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Table of Contents

 
 
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): July 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
(IRS 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))
 
 

 


TABLE OF CONTENTS

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 July 26, 2006


Table of Contents

Item 2.02 Results of Operations and Financial Condition.
     On July 26, 2006, the registrant issued a press release announcing its unaudited results of operations and financial condition for the three months ended June 30, 2006. A copy of the press release is furnished as Exhibit 99.1.
     The 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   Registrant’s press release dated July 26, 2006.
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/ Daniel S. Char    
    Daniel S. Char   
    Associate General Counsel and
     Assistant Secretary 
 
 
Date: July 26, 2006

 


Table of Contents

EXHIBIT INDEX
     
Exhibit    
Number   Description
 
   
99.1
  Registrant’s press release dated July 26, 2006.

 

exv99w1
 

Exhibit 99.1
Page 1     Biogen Idec Reports Second 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 Second Quarter 2006 Results
Cambridge, MA, July 26, 2006 — Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology company with leading products and capabilities in oncology, neurology and immunology, today reported its second quarter 2006 results.
Second Quarter 2006 Highlights
  Total revenues for the second quarter were $660 million vs. prior year $606 million, an increase of 9%, driven primarily by AVONEXÒ (Interferon beta-1a) worldwide sales up 12% to $429 million and RITUXANÒ (rituximab) revenues from the unconsolidated joint business arrangement up 11% to $206 million.
  On a reported basis, calculated in accordance with U.S. generally accepted accounting principles (GAAP), the loss per share was $0.50 for the second quarter. The GAAP earnings loss reflects a $331 million write-off of acquired in-process R&D, an accounting implication of the two successful acquisitions in the quarter (Conforma Therapeutics Corporation and Fumapharm AG), as well as other acquisition related adjustments, and the impact of share-based payment expense in accordance with FAS 123R, primarily employee stock options.
  Biogen Idec’s second quarter 2006 non-GAAP earnings per share (EPS) increased to $0.57, up 33% from the same period last year.
  TYSABRIÒ (natalizumab) has been approved for reintroduction by the U.S. Food and Drug Administration (FDA), and for marketing by the European Commission, as a treatment for relapsing forms of multiple sclerosis (MS) to slow the progression of

 


 

Page 2     Biogen Idec Reports Second Quarter 2006 Results
disability and reduce the frequency of clinical relapses. Recently, patient dosing has begun in both Europe and the U.S.
James Mullen, Biogen Idec’s Chief Executive Officer, commented, “The core businesses demonstrated double-digit growth in the second quarter, driven by strong AVONEX and RITUXAN performance. With TYSABRI recently approved in both the US and Europe, this important therapeutic option is now available to the multiple sclerosis community. We expect TYSABRI will enhance our neurology business and begin to accelerate top-line growth over the coming quarters. Additionally, we completed two acquisitions of private companies this quarter and continue to focus on business development opportunities.”
Financial Performance
On a reported basis, calculated in accordance with GAAP, Biogen Idec reported a net loss of $171 million (or loss per share of $0.50) in the second quarter of 2006 (Q2 2005: net income of $35 million, or EPS of $0.10).
On a non-GAAP basis, Biogen Idec reported non-GAAP EPS of $0.57 for the second quarter of 2006 (Q2 2005 non-GAAP EPS: $0.43). Non-GAAP net income was $197 million in the second quarter of 2006 (Q2 2005 non-GAAP net income: $149 million).
The differences between non-GAAP net income and EPS and GAAP net income and EPS in the second quarter are itemized in Table 3 and are primarily due to:
  pre-tax charges related to the acquisitions of Conforma and Fumapharm, including a $331 million write-off of acquired in-process R&D, offset by a $34 million gain on settlement of the license agreement with Fumapharm,
  pre-tax charges related to the Biogen and Idec merger, consisting of $76 million amortization of intangibles and $1 million inventory step-up,
  pre-tax share-based payment expense under FAS 123R of $15 million (or $0.03 per share), primarily employee stock option expense.
Revenue Performance for the 3 Months ended June 30, 2006
  Revenues from AVONEX increased 12% to $429 million (Q2 2005: $382 million).
  -   U.S. sales increased 14% to $261 million (Q2 2005: $230 million)
 
  -   International sales increased 11% to $169 million. (Q2 2005: $152 million)
  Revenues from Biogen Idec’s joint business arrangement with Genentech, Inc. related to RITUXAN were up 11% to $206 million (Q2 2005: $185 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 17% to $526 million in the second quarter of 2006 (Q2 2005: $450 million), as reported by Genentech.
  Revenues from other products were $7 million (Q2 2005: $17 million). Details are provided in Table 4.

