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


FORM 10-Q


ý

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

For the quarterly period ended September 30, 2003

or

o

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

For the transition period from                               to                              

Commission file number 0-14680


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

Massachusetts
(State or other jurisdiction of
incorporation or organization)
  06-1047163
(I.R.S. Employer
Identification No.)

One Kendall Square, Cambridge, Massachusetts
(Address of principal executive offices)

 

02139
(zip code)

(617) 252-7500
(Registrant's telephone number, including area code)

        Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý    No o

        Indicate by check mark whether the Registrant is an accelerated filer (as defined by Rule 12b-2 of the Exchange Act). Yes ý    No o

        The number of shares outstanding of the issuer's common stock as of October 31, 2003:

Genzyme General Division Common Stock   224,143,145



NOTE REGARDING REFERENCES TO GENZYME DIVISIONS AND SERIES OF STOCK

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

        Through June 30, 2003, we had three operating divisions, which we refer to as follows:

        Through June 30, 2003, we also had three outstanding series of common stock. Each series was designed to reflect the value and track the performance of one of our divisions. We refer to each series of common stock as follows:

        Through June 30, 2003, we allocated earnings or losses to each series of tracking stock based on the net income or loss attributable to the corresponding division determined in accordance with accounting principles generally accepted in the United States of America, as adjusted for the allocation of tax benefits. For further information regarding our earnings allocations, please read our "Management and Accounting Policies Governing the Relationship of Genzyme's Divisions," which were filed as Exhibit 99.2 to our Annual Report on Form 10-K for the year ended December 31, 2002.

        Effective July 1, 2003, we eliminated our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Biosurgery Stock for 0.04914 of a share of Genzyme General Stock and each share of Molecular Oncology Stock for 0.05653 of a share of Genzyme General Stock. Options and warrants to purchase shares of Biosurgery Stock and options to purchase shares of Molecular Oncology Stock were converted into options and warrants to purchase shares of Genzyme General Stock. While our charter continues to designate 100,000,000 shares as Biosurgery Stock and 40,000,000 shares as Molecular Oncology Stock, no shares of either series remain outstanding, and all of our assets and liabilities that had been allocated to Genzyme Biosurgery and Genzyme Molecular Oncology are now allocated to Genzyme General. Effective July 1, 2003, we have one outstanding series of common stock, which we refer to as Genzyme General Stock.

        Effective July 1, 2003, as a result of the elimination of our tracking stock capital structure, all of our earnings or losses are now allocated to Genzyme General Stock. Earnings or losses allocated to Biosurgery Stock and Molecular Oncology Stock prior to that date remain allocated to those series of stock in the preparation of our consolidated financial statements and are not affected by the elimination of our tracking stock structure. Accordingly, earnings or losses allocated to Biosurgery Stock and Molecular Oncology Stock represent earnings allocated to those tracking stocks through June 30, 2003. Earnings or losses allocated to Genzyme General Stock through June 30, 2003 represent the earnings or losses of Genzyme General, as adjusted for the allocation of tax benefits. Earnings or losses allocated to Genzyme General Stock after June 30, 2003 represent the earnings or losses for the corporation as a whole.

        On July 1, 2003, we reclassified the Biosurgery Stock and Molecular Oncology Stock equity accounts into the Genzyme General Stock equity accounts. The elimination of our tracking stock capital structure had no effect on our consolidated net income or loss. Because we now have only one series of common stock outstanding, we rescinded the management and accounting policies that

i



governed the relationships between our former divisions. In this Quarterly Report on Form 10-Q, and future Quarterly and Annual Reports, we will not provide separate financial statements and management's discussion and analysis for each of our former divisions, but will continue to provide our consolidated financial statements and management's discussion and analysis for the corporation as a whole.

NOTE REGARDING FORWARD-LOOKING STATEMENTS

        This Form 10-Q contains forward-looking statements, including statements regarding our:

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

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        We have included more detailed descriptions of these and other risks and uncertainties in Item 2 of this report under the heading "Factors Affecting Future Operating Results." We encourage you to read those descriptions carefully. We caution investors not to place undue reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak

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only as of the date of this report (unless another date is indicated) and we undertake no obligation to update or revise the statements.

NOTE REGARDING INCORPORATION BY REFERENCE

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

NOTE REGARDING TRADEMARKS

        Genzyme®, Cerezyme®, Fabrazyme®, Thyrogen®, Renagel®, Seprafilm®, Sepragel®, Carticel®, Epicel®, Synvisc® and Hylaform® are registered trademarks of Genzyme. Myozyme™ and Sepra™ are trademarks of Genzyme. Thymoglobulin® and Lymphoglobuline® are registered trademarks of SangStat Medical Corporation. FocalSeal® is a registered trademark of Focal, Inc. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC. WelChol® is a registered trademark of Sankyo Pharma, Inc. Zavesca® is a registered trademark of Celltech Group plc. TUMS® is a registered trademark of GlaxoSmithKline plc. PhosLo® is a registered trademark of Nabi Biopharmaceuticals. Replagal™ is a trademark of Transkaryotic Therapies, Inc. All rights reserved.

iv


GENZYME CORPORATION AND SUBSIDIARIES

FORM 10-Q, SEPTEMBER 30, 2003
TABLE OF CONTENTS

 
   
  PAGE NO.
PART I.   FINANCIAL INFORMATION    

ITEM 1.

