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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 22, 2008
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 The Company's press release dated July 22, 2008.


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Item 2.02    Results of Operations and Financial Condition.
     On July 22, 2008, Biogen Idec Inc. issued a press release announcing its results of operations and financial condition for the three months ended June 30, 2008. 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   
    Vice President and Assistant Secretary   
Date: July 22, 2008

 


Table of Contents

EXHIBIT INDEX
     
Exhibit
Number
  Description
 
   
99.1
  The Company’s press release dated July 22, 2008.

 

exv99w1
Exhibit 99.1
Page 1    Biogen Idec Reports Second Quarter 2008 Results
(Logo)
Media Contact:
Naomi Aoki
Director, Public Affairs
Biogen Idec
Tel: (617) 914-6524
Investment Community Contact:
Eric Hoffman
Director, Investor Relations
Biogen Idec
Tel: (617) 679-3916
FOR IMMEDIATE RELEASE
Biogen Idec Reports Second Quarter 2008 Results
28% Revenue Growth and 30% Earnings Growth
Cambridge, MA, July 22, 2008 — Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today reported its second quarter 2008 results.
Second Quarter 2008 Highlights:
  Second quarter revenues were $993 million, an increase of 28% from $773 million in the second quarter of 2007, driven primarily by AVONEXÒ (interferon beta-1a) sales up 14% to $527 million, TYSABRIÒ (natalizumab) sales up 210% to $147 million, and RITUXANÒ (rituximab) revenues from the unconsolidated joint business arrangement up 21% to $279 million.
  On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), second quarter 2008 diluted earnings per share (EPS) were $0.70, an increase of 30% from $0.54 in the second quarter of 2007. GAAP net income for the second quarter was $207 million, an increase of 11% from $186 million in the second quarter of 2007.
  Second quarter 2008 non-GAAP diluted EPS were $0.91, an increase of 30% from $0.70 in the second quarter of 2007. Non-GAAP net income for the second quarter was $269 million, an increase of 12% from $240 million in the second quarter of 2007. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.

 


 

Page 2    Biogen Idec Reports Second Quarter 2008 Results
  Global in-market net sales of TYSABRIÒ (natalizumab) in the second quarter of 2008 were $200 million. Based on our collaboration structure with Elan, Biogen Idec recognized revenue of $147 million related to TYSABRI in the second quarter of 2008.
“Our prospects for growth remain strong,” said James Mullen, Biogen Idec’s Chief Executive Officer. “TYSABRI sales nearly tripled compared to the same period last year, our core products continue to grow, our pipeline is overflowing, and our revenues have grown more than 25 percent year-over-year for three consecutive quarters. Given the strong momentum underway, we are raising our full-year guidance and setting an aspirational goal of generating a record $4 billion in revenues this year.”
Financial Performance
On a reported basis, calculated in accordance with GAAP, Biogen Idