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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 26, 2006
Biogen Idec Inc.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other jurisdiction
of incorporation)
  0-19311
(Commission
File Number)
  33-0112644
(I.R.S. Employer
Identification No.)
     
14 Cambridge Center, Cambridge, Massachusetts
(Address of principal executive offices)
  02142
(Zip Code)
Registrant’s telephone number, including area code: (617) 679-2000
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


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Item 2.02 Results of Operations and Financial Condition
Item 9.01 — Financial Statements and Exhibits
SIGNATURES
EXHIBIT INDEX
Ex-99.1 Press Release dated April 26, 2006


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Item 2.02 Results of Operations and Financial Condition.
     On April 26, 2006, the Registrant issued a press release announcing its unaudited results of operations and financial condition for the three months ended March 31, 2006. A copy of the press release is furnished as Exhibit 99.1.
     This press release is being furnished pursuant to Item 2.02 of this Current Report on Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that Section, nor shall such documents be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
Item 9.01 — Financial Statements and Exhibits
99.1   The Registrant’s Press Release dated April 26, 2006.

 


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SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  Biogen Idec Inc.
 
 
  By:   /s/ Susan H. Alexander    
    Susan H. Alexander   
    Executive Vice President, General Counsel   
 
Date: April 26, 2006

 


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EXHIBIT INDEX
     
Exhibit    
Number   Description
99.1
  The Registrant’s Press Release dated April 26, 2006.

 

exv99w1
 

Exhibit 99.1
Page 1 Biogen Idec Reports First Quarter 2006 Results
(BIOGEN IDEC LOGO)
Media Contact:
Jose Juves
Director, Public Affairs
Biogen Idec
Tel: (617) 914-6524
Investment Community Contact:
Elizabeth Woo
Vice President, Investor Relations
Biogen Idec
Tel: (617) 679-2812
FOR IMMEDIATE RELEASE
Biogen Idec Reports First Quarter 2006 Results
Cambridge, MA, April 26, 2006 — Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader with leading products and capabilities in oncology, neurology and immunology, today reported its first quarter 2006 results.
First Quarter 2006 Highlights
  Total revenues for the first quarter were $611 million vs. prior year $588 million, an increase of 4%, driven primarily by RITUXANÒ (rituximab) revenues from the unconsolidated joint business arrangement up 14% to $183 million and AVONEXÒ (Interferon beta-1a) worldwide sales up 5% to $393 million.
 
  On a reported basis, calculated in accordance with U.S. generally accepted accounting principles (GAAP), first quarter diluted earnings per share (EPS) were $0.36, an increase of 200% over the same period last year; excluding merger-related accounting impacts and employee stock option expense, non-GAAP EPS were $0.55, an increase of 83% over the same period last year.
 
  With the adoption of Statement of Financial Accounting Standards (FAS) 123R as of January 1, 2006, Biogen Idec is reporting employee stock option expense in its GAAP results for the first time. Total stock option expense on a pre-tax basis in R&D and SG&A for the first quarter 2006 was $13 million, or $0.03 per share. This impact has been excluded from non-GAAP performance metrics.

 


 

Page 2 Biogen Idec Reports First Quarter 2006 Results
James Mullen, Biogen Idec’s Chief Executive Officer, commented, “During the quarter we took several key steps to secure the continued growth of our core business, specifically achieving major milestones with two products, TYSABRI and RITUXAN. We are pleased with the unanimous vote by the U.S. Food and Drug Administration’s Advisory Committee supporting the reintroduction of TYSABRI and expect to have this important therapeutic option available to multiple sclerosis patients later this year. The approval and launch of RITUXAN in rheumatoid arthritis has allowed us to expand our business focus and enter a therapeutic area with significant unmet medical need.”
Financial Performance
On a reported basis, calculated in accordance with GAAP, Biogen Idec reported net income of $123 million (or EPS of $0.36) in the first quarter of 2006 (Q1 2005: net income of $43 million, or EPS of $0.12).
The 2006 first quarter results include an after-tax credit of $4 million ($0.01 per share after-tax) attributable to the cumulative effect of a change in accounting principle associated with the adoption of FAS 123R on January 1, 2006. The cumulative effect adjustment reflects the impact of estimating forfeitures of equity awards at the date of grant instead of the prior accounting practice of recognizing forfeitures as incurred.
The difference between non-GAAP net income and EPS and GAAP net income and EPS in the first quarter are itemized in Table 3 and are primarily due to:
  pre-tax charges of $75 million, consisting of amortization of intangibles ($70.7 million), inventory step-up ($4.0 million), and severance ($0.7 million).
  pre-tax employee stock option expense of $13 million.
On a non-GAAP basis, Biogen Idec reported net income of $189 million in the first quarter of 2006 (Q1 2005 non-GAAP: $106 million). Non-GAAP EPS were $0.55 for the first quarter of 2006 (Q1 2005 non-GAAP: $0.30).
Revenue Performance for the 3 Months ended March 31, 2006:
  Revenues from AVONEX increased 5% to $393 million (Q1 2005: $374 million).
    U.S. sales were $232 million (Q1 2005: $233 million)
 