 

Financial Statements

 

1

 

 

Unaudited, Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2003 and 2002

 

1
    Unaudited, Consolidated Balance Sheets as of September 30, 2003 and December 31, 2002   3
    Unaudited, Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2003 and 2002   4
    Notes to Unaudited, Consolidated Financial Statements   5

ITEM 2.

 

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

 

28

ITEM 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

66

ITEM 4.

 

Controls and Procedures

 

66

PART II.

 

OTHER INFORMATION

 

 

ITEM 1.

 

Legal Proceedings

 

67

ITEM 6.

 

Exhibits and Reports on Form 8-K

 

68

Signatures

 

69

v



PART 1.     Financial Information

ITEM 1.    Financial Statements

GENZYME CORPORATION AND SUBSIDIARIES
Consolidated Statements of Operations
(Unaudited, amounts in thousands)

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
 
  2003
  2002
  2003
  2002
 
Revenues:                          
  Net product sales   $ 394,285   $ 308,190   $ 1,124,006   $ 874,796  
  Net service sales     33,888     28,871     96,936     83,578  
  Revenues from research and development contracts:                          
    Related parties     714     649     1,836     2,045  
    Other     8,091     2,456     14,962     9,879  
   
 
 
 
 
      Total revenues     436,978     340,166     1,237,740     970,298  
   
 
 
 
 
Operating costs and expenses:                          
  Cost of products sold     95,210     76,299     290,350     224,975  
  Cost of services sold     19,653     17,342     55,902     48,799  
  Selling, general and administrative     127,340     115,514     372,371     329,354  
  Research and development (including research and development related to contracts)     82,974     74,698     237,668     232,773  
  Amortization of intangibles     19,267     17,583     54,413     52,766  
  Purchase of in-process research and development     158,000     1,879     158,000     1,879  
  Charge for impairment of goodwill             102,792      
  Charge for impaired assets     7,996     8,958     10,894     8,958  
   
 
 
 
 
      Total operating costs and expenses     510,440     312,273     1,282,390     899,504  
   
 
 
 
 
Operating income (loss)     (73,462 )   27,893     (44,650 )   70,794  
   
 
 
 
 
Other income (expenses):                          
  Equity in net loss of unconsolidated affiliates     (5,503 )   (2,387 )   (14,501 )   (10,429 )
  Gain (loss) on investments in equity securities     1,183     29     (2,437 )   538  
  Loss on sale of product line             (29,367 )    
  Other     (338 )   (234 )   1,181     729  
  Investment income     11,422     12,956     35,464     39,017  
  Interest expense     (4,382 )   (6,602 )   (17,207 )   (20,467 )
   
 
 
 
 
      Total other income (expenses)     2,382     3,762     (26,867 )   9,388  
   
 
 
 
 
Income (loss) before income taxes     (71,080 )   31,655     (71,517 )   80,182  
Provision for income taxes     (24,653 )   (6,600 )   (53,377 )   (20,031 )
   
 
 
 
 
Net income (loss) before cumulative effect of change in accounting for goodwill     (95,733 )   25,055     (124,894 )   60,151  
Cumulative effect of change in accounting for goodwill                 (98,270 )
   
 
 
 
 
Net income (loss)   $ (95,733 ) $ 25,055   $ (124,894 ) $ (38,119 )
   
 
 
 
 
Comprehensive income (loss), net of tax:                          
  Net income (loss)   $ (95,733 ) $ 25,055   $ (124,894 ) $ (38,119 )
   
 
 
 
 
  Other comprehensive income (loss), net of tax:                          
    Foreign currency translation adjustments     11,857     2,311     70,751     41,110  
    Gain on affiliate sale of stock, net of tax             2,856      
    Unrealized gains (losses) on securities:                          
      Unrealized gains (losses) arising during the period     (10,012 )   162     1,521     (26,547 )
      Reclassification adjustment for losses included in net income (loss)     (737 )   (18 )   1,551     63  
   
 
 
 
 
    Unrealized gains (losses) on securities, net of tax     (10,749 )   144     3,072     (26,484 )
   
 
 
 
 
    Other     200     (585 )   123     (748 )
   
 
 
 
 
  Other comprehensive income     1,308     1,870     76,802     13,878  
   
 
 
 
 
Comprehensive income (loss)   $ (94,425 ) $ 26,925   $ (48,092 ) $ (24,241 )
   
 
 
 
 

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

1


GENZYME CORPORATION AND SUBSIDIARIES
Consolidated Statements of Operations (Continued)
(Unaudited, amounts in thousands, except per share amounts)

