to increased end-user demand worldwide, and $21.9 million is attributable to a 9.5% price increase for Renagel in the United States, which became effective in December 2005. The 1% increase in the Euro against the U.S. dollar for

F-22



2006, as compared to 2005, positively impacted Renagel revenue by $1.5 million in 2006. Sales of Renagel, including sales of bulk sevelamer, were 18% of our total product revenue for 2006, as compared to 17% for 2005.

        Sales of Hectorol increased more than 100% to $93.4 million for 2006, as compared to $34.5 million for 2005 because we did not own Hectorol until July 1, 2005 and due to higher wholesaler inventories on the date of acquisition.

Therapeutics

        Therapeutics product revenue increased 15% to $1.5 billion for 2006, as compared to 2005, primarily due to continued growth in sales of Cerezyme, Fabrazyme and Thyrogen and the launch of Myozyme in the European Union, United States and Canada in 2006.

        The 8% growth in sales of Cerezyme to $1.0 billion for 2006, as compared to 2005, is attributable to our continued identification of new Gaucher disease patients, particularly in international markets. Our price for Cerezyme has remained consistent from period to period. The 1% increase in the Euro against the U.S. dollar in 2006, as compared to 2005, positively impacted Cerezyme revenue by $3.2 million in 2006.

        The 18% increase to $359.3 million for 2006 in sales of Fabrazyme, as compared to 2005, was primarily attributable to increased patient identification worldwide as Fabrazyme is introduced into new markets. In addition, we recognized $3.4 million in September 2006 upon receiving reimbursement approval for past shipments of Fabrazyme in Canada. The 1% increase in the Euro against the U.S. dollar in 2006, as compared to 2005, positively impacted Fabrazyme revenue by $1.0 million in 2006.

        Sales of Thyrogen increased 21% to $93.7 million for 2006, as compared to 2005, due to worldwide volume growth which positively impacted sales by $15.4 million. Additionally, a 10% increase in price impacted sales by $3.6 million in 2006, as compared to 2005. The 1% increase in the Euro against the U.S. dollar during 2006, as compared to 2005, did not have a material impact on Thyrogen revenue in 2006.

        Sales of Myozyme were $59.2 million for 2006 as compared to $3.8 million in 2005. In March 2006, we received marketing authorization for Myozyme in the European Union. The 1% increase in the Euro against the U.S. dollar during 2006, as compared to 2005, positively impacted Myozyme revenue by $2.0 million in 2006.

Transplant

        Transplant product revenue increased 7% to $156.0 million for 2006, as compared to 2005. The increase is primarily due to a $22.7 million increase in sales of Thymoglobulin as a result of increased utilization of Thymoglobulin in transplant procedures worldwide. The increase was partially offset by a $9.0 million decrease in revenue from an upfront license fee we had received from Procter & Gamble Pharmaceuticals, Inc., or PGP, a subsidiary of The Procter and Gamble Company in 2005, for which there was no comparable amount in 2006. In December 2005, PGP exercised its option to terminate an agreement under which we had granted PGP an exclusive, worldwide license to develop and market RDP58 for the treatment of gastrointestinal and other disorders.

Biosurgery

        Biosurgery product revenue increased 10% to $347.2 million for 2006, as compared to 2005. The increase was largely attributable to a $17.2 million increase in sales of our Sepra products and a $15.0 million increase in sales of Synvisc. Sales of Seprafilm increased $15.1 million primarily due to greater penetration into the U.S. and Japanese market. Synvisc sales increased primarily due to an expanded sales and marketing investment.

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Oncology

        Oncology product revenue increased 41% to $48.1 million for 2006, as compared to 2005, primarily due to increased demand for Campath and Clolar.

Other Product Revenue

        Other product revenue increased 12% to $208.0 million for 2006, as compared to 2005, primarily due to a 10%, or $10.8 million, increase in sales of our diagnostics products and a 14%, or $11.7 million, increase in sales of bulk pharmaceuticals, including WelChol. The increase in sales of diagnostics products was attributable to a 17%, or $10.2 million, increase in clinical chemistry revenue resulting from our acquisition of Equal Diagnostics in July 2005. The increase in sales of bulk pharmaceuticals was primarily due to a 22%, or $7.2 million, increase in 2006, of bulk sales of and royalties earned on WelChol due to an increased demand from our U.S. marketing partner, Sankyo Pharma, Inc.

Service Revenue

        We derive service revenues primarily from the following sources:

    sales of MACI, a proprietary cell therapy product for cartilage repair, in Europe and Australia, Carticel for the treatment of cartilage damage, and Epicel for the treatment of severe burns, all of which are included in our Biosurgery reporting segment; and

    reproductive/genetics and pathology/oncology diagnostic testing services, which are included in our Genetics reporting segment.

        The following table sets forth our service revenue on a segment basis:

 
  2007
  2006
  2005
  07/06
Increase/ (Decrease) % Change

  06/05
Increase/ (Decrease) % Change

 
 
  (Amounts in thousands)

   
   
 
Biosurgery   $ 39,880   $ 39,458   $ 38,553   1 % 2 %
Genetics     285,114     240,857     222,328   18 % 8 %
Oncology     980     1,102       (11 )% N/A  
Other     352     701     498   (50 )% 41 %
   
 
 
         
  Total service revenue   $ 326,326   $ 282,118   $ 261,379   16 % 8 %
   
 
 
         

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2007 As Compared to 2006

        Service revenue attributable to our Biosurgery reporting segment increased 1% to $39.9 million for 2007, as compared to 2006. The increase is primarily due to higher demand for Carticel, offset, in part, by a decline in sales of MACI.

        Service revenue attributable to our Genetics reporting segment increased 18% to $285.1 million for 2007, as compared to 2006. The increase was primarily attributable to continued growth in sales of genetic testing services as well as growth in the prenatal screening and diagnosis market.

2006 As Compared to 2005

        Service revenue attributable to our Biosurgery reporting segment increased 2% to $39.5 million for 2006, as compared to 2005. The increase is primarily due to a full year of MACI sales during 2006. We acquired MACI from Verigen in February 2005. In addition, sales of Epicel increased due to an increase in patient demand in 2006.

        Service revenue attributable to our Genetics reporting segment increased 8% to $240.9 million for 2006, as compared to 2005. The increase was primarily attributable to continued growth in sales of genetic testing services as well as the prenatal screening and diagnosis market.

International Product and Service Revenue

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

 
  2007
  2006
  2005
  07/06
Increase/ (Decrease) % Change

  06/05
Increase/ (Decrease) % Change

 
 
  (Amounts in thousands)

   
   
 
International product and service revenue   1,815,160   1,455,795   $ 1,215,621   25 % 20 %
% of total product and service revenue   48 % 46 %   45 %        

2007 As Compared to 2006

        The 25% increase to $1.8 billion for 2007 in international product and service revenue, as compared to 2006, is primarily due to a $311.4 million increase in the combined international sales of Renagel, Cerezyme, Fabrazyme and Myozyme primarily due to an increase in the number of patients using these products in the European Union, South America and the Asia-Pacific rim.

        The strengthening of foreign currencies, primarily the Euro and British pound sterling, against the U.S. dollar positively impacted total product and service revenue by $90.8 million in 2007, as compared to 2006.

2006 As Compared to 2005

        The 20% increase to $1.5 billion for 2006 in international product and service revenue, as compared to 2005, is primarily due to a $221.8 million increase in the combined international sales of Renagel, Cerezyme, Fabrazyme, Thyrogen, Myozyme, Thymoglobulin, Synvisc and Campath, primarily due to an increase in the number of patients using these products in countries outside of the United States.

        The Euro increased 1% against the U.S. dollar for 2006, as compared to 2005. Therefore, total product and service revenue was positively impacted by $8.8 million.

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        International product and service revenue as a percentage of total product and service revenue increased 1% for 2006, as compared to 2005. This was primarily due to the increase in total revenue outside the United States, as we continue to identify new patients in the international market for our products and services.

Research and Development Revenue

        The following table sets forth our research and development revenue on a segment basis:

 
  2007
  2006
  2005
  07/06
Increase/
(Decrease)
% Change

  06/05
Increase/
(Decrease)
% Change

 
 
  (Amounts in thousands)

   
   
 
Therapeutics   $ 1,202   $ 1,068   $ 789   13 % 35 %
Transplant     180         30   NA   (100 )%
Biosurgery     5,337     893     144   >100 % >100 %
Oncology     18,421     10,208     10,978   80 % (7 )%
Other     2,661     4,945     6,500   (46 )% (24 )%
Corporate     1,614     372     1,719   >100 % (78 )%
   
 
 
         
  Total research and development revenue   $ 29,415   $ 17,486   $ 20,160   68 % (13 )%
   
 
 
         

2007 As Compared to 2006

        Total research and development revenue increased $11.9 million in 2007, as compared to 2006, primarily due to increases in revenue recognized by our Biosurgery and Oncology reporting segments. Biosurgery research and development revenue primarily represents work related to dermal filler products as a result of new contracts entered into with Mentor Corporation in September 2006 and February 2007. Oncology research and development revenue in 2007 includes the reimbursement of research and development work related to alemtuzumab for the treatment of multiple sclerosis, for which there are no similar amounts in 2006. Other research and development revenue includes revenue related to our pharmaceuticals and cardiovascular businesses.

2006 As Compared to 2005

        Total research and development revenue decreased $2.7 million for 2006, as compared to 2005, primarily due to lower reimbursement revenue recognized by our cardiovascular business as a result of lower spending on MG Biotherapeutics, Inc., our joint venture with Medtronic, Inc., or Medtronic, due to the change in our scope of the joint venture. Oncology research and development revenue for the year ended December 31, 2006, includes research and development work related to alemtuzumab, for the treatment of multiple sclerosis, and Campath. Other research and development revenue includes revenue related to our pharmaceuticals and cardiovascular businesses.

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MARGINS

        The components of our total margins are described in the following table:

 
  2007
  2006
  2005
  07/06
Increase/
(Decrease)
% Change

  06/05
Increase/
(Decrease)
% Change

 
 
  (Amounts in thousands)

   
   
 
Product margin   $ 2,742,274   $ 2,351,021   $ 1,991,126   17 % 18 %
% of total product revenue     79 %   81 %   81 %        
Service margin   $ 114,500   $ 82,835   $ 90,904   38 % (9 )%
% of total service revenue     35 %   29 %   35 %        
Total product and service gross margin   $ 2,856,774   $ 2,433,856   $ 2,082,030   17 % 17 %
% of total product and service revenue     75 %   77 %   77 %        

Product Margin

2007 As Compared to 2006

        Our overall product margin increased $391.3 million, or 17%, in 2007, as compared to 2006. This is primarily due to:

    increased margins for Hectorol and Renagel due to price increases, increased unit volume and increased efficiency at our global manufacturing facilities;

    increased margins for Cerezyme, Fabrazyme and Thyrogen due to increased sales volume;

    increased margins for Myozyme due to increased sales volume. We launched Myozyme in the European Union, the United States and Canada in 2006;

    an increase in product margin for Seprafilm due to increased sales; and

    an increase in product margin for our oncology business due to increased global sales of Campath and increased U.S. sales of Clolar.

These increases in product margin were partially offset by a $5.3 million increase in stock-based compensation expenses charged to cost of goods sold in 2007, as compared to 2006. In 2006, we began amortizing stock-based compensation expense capitalized to inventory based on margin turns.

        Total product margin as a percentage of total product revenue in 2007 decreased as compared to 2006 due to the change in product mix, principally the increase of sales of the lower margin Myozyme, and $20.9 million of manufacturing-related charges recorded in 2007 to write off and reserve for certain lots of our Thymoglobulin inventory which did not meet product specifications for saleable product.

        The amortization of product related intangible assets is included in amortization expense and, as a result, is excluded from cost of products sold and the determination of product margins.

2006 As Compared to 2005

        Our overall product margin increased $359.9 million, or 18%, for 2006, as compared to 2005. This is primarily due to:

    improved margins for Renagel due to increased unit volume and increased efficiency at our global manufacturing facilities;

    an increase in product margin for Cerezyme, Fabrazyme, Thyrogen, and Thymoglobulin due to increased sales and improved unit costs;

    improved margins for Myozyme due to the launch of Myozyme in the European Union, United States and Canada in 2006;

F-27


    a full year of Hectorol's margin contribution in 2006, as compared to six months in 2005 as a result of the acquisition of Bone Care in July 2005; and

    an increase in product margin for our oncology business due to the increase in global sales of Campath and Clolar.

These increases in product margin were partially offset by stock-based compensation expenses of $12.0 million associated with our adoption of FAS 123R in 2006 for which there was no comparable amount in 2005.

        Total product margin as a percentage of product revenue for 2006 was consistent with 2005.

Service Margin

2007 As Compared to 2006

        Our overall service margin increased $31.7 million, or 38%, in 2007 as compared to 2006. This is primarily due to the increases in revenue recorded from our DNA and cancer testing services as well as the prenatal screening and diagnosis market.

        Total service margin as a percent of total service revenue increased in 2007, as compared to 2006, primarily due to increased productivity and efficiencies in lab operations for our Genetics reporting segment.

2006 As Compared to 2005

        Our overall service margin decreased $8.1 million, or 9%, for 2006, as compared to 2005. This is primarily due to additional costs in Corporate of $9.5 million related to the adoption of FAS 123R in 2006 for which there was no comparable amount in 2005. This was partially offset by an increase in service margin related to our Biosurgery reporting segment due to an increased demand for Epicel in 2006.

        Total service margin as a percent of total service revenue decreased in 2006, as compared to 2005, primarily due to additional costs in Corporate related to the adoption of FAS 123R in 2006. Genetics service margin as a percentage of total service revenue decreased for 2006, as compared to 2005 due to higher costs for payroll, chemicals and supplies.

OPERATING EXPENSES

Selling, General and Administrative Expenses

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

 
  2007
  2006
  2005
  07/06
Increase/
(Decrease)
% Change

  06/05
Increase/
(Decrease)
% Change

 
 
  (Amounts in thousands)

   
   
 
Selling, general and administrative expenses   $ 1,187,184   $ 1,010,400   $ 787,839   17 % 28 %
% of total revenue     31 %   32 %   29 %        

2007 As Compared to 2006

        SG&A increased $176.8 million in 2007, as compared to 2006, primarily due to spending increases of:

    $19.1 million for Renal, primarily due to continued support of the growth in Renal's international business operations;

F-28


    $34.2 million for Therapeutics, primarily due to costs incurred related to Myozyme's launch in additional countries during 2007;

    $8.9 million for Transplant, primarily due to expenses incurred for pre-launch activities for Mozobil. Also contributing to this increase is spending on additional personnel to support the expansion of Thymoglobulin into new markets;

    $16.7 million for Biosurgery, primarily due to sales force expansion;

    $12.7 million for Genetics, primarily due to personnel additions;

    $5.9 million for Oncology, primarily due to the inclusion of Bioenvision activities after the acquisition; and

    $96.0 million for Corporate SG&A primarily due to a charge of $64.0 million recorded in June 2007 related to the final court approved settlement agreement of the litigation related to the consolidation of our former tracking stocks, and increased spending for information technology, legal expenses, employee recruiting and temporary help.

        These increases were partially offset in 2007 by decreases of:

    $6.1 million for Genetics due to an adjustment in June 2007 to accruals related to our acquisition of the Physician Services and Analytical Services business units of IMPATH Inc. in May 2004; and

    $15.6 million attributable to a decrease in stock-based compensation expenses charged to SG&A. In May 2007, in connection with a general grant to employees, we issued a combination of stock options and RSUs whereas in prior years we had only issued stock options for the general grant to employees. The fair value of our RSUs is the market value of Genzyme Stock on the date of grant. As a result, RSUs generate lower stock-based compensation expense than stock options, the fair value of which is determined using the Black-Scholes valuation model at the date of grant.

2006 As Compared to 2005

        SG&A increased $222.6 million for 2006, as compared to 2005, primarily due to increases of:

    $26.8 million for Renal products, primarily due to our acquisition of Bone Care in July 2005 and continued support of Renal's international business operations growth;

    $21.8 million for Therapeutics products, primarily due to expenses incurred to launch Myozyme in the United States, Canada and in several countries in the European Union and to prepare for its launch in additional countries in 2007;

    $16.8 million for Biosurgery products and services, primarily due to additional expenses related to an increase in staffing and an increase in marketing efforts; and

    $148.5 million for Corporate SG&A, primarily due to $121.8 million of stock-based compensation expenses related to our adoption of FAS 123R and increased spending on legal and information technology expenses.

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Research and Development Expenses

        The following table provides information regarding the change in research and development expense during the periods presented:

 
  2007
  2006
  2005
  07/06
Increase/
(Decrease)
% Change

  06/05
Increase/
(Decrease)
% Change

 
 
  (Amounts in thousands)

   
   
 
Research and development expenses   $ 737,685   $ 649,951   $ 502,657   13 % 29 %
% of total revenue     19 %   20 %   18 %        

2007 As Compared to 2006

        Research and development expenses increased $87.7 million in 2007, as compared to 2006, primarily due to:

    an increase of $56.7 million in spending on certain Therapeutics research and development programs, including a $25.0 million up-front payment paid to Ceregene in June 2007 in connection with our entry into a collaboration agreement for the development and commercialization of CERE-120, a gene therapy product for the treatment of Parkinson's disease;

    an increase of $39.2 million in spending on Transplant research and development programs, primarily due to our acquisition of AnorMED in November 2006; and

    an increase of $21.2 million in spending on Oncology research and development programs, primarily on alemtuzumab for the treatment of multiple sclerosis and Clolar for adult AML.

        These increases were partially offset by decreases of:

    $7.7 million in spending on our Renal programs due to the termination of our collaboration with RenaMed, in February 2007;

    $11.1 million in spending on certain Therapeutics research and development programs, including a $10.9 million decrease in spending due to the termination in February 2007 of our joint venture with Dyax Corp., or Dyax, for development of DX-88 for the treatment of hereditary angioedema, or HAE; and

    $15.2 million for our Corporate research and development programs, primarily due to decreases of $7.1 million in stock-based compensation expenses attributable to the issuance of a combination of stock options and RSUs in connection with a general grant to employees in May 2007. In prior years, only stock options were awarded in the general grant to employees. The fair value of our RSUs is the market value of Genzyme Stock on the date of grant. As a result, RSUs generate lower stock-based compensation expense than stock options, the fair value of which is determined using the Black-Scholes valuation method at the date of grant.

2006 As Compared to 2005

        Research and development expenses increased $147.3 million for 2006, as compared to 2005, primarily due to:

    a $29.7 million increase in spending on Renal research and development programs, primarily due to our acquisition of Bone Care in July 2005 and to a $12.6 million increase in spending on the tolevamer program due to accelerated patient enrollment in clinical studies;

    a $19.5 million increase in spending on certain Therapeutics research and development programs including $7.3 million in spending for the Myozyme program due to FDA required

F-30


      post-marketing commitments and $8.9 million of spending for the Parkinson's disease program we acquired from Avigen;

    a $7.9 million increase in spending on Transplant research and development programs, primarily due to our acquisition of AnorMED in November 2006;

    a $10.2 million increase in spending on Biosurgery research and development programs, primarily on next generation orthopaedics products;

    a $13.0 million increase in spending on Oncology research and development programs primarily on our Campath and Clolar product lines; and

    an $84.6 million increase in spending on Corporate research and development programs primarily due to stock-based compensation expenses of $65.2 million recorded in 2006 related to our adoption of FAS 123R.

These increases were partially offset by decreases in research and development expenses of $24.3 million in spending on certain Therapeutics research and development programs, including:

    $5.1 million on our Cerezyme program, as patients completed clinical studies during the second quarter of 2006, resulting in a decrease in spending on follow-up monitoring;

    $5.6 million on our deferitrin (iron chelator) program due to the completion of our phase 1/2 study in 2005; and

    $6.8 million from the consolidation of Dyax-Genzyme LLC. Spending decreased for DX-88 in both periods due to the completion of clinical trials.

Amortization of Intangibles

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

 
  2007
  2006
  2005
  07/06 Increase/ (Decrease) % Change
  06/05 Increase/ (Decrease) % Change
 
 
  (Amounts in thousands)

   
   
 
Amortization of intangibles   $ 201,105   $ 209,355   $ 181,632   (4 )% 15 %
% of total revenue     5 %   7 %   7 %        

2007 As Compared to 2006

        Amortization of intangibles expense decreased $8.3 million for 2007, as compared to 2006, primarily due to customer lists related to our acquisition of Bone Care in July 2005, which became fully amortized in the first quarter of 2007.

        As discussed in Note H., "Goodwill and Other Intangible Assets," to our financial statements included in this report, we calculate amortization expense for the Synvisc sales and marketing rights we reacquired from Wyeth and the Myozyme patent and technology rights pursuant to a licensing agreement with Synpac by taking into account forecasted future sales of Synvisc and Myozyme, respectively and the resulting estimated future contingent payments we will be required to make to Wyeth and Synpac. As a result, we expect amortization of intangibles to fluctuate over the next five years based on these future contingent payments.

2006 As Compared to 2005

        Amortization of intangibles expense increased $27.7 million for 2006, as compared to 2005, primarily due to additional amortization expense attributable to the intangible assets acquired in

F-31



connection with our acquisitions of Surgi.B in March 2006 and Bone Care in July 2005, as well as the reacquisition of Synvisc sales and marketing rights in several countries from Wyeth in January 2005.

Purchase of In-Process Research and Development

        In connection with six of our acquisitions we completed between January 1, 2004 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.

        The following table sets forth IPR&D projects for companies and certain assets acquired since 2004 (amounts in millions, except percent data):

Company/Assets Acquired

  Purchase Price
  IPR&D(1)
  Programs Acquired
  Discount Rate Used in Estimating Cash Flows(1)
  Year of Expected Launch
  Estimated Cost to Complete
Bioenvision (2007)   $ 349.9   $ 125.5   Evoltra (clofarabine)(2,5)   17 % 2008-2010   $ 41
         
                 

AnorMED (2006)

 

$

589.2

 

$

526.8

 

Mozobil (stem cell transplant)

 

15

%

2009-2014

 

$

125
            26.1   AMD070 (HIV)(3)   15 %   $
         
                 
          $ 552.9                  
         
                 

Avigen (2005)

 

$

12.0

 

$

7.0

 

AV201 (Parkinson's disease)

 

N/A

 

2016

 

$

100
         
                 

Bone Care (2005)

 

$

712.3

 

$

12.7

 

LR-103 (secondary hyperparathyroidism)(4)

 

25

%


 

$

         
                 

Verigen (2005)

 

$

12.7

 

$

9.5

 

MACI (cartilage repair)

 

24

%

2012-2014

 

$

35
         
                 

ILEX Oncology (2004)

 

$

1,080.3

 

$

96.9

 

Campath (alemtuzumab)(5)

 

11

%

2011-2012

 

$

53
            113.4   Clolar (clofarabine)(5)   12 % 2008-2011   $ 131
            44.2   Tasidotin(6)   16 %   $
         
                 
          $ 254.5                  
         
                 

(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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(3)
Year of expected launch and estimated cost to complete data is not provided for AMD070 at this time because we are assessing our future plans for this program.

(4)
Year of expected launch and estimated cost to complete data is not provided for LR-103 at this time because this program is in its early stages and we are evaluating several potential applications for LR-103 to determine which application we shall pursue. Therefore, the year of expected launch and cost to complete cannot be determined.

(5)
Campath is currently marketed for the treatment of B-CLL and Clolar is marketed for the treatment of relapsed and refractory pediatric ALL. The IPR&D projects for Campath and Clolar are related to the development of these products for the treatment of other medical issues.

(6)
Year of expected launch and estimated cost to complete are not provided for tasidotin at this time because we are assessing our future plans for this program.

Charge for Impaired Goodwill

        We are required to perform impairment tests related to our goodwill under FAS 142 annually and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. For 2007, we completed the required annual impairment tests for our $1.3 billion of goodwill that had been recorded as of September 30, 2007 and determined that no impairment charge was required. For 2006, we completed the required annual impairment tests for our $1.5 billion of goodwill that had been recorded as of September 30, 2006 and determined that the $219.2 million of goodwill assigned to our Genetics reporting unit was fully impaired. We discuss our assessment of goodwill for potential impairment under the heading "Critical Accounting Policies—Asset Impairments—Impairment of Goodwill" included in this report.

OTHER INCOME AND EXPENSES

 
  2007
  2006
  2005
  07/06
Increase/
(Decrease)
% Change

  06/05
Increase/
(Decrease)
% Change

 
 
  (Amounts in thousands)

   
   
 
Equity in income of equity method investments   $ 7,398   $ 15,705   $ 151   (53 )% >100 %
Minority interest     3,932     10,418     11,952   (62 )% (13 )%
Gains on investments in equity securities, net     13,067     73,230     5,698   (82 )% >100 %
Other     (637 )   (2,045 )   (1,535 ) (69 )% 33 %
Investment income     70,196     56,001     31,429   25 % 78 %
Interest expense     (12,147 )   (15,478 )   (19,638 ) (22 )% (21 )%
   
 
 
         
Total other income   $ 81,809   $ 137,831   $ 28,057   (41 )% >100 %
   
 
 
         

2007 As Compared to 2006

Equity in Income of Equity Method Investments

        Under this caption, in 2007 and 2006 we recorded our portion of the results of our joint ventures with BioMarin and Medtronic, and our investments in Peptimmune, Inc., or Peptimmune, and in 2007, our initial investment in the common stock of Bioenvision.

        Equity in income of equity method investments decreased by 53% to $7.4 million in 2007, as compared to 2006, primarily due to charges totaling $21.1 million in 2007 related to our initial investment in the common stock of Bioenvision, which was accounted for under the equity method of accounting for the period from July 1, 2007 through October 22, 2007. These charges were offset, in part, by an $11.6 million increase in our portion of the net income of BioMarin/Genzyme LLC.

        Beginning January 1, 2008, as a result of our restructured relationship with BioMarin, we will no longer account for BioMarin/Genzyme LLC using the equity method of accounting.

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Minority Interest

        Prior to February 20, 2007, as a result of our application of FIN 46R, "Consolidation of Variable Interest Entities," we consolidated the results of Dyax-Genzyme LLC and Excigen Inc. On February 20, 2007, we agreed with Dyax to terminate our participation and interest in Dyax-Genzyme LLC effective February 20, 2007. In connection with this termination, we made a capital contribution of approximately $17 million in cash to Dyax-Genzyme LLC and Dyax purchased our interest in the joint venture for 4.4 million shares of Dyax common stock, valued at $16.9 million, based on the closing price of Dyax common stock on February 23, 2007. We recorded Dyax's portion of this joint venture's losses as minority interest in our consolidated statements of operations through February 20, 2007. The results of Excigen were not significant.

Gains on Investments in Equity Securities, net

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

 
  2007
  2006
 
Gross gains on investments in equity securities:              
  THP   $ 10,848   $  
  CAT         69,359  
  BioMarin         6,416  
  Other     2,219     2,848  
   
 
 
    Total gains on investments in equity securities     13,067     78,623  
Less: charges for impaired investments         (5,393 )
   
 
 
Gains on investments in equity securities, net   $ 13,067   $ 73,230  
   
 
 

        In March 2007, we recorded a $10.8 million gain on the sale of our entire investment in the common stock of THP, which had a zero cost basis.

Investment Income

        Our investment income increased 25% to $70.2 million for 2007, as compared to $56.0 million for 2006, primarily due to an increase in the average portfolio yield and higher average cash balances.

Interest Expense

        Our interest expense decreased 22% to $12.1 million for 2007, as compared to $15.5 million for 2006, primarily due to a $5.3 million increase in capitalized interest, which resulted in a decrease in interest expense. This decrease was offset in part by a $3.1 million increase in interest expense in 2007 related to asset retirement obligations, for which there was no similar amount in 2006.

2006 As Compared to 2005

Equity in Income of Equity Method Investments

        Under this caption, in 2006 and 2005, we recorded our portion of the results of our joint ventures with BioMarin and Medtronic, and our investments in Peptimmune and THP.

        Equity in income of equity method investments increased more than 100% to $15.7 million in 2006, as compared to 2005, primarily due to an increase of $11.4 million in our portion of the net income of BioMarin/Genzyme LLC attributable to increased sales of Aldurazyme.

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Minority Interest

        As a result of our application of FIN 46R, "Consolidation of Variable Interest Entities," we have consolidated the results of Dyax-Genzyme LLC and Excigen Inc. Our consolidated balance sheet as of December 31, 2006, includes assets related to Dyax-Genzyme LLC, which are not significant, and substantially all of which are lab equipment net of their associated accumulated depreciation. We have recorded Dyax's portion of this joint venture's losses as minority interest in our consolidated statements of operations. The results of Excigen were not significant.