 


 

Page 3     Biogen Idec Reports Second Quarter 2006 Results
  Royalties were $18 million (Q2 2005: $22 million).
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 the write-off of acquired in-process R&D ($331 million recorded in the current quarter) and 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 continues to be estimated to be in the range of $0.08 — $0.12. Additionally, the Company 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 continues to anticipate that 2006 capital expenditures will be in the range of $190-$275 million.
Recent Highlights
  In May 2006, Biogen Idec acquired Conforma, a privately held biopharmaceutical company focused on the design and development of novel drugs for the treatment of cancer. Conforma focused on the discovery and development of drugs that inhibit heat shock protein 90 (HSP90) molecules, which are involved in protecting and supporting the growth of cancer cells across a range of tumor types, and play a role in tumor resistance to a number of leading cancer therapies. Biogen Idec acquired two compounds in Phase I clinical trials: CNF1010, a proprietary form of the geldanamycin derivative 17-AAG; and CNF2024, a totally synthetic, orally bioavailable HSP90 inhibitor.
  On May 30, 2006, Biogen Idec and Fumapharm announced positive results from a Phase II study designed to evaluate the efficacy and safety of BG-12, an oral fumarate, in patients with relapsing-remitting MS. The study achieved its primary endpoint, demonstrating that treatment with BG-12 led to a statistically significant reduction in the total number of gadolinium-enhancing brain lesions as measured by MRI with six months of treatment versus placebo. These data were presented at the annual meeting of the European Neurological Society in Lausanne, Switzerland. In June 2006, Biogen Idec acquired privately held Fumapharm. Fumapharm developed therapeutics derived from fumaric acid esters for patients with high unmet medical need and had FUMADERM, a commercial product available in Germany for the

 


 

Page 4     Biogen Idec Reports Second Quarter 2006 Results
treatment of psoriasis, and BG-12, a clinical-stage compound that has been jointly developed with Biogen Idec.
  On June 5, 2006, Biogen Idec and Elan Corporation, plc announced the approval of a supplemental Biologics License Application (sBLA) by the FDA for the reintroduction of TYSABRI as a monotherapy treatment for relapsing forms of MS to slow the progression of disability and reduce the frequency of clinical relapses. On June 29, 2006, Biogen Idec and Elan announced that they had received approval from the European Commission to market TYSABRI as a treatment for relapsing remitting MS to delay the progression of disability and reduce the frequency of relapses.
  On June 22, 2006, Genentech and Biogen Idec announced positive results from an analysis of REFLEX, a Phase III clinical study of RITUXAN in patients with rheumatoid arthritis (RA) who have had an inadequate response to previous treatment with one or more tumor necrosis factor (TNF) antagonist therapies. The findings showed that treatment with RITUXAN in combination with a stable dose of methotrexate (MTX) reduced joint erosion and joint space narrowing at 56 weeks, compared to placebo and MTX. These were the first data to measure the progression of joint damage in this difficult-to-treat patient population. Results were presented for the first time at the European League Against Rheumatism (EULAR) meeting in Amsterdam, Netherlands.
  On July 12, 2006, Biogen Idec announced that Cecil B. Pickett, Ph.D., has been named President, Research & Development (R&D). In September, Dr. Pickett will join the Biogen Idec Board of Directors, and will report to James C. Mullen, Biogen Idec’s President and Chief Executive Officer. Dr. Pickett joins Biogen Idec from Schering-Plough Corporation, where he held several senior R&D positions since 1993, most recently as Corporate Senior Vice President & President, Schering-Plough Research Institute. In this capacity, Dr. Pickett helped bring several large and small molecule candidates into the Schering-Plough clinical development pipeline. Prior to joining Schering-Plough, he held several senior R&D positions at Merck & Company.
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 in-process R&D, 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.

