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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): July 16, 2009
Biogen Idec Inc.
(Exact name of registrant as specified in its charter)
         
Delaware   0-19311   33-0112644
(State or other jurisdiction
of incorporation)
  (Commission
file number)
  (IRS Employer
Identification No.)
     
14 Cambridge Center, Cambridge, Massachusetts   02142
(Address of principal executive offices)   (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 Biogen Idec's press release dated July 16, 2009


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Item 2.02 Results of Operations and Financial Condition.
     On July 16, 2009, Biogen Idec Inc. issued a press release announcing its results of operations and financial condition for the three months ended June 30, 2009. A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference.
     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 document 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.
     The exhibits listed on the Exhibit Index immediately preceding such exhibits are furnished as part of this Current Report on Form 8-K.

 


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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/ Robert A. Licht    
    Robert A. Licht   
    Senior Vice President   
 
Date: July 16, 2009

 


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EXHIBIT INDEX
         
Exhibit    
Number   Description
       
 
  99.1    
Biogen Idec’s press release dated July 16, 2009.

 

exv99w1
Exhibit 99.1
(BIOGEN IDEC LOGO)
Media Contact:
Jennifer Neiman
Senior Manager, Public Affairs
Biogen Idec
Tel: (617) 914-6524
Investment Community Contact:
John Applegate
Associate Director, Investor Relations
Biogen Idec
Tel: (617) 679-2812
FOR IMMEDIATE RELEASE
Biogen Idec Reports Second Quarter 2009 Results
Double Digit Revenue Growth; TYSABRI
® Reaches $1 Billion Sales Run Rate
Cambridge, MA, July 16, 2009 — Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today reported its second quarter 2009 results.
Second Quarter 2009 Highlights:
  Total revenues were $1.1 billion, an increase of 10% from $1.0 billion in the second quarter of 2008. The increase was driven primarily by the continued growth of TYSABRI (natalizumab) revenues, which were up 27% over the prior year to $188 million for the quarter, and AVONEXÒ (interferon beta-1a) sales, which increased 12% over the prior year to $591 million for the quarter.
 
  TYSABRI global in-market net sales reached a $1 billion run rate. Global in-market net sales of TYSABRI in the second quarter of 2009 were $254 million, of which $125 million was in the U.S. and $129 million was in rest of world markets.
 
  The financial results for the second quarter included a payment of $110 million related to our recently announced collaboration and license agreement with Acorda Therapeutics, Inc.
— MORE —

 


 

Page 2     Biogen Idec Reports Second Quarter 2009 Results
  On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), second quarter 2009 diluted earnings per share (EPS) was $0.49. GAAP net income attributable to Biogen Idec for the second quarter of 2009 was $143 million.
 
  Non-GAAP diluted EPS for the second quarter of 2009 was $0.75. Non-GAAP net income attributable to Biogen Idec for the second quarter was $219 million. These totals include the impact of the collaboration payment to Acorda. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
“During the second quarter we drove a clear acceleration of TYSABRI patient growth that puts the drug on a blockbuster run-rate,” said Biogen Idec CEO James C. Mullen, “Going forward, we continue to focus on products, pipeline and performance as the drivers of long-term shareholder value.”
Revenue Performance
Revenues from AVONEX, one of Biogen Idec’s therapies for patients with relapsing forms of multiple sclerosis (MS), increased 12% in the second quarter to $591 million as compared to the second quarter of 2008. U.S. sales of AVONEX increased 20% to $366 million and international sales increased 2% to $225 million year over year.
Revenues for the second quarter of 2009 included $276 million from Biogen Idec’s joint business arrangement related to RITUXAN®, a treatment for certain B-cell non-Hodgkin’s lymphomas (NHL) and rheumatoid arthritis (RA) that Biogen Idec co-promotes in the U.S. with Genentech. All U.S. sales of RITUXAN are recognized by Genentech, and Biogen Idec records its share of the pretax co-promotion profits. U.S. net sales of RITUXAN were $696 million in the second quarter 2009, as compared to $651 million in the second quarter of 2008, an increase of 7%.
During the second quarter of 2009, Biogen Idec recognized revenue of $188 million related to TYSABRI. This amount is comprised of:
  $57 million related to product sold through Elan in the U.S. (based on $125 million of in-market sales) and milestone amortization; and
 