Gross Gains on Investments in Equity Securities

        Gross gains on investments in equity securities increased $72.9 million in 2006, as compared to 2005, primarily due to $69.4 million of gains recorded in connection with the sale of our entire investment in CAT and a $6.4 million gain on the sale of our entire investment in BioMarin, for which there are no similar amounts in 2005.

        In April 2005, we sold our entire investment in the common stock of Theravance, Inc., or Theravance, for $4.5 million in cash. Our investment in Theravance had a zero cost basis and, as a result, we recorded a gain of $4.5 million in April 2005 related to this sale.

Charges for Impaired Investments

        We review the carrying value of each of our strategic investments in equity securities on a quarterly basis for potential impairment. Gains on investments in equity securities, net, includes charges for impaired investments of $5.4 million for 2006, including $2.5 million to write-off our investment in RenaMed and $2.2 million to write down our investment in ViaCell for which there were no comparable amounts in 2005. We concluded that it was unclear over what period the recovery of the stock prices for these investments would take place and that any evidence suggesting that the investment would recover to at least our historical cost was not sufficient to overcome the presumption that the current market price was the best indicator of the value of these investments.

Investment Income

        Our investment income increased 78% to $56.0 million for 2006, as compared to $31.4 million for 2005, primarily due to higher average cash balances and an increase in our average portfolio yield.

Interest Expense

        Our interest expense decreased 21% to $15.5 million for 2006, as compared to $19.6 million for 2005, primarily due to reduced interest expense of $2.2 million on our 2003 revolving credit facility, which we replaced with the 2006 credit facility in July 2006, and a $1.5 million decrease due to the payoff of a capital lease obligation related to our facilities in Waltham, Massachusetts in October 2005.

F-35


(Provision for) Benefit from Income Taxes

 
  2007
  2006
  2005
  07/06
Increase/
(Decrease)
% Change

  06/05
Increase/
(Decrease)
% Change

 
 
  (Amounts in thousands)

   
   
 
(Provision for) benefit from income taxes   $ (255,481 ) $ 35,881   $ (187,430 ) >100%   >(100 )%
Effective tax rate     35 %   (68 )%   30 %        

        Our provisions for income taxes were at rates other than the U.S. federal statutory tax rate for the following reasons:

 
  For the Years Ended December 31,
 
 
  2007
  2006
  2005
 
Tax provision at U.S. statutory rate   35.0 % (35.0 )% 35.0 %
State taxes, net   0.7   (1.7 ) 1.6  
Export sales benefits     (37.2 ) (2.8 )
Domestic manufacturing deduction   (0.5 ) (15.5 ) (1.2 )
Goodwill impairment     19.6    
Legal settlements   3.0      
Audit settlements   0.5   (62.9 )  
Stock compensation   1.3   15.8    
Tax credits   (3.5 ) (30.5 ) (4.1 )
Foreign rate differential   (2.1 ) 76.0   0.1  
Other   0.3   3.3   1.2  
   
 
 
 
Effective tax rate   34.7 % (68.1 )% 29.8 %
   
 
 
 

        Our effective tax rate for 2007 was impacted by:

    the charge for IPR&D of $106.4 million recorded in October 2007 in connection with our acquisition of Bioenvision, of which $100.3 million was deductible and taxed at rates other than the U.S. statutory income tax rate and $6.1 million was non-deductible;

    non-deductible stock compensation expense of $32.0 million; and,

    a non-deductible charge of $64.0 million for the settlement of the Biosurgery tracking stock suit in August 2007.

        Our effective tax rates for 2006 and 2005 were impacted by:

    the deductible charge for IPR&D of $552.9 million recorded in November 2006 in connection with our acquisition of AnorMED, of which $195.7 million was taxed at rates other than the U.S. statutory tax rate;

    non-deductible stock compensation expense in 2006 of $33.2 million;

    a charge for impaired goodwill of $219.2 million recorded in September 2006, of which $29.5 million was not deductible for tax purposes;

    the settlement of the 1996 to 1999 IRS audit and various state and foreign income tax audits. We recorded a $33.2 million tax benefit to our income tax provision primarily related to export sales benefits, tax credits and deductible intangibles from a prior period acquisition. In conjunction with those settlements, we reduced our tax reserves by approximately $13.1 million

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      and recorded current and deferred tax benefits for the remaining portion of the settlement amounts; and

    the non-deductible IPR&D charges of $22.2 million, of which $9.5 million was recorded in the first quarter of 2005 in connection with the acquisition of Verigen and $12.7 million was recorded in the third quarter of 2005 in connection with the acquisition of Bone Care.

In addition, our overall tax rate has changed significantly due to fluctuations in our income (loss) before taxes, which was $735.7 million in 2007, $(52.7) million in 2006, and $628.9 million in 2005.

        The impact of the adoption of FIN 48 effective January 1, 2007 is included in Note A., "Significant Accounting Policies-Income Taxes," included in this report.

        We are currently under IRS audit for tax years 2004 to 2005. We believe that we have provided sufficiently for all audit exposures. Favorable settlement of these audits or the expiration of the statute of limitations on the assessment of income taxes for any tax year may result in a reduction of future tax provisions. Any such benefit would be recorded upon final resolution of the audit or expiration of the applicable statute of limitations.

Research and Development Programs

        Our research and development programs are focused on the areas of medicine where we market commercial products, namely rare inherited disorders, kidney disease, transplant and immune diseases, orthopaedics and oncology. We also conduct research in cardiovascular disease, diagnostic testing and other areas of unmet medical needs. Before we can commercialize our development-stage products, we will need to:

    conduct substantial research and development;

    undertake pre-clinical and clinical testing;

    develop and scale-up manufacturing processes and validate facilities; and

    pursue marketing authorization and other regulatory approvals and, in some countries, pricing approvals.

        This process is risky, expensive, and may take several years. We cannot guarantee that we will be able to successfully develop any product, or that we would be able to recover our development costs upon commercialization of a product that we successfully develop.

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        Below is a brief description of our significant research and development programs:

Program

  Program Description
or Indication

  Development Status
at December 31, 2007

  Year of
Expected
Product
Launch

Renvela (sevelamer carbonate)   Control of serum phosphorus in patients with CKD on and off hemodialysis   Completed open-label study to compare powder to tablet formulation that showed the two formulations are equivalent in controlling serum phosphorus in hemodialysis patients. Commenced enrollment in trial for powder formulation to allow once daily dosing in 2006. Filed NDA with the FDA for approval for the control of serum phosphorus in patients with CKD on hemodialysis in December 2006. As of December 31, 2007 all trials to support the regulatory filing have been completed. We received FDA approval for End-stage renal disease (ESRD) tablet in October 2007 and have filed for approval in Brazil. We are preparing to file for approval in the European Union and other key markets throughout 2008.   2008
Fabrazyme   Fabry disease   Marketed in the European Union since 2001, the United States since 2003, and Japan since 2004; marketing approval received in 47 countries and commercial sales in 37 countries; several post-marketing commitments in Europe have been completed.   Product was launched in 2001

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Myozyme   Pompe disease   Received marketing approval in the European Union in March 2006, in the United States in April 2006, in Canada in August 2006 and in Japan in April 2007; marketing approval received in 36 countries and commercial sales in 32 countries; several post-marketing commitments ongoing; regulatory submissions filed and under review in Switzerland, Argentina, Colombia, Australia and Korea with several more planned for submission in 2008.   Product was launched in 2006
GENZ-112638   Gaucher disease   Enrollment of patients in a phase 2 trial is complete.   2011
Aldurazyme   MPS I   Marketed in the United States and the European Union since 2003; marketing approval received in 54 countries and commercial sales in 37 countries; several post-marketing commitments ongoing.   Product was launched in 2003
Mozobil(1)   Improve the efficacy of stem cell transplantation in patients with blood cancers   Announced phase 3 trials in multiple myeloma and non-Hodgkin's lymphoma met their respective primary endpoints in August 2007. Plan to file for marketing authorizations in the United States in the first half of 2008 and in the European Union in the second half of 2008 for both indications.   2009 through 2014

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Synvisc-One   Viscosupplementation products to treat osteoarthritis of the knee and other joints   We filed for marketing approval of single-injection Synvisc in the United States in the second quarter of 2007 and in the European Union in the third quarter of 2007. We received approval in the European Union in the fourth quarter of 2007. We expect to receive regulatory action on our application to market Synvisc-One in the United States in the second half of 2008.   2008
Sepra products   Next stage products to prevent surgical adhesions for various indications   Initiated two clinical studies for Sepraspray in the second half of 2007.   2009 through 2012
Campath(2)   B-CLL   The FDA granted front-line approval of Campath in CLL in the third quarter of 2007; phase 3 combination therapy trial in second-line CLL ongoing;   2009 through 2011
Alemtuzumab (Campath) MS(2)   Multiple Sclerosis   Data from phase 2 trial (CAMMS23) analyzed at the predefined 1 and 2 year interim analyses; began enrollment of two phase 3 trials in 2007. Expected completion of phase 3 trials in 2011 to 2012.   2012

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Clolar/Evoltra (clofarabine)(2)   Pediatric and adult leukemias, myelodysplastic syndromes (MDS) and solid tumors   Phase 1/2 trial in pediatric acute leukemias: Phase 1 enrollment completed in 2007; phase 2 opened in late 2007. Phase 2 study in pediatric acute leukemias completed enrollment in 2007. Phase 2 study in treatment-naive adult leukemia completed enrollment in 2007; follow-up is ongoing. Phase 3 trial in relapsed refractory adult leukemia commenced in 2006 and enrollment is ongoing. Phase 1 trial in solid tumors completed enrollment and follow-up in 2007. Phase 2 trial in relapsed refractory MDS commenced enrollment in 2007 and is ongoing.   2008 through 2011; MDS is 2012

(1)
Program acquired in connection with the November 2006 acquisition of AnorMED.

(2)
Program acquired in connection with the December 2004 acquisition of ILEX Oncology, and with respect to clofarabine rights outside of North America, acquired in connection with the October 2007 acquisition of Bioenvision.

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        The aggregate actual and estimated research and development expense for the programs described above is as follows (amounts in millions):

Costs incurred for the year ended December 31, 2006   $ 247.1
Costs incurred for the year ended December 31, 2007   $ 330.2
Cumulative costs incurred as of December 31, 2007   $ 1,466.1
Estimated costs to complete as of December 31, 2007   $ 1,400 to $1,700

        Our current estimates of the time and investment required to develop these products may change depending on the approach we take to pursue them, the results of preclinical and clinical studies, and the content and timing of decisions made by the FDA and other regulatory authorities. We cannot provide assurance that any of these programs will ever result in 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 indication. If certain of our development-stage programs do not result in commercially viable products, our results of operations could be materially adversely affected.

Liquidity and Capital Resources

        We continue to generate cash from operations. We had cash, cash equivalents and short- and long-term investments of $1.5 billion at December 31, 2007 and $1.3 billion at December 31, 2006.

        The following is a summary of our statements of cash flows for 2007 and 2006.

Cash Flows from Operating Activities

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

 
  2007
  2006
 
Cash flows from operating activities:              
Net income (loss)   $ 480,193   $ (16,797 )
Non-cash charges, net     556,341     978,677  
Decrease in cash from working capital changes (excluding impact of acquired assets and assumed liabilities)     (117,862 )   (73,311 )
   
 
 
Cash flows from operating activities   $ 918,672   $ 888,569  
   
 
 

        Cash provided by operating activities increased $30.1 million in 2007, as compared to 2006, primarily driven by a $497.0 million increase in earnings, excluding non-cash charges, offset, in part, by a decrease of $422.3 million in non-cash charges, net, and a $44.6 million increase in cash used for working capital. The decrease in non-cash charges, net, in 2007, as compared to 2006, is primarily attributable to:

    a reduction of $446.6 million in IPR&D; and

    a $219.2 million charge for impaired goodwill in 2006 for which there is no similar amount in 2007; offset, in part by

    a $173.7 million decrease in deferred tax benefits and a $60.2 million decrease in gains on investments in equity securities.

F-42


Cash Flows from Investing Activities

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

 
  2007
  2006
 
Cash flows from investing activities:              
Net sales of investments, excluding investments in equity securities   $ 205,614   $ 13,168  
Net sales (purchases) of investments in equity securities     (1,282 )   132,588  
Purchases of property, plant and equipment     (412,872 )   (333,675 )
Acquisitions, net of acquired cash     (342,456 )   (568,953 )
Distributions from equity method investments     17,100     19,800  
Payment of note receivable from Dyax Corp     7,771      
Purchases of other intangible assets     (60,350 )   (105,348 )
Other investing activities     (4,581 )   6,008  
   
 
 
  Cash flows from investing activities   $ (591,056 ) $ (836,412 )
   
 
 

        In 2007, we used a total of $815.7 million of cash to fund capital expenditures, acquisitions and purchases of intangible assets including:

    approximately $17 million of cash for a capital contribution in connection with the termination of our participation and interest in Dyax-Genzyme LLC;

    $412.9 million in cash to fund the purchase of property, plant and equipment, primarily related to the ongoing expansion of our manufacturing capacity in the Republic of Ireland, the United Kingdom and Belgium, the construction of a new research and development facility in Framingham, Massachusetts and capitalized costs of an internally developed enterprise software system for the Genetics business;

    $288.6 million of cash to fund the acquisition of Bioenvision in October 2007;

    $53.8 million of cash to fund the acquisition of certain diagnostic assets of DCL in December 2007; and

    $60.4 million to purchase other intangible assets.

These decreases in cash were partially offset by cash provided by:

    $205.6 million of cash received from the net sales of investments;

    $17.1 million of cash distributions from our joint venture with BioMarin; and

    $7.8 million of cash from Dyax, including $7.0 million to satisfy the outstanding principal balance due under the note receivable from Dyax and $0.8 million of accrued interest due under the note.

        In 2006, acquisitions, capital expenditures and purchases of intangible assets accounted for significant cash outlays for investing activities. In 2006 we used:

    $569.0 million in cash to fund the acquisition of AnorMED;

    $333.7 million in cash to fund the purchase of property, plant and equipment, primarily related to the ongoing expansion of our manufacturing capacity in the Republic of Ireland, the United Kingdom and Belgium, and the construction of a new research and development facility in Framingham, Massachusetts; and

    $105.3 million in cash for purchases of other intangible assets.

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These decreases in cash were partially offset by cash provided by:

    $132.6 million in cash from the net sales of investments in equity securities, of which $24.4 million is attributable to the sale of our entire investment of 2.1 million shares in the common stock of BioMarin in January 2006, $11.4 million is attributable to the sale of a portion of our investment in the common stock of CAT in May 2006 and $99.0 million is attributable to the sale of the remainder of our investment in the common stock of CAT in July 2006;

    $19.8 million of cash distributions from our joint venture with BioMarin; and

    $13.2 million in cash from the net sales of investments.

Cash Flows from Financing Activities

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

 
  2007
  2006
 
Cash flows from financing activities:              
Proceeds from issuance of common stock   $ 285,762   $ 158,305  
Repurchases of common stock     (231,576 )    
Excess tax benefits from stock-based compensation     13,575     7,114  
Payments of debt and capital lease obligations     (5,909 )   (4,501 )
Decrease in bank overdrafts     (5,910 )   (21,124 )
Minority interest contributions     3,979     11,153  
Other financing activities     4,702     1,210  
   
 
 
  Cash flows from financing activities   $ 64,623   $ 152,157  
   
 
 

        In May 2007, our board of directors authorized a stock repurchase program to repurchase up to an aggregate maximum amount of $1.5 billion or 20,000,000 shares of our outstanding common stock over the next three years, beginning in June 2007. The repurchases are being made from time to time and can be effectuated through open market purchases, privately negotiated transactions, transactions structured through investment banking institutions, or by other means, subject to management's discretion and as permitted by securities laws and other legal requirements. As of December 31, 2007, we had repurchased a total of 3.5 million shares of our common stock at an average price of $66.14 per share for a total of $231.6 million of cash, including fees.

        In 2006, cash flows from financing activities decreased $106.4 million, as compared to 2005, primarily due to a $196.4 million decrease in cash proceeds from the issuance of common stock and $350.0 million of cash proceeds drawn under our 2003 revolving credit facility in 2005 for which there were no similar amounts in 2006. These decreases were offset, in part, by a $474.3 million decrease in cash used for the payment of debt and capital lease obligations. Cash used for the payment of debt and capital lease obligations in 2005 includes the repayment of $450.0 million in principal drawn under our 2003 revolving credit facility for which there are no similar repayments in 2006.

Revolving Credit Facility

        In July 2006, we terminated our 2003 revolving credit facility and replaced it with a new five-year $350.0 million senior unsecured revolving credit facility with JPMorgan Chase Bank, N.A., as administrative agent, Bank of America, N.A., as syndication agent, ABN AMRO Bank N.V., Citizens Bank of Massachusetts and Wachovia Bank, National Association, as co-documentation agents, and a syndicate of lenders, which we refer to as our 2006 revolving credit facility. The proceeds of loans under our 2006 revolving credit facility can be used to finance working capital needs and for general corporate purposes. Our 2006 revolving credit facility may be increased at any time by up to an

F-44



additional $350.0 million in the aggregate, as long as no default or event of default has occurred or is continuing and certain other customary conditions are satisfied. Borrowings under our 2006 revolving credit facility will bear interest (at various rates depending on the nature of the loan).

        As of December 31, 2007, no amounts were outstanding under our 2006 revolving credit facility. The terms of our 2006 revolving credit facility include various covenants, including financial covenants that require us to meet minimum interest coverage ratios and maximum leverage ratios. As of December 31, 2007, we were in compliance with these covenants.

1.25% Convertible Senior Notes

        In December 2003 we issued $690.0 million of 1.25% convertible senior notes. Holders of the notes may require us to repurchase all or any part of the notes for cash, common stock, or a combination, at our option, on December 1, 2008, 2013 or 2018, at a price equal to 100% of the principal amount of the notes plus accrued and unpaid interest through the date prior to the date of repurchase. Additionally, upon a change of control, each holder may require us to repurchase for cash, at 100% of the principal amount of the notes plus accrued interest, all or a portion of the holder's notes. On or after December 1, 2008, we may redeem for cash at 100% of the principal amount of the notes plus accrued interest, all or part of the notes that have not been previously converted or repurchased.

Contractual Obligations

        As of December 31, 2007, we had committed to make the following payments under contractual obligations (amounts in millions):

 
  Payments Due by Period
Contractual Obligations

  Total
  2008
  2009
  2010
  2011
  2012
  After 2012
Long-term debt obligations(1)   $ 698.0   $ 691.0 (1) $ 1.1   $ 1.1   $ 1.1   $ 1.2   $ 2.5
Capital lease obligations(1)     180.4     15.5     15.5     15.4     15.4     15.5     103.1
Operating leases(1)     302.3     57.6     45.9     34.9     27.6     22.9     113.4
Contingent payments(2)     90.0     70.0     20.0                
Interest obligations(3)     8.7     8.1     0.2     0.1     0.1     0.1     0.1
Defined pension benefit plans payments     24.8     1.3     1.6     1.5     1.7     2.0     16.7
Unconditional purchase obligations     234.4     50.8     47.2     48.4     48.7     39.3    
Capital commitments(4)     867.6     526.5     251.6     77.3     12.2        
Research and development agreements(5)     44.4     7.4     7.4     7.4     7.4     7.4     7.4
   
 
 
 
 
 
 
Total contractual obligations   $ 2,450.6   $ 1,428.2   $ 390.5   $ 186.1   $ 114.2   $ 88.4   $ 243.2
   
 
 
 
 
 
 

(1)
See Note L., "Long-term Debt and Leases" to our consolidated financial statements for additional information on long-term debt and lease obligations.

(2)
From time to time, as a result of mergers, acquisitions or license arrangements, we may enter into agreements under which we may be obligated to make contingent payments upon the occurrence of certain events, and/or royalties on sales of acquired products or distribution rights. The actual amounts for and the timing of contingent payments may depend on numerous factors outside of our control, including the success of our preclinical and clinical development efforts with respect to the products being developed under these agreements, the content and timing of decisions made by the United States Patent and Trademark Office, or USPTO, the FDA and other regulatory authorities, the existence and scope of third party intellectual property, the reimbursement and competitive landscape around these products, the volume of sales or gross margin of a product in a specified territory and other factors described under the heading "Risk Factors" below. Because

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    we cannot predict with certainty the amount or specific timing of contingent payments, we have included amounts for contingent payments that we believe are probable of being paid in our contractual obligations table. See Note C., "Mergers and Acquisitions" to our consolidated financial statements for additional information on contingent payments resulting from our acquisitions of Verigen, Equal Diagnostics and the sales and marketing rights to Synvisc from Wyeth.

    Contingent payments also excludes any liabilities pertaining to uncertain tax positions as we cannot make a reliable estimate of the period of cash settlement with the respective taxing authorities. At December 31, 2007, we have approximately $31.1 million of long-term liabilities associated with uncertain tax positions.

(3)
Represents interest payment obligations related to our 1.25% convertible senior notes due December 2023 but callable beginning on December 1, 2008 and the promissory notes to three former shareholders of Equal Diagnostics.

(4)
Consists of contractual commitments to vendors that we have entered into as of December 31, 2007 related to our outstanding capital and internally developed software projects. Our estimated cost of completion for assets under construction as of December 31, 2007 is $867.6 million, as follows (amounts in millions):

Location

  Cost to
Complete at
December 31, 2007

Framingham, Massachusetts, U.S.    $ 243.8
Westborough, Massachusetts, U.S. (primarily software development)     162.3
Lyon, France     134.4
Geel, Belgium     23.9
Waterford, Ireland     39.7
Allston, Massachusetts, U.S.      138.1
Ridgefield, New Jersey, U.S.      11.5
Haverhill, United Kingdom     7.2
Other     106.7
   
  Total estimated cost to complete   $ 867.6
   
(5)
From time to time, we enter into agreements with third parties to obtain access to scientific expertise or technology that we do not already have. These agreements frequently require that we pay our licensor or collaborator a technology access fee, milestone payments upon the occurrence of certain events, and/or royalties on sales of products that utilize the licensed technology or arise out of the collaborative research. In addition, these agreements may call for us to fund research activities not being performed by us. The amounts indicated on the research and development agreements line of the contractual obligations table above represent committed funding obligations to our key collaborators under our significant development programs. Should we terminate any of our license or collaboration agreements, the funding commitments contained within them would expire. In addition, the actual amounts that we pay our licensors and collaborators will depend on numerous factors outside of our control, including the success of our preclinical and clinical development efforts with respect to the products being developed under these agreements, the content and timing of decisions made by the USPTO, the FDA and other regulatory authorities, the existence and scope of third party intellectual property, the reimbursement and competitive landscape around these products, and other factors described under the heading "Risk Factors" below.

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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. Initially, we will focus on developing mipomersen for patients with FH that are at significant cardiovascular risk as a result of being unable to achieve target cholesterol levels with statins alone or who are intolerant of statins. In February 2008, we paid Isis $150.0 million to purchase five million shares of Isis common stock for $30 per share. We are working with Isis to finalize the contracts under which we will develop and commercialize mipomersen.

Financial Position

        We believe that our available cash, investments and cash flows from operations will be sufficient to fund our planned operations and capital requirements for the foreseeable future. Although we currently have substantial cash resources and positive cash flow, we have used or intend to use substantial portions of our available cash and may make additional borrowings for:

    product development and marketing;

    payments related to the cash consideration due to the dissenting Bioenvision shareholders, the amount of which will be determined by the Delaware Court of Chancery;

    business combinations and strategic business initiatives, including our strategic alliance with Isis;

    the remaining $1.3 billion approved for our ongoing stock repurchase program over approximately the next 2.5 years;

    expanding existing and constructing additional manufacturing facilities;

    upgrading our information technology systems;

    contingent payments under license and other agreements, including payments related to our formation of a strategic alliance with Isis in January 2008;

    expanding staff; and

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

        Our cash reserves may be further reduced to pay principal and interest on the $690.0 million in principal under our 1.25% convertible senior notes due December 1, 2023. The notes are initially convertible into Genzyme Stock at a conversion price of approximately $71.24 per share. Holders of the notes may require us to repurchase all or any part of the notes for cash, common stock, or a combination, at our option, on December 1, 2008, 2013 or 2018, at a price equal to 100% of the principal amount of the notes plus accrued and unpaid interest through the date prior to the date of repurchase. Additionally, upon a change of control, each holder may require us to repurchase for cash, at 100% of the principal amount of the notes plus accrued interest, all or a portion of the holder's notes. On or after December 1, 2008, we may redeem for cash at 100% of the principal amount of the notes plus accrued interest, all or part of the notes that have not been previously converted or repurchased.

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

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        To satisfy these and other commitments, we may have to obtain additional financing. We cannot guarantee that we will be able to obtain any additional financing, extend any existing financing arrangement, or obtain either on favorable terms.

Off-Balance Sheet Arrangements

        We do not use special purpose entities or other off-balance sheet financing arrangements. We enter into guarantees in the ordinary course of business related to the guarantee of our own performance and the performance of our subsidiaries. In addition, we have joint ventures and certain other arrangements that are focused on research, development, and the commercialization of products. Entities falling within the scope of FIN 46R are included in our consolidated statements of operations if we qualify as the primary beneficiary. Entities not subject to consolidation under FIN 46R are accounted for under the equity method of accounting if our ownership percent exceeds 20% or if we exercise significant influence over the entity. We account for our portion of the income/losses of these entities in the line item "Equity in income of equity method investments" in our statements of operations. We also acquire companies in which we agree to pay contingent consideration based on attaining certain thresholds.

Recent Accounting Pronouncements

        FAS 157, "Fair Value Measurements." In September 2006, the FASB issued FAS 157, "Fair Value Measurements," which provides enhanced guidance for using fair value to measure assets and liabilities. FAS 157 establishes a common definition of fair value, provides a framework for measuring fair value under accounting principles generally accepted in the United States of America and expands disclosure requirements regarding fair value measurements. FAS 157 will be effective for us as of January 1, 2008. In February 2008, the FASB issued FASB Statement of Position, or FSP, No. 157-2 "Partial Deferral of the Effective Date of Statements 157," or FSP 157-2, which delays the effective date of FAS 157, for all non-financial assets and non-financial liabilities, except those that are recognized or disclosed at fair value in the financials statements on a recurring basis (at least annually) to fiscal years beginning after November 15, 2008. Although we will continue to evaluate the application of FAS 157, we do not believe adoption will have a material impact on our results of operations or financial position.

        FAS 159, "The Fair Value Option for Financial Assets and Financial Liabilities—Including an Amendment of FASB Statement No. 115." In February 2007, the FASB issued 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. FAS 159 will be effective for us as of January 1, 2008. We do not expect the adoption of FAS 159 to have a material impact our financial position and results of operations.

        EITF Issue No. 07-1, "Accounting for Collaborative Arrangements." In December 2007, the 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. Based on the nature of the arrangement, payments to or from collaborators would be evaluated and its terms, the nature of the entity's business, and whether those payments are within the scope of other accounting literature would be presented. 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 amounts related to the arrangements. Activities in the arrangement conducted in a separate legal entity should be accounted for under other accounting literature; however required disclosure under

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EITF 07-1 applies to the entire collaborative agreement. EITF 07-1 is effective for us January 1, 2008 and is to be applied retrospectively to all periods presented for all collaborative arrangements existing as of the effective date. We do not expect the adoption of EITF 07-1 will have a material impact 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 is effective for us January 1, 2008 and will be applied prospectively to new contracts we enter into on or after that date. Earlier application is not permitted. We do not expect the adoption of EITF No. 07-3 to 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 FAS 141R changed the method of applying the acquisition method in a number of significant aspects. Acquisition costs will generally be expensed as incurred; noncontrolling interests will be valued at fair value at the acquisition date; 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, with the exception of the accounting for valuation allowances on deferred taxes and acquired tax contingencies. FAS 141R amends FAS 109 such that adjustments made to valuation allowances on deferred taxes and acquired tax contingencies associated with acquisitions completed prior to the effective date of FAS 141R would also apply the provisions of FAS 141R. Early adoption is not permitted. We are currently evaluating the effects, if any, that FAS 141R may 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-controlling 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-controlling 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-controlling 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-controlling owners. FAS 160 is effective for us January 1, 2009 and adoption is prospective only; however, upon adoption, presentation and disclosure requirements described above must be applied retrospectively for all periods presented in our financial statements. We are currently evaluating the effects, if any, that FAS 160 may have on our consolidated financial statements.

