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SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the Quarterly Period ended June 30, 2003

Commission File Number 0-12042

BIOGEN, INC.

(Exact name of registrant as specified in its charter)
     
Massachusetts   04-3002117
     
(State or other jurisdiction of   (I.R.S. Employer
incorporation or organization)   Identification No.)

14 Cambridge Center, Cambridge, MA 02142
(617) 679-2000

(Address, including zip code, and telephone number, including
area code, of registrant’s principal executive offices)

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 [ X ]     No [    ]

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Securities Exchange Act of 1934)

Yes [ X ]     No [    ]

The number of shares of the registrant’s Common Stock, $0.01 par value, outstanding as of July 1, 2003 was 149,468,321 shares.

 


TABLE OF CONTENTS

PART I — FINANCIAL INFORMATION
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
CONDENSED CONSOLIDATED BALANCE SHEETS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
PART II — OTHER INFORMATION
EX-31.1 CERTIFICATION OF THE CEO
EX-31.2 CERTIFICATION OF THE CFO
EX-32.1 CERTIFICATION (SARBANES-OXLEY ACT OF 2002)


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BIOGEN, INC.

INDEX

         
    Page
    Number
   
PART I — FINANCIAL INFORMATION
       
Condensed Consolidated Statements of Income – Three and six months ended June 30, 2003 and 2002
    3  
Condensed Consolidated Balance Sheets – June 30, 2003 and December 31, 2002
    4  
Condensed Consolidated Statements of Cash Flows – Six months ended June 30, 2003 and 2002
    5  
Notes to Condensed Consolidated Financial Statements
    6  
Management’s Discussion and Analysis of Financial Condition and Results of Operations
    14  
PART II — OTHER INFORMATION
    24  

Note concerning trademarks: AVONEX® and AMEVIVE® are registered trademarks of Biogen, Inc.

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BIOGEN, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME

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

                                   
      Three months ended   Six months ended
      June 30,   June 30,
      2003   2002   2003   2002
     
 
 
 
REVENUES:
                               
 
Product
  $ 293,149     $ 250,542     $ 571,326     $ 516,527  
 
Royalties
    30,510       18,721       71,883       41,079  
 
Contract
    1,987             3,136        
 
 
   
     
     
     
 
Total revenues
    325,646       269,263       646,345       557,606  
 
 
   
     
     
     
 
COSTS AND EXPENSES:
                               
 
Cost of product revenues
    43,434       35,042       87,287       72,936  
 
Cost of royalty revenues
    2,212       1,167       4,625       2,591  
 
Research and development
    116,083       89,348       201,189       171,815  
 
Selling, general and administrative
    92,147       91,567       187,570       164,957  
 
Merger related expenses
    3,804             3,804        
 
 
   
     
     
     
 
Total costs and expenses
    257,680       217,124       484,475       412,299  
 
 
   
     
     
     
 
Income from operations
    67,966       52,139       161,870       145,307  
Other income, net
    12,411       8,104       6,747       15,132  
 
 
   
     
     
     
 
INCOME BEFORE INCOME TAXES
    80,377       60,243       168,617       160,439  
Income taxes
    22,506       16,868       47,213       44,923  
 
 
   
     
     
     
 
NET INCOME
  $ 57,871     $ 43,375     $ 121,404     $ 115,516  
 
 
   
     
     
     
 
BASIC EARNINGS PER SHARE
  $ 0.39     $ 0.29     $ 0.81     $ 0.78  
DILUTED EARNINGS PER SHARE
  $ 0.38     $ 0.29     $ 0.80     $ 0.76  
SHARES USED IN COMPUTING:
                               
Basic earnings per share
    149,493       149,231       149,552       148,945  
Diluted earnings per share
    151,440       152,033       151,467       152,118  

See Notes to Condensed Consolidated Financial Statements.

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BIOGEN, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

                   
      June 30,   December 31,
      2003   2002
     
 
      (unaudited)        
ASSETS
               
Current assets
               
 
Cash and cash equivalents
  $ 62,151     $ 45,113  
 
Marketable securities
    795,744       821,996  
 
Accounts receivable, net
    197,154       171,067  
 
Deferred tax assets
    31,556       38,592  
 
Inventory
    83,505       95,378  
 
Other current assets
    46,268       43,878  
 
   
     
 
 
Total current assets
    1,216,378       1,216,024  
 
   
     
 
Property, plant and equipment
               
 
Cost
    1,008,717       953,805  
 
Less accumulated depreciation
    244,119       215,746  
 
   
     
 
 
Property, plant and equipment, net
    764,598       738,059  
 
   
     
 
Patents, net
    16,762       15,994  
Other assets
    40,610       36,911  
 
   
     
 
 
  $ 2,038,348     $ 2,006,988  
 
 
   
     
 