  $130 million related to product sold in rest of world markets and milestone amortization.
As of the end of June 2009, approximately 43,300 patients were on commercial and clinical TYSABRI therapy worldwide. According to data available as of the end of June 2009:
  In the U.S., approximately 22,000 patients were on TYSABRI therapy commercially;
 
  In the rest of world, approximately 20,700 patients were on TYSABRI therapy commercially; and,
 
  In global clinical trials, approximately 600 patients were on TYSABRI therapy.
Cumulatively, in the post-marketing setting:
  Approximately 56,500 patients have been treated with TYSABRI; and

 


 

Page 3     Biogen Idec Reports Second Quarter 2009 Results
  Of those patients, approximately 30,600 have received at least one year of TYSABRI therapy, approximately 18,400 patients have received at least 18 months of TYSABRI therapy, and approximately 10,000 patients have received at least 24 months of TYSABRI therapy.
Revenues from other products in the second quarter of 2009 were $12 million, as compared to $10 million in the second quarter of 2008.
Table 4 provides individual product revenues.
Royalties were $25 million in the second quarter of 2009 compared to $28 million in the second quarter of 2008.
Financial Guidance
As a result of its strong second quarter performance, Biogen Idec updated its 2009 full year guidance as follows:
    Revenue growth is expected to be in the high single digits on a year over year basis.
 
    Operating expenses, excluding collaboration profit share, are expected to be between $2.1 and $2.2 billion. This now includes the payment of $110 million to Acorda.
 
    R&D is expected to be approximately 28% to 30% of total revenue.
 
    SG&A is expected to be between 19% and 20% of total revenue.
 
    Our Non-GAAP tax rate is expected to be between 29% and 31%. Our GAAP tax rate is expected to be between 30% and 32%.
 
    Non-GAAP diluted EPS is expected to be above $3.85. GAAP diluted EPS is expected to be above $2.75. This includes the impact of the Acorda payment of approximately $0.38 per share.
 
    The difference between the GAAP and non-GAAP EPS is the result of the full year effects of the reconciling items detailed in Table 3 within our press release.
 
    Capital Expenditures are expected to be in the range of $180-$200 million.
This guidance excludes any significant business development activities.

 


 

Page 4     Biogen Idec Reports Second Quarter 2009 Results
Recent Events
    On July 8, 2009, Biogen Idec announced the U.S. Food and Drug Administration (FDA) had granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). The FDA’s Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
 
    On July 1, 2009, Biogen Idec and Acorda Therapeutics, Inc. announced an exclusive collaboration and license agreement to develop and commercialize Fampridine-SR, an MS therapy, in markets outside the United States. Fampridine-SR is a novel, oral sustained-release compound being developed to improve walking ability in people with MS.
 
      Acorda previously announced that the European Medicines Agency notified Acorda that Fampridine-SR is eligible to be submitted for a Marketing Authorization Application via the agency’s centralized procedure as a new active substance.
 
    On June 22, 2009, Biogen Idec announced enrollment of the first patient in a global Phase III, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of PEGylated interferon beta-1a (BIIB017) in patients with RMS. The trial, called ADVANCE, will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients with RMS.
 
    On May 19, 2009, Biogen Idec and Genentech, Inc. announced that the companies submitted two supplemental Biologics License Applications to the FDA for RITUXAN plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia.
 