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
 
  2003
  2002
  2003
  2002
 
Net income (loss) per share:                          
Allocated to Genzyme General Stock:                          
  Genzyme General division net income (loss)   $ (95,733 ) $ 44,518   $ 24,841   $ 113,238  
  Tax benefit allocated from Genzyme Biosurgery         6,325     8,720     13,618  
  Tax benefit allocated from Genzyme Molecular Oncology         2,573     3,420     6,938  
   
 
 
 
 
  Net income (loss) allocated to Genzyme General Stock   $ (95,733 ) $ 53,416   $ 36,981   $ 133,794  
   
 
 
 
 
  Net income (loss) per share of Genzyme General Stock:                          
    Basic   $ (0.43 ) $ 0.25   $ 0.17   $ 0.63  
   
 
 
 
 
    Diluted   $ (0.43 ) $ 0.25   $ 0.17   $ 0.61  
   
 
 
 
 
  Weighted average shares outstanding:                          
    Basic     222,000     214,303     217,801     213,851  
   
 
 
 
 
    Diluted     222,000     217,541     223,972     219,413  
   
 
 
 
 

Allocated to Biosurgery Stock:

 

 

 

 

 

 

 

 

 

 

 

 

 
  Genzyme Biosurgery division net loss before cumulative effect of change in accounting for goodwill         $ (24,464 ) $ (166,656 ) $ (62,368 )
  Cumulative effect of change in accounting for goodwill                   (98,270 )
         
 
 
 
  Genzyme Biosurgery division net loss           (24,464 )   (166,656 )   (160,638 )
  Allocated tax benefit           2,408     14,005     7,298  
         
 
 
 
  Net loss allocated to Biosurgery Stock         $ (22,056 ) $ (152,651 ) $ (153,340 )
         
 
 
 
  Net loss per share of Biosurgery Stock—basic and diluted:                          
    Net loss per share before cumulative effect of change in accounting for goodwill         $ (0.55 ) $ (3.76 ) $ (1.38 )
    Per share cumulative effect of change in accounting for goodwill                   (2.47 )
         
 
 
 
  Net loss per share of Biosurgery Stock—basic and diluted         $ (0.55 ) $ (3.76 ) $ (3.85 )
         
 
 
 
  Weighted average shares outstanding           40,179     40,630     39,793  
         
 
 
 

Allocated to Molecular Oncology Stock:

 

 

 

 

 

 

 

 

 

 

 

 

 
  Genzyme Molecular Oncology division net loss         $ (6,305 ) $ (9,224 ) $ (18,573 )
         
 
 
 
  Net loss per share of Molecular Oncology Stock—basic and diluted         $ (0.37 ) $ (0.54 ) $ (1.11 )
         
 
 
 
  Weighted average shares outstanding           16,847     16,958     16,804  
         
 
 
 

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

2


GENZYME CORPORATION AND SUBSIDIARIES
Consolidated Balance Sheets
(Unaudited, amounts in thousands, except par value amounts)

 
  September 30,
2003

  December 31,
2002

 
ASSETS
             
Current assets:              
  Cash and cash equivalents   $ 348,908   $ 406,811  
  Short-term investments     59,923     105,992  
  Accounts receivable, net     369,241     287,141  
  Inventories     236,063     238,809  
  Prepaid expenses and other current assets     63,770     45,187  
  Deferred tax assets     173,106     105,094  
   
 
 
    Total current assets     1,251,011     1,189,034  

Property, plant and equipment, net

 

 

926,569

 

 

802,448

 
Long-term investments     461,081     682,201  
Notes receivable—related parties     12,235     11,918  
Goodwill, net     619,578     592,075  
Other intangible assets, net     917,993     734,478  
Investments in equity securities     87,708     42,945  
Other noncurrent assets     51,141     27,950  
   
 
 
    Total assets   $ 4,327,316   $ 4,083,049  
   
 
 
LIABILITIES AND STOCKHOLDERS' EQUITY
             
Current liabilities:              
  Accounts payable   $ 60,820   $ 44,458  
  Accrued expenses     273,349     190,754  
  Income taxes payable     82,069     61,964  
  Deferred revenue     8,005     15,887  
  Current portion of long-term debt, convertible note and capital lease obligations     311,733     294,737  
   
 
 
    Total current liabilities     735,976     607,800  

Long-term debt and capital lease obligations

 

 

30,404

 

 

25,038

 
Convertible debentures     575,000     575,000  
Deferred revenue—noncurrent     3,634     1,771  
Deferred tax liabilities     187,816     159,747  
Other noncurrent liabilities     18,783     15,846  
   
 
 
    Total liabilities     1,551,613     1,385,202  
   
 
 

Commitments and contingencies (Note 13)

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 
  Preferred stock, $0.01 par value          
  Common stock:              
    Genzyme General Stock, $0.01 par value     2,229     2,148  
    Biosurgery Stock, $0.01 par value         405  
    Molecular Oncology Stock, $0.01 par value         169  
  Additional paid-in capital—Genzyme General Stock     2,909,386     1,810,358  
  Additional paid-in capital—Biosurgery Stock         823,364  
  Additional paid-in capital—Molecular Oncology Stock