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Market Risk

        We are exposed to potential loss from exposure to market risks represented principally by changes in interest rates and equity prices. At December 31, 2007, we held derivative contracts in the form of foreign exchange forward contracts. We also held a number of other financial instruments, including investments in marketable securities and we had debt securities outstanding. We do not hold derivatives or other financial instruments for speculative purposes.

Equity Price Risk

        We hold investments in a limited number of U.S. and European equity securities. We estimated the potential loss in fair value due to a 10% decrease in the equity prices of each marketable security held at December 31, 2007 to be $6.5 million, as compared to $4.2 million at December 31, 2006. The primary reason for the increase is due to the acquisition of 4.4 million shares of Dyax common stock for approximately $17 million in cash. This estimate assumes no change in foreign exchange rates from quarter-end spot rates and excludes any potential risk associated with securities that do not have readily determinable market value.

Interest Rate Risk

        We are exposed to potential loss due to changes in interest rates. Our principal interest rate exposure is to changes in U.S. interest rates. Instruments with interest rate risk include short- and long-term investments in fixed income securities. Other exposures to interest rate risk include fixed rate convertible debt and other fixed rate debt. To estimate the potential loss due to changes in interest rates, we performed a sensitivity analysis using the instantaneous adverse change in interest rates of 100 basis points across the yield curve.

        We used the following assumptions in preparing the sensitivity analysis for our convertible bonds:

    convertible notes that are "in-the-money" at year end are considered equity securities and are excluded;

    convertible notes that are "out-of-the-money" at year end are analyzed by taking into account both fixed income and equity components; and

    convertible notes will mature on the first available date.

        On this basis, we estimate the potential loss in fair value that would result from a hypothetical 1% (100 basis points) decrease in interest rates to be $3.3 million as of December 31, 2007, as compared to $4.2 million as of December 31, 2006.

Foreign Exchange Risk

        As a result of our worldwide operations, we may face exposure to adverse movements in foreign currency exchange rates, primarily to the Euro, British pound and Japanese yen. Exposures to currency fluctuations that result from sales of our products in foreign markets are partially offset by the impact of currency fluctuations on our international expenses. We use forward foreign exchange contracts to further reduce our exposure to changes in exchange rates. We also hold a limited amount of foreign cash and foreign currency denominated equity securities.

        As of December 31, 2007, we estimate the potential loss in fair value of our foreign currency contracts, foreign cash, and foreign equity holdings that would result from a hypothetical 10% adverse change in exchange rates to be $36.2 million, as compared to $34.2 million as of December 31, 2006. The change from the prior period is primarily due to an increase in our net foreign currency exposure.

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Risk Factors

        Our future operating results could differ materially from the results described in this report due to the risks and uncertainties related to our business, including those discussed below.

Our financial results are highly dependent on sales of Cerezyme.

        We generate a significant portion of our revenue from sales of Cerezyme, our enzyme-replacement product for patients with Gaucher disease. Sales of Cerezyme totaled $1.1 billion for the year ended December 31, 2007, representing approximately 30% of our total revenue. Because our business is highly dependent on Cerezyme, negative trends in revenue from this product could have a significant adverse effect on our results of operations and cause the value of our securities to decline substantially. We will lose revenue if alternative treatments gain commercial acceptance, if our marketing activities are restricted, or if reimbursement is limited. In addition, the patient population with Gaucher disease is not large. Because a significant percentage of that population already uses Cerezyme, opportunities for future sales growth are constrained. Furthermore, changes in the methods for treating patients with Gaucher disease, including treatment protocols that combine Cerezyme with other therapeutic products or reduce the amount of Cerezyme prescribed, could limit growth, or result in a decline, in Cerezyme sales.

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

        Over the next few years, our success will depend substantially on our ability to increase revenue from our existing products and services. These products and services include Renagel, Renvela, Synvisc, Synvisc-One, Fabrazyme, Myozyme, Hectorol, Thymoglobulin, Thyrogen, Clolar, Campath, Aldurazyme and diagnostic testing services. Our ability to increase sales will depend on a number of factors, including:

    acceptance by the medical community of each product or service;

    the availability of competing treatments that are deemed more efficacious, more convenient to use, or more cost effective;

    our ability, and the ability of our collaborators, to efficiently manufacture sufficient quantities of each product to meet demand and to do so in a cost efficient manner;

    regulation by the U.S. Food and Drug Administration, commonly referred to as the FDA, and the European Agency for the Evaluation of Medicinal Products, or EMEA, and other regulatory authorities of these products and the facilities and processes used to manufacture these products;

    the scope of the labeling approved by regulatory authorities for each product and competitive products;

    the effectiveness of our sales force;

    the availability and extent of coverage, pricing and level of reimbursement from governmental agencies and third party payors; and

    the size of the patient population for each product or service and our ability to identify new patients.

        Part of our growth strategy involves conducting additional clinical trials to support approval of expanded uses of some of our products, including Clolar and alemtuzumab, pursuing marketing approval for our products in new jurisdictions and developing next generation products such as Renvela and Synvisc-One. The success of this component of our growth strategy will depend on the outcome of

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these additional clinical trials, the content and timing of our submissions to regulatory authorities and whether and when those authorities determine to grant approvals.

        Because the healthcare industry is extremely competitive and regulatory requirements are rigorous, we spend substantial funds marketing our products and attempting to expand approved uses for them. These expenditures depress near-term profitability, with no assurance that the expenditures will generate future profits that justify the expenditures.

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

        The human healthcare products and services industry is extremely competitive. Other organizations, including pharmaceutical, biotechnology, device and diagnostic testing companies, have developed and are developing products and services to compete with our products, services, and product candidates. If healthcare providers, patients or payors prefer these competitive products or services or these competitive products or services have superior safety, efficacy, pricing or reimbursement characteristics, we will have difficulty maintaining or increasing the sales of our products and services.

        Renagel competes with two other products approved in the United States for the control of elevated phosphorus levels in patients with chronic kidney failure on hemodialysis. Fresenius Medical Care markets PhosLo®, a calcium-based phosphate binder. Shire Pharmaceuticals Group plc, or Shire, markets Fosrenol®, a non-calcium based phosphate binder. Amgen, Inc. recently acquired Ilypsa and its product candidate, ILY101, a polymeric phosphate binder that completed a phase 2 trial in CKD patients on dialysis. Renagel also competes with over-the-counter calcium carbonate products such as TUMS® and metal-based options such as aluminum and magnesium.

        UCB S.A. has developed Zavesca®, a small molecule drug for the treatment of Gaucher disease, the disease addressed by Cerezyme. Zavesca has been approved in the United States, European Union and Israel as an oral therapy for use in patients with mild to moderate Type 1 Gaucher disease for whom enzyme replacement therapy is unsuitable. In addition, Shire reported top-line data from a phase 1/2 clinical trial for its gene-activated glucocerebrosidase program, also to treat Gaucher disease, and initiated phase 3 studies in July 2007. Protalix Biotherapeutics Ltd. initiated a phase 3 trial for plant-derived enzyme replacement therapy to treat Gaucher disease in the third quarter of 2007. Amicus Therapeutics, Inc., or Amicus, is conducting phase 2 trials for oral chaperone medication to treat Gaucher disease. We are also aware of other development efforts aimed at treating Gaucher disease.

        Outside the United States, Shire is marketing Replagal, a competitive enzyme replacement therapy for Fabry disease which is the disease addressed by Fabrazyme. In addition, while Fabrazyme has received orphan drug designation, which provides us with seven years of market exclusivity for the product in the United States, other companies may seek to overcome our market exclusivity and, if successful, compete with Fabrazyme in the United States. Amicus has initiated phase 2 trials for an oral chaperone medication to treat Fabry disease. We are aware of other development efforts aimed at treating Fabry disease.

        Current competition for Synvisc and Synvisc-One includes Supartz®, a product manufactured by Seikagaku Kogyo that is sold in the United States by Smith & Nephew Orthopaedics and in Japan by Kaken Pharmaceutical Co. under the name Artz®; Hyalgan®, produced by Fidia Farmaceutici S.p.A. and marketed in the United States by Sanofi-Aventis; Orthovisc®, produced by Anika Therapeutics, Inc., and marketed in the United States by Johnson & Johnson's Mitek division and marketed outside the United States through distributors; Euflexxa™, a product manufactured and sold by Ferring Pharmaceuticals and marketed in the United States and Europe; and Durolane®, manufactured by Q-Med AB and distributed outside the United States by Smith & Nephew

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Orthopedics. Durolane and Euflexxa are produced by bacterial fermentation, which may provide these products a competitive advantage over avian-sourced Synvisc and Synvisc-One. We are aware of various viscosupplementation products on the market or in development, but are unaware of any products that have physical properties of viscosity, elasticity or molecular weight comparable to those of Synvisc and Synvisc-One. Furthermore, several companies market products that are not viscosupplementation products but which are designed to relieve the pain associated with osteoarthritis. Synvisc and Synvisc-One will have difficulty competing with any of these products to the extent the competitive products are considered more efficacious, less burdensome to administer or more cost-effective.

        Myozyme has marketing exclusivity in the United States until 2013 and in the European Union until 2016 due to its orphan drug status. Amicus Therapeutics has completed two phase 1 clinical studies for a small molecule treatment for Pompe disease and has announced their plans to initiate a phase 2 clinical trial in early 2008.

        Several companies market products that, like Thymoglobulin, are used for the prevention and treatment of acute rejection in renal transplant. These products include Novartis' Simulect® and Pfizer Inc.'s ATGAM®. Competition in the acute transplant rejection market is driven largely by product efficacy due to the potential decreased long-term survival of transplanted organs as the result of an acute organ rejection episode.

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

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

        A substantial portion of our domestic and international revenue comes from payments by third party payors, including government health administration authorities and private health insurers. Governments and other third party payors may not provide adequate insurance coverage or reimbursement for our products and services, which could impair our financial results.

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

    challenging the prices charged for healthcare products and services;

    limiting both the coverage and the amount of reimbursement for new therapeutic products;

    reducing existing reimbursement rates for commercialized products and services;

    limiting coverage for the treatment of a particular patient to a maximum dollar amount or specified period of time;

    denying or limiting coverage for products that are approved by the FDA or other governmental regulatory bodies but are considered experimental or investigational by third party payors; and

    refusing in some cases to provide coverage when an approved product is used for disease indications in a way that has not received FDA or other applicable marketing approval.

        Attempts by third party payors to reduce costs in any of these ways could decrease demand for our products. In addition, in certain countries, including countries in the European Union and Canada, the

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coverage of prescription drugs, the pricing, and the level of reimbursement are subject to governmental control. Therefore, we may be unable to negotiate coverage, pricing and/or reimbursement on terms that are favorable to us. Government health administration authorities may also rely on analyses of the cost-effectiveness of certain therapeutic products in determining whether to provide reimbursement for such products. Our ability to obtain satisfactory pricing and reimbursement may depend in part on whether our products, the cost of some of which is high in comparison to other therapeutic products, are viewed as cost-effective.

        Furthermore, governmental regulatory bodies, such as the Centers for Medicare and Medicaid Services (CMS), may from time-to-time make unilateral changes to reimbursement rates for our products and services. These changes could reduce our revenues by causing healthcare providers to be less willing to use our products and services. Although we actively seek to assure that any initiatives that are undertaken by regulatory agencies involving reimbursement for our products and services do not have an adverse impact on us, we may not always be successful in these efforts.

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

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

        Before we can commercialize our development-stage product candidates, we will need to:

    conduct substantial research and development;

    undertake preclinical and clinical testing;

    develop and scale-up manufacturing processes; and

    pursue marketing approvals and, in some jurisdictions, pricing and reimbursement approvals.

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

    failure of the product candidate in preclinical studies;

    difficulty enrolling patients in clinical trials, particularly for disease indications with small patient populations;

    patients exhibiting adverse reactions to the product candidate or indications of other safety concerns;

    insufficient clinical trial data to support the effectiveness of the product candidate;

    our inability to manufacture sufficient quantities of the product candidate for development or commercialization activities in a timely and cost-efficient manner;

    our failure to obtain the required regulatory approvals for the product candidate, the facilities or the process used to manufacture the product candidate; or

    changes in the regulatory environment, including pricing and reimbursement, that make development of a new product or indication no longer desirable.

        Few research and development projects result in commercial products, and success in preclinical studies or early clinical trials often is not replicated in later studies. For example, in our phase 3 trial known as the Polymer Alternative for CDAD treatment (PACT) study, tolevamer did not meet its primary endpoint. In our pivotal study of hylastan for treatment of patients with osteoarthritis of the knee, hylastan did not meet its primary endpoint. We may decide to abandon development of a product or service candidate at any time or we may be required to expend considerable resources repeating

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clinical trials or conducting additional trials, either of which would increase costs of development and delay any revenue from those product candidates.

        Our efforts to expand the approved indications for our products and to gain marketing approval in new jurisdictions and to develop next generation products also may fail. These expansion efforts are subject to many of the risks associated with completely new products and accordingly, we may fail to recoup the investments we make pursuing these strategies.

We may encounter substantial difficulties managing our growth.

        Several risks are inherent to our plans to grow our business. Achieving our goals will require substantial investments in research and development, sales and marketing, and facilities. For example, we have spent considerable resources building and seeking regulatory approvals for our manufacturing plants. We cannot assure you that these facilities will prove sufficient to meet demand for our products or that we will not have excess capacity at these facilities. In addition, building our facilities is expensive, and our ability to recover these costs will depend on increased revenue from the products produced at the facilities.

        We produce relatively small amounts of material for research and development activities and pre-clinical trials. Even if a product candidate receives all necessary approvals for commercialization, we may not be able to successfully scale-up production of the product material at a reasonable cost or at all and we may not receive manufacturing approvals in sufficient time to meet product demand.

        If we are able to grow sales of our products, we may have difficulty managing inventory levels. Marketing new therapies is a complicated process, and gauging future demand is difficult. With Renagel, for example, we have encountered problems in the past managing inventory levels at wholesalers. Comparable problems may arise with any of our products, particularly during market introduction.

        Growth in our business may also contribute to fluctuations in our operating results, which may cause the price of our securities to decline. Our revenue may fluctuate due to many factors, including changes in:

    wholesaler buying patterns;

    reimbursement rates;

    physician prescribing habits;

    the availability or pricing of competitive products; and

    currency exchange rates.

        We may also experience fluctuations in our quarterly results due to price changes and sales incentives. For example, purchasers of our products, particularly wholesalers, may increase purchase orders in anticipation of a price increase and reduce order levels following the price increase. We occasionally offer sales incentives and promotional discounts on some of our products and services that could have a similar impact. In addition, some of our products, including Synvisc, are subject to seasonal fluctuation in demand.

Our operating results and financial position may be impacted when we attempt to grow through business combination transactions.

        We may encounter problems assimilating operations acquired in business combination transactions. These transactions often entail the assumption of unknown liabilities, the loss of key employees, and the diversion of management attention. Furthermore, in any business combination, including our acquisitions of AnorMED and Bioenvision, there is a substantial risk that we will fail to realize the

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benefits we anticipated when we decided to undertake the transaction. We have in the past taken significant charges for impaired goodwill and for impaired assets acquired in business combination transactions. We may be required to take similar charges in the future.

Manufacturing problems may cause product launch delays, inventory shortages, recalls and unanticipated costs.

        In order to generate revenue from our approved products, we must be able to produce sufficient quantities of the products. Many of our products are difficult to manufacture. Our products that are biologics, for example, require product characterization steps that are more onerous than those required for most chemical pharmaceuticals. Accordingly, we employ multiple steps to attempt to control the manufacturing processes. Minor deviations in these manufacturing processes could result in unacceptable changes in the products that result in lot failures, product recalls, product liability claims and insufficient inventory.

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

        In addition, we may only be able to produce certain of our products at a very limited number of facilities and, in some cases, we rely on third parties to formulate and manufacture our products. For example, we manufacture all of our Cerezyme and a portion of our Fabrazyme and Myozyme products at our facility in Allston, Massachusetts. A number of factors could cause production interruptions at our facilities or the facilities of our third party providers, including equipment malfunctions, labor problems, natural disasters, power outages, terrorist activities, or disruptions in the operations of our suppliers.

        Manufacturing is also subject to extensive government regulation. Regulatory authorities must approve the facilities in which human healthcare products are produced and those facilities are subject to ongoing inspections. In addition, changes in manufacturing processes may require additional regulatory approvals. Obtaining and maintaining these regulatory approvals could cause us to incur significant additional costs and lose revenue. For example, we have had to transition U.S. Myozyme patients to a clinical access program because we have not yet received FDA approval of our larger-scale manufacturing process for Myozyme. This has had an adverse effect on our revenues for the product and will continue to have an adverse effect until we receive regulatory approval. Furthermore, any third party we use to manufacture, fill-finish or package our products to be sold must also be licensed by the applicable regulatory authorities. As a result, alternative third party providers may not be readily available on a timely basis.

        Additionally, in 2007, we wrote off or reserved for $20.9 million worth of Thymoglobulin finished goods inventory for failure to meet our internal specifications for saleable product. We will continue to closely monitor our inventory levels and intend to manage production to maintain adequate supply levels in 2008.

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Guidelines and recommendations published by various organizations can reduce the use of our products.

        Professional societies, practice management groups, private health/science foundations, and organizations involved in various diseases may publish guidelines or recommendations to the healthcare and patient communities from time to time. Recommendations of government agencies or these other groups/organizations may relate to such matters as usage, dosage, route of administration, cost-effectiveness, and use of related therapies. Organizations like these have in the past made recommendations about our products and products of our competitors. Recommendations or guidelines that are followed by patients and healthcare providers could result in decreased use of our products. The perception by the investment community or shareholders that recommendations or guidelines will result in decreased use of our products could adversely affect prevailing market price for our common stock. In addition, our success also depends on our ability to educate patients and healthcare providers about our products and their uses. If these education efforts are not effective, then we may not be able to increase the sales of our existing products or successfully introduce new products to the market.

We rely on third parties to provide us with materials and services in connection with the manufacture of our products.

        Certain materials necessary for commercial production of our products, including specialty chemicals and components necessary for manufacture, fill-finish and packaging, are provided by unaffiliated third party suppliers. In some cases, such materials are specifically cited in our marketing application with regulatory authorities so that they must be obtained from that specific source unless and until the applicable authority approved another supplier. In addition, there may only be one available source for a particular chemical or component. For example, we acquire polyalylamine (PAA), used in the manufacture of Renagel, Renvela, Cholestagel and WelChol, from Cambrex Charles City, Inc., the only source for this material currently qualified in our FDA drug applications for these products. Our suppliers also may be subject to FDA regulations or the regulations of other governmental agencies outside the United States regarding manufacturing practices. We may be unable to manufacture our products in a timely manner or at all if these third party suppliers were to cease or interrupt production or otherwise fail to supply these materials or products to us for any reason, including due to regulatory requirements or actions, adverse financial developments at or affecting the supplier, or labor shortages or disputes.

        We also source some of our manufacturing, fill-finish, packaging and distribution operations to third party contractors. The manufacture of products, fill-finish, packaging and distribution of our products requires successful coordination among these third party providers and Genzyme. Our inability to coordinate these efforts, the lack of capacity available at a third party contractor or any other problems with the operations of these third party contractors could require us to delay shipment of saleable products, recall products previously shipped or could impair our ability to supply products at all. This could increase our costs, cause us to lose revenue or market share and damage our reputation.

Government regulation imposes significant costs and restrictions on the development and commercialization of our products and services.

        Our success will depend on our ability to satisfy regulatory requirements. We may not receive required regulatory approvals on a timely basis or at all. Government agencies heavily regulate the production and sale of healthcare products and the provision of healthcare services. In particular, the FDA and comparable regulatory agencies in foreign jurisdictions must approve human therapeutic and diagnostic products before they are marketed, as well as the facilities in which they are made. This approval process can involve lengthy and detailed laboratory and clinical testing, sampling activities and other costly and time-consuming procedures. Several biotechnology companies have failed to obtain regulatory approvals because regulatory agencies were not satisfied with the structure or conduct of

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clinical trials. Similar problems could delay or prevent us from obtaining approvals. Furthermore, regulatory authorities, including the FDA, may not agree with our interpretations of our clinical trial data, which could delay, limit or prevent regulatory approvals.

        Therapies that have received regulatory approval for commercial sale may continue to face regulatory difficulties. If we fail to comply with applicable regulatory requirements, regulatory authorities could take actions against us, including:

    issuing warning letters;

    issuing fines and other civil penalties;

    suspending regulatory approvals;

    refusing to approve pending applications or supplements to approved applications;

    suspending product sales, imports and/or exports;

    requiring us to communicate with physicians and other customers about concerns related to potential safety, efficacy, and other issues involving Genzyme products;

    mandating product recalls; and

    seizing products.

        Furthermore, the FDA and comparable foreign regulatory agencies may require post-marketing clinical trials or patient outcome studies. We have agreed with the FDA, for example, to a number of post-marketing commitments as a condition to U.S. marketing approval for Fabrazyme, Aldurazyme and Myozyme. In addition, regulatory agencies subject a marketed therapy, its manufacturer and the manufacturer's facilities to continual review and periodic inspections. The discovery of previously unknown problems with a therapy or the facility or process used to produce the therapy could prompt a regulatory authority to impose restrictions on us, or could cause us to voluntarily adopt such restrictions, including withdrawal of one or more of our products or services from the market. For example, we received a warning letter from the FDA in September 2007 that addresses certain of our manufacturing procedures in our Thymoglobulin production facility in Lyon, France. The FDA has accepted our response to the warning letter and we continue to work to optimize our processes at this plant.

We may incur substantial costs as a result of litigation or other proceedings.

        A third party may sue us or one of our strategic collaborators for infringing the third party's patent or other intellectual property rights. Likewise, we or one of our strategic collaborators may sue to enforce intellectual property rights or to determine the scope and validity of third party proprietary rights. If we do not prevail in this type of litigation, we or our strategic collaborators may be required to:

    pay monetary damages;

    stop commercial activities relating to the affected products or services;

    obtain a license in order to continue manufacturing or marketing the affected products or services; or

    compete in the market with a different product.

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        We are also currently involved in litigation matters and investigations that do not involve intellectual property claims and may be subject to additional actions in the future. For example, the federal government, state governments and private payors are investigating and have begun to file actions against numerous pharmaceutical and biotechnology companies, including Genzyme, alleging that the companies have overstated prices in order to inflate reimbursement rates. Domestic and international enforcement authorities also have instituted actions under healthcare "fraud and abuse" laws, including anti-kickback and false claims statutes. Moreover, individuals who use our products or services, including our diagnostic products and genetic testing services, sometimes bring product and professional liability claims against us or our subsidiaries.

        We may also become subject to investigations by government authorities in connection with our business activities. For example, we are currently cooperating with an investigation of Bone Care by the United States Attorney for the Eastern District of New York which was initiated in October 2004, when Bone Care received a subpoena requiring it to provide a wide range of documents related to numerous aspects of its business.

        We believe some of our products are prescribed by physicians for uses not approved by the FDA or comparable regulatory agencies outside the United States. Although physicians may lawfully prescribe our products for off-label uses, any promotion by us of off-label uses would be unlawful. Some of our practices intended to make physicians aware of off-label uses of our products without engaging in off-label promotion could nonetheless be construed as off-label promotion. Although we have policies and procedures in place designed to help assure ongoing compliance with regulatory requirements regarding off-label promotion, some non-compliant actions may nonetheless occur. Regulatory authorities could take enforcement action against us if they believe we are promoting, or have promoted, our products for off-label use.

        We have only limited amounts of insurance, which may not provide coverage to offset a negative judgment or a settlement payment. We may be unable to obtain additional insurance in the future, or we may be unable to do so on acceptable terms. Our insurers may dispute our claims for coverage. For example, we have submitted claims to our insurers for reimbursement of portions of the expenses incurred in connection with the litigation and settlement related to the consolidation of our tracking stock and are seeking coverage for the settlement. The insurer has purported to deny coverage. Any additional insurance we do obtain may not provide adequate coverage against any asserted claims.

        Regardless of merit or eventual outcome, investigations and litigations can result in:

    diversion of management's time and attention;

    expenditure of large amounts of cash on legal fees, expenses, and payment of damages;

    limitations on our ability to continue some of our operations;

    decreased demand for our products and services; and

    injury to our reputation.

Our international sales, clinical activities, manufacturing and other operations are subject to the economic, political, legal and business environments of the countries in which we do business, and our failure to operate successfully or adapt to changes in these environments could cause our international sales and operations to be limited or disrupted.

        Our international operations accounted for approximately 48% of our consolidated product and service revenues for the year ended December 31, 2007. We expect that international product and service sales will continue to account for a significant percentage of our revenues for the foreseeable future. In addition, we have direct investments in a number of subsidiaries outside of the United States.

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Our international sales and operations could be limited or disrupted, and the value of our direct investments may be diminished, by any of the following:

    economic problems that disrupt foreign healthcare payment systems;

    the imposition of governmental controls, including foreign exchange and currency restrictions;

    less favorable intellectual property or other applicable laws;

    the inability to obtain any necessary foreign regulatory or pricing approvals of products in a timely manner;

    the inability to obtain third party reimbursement support for products;

    product counterfeiting and intellectual property piracy;

    parallel imports;

    anti-competitive trade practices;

    import and export license requirements;

    political instability;

    terrorist activities, armed conflict, or outbreak of diseases such as severe acute respiratory syndrome (SARS) or avian influenza;

    restrictions on direct investments by foreign entities and trade restrictions;

    changes in tax laws and tariffs;

    difficulties in staffing and managing international operations; and

    longer payment cycles.

        Our operations and marketing practices are also subject to regulation and scrutiny by the governments of the other countries in which we operate. In addition, the United States Foreign Corrupt Practices Act prohibits U.S. companies and their representatives from offering, promising, authorizing or making payments to foreign officials for the purpose of obtaining or retaining business abroad. Failure to comply with domestic or foreign laws could result in various adverse consequences, including possible delay in the approval or refusal to approve a product, recalls, seizures, withdrawal of an approved product from the market, and/or the imposition of civil or criminal sanctions.

Our international sales are subject to fluctuations in currency exchange rates.

        A significant portion of our business is conducted in currencies other than our reporting currency, the U.S. dollar. We recognize foreign currency gains or losses arising from our operations in the period in which we incur those gains or losses. As a result, currency fluctuations among the U.S. dollar and the currencies in which we do business have caused foreign currency translation gains and losses in the past and will likely do so in the future. Because of the number of currencies involved, the variability of currency exposures and the potential volatility of currency exchange rates, we may suffer significant foreign currency translation losses in the future due to the effect of exchange rate fluctuations.

We may fail to adequately protect our proprietary technology, which would allow competitors or others to take advantage of our research and development efforts.

        Our long-term success largely depends on our ability to market technologically competitive products. If we fail to obtain or maintain adequate intellectual property protection in the United States or abroad, we may not be able to prevent third parties from using our proprietary technologies. Our currently pending or future patent applications may not result in issued patents. Patent applications are confidential for 18 months following their filing, and because third parties may have filed patent applications for technology covered by our pending patent applications without us being aware of those

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applications, our patent applications may not have priority over patent applications of others. In addition, our issued patents may not contain claims sufficiently broad to protect us against third parties with similar technologies or products, or provide us with any competitive advantage. If a third party initiates litigation regarding our patents, our collaborators' patents, or those patents for which we have license rights, and is successful, a court could declare our patents invalid or unenforceable or limit the scope of coverage of those patents. Governmental patent offices and courts have not consistently treated the breadth of claims allowed in biotechnology patents. If patent offices or the courts begin to allow or interpret claims more broadly, the incidence and cost of patent interference proceedings and the risk of infringement litigation will likely increase. On the other hand, if patent offices or the courts begin to allow or interpret claims more narrowly, the value of our proprietary rights may be reduced. Any changes in, or unexpected interpretations of, the patent laws may adversely affect our ability to enforce our patent position.

        We also rely upon trade secrets, proprietary know-how, and continuing technological innovation to remain competitive. We attempt to protect this information with security measures, including the use of confidentiality agreements with employees, consultants, and corporate collaborators. These individuals may breach these agreements and any remedies available to us may be insufficient to compensate for our damages. Furthermore, our trade secrets, know-how and other technology may otherwise become known or be independently discovered by our competitors.

Some of our products may face competition from lower cost generic or follow-on products in the future.

        Some of our drug products, for example Renagel, Renvela, Clolar and Hectorol, are approved under provisions of the United States Food, Drug and Cosmetic Act that render them susceptible to potential competition from generic manufacturers via the Abbreviated New Drug Application (ANDA) procedure. Generic manufacturers pursuing ANDA approval are not required to conduct costly and time-consuming clinical trials to establish the safety and efficacy of their products; rather, they are permitted to rely on the innovators data regarding safety and efficacy. Thus, generic manufacturers can sell their products at prices much lower than those charged by the innovative pharmaceutical companies who have incurred substantial expenses associated with the research and development of the drug product.