    On April 30, 2009, Biogen Idec announced data results from the CHAMPIONS (Controlled High-Risk AVONEX Multiple Sclerosis Prevention Study In Ongoing Neurologic Surveillance) study, an open label follow-up to CHAMPS (Controlled High Risk Subjects AVONEX Multiple Sclerosis Prevention Study). Based on the CHAMPS study, AVONEX was granted approval for use in patients who experienced their first clinical MS episode with MRI findings. The CHAMPIONS ten-year follow up showed that patients treated immediately after their first episode had significantly less chance of experiencing a second attack versus those patients with delayed treatment. These results at ten years also indicate that 80 percent of patients taking AVONEX were below an expanded disability status scale score of three. These data were presented as a poster at the 61st Annual American Academy of Neurology (AAN) meeting.
 
    On April 28, 2009, Biogen Idec and Elan Corporation, plc presented results of a study demonstrating that TYSABRI promoted regeneration and stabilization of damage done to the myelin sheath as measured by advanced MRI technology at the annual AAN meeting. Damage to the myelin sheath causes the symptoms of MS. Additional posters were also presented during the meeting highlighting the

 


 

Page 5     Biogen Idec Reports Second Quarter 2009 Results
      ability of TYSABRI, in some patients, to improve physical function and patient reported outcomes on cognition, quality of life, and fatigue. TYSABRI is the first approved MS therapy with reported data suggesting that some of the signs of disease progression can be stopped. The strong efficacy profile demonstrated in clinical trials is enhanced further from these data and may help redefine success in MS.
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 16, 2009, and will be accessible through the investor relations section of Biogen Idec’s homepage, www.biogenidec.com. Supplemental information in the form of a slide presentation will also be accessible at the same location on the internet at the time of the earnings conference call and will be available on our web site subsequently through August 21, 2009.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec’s significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
Safe Harbor
In addition to historical information, this press release contains forward-looking statements that are based on our current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those which we expect. Important factors which could cause actual results to differ from our expectations and which could negatively impact our financial condition and results of operations include our dependence on our three principal products, AVONEX, RITUXAN and TYSABRI, the importance of market acceptance and successful sales growth of TYSABRI, uncertainty of success in commercializing other products, the occurrence of adverse safety events with our products, competitive pressures, changes in the availability of reimbursement for our products, our dependence on collaborations over which we may not always have full control, failure to execute our growth initiatives, failure to comply with government regulation and possible adverse impact of changes in such regulation, problems with our manufacturing processes and our reliance on third parties, the impact of the global credit crisis, fluctuations in our effective tax rate, our significant investment in a new manufacturing facility in Denmark, our ability to attract and retain qualified personnel, the risks of doing business internationally, the election of two directors nominated by an activist shareholder, fluctuations in our operating results, our ability to protect our intellectual property rights and the cost of doing so, product liability claims, the market, interest and credit risks associated with our portfolio of marketable securities, our level of indebtedness, environmental risks, aspects of our corporate governance and collaborations and the other risks and uncertainties that are

 


 

Page 6     Biogen Idec Reports Second Quarter 2009 Results
described in Item 1.A. Risk Factors in our annual report on Form 10-K and in other reports we file with the SEC. Forward-looking statements, like all statements in this press release, speak only as of the date of this press release (unless another date is indicated). Unless required by law, we do 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, 2009
Consolidated Statements of Income
(in thousands, except per share amounts)
(unaudited)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2009     2008     2009     2008  
REVENUES
                               
Product
  $ 790,970     $ 684,486     $ 1,524,378     $ 1,349,556  
Unconsolidated joint business
    275,570       278,822       554,388       526,045  
Royalties
    25,009       28,115       49,093       52,096  
Corporate partner
    1,740       2,021       1,915       7,933  
 
                       
Total revenues
    1,093,289       993,444       2,129,774       1,935,630  
 
                       
COST AND EXPENSES
                               
Cost of sales
    90,721       92,401       188,918       193,335  
Research and development
    416,453       252,259       695,931       510,491  
Selling, general and administrative
    220,829       245,689       442,660       461,518  
Amortization of acquired intangible assets
    93,234       72,869       182,482       147,650  
Collaboration profit (loss) sharing
    49,138       33,429       91,911       54,835  
In-process research and development
                      25,000  
 