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
Current liabilities
               
 
Accounts payable
  $ 31,924     $ 64,876  
 
Current portion of long-term debt
    4,888       4,888  
 
Current taxes payable
    70,916       73,824  
 
Accrued expenses and other
    132,757       182,745  
 
   
     
 
 
Total current liabilities
    240,485       326,333  
 
   
     
 
Long-term debt, less current portion
    34,966       37,410  
Long-term deferred tax liabilities
    33,702       33,678  
Other long-term liabilities
    19,053       14,146  
Commitments and contingencies
           
Shareholders’ equity
               
 
Common stock
    1,517       1,517  
 
Additional paid-in capital
    840,237       829,993  
 
Treasury stock, at cost
    (73,391 )     (90,844 )
 
Retained earnings
    913,296       838,756  
 
Accumulated other comprehensive income
    28,483       15,999  
 
   
     
 
 
Total shareholders’ equity
    1,710,142       1,595,421  
 
   
     
 
 
  $ 2,038,348     $ 2,006,988  
 
 
   
     
 

See Notes to Condensed Consolidated Financial Statements.

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BIOGEN, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)
(in thousands)

                         
            Six months ended
            June 30,
           
            2003   2002
           
 
CASH FLOWS FROM OPERATING ACTIVITIES
               
 
Net income
  $ 121,404     $ 115,516  
 
Adjustments to reconcile net income to net cash provided from operating activities:
               
   
Depreciation and amortization
    28,766       20,530  
   
Tax benefit of stock options
    9,720       14,294  
   
Equity in net loss of unconsolidated affiliate
          2,828  
   
Stock based compensation
    524       1,023  
   
Realized (gain) loss on sale of non-current marketable securities
    (1,431 )     301  
   
Impairment of non-current investments or marketable securities
    3,079       2,182  
   
Writedown of inventory to net realizable value
    9,520        
   
Changes in:
               
     
Accounts receivable
    (23,157 )     (833 )
     
Inventory
    2,353       (28,210 )
     
Other current and other assets
    (11,750 )     (15,417 )
     
Accounts payable, accrued expenses, current taxes payable and other current and long-term liabilities
    (84,789 )     (11,316 )
 
 
   
     
 
   
Net cash flows from operating activities
    54,239       100,898  
 
   
     
 
CASH FLOWS FROM INVESTING ACTIVITIES
               
 
Purchases of current marketable securities
    (204,248 )     (220,539 )
 
Proceeds from sales and maturities of current marketable securities
    240,175       201,957  
 
Proceeds from sales of non-current marketable securities
    2,143       493  
 
Proceeds from withdrawal from an equity fund
    7,217        
 
Acquisitions of property and equipment, net
    (49,584 )     (113,436 )
 
Additions to patents
    (1,617 )     (1,574 )
 
   
     
 
   
Net cash flows from investing activities
    (5,914 )     (133,099 )
 
   
     
 
CASH FLOWS FROM FINANCING ACTIVITIES
               
 
Repayments on long-term debt
    (2,444 )     (2,443 )
 
Purchases of treasury stock
    (45,785 )     (8,384 )
 
Issuance of treasury stock related to stock option exercises
    16,376       18,406  
 
Other
    451       84  
 
   
     
 
   
Net cash flows from financing activities
    (31,402 )     7,663  
 
   
     
 
 
Effect of exchange rate changes on cash
    115       731  
 
   
     
 
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS
    17,038       (23,807 )
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
    45,113       54,042  
 
   
     
 
CASH AND CASH EQUIVALENTS, END OF PERIOD
  $ 62,151     $ 30,235  
 
 
   
     
 

See Notes to Condensed Consolidated Financial Statements.

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BIOGEN, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

1. BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES

Biogen, Inc. (“Biogen” or the “Company”) is a global biopharmaceutical company that develops, manufactures and markets novel human therapeutic products. Biogen’s primary focus is developing pharmaceutical products that meet unmet medical needs particularly in its core therapeutic areas of neurology, dermatology and rheumatology. Biogen currently sells AVONEX® (Interferon beta-1a) for the treatment of relapsing multiple sclerosis (“MS”) and AMEVIVE® (alefacept) for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Biogen also receives revenues from royalties on sales by its licensees of a number of products covered under patents that Biogen controls and from contract revenues related to a collaborative agreement with IDEC Pharmaceuticals Corporation (“IDEC”).

In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of only normal recurring accruals, necessary to present fairly the financial position, results of operations and cash flows of Biogen and its subsidiaries. The Company’s accounting policies are described in the Notes to the Consolidated Financial Statements in the Company’s 2002 Annual Report on Form 10-K and updated, as necessary, in this Form 10-Q. Interim results are not necessarily indicative of the operating results for the full year.