    International sales increased 15% to $161 million. (Q1 2005: $141 million)
  Revenues from Biogen Idec’s joint business arrangement with Genentech, Inc. related to RITUXAN were up 14% to $183 million (Q1 2005: $160 million). All U.S. sales of RITUXAN are recognized by Genentech and Biogen Idec records its share of the pretax co-promotion profits on a quarterly basis.
    U.S. net sales of RITUXAN increased 8% to $477 million in the first quarter of 2006 (Q1 2005: $440 million), as reported by Genentech.
  Revenues from other products were $13 million (Q1 2005: $24 million). Details are provided in Table 4.
  Royalties were $21 million (Q1 2005: $27 million).

 


 

Page 3 Biogen Idec Reports First Quarter 2006 Results
Financial Guidance
Biogen Idec continues to expect that its 2006 non-GAAP earnings per share will be in the range of $1.95 — $2.10.
Guidance for full year 2006 reported earnings per share (GAAP-based financial measure) is not currently known, as the Company cannot predict with any certainty the nature or the amount of non-operating or unusual charges for subsequent quarters. The Company does anticipate that certain charges related to purchase accounting will be included in the GAAP financials, such as amortization of intangibles of approximately $250 – 330 million, primarily related to the AVONEX intangibles. Separately, the impact of stock options being expensed due to FAS 123R in 2006 is now estimated to be in the range of $0.08 — $0.12. The Company additionally anticipates that it may have to take other charges in subsequent quarters and that such charges, if material, would cause reported earnings per share to further differ from non-GAAP earnings per share.
The Company anticipates that 2006 capital expenditures will be in the range of $190 — $275 million.
Recent Highlights
  On February 28, 2006, Biogen Idec and Genentech announced that the FDA had approved, following Priority Review, the therapeutic antibody RITUXAN in combination with methotrexate (MTX) to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
  On March 8, 2006, Biogen Idec and Elan Corporation, plc announced that the Peripheral and Central Nervous System Drugs Advisory Committee of the FDA voted unanimously to recommend reintroduction of TYSABRIÒ (natalizumab) as a treatment for relapsing forms of MS. The Committee’s recommendation is advisory to the FDA, and the agency is not bound by this recommendation. The FDA has designated TYSABRI for Priority Review, a status for products that are considered to be significant therapeutic advancements over existing therapies that address an unmet medical need. Biogen Idec and Elan will continue to work closely with the FDA in the weeks ahead with the goal of making TYSABRI available. Discussions with FDA will include, among other things, finalizing the details of the TYSABRI risk management plan. The companies anticipate action by the FDA by June 28, 2006.
  On March 29, 2006, Biogen Idec and Elan announced that the first patients in the TYSABRI monotherapy safety extension study program in MS have been enrolled and dosed. Patients who previously participated in the Phase III MS trials and subsequent safety evaluation are eligible to be screened for entry in this open label multi-center study. Sites throughout Europe, the United States, Canada, Australia, New Zealand and Israel are expected to enroll patients. This safety extension study is

 


 

Page 4 Biogen Idec Reports First Quarter 2006 Results
    being conducted under an FDA Investigational New Drug (IND) application in the U.S. and similar investigational approvals internationally.
  On March 30, 2006, Biogen Idec and Genentech announced that the companies submitted a supplemental Biologics License Application (sBLA) to the FDA for the use of RITUXAN as first-line treatment of previously-untreated patients with low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma in combination with CVP (cyclophosphamide, vincristine and prednisone) or CHOP chemotherapy or following CVP chemotherapy in those patients who achieved a response of stable disease or better.
  As part of the restructuring plan announced in September 2005, Biogen Idec completed the sale of the worldwide rights for AMEVIVE® (alefacept) to Astellas Pharma US, Inc. in April 2006. AMEVIVE is a biologic anti-inflammatory compound used in the treatment of moderate-to-severe plaque psoriasis.
Use of Non-GAAP Financial Measures
The non-GAAP financial measures presented in this press release are utilized by Biogen Idec management to gain an understanding of the comparative financial performance of the Company. Management believes that the non-GAAP financial measures are useful because they exclude those non-operational activities or transactions that are not necessarily relevant to understanding the trends of the Company or the prospects of future performance such as charges related to amortization of intangibles, inventory step-up values, and employee stock option expense. Management uses these measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in the Company’s business over time. The presentation of this information is not meant to be considered in isolation or as a substitute for GAAP financial measures.
Conference Call and Webcast
The Company’s earnings conference call for the first quarter will be broadcast via the Internet at 8:30 a.m. ET on April 26, 2006, and will be accessible through the investor relations section of Biogen Idec’s homepage, http://www.biogenidec.com.
About Biogen Idec
Biogen Idec (NASDAQ: BIIB) creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.