        The ANDA procedure includes provisions allowing generic manufacturers to challenge the effectiveness of the innovator's patent protection long prior to the generic manufacturer actually commercializing their products—the so-called "Paragraph IV" certification procedure. In recent years, generic manufacturers have used Paragraph IV certifications extensively to challenge patents on a wide array of innovative pharmaceuticals, and we expect this trend to continue and to implicate drug products with even relatively small total revenues.

        Other of our products, including Cerezyme, Fabrazyme, Aldurazyme, Myozyme and Campath (so-called "biotech drugs") are not currently considered susceptible to an abbreviated approval procedure, either due to current United States law or FDA practice in approving biologic products. However, the United States Congress is expected to continue to explore, and ultimately enact, legislation that would establish a procedure for the FDA to accept ANDA-like abbreviated applications for the approval of "follow-on", "biosimilar" or "comparable" biotech drugs. Such legislation has already been adopted in the European Union.

        A generic manufacturer has filed an ANDA seeking to market a generic version of Hectorol prior to the expiration dates of our patents covering that product. If this or any other manufacturer were to receive approval to sell a generic or follow-on version of one of our products, that product would become subject to increased competition and our revenues for that product would likely be impacted negatively.

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We may be required to license technology from competitors or others in order to develop and commercialize some of our products and services, and it is uncertain whether these licenses would be available.

        Third party patents may cover some of the products or services that we or our strategic partners are developing or producing. A patent is entitled to a presumption of validity and accordingly, we face significant hurdles in any challenge to a patent. In addition, even if we are successful in challenging the validity of a patent, the challenge itself may be expensive and require significant management attention.

        To the extent valid third party patent rights cover our products or services, we or our strategic collaborators would be required to seek licenses from the holders of these patents in order to manufacture, use, or sell these products and services, and payments under them would reduce our profits from these products and services. We may not be able to obtain these licenses on acceptable terms, or at all. If we fail to obtain a required license or are unable to alter the design of our technology to fall outside the scope of a third party patent, we may be unable to market some of our products and services, which would limit our profitability.

Importation of products may lower the prices we receive for our products.

        In the United States and abroad, many of our products are subject to competition from lower-priced versions of our products and competing products from other countries where government price controls or other market dynamics result in lower prices for such products. Our products that require a prescription in the United States may be available to consumers in markets such as Canada, Mexico, Taiwan and the Middle East without a prescription, which may cause consumers to further seek out these products in these lower priced markets. The ability of patients and other customers to obtain these lower priced imports has grown significantly as a result of the Internet, an expansion of pharmacies in Canada and elsewhere that target American purchasers, the increase in U.S.-based businesses affiliated with Canadian pharmacies marketing to American purchasers, and other factors. Most of these foreign imports are illegal under current United States law. However, the volume of imports continues to rise due to the limited enforcement resources of the FDA and the United States Customs Service, and there is increased political pressure to permit such imports as a mechanism for expanding access to lower priced medicines. The importation of lower-priced versions of our products into the United States and other markets adversely affects our profitability. This impact could become more significant in the future.

Legislative or regulatory changes may adversely impact our business.

        The United States government and other governments have shown significant interest in pursuing healthcare reform. Any government-adopted reform measures could adversely impact:

    the pricing of healthcare products in the United States or internationally; and

    the amount of reimbursement available from governmental agencies or other third party payors.

        New laws, regulations and judicial decisions, or new interpretations of existing laws, regulations and decisions, that relate to healthcare availability, methods of delivery or payment for products and services, or sales, marketing or pricing may cause our revenue to decline, and we may need to revise our research and development programs.

        On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (the "FDAAA") was enacted, giving the FDA enhanced post-market authority, including the authority to require post-market studies and clinical trials, labeling changes based on new safety information, and compliance with risk evaluation and mitigation strategies approved by the FDA. The FDA's exercise of its new authority could result in delays or increased costs during the period of product development, clinical trials and regulatory review and approval, increased costs to assure compliance with new post-approval regulatory requirements, and potential restrictions on the sale of approved products.

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If our strategic alliances are unsuccessful, our operating results will be negatively impacted.

        Several of our strategic initiatives involve alliances with other biotechnology and pharmaceutical companies, including a collaboration with BioMarin Pharmaceutical Inc. with respect to Aldurazyme. The success of these arrangements is largely dependent on technology and other intellectual property contributed by our strategic partners or the resources, efforts, and skills of our partners. Disputes and difficulties in such relationships are common, often due to conflicting priorities or conflicts of interest. Merger and acquisition activity may exacerbate these conflicts. The benefits of these alliances are reduced or eliminated when strategic partners:

    terminate the agreements or limit our access to the underlying intellectual property;

    fail to devote financial or other resources to the alliances and thereby hinder or delay development, manufacturing or commercialization activities;

    fail to successfully develop, manufacture or commercialize any products; or

    fail to maintain the financial resources necessary to continue financing their portion of the development, manufacturing, or commercialization costs of their own operations.

        Furthermore, payments we make under these arrangements may exacerbate fluctuations in our financial results. In addition, under some of our strategic alliances, we make milestone payments well in advance of commercialization of products with no assurance that we will ever recoup these payments. We also may make equity investments in our strategic partners, as we did with RenaMed Biologics, Inc., or RenaMed, in June 2005. Our strategic equity investments are subject to market fluctuations, access to capital and other business events, such as initial public offerings, the completion of clinical trials and regulatory approvals, which can impact the value of these investments. For example, in October 2006, RenaMed suspended clinical trials of its renal assist device which was being developed to treat patients with acute renal failure, causing us to write off our entire investment in RenaMed. If any of our other strategic equity investments decline in value and remain below cost for an extended duration, we may incur additional financial statement charges.

We may require significant additional financing, which may not be available to us on favorable terms, if at all.

        As of December 31, 2007, we had $1.5 billion in cash, cash equivalents and short- and long-term investments, excluding our investments in equity securities.

        We intend to use substantial portions of our available cash for:

    product development and marketing;

    payments related to the cash consideration due to the dissenting Bioenvision shareholders, the amount of which will be determined by the Delaware Court of Chancery;

    business combinations and strategic business initiatives, including our strategic alliance with Isis;

    the remaining $1.3 billion approved for our ongoing stock repurchase program over approximately the next 2.5 years;

    upgrading our information technology systems;

    expanding existing and constructing additional manufacturing facilities;

    expanding staff; and

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

        We may further reduce available cash reserves to pay principal and interest on outstanding debt, including our $690.0 million in principal of 1.25% convertible senior notes.

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        To satisfy our cash requirements, we may have to obtain additional financing. We may be unable to obtain any additional financing or extend any existing financing arrangements at all or on terms that we or our investors consider favorable.

Our level of indebtedness may harm our financial condition and results of operations.

        As of December 31, 2007, we had $698.0 million of outstanding indebtedness, excluding capital leases. We may incur additional indebtedness in the future. Our level of indebtedness will have several important effects on our future operations, including:

    increasing our vulnerability to adverse changes in general economic and industry conditions; and

    limiting our ability to obtain additional financing for capital expenditures, acquisitions and general corporate and other purposes.

        Our ability to make payments and interest on our indebtedness depends upon our future operating results and financial performance.

Management's Report on Internal Control Over Financial Reporting

        Our management is responsible for establishing and maintaining adequate internal control over our financial reporting. Internal control over financial reporting refers to the process designed by, or under the supervision of, our chief executive officer and chief financial officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that:

    (1)
    pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets;

    (2)
    provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures are being made only in accordance with the authorizations of management and directors; and

    (3)
    provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements.

        Under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework provided in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2007.

        We have excluded the acquisition of Bioenvision from our assessment of internal controls over financial reporting as of December 31, 2007, because we acquired Bioenvision in a purchase business combination during 2007. The Bioenvision business is a component of our Oncology reporting segment and the Bioenvision business represents less than 2% of our consolidated assets as of December 31, 2007 and has insignificant revenue for the year ended December 31, 2007.

        The effectiveness of our internal controls over financial reporting as of December 31, 2007 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which is included below.

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Report of Independent Registered Public Accounting Firm

To the Board of Directors and Shareholders of Genzyme Corporation:

        In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of operations and comprehensive income, of cash flows and of stockholders' equity present fairly, in all material respects, the financial position of Genzyme Corporation and its subsidiaries at December 31, 2007 and 2006, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2007 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2007, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company's management is responsible for these financial statements, for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying "Management's Report on Internal Control over Financial Reporting." Our responsibility is to express opinions on these financial statements and on the Company's internal control over financial reporting based on our integrated audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the financial statements included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.

        As discussed in Note M. to the consolidated financial statements, in 2006 the Company changed its method of accounting for stock-based compensation in accordance with Statement of Financial Accounting Standards No. 123R, "Share-Based Payment." As discussed in Note O., "Income Taxes," to the consolidated financial statements, in 2007 the Company changed its accounting for uncertain tax portions in accordance with Financial Accounting Standards Board Interpretation No. 48, "Accounting for Uncertainty in Income Taxes—an interpretation of FASB Statement No. 109."

        A company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.

        Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject

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to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

        As described in "Management's Report on Internal Control Over Financial Reporting," management has excluded Bioenvision, Inc. from its assessment of internal control over financial reporting as of December 31, 2007 because it was acquired by the Company in a purchase business combination during 2007. We have also excluded Bioenvision, Inc. from our audit of internal control over financial reporting. Bioenvision, Inc. is a component of the Company's Oncology reporting segment and the Bioenvision business represents less than 2% of the Company's total assets as of December 31, 2007 and less than 1% of revenues for the year ended December 31, 2007.

/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
February 29, 2008
   

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GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Statements of Operations and Comprehensive Income

(Amounts in thousands, except per share amounts)

 
  For the Years Ended December 31,
 
 
  2007
  2006
  2005
 
Revenues:                    
  Net product sales   $ 3,457,778   $ 2,887,409   $ 2,453,303  
  Net service sales     326,326     282,118     261,379  
  Research and development revenue     29,415     17,486     20,160  
   
 
 
 
    Total revenues     3,813,519     3,187,013     2,734,842  
   
 
 
 
Operating costs and expenses:                    
  Cost of products sold     715,504     536,388     462,177  
  Cost of services sold     211,826     199,283     170,475  
  Selling, general and administrative     1,187,184     1,010,400     787,839  
  Research and development     737,685     649,951     502,657  
  Amortization of intangibles     201,105     209,355     181,632  
  Purchase of in-process research and development     106,350     552,900     29,200  
  Charge for impaired goodwill         219,245      
   
 
 
 
    Total operating costs and expenses     3,159,654     3,377,522     2,133,980  
   
 
 
 
Operating income (loss)     653,865     (190,509 )   600,862  
   
 
 
 
Other income (expenses):                    
  Equity in income of equity method investments     7,398     15,705     151  
  Minority interest     3,932     10,418     11,952  
  Gains on investments in equity securities, net     13,067     73,230     5,698  
  Other     (637 )   (2,045 )   (1,535 )
  Investment income     70,196     56,001     31,429  
  Interest expense     (12,147 )   (15,478 )   (19,638 )
   
 
 
 
    Total other income     81,809     137,831     28,057  
   
 
 
 
Income (loss) before income taxes     735,674     (52,678 )   628,919  
   
 
 
 
(Provision for) benefit from income taxes     (255,481 )   35,881     (187,430 )
   
 
 
 
Net income (loss)   $ 480,193   $ (16,797 ) $ 441,489  
   
 
 
 
Net income (loss) per share:                    
  Basic   $ 1.82   $ (0.06 ) $ 1.73  
   
 
 
 
  Diluted   $ 1.74   $ (0.06 ) $ 1.65  
   
 
 
 
Weighted average shares outstanding:                    
  Basic     263,895     261,624     254,758  
   
 
 
 
  Diluted     280,767     261,624     272,224  
   
 
 
 
Comprehensive income (loss), net of tax:                    
Net income (loss)   $ 480,193   $ (16,797 ) $ 441,489  
   
 
 
 
Other comprehensive income (loss):                    
  Foreign currency translation adjustments     149,425     130,500     (122,568 )
   
 
 
 
  Gain (loss) on affiliate sale of stock, net of tax     (72 )   817     996  
   
 
 
 
  Pension liability adjustments, net of tax     1,056     (8,564 )   (4,627 )
   
 
 
 
  Other, net of tax         (680 )   561  
   
 
 
 
  Unrealized gains (losses) on securities, net of tax:                    
    Unrealized gains (losses) arising during the period, net of tax     18,050     41,504     (15,182 )
    Reclassification adjustment for gains included in net income (loss), net of tax     (8,586 )   (45,065 )   (898 )
   
 
 
 
    Unrealized gains (losses) on securities, net of tax     9,464     (3,561 )   (16,080 )
   
 
 
 
  Other comprehensive income (loss)     159,873     118,512     (141,718 )
   
 
 
 
Comprehensive income   $ 640,066   $ 101,715   $ 299,771  
   
 
 
 

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

F-67



GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Balance Sheets

(Amounts in thousands, except par value amounts)

 
  December 31,
 
 
  2007
  2006
 
ASSETS              
Current assets:              
  Cash and cash equivalents   $ 867,012   $ 492,170  
  Short-term investments     80,445     119,894  
  Accounts receivable, net     904,101     746,746  
  Inventories     439,115     374,644  
  Prepaid expenses and other current assets     154,183     119,122  
  Deferred tax assets     164,341     136,925  
   
 
 
    Total current assets     2,609,197     1,989,501  

Property, plant and equipment, net

 

 

1,968,402

 

 

1,610,593

 
Long-term investments     512,937     673,540  
Notes receivable—related party         7,290  
Goodwill     1,403,828     1,298,781  
Other intangible assets, net     1,555,652     1,492,038  
Deferred tax assets     95,664      
Investments in equity securities     89,181     66,563  
Other noncurrent assets     66,880     52,882  
   
 
 
    Total assets   $ 8,301,741   $ 7,191,188  
   
 
 
LIABILITIES AND STOCKHOLDERS' EQUITY              
Current liabilities:              
  Accounts payable   $ 128,380   $ 98,063  
  Accrued expenses     645,645     477,442  
  Income taxes payable     18,479     54,853  
  Deferred revenue and other income     13,277     14,855  
  Current portion of long-term debt and capital lease obligations     696,625     6,226  
   
 
 
    Total current liabilities     1,502,406     651,439  

Long-term debt and capital lease obligations

 

 

113,748

 

 

119,803

 
Convertible notes         690,000  
Deferred revenue—noncurrent     16,662     6,675  
Deferred tax liabilities         10,909  
Other noncurrent liabilities     55,988     51,651  
   
 
 
    Total liabilities     1,688,804     1,530,477  

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 
  Preferred stock, $0.01 par value          
  Common stock, $0.01 par value     2,660     2,630  
  Additional paid-in capital     5,385,154     5,106,274  
  Notes receivable from stockholders     (15,670 )   (15,057 )
  Accumulated earnings     826,715     312,659  
  Accumulated other comprehensive income     414,078     254,205  
   
 
 
    Total stockholders' equity     6,612,937     5,660,711  
   
 
 
    Total liabilities and stockholders' equity   $ 8,301,741   $ 7,191,188  
   
 
 

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

F-68



GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Statements of Cash Flows

(Amounts in thousands)

 
  For the Years Ended December 31,
 
 
  2007
  2006
  2005
 
Cash Flows from Operating Activities:                    
  Net income (loss)   $ 480,193   $ (16,797 ) $ 441,489  
  Reconciliation of net income (loss) to cash flows from operating activities:                    
    Depreciation and amortization     338,196     331,389     284,620  
    Stock-based compensation     190,070     208,614     444  
    Provision for bad debts     9,665     10,050     9,444  
    Purchase of in-process research and development     106,350     552,900     29,200  
    Charge for impaired goodwill         219,245      
    Equity in income of equity method investments     (7,398 )   (15,705 )   (151 )
    Minority interest     (3,932 )   (10,418 )   (11,952 )
    Gains on investments in equity securities, net     (13,067 )   (73,230 )   (5,698 )
    Deferred income tax provision (benefit)     (106,140 )   (279,795 )   15,300  
    Tax benefit from employee stock-based compensation     51,041     46,174     102,561  
    Excess tax benefits from stock-based compensation     (13,575 )   (7,114 )    
    Other     5,131     (3,433 )   3,867  
    Increase (decrease) in cash from working capital changes (excluding impact of acquired assets and assumed liabilities):                    
      Accounts receivable     (105,230 )   (120,505 )   (93,931 )
      Inventories     (15,011 )   (37,632 )   (17,241 )
      Prepaid expenses and other current assets     (23,897 )   (19,784 )   (20,230 )
      Income taxes payable     (132,314 )   50,123     (28,650 )
      Accounts payable, accrued expenses and deferred revenue     158,590     54,487     22,705  
   
 
 
 
        Cash flows from operating activities     918,672     888,569     731,777  
   
 
 
 
Cash Flows from Investing Activities:                    
    Purchases of investments     (779,932 )   (913,159 )   (1,094,576 )
    Sales and maturities of investments     985,546     926,327     962,948  
    Purchases of equity securities     (21,994 )   (7,577 )   (7,477 )
    Proceeds from sales of investments in equity securities     20,712     140,165     7,067  
    Purchases of property, plant and equipment     (412,872 )   (333,675 )   (192,461 )
    Acquisitions, net of acquired cash     (342,456 )   (568,953 )   (703,074 )
    Distributions from equity method investments     17,100     19,800     3,000  
    Payment of note receivable from Dyax Corp.      7,771          
    Purchases of other intangible assets     (60,350 )   (105,348 )   (172,092 )
    Other     (4,581 )   6,008     5,682  
   
 
 
 
        Cash flows from investing activities     (591,056 )   (836,412 )   (1,190,983 )
   
 
 
 

F-69


GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Statements of Cash Flows (Continued)

(Amounts in thousands)

 
  For the Years Ended December 31,
 
 
  2007
  2006
  2005
 
Cash Flows from Financing Activities:                    
  Proceeds from issuance of common stock     285,762     158,305     354,708  
  Repurchases of our common stock     (231,576 )        
  Excess tax benefits from stock-based compensation     13,575     7,114      
  Proceeds from draws on our 2003 revolving credit facility             350,000  
  Payments of debt and capital lease obligations     (5,909 )   (4,501 )   (478,770 )
  Increase (decrease) in bank overdrafts     (5,910 )   (21,124 )   17,951  
  Minority interest contributions     3,979     11,153     11,423  
  Other     4,702     1,210     3,261  
   
 
 
 
    Cash flows from financing activities     64,623     152,157     258,573  
   
 
 
 
Effect of exchange rate changes on cash     (17,397 )   (4,104 )   12,395  
   
 
 
 
Increase (decrease) in cash and cash equivalents     374,842     200,210     (188,238 )
Cash and cash equivalents at beginning of period     492,170     291,960     480,198  
   
 
 
 
Cash and cash equivalents at end of period   $ 867,012   $ 492,170   $ 291,960  
   
 
 
 
Supplemental disclosures of cash flows:                    
  Cash paid during the year for:                    
    Interest, net of capitalized interest   $ 5,490   $ 11,990   $ 16,266  
    Income taxes   $ 447,566   $ 154,729   $ 105,173  
Supplemental disclosures of non-cash transactions:                    
  Mergers and Acquisitions—Note C.                    
  Property, Plant and Equipment—Note G.                    
  Capital lease obligation for Genzyme Center—Note L.                    

        In conjunction with acquisitions completed since January 1, 2005, as described in Note C., "Mergers and Acquisitions," we assumed the following liabilities (amounts in thousands):

 
  For the Years Ended December 31,
 
 
  2007
  2006
  2005
 
Net cash paid for acquisitions and acquisition costs   $ (342,456 ) $ (568,953 ) $ (703,074 )
Fair value of assets acquired     226,579     13,202     640,297  
Accrual for dissenting shares     (16,128 )        
Acquired in-process research and development     125,500     552,900     29,200  
Goodwill     100,393     30,177     200,184  
Liabilities for exit activities and integration     (2,671 )   (6,348 )   (14,635 )
Income taxes payable     (72,461 )       (6,683 )
Net deferred tax assets (liabilities)     (8,210 )   2,067     (96,311 )
   
 
 
 
  Net liabilities assumed   $ 10,546   $ 23,045   $ 48,978  
   
 
 
 

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

F-70



GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Statements of Stockholders' Equity

(Amounts in thousands)

 
  Common Stock
   
   
   
  Accumulated
Other
Comprehensive
Income

   
 
 
  Additional
Paid-In
Capital

  Notes
Receivable
from Stockholders

  Accumulated
Earnings
(Deficit)

  Total
Stockholders'
Equity

 
 
  Shares
  Par Value
 
Balance, January 1, 2005   249,018   $ 2,490   $ 4,217,358   $ (13,865 ) $ (112,033 ) $ 286,206   $ 4,380,156  
Stock issued through stock option and stock purchase plans   10,133     102     354,606                 354,708  
Tax benefit from stock option exercises           102,561                 102,561  
Stock-based compensation           444                 444  
Accrued interest receivable on notes receivable from stockholders, net               (580 )           (580 )
Foreign currency translation adjustments                       (122,568 )   (122,568 )
Change in unrealized gains and losses on investments, net of tax(1)                       (16,080 )   (16,080 )
Gain on affiliate sale of stock, net of tax(2)                       996     996  
Pension liability adjustment, net of tax(3)                       (4,627 )   (4,627 )
Other           12,807             561     13,368  
Net income                   441,489         441,489  
   
 
 
 
 
 
 
 
Balance, December 31, 2005   259,151     2,592     4,687,776     (14,445 )   329,456     144,488     5,149,867  
Stock issued through stock option and stock purchase plans   3,875     38     158,267                 158,305  
Tax benefit from stock option exercises           46,174                 46,174  
Stock-based compensation           215,419                 215,419  
Accrued interest receivable on notes receivable from stockholders, net               (612 )           (612 )
Foreign currency translation adjustments                       130,500     130,500  
Change in unrealized gains and losses on investments, net of tax(1)                       (3,561 )   (3,561 )
Gain on affiliate sale of stock, net of tax(2)                       817     817  
Pension liability adjustment, net of tax(3)                       (8,564 )   (8,564 )
Adoption of FAS 158, net of tax(4)                       (8,795 )   (8,795 )
Other           (1,362 )           (680 )   (2,042 )
Net loss                   (16,797 )       (16,797 )
   
 
 
 
 
 
 
 
Balance, December 31, 2006   263,026     2,630     5,106,274     (15,057 )   312,659     254,205     5,660,711  

F-71


GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Statements of Stockholders' Equity (Continued)

(Amounts in thousands)

 
  Common Stock
   
   
   
  Accumulated
Other
Comprehensive
Income

   
 
 
  Additional
Paid-In
Capital

  Notes
Receivable
from Stockholders

  Accumulated
Earnings
(Deficit)

  Total
Stockholders'
Equity

 
 
  Shares
  Par Value
 
Stock issued through stock option and stock purchase plans   6,482     65     285,697                 285,762  
Tax benefit from stock option exercises           27,654                 27,654  
Stock-based compensation           189,661                 189,661  
Adoption of FIN 48           6,933         33,863           40,796  
Repurchases of common stock   (3,500 )   (35 )   (231,541 )               (231,576 )
Accrued interest receivable on notes receivable from stockholders               (613 )           (613 )
Foreign currency translation adjustments                       149,425     149,425  
Change in unrealized gains and losses on investments, net of tax(1)                       9,464     9,464  
Gain on affiliate sale of stock, net of tax(2)                       (72 )   (72 )
Pension liability adjustment, net of tax(3)                       1,056     1,056  
Other           476                   476  
Net income                   480,193         480,193  
   
 
 
 
 
 
 
 
Balance, December 31, 2007   266,008   $ 2,660   $ 5,385,154   $ (15,670 ) $ 826,715   $ 414,078   $ 6,612,937  
   
 
 
 
 
 
 
 

(1)
Net of $(5.2) million of tax in 2007, $2.1 million of tax in 2006 and $9.0 million of tax in 2005.

(2)
Net of $(0.1) million of tax in 2007, $(0.3) million of tax in 2006 and $(0.6) million of tax in 2005.

(3)
Net of $3.8 million of tax in 2006 and $1.9 million of tax in 2005. Tax amounts for 2007 were not significant.

(4)
Net of $3.7 million of tax in 2006.

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

F-72



GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements

NOTE A.  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

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:

    Renal, which develops, manufactures and distributes products that treat patients suffering from renal diseases, including chronic renal failure. The unit derives substantially all of its revenue from sales of Renagel (including sales of bulk sevelamer) and Hectorol;

    Therapeutics, which develops, manufactures and distributes therapeutic products, with an expanding focus on products to treat patients suffering from genetic diseases and other chronic debilitating diseases, including a family of diseases known as LSDs, and other specialty therapeutics, such as Thyrogen. The unit derives substantially all of its revenue from sales of Cerezyme, Fabrazyme, Myozyme and Thyrogen;

    Transplant, which develops, manufactures and distributes therapeutic products that address pre-transplantation, prevention and treatment of graft rejection in organ transplantation and other hematologic and auto-immune disorders. The unit derives substantially all of its revenue from sales of Thymoglobulin;

    Biosurgery, which develops, manufactures and distributes biotherapeutics and biomaterial-based products, with an emphasis on products that meet medical needs in the orthopaedics and broader surgical areas. The unit derives substantially all of its revenue from sales of Synvisc, the Sepra line of products, Carticel and MACI;

    Genetics, which provides testing services for the oncology, prenatal and reproductive markets; and

    Oncology, which develops, manufactures and distributes products for the treatment of cancer, with a focus on antibody- and small molecule-based therapies. The unit derives substantially all of its revenue from sales and royalties received on sales of Campath and Clolar and from the reimbursement of Campath development expenses.

        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."

        As a result of the acquisition of Bioenvision in 2007, our Oncology business unit, which was formerly reported combined with "Other", now meets the criteria for disclosure as a separate reporting segment. This change in presentation is retrospectively applied to all periods presented.

        We have reclassified our 2006 and 2005 segment disclosures to conform to our 2007 presentation.

Risks and Uncertainties

        We are subject to risks and uncertainties common to companies in the biotechnology industry. These risks and uncertainties may affect our future results, and include:

    our ability to successfully complete preclinical and clinical development of our products and services;

F-73


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE A.  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

    our ability to secure regulatory approvals for our products, services and manufacturing facilities, and to do so in the anticipated timeframes;

    the content and timing of submissions to and decisions made by the FDA, the EMEA and other regulatory agencies related to our products and the facilities and processes used to manufacture our products (including FDA approval of larger-scale manufacturing of Myozyme);

    our ability to satisfy the post-marketing commitments made as a condition of the marketing approvals of Fabrazyme, Aldurazyme and Myozyme;

    our ability to manufacture sufficient amounts of our products for development and commercialization activities and to do so in a timely and cost-effective manner, including our ability to manufacture Thymoglobulin that meets product specifications and in quantities to meet projected market demand;

    our reliance on third parties to provide us with materials and services in connection with the manufacture of our products;

    our ability to obtain and maintain adequate patent and other proprietary rights protection for our products and services and successfully enforce these proprietary rights;

    the scope, validity and enforceability of patents and other proprietary rights held by third parties and their impact on our ability to commercialize our products and services;

    the accuracy of our estimates of the size and characteristics of the markets to be addressed by our products and services, including growth projections;

    market acceptance of our products and services in expanded areas of use and new markets;

    our ability to identify new patients for our products and services;

    our ability to increase market penetration both outside and within the United States of our products and services;

    the accuracy of our information regarding the products and resources of our competitors and potential competitors;

    the availability of reimbursement for our products and services from third party payors, the extent of such coverage and the accuracy of our estimates of the payor mix for our products;

    our ability to effectively manage wholesaler inventories of our products and the levels of their compliance with our inventory management programs;

    our ability to establish and maintain strategic license, collaboration and distribution arrangements and to successfully manage our relationships with licensors, collaborators, distributors and partners;

    the continued funding and operation of our joint ventures by our partners;

    our use of cash in business combinations or other strategic initiatives;

    the resolution of the dispute with our insurance carriers regarding our claim for coverage under a director and officer liability insurance program;

F-74


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE A.  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

    the initiation of legal proceedings by or against us;

    the impact of changes in the exchange rate for the Euro and other currencies on our product and service revenues in future periods;

    our ability to successfully integrate the business we acquired from AnorMED;

    our ability to successfully integrate the business we acquired from Bioenvision effective October 23, 2007;

    the number of diluted shares of our stock considered outstanding, which will depend on business combination activity and our stock price;

    the estimates and input variables used in accounting for stock options and the related stock-based compensation expense;

    the outcome of our IRS and foreign tax audits; and

    the possible disruption of our operations due to terrorist activities, armed conflict, severe climate change or outbreak of diseases such as severe acute respiratory syndrome (SARS) or avian influenza, including as a result of the disruption of operations of regulatory authorities, our subsidiaries, manufacturing facilities, customers, suppliers, distributors, couriers, collaborative partners, licensees and clinical trial sites.