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

On June 20, 2003, Biogen entered into an Agreement and Plan of Merger with IDEC and Bridges Merger Corporation, a wholly owned subsidiary of IDEC. Under the merger agreement, if all of the applicable conditions are met, Biogen will merge with and into Bridges Merger Corporation and become a wholly owned subsidiary of IDEC and IDEC will change its name to BIOGEN IDEC INC. If the merger is completed, Biogen stockholders will receive 1.15 shares of IDEC common stock for each share of Biogen common stock, plus cash in lieu of fractional shares. The shares of the combined company are expected to be traded on the NASDAQ National Market under a new trading symbol. IDEC will account for the merger under the purchase method of accounting for business combinations under accounting principles generally accepted in the United States, which means that the assets and liabilities of Biogen will be recorded, as of the completion of the merger, at their fair values and added to those of IDEC. The merger has been unanimously approved by the board of directors of both IDEC and Biogen. The transaction is subject to approval by the stockholders of both companies, as well as regulatory approvals and satisfaction of other customary closing conditions. The transaction is expected to be completed in late 2003. The merger agreement provides for the payment of a termination fee of up to $230 million, under certain termination scenarios. In connection with the proposed merger with IDEC, the Company has agreed to pay certain advisors up to $15 million upon completion of the merger, in addition to amounts previously paid, and a lesser amount should the merger terminate, contingent upon certain conditions.

INVENTORIES

Inventories are stated at the lower of cost or market with cost determined under the first-in/first-out (“FIFO”) method. Included in inventory are raw materials used in the production of pre-clinical and clinical products which are expensed as research and development costs when consumed. The components of inventories are as follows:

                 
    June 30,   December 31,
(in thousands)   2003   2002
   
 
Raw materials
  $ 30,852     $ 27,027  
Work in process
    17,927       25,892  
Finished goods
    34,726       42,459  
 
   
     
 
 
  $ 83,505     $ 95,378  
 
   
     
 

Biogen writes down obsolete or otherwise unmarketable inventory to its estimated net realizable value. If the actual realizable value is less than that estimated by Biogen, additional inventory write-downs may be required. The Company wrote down $6.1 million and

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$9.5 million of unmarketable inventory for the three and six months ended June 30, 2003, respectively, which was charged to cost of product revenues. Biogen wrote down an additional $2.9 million of inventory to research and development since it met clinical specifications but not commercial specifications.

REVENUE RECOGNITION AND ACCOUNTS RECEIVABLE

SEC Staff Accounting Bulletin No. 101 (“SAB 101”) provides guidance on the recognition, presentation, and disclosure of revenue in financial statements. SAB 101 establishes the SEC’s view that it is not appropriate to recognize revenue until all of the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; the seller’s price to the buyer is fixed or determinable; and collectibility is reasonably assured. Further, SAB 101 requires that both title and the risks and rewards of ownership be transferred to the buyer before revenue can be recognized. The Company believes that its revenue recognition policies are in compliance with SAB 101.

Revenues from product sales are recognized when product is shipped and title and risk of loss has passed to the customer. When customers have inspection and approval rights for products, Biogen defers revenue until lapse of that right. Revenues are recorded net of applicable allowances for returns, rebates and other applicable discounts and allowances. The Company prepares its estimates for sales returns and allowances, discounts and rebates quarterly based primarily on historical experience updated for changes in facts and circumstances, as appropriate.

In January 2003, Biogen received regulatory approval to market AMEVIVE in the U.S. In connection with the introduction of AMEVIVE, Biogen implemented a limited launch period initiative undertaken in cooperation with one of Biogen’s distributors which provides a refund on purchases of AMEVIVE made after a private payor has initially verified that it will cover the product but later denies the claim after appeal and where the other requirements of the initiative are met. Under this initiative, Biogen’s exposure is contractually limited to 10% of the price of all AMEVIVE purchased by the distributor. As a result, Biogen will defer recognition of revenue of 10% of AMEVIVE purchased by the distributor while this initiative is in effect until such time as sufficient history of insurance claims reimbursement becomes available. In connection with the launch initiative, the Company has recorded $0.9 million of deferred revenue in accrued expenses and other at June 30, 2003. This launch initiative is applicable to purchases of AMEVIVE made on or before July 31, 2003 and will be replaced with a new initiative undertaken in cooperation with the same distributor. Under this new initiative, the distributor will provide a purchaser with a discount on future purchases of AMEVIVE if a payor has initially verified that it will cover the purchase of AMEVIVE by the purchaser but later denies the claim after appeal and where the other requirements of the initiative are met. Biogen will provide the distributor with a discount on its future purchases of AMEVIVE by the purchaser equal to the amount of the discount provided by the distributor under the initiative, up to a maximum discount of 5% on any purchase order submitted to Biogen by the distributor. This initiative is applicable to purchases of AMEVIVE made on or after August 1, 2003 through July 31, 2004. As a result, effective as of August 1, 2003, Biogen will defer recognition of revenue of 5% of AMEVIVE purchased by the distributor until such time as sufficient history of insurance claims reimbursement becomes available.