                       
Total cost and expenses
    870,375       696,647       1,601,902       1,392,829  
 
                       
Income from operations
    222,914       296,797       527,872       542,801  
Other income (expense), net
    14,680       (4,018 )     21,526       (938 )
 
                       
INCOME BEFORE INCOME TAXES
    237,594       292,779       549,398       541,863  
Income taxes
    92,709       84,706       157,934       167,983  
 
                       
NET INCOME
  $ 144,885     $ 208,073     $ 391,464     $ 373,880  
 
                       
Less: Net income attributable to noncontrolling interests
    2,040       1,445       4,632       4,155  
 
                       
NET INCOME ATTRIBUTABLE TO BIOGEN IDEC INC.
  $ 142,845     $ 206,628     $ 386,832     $ 369,725  
 
                       
BASIC EARNINGS PER SHARE
  $ 0.49     $ 0.71     $ 1.34     $ 1.26  
 
                       
DILUTED EARNINGS PER SHARE
  $ 0.49     $ 0.70     $ 1.33     $ 1.24  
 
                       
WEIGHTED-AVERAGE SHARES USED IN CALCULATING:
                               
BASIC EARNINGS PER SHARE
    288,615       290,356       288,162       293,268  
 
                       
DILUTED EARNINGS PER SHARE
    290,359       293,476       290,014       296,554  
 
                       

 


 

TABLE 2
Biogen Idec Inc.
June 30, 2009
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
                 
    June 30, 2009     December 31, 2008  
ASSETS
               
Cash, cash equivalents and marketable securities
  $ 1,623,074     $ 1,341,971  
Collateral received for loaned securities
          29,991  
Accounts receivable, net
    511,286       446,665  
Loaned securities
          29,446  
Inventory
    268,529       263,602  
Other current assets
    341,389       346,325  
 
           
Total current assets
    2,744,278       2,458,000  
 
           
Marketable securities
    1,047,611       891,406  
Property, plant and equipment, net
    1,608,660       1,594,754  
Intangible assets, net
    1,978,519       2,161,058  
Goodwill
    1,138,621       1,138,621  
Investments and other assets
    259,507       235,152  
 
           
TOTAL ASSETS
  $ 8,777,196     $ 8,478,991  
 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
Collateral payable on loaned securities
  $     $ 29,991  
Current portion of notes payable
    14,697       27,667  
Other current liabilities
    789,229       865,564  
Long-term deferred tax liability
    310,962       356,017  
Notes payable
    1,085,607       1,085,431  
Other long-term liabilities
    330,996       280,369  
Shareholders’ equity
    6,245,705       5,833,952  
 
           
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 8,777,196     $ 8,478,991  
 
           

 


 

TABLE 3
Biogen Idec Inc.
June 30, 2009
Condensed Consolidated Statements of Income — Non-GAAP
(in millions, except per share amounts)
(unaudited)
EARNINGS PER SHARE
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2009     2008     2009     2008  
 
                               
GAAP earnings per share — Diluted
  $ 0.49     $ 0.70     $ 1.33     $ 1.24  
Adjustments to net income attributable to Biogen Idec, Inc. (as detailed below)
    0.26       0.21       0.47       0.51  
 
                       
Non-GAAP earnings per share — Diluted
  $ 0.75     $ 0.91     $ 1.80     $ 1.75  
 
                       
An itemized reconciliation between net income attributable to Biogen Idec, Inc. on a GAAP basis and net income attributable to Biogen Idec, Inc. on a non-GAAP basis is as follows:
                                 
GAAP net income attributable to Biogen Idec, Inc.
  $ 142.8     $ 206.6     $ 386.8     $ 369.7  
Adjustments:
                               