Basis of Presentation and Principles of Consolidation

        Our consolidated financial statements include the accounts of our wholly owned and majority owned subsidiaries. We also consolidate certain variable interest entities for which we are the primary beneficiary. For consolidated subsidiaries in which we own less than 100% interest, we record minority interest in our statements of operations for the ownership interest of the minority owner. We use the equity method to account for investments in entities in which we have a substantial ownership interest (20% to 50%) which do not require consolidation pursuant to FIN 46, or over which we exercise significant influence. Our consolidated net income includes our share of the earnings and losses of these entities. All intercompany accounts and transactions have been eliminated in consolidation.

Dividend Policy

        We have never paid a cash dividend on shares of our stock. We currently intend to retain our earnings to finance future growth and do not anticipate paying any cash dividends on our stock in the foreseeable future.

Use of Estimates

        Under accounting principles generally accepted in the United States of America, we are required to make certain estimates and assumptions that affect reported amounts of assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities in our consolidated financial statements. Our actual results could differ from these estimates.

F-75


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE A.  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

Cash and Cash Equivalents

        We value our cash and cash equivalents at cost plus accrued interest, which we believe approximates their market value. Our cash equivalents consist principally of money market funds at December 31, 2007 but on a global basis can consist of corporate, government, agency, and municipal notes with original maturities of three months or less at any time. We generally invest our cash in investment-grade securities to mitigate risk.

Investments

        We can invest our excess cash balances on a global basis in short-term and long-term marketable debt securities, which can consist of corporate, government, agency and municipal notes. As part of our strategic relationships, we may also invest in equity securities of other biotechnology companies, some of which are currently, or have been in the past, considered related parties. Other investments are accounted for as described below.

        We classify all of our marketable equity investments as available-for-sale. We classify our investments in marketable debt securities as either held-to-maturity or available-for-sale based on facts and circumstances present at the time we purchase the securities. As of each balance sheet date presented, we classified all of our investments in debt securities as available-for-sale. We report available-for-sale investments at fair value as of each balance sheet date and include any unrealized holding gains and losses (the adjustment to fair value) in stockholders' equity. Realized gains and losses are determined on the specific identification method and are included in investment income. If any adjustment to fair value reflects a decline in the value of the investment, we consider all available evidence to evaluate the extent to which the decline is "other than temporary" and mark the investment to market through a charge to our statement of operations. Investments in equity securities for which fair value is not readily determinable are carried at cost, subject to review for impairment. We classify our investments with remaining maturities of twelve months or less as short-term investments exclusive of those categorized as cash equivalents. We classify our investments with remaining maturities of greater than twelve months as long-term investments, unless we expect to sell the investment in less than 1 year.

        For additional information on our investments, please read Note I., "Investments in Marketable Securities and Strategic Equity Investments," and Note J., "Equity Method Investments."

Inventories

        We value inventories at cost or, if lower, fair value. We determine cost using the first-in, first-out method.

        We analyze our inventory levels quarterly and write down to its net realizable value:

    inventory that has become obsolete;

    inventory that has a cost basis in excess of its expected net realizable value;

    inventory in excess of expected requirements; and

    expired inventory.

F-76


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE A.  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

        We capitalize inventory produced for commercial sale, which may result in the capitalization of inventory prior to regulatory approval or prior to approval of a manufacturing facility. In no event is inventory capitalized prior to completion of a phase 3 clinical trial. If a product is not approved for sale or a manufacturing facility does not receive approval, it would likely result in the write-off of the inventory and a charge to earnings. At December 31, 2007, we did not have any inventory related to unapproved products.

Property, Plant and Equipment

        We record property, plant and equipment at cost. When we dispose of these assets, we remove the related cost and accumulated depreciation and amortization from the related accounts on our balance sheet and include any resulting gain or loss in our statement of operations.

        We generally compute depreciation using the straight-line method over the estimated useful lives of the assets. We compute economic lives as follows:

    plant and equipment—three to fifteen years;

    furniture and fixtures—five to seven years; and

    buildings—twenty to forty years.

        We evaluate the remaining life and recoverability of this equipment periodically based on the appropriate facts and circumstances.

        We amortize leasehold improvements and assets under capital leases over their useful life or, if shorter, the term of the applicable lease.

        We capitalize certain computer software and software development costs incurred in connection with developing or obtaining computer software for internal use. Capitalized software costs are included in property, plant and equipment, net on our consolidated balance sheet and amortized on a straight-line basis over the estimated useful lives of the software, which generally do not exceed 5 years.

        For products we expect to commercialize, we capitalize, to construction-in-progress, the costs we incur in validating facilities and equipment. We begin this capitalization when the validation process begins, provided that the product to be manufactured has demonstrated technological feasibility, and end this capitalization when the asset is substantially complete and ready for its intended use. These capitalized costs include incremental labor and direct material, and incremental fixed overhead and interest. We depreciate these costs using the straight-line method.

        Costs of idle production facilities, including related depreciation, are charged directly to cost of products sold.

Goodwill and Other Intangible Assets

        Our intangible assets consist of:

    goodwill;

    purchased technology rights;

    patents, trademarks and trade names;

F-77


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE A.  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

    distribution rights;

    customer lists; and

    covenants not to compete.

        We are required to perform impairment tests related to our goodwill under SFAS No. 142 annually and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable.

        We amortize intangible assets using the straight-line method over their estimated useful lives, which range between 1 and 15 years or, using the economic use method if that method results in significantly greater amortization than the straight-line method.

        For certain acquired intangible assets, we may be required to make additional payments contingent upon meeting certain sales targets. We record amortization expense for these intangibles based on estimated future sales of the related products and include in the determination of amortization all contingent payments that we believe are probable of being made. We apply this amortization model to our Synvisc distribution rights (acquired from Wyeth), our license agreement with Synpac related to Myozyme patent and technology rights and our license to two products acquired from Surgi.B. We review the sales forecasts of these products on a quarterly basis and assess the impact changes in the forecasts have on the rate of amortization and the likelihood that contingent payments will be made. Adjustments to amortization expense resulting from changes in estimated sales are reflected prospectively.

Accounting for the Impairment of Long-Lived Assets

        We periodically evaluate our long-lived assets for potential impairment under FAS 144. We perform these evaluations whenever events or changes in circumstances suggest that the carrying amount of an asset or group of assets is not recoverable. Indicators of potential impairment include:

    a significant change in the manner in which an asset is used;

    a significant decrease in the market value of an asset;

    a significant adverse change in its business or the industry in which it is sold; and

    a current period operating cash flow loss combined with a history of operating or cash flow losses or a projection or forecast that demonstrates continuing losses associated with the asset.

        If we believe an indicator of potential impairment exists, we test to determine whether impairment recognition criteria in FAS 144 have been met. We charge impairments of the long-lived assets to operations if our evaluations indicate that the carrying value of these assets is not recoverable.

Translation of Foreign Currencies

        We translate the financial statements of our foreign subsidiaries from local currency into U.S. dollars using:

    the current exchange rate at each balance sheet date for assets and liabilities;

    the average exchange rate prevailing during each period for revenues and expenses; and

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GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE A.  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

    the historical exchange rate for our investments in our foreign subsidiaries.

        We consider the local currency for all of our foreign subsidiaries to be the functional currency for that subsidiary. As a result, we include translation adjustments for these subsidiaries in stockholders' equity. We also record in stockholders' equity, exchange gains and losses on intercompany balances that are of a long-term investment nature. Our stockholders' equity includes net cumulative foreign currency translation gains of $411.0 million at December 31, 2007 and $261.5 million at December 31, 2006. Gains and losses on all other foreign currency transactions, including gains and losses attributable to foreign currency forward contracts, are included in SG&A in our results of operations and were a net gain of $5.8 million for fiscal year 2007, a net gain of $7.8 million for fiscal year 2006 and a net loss of $3.8 million for fiscal year 2005.

Derivative Instruments

        FAS 133, "Accounting for Derivative Instruments and Hedging Activities," establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other contracts, and for hedging activities. It requires that we recognize all derivative instruments as either assets or liabilities in our consolidated balance sheets and measures those instruments at fair value. Subsequent changes in fair value are reflected in current earnings or other comprehensive income (loss), depending on whether a derivative instrument is designated as part of a hedge relationship and, if it is, the type of hedge relationship.

Defined Benefit Plan Accounting

        FAS 158, "Employers' Accounting for Defined Benefit Pension and Other Postretirement Plans—an amendment of FASB Statements No. 87, 88, 106 and 132(R)," requires us to recognize the overfunded or underfunded status of any pension or other postretirement plans we may have as a net asset or a net liability on our statement of financial position and to recognize changes in that funded status in the year in which the changes occur as an adjustment to accumulated other comprehensive income in stockholders' equity. Currently, we have defined benefit pension plans for certain of our foreign subsidiaries and a defined benefit postretirement plan for one of our U.S. subsidiaries, which has been frozen since 1995 and is not significant. Under FAS 158, actuarial gains and losses, prior service costs or credits, and any remaining transition assets or obligations that have not been recognized for our defined benefit pension plans under previous accounting standards must be recognized in accumulated other comprehensive income, net of tax effects, until they are amortized as a component of net periodic benefit cost. In addition, FAS 158 requires that the measurement date, which is the date at which the benefit obligation and plan assets are measured, be as of our fiscal year end, which is December 31. We adopted FAS 158 in our fiscal year ending December 31, 2006.

        Accounting for our defined benefit plans requires management make certain assumptions relating to the following:

    long-term rate of return on plan assets;

    discount rates used to measure future obligations and interest expense;

    salary scale inflation rates; and

    other assumptions based on the terms of each individual plan.

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GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE A.  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

        We obtained actuarial reports to compute the amounts of liabilities and expenses relating to the majority of our plans subject to the assumptions that management selects as of the beginning of the plan year. Management reviews the long-term rate of return, discount, and salary scale inflation on an annual basis and makes modifications to the assumptions based on current rates and trends as appropriate.

Revenue Recognition

        We recognize revenue from product sales when persuasive evidence of an arrangement exists, the product has been shipped, title and risk of loss have passed to the customer and collection from the customer is reasonably assured. We recognize revenue from service sales, such as Carticel services and genetic testing services, when we have finished providing the service. We recognize the revenue from the contracts to perform research and development services and selling and marketing services over the term of the applicable contract and as we complete our obligations under that contract. We recognize non-refundable, up-front license fees over the related performance period or when we have no remaining performance obligations.

        Revenue from milestone payments for which we have no continuing performance obligations is recognized upon achievement of the related milestone. When we have continuing performance obligations, the milestone payments are deferred and recognized as revenue over the term of the arrangement as we complete our performance obligations.

        We evaluate revenue from agreements that have multiple elements to determine whether the components of the arrangement represent separate units of accounting as defined in EITF Issue No. 00-21, "Revenue Arrangements with Multiple Deliverables." To recognize a delivered item in a multiple element arrangement, EITF Issue No. 00-21 requires that the delivered items have value to the customer on a stand alone basis, that there is objective and reliable evidence of fair value of the undelivered items and that delivery or performance is probable and within our control for any delivered items that have a right of return.

        We follow the guidance of EITF Issue No. 99-19, "Reporting Revenue Gross as a Principal versus Net as an Agent" in the presentation of revenues and direct costs of revenues. This guidance requires us to assess whether we act as a principal in the transaction or as an agent acting on behalf of others. We record revenue transactions gross in our statements of operations if we are deemed the principal in the transaction, which includes being the primary obligor and having the risks and rewards of ownership.

        We receive royalties related to the manufacture, sale or use of our products or technologies under license arrangements with third parties. For those arrangements where royalties are reasonably estimable, we recognize revenue based on estimates of royalties earned during the applicable period and adjust for differences between the estimated and actual royalties in the following quarter. Historically, these adjustments have not been material. For those arrangements where royalties are not reasonably estimable, we recognize revenue upon receipt of royalty statements from the licensee.

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GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE A. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

        We record allowances for product returns, rebates payable to Medicaid, managed care organizations or customers, chargebacks and sales discounts. These allowances are recorded as a reduction to revenue at the time product sales are recorded. These amounts are based on our historical activity, estimates of the amount of product in the distribution channel and the percent of end-users covered by Medicaid or managed care organizations. We record consideration paid to a customer or reseller of our products as a reduction of revenue unless we receive an identifiable and separable benefit for the consideration, and we can reasonably estimate the fair value of the benefit received. If both conditions are met, we record the consideration paid to the customer as an expense.

        We maintain allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. If the financial condition of our customers was to deteriorate and result in an impairment of their ability to make payments, additional allowances may be required.

Stock-Based Compensation

        All stock-based awards to non-employees are accounted for at their fair value in accordance with FAS 123R and EITF Issue No. 96-18, "Accounting for Equity Instruments that are Issued to Other than Employees for Acquiring, or in Conjunction with Selling, Goods or Services."

        Prior to January 1, 2006, we elected to:

    account for share-based payment awards under APB 25, under which compensation expense was recorded for options issued to employees to the extent that the fair market value of our common stock exceeded the exercise price of the option at the date of grant and all other criteria for fixed accounting were met; and

    disclose the pro forma impact of expensing the fair value of our employee and director stock options and purchases made under our ESPP in the notes to our consolidated financial statements.

        Effective January 1, 2006, we adopted the provisions of:

    FAS 123R, which requires us to recognize stock-based compensation expense in our financial statements for all share-based payment awards made to employees and directors based upon the grant date fair value of those awards; and

    SAB 107, which provides guidance to public companies related to the adoption of FAS 123R.

        FAS 123R applies to stock options granted under our employee and director stock option plans, purchases made under our ESPP, and to any restricted stock or RSUs.

        We adopted FAS 123R using the modified prospective transition method, which requires us to apply the standard to new equity awards and to equity awards modified, repurchased or canceled after January 1, 2006, our adoption date. Compensation expense for the unvested portion of awards granted prior to our adoption date is:

    recognized over the requisite service period, which is generally commensurate with the vesting term; and

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GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE A. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

    based on the original grant date fair value of those awards, as calculated in our pro forma disclosures, prior to January 1, 2006, under FAS 123. Changes to the grant date fair value of equity awards granted prior to our adoption date are not permitted under FAS 123R.

        The modified prospective transition method does not allow for the restatement of prior periods. Accordingly, our results of operations for 2007 and 2006 and future periods will not be comparable to our results of operations prior to January 1, 2006 because our historical results prior to 2006 do not reflect the impact of expensing the fair value of share-based payment awards.

        Prior to January 1, 2006, in the pro forma disclosures regarding stock-based compensation included in the notes to our consolidated financial statements, we recognized forfeitures of stock options only as they occurred. Effective January 1, 2006, in accordance with the provisions of FAS 123R, we are now required to estimate an expected forfeiture rate for stock options and RSUs, which is factored into the determination of our monthly stock-based compensation expense.

        In connection with the adoption of FAS 123R, we were also required to change the classification, in our consolidated statements of cash flows, of any tax benefits realized upon the exercise of stock options in excess of that which is associated with the expense recognized for financial reporting purposes. These amounts are presented as a financing cash inflow rather than as a reduction of income taxes paid in our consolidated statements of cash flows for the years ended December 31, 2007 and 2006.

Research and Development

        We expense internal and external research and development costs, including costs of funded research and development arrangements, in the period incurred. We also expense the cost of purchased technology in the period of purchase if we believe that the technology has not demonstrated technological feasibility and that it does not have an alternative future use.

Income Taxes

        We use the asset and liability method of accounting for deferred income taxes. We are subject to income taxes in both the United States and numerous foreign jurisdictions; however, our most significant tax jurisdictions are the U.S. federal and states. Significant judgments, estimates and assumptions regarding future events, such as the amount, timing and character of income, deductions and tax credits, are required in the determination of our provision for income taxes and whether valuation allowances are required against deferred tax assets. These judgments, estimates and assumptions involve:

    interpreting the tax laws in various jurisdictions in which we operate;

    analyzing changes in tax laws, regulations, and treaties, foreign currency exchange restrictions; and

    estimating our levels of income, expenses and profits in each jurisdiction and the potential impact of that income on the tax liability in any given year.

        We operate in many jurisdictions where the tax laws relating to the pricing of transactions between related parties are open to interpretation, which could potentially result in tax authorities asserting additional tax liabilities with no offsetting tax recovery in other countries.

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GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE A. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

        Effective January 1, 2007, we adopted the provisions of FIN 48, which clarifies the accounting for income tax positions by prescribing a minimum recognition threshold that a tax position is required to meet before being recognized in the financial statements. FIN 48 also provides guidance on the derecognition of previously recognized deferred tax items, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. Under FIN 48, we recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities, based on the technical merits of the tax position. The tax benefits recognized in our consolidated financial statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution. For more information regarding the impact the adoption of FIN 48 had on our results of operations, financial condition and liquidity, see Note O., "Income Taxes," included in this report.

        We continue to recognize interest relating to unrecognized tax benefits within our provision for income taxes but have not recorded any amounts related to potential penalties. The amount of accrued interest related to unrecognized tax benefits within our provision for income taxes for the year ended December 31, 2007, and our accrued interest related to unrecognized tax benefits as of January 1, 2007 and December 31, 2007 were not significant.

Comprehensive Income (Loss)

        Comprehensive income (loss) consists of net income or loss and all changes in equity from non-shareholder sources, including changes in unrealized gains and losses on investments and on derivative instruments designated as hedges, foreign currency translation adjustments and liabilities for pension obligations, net of taxes.

Net Income (Loss) Per Share

        To calculate base earnings per share, we divide our earnings by the weighted average number of outstanding shares during the applicable period. To calculate diluted earnings per share, we also include in the denominator all potentially dilutive securities outstanding during the applicable period unless inclusion of such securities is anti-dilutive.

Recent Accounting Pronouncements

        FAS 157, "Fair Value Measurements." In September 2006, the FASB issued FAS 157, "Fair Value Measurements," which provides enhanced guidance for using fair value to measure assets and liabilities. FAS 157 establishes a common definition of fair value, provides a framework for measuring fair value under accounting principles generally accepted in the United States of America and expands disclosure requirements regarding fair value measurements. FAS 157 will be effective for us as of January 1, 2008. In February 2008, the FASB issued FSP 157-2 "Partial Deferral of the Effective Date of Statements 157," which delays the effective date of FAS 157, for all non-financial assets and non-financial liabilities, except those that are recognized or disclosed at fair value in the financials statements on a recurring basis (at least annually) to fiscal years beginning after November 15, 2008. Although we will continue to evaluate the application of FAS 157, we do not believe adoption will have a material impact on our results of operations or financial position.

        FAS 159, "The Fair Value Option for Financial Assets and Financial Liabilities—Including an Amendment of FASB Statement No. 115." In February 2007, the FASB issued FAS 159, "The Fair Value

F-83


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE A. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)


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. FAS 159 will be effective for us as of January 1, 2008. We do not expect the adoption of FAS 159 to have a material impact on our financial position and results of operations.

        EITF Issue No. 07-1, "Accounting for Collaborative Arrangements." In December 2007, the 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. Based on the nature of the arrangement, payments to or from collaborators would be evaluated and its terms, the nature of the entity's business, and whether those payments are within the scope of other accounting literature would be presented. 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 amounts related to the arrangements. Activities in the arrangement conducted in a separate legal entity should be accounted for under other accounting literature; however required disclosure under EITF 07-1 applies to the entire collaborative agreement. EITF 07-1 is effective for us January 1, 2008 and is to be applied retrospectively to all periods presented for all collaborative arrangements existing as of the effective date. We do not expect the adoption of EITF 07-1 to have a material impact 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 is effective for us January 1, 2008 and will be applied prospectively to new contracts we enter into on or after that date. Earlier application is not permitted. We do not expect the adoption of EITF No. 07-3 to 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 FAS 141R changed the method of applying the acquisition method in a number of significant aspects. Acquisition costs will generally be expensed as incurred; noncontrolling interests will be valued at fair value at the acquisition date; 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.

F-84


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE A. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

        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, with the exception of the accounting for valuation allowances on deferred taxes and acquired tax contingencies. FAS 141R amends FAS 109 such that adjustments made to valuation allowances on deferred taxes and acquired tax contingencies associated with acquisitions completed prior to the effective date of FAS 141R would also apply the provisions of FAS 141R. Early adoption is not permitted. We are currently evaluating the effects, if any, that FAS 141R may 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-controlling 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-controlling 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-controlling 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-controlling owners. FAS 160 is effective for us January 1, 2009 and adoption is prospective only; however, upon adoption, presentation and disclosure requirements described above must be applied retrospectively for all periods presented in our financial statements. We are currently evaluating the effects, if any, that FAS 160 may have on our consolidated financial statements.

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GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE B. NET INCOME (LOSS) PER SHARE

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

 
  For the Years Ended December 31,
 
  2007
  2006
  2005
Net income (loss)   $ 480,193   $ (16,797 ) $ 441,489
Effect of dilutive securities:                  
  Interest expense and debt fee amortization, net of tax, related to our 1.25% convertible senior notes     7,543         7,496
   
 
 
Net income (loss)—diluted   $ 487,736   $ (16,797 ) $ 448,985
   
 
 
Shares used in computing net income (loss) per common share—basic     263,895     261,124     254,758
Effect of dilutive securities(1):                  
  Shares issuable upon the assumed conversion of our 1.25% convertible senior notes     9,686         9,686
  Stock options(2)     7,039         7,769
  Warrants and stock purchase rights     11         11
  Restricted stock units     136        
   
 
 
    Dilutive potential common shares     16,872         17,466
   
 
 
Shares used in computing net income (loss) per common share—diluted(1,2)     280,767     261,124     272,224
   
 
 
Net income (loss) per share:(1)                  
    Basic   $ 1.82   $ (0.06 ) $ 1.73
   
 
 
    Diluted   $ 1.74   $ (0.06 ) $ 1.65
   
 
 

(1)
For the year ended December 31, 2006, basic and diluted net loss per share are the same. We did not include the securities described in the following table in the computation of diluted net loss per share because these securities would have an anti-dilutive effect due to our net loss for the period (amounts in thousands):

 
  For the Year Ended
December 31,
2006

Shares issuable upon the assumed conversion of our 1.25% convertible senior notes   9,686
Shares issuable for options   6,881
Shares issuable for warrants and stock purchase rights   11
   
  Total shares excluded from the computation of diluted loss per share   16,578
   

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GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE B. NET INCOME (LOSS) PER SHARE (Continued)

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

 
  For the Years Ended December 31,
 
  2007
  2006
  2005
Shares of Genzyme Stock issuable upon exercise of outstanding options   12,262   11,840   7,269
   
 
 

NOTE C. MERGERS AND ACQUISITIONS

2007 Acquisitions:

Diagnostic Assets of Diagnostic Chemicals Limited

        On December 3, 2007, we acquired certain diagnostic assets from 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 its diagnostics operations in Prince Edward Island, Canada and Connecticut. We paid gross consideration of $53.3 million Canadian dollars, or $53.8 million U.S. dollars (based on the December 3, 2007 spot rate for the Canadian dollar), in cash. We closed the transaction on December 3, 2007. We accounted for the acquisition as a business combination and accordingly, included its results of operations in our consolidated statements of operations from December 3, 2007, the date of acquisition.

        The purchase price was allocated to the estimated fair value of the acquired tangible and intangible assets and assumed liabilities as follows (amounts in thousands):

Initial cash payments   $ 53,261  
Cash hold back     255  
Acquisition costs     568  
   
 
Total purchase price   $ 54,084  
   
 

Accounts receivable

 

$

2,618

 
Inventory     5,179  
Property, plant and equipment     1,843  
Goodwill     15,124  
Other intangible assets (to be amortized over 5 to 10 years)     29,827  
Deferred tax assets—noncurrent     40  

Assumed liabilities:

 

 

 

 
  Deferred tax liability     (421 )
  Other     (126 )
   
 
Allocated purchase price   $ 54,084  
   
 

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GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE C. MERGERS AND ACQUISITIONS (Continued)

        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 $15.1 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 tax restructuring activities.

Bioenvision

        On May 29, 2007, we entered into an agreement and plan of merger with Bioenvision, a publicly-traded biopharmaceutical company based in New York City and Edinburgh, Scotland, and Wichita Bio Corporation, one of our wholly-owned subsidiaries, to acquire Bioenvision in an all-cash transaction valued at $11.20 per outstanding share of Bioenvision Series A Preferred Stock (plus accrued but unpaid dividends) and $5.60 per outstanding share of Bioenvision Common Stock. 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. Effective October 23, 2007, we completed the acquisition of Bioenvision the culmination of a two step process consisting of a tender offer completed in July 2007, and a merger approved in October 2007.

        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. 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 Bioenvision has 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 acute myeloid leukemia, or AML. Clofarabine has been granted orphan drug status for ALL and AML in both the United States and European Union.

    Tender Offer—Step One

        On July 10, 2007, we completed the tender offer and purchased 2,250,000 shares of Bioenvision Series A Preferred Stock for $25.2 million, which we recorded as a component of investments in equity securities, and 8,398,098 shares of Bioenvision Common Stock for $47.0 million, which we recorded as a component of other noncurrent assets in our consolidated balance sheet. As a result of the tender offer, we acquired approximately 22% of the then outstanding shares of Bioenvision Common Stock on an as-converted basis, including 100% of the outstanding Bioenvision Series A Preferred Stock.

        Our initial investments in Bioenvision Common Stock and Bioenvision Series A Preferred Stock gave us significant influence over Bioenvision and, as a result, we accounted for our investment in Bioenvision Common Stock under the equity method of accounting from July 10, 2007 through October 22, 2007. We recorded our initial $47.0 million investment in Bioenvision Common Stock as a single amount in other noncurrent assets in our consolidated balance sheet. The purchase price of our initial investment in Bioenvision Common Stock was attributed to the fair value of our 15%

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GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE C. MERGERS AND ACQUISITIONS (Continued)


proportional share of the tangible assets and liabilities of Bioenvision as of July 10, 2007. The excess of the purchase price over our proportional share of the net assets of Bioenvision as of that date was attributed to the underlying intangible assets and IPR&D, net of tax, and goodwill. The following table sets forth the purchase price allocation for our initial investment in Bioenvision Common Stock and the components of the $21.1 million of charges we recorded to equity in income of equity method investments for the period from July 10, 2007 through October 22, 2007 related to our initial investment in Bioenvision Common Stock (amounts in thousands):

 
  Investment in
Bioenvision
Common
Stock

  Equity in
Income (Loss) of
Equity Method
Investments

 
Our 15% proportional share of the tangible assets and liabilities of Bioenvision   $ 7,062   $  
Goodwill     4,008      
Other intangible assets     26,531      
IPR&D     19,150      
Deferred tax liabilities     (9,722 )    
   
 
 
Initial investment in Bioenvision Common Stock     47,029      
Effect of equity method of accounting:              
  IPR&D     (19,150 )   (19,150 )
  Our 15% proportional share of the losses of Bioenvision(1)     (1,424 )   (1,424 )
  Amortization expense(1)     (829 )   (829 )
  Deferred tax benefits(1)     302     302  
   
 
 
Total   $ 25,928   $ (21,101 )
   
 
 

      (1)
      Represents charges for the period from July 10, 2007 through October 22, 2007.

    The Merger—Step Two

        On October 22, 2007, holders of a majority of the issued and outstanding shares of Bioenvision Common Stock and Bioenvision Series A Preferred Stock, voting together as a single class on an as-converted basis, approved the merger. On October 23, 2007, we paid approximately $245 million in cash consideration to the former Bioenvision stockholders and Bioenvision Common Stock ceased trading and was delisted from The NASDAQ. In December 2007, we paid approximately $12 million in cash for the outstanding options to purchase shares of Bioenvision Common Stock. We accounted for the acquisition as a business combination and, accordingly, included its results of operations in our consolidated statements of operations from October 23, 2007, the date of acquisition.

        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 have, as a result, 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 have accounted for the merger based on 100% ownership of Bioenvision. We have accrued

F-89


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE C. MERGERS AND ACQUISITIONS (Continued)


$16.1 million, which represents our estimate of the price to be paid to the dissenting shareholders upon resolution of their appraisal demand.