 


 

Page 5 Biogen Idec Reports First Quarter 2006 Results
Safe Harbor
This press release contains forward-looking statements regarding expected future financial results, including non-GAAP EPS and capital expenditures, the potential reintroduction of TYSABRI in MS, and the potential for RITUXAN in RA.
These statements are based on the Company’s current beliefs and expectations. A number of risks and uncertainties could cause actual results to differ materially. For example, financial results and external growth opportunities may be affected by a number of factors, including any unexpected slowing of growth of the markets for AVONEX and RITUXAN, any change in market acceptance of AVONEX and RITUXAN in key markets worldwide, the impact of reimbursement and pricing decisions related to the Company’s products, the impact of competitive products on the Company’s products, any material decreases in royalties which the Company receives, the impact of litigation, increases in costs related to, or an inability for us to enter into in-licensing deals, collaborations or acquisitions on acceptable terms, increases in costs related to research and development of new products as well as increases in costs related to development of existing products in new indications, and any material issues, delays or failures related to the manufacturing or supply of the Company’s products.
Our long-term growth will depend on the successful development and commercialization of new products as well as the development and commercialization of existing products in new indications. Drug development involves a high degree of risk. For example, the plans for our development programs could be negatively affected if unexpected concerns arise from additional data or analysis, if regulatory authorities require additional information or further studies, or if we were to encounter other unexpected hurdles.
The potential for TYSABRI in MS is subject to a number of risks and uncertainties. There is no assurance, for example, that we will be able to gain sufficient information to fully understand the risks associated with the product. There is also no assurance that the Company and Elan will be able to resume marketing and sales of TYSABRI.
For more detailed information on the risks and uncertainties associated with these forward looking statements and the Company’s other activities, see the periodic reports filed by the Company with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.

 


 

TABLE 1
Biogen Idec Inc.
First Quarter 2006
Condensed Consolidated Statements Of Income
(in thousands, except per share amounts)
                 
    Three Months Ended  
    March 31,  
    2006     2005  
REVENUES
               
 
               
Product
  $ 406,519     $ 397,584  
 
               
Unconsolidated joint business
    183,380       160,453  
 
               
Royalties
    20,561       26,749  
 
               
Corporate partner
    715       3,016  
 
           
 
               
Total revenues
    611,175       587,802  
 
           
 
               
COST AND EXPENSES
               
 
               
Cost of goods sold and royalty revenues
    67,494       99,609  
 
               
Research and development
    145,892       172,477  
 
               
Selling, general and administrative
    154,391       158,472  
 
               
Amortization of acquired intangible assets
    70,707       75,677  
 
               
Impairment and loss on sale of long lived assets
    (298 )     6,293  
 
           
 
               
Total cost and expenses
    438,186       512,528  
 
           
 
               
Income from operations
    172,989       75,274  
 
               
Other income, net
    18,665       (8,926 )
 
           
 
               
INCOME BEFORE TAXES AND CUMULATIVE EFFECT OF ACCOUNTING CHANGE
    191,654       66,348  
 
               
Income taxes
    72,464       22,890  
 
           
 
               
INCOME BEFORE CUMULATIVE EFFECT OF ACCOUNTING CHANGE
    119,190       43,458  
 
               
Cumulative effect of accounting change, net of income tax
    3,779        
 
           
 
               
NET INCOME
  $ 122,969     $ 43,458  
 
           
 
               
BASIC EARNINGS PER SHARE
               
Income before cumulative effect of accounting change
  $ 0.35     $ 0.13  
Cumulative effect of accounting change, net of income tax
    0.01        
 
           
BASIC EARNINGS PER SHARE
  $ 0.36     $ 0.13  
 
           
 
               
DILUTED EARNINGS PER SHARE
               
Income before cumulative effect of accounting change
  $ 0.34     $ 0.12  
Cumulative effect of accounting change, net of income tax
    0.01        
 
           
DILUTED EARNINGS PER SHARE
  $ 0.36     $ 0.12  
 
           
 
               
SHARES USED IN CALCULATING:
               
 
               
BASIC EARNINGS PER SHARE
    339,653       335,279  
 
           
 
               
DILUTED EARNINGS PER SHARE
    345,815       352,173  
 
           
Numbers may not foot due to rounding.