R&D: Restructuring
    0.7             1.7        
R&D: Stock option expense
    1.4       1.4       3.6       4.1  
R&D: Expenses paid by Cardiokine
    2.2       1.5       3.8       2.3  
SG&A: Restructuring
    0.2             0.3        
SG&A: Stock option expense
    5.0       3.8       9.5       6.9  
Amortization of acquired intangible assets
    93.2       72.8       182.5       147.6  
In-process research and development related to the contingent consideration payment in 2008 associated with the 2006 Conforma acquisition
                      25.0  
Income taxes: Income tax effect primarily related to reconciling items
    (24.8 )     (16.1 )     (60.3 )     (34.5 )
Noncontrolling interest: Expenses paid by Cardiokine
    (2.2 )     (1.5 )     (3.8 )     (2.3 )
 
                       
Non-GAAP net income attributable to Biogen Idec, Inc.
  $ 218.5     $ 268.5     $ 524.1     $ 518.8  
 
                       
2009 Full Year Guidance GAAP to non-GAAP adjustments
An itemized reconciliation between projected EPS on a GAAP basis and on a non-GAAP basis is as follows:
                         
          Shares     Diluted EPS  
Projected GAAP net income attributable to Biogen Idec, Inc.
  $ 800.2       291.0     $ 2.75  
Adjustments:
                       
In-process research and development
    40.0                  
Stock option expense
    29.1                  
Amortization of acquired intangible assets
    365.2                  
Other items
    1.6                  
Income taxes
    (114.1 )                
 
                 
Projected Non-GAAP net income attributable to Biogen Idec, Inc.
  $ 1,122.0       291.0     $ 3.85  
 
                 
Use of Non-GAAP Financial Measures
Our “non-GAAP net income attributable to Biogen Idec, Inc.” and “non-GAAP diluted EPS” financial measures exclude the following items from GAAP net income attributable to Biogen Idec, Inc. and diluted EPS:
1. Purchase accounting and merger-related adjustments.
We exclude certain purchase accounting impacts, such as those related to the 2003 merger between Biogen, Inc. and Idec Pharmaceuticals, Inc., the acquisitions of Fumapharm AG, Conforma Therapeutics and Syntonix Pharmaceuticals, and the consolidation of Cardiokine and Neurimmune. These include charges for in-process research and development and the incremental charges related to the amortization of the acquired intangible assets. Excluding these charges provides management and investors with a supplemental measure of performance in which the Company’s acquired intellectual property is treated in a comparable manner to its internally developed intellectual property.
2. Stock option expense recorded in accordance with SFAS 123R.
We believe that excluding the impact of expensing stock options better reflects the recurring economic characteristics of our business. We also exclude stock option expense from our non-GAAP R&D expenses and SG&A expenses, but include P&L impact of restricted stock awards and cash incentives in our non-GAAP results.
3. Unusual or non-recurring items.
We evaluate these on an individual basis, and consider both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to our ongoing business operations, and (iii) whether or not we expect it to occur as part of our normal business on a regular basis.
We believe it is important to share these non-GAAP financial measures with shareholders as they better represent the ongoing economics of the business, reflect how we manage the business internally and set operational goals, and form the basis of our management incentive programs. Non-GAAP net income attributable to Biogen Idec, Inc. and diluted EPS should not be viewed in isolation or as a substitute for reported, or GAAP, net income attributable to Biogen Idec, Inc. and diluted EPS.

 


 

TABLE 4
Biogen Idec Inc.
June 30, 2009
Product Revenues
(in thousands)
(unaudited)
                 
    Three Months Ended  
    June 30,  
    2009     2008  
PRODUCT REVENUES
               
Avonex®
  $ 591,160     $ 527,152  
Tysabri®
    187,625       147,173  
Fumaderm®
    12,185       9,989  
Other
          172  
 
           
Total product revenues
  $ 790,970     $ 684,486  
 
           
                 
    Six Months Ended  
    June 30,  
    2009     2008  
PRODUCT REVENUES
               
Avonex®
  $ 1,146,449     $ 1,063,261  
Tysabri®
    352,829       261,836  
Fumaderm®
    22,769       21,703  
Other
    2,331       2,756  
 
           
Total product revenues
  $ 1,524,378     $ 1,349,556