        The purchase price, including amounts paid for shares of Bioenvision Common Stock and Bioenvision Series A Preferred Stock in July 2007, was allocated to the estimated fair value of the acquired tangible and intangible assets and assumed liabilities as follows (amounts in thousands, except share data):

Purchase of 52,157,771 shares of Bioenvision common stock   $ 292,084  
Purchase of 2,250,000 shares of Bioenvision preferred stock     25,200  
Buyout of stock options     11,975  
Acquisition costs     4,554  
   
 
Subtotal purchase price     333,813  
Accrual for dissenting shares     16,128  
   
 
Total purchase price   $ 349,941  
   
 
Cash and cash equivalents   $ 45,186  
Accounts receivable     5,537  
Inventory     1,684  
Other current assets     5,130  
Goodwill     85,269  
Other intangible assets (to be amortized over 9 years)     172,441  
In-process research and development     106,350  
Equity in net loss of Bioenvision pre-acquisition ownership(1)     21,101  
Other noncurrent assets     624  
Assumed liabilities:        
  Income taxes payable     (72,461 )
  Deferred tax liability—current     (2,575 )
  Deferred tax liability—noncurrent     (5,254 )
  Liabilities for exit activities     (2,671 )
  Other     (10,420 )
   
 
Allocated purchase price   $ 349,941  
   
 

      (1)
      Consists of charges recorded from July 10, 2007 through October 22, 2007 during which time we accounted for our investment in Bioenvision Common Stock under the equity method of accounting.

        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 activities and tax restructuring activities.

F-90


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE C. MERGERS AND ACQUISITIONS (Continued)

2006 and 2005 Acquisitions:

        Our 2006 and 2005 acquisitions were accounted for as business combinations and, accordingly, we included the results of operations of each acquisition in our consolidated statements of operations beginning on the date of each acquisition.

    2006:  

    On November 7, 2006, we acquired AnorMED, a publicly-held chemical-based biopharmaceutical company based in Langley, British Columbia, Canada; with a focus on the discovery, development and commercialization of new therapeutic products in the area of hematology, oncology and HIV.

    2005:  

    On July 1, 2005, we acquired Bone Care, a publicly-held specialty pharmaceutical company based in Middleton, Wisconsin; with a focus on nephrology. As part of the transaction, we acquired Hectorol, a line of vitamin D2 pro-hormone products used to treat secondary hyperparathyroidism in patients on dialysis and those with earlier stage CKD which product we have added to our Renal business.

    Other 2005 acquisitions:

    On July 15, 2005, we acquired Equal Diagnostics, a privately-held diagnostics company in Exton, Pennsylvania, that formerly served as a distributor for our clinical chemistry reagents.

    On February 8, 2005, we acquired Verigen, a private company based in Leverkusen, Germany with a proprietary cell therapy product for cartilage repair (referred to as MACI) that is currently sold in Europe and Australia.

F-91


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE C. MERGERS AND ACQUISITIONS (Continued)

        The purchase price for each of our 2006 and 2005 acquisitions was allocated to the estimated fair value of the acquired tangible and intangible assets and assumed liabilities as of the date of each acquisition as follows (amounts in thousands):

 
  Year Ended December 31, 2006
  Year Ended
December 31, 2005

 
 
  AnorMED
  Bone Care
  Other
  Total
 
Net cash paid for acquisitions, including acquisition costs   $ 589,173   $ 712,345   $ 17,965   $ 730,310  
Present value of notes payable             8,586     8,586  
Contingent purchase price liabilities             5,660     5,660  
   
 
 
 
 
Total purchase price   $ 589,173   $ 712,345   $ 32,211   $ 744,556  
   
 
 
 
 
Cash and cash equivalents   $ 20,220   $ 41,012   $ 1,424   $ 42,436  
Other current assets     6,340     97,292     7,597     104,889  
Property, plant and equipment     758     2,895     2,731     5,626  
Deferred asset—current         29,262         29,262  
Goodwill     32,349     228,836     5,344     234,180  
Other intangible assets     3,500     504,200     16,814     521,014  
Acquired in-process research and development     552,900     12,700     9,500     22,200  
Deferred tax assets—noncurrent     28,336     13,453         13,453  
Other noncurrent assets     120         1,037     1,037  
Assumed liabilities:                          
  Deferred tax liabilities     (25,288 )   (185,546 )   (4,641 )   (190,187 )
  Liabilities for exit activities and integration     (8,882 )   (11,090 )   (2,475 )   (13,565 )
  Other liabilities     (21,180 )   (20,669 )   (5,120 )   (25,789 )
   
 
 
 
 
Total purchase price allocation   $ 589,173   $ 712,345   $ 32,211   $ 744,556  
   
 
 
 
 

F-92


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE C. MERGERS AND ACQUISITIONS (Continued)

        For our acquisitions of AnorMED, Bone Care and Equal Diagnostics, the excess of the purchase price over the estimated fair value of the assets acquired and liabilities assumed, was allocated to goodwill. We expect that substantially all of the amount allocated to goodwill for these three acquisitions will be deductible for tax purposes.

        The estimated fair value of the assets acquired and liabilities assumed from Verigen exceeded our initial payments for Verigen by $5.7 million resulting in negative goodwill. Based on the development, approval and commercialization of MACI in the United States, we may be obligated to pay Verigen up to approximately $38 million through 2011. Pursuant to FAS 142, we recorded as a liability, contingent consideration up to the amount of the negative goodwill. As contingent payments related to the acquisition of Verigen come due, we will apply the payments against the contingent liability and contingent payments in excess of $5.7 million, if any, will be recorded as goodwill.

In-Process Research and Development

        In connection with six of the acquisitions we completed since between January 1, 2004 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.

        The following table sets forth the significant IPR&D projects for companies and certain assets we have acquired between January 1, 2005 and December 31, 2007 (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
Bioenvision (2007)   $ 349.9   $ 125.5   Evoltra (clofarabine)(2,3)   17 % 2008-2010
         
           

AnorMED (2006)

 

$

589.2

 

$

526.8

 

Mozobil (stem cell transplant)

 

15

%

2009-2014
            26.1   AMD070 (HIV)(4)   15 %
         
           
          $ 552.9            
         
           

Bone Care (2005)

 

$

712.3

 

$

12.7

 

LR-103 (secondary

 

 

 

 
         
  hyperparathyroidism)(5)   25 %

(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

F-93


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE C. MERGERS AND ACQUISITIONS (Continued)

    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.

(3)
Clolar is marketed for the treatment of relapsed and refractory pediatric ALL. The IPR&D projects for Clolar are related to the development of the product for the treatment of other medical issues.

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

(5)
Year of expected launch is not provided for LR-103 at this time because this program is in its early stages and we are evaluating several potential applications for LR-103 to determine which application we might pursue. Therefore, the year of expected launch cannot be determined.

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 assumed in connection with the acquisition of these entities in accordance with EITF Issue No. 95-3, "Recognition of Liabilities in Connection with a Purchase or Business Combination," and are subject to potential 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, 2005   $ 2,249   $ 199   $ 8,117   $ 10,565  
  Acquisition(1)     6,478             6,478  
  Revision of estimates     (165 )   (132 )   (750 )   (1,047 )
  Payments     (2,457 )   (43 )   (7,367 )   (9,867 )
   
 
 
 
 
Balance at December 31, 2006     6,105     24         6,129  
  Acquisition(2)     2,601         70     2,671  
  Revision of estimates     931     2,593         3,524  
  Payments     (5,602 )   (453 )       (6,055 )
   
 
 
 
 
Balance at December 31, 2007   $ 4,035   $ 2,164   $ 70   $ 6,269  
   
 
 
 
 

(1)
We expect to pay employee related benefits related to the acquisition of AnorMED through 2008 and payments related to the closing of the leased facility through January 2012.

(2)
We expect to pay employee related benefits related to the acquisition of Bioenvision through the first quarter of 2008.

F-94


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE C. MERGERS AND ACQUISITIONS (Continued)

Pro Forma Financial Summary (Unaudited)

        The following pro forma financial summary is presented as if the acquisition of Bioenvision was completed as of January 1, 2007 and 2006, and as if the acquisition of AnorMED was completed as of January 1, 2006 and 2005. The pro forma combined results are not necessarily indicative of the actual results that would have occurred had the acquisition been consummated on that date, or of the future operations of the combined entities. Material nonrecurring charges related to these acquisitions, such as IPR&D charges, are included in the pro forma financial summary for the year in which the acquisition occurred and the year prior to acquisition only. Specifically, the pro forma financial summary includes:

    for 2007 and 2006, IPR&D charges totaling $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; and

    for 2006 and 2005, $552.9 million of IPR&D charges related to the acquisition of AnorMED.

        The following table provides our pro forma summary for the years ended December 31, 2007, 2006 and 2005 (amounts in thousands, except per share amounts):

 
  2007
  2006
  2005
Total revenues   $ 3,824,600   $ 3,205,422   $ 2,735,145
Net income (loss)   $ 457,675   $ (167,545 ) $ 19,035
Net income (loss) per share:                  
  Basic   $ 1.73   $ (0.64 ) $ 0.07
  Diluted   $ 1.66   $ (0.64 ) $ 0.07
Weighted average shares outstanding:                  
  Basic     263,895     261,124     254,758
  Diluted     280,767     261,124     262,538

        Pro forma results are not presented for the acquisition of assets from DCL or the acquisitions of Equal Diagnostics, Bone Care or Verigen for the years ended December 31, 2007 and 2006 because those acquisitions individually, and in the aggregate, did not have a material effect on our results of operations in those periods.

NOTE D. DERIVATIVE FINANCIAL INSTRUMENTS

        We periodically enter into foreign currency forward contracts, all of which have a maturity of less than three years. These contracts have not been designated as hedges and accordingly, unrealized gains or losses on these contracts are reported in current earnings. The notional settlement value of foreign currency forward contracts outstanding at December 31, 2007 is $347.1 million. At December 31, 2007, these contracts had a fair value of $(15.1) million, representing an unrealized loss, which has been recorded in SG&A in our consolidated statement of operations for the year ended December 31, 2007 and in accrued expenses in our consolidated balance sheet as of December 31, 2007. The notional settlement value of foreign currency forward contracts outstanding at December 31, 2006 was $455.1 million. At December 31, 2006, these contracts had a fair value of $(1.5) million, representing an unrealized loss, which has been recorded in SG&A in our consolidated statement of operations for the year ended December 31, 2006 and in accrued expenses in our consolidated balance sheet as of December 31, 2006. At December 31, 2005, the fair value of these contracts was not significant.

F-95


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE E. ACCOUNTS RECEIVABLE

        Our trade receivables primarily represent amounts due from distributors, healthcare service providers, and companies and institutions engaged in research, development or production of pharmaceutical and biopharmaceutical products. We perform credit evaluations of our customers on an ongoing basis and generally do not require collateral. We state accounts receivable at fair value after reflecting certain allowances for bad debts, chargebacks and prompt pay discounts. The allowances were $40.3 million at December 31, 2007 and $52.6 million at December 31, 2006.

NOTE F. INVENTORIES

 
  December 31,
 
  2007
  2006
 
  (Amounts in thousands)

Raw materials   $ 120,409   $ 100,698
Work-in-process     130,812     119,510
Finished goods     187,894     154,436
   
 
Total   $ 439,115   $ 374,644
   
 

        On October 22, 2007, the FDA granted marketing approval for Renvela. At December 31, 2007, we had $22.8 million of Renvela inventory for which there is no similar amount as of December 31, 2006.

        In 2007, we recorded a total of $20.9 million of charges to cost of products sold to write off certain lots of our Thymoglobulin finished goods inventory that did not meet our specifications for saleable product, of which $11.8 million was recorded in September 2007 and $9.1 million was recorded in December 2007.

NOTE G. PROPERTY, PLANT AND EQUIPMENT

 
  December 31,
 
 
  2007
  2006
 
 
  (Amounts in thousands)

 
Plant and equipment   $ 846,974   $ 734,669  
Land and buildings     931,916     763,072  
Leasehold improvements     265,242     239,268  
Furniture and fixtures     62,238     53,689  
Construction in progress     698,824     515,307  
   
 
 
      2,805,194     2,306,005  
Less accumulated depreciation     (836,792 )   (695,412 )
   
 
 
Property, plant and equipment, net   $ 1,968,402   $ 1,610,593  
   
 
 

        Our total depreciation expense was $137.1 million in 2007, $122.0 million in 2006 and $103.0 million in 2005.

F-96


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE G. PROPERTY, PLANT AND EQUIPMENT (Continued)

        Our property, plant and equipment includes the following amounts for assets subject to capital leases (amounts in thousands):

 
  December 31, 2007
 
Building—Corporate headquarters in Cambridge, Massachusetts   $ 131,031  
Less accumulated depreciation     (37,385 )
   
 
Assets subject to capital leases, net   $ 93,646  
   
 

        We capitalize costs we have incurred in validating manufacturing equipment and facilities for products which have reached technological feasibility. Capitalized validation costs, net of accumulated depreciation, were $15.5 million at December 31, 2007 and $17.2 million at December 31, 2006.

        Net capitalized software totaled $15.5 million at December 31, 2007 and $14.2 million at December 31, 2006. Capitalized software development costs, a component of construction in progress, were $43.0 million at December 31, 2007 and $19.0 million at December 31, 2006.

        We have capitalized the following amounts of interest costs (amounts in millions):

For the Years Ended December 31,
2007

  2006
  2005
$ 14.5   $ 9.2   $ 8.9

        As of December 31, 2007, the estimated remaining cost to complete our assets under construction is approximately $900 million.

        Under certain lease agreements for our worldwide facilities, we are contractually obligated to return leased space to its original condition upon termination of the lease agreement. At the inception of a lease with such conditions, we record an asset retirement obligation liability and a corresponding capital asset in an amount equal to the estimated fair value of the obligation. In subsequent periods, for each such lease, we record interest expense to accrete the asset retirement obligation liability to full value and depreciate each capitalized asset retirement obligation asset, both over the term of the associated lease agreement. Our asset retirement obligations were not significant as of December 31, 2007 or 2006.

F-97


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE H. GOODWILL AND OTHER INTANGIBLE ASSETS

Goodwill

        The following tables contains the change in our goodwill during the years ended December 31, 2007 and 2006 (amounts in thousands):

 
  As of
December 31,
2006

  Acquisitions
  Adjustments
  As of
December 31,
2007

Renal   $ 305,528   $   $ (1,577 ) $ 303,951
Therapeutics     354,709         785     355,494
Transplant(1)     157,591         5,470     163,061
Biosurgery     7,585             7,585
Oncology(2)     445,640     85,269         530,909
Other(3)     27,728     14,916     184     42,828
   
 
 
 
Goodwill   $ 1,298,781   $ 100,185   $ 4,862   $ 1,403,828
   
 
 
 
 
 
  As of
December 31,
2005

  Acquisitions
  Adjustments
  Impairment
  As of
December 31,
2006

Renal   $ 304,492   $   $ 1,036   $   $ 305,528
Therapeutics     354,709                 354,709
Transplant(1)     128,511     29,080             157,591
Biosurgery     7,585                 7,585
Genetics(4)     218,962         283     (219,245 )  
Oncology     445,640                   445,640
Other     27,668         60         27,728
   
 
 
 
 
Goodwill   $ 1,487,567   $ 29,080   $ 1,379   $ (219,245 ) $ 1,298,781
   
 
 
 
 

(1)
Includes the goodwill and related adjustments from the acquisition of AnorMED in November 2006. The adjustments in 2007 include increases of $2.6 million to the reserve for the facility closure, $2.3 million of adjustments to the tax reserve and $1.3 million from the write off of certain fixed assets associated with the acquisition, offset by a decrease of $(0.7) million in exit activity accruals.

(2)
Includes the goodwill resulting from our acquisition of Bioenvision in 2007.

(3)
Includes the goodwill resulting from our acquisition of the diagnostic assets from DCL in 2007.

(4)
In 2006, impairment for Genetics represents the write off of the goodwill assigned to our Genetics reporting unit in accordance with FAS 142, "Goodwill and Other Intangible Assets."

        We are required to perform impairment tests related to our goodwill under FAS 142 annually, which we perform in the third quarter of each year, and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. For 2007, we completed the required annual impairment tests for our $1.3 billion of goodwill that had been recorded as of September 30, 2007 and determined that no impairment charge was required. For 2006, we completed the required annual impairment tests for our $1.5 billion of goodwill that had been recorded as of

F-98


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE H. GOODWILL AND OTHER INTANGIBLE ASSETS (Continued)


September 30, 2006 and determined that the $219.2 million of goodwill assigned to our Genetics reporting unit was impaired. Such goodwill was derived as a result of our acquisitions of substantially all of the pathology/oncology testing assets related to the Physician Services and Analytical Services business units of IMPATH in May 2004, Genetrix, Inc. in February 1996 and the minority share of IG Laboratories, Inc. in October 1995.

        We determined the fair value of the net assets of our Genetics reporting unit by discounting, to present value, its estimated future cash flows. Due to the reduction of reimbursement rates for certain test offerings and increased infrastructure costs, the discounted future cash flows of our Genetics reporting unit were negatively impacted causing the fair value of the net assets of our Genetics reporting unit to be lower than the carrying value. We calculated the fair value and determined that the goodwill assigned to our Genetics reporting unit was fully impaired and we recorded a pre-tax impairment charge of $219.2 million and $69.8 million of related tax benefits in September 2006. No additional impairment charges were required in 2006 for the remaining $1.3 billion of goodwill related to our other reporting units.

Other Intangible Assets

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

 
  As of December 31, 2007
  As of December 31, 2006
 
  Gross
Other
Intangible
Assets

  Accumulated
Amortization

  Net
Other
Intangible
Assets

  Gross
Other
Intangible
Assets

  Accumulated
Amortization

  Net
Other
Intangible
Assets

Technology(1)   $ 1,680,190   $ (545,817 ) $ 1,134,373   $ 1,505,748   $ (424,650 ) $ 1,081,098
Patents     194,560     (104,413 )   90,147     194,560     (87,063 )   107,497
Trademarks     60,634     (36,787 )   23,847     60,227     (31,439 )   28,788
License fees     90,237     (28,833 )   61,404     77,807     (20,597 )   57,210
Distribution rights(2)     307,260     (125,678 )   181,582     260,073     (85,543 )   174,530
Customer lists(3)     97,031     (33,209 )   63,822     90,783     (48,760 )   42,023
Other     2,050     (1,573 )   477     2,045     (1,153 )   892
   
 
 
 
 
 
Total   $ 2,431,962   $ (876,310 ) $ 1,555,652   $ 2,191,243   $ (699,205 ) $ 1,492,038
   
 
 
 
 
 

(1)
Includes an additional $172.4 million of intangible assets resulting from our acquisition of Bioenvision in October 2007.

(2)
Includes an additional $39.1 million in 2007 and $58.7 million in 2006 for additional payments made or accrued in connection with the reacquisition of the Synvisc sales and marketing rights from Wyeth in January 2005. In addition, we will make a series of additional contingent royalty and milestone payments to Wyeth based on the volume of Synvisc sales in the covered territories. These contingent royalty and milestone payments could extend out to June 2012, or could total a maximum of $293.7 million, whichever comes first.

(3)
Includes an additional $29.8 million of intangible assets resulting from our acquisition of the diagnostic assets from DCL in December 2007, offset in part by the write off, during the first

F-99


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE H. GOODWILL AND OTHER INTANGIBLE ASSETS (Continued)

    quarter of 2007, of $23.7 million of fully amortized customer lists, related to our acquisition of Bone Care in July 2005.

        Net technology includes $4.3 million at December 31, 2007 and $4.7 million at December 31, 2006 related to our acquisition of certain gene therapy assets from Avigen in December 2005. In addition, we may be obligated to make up to approximately $38 million of potential milestone payments based on the development and approval of, and royalty payments based on the sale of, products developed between now and 2020 that rely on the intellectual property purchased from Avigen.

        All of our other intangible assets are amortized over their estimated useful lives. The estimated future amortization expense for other intangible assets for the five succeeding fiscal years and thereafter is as follows (amounts in thousands):

Year Ended December 31,

  Estimated
Amortization
Expense(1)

2008   $ 224,706
2009     228,908
2010     241,214
2011     259,630
2012     200,692
Thereafter     569,815

      (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 regulatory approvals. These contingent payments will be recorded as intangible assets when the payments are accrued. Estimated future amortization expense also includes estimated amortization for other arrangements involving contingent payments.

F-100


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE I.  INVESTMENTS IN MARKETABLE SECURITIES AND EQUITY INVESTMENTS

Marketable Securities (amounts in thousands):

 
  December 31,
 
  2007
  2006
 
  Cost
  Market Value
  Cost
  Market Value
Cash equivalents(1):                        
  Money market funds   $ 660,648   $ 660,648   $ 222,804   $ 222,804
Short-term investments:                        
  Corporate notes     47,095     47,114     65,932     65,607
  U.S. Government agencies     33,303     33,331     21,347     21,174
  U.S. Treasury notes             33,287     33,113
   
 
 
 
      80,398     80,445     120,566     119,894
Long-term investments:                        
  Corporate notes     274,861     274,862     355,008     353,497
  U.S. Government agencies     132,464     133,979     189,372     188,148
  Fixed income fund     252     235     252     250
  U.S. Treasury notes     101,758     103,861     132,192     131,645
   
 
 
 
      509,335     512,937     676,824     673,540
   
 
 
 
Total cash equivalents, short- and long-term investments   $ 1,250,381   $ 1,254,030   $ 1,020,194   $ 1,016,238
   
 
 
 
Investments in equity securities   $ 61,291   $ 89,181   $ 45,766   $ 66,563
   
 
 
 

(1)
Cash equivalents are included as part of cash and cash equivalents on our consolidated balance sheets.

        The following table contains information regarding the range of contractual maturities of our investments in debt securities (amounts in thousands):

 
  December 31,
 
  2007
  2006
 
  Cost
  Market Value
  Cost
  Market Value
Within 1 year   $ 741,046   $ 741,093   $ 343,370   $ 342,698
1-2 years     175,433     175,016     157,682     156,944
2-10 years     333,902     337,921     519,142     516,596
   
 
 
 
    $ 1,250,381   $ 1,254,030   $ 1,020,194   $ 1,016,238
   
 
 
 

F-101


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE I.  INVESTMENTS IN MARKETABLE SECURITIES AND EQUITY INVESTMENTS (Continued)

Investments in Equity Securities

        The following table shows the investments in equity securities of unconsolidated entities as of December 31, 2007 and 2006 (amounts in thousands):

 
  December 31, 2007
  December 31, 2006
 
 
  Adjusted Cost
  Market Value
  Unrealized Gain/(Loss)
  Adjusted Cost
  Market Value
  Unrealized Gain/(Loss)
 
Publicly-held companies(1):                                      
  Dyax Corp.    $ 17,992   $ 18,190   $ 198   $ 1,096   $ 1,727   $ 631  
  ABIOMED, Inc(2)     12,185     35,861     23,676     12,185     32,539     20,354  
  Sirtris Pharmaceuticals, Inc     4,500     9,038     4,538              
  GTC Biotherapeutics, Inc.      1,973     1,455     (518 )   4,910     4,618     (292 )
  Other     183     179     (4 )   2,455     2,559     104  
   
 
 
 
 
 
 
  Total publicly-held companies     36,833     64,723     27,890     20,646     41,443     20,797  
Private equity funds(3)     19,167     19,167         16,732     16,732      
Privately-held companies(4)     5,291     5,291         8,388     8,388      
   
 
 
 
 
 
 
Total   $ 61,291   $ 89,181   $ 27,890   $ 45,766   $ 66,563   $ 20,797  
   
 
 
 
 
 
 

(1)
Marketable equity securities that have readily determinable market values are stated at market value. We record temporary unrealized gains and losses related to these investments in other comprehensive income (loss).

(2)
We consider ABIOMED to be a related party because our chairman and chief executive officer is a director of ABIOMED. As of December 31, 2007, we hold approximately 7% of the outstanding shares of ABIOMED common stock.

(3)
Our investments in private equity funds are stated at adjusted cost basis, which approximates market value.

(4)
Equity securities without readily determinable market values and for which we do not exercise significant influence are stated at cost and are periodically reviewed for impairment.

Unrealized Gains and Losses on Marketable Securities and Investments in Equity Securities

        We record unrealized holding gains and losses, net of tax, related to our investments in marketable securities and strategic investments, to the extent they are determined to be temporary, in stockholders' equity. The following table sets forth the gross amounts recorded:

 
  December 31,
 
  2007
  2006
Unrealized holding gains   $ 34.1 million   $ 21.9 million
Unrealized holding losses   $ 2.6 million   $ 5.1 million

        We also collaborate with or provide services to certain of the companies in which we hold or have held equity investments, including Dyax, Isis and BioMarin. Our relationships with Dyax and Isis are described below. Our relationship with BioMarin is described in Note J., "Equity Method Investments."

F-102


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE I.  INVESTMENTS IN MARKETABLE SECURITIES AND EQUITY INVESTMENTS (Continued)

Dyax Corp.

        In October 1998, we entered into a collaboration agreement with Dyax to develop and commercialize DX-88, one of Dyax's proprietary compounds for the treatment of chronic inflammatory diseases. In 2003, we acquired a 49.99% interest in Dyax-Genzyme LLC, formerly known as Kallikrein LLC, a joint venture with Dyax for the development of DX-88 for HAE and other chronic inflammatory diseases. As a result of the adoption of FIN 46, we consolidated the results of Dyax-Genzyme LLC.

        In February 2007, we agreed with Dyax to terminate our participation and interest in Dyax-Genzyme LLC effective February 20, 2007. In connection with this termination, we made a capital contribution of approximately $17 million in cash to Dyax-Genzyme LLC and Dyax purchased our interest in the joint venture for 4.4 million shares of Dyax common stock, valued at $16.9 million, based on the closing price of Dyax common stock on February 23, 2007. Dyax now owns all of the assets of the joint venture, including worldwide rights to develop and commercialize DX-88.

        In August 2006, we amended our $7.0 million secured promissory note receivable from Dyax to extend the maturity date from May 2007 to May 2010, eliminate the existing financial covenants and replace the original collateral on the note with a letter of credit from a major bank for $7.2 million.

        In August 2007, we received cash payments totaling $7.8 million from Dyax to settle the secured promissory note receivable from Dyax.

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 paid Isis $150.0 million to purchase five million shares of Isis common stock for $30 per share. We are working with Isis to finalize the contracts under which we will develop and commercialize mipomersen.

NOTE J.  EQUITY METHOD INVESTMENTS

        Our equity method investments are included in other noncurrent assets in our consolidated balance sheets and totaled $45.8 million at December 31, 2007 and $34.4 million at December 31, 2006.

        The following tables describe:

    our portion of the net income (loss) of each equity method investment for the periods presented, which we have recorded as income (charges) to equity in income (loss) of equity method investments in our consolidated statements of operations; and

F-103


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE J.  EQUITY METHOD INVESTMENTS (Continued)

    total net income (loss) of each equity method investment for the periods presented.

 
  Our Portion of the Net Income (Loss) of Our Equity Method Investments
  Total Income (Loss) of Our Equity Method Investments
 
Equity Method Investment

 
  2007
  2006
  2005
  2007
  2006
  2005
 
 
  (Amounts in millions)

  (Amounts in millions)

 
BioMarin/Genzyme LLC   $ 30.1   $ 18.5   $ 7.1   $ 60.2   $ 37.1   $ 14.0  
Bioenvision, Inc.(1)     (21.1 )           (9.6 )        
MG Biotherapeutics LLC     (0.9 )   (1.8 )   (4.0 )   (1.7 )   (3.6 )   (7.9 )
Other     (0.7 )   (1.0 )   (2.9 )   (7.7 )   (13.6 )   (22.3 )
   
 
 
 
 
 
 
  Totals   $ 7.4   $ 15.7   $ 0.2   $ 41.2   $ 19.9   $ (16.2 )
   
 
 
 
 
 
 

(1)
For the period from July 10, 2007 through October 22, 2007, we accounted for our initial investment in Bioenvision Common Stock under the equity method of accounting. We completed the acquisition of Bioenvision effective October 23, 2007.