In February 2002, the FASB Emerging Issues Task Force (“EITF”) released EITF Issue No. 01-09 (“EITF 01-09”), “Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendor’s Products)”. EITF 01-09 states 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 when recognized in the vendor’s income statement, rather than a sales and marketing expense. The Company has various contracts with distributors that provide for discounts and rebates. These contracts are classified as a reduction of revenue. The Company also maintains select customer service contracts with distributors and other customers in the distribution channel. In accordance with EITF 01-09, the Company has established the fair value of these contracts and, as provided by EITF 01-09, classified these customer service contracts as sales and marketing expense. If the Company should not be able to sustain the fair value of these contracts, the Company would be required to classify these costs as a reduction of revenue. The adoption of EITF 01-09 did not have a significant impact on the Company’s financial statements.

The Company receives royalty revenues under license agreements with a number of third parties that sell products based on technology developed by the Company or to which the Company has rights. The license agreements provide for the payment of royalties to the Company based on sales of the licensed product. The Company records these revenues based on estimates of the sales that occurred during the relevant period. Differences between actual royalty revenues and estimated royalty revenues are reconciled and adjusted for in the period which they become known, typically the following quarter. Historically, adjustments have not been material based on actual amounts paid by licensees. During the second quarter of 2003, royalty revenues were negatively impacted by approximately $8 million due to Schering-Plough’s announced first quarter 2003 INTRON® A (interferon alpha-2b) sales decline, which Schering-Plough indicated was driven by a channel inventory reduction and an increasingly competitive environment. There are no future performance obligations on the part of the Company under these license agreements.

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Revenue is not recognized in any circumstances unless collectibility is reasonably assured.

Biogen maintains allowances for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. If the financial condition of Biogen’s customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances may be required, which could affect future earnings.

In January 2003, the Company signed a collaboration agreement (the “IDEC Agreement”) with IDEC, under which Biogen and IDEC are collaborating on the development of three oncology therapeutics from Biogen’s pipeline of early-stage product candidates. Under the terms of the IDEC Agreement, IDEC initially will be responsible for the development costs of the product candidates, until that time, if any, when the Company exercises its opt-in rights (which must be done within a certain timeframe) with respect to each specific product candidate. Prior to exercising its opt-in rights, to the extent that the Company incurs any development costs in relation to the programs contained in the IDEC Agreement, they will be recorded as research and development expense. The reimbursement by IDEC of these costs will be recorded as contract revenue. For the three and six months ended June 30, 2003, the Company recorded $2.0 million and $3.1 million, respectively, for contract revenue. Upon completion of the proposed merger, contract revenue related to this collaboration agreement will be eliminated.

ACCOUNTING FOR STOCK BASED COMPENSATION

The Company has several stock-based compensation plans. The Company applies APB Opinion No. 25 “Accounting for Stock Issued to Employees” in accounting for qualifying options granted to its employees under its plans and applies Statement of Financial Accounting Standards No. 123 “Accounting for Stock Issued to Employees” (“SFAS 123”) for disclosure purposes only. The SFAS 123 disclosures include pro forma net income and earnings per share as if the fair value method of accounting had been used. Stock issued to non-employees is accounted for in accordance with SFAS 123 and related interpretations.

If compensation for employee options had been determined based on SFAS 123, the Company’s pro forma net income, and pro forma earnings per share for the three and six months ending June 30, would have been as follows:

                                 
    Three months ended   Six months ended
    June 30,   June 30,
   
 
(in thousands, except per share data)   2003   2002   2003   2002

 
 
 
 
Reported net income
  $ 57,871     $ 43,375     $ 121,404     $ 115,516  
Pro forma stock compensation expense, net of tax
    10,195       10,384       20,757       21,707  
 
   
     
     
     
 
Pro forma net income
  $ 47,676     $ 32,991     $ 100,647     $ 93,809  
 
   
     
     
     
 
Reported basic earnings per share
  $ 0.39     $ 0.29     $ 0.81     $ 0.78  
 
   
     
     
     
 
Pro forma basic earnings per share
  $ 0.32     $ 0.22     $ 0.67     $ 0.63  
 
   
     
     
     
 
Reported diluted earnings per share
  $ 0.38     $ 0.29     $ 0.80     $ 0.76  
 
   
     
     
     
 
Pro forma diluted earnings per share
  $ 0.31     $ 0.22     $ 0.66     $ 0.62  
 
   
     
     
     
 

The fair value of options granted was estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions:

                                 
    Three months ended   Six months ended
    June 30,   June 30,
    2003   2002   2003   2002
   
 
 
 
Expected dividend yield
    0 %     0 %     0 %     0 %