 


 

TABLE 2
Biogen Idec Inc.
First Quarter 2006
Condensed Consolidated Balance Sheets
(in thousands)
                 
    Mar. 31, 2006     Dec. 31, 2005  
Assets
               
 
               
Cash, cash equivalents and securities available-for-sale
  $ 849,355     $ 850,753  
 
               
Accounts receivable, net
    276,441       265,742  
 
               
Inventory
    191,022       182,815  
 
               
Other current assets
    278,863       318,771  
 
           
Total current assets
    1,595,681       1,618,081  
 
           
 
               
Long-term securities available-for-sale
    1,407,541       1,204,378  
 
               
Property and equipment, net
    1,191,968       1,174,396  
 
               
Intangible assets, net
    2,904,838       2,975,601  
 
Goodwill
    1,130,430       1,130,430  
 
               
Other
    293,768       264,061  
 
           
Total assets
  $ 8,524,226     $ 8,366,947  
 
           
 
               
Liabilities and shareholders’ equity
               
 
               
Current liabilities
  $ 520,797     $ 583,036  
 
               
Long-term deferred tax liability
    736,255       762,282  
 
               
Non-current liabilities
    124,332       115,753  
 
               
Shareholders’ equity
    7,142,842       6,905,876  
 
           
 
               
Total liabilities and shareholders’ equity
  $ 8,524,226     $ 8,366,947  
 
           
Numbers may not foot due to rounding.

 


 

TABLE 3
Biogen Idec Inc.
First Quarter 2006
Condensed Consolidated Statements Of Income — Non-GAAP
(in millions, except per share amounts)
                 
    Three Months Ended  
    March 31,  
    2006     2005  
Earnings per share
               
GAAP Earnings per share — Diluted
  $ 0.36     $ 0.12  
Adjustment to Net Income (as detailed below)
    0.19       0.18  
 
           
Non-GAAP Earnings per share — Diluted
  $ 0.55     $ 0.30  
 
           
 
               
AN ITEMIZED RECONCILIATION BETWEEN NET INCOME ON A GAAP BASIS AND NET INCOME ON A NON-GAAP BASIS IS AS FOLLOWS:
               
 
               
GAAP Net Income
  $ 123.0     $ 43.5  
 
               
COGS: Fair value step up of inventory acquired from former Biogen, Inc
    4.0       9.3  
 
               
R&D: Stock option expense
    4.8        
 
               
SG&A: Severance and restructuring
    0.7       0.5  
 
               
SG&A: Stock option expense
    8.3        
 
               
Purchase accounting: Amortization of acquired intangible assets related to the merger with former Biogen, Inc.
    70.7       75.7  
 
               
Impairment and loss on sale of long lived assets
    (0.3 )      
 
               
Income taxes: Income tax effect of reconciling items
    (18.4 )     (23.1 )
 
               
Cumulative effect of accounting change from adoption of FAS123R, net of income tax
    (3.8 )      
 
               
 
           
Non-GAAP Net Income
  $ 188.9     $ 105.8  
 
           
Numbers may not foot due to rounding.
The non-GAAP financial measures presented in this table are utilized by Biogen Idec management to gain an understanding of the comparative financial performance of the Company. Management believes that the non-GAAP financial measures are useful because they exclude those non-operational activities or transactions that are not necessarily relevant to understanding the trends of the Company or the prospects of future performance. Management uses these measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in the Company’s business over time. The presentation of this information is not meant to be considered in isolation or as a substitute for GAAP financial measures.

 


 

TABLE 4
Biogen Idec Inc.
First Quarter 2006
Product Revenues
(in thousands)
                 
    Three Months Ended  
    March 31,  
    2006     2005  
PRODUCT REVENUES
               
 
               
Avonex®
  $ 393,427     $ 373,586  
 
               
Amevive®
    8,278       12,016  
 
               
Tysabri®
    (196 )     5,946  
 
               
Zevalin®
    5,010       6,036  
 
               
 
           
Total Product Revenues
  $ 406,519     $ 397,584  
 
           
Numbers may not foot due to rounding.