        Condensed financial information for our equity method investees, excluding Bioenvision, is summarized below in aggregate:

 
  For the Years Ended December 31,
 
 
  2007
  2006
  2005
 
 
  (Amounts in thousands)

 
Revenue   $ 124,203   $ 97,060   $ 76,698  
Gross profit     97,092     72,642     52,185  
Operating expenses     (46,656 )   (53,931 )   (62,361 )
Net income (loss)     50,866     19,865     (16,251 )
 
 
  December 31,
 
  2007
  2006
 
  (Amounts in thousands)

Current assets   $ 109,936   $ 96,727
Noncurrent assets     1,098     2,297
Current liabilities     15,359     16,245
Noncurrent liabilities     4,168     7,878

BioMarin/Genzyme LLC

        Effective January 1, 2008, we restructured the relationship 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:

    hold the intellectual property relating to Aldurazyme and other collaboration products; and

    engage in research and development activities that are mutually selected and funded by BioMarin and us, the costs of which will be shared equally.

Under the restructured relationship, BioMarin/Genzyme LLC will license all intellectual property relating to Aldurazyme and other collaboration products on a royalty-free basis to BioMarin and us.

F-104


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE J.  EQUITY METHOD INVESTMENTS (Continued)


BioMarin will hold the manufacturing rights and we will hold the global marketing rights. We will pay BioMarin a tiered payment ranging from 39.5% to 50% of worldwide net product sales of Aldurazyme.

        Our portion of the net income of BioMarin/Genzyme LLC is included in equity in income of equity method investments in our consolidated statements of operations.

NOTE K.  ACCRUED EXPENSES

 
  December 31,
 
  2007
  2006
 
  (Amounts in thousands)
Compensation   $ 204,912   $ 169,350
Rebates     90,437     62,166
Bank overdraft     19,262     25,172
Other     331,034     220,754
   
 
  Total   $ 645,645   $ 477,442
   
 

NOTE L. LONG-TERM DEBT AND LEASES

Long-Term Debt, Capital Lease Obligations and Convertible Debt

        Our long-term debt, capital lease obligations and convertible debt consist of the following (amounts in thousands):

 
  December 31,
 
 
  2007
  2006
 
1.25% convertible senior notes due December 2023   $ 690,000   $ 690,000  
Revolving credit facility maturing in December 2006          
Revolving credit facility maturing in July 2011          
Notes payable     7,952     8,958  
Capital lease obligations     112,421     117,071  
   
 
 
Long-term debt, capital lease obligations and convertible debt, including current portion     810,373     816,029  
Less current portion     (696,625 )   (6,226 )
   
 
 
Noncurrent portion   $ 113,748   $ 809,803  
   
 
 

        Over the next five years and thereafter, we will be required to repay the following principal amounts of our long-term debt (excluding capital leases) (amounts in millions):

2008
  2009
  2010
  2011
  2012
  After 2012
$691.0   $ 1.1   $ 1.1   $ 1.1   $ 1.2   $ 2.5

1.25% Convertible Senior Notes

        On December 9, 2003, we completed the private placement of $690.0 million in principal of 1.25% convertible senior notes due December 1, 2023. After deducting offering costs of $17.0 million, net proceeds from the offering were approximately $673.0 million. We pay interest on these notes on June 1st and December 1st each year.

F-105


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE L. LONG-TERM DEBT AND LEASES (Continued)

        The notes are convertible into shares of Genzyme Stock at an initial conversion rate, subject to adjustment, of 14.0366 shares per $1,000 principal amount of notes (representing an initial conversion price of approximately $71.24 per share) in the following circumstances:

    if the closing sale price of Genzyme Stock for at least 20 consecutive trading days in the 30 consecutive trading day period ending on the trading day immediately preceding the day the notes are surrendered for conversion exceeds 120% of the conversion price in effect on that 30th trading day;

    during the five consecutive trading day period immediately following any 10 consecutive trading day period (the "Note Measurement Period"), if the trading price per $1,000 principal amount of notes on each trading day during the Note Measurement Period was less than 95% of the conversion value of the notes on such trading day, unless the notes are surrendered after December 1, 2018 and the closing sale price of Genzyme Stock on the trading day immediately preceding the day the notes are surrendered is greater than 100% but equal to or less than 120% of the conversion price then in effect;

    if certain specified corporate transactions have occurred, as provided in the indenture and terms of the note; or

    if we redeem the notes. We have the right to redeem the notes for cash, in whole or in part, at our sole option on and after December 1, 2008.

        Furthermore, on each of December 1, 2008, December 1, 2013 and December 1, 2018, holders of the notes may require us to purchase all or a portion of their notes at a purchase price equal to 100% of the principal amount of notes to be purchased, plus any accrued and unpaid interest to, but excluding, the purchase date. As a result, we have included the $690.0 million in principal outstanding under the notes as a component of current portion of long-term debt and capital lease obligations in our consolidated balance sheets as of December 31, 2007. We may pay the purchase price, solely at our option, in cash, shares of Genzyme Stock or a combination of cash and shares of Genzyme Stock, provided that we pay any accrued and unpaid interest in cash. The shares of Genzyme Stock will be valued at 100% of the average closing sale price of Genzyme Stock for the 10 trading days immediately preceding, and including, the third business day immediately preceding the purchase date.

        Interest expense related to these notes was $11.9 million in each of 2007, 2006 and 2005. These amounts include $3.2 million in each year for amortization of debt offering costs. The fair value of these notes was $810.4 million at December 31, 2007 and $716.8 million at December 31, 2006.

Revolving Credit Facility

        In December 2003, we entered into our 2003 revolving credit facility. On July 14, 2006, we terminated our 2003 revolving credit facility and replaced it with our 2006 revolving credit facility. The proceeds of loans under our 2006 revolving credit facility can be used to finance working capital needs and for general corporate purposes. Our 2006 revolving credit facility may be increased at any time by up to an additional $350.0 million in the aggregate, as long as no default or event of default has occurred or is continuing and certain other customary conditions are satisfied. Borrowings under our 2006 revolving credit facility will bear interest at various rates depending on the type of loan. We are required to pay a facility fee of between 7 to 20 basis points based on the aggregate commitments

F-106


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE L. LONG-TERM DEBT AND LEASES (Continued)


under our 2006 revolving credit facility, and in certain circumstances a utilization fee of 10 basis points as follows:

    revolving loans denominated in U.S. dollars or a foreign currency (other than Euros) bear interest at a variable rate equal to LIBOR for loans in U.S. dollars and a comparable index rate for foreign currency loans, plus an applicable margin;

        As of December 31, 2007, no amounts were outstanding under our 2006 revolving credit facility. The terms of our 2006 revolving credit facility include various covenants, including financial covenants that require us to meet minimum interest coverage ratios and maximum leverage ratios. As of December 31, 2007 we were in compliance with these covenants.

Notes Payable

        We assumed a $10.0 million note payable in July 2005 in connection with our acquisition of Equal Diagnostics. This note bears interest at 3.86% and is payable to three former shareholders of Equal Diagnostics over eight years in equal annual installments of $1.3 million.

Capital Leases

        We have non-cancelable capital lease obligations related to certain machinery and equipment, administrative offices and our corporate headquarters.

        Our capital lease obligation related to our corporate headquarters in Cambridge, Massachusetts requires us to make monthly payments of $1.3 million, which will be adjusted to $1.6 million in August 2013. We have recorded the value of the building and related obligations of $131.0 million in our consolidated balance sheets. The term of the lease is fifteen years and may be extended at our option for two successive ten-year periods.

        Over the next five years and thereafter, we will be required to pay the following amounts under our non-cancelable capital leases (amounts in millions):

2008   $ 15.5  
2009     15.5  
2010     15.4  
2011     15.4  
2012     15.5  
Thereafter     103.1  
   
 
  Total lease payments     180.4  
Less: interest     (68.0 )
   
 
  Total principal payments     112.4  
Less current portion     (5.4 )
   
 
  Total   $ 107.0  
   
 

F-107


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE L. LONG-TERM DEBT AND LEASES (Continued)

Operating Leases

        We lease facilities and personal property under non-cancelable operating leases with terms in excess of one year. Our total expense under operating leases was (amounts in millions):

For the Years Ended December 31,
2007
  2006
  2005
$74.3   $ 60.9   $ 49.5

        Over the next five years and thereafter, we will be required to pay the following amounts under non-cancelable operating leases (amounts in millions):

2008
  2009
  2010
  2011
  2012
  After 2012
  Total
$57.6   $ 45.9   $ 34.9   $ 27.6   $ 22.9   $ 113.4   $ 302.3

NOTE M. STOCKHOLDERS' EQUITY

Preferred Stock

 
  At December 31, 2007
  At December 31, 2006
Series
  Authorized
  Issued
  Outstanding
  Authorized
  Issued
  Outstanding
Series A Junior Participating, $0.01 par value   3,000,000       3,000,000    
Undesignated   7,000,000       7,000,000    
   
         
       
    10,000,000       10,000,000    
   
         
       

        Our charter permits us to issue shares of preferred stock at any time in one or more series. Our board of directors will establish the preferences, voting powers, qualifications, and special or relative rights or privileges of any series of preferred stock before it is issued.

Common Stock

        The following table describes the number of authorized and outstanding shares of our common stock at December 31, 2007 and 2006:

 
   
  Outstanding at December 31,
Series

   
  Authorized
  2007
  2006
Genzyme Stock, $0.01 par value   690,000,000   266,008,500   263,026,163
   
 
 

Stock Rights

        Under our shareholder rights plan, each outstanding share of Genzyme Stock also represents one preferred stock purchase right. When the stock purchase rights become exercisable, the holders of Genzyme Stock will be entitled to purchase one two-hundredth of a newly issued share of Series A Preferred Stock, $0.01 par value per share, for $150.00.

F-108


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE M. STOCKHOLDERS' EQUITY (Continued)

        Each share of Series A Preferred Stock will be entitled to a minimum preferential quarterly dividend payment of $1 per share, but will be entitled to an aggregate dividend of 100 times the cash dividend declared per share of Genzyme Stock. Each share of Series A Preferred Stock will have 100 votes and will vote together with Genzyme Stock. In the event of any merger, consolidation or other transaction in which Genzyme Stock is exchanged, each share of Series A Preferred Stock will be entitled to receive 100 times the amount received per share of Genzyme Stock.

        A stock purchase right becomes exercisable either:

    ten days after our board of directors announces that a third party has become the owner of 15% or more of the total voting power of our outstanding common stock combined; or

    ten business days after a third party announces or initiates a tender or exchange offer that would result in that party owning 15% or more of the total voting power of our outstanding common stock combined.

        In either case, the board of directors can extend the ten-day delay. These stock purchase rights expire in March 2009.

Directors' Deferred Compensation Plan

        Each member of our board of directors who is not also one of our employees may defer receipt of all or a portion of the cash compensation payable to him or her as a director and receive either cash or stock in the future. Under this plan, the director may defer his or her compensation until his or her services as a director cease or until another date specified by the director.

        Under a deferral agreement, a participant indicates the percentage of deferred compensation to allocate to cash and stock, upon which a cash deferral account and a stock deferral account are established. The cash account bears interest at the rate paid on 90-day Treasury bills with interest accruing quarterly. The stock account is for amounts invested in hypothetical shares of Genzyme Stock. These amounts are converted into hypothetical shares quarterly at the average closing price of Genzyme Stock for all trading days during the quarter.

        Distributions are paid in a lump sum or in annual installments for up to five years. Payments begin the year following a director's termination of service or, subject to certain restrictions, in a year elected by the participant. As of December 31, 2007, four of the seven eligible directors had established accounts under this plan, and three of these four directors are currently deferring their compensation. We have reserved 105,962 shares of Genzyme Stock to cover distributions credited to stock accounts under the plan. We had not made any stock distributions under this plan as of December 31, 2007. As of December 31, 2007, we have made cash distributions totaling $69,492 to one director under the terms of his deferral agreement.

Stock-Based Compensation

Equity Plans

        The purpose of each of our equity plans is to attract, retain and motivate our key employees, consultants and directors. Awards granted under these plans can be either incentive stock options (ISO), nonstatutory stock options (NSO), or RSU's, as specified in the individual plans. Shares issued as a result of stock option exercises are funded through the issuance of new shares. In May 2007,

F-109


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE M. STOCKHOLDERS' EQUITY (Continued)


shareholders approved a new 2007 Director Equity Plan, which allows for the granting of stock options, and RSUs. In May 2006, shareholders approved amendments to the 2004 Equity Incentive Plan that allow for the granting of restricted stock and RSUs in addition to stock options. The following table contains information about our equity plans:

 
   
   
  As of December 31, 2007
Plan Name
  Group
Eligible

  Type of
Award
Granted

  Awards
Reserved for
Issuance

  Awards
Outstanding

  Awards
Available
for Grant

2004 Equity Incentive Plan(1)   All key employees and consultants   ISO/NSO/RSU   35,068,397   26,470,290   8,598,107

2001 Equity Incentive Plan(1)

 

All key employees and consultants

 

ISO/NSO

 

8,956,311

 

8,775,989

 

180,322

2007 Director Equity Plan(2)

 

Non-employee board members

 

NSO

 

901,291

 

643,916

 

257,375

Assumed Options(3)

 

 

 

 

 

192,634

 

192,634

 


 

 

 

 

 

 



 



 



 

 

 

 

 

 

45,118,633

 

36,082,829

 

9,035,804

 

 

 

 

 

 



 



 



(1)
The exercise price of option grants may not be less than the fair market value at the date of grant. Option grants have a maximum term of ten years. The compensation committee of our board of directors, or its delegates as applicable, determines the terms and conditions of each option grant, including who, among eligible persons, will receive option grants, the form of payment of the exercise price, the number of shares granted, the vesting schedule and the terms of exercise. In 2007, we began granting RSUs as part of our general grant of awards to employees.

(2)
Options are automatically granted on the date of our annual shareholders meeting or at a director's initial appointment to the board, have an exercise price equal to the fair market value of Genzyme Stock on the date of grant, expire ten years after the initial grant date and vest on the date of the next annual shareholders meeting following the date of grant. As of December 31, 2007, no restricted stock or RSUs have been issued under the plan.

(3)
Consists of options we assumed through our acquisitions.

        In 2007 and 2006, we accounted for options granted to our employees and directors under the fair value method of accounting using the Black-Scholes valuation model to measure stock option expense at the date of grant. All stock option grants have an exercise price equal to the fair market value of Genzyme Stock on the date of grant and generally have a 10-year term and vest in increments, generally over four years from the date of grant, although we may grant options with different vesting terms from time to time. Upon termination of employment other than by death, disability or change of control, unvested options are cancelled, and any unexercised vested options will expire three months after the employee's termination date. Excluding our directors who are not employees, when an employee meets a retirement eligibility age of 60 with at least five years of service, upon termination (except for cause) the employee's options automatically become fully vested and will expire three years after the employee's termination date or on the original expiration date set at the time the options were granted, whichever is earlier. When a director leaves the board, unvested options are cancelled and any unexercised vested options will expire at the end of their term. We recognize stock-based compensation expense for each grant on a straight-line basis over the employee's or director's requisite service period, generally the vesting period of the award. Additionally, stock-based compensation expense related to stock options includes an estimate for pre-vesting forfeitures. Effective January 1, 2006, in connection with our adoption of FAS 123R, we recognize stock-based compensation expense immediately for awards granted to retirement eligible employees or over the period from the grant date to the date retirement eligibility is achieved, if that is expected to occur during the nominal vesting

F-110


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE M. STOCKHOLDERS' EQUITY (Continued)

period. For stock-based compensation expense recognition purposes only, grants to retirement eligible employees prior to January 1, 2006 are not subject to accelerated vesting and expense is recognized over the nominal vesting period.

        We award time-vested RSUs to employees that generally vest no sooner than one-third per year over three years on the anniversary of the date of grant, or upon the third anniversary of the date of grant, provided the employee remains continuously employed with us. Shares of Genzyme Stock will be delivered to the employee upon vesting, subject to payment of applicable withholding taxes. Time-vested RSUs awarded to our directors for service on our board of directors vest on the first anniversary of the date of grant, provided that the director continues to serve on our board of directors through the vesting date. Shares of Genzyme Stock will be delivered to the director upon vesting. The fair value of all time-vested RSUs is based on the market value of Genzyme Stock on the date of grant. We recognize compensation expense for our RSUs, including the effect of forfeitures, over the applicable service period.

ESPP

        Our 1999 ESPP allows employees to purchase our stock at a discount. Under this plan, the purchase price per share of Genzyme Stock is 85% of the lower of the fair market value of Genzyme Stock at the beginning of an enrollment period or on the purchase date. Employees working at least 20 hours per week may elect to participate in our ESPP during specified open enrollment periods, which occur twice each year shortly before the start of each new enrollment period. New enrollment periods begin on the first trading day of January and July and each enrollment period lasts two years. Employee contributions for each enrollment period are automatically used to purchase stock on behalf of each participating employee on eight pre-determined purchase dates during the two-year enrollment period, which occur once every three months, in January, April, July and October. We place limitations on the total number of shares of stock that employees can purchase under the plan in a given year. As of December 31, 2007, 7,329,391 shares of Genzyme Stock were authorized for purchase under the ESPP, of which 1,445,791 remain available.

F-111


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE M. STOCKHOLDERS' EQUITY (Continued)

Adoption of FAS 123R

        As a result of adopting FAS 123R, for the years ended December 31, 2007 and 2006, we recorded pre-tax stock-based compensation expense, net of estimated forfeitures, which were allocated based on the functional cost center of each employee as follows (amounts in thousands, except per share amounts):

 
  2007
  2006
 
Pre-tax stock-based compensation expense, net of estimated forfeitures(1):              
  Cost of products and services sold   $ (25,677 ) $ (21,430 )
  Selling, general and administrative     (106,172 )   (121,822 )
  Research and development     (58,101 )   (65,248 )
   
 
 
    Total     (189,950 )   (208,500 )
Less: tax benefit of stock options     58,148     66,331  
   
 
 
  Stock-based compensation expense, net of tax   $ (131,802 ) $ (142,169 )
   
 
 
Per basic and diluted share   $ (0.50 ) $ (0.54 )
   
 
 

      (1)
      We capitalized $13.5 million in 2007 and $15.1 million in 2006 of stock-based compensation expense to inventory, all of which is attributable to participating employees that support our manufacturing operations. We amortize stock-based compensation expense capitalized to inventory based on inventory turns.

        At December 31, 2007, there was $255.0 million of pre-tax stock-based compensation expense, net of estimated forfeitures, related to unvested awards not yet recognized which is expected to be recognized over a weighted average period of 2.1 years.

Pro Forma Information for the Period Prior to Adoption of FAS 123R

        Prior to the adoption of FAS 123R, we accounted for stock options granted to employees in accordance with APB 25 and provided the disclosures required under FAS 123 only in the notes to our financial statements. As a result, no stock-based compensation expense related to our ESPP or stock options was reflected in our net income for the year ended December 31, 2005 since all options granted had an exercise price equal to the market value of the underlying common stock on the date of grant.

F-112


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE M. STOCKHOLDERS' EQUITY (Continued)

        The following table sets forth our historical disclosure of pro forma net income and net income per share data for the year ended December 31, 2005, as if compensation expense for our stock-based compensation plans was determined in accordance with FAS 123 based on the individual grant date fair value of the awards (amounts in thousands, except per share amounts):

 
  For the Year Ended
December 31, 2005

 
Net income(1):        
As reported   $ 441,489  
  Add: employee stock-based compensation included in as reported, net of tax     280  
  Deduct: pro forma employee stock-based compensation expense, net of tax     (112,808 )
   
 
Pro forma net income   $ 328,961  
   
 
Net income per share:        
  Basic:        
    As reported   $ 1.73  
   
 
    Pro forma   $ 1.29  
   
 
  Diluted:        
    As reported   $ 1.65  
   
 
    Pro forma   $ 1.24  
   
 

      (1)
      Under FAS 123 we did not capitalize any stock-based compensation expenses to inventory.

Valuation Assumptions for Stock Option Plans and ESPP

        The employee stock-based compensation expense recognized under FAS 123R and presented in the pro forma disclosure required under FAS 123 was determined using the Black-Scholes option valuation model. Option valuation models require the input of subjective assumptions and these assumptions can vary over time. The weighted average assumptions used are as follows:

 
  For the Years Ended December 31,
 
 
  2007
  2006
  2005
 
Risk-free interest rate   4 % 5 % 4 %
Dividend yield   0 % 0 % 0 %
Expected option life (in years)—directors   7   7   5  
Expected option life (in years)—officers   6   6   5  
Expected option life (in years)—all other employees   4   4   5  
Volatility-stock options   28 % 39 % 46 %
Volatility-ESPP   23 % 27 % 28 %

F-113


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE M. STOCKHOLDERS' EQUITY (Continued)

        The risk-free interest rate is based on the U.S. Treasury yield curve in effect on the date of grant. The dividend yield percentage is zero because we do not currently pay dividends nor intend to do so during the expected option life. We used historical data from exercises of our stock options and other factors to estimate the expected option life (in years), or term, of the share-based payments granted. We determined the volatility rate for our stock options based on the expected term of the equity award granted. We determine separate volatility rates for each enrollment under our ESPP based on the period from the commencement date of each enrollment to each applicable purchase date. Stock option expense in future periods will be based upon the Black-Scholes values determined at the date of each grant or the date of each purchase under our ESPP.

Stock Option Plan Activity

        The following table contains information regarding our stock option activity for the years ended December 31, 2006 and 2007:

 
  Shares Under Option
  Weighted Average Exercise Price
  Weighted Average Remaining Contractual Term (in years)
  Aggregate Intrinsic Value
Outstanding at December 31, 2005   32,345,317   $ 47.71          
Granted   7,821,546     59.16          
Exercised   (2,976,739 )   39.57          
Forfeited and cancelled   (866,861 )   63.32          
   
               
Outstanding at December 31, 2006   36,323,263     50.48          
Granted   4,846,138     62.48          
Exercised   (5,615,041 )   43.22          
Forfeited and cancelled   (783,388 )   68.20          
   
               
Outstanding at December 31, 2007   34,770,972   $ 52.94   6.41   $ 778,857,052
   
 
         

Vested and expected to vest at December 31, 2007

 

34,191,622

 

$

52.82

 

6.38

 

$

770,388,303
   
 
         

Exercisable at December 31, 2007

 

22,740,931

 

$

49.31

 

5.42

 

$

602,139,069
   
 
         

        The following table contains information regarding the pre-tax intrinsic value of our stock options, the estimated fair value of shares vested and the weighted average grant date fair value per share of stock granted under our stock option plans for the periods presented (amounts in thousands, except per share amounts):

 
  For the Years Ended December 31,
 
  2007
  2006
  2005
Pre-tax intrinsic value of options exercised   $ 153,772   $ 81,928   $ 296,949
Weighted average grant date fair value per share of stock granted under our stock option plans   $ 19.39   $ 25.01   $ 29.73

F-114


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE M. STOCKHOLDERS' EQUITY (Continued)

        For the year ended December 31, 2007, we:

    received a total of $285.8 million of cash proceeds and recognized $51.0 million of tax benefits from the issuance of stock under our stock option plans and ESPP; and

    classified $13.6 million of excess tax benefits from stock-based compensation as a financing cash inflow in our consolidated statements of cash flows.

Time-Vested RSU Activity

        We granted RSUs for the first time in connection with our 2007 general grant to employees. The following table contains information regarding our time-vested RSUs for the year ended December 31, 2007 (shares are in thousands):

 
  Shares Under
Award

  Weighted
Average
Grant Date
Fair Value

  Weighted
Average
Remaining
Contractual
Term (in
years)

  Aggregate
Intrinsic Value

Outstanding at December 31, 2006                  
Granted   1,348,003   $ 62.16          
Released and issued                
Forfeited and cancelled   (36,146 ) $ 62.16          
   
               
Outstanding at December 31, 2007   1,311,857   $ 62.16   2.39   $ 97,654,635
   
               
Vested and expected to vest at December 31, 2007   1,238,805   $ 62.16   2.39     92,216,670
   
               
Issued at December 31, 2007                  
   
               

ESPP Activity

        The following table contains information regarding our ESPP activity for the years ended December 31, 2006 and 2007:

Shares available and issued:      
Available for purchase as of December 31, 2005   1,712,481  
Shares purchased by employees   (898,756 )
   
 
Available for purchase as of December 31, 2006   813,725  
Additional shares authorized   1,500,000  
Shares purchased by employees   (867,934 )
   
 
Available for purchase as of December 31, 2007   1,445,791  
   
 

Notes Receivable from Stockholders

        In connection with our acquisition of Biomatrix, we assumed notes receivable from certain former employees, directors and consultants of Biomatrix. 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

F-115


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE M. STOCKHOLDERS' EQUITY (Continued)


through September 2009, at which point the outstanding principal and accrued interest for each note will become payable. As of December 31, 2007, there is a total of $15.7 million outstanding for these notes, including $10.2 million of principal and $5.5 million of accrued interest, which we recorded in stockholders' equity because the notes were originally received in exchange for the issuance of stock. The amount due in 2007 of $0.4 million and the amount that became due in January 2008 of $1.1 million, both of which include interest, were not repaid, however, we are pursuing collection of these notes and the notes will continue to accrue interest until the outstanding principal and accrued interest are repaid. In the first half of 2008, an additional $8.3 million in principal will become due and payable with interest.

NOTE N. COMMITMENTS AND CONTINGENCIES

Legal Proceedings

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

        Through June 30, 2003, we had three outstanding series of common stock, which we referred to as tracking stocks; Genzyme General Stock (which we now refer to as Genzyme Stock), Biosurgery Stock and Molecular Oncology Stock. In 2003, four lawsuits were filed against us regarding the exchange of all of the outstanding shares of Biosurgery Stock for shares of Genzyme Stock in connection with the elimination of our tracking stocks in July 2003. Each of the lawsuits was a purported class action on behalf of holders of Biosurgery Stock. Three cases were filed in Massachusetts state court, and one case was filed in the United States District Court for the Southern District of New York, which we refer to as the U.S. District Court. On June 4, 2007, the Massachusetts Supreme Judicial Court reversed an order of the Massachusetts Appeals Court and affirmed dismissal of the first of the state court actions. The remaining two state court actions remained stayed while the action filed in the U.S. District Court progressed. In that action, the U.S. District Court had denied our motion to dismiss the successive amended complaints and granted plaintiffs' motion to certify a class. On August 6, 2007, we reached an agreement in principle with counsel for the plaintiff class to settle and dismiss that case for $64.0 million. The U.S. District Court entered an order approving the settlement on December 30, 2007. Because the members of the class in the New York action released all claims, the settlement and its approval, as a practical matter, resolved the two remaining actions in Massachusetts state court. Those two cases have been dismissed. As a result, we recorded a liability for the settlement payment of $64.0 million as a charge to SG&A in our consolidated statement of operations in June 2007, which we subsequently paid in August 2007. We have submitted claims to our insurers for reimbursement of portions of the expenses incurred in connection with these cases; the insurer has purported to deny coverage and therefore, we have not recorded a receivable for any potential recovery from our insurer. 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. We believe we have meritorious arguments in our current litigation matters and our view as of this report is that any outcome, either individually or in the aggregate, is not expected to be material to our financial position or results of operations.

F-116


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE O. INCOME TAXES

        Our income (loss) before income taxes and the related income tax provision (benefit) are as follows:

 
  For the Years Ended December 31,
 
 
  2007
  2006
  2005
 
 
  (Amounts in thousands)

 
Income (loss) before income taxes:                    
  Domestic   $ 753,987   $ 4,158   $ 558,434  
  Foreign     (18,313 )   (56,836 )   70,485  
   
 
 
 
    Total   $ 735,674   $ (52,678 ) $ 628,919  
   
 
 
 
Currently payable:                    
  Federal   $ 313,136   $ 119,037   $ 105,542  
  State     19,498     27,194     33,804  
  Foreign     28,986     97,684     32,784  
   
 
 
 
    Total     361,620     243,915     172,130  
   
 
 
 
Deferred:                    
  Federal     (75,931 )   (219,383 )   32,591  
  State     (10,311 )   (29,048 )   (19,282 )
  Foreign     (19,897 )   (31,365 )   1,991  
   
 
 
 
    Total     (106,139 )   (279,796 )   15,300  
   
 
 
 
Provision for (benefit from) income taxes   $ 255,481   $ (35,881 ) $ 187,430  
   
 
 
 

        Our provisions for income taxes were at rates other than the U.S. federal statutory tax rate for the following reasons:

 
  For the Years Ended December 31,
 
 
  2007
  2006
  2005
 
Tax provision at U.S. statutory rate   35.0 % (35.0 )% 35.0 %
State taxes, net   0.7   (1.7 ) 1.6  
Export sales benefits     (37.2 ) (2.8 )
Domestic manufacturing deduction   (0.5 ) (15.5 ) (1.2 )
Goodwill impairment     19.6    
Legal settlements   3.0      
Audit settlements   0.5   (62.9 )  
Stock compensation   1.3   15.8    
Tax credits   (3.5 ) (30.5 ) (4.1 )
Foreign rate differential   (2.1 ) 76.0   0.1  
Other   0.3   3.3   1.2  
   
 
 
 
Effective tax rate   34.7 % (68.1 )% 29.8 %
   
 
 
 

F-117


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE O. INCOME TAXES (Continued)

        Our effective tax rate for 2007 was impacted by:

    the charge for IPR&D of $106.4 million recorded in October 2007 in connection with our acquisition of Bioenvision, of which $100.3 million was deductible and taxed at rates other than the U.S. statutory income tax rate and $6.1 million was non-deductible;

    non-deductible stock compensation expense of $32.0 million; and

    a non-deductible charge of $64.0 million for the settlement of the Biosurgery tracking stock suit in August 2007.