 


 

Page 5     Biogen Idec Reports Second Quarter 2006 Results
Conference Call and Webcast
The Company’s earnings conference call for the second quarter will be broadcast via the Internet at 8:30 a.m. ET on July 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.
Safe Harbor
This press release contains forward-looking statements regarding expected future financial results, including future growth rates, non-GAAP EPS and capital expenditures, and the potential for TYSABRI in MS and RITUXAN in RA.
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 slowness in the demand for TYSABRI, AVONEX, RITUXAN and ZEVALIN, 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.
The potential for TYSABRI is subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the Company’s current expectations include the risk that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, that TYSABRI may not be accepted by the medical community and patients, or that the Company may encounter other unexpected issues.
Our long-term growth will depend on the successful development and commercialization of new products, such as BG-12, 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.
For more detailed information on the risks and uncertainties associated with these forward looking statements and the Company’s other activities, see “Risk Factors” in the

 


 

Page 6     Biogen Idec Reports Second Quarter 2006 Results
Company’s quarterly report on Form 10-Q for the fiscal quarter ended March 31, 2006 and the other periodic and current 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.
June 30, 2006
Consolidated Statements Of Income
(in thousands, except per share amounts)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2006     2005     2006     2005  
REVENUES
                               
 
                               
Product
  $ 436,081     $ 398,822     $ 842,600     $ 796,406  
 
                               
Unconsolidated joint business
    206,095       184,934       389,476       345,387  
 
                               
Royalties
    18,286       21,734       38,847       48,483  
 
                               
Corporate partner
    (421 )     144       293       3,160  
 
                       
 
                               
Total revenues
    660,041       605,634       1,271,216       1,193,436  
 
                       
 
                               
COST AND EXPENSES
                               
 
                               
Cost of goods sold and royalty revenues
    77,993       71,093       145,488       170,701  
 
                               
Research and development
    161,985       179,843       307,877       358,611  
 
                               
Selling, general and administrative
    170,289       155,754       324,680       314,227  
 
                               
Amortization of acquired intangible assets
    76,260       77,078       146,967       152,756  
 
                               
Acquired in-process R&D
    330,520             330,520        
 
                               
Impairment and loss on sale of long lived assets
    (799 )     75,565       (1,098 )     75,565  
 
                               
Gain on settlement of license agreement
    (34,192 )           (34,192 )      
 
                       
 
                               
Total cost and expenses
    782,056       559,333       1,220,242       1,071,860  
 
                       
 
                               
Income (loss) from operations
    (122,015 )     46,301       50,974       121,576  
 
                               
Other income (expense), net
    21,806       6,051       40,471       (2,874 )
 
                       
 
                               
INCOME (LOSS) BEFORE TAXES AND CUMULATIVE EFFECT OF ACCOUNTING CHANGE
    (100,209 )     52,352       91,445       118,702  
 
                               
Income taxes
    70,404       17,848       142,868       40,738  
 
                       
 
                               
INCOME (LOSS) BEFORE CUMULATIVE EFFECT OF ACCOUNTING CHANGE
    (170,613 )     34,504       (51,423 )     77,964  
 
                               
Cumulative effect of accounting change, net of income tax
                3,779        
 
                       
 
                               
NET INCOME (LOSS)
  $ (170,613 )   $ 34,504     $ (47,644 )   $ 77,964  
 
                       
 
                               
BASIC EARNINGS PER SHARE
                               
Income (loss) before cumulative effect of accounting change
  $ (0.50 )   $ 0.10     $ (0.15 )   $ 0.23  
Cumulative effect of accounting change, net of income tax
                0.01        
 
                       
BASIC EARNINGS (LOSS) PER SHARE
  $ (0.50 )   $ 0.10     $ (0.14 )   $ 0.23  
 
                       
 
                               
DILUTED EARNINGS PER SHARE
                               
Income (loss) before cumulative effect of accounting change
  $ (0.50 )   $ 0.10     $ (0.15 )   $ 0.23  
Cumulative effect of accounting change, net of income tax
                0.01        
 
                       
DILUTED EARNINGS (LOSS) PER SHARE
  $ (0.50 )   $ 0.10     $ (0.14 )   $ 0.23  
 
                       
 
                               
SHARES USED IN CALCULATING:
                               
 
                               
BASIC EARNINGS (LOSS) PER SHARE
    342,375       332,629       341,742       333,946  
 
                       
 
                               
DILUTED EARNINGS (LOSS) PER SHARE
    342,375       344,735       341,742       348,086  
 
                       
Numbers may not foot due to rounding.