        Our effective tax rates for 2006 and 2005 were impacted by:

    the deductible charge for IPR&D of $552.9 million recorded in November 2006 in connection with our acquisition of AnorMED, of which $195.7 million was taxed at rates other than the U.S. statutory tax rate;

    non-deductible stock compensation expense in 2006 of $33.2 million; and

    a charge for impaired goodwill of $219.2 million recorded in September 2006, of which $29.5 million was not deductible for tax purposes;

    the settlement of the 1996 to 1999 IRS audit and various state and foreign income tax audits. We recorded a $33.2 million tax benefit to our income tax provision primarily related to export sales benefits, tax credits and deductible intangibles from a prior period acquisition. In conjunction with those settlements, we reduced our tax reserves by approximately $13.1 million and recorded current and deferred tax benefits for the remaining portion of the settlement amounts; and

    the non-deductible IPR&D charges of $22.2 million, of which $9.5 million was recorded in the first quarter of 2005 in connection with the acquisition of Verigen and $12.7 million was recorded in the third quarter of 2005 in connection with the acquisition of Bone Care.

In addition, our overall tax rate has changed significantly due to fluctuations in our income (loss) before taxes, which was $735.7 million in 2007, $(52.7) million in 2006, and $628.9 million in 2005.

        Effective January 1, 2007, we adopted the provisions of FIN 48, which clarifies the accounting for income tax positions by prescribing a minimum recognition threshold that a tax position is required to meet before being recognized in the financial statements. FIN 48 also provides guidance on the derecognition of previously recognized deferred tax items, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. Under FIN 48, we recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities, based on the technical merits of the tax position. The tax benefits recognized in our consolidated financial statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution.

        As of December 31, 2007, we had approximately $41.8 million of total gross unrecognized tax benefits, of which approximately $32.0 million represents the amount of unrecognized tax benefits that, if recognized, would favorably affect our effective income tax rate in future periods. Management has concluded that it is not reasonably possible that the total amounts of unrecognized tax benefits will

F-118


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE O. INCOME TAXES (Continued)


significantly increase or decrease within 12 months of the reporting date. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (amounts in thousands):

Balance as of January 1, 2007   $ 36,515  
Additions to tax provisions related to the current year     9,634  
Additions to tax provisions related to prior years     829  
Reduction for tax provisions of prior years     (5,155 )
   
 
Balance as of December 31, 2007   $ 41,823  
   
 

        We continue to recognize interest and penalties related to unrecognized tax benefits, which are not significant, within our provision for income taxes.

        The components of net deferred tax assets (liabilities) are described in the following table:

 
  December 31,
 
 
  2007
  2006
 
 
  (Amounts in thousands)

 
Deferred tax assets:              
  Net operating loss carryforwards   $ 29,716   $ 22,772  
  Tax credits     15,071     14,770  
  Inventory     66,868     76,004  
  Depreciable assets     2,834     10,154  
  Stock compensation     103,709     65,459  
  Reserves, accruals and other     111,083     43,759  
   
 
 
    Total deferred tax assets     329,281     232,918  
Deferred tax liabilities:              
  Realized and unrealized capital gains     (6,292 )   (914 )
  Intangible assets     (62,984 )   (105,988 )
   
 
 
    Net deferred tax assets   $ 260,005   $ 126,016  
   
 
 

        Our ability to realize the benefit of the net deferred tax assets is dependent on our generating sufficient taxable income. While it is not assured, we believe that it is more likely than not that we will be able to realize all of our net deferred tax assets. The amount we can realize, however, could be reduced in the near term if estimates of future taxable income during the carryforward period are reduced.

        At December 31, 2007, we had for U.S. income tax purposes, net operating loss carryforwards of $6.2 million and tax credit carryforwards of $3.1 million. The net operating loss carryforwards expire between 2009 and 2014 and the tax credits begin expiring after 2015. Ownership changes, as defined under Internal Revenue Code, may have limited the amount of net operating loss carryforwards which may be utilized annually to offset future taxable income. We had foreign net operating loss carryforwards of $90.3 million as of December 31, 2007, which begin expiring after 2013.

        We are currently under IRS audit for tax years 2004 to 2005. We believe that we have provided sufficiently for all audit exposures. Favorable settlement of these audits or the expiration of the statute of limitations on the assessment of income taxes for any tax year may result in a reduction of future tax

F-119


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE O. INCOME TAXES (Continued)


provisions. Any such benefit would be recorded upon final resolution of the audit or expiration of the applicable statute of limitations.

NOTE P. BENEFIT PLANS

Defined Contribution Plans

        We have four defined contribution plans:

    the Genzyme Corporation 401(k) Plan, which we refer to as the 401(k) Plan;

    the Genzyme Surgical Products Corporation Savings and Investment Plan, which we refer to as the GSP Plan;

    the SangStat Medical Corporation 401(k) Plan, which we refer to as the SangStat Plan; and

    the Biomatrix, Inc. Retirement Plan, which we refer to as the Biomatrix Plan.

        The 401(k) Plan was established effective January 1, 1988 to provide a long-range program of systematic savings for eligible employees. Employees of Genzyme Corporation as well as our wholly-owned subsidiaries in the United States are eligible to participate in the 401(k) Plan. For 2007, eligible employees could elect, through salary reduction agreements, to have up to 18% or a maximum of $15,500 of their eligible compensation contributed on a pre-tax basis to the 401(k) Plan. We made bi-weekly matching contributions to the 401(k) Plan equal to:

    100% of the elective contributions made to the 401(k) Plan by each participant to the extent that such elective contributions do not exceed 4% of the participant's eligible compensation for such pay period; and

    50% of the amount of elective contributions made to the 401(k) Plan by the participant to the extent such elective contributions exceed 4% but do not exceed 6% of the participant's eligible compensation for such pay period.

        SG&A includes the following charges related to the 401(k) Plan, representing our matching contributions incurred in each year:

    $25.0 million in 2007;

    $23.9 million in 2006; and


    $16.0 million in 2005.

        Effective December 31, 2000, the GSP Plan and the Biomatrix Plan were frozen and the participants in these plans became eligible to participate in the 401(k) Plan.

        In September 2003, in connection with the acquisition of SangStat, we terminated the SangStat Plan. In November 2004, we received approval for the termination from the IRS, at which time all participants in the SangStat Plan became fully vested in their account balances and had the option of receiving a distribution, less applicable taxes and penalties, or transferring their balance to another qualified fund. As of December 31, 2007, the SangStat Plan had not been fully liquidated.

F-120


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE P. BENEFIT PLANS (Continued)

Defined Benefit Plans

        We have defined benefit pension plans for certain employees in countries outside the U.S. and a defined benefit post-retirement plan for one of our U.S. subsidiaries, which has been frozen since 1995 and is not significant. These plans are funded in accordance with requirements of the appropriate regulatory bodies governing each plan.

        The following table sets forth the funded status and the amounts recognized for our defined benefit pension plans outside the U.S. (amounts in thousands):

 
  December 31,
 
 
  2007
  2006
 
Change in benefit obligation:              
Projected benefit obligation, beginning of year   $ 95,385   $ 64,785  
Service cost     6,436     4,751  
Interest cost     5,064     3,487  
Plan participants' contributions     1,798     1,417  
Actuarial (gain) loss     (11,713 )   12,037  
Foreign currency exchange rate changes     2,395     10,265  
Benefits paid     (1,757 )   (1,357 )
   
 
 
Projected benefit obligation, end of year   $ 97,608   $ 95,385  
   
 
 
Change in plan assets:              
Fair value of plan assets, beginning of year   $ 63,603   $ 46,752  
Return on plan assets     3,421     6,269  
Employer contribution     3,920     3,302  
Plan participants' contributions     1,798     1,416  
Foreign currency exchange rate changes     1,082     7,097  
Benefits paid     (1,437 )   (1,233 )
   
 
 
Fair value of plan assets, end of year   $ 72,387   $ 63,603  
   
 
 
Funded status at end of year   $ (25,221 ) $ (31,782 )
   
 
 

        Amounts recognized in our consolidated balance sheets consist of (amounts in thousands):

 
  December 31,
 
 
  2007
  2006
 
Noncurrent assets   $   $  
Accrued expenses     (1,343 )   (1,297 )
Other noncurrent liabilities     (23,878 )   (30,485 )
   
 
 
Net amount recognized   $ (25,221 ) $ (31,782 )
   
 
 

F-121


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE P. BENEFIT PLANS (Continued)

        The incremental effect of applying FAS 158 on individual line items in our consolidated balance sheets as of December 31, 2006, was as follows (amounts in thousands):

 
  December 31, 2006
 
  Before
Application
of FAS 158

  FAS 158
Adjustments

  After
Application
of FAS 158

Accrued expenses   $ 476,145   $ 1,297   $ 477,442
Deferred tax liabilities     14,730     (3,821 )   10,909
Other noncurrent liabilities     40,332     11,319     51,651
Total liabilities     1,521,682     8,795     1,530,477
Accumulated other comprehensive income     263,000     (8,795 )   254,205
Total stockholders' equity     5,669,506     (8,795 )   5,660,711
Total liabilities and stockholders' equity   $ 7,191,188       $ 7,191,188

        Amounts recognized in other comprehensive income (loss) consist of (amounts in thousands):

 
  December 31,
 
 
  2007
  2006
 
Additional minimum pension liability, net of tax   $ 1,056   $ (8,564 )
   
 
 

        The amounts recognized in accumulated other comprehensive income (loss) for net actuarial gains and losses, prior service costs and transition obligations were not significant for the years ended December 31, 2007, 2006 or 2005. The estimated amounts that will be amortized from accumulated other comprehensive income (loss) at December 31, 2007 into net pre-tax periodic pension costs in 2008 is also not significant.

        We recognized the underfunded status of our defined benefit pension plans in our consolidated balance sheets as of December 31, 2006, including $12.6 million of additional minimum pension liabilities and $3.8 million of related deferred tax assets offset by an $8.8 million charge, net of tax, to accumulated other comprehensive income in stockholders' equity.

        The weighted average assumptions used in determining related obligations of pension benefit plans are shown below:

 
  December 31,
 
 
  2007
  2006
 
Weighted average assumptions:          
  Discount rate   5.79 % 5.07 %
  Rate of compensation increase   4.81 % 4.42 %

        For the year ended December 31, 2007, the discount rate used to determine the benefit obligations for our plans was based on highly rated long-term bond indices and yield curves that match the duration of each plan's benefit obligations. The bond indices and yield curve analyses include only bonds rated Aa or higher from reputable rating agencies. The discount rate represents the average of the discount rates for each plan weighted by plan liabilities as of December 31, 2007. The discount rate reflects the rate at which the pension benefits could be effectively settled.

F-122


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE P. BENEFIT PLANS (Continued)

        The weighted average assumptions used to determine the net pension expense are shown below:

 
  December 31,
 
 
  2007
  2006
  2005
 
Weighted average assumptions:              
  Discount rate   5.12 % 4.73 % 5.23 %
  Rate of return on assets   7.67 % 7.47 % 7.32 %
  Rate of compensation increase   4.44 % 3.93 % 3.92 %

        The components of net pension expense are as follows (amounts in thousands):

 
  December 31,
 
 
  2007
  2006
  2005
 
Service cost   $ 6,436   $ 4,751   $ 2,983  
Interest cost     5,063     3,488     2,761  
Expected return on plan assets     (3,411 )   (6,269 )   (8,149 )
Amortization and deferral of actuarial loss     (456 )   3,334     5,793  
   
 
 
 
Net pension expense   $ 7,632   $ 5,304   $ 3,388  
   
 
 
 

        The projected benefit obligation, accumulated benefit obligation, and fair value of plan assets for pension plans with accumulated benefit obligations in excess of plan assets are as follows (amounts in thousands):

 
  December 31,
 
  2007
  2006
Projected benefit obligation   $ 97,608   $ 95,385
Accumulated benefit obligation     86,635     82,762
Fair value of plan assets     72,387     63,603

        At December 31, 2007 and 2006, plan assets for our foreign defined pension benefit plans consist primarily of the assets of our U.K. Pension Plan. Defined pension benefit plan assets for our other foreign subsidiaries as of December 31, 2007 and 2006 were not significant.

        The investment objective of our U.K. Pension Plan is to maximize the overall return from investment income and capital appreciation without resorting to a high risk investment strategy. The plan has no employer-related investments. Our U.K. Pension Plan retains professional investment managers that invest plan assets primarily in equity securities, bonds, property, and cash and other investments, which is consistent with the plan's liability profile. The weighted average asset allocations for our U.K. Pension Plan are as follows:

 
  December 31,
 
 
  2007
  2006
 
U.K. equity securities   57 % 55 %
Other overseas equity securities   26   27  
Bonds   9   8  
Real estate   4   6  
Other   4   4  
   
 
 
  Total   100 % 100 %
   
 
 

F-123


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE P. BENEFIT PLANS (Continued)

        The assumption made for the expected return on assets is based on the benchmark allocation strategy for our U.K. Pension Plan. Returns for individual asset categories are derived from market yields at the effective date, together with, in the case of equity-type assets, allowance for the additional future return expected from such assets compared to fixed interest investments.

Contributions

        We expect to contribute approximately $4 million to our U.K. Pension Plan in 2008.

Estimated Future Benefit Payments

        We expect to pay the following benefit payments for our defined pension benefit plans outside the United States, which reflect expected future service, as appropriate (amounts in thousands):

 
  Estimated
Future
Benefit
Payments

2008   $ 1,333
2009     1,585
2010     1,525
2011     1,659
2012     2,000
2013-2017     16,745
   
  Total   $ 24,847
   

NOTE Q. 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 in Note A., under the heading "Summary of Significant Accounting Policies—Business," to these financial statements. As described in Note A., above, as a result of the acquisition of Bioenvision in 2007, our Oncology business unit, which was formerly reported combined with "Other," now meets the criteria for disclosure as a separate reporting segment. This change in presentation has been retrospectively applied for all periods presented. We have revised our 2006 and 2005 segment presentations to conform to our 2007 presentation.

F-124


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE Q. SEGMENT INFORMATION (Continued)

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

 
  For the Years Ended December 31,
 
 
  2007
  2006
  2005
 
Revenues:                    
  Renal(1)   $ 718,378   $ 608,479   $ 452,000  
  Therapeutics     1,881,268     1,520,713     1,322,034  
  Transplant(1)     175,006     155,966     145,912  
  Biosurgery     426,647     387,569     353,176  
  Genetics     285,114     240,857     222,328  
  Oncology(1)     88,348     59,387     45,076  
  Other     237,143     213,669     192,597  
  Corporate(1)     1,615     373     1,719  
   
 
 
 
    Total   $ 3,813,519   $ 3,187,013   $ 2,734,842  
   
 
 
 
Depreciation and amortization expense:                    
  Renal(1)   $ 82,466   $ 94,809   $ 66,626  
  Therapeutics     24,612     19,112     14,602  
  Transplant(1)     25,824     24,709     30,199  
  Biosurgery     71,520     73,788     69,200  
  Genetics     18,236     20,287     15,879  
  Oncology(1)     23,628     19,851     20,003  
  Other     16,721     16,962     14,560  
  Corporate(1)     75,189     61,871     53,551  
   
 
 
 
    Total   $ 338,196   $ 331,389   $ 284,620  
   
 
 
 
Equity in income (loss) of equity method investments:                    
  Renal   $   $   $  
  Therapeutics     30,065     18,508     7,076  
  Transplant             (893 )
  Biosurgery              
  Genetics              
  Oncology     (21,101 )            
  Other     (852 )   (1,814 )   (3,988 )
  Corporate     (714 )   (989 )   (2,044 )
   
 
 
 
    Total   $ 7,398   $ 15,705   $ 151  
   
 
 
 
Income (loss) before income taxes:                    
  Renal(1)   $ 275,105   $ 175,486   $ 102,739  
  Therapeutics(2)     1,199,830     1,015,375     820,921  
  Transplant(1)     (55,941 )   (542,789 )   15,495  
  Biosurgery     60,082     40,734     35,468  
  Genetics(3)     19,825     (227,796 )   (3,039 )
  Oncology(1)     (180,419 )   (52,119 )   (58,803 )
  Other     5,866     11,971     8,735  
  Corporate(1,4)     (588,674 )   (473,540 )   (292,597 )
   
 
 
 
    Total   $ 735,674   $ (52,678 ) $ 628,919  
   
 
 
 

(1)
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.

F-125


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE Q. SEGMENT INFORMATION (Continued)

    Charges for IPR&D related to these acquisitions are included in segment results in the year of acquisition. Significant acquisitions impacting the segment results above are:

Acquisition

  Date Acquired
  Business Segment(s)
  IPR&D Charge
Bioenvision   October 23, 2007   Oncology   $125.5 million
AnorMED   November 7, 2006   Transplant   $552.9 million
Bone Care   July 1, 2005   Renal/Corporate   $12.7 million
(2)
Includes a $25.0 million upfront payment made to Ceregene, Inc., or Ceregene, in June 2007 in connection with a collaboration agreement for the development and commercialization of CERE-120, a gene therapy product for the treatment of Parkinson's disease.

(3)
Loss before income taxes for Genetics for 2006 includes a $219.2 million charge for impaired goodwill recorded in September 2006.

(4)
Loss before income taxes for Corporate includes our corporate, general and administrative and corporate science activities, all of the stock-based compensation expenses as a result of the adoption of FAS 123R in 2006, as well as net gains on investments in equity securities, interest income, interest expense and other income and expense items that we do not specifically allocate to a particular reporting segment. Loss before income taxes for Corporate includes a charge of $64.0 million in 2007 for the settlement of the litigation related to the consolidation of our former tracking stocks.

    Segment Assets

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

 
  December 31,
 
  2007
  2006
  2005
Segment Assets(1):                  
  Renal   $ 1,468,428   $ 1,380,003   $ 1,344,117
  Therapeutics     1,230,128     1,094,520     972,504
  Transplant(2)     415,903     410,436     369,366
  Biosurgery     458,412     477,334     456,634
  Genetics(3)     148,787     133,839     364,469
  Oncology(4)     940,097     682,343     678,794
  Other(5)     246,496     169,000     160,261
  Corporate(6)     3,393,490     2,843,713     2,532,720
   
 
 
    Total   $ 8,301,741   $ 7,191,188   $ 6,878,865
   
 
 

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

F-126


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE Q.  SEGMENT INFORMATION (Continued)

(2)
In November 2006, we acquired AnorMED for net consideration of $569.0 million. Total assets for AnorMED as of November 7, 2006, the date of acquisition, include (amounts in millions):

 
  Amount
  Business Segment
Cash and cash equivalents   $ 20.2   Corporate
Other tangible assets     35.6   Transplant
Goodwill and other intangible assets     35.8   Transplant
   
   
Total   $ 91.6    
   
   
(3)
In September 2006, upon completion of the required annual impairment tests for our goodwill, we determined that the $219.2 million of goodwill for our Genetics reporting unit was fully impaired and, as a result, we recorded a charge of $219.2 million in our consolidated statement of operations in September 2007 to write off the goodwill for our Genetics reporting unit.

(4)
In October 2007, we acquired Bioenvision for net consideration of $304.7 million. Total assets for the acquisition as of October 23, 2007, the date of acquisition, include (amounts in millions):

 
  Amount
  Business
Segment

Cash and cash equivalents   $ 45.2   Corporate
Goodwill and other intangible assets     257.7   Oncology
Other tangible assets     13.0   Oncology
   
   
Total   $ 315.9    
   
   
(5)
In December 2007, we acquired certain diagnostic assets from DCL for net consideration of $54.1 million. Total assets for the acquisition as of December 3, 2007, the date of acquisition, include (amounts in millions):

 
  Amount
  Business
Segment

Goodwill and other intangible assets   $ 44.9   Other
Other tangible assets     10.0   Other
   
   
Total   $ 54.9    
   
   
(6)
Includes the assets related to our corporate, general and administrative operations, and corporate science activities that we do not allocate to a particular segment, including cash, cash equivalents, short-and long-term investments in debt securities, net property, plant and equipment and deferred tax assets.

F-127


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE Q.  SEGMENT INFORMATION (Continued)

        Segment assets for Corporate consist of the following (amounts in thousands):

 
  December 31,
 
  2007
  2006
  2005
Cash, cash equivalents, short- and long-term investments in debt securities   $ 1,460,394   $ 1,285,604   $ 1,089,102
Deferred tax assets, net     260,005     136,925     170,443
Property, plant & equipment, net     1,240,992     1,036,182     826,221
Investments in equity securities     89,181     66,563     135,930
Other     342,918     318,439     311,024
   
 
 
Total   $ 3,393,490   $ 2,843,713   $ 2,532,720
   
 
 

Geographic Segments

        We operate in the healthcare industry and we manufacture and market our products primarily in the United States and Europe. Our principal manufacturing facilities are located in the United States, United Kingdom, Switzerland, Republic of Ireland, France, Belgium and Germany. The following tables contain certain financial information by geographic area (amounts in thousands):

 
  For the Years Ended December 31,
 
  2007
  2006
  2005
Revenues:                  
  United States   $ 1,996,764   $ 1,728,497   $ 1,517,000
  Europe     1,238,360     990,745     858,913
  Other     578,395     467,771     358,929
   
 
 
    Total   $ 3,813,519   $ 3,187,013   $ 2,734,842
   
 
 
 
 
  December 31,
 
  2007
  2006
  2005
Long-lived assets:                  
  United States   $ 1,067,918   $ 928,547   $ 915,107
  Europe     1,044,901     801,767     611,657
  Other     11,644     7,014     5,444
   
 
 
    Total   $ 2,124,463   $ 1,737,328   $ 1,532,208
   
 
 

        Our results of operations are highly dependent on sales of Cerezyme. Sales of this product represented 30% of our total revenue in 2007, 32% of our total revenue in 2006 and 34% of our total revenue in 2005. We manufacture Cerezyme at our facility in Allston, Massachusetts and perform certain fill-finish activities at our facility in Waterford, Ireland. We sell this product directly to physicians, hospitals and treatment centers as well as through an unaffiliated distributor. Distributor sales of Cerezyme represented 17% of Cerezyme revenue in 2007, 21% in 2006 and 23% in 2005. We believe that our credit risk associated with trade receivables is mitigated as a result of the fact that this product is sold to a large number of customers over a broad geographic area.

F-128


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE Q.  SEGMENT INFORMATION (Continued)

        Sales of Renagel, including sales of bulk sevelamer, represented 16% of our total revenue in both 2007 and 2006 and 15% of our total revenue in 2005. A substantial majority of the sales of Renagel are to wholesale distributors.

NOTE R.  QUARTERLY RESULTS (Unaudited)

 
  1st Quarter
2007

  2nd Quarter
2007

  3rd Quarter
2007

  4th Quarter
2007

 
  (Amounts in thousands, except per share amounts)

Total revenues   $ 883,183   $ 933,419   $ 960,159   $ 1,036,758
Operating income(1)     195,562     128,434     219,622     110,247
Net income(1,2)     158,187     83,794     159,313     78,899
Net income per share:                        
  Basic   $ 0.60   $ 0.32   $ 0.61   $ 0.30
  Diluted   $ 0.57   $ 0.31   $ 0.58   $ 0.29
 
 
  1st Quarter 2006
  2nd Quarter 2006
  3rd Quarter 2006
  4th Quarter 2006
 
 
  (Amounts in thousands, except per share amounts)

 
Total revenues   $ 730,842   $ 793,356   $ 808,574   $ 854,241  
Operating income (loss)(3)     128,208     112,719     (47,882 )   (383,554 )
Net income (loss)(3)     100,974     134,497     15,966     (268,234 )
Net income (loss) per share:                          
  Basic   $ 0.39   $ 0.52   $ 0.06   $ (1.02 )
  Diluted   $ 0.37   $ 0.49   $ 0.06   $ (1.02 )

(1)
Includes:

for the second quarter of 2007:

a $64.0 million non-deductible charge for the final court approved settlement agreement of the litigation related to the consolidation of our former tracking stocks;

a $25.0 million pre-tax charge ($15.9 million after tax) for the up-front payment we made to Ceregene in June 2007 related to our collaboration with Ceregene for the development of a gene therapy product for Parkinson's disease;

for the third quarter of 2007, $11.8 million of pre-tax charges ($7.5 million after tax) to write off certain lots of our Thymoglobulin finished goods inventory that did not meet our specifications for saleable product; and

for the fourth quarter of 2007:

a $106.4 million pre-tax charge for IPR&D ($97.5 million after tax), related to our acquisition of Bioenvision in October 2007; and

$14.8 million of pre-tax manufacturing related charges ($9.5 million after tax), including $9.1 million of pre-tax charges to write off additional lots of our Thymoglobulin finished goods inventory that did not meet our specifications for saleable product and $5.7 million of pre-tax charges to write off costs related to the manufacture of tolevamer at our manufacturing plants in Ireland and the United Kingdom.

F-129


GENZYME CORPORATION AND SUBSIDIARIES

Notes To Consolidated Financial Statements (Continued)

NOTE R.  QUARTERLY RESULTS (Unaudited) (Continued)

(2)
Includes:

for the first quarter of 2007, a $10.8 million pre-tax gain ($8.2 million after tax) related to the sale of our investment in THP; and

for the third quarter of 2007, a $19.1 million pre-tax charge for IPR&D ($12.2 million after tax), which we recorded as equity in income (loss) of equity method investments, representing our proportionate share of the fair value of the IPR&D programs of Bioenvision following the completed tender offer in July 2007.

(3)
For the fourth quarter of 2006, includes:

a $552.9 million pre-tax charge for IPR&D ($404.3 million after tax) related to our acquisition of AnorMED in November 2006; and

a $7.9 million pre-tax charge for the settlement of a case before the Competition Appeal Tribunal in the United Kingdom relating to our homecare business in the United Kingdom.

F-130



Report of Independent Registered Public Accounting Firm on
Financial Statement Schedule

To the Board of Directors and Shareholders
of Genzyme Corporation:

        Our audits of the consolidated financial statements and of the effectiveness of internal control over financial reporting referred to in our report dated February 29, 2008 appearing in the 2007 Genzyme Corporation Annual Report (which report and consolidated financial statements are incorporated by reference in this Annual Report on Form 10-K) also included an audit of the financial statement schedule listed in Item 15(a)(2) of this Form 10-K. In our opinion, this financial statement schedule presents fairly, in all material respects, the information set forth therein when read in conjunction with the related consolidated financial statements.

/s/ PricewaterhouseCoopers LLP
   

PricewaterhouseCoopers LLP
Boston, Massachusetts
February 29, 2008

 

 

F-131


GENZYME CORPORATION

SCHEDULE II—VALUATION AND QUALIFYING ACCOUNTS
FOR THE YEARS ENDED DECEMBER 31, 2007, 2006 AND 2005

Column A
  Column B
  Column C
  Column D
  Column E
 
   
  Additions
   
   
Description

  Balance at
Beginning
of Period

  Charged to
Costs and
Expenses

  Charged to
Other
Accounts

  Deductions
  Balance at
End of
Period

Year ended December 31, 2007:                              
  Accounts receivable allowances   $ 52,563,000   $ 9,664,000   $ 10,964,000   $ 32,904,000   $ 40,287,000
  Rebates   $ 62,166,000   $   $ 149,967,000   $ 121,696,000   $ 90,437,000

Year ended December 31, 2006:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
  Accounts receivable allowances   $ 46,127,000   $ 10,050,000   $ 13,627,000   $ 17,241,000   $ 52,563,000
  Rebates   $ 50,304,000   $   $ 115,500,000   $ 103,638,000   $ 62,166,000

Year ended December 31, 2005:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
  Accounts receivable allowances   $ 42,397,000   $ 9,444,000   $ 6,702,000   $ 12,416,000   $ 46,127,000
  Rebates   $ 33,464,000   $   $ 89,713,000   $ 72,873,000   $ 50,304,000

F-132