 


 

TABLE 2
Biogen Idec Inc.
June 30, 2006
Condensed Consolidated Balance Sheets
(in thousands)
                 
ASSETS   June 30, 2006     Dec. 31, 2005  
 
           
 
               
Cash, cash equivalents and securities available-for-sale
  $ 713,774     $ 850,753  
 
               
Accounts receivable, net
    290,325       265,742  
 
               
Inventory
    147,024       182,815  
 
               
Other current assets
    304,030       318,771  
 
           
 
               
Total current assets
    1,455,153       1,618,081  
 
           
 
               
Long-term securities available-for-sale
    1,417,482       1,204,378  
 
               
Property and equipment, net
    1,227,296       1,174,396  
 
               
Intangible assets, net
    2,856,292       2,975,601  
 
               
Goodwill
    1,150,935       1,130,430  
 
               
Other
    233,004       264,061  
 
           
 
               
TOTAL ASSETS
  $ 8,340,162     $ 8,366,947  
 
           
 
               
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
 
               
Current liabilities
  $ 499,982     $ 583,036  
 
               
Long-term deferred tax liability
    691,395       762,282  
 
               
Non-current liabilities
    140,194       115,753  
 
               
Shareholders’ equity
    7,008,591       6,905,876  
 
           
 
               
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 8,340,162     $ 8,366,947  
 
           
Numbers may not foot due to rounding.

 


 

TABLE 3
Biogen Idec Inc.
June 30, 2006
Condensed Consolidated Statements Of Income — Non-GAAP
(in millions, except per share amounts)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
EARNINGS (LOSS) PER SHARE   2006     2005     2006     2005  
 
                       
 
                               
GAAP Earnings (loss) per share — Diluted
  $ (0.50 )   $ 0.10     $ (0.14 )   $ 0.23  
Adjustment to Net Income (loss) (as detailed below)
    1.06       0.33       1.26       0.50  
 
                       
Non-GAAP Earnings per share — Diluted
  $ 0.57     $ 0.43     $ 1.11     $ 0.73  
 
                       
 
                               
An itemized reconciliation between net income (loss) on a GAAP basis and net income on a non-GAAP basis is as follows:
                               
 
                               
GAAP Net Income (loss)
  $ (170.6 )   $ 34.5     $ (47.6 )   $ 78.0  
Adjustments:
                               
COGS: Fair value step up of inventory acquired from former Biogen, Inc.
    0.9       9.0       4.9       18.3  
COGS: Stock option expense
    0.1             0.1        
R&D: Costs associated with sale of Oceanside Manufacturing Facility
          1.9             1.9  
R&D: Severance and restructuring
    0.3             0.3        
R&D: Stock option expense
    6.4             11.2        
SG&A: Merger related and purchase accounting costs
    0.1             0.1       0.4  
SG&A: Severance and restructuring
    0.9             1.6        
SG&A: Stock option expense
    8.3             16.6        
Purchase accounting: Amortization of acquired intangible assets related to the merger with former Biogen, Inc.
    76.3       77.1       147.0       152.8  
Purchase accounting: In-process research and development related to the acquisition of Conforma Therapeutics Corporation and Fumapharm AG
    330.5             330.5        
Purchase accounting: Gain on settlement of license agreement with Fumapharm AG
    (34.2 )           (34.2 )      
Impairment and loss on sale of long lived assets
    (0.8 )     75.6       (1.1 )     75.6  
Income taxes: Income tax effect of reconciling items
    (20.9 )     (49.0 )     (39.3 )     (72.1 )
Cumulative effect of accounting change from adoption of FAS123R, net of income tax
                (3.8 )      
 
                               
 
                       
Non-GAAP Net Income
  $ 197.3     $ 149.0     $ 386.4     $ 254.8  
 
                       
Numbers may not foot due to rounding.
Shares used in calculating adjustments to net loss and diluted non-GAAP earnings per share are 348,730,000 and 348,222,000 for the three and six months ended June 30, 2006, respectively.
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.
June 30, 2006
Product Revenues
(in thousands)
                 
    Three Months Ended  
    June 30,  
PRODUCT REVENUES   2006     2005  
 
           
 
               
Avonex®
  $ 429,377     $ 381,789  
 
               
Amevive®
  $ 2,460     $ 12,456  
 
               
Tysabri®
  $ (196 )   $ (897 )
 
               
Zevalin®
  $ 4,440     $ 5,474  
 
               
 
           
Total Product Revenues
  $ 436,081     $ 398,822  
 
           
                 
    Six Months Ended  
    June 30,  
PRODUCT REVENUES   2006     2005  
 
           
 
               
Avonex®
  $ 822,805     $ 755,374  
 
               
Amevive®
  $ 10,737     $ 24,473  
 
               
Tysabri®
  $ (393 )   $ 5,049  
 
               
Zevalin®
  $ 9,450     $ 11,510  
 
               
 
           
Total Product Revenues
  $ 842,600     $ 796,406  
 
           
Numbers may not foot due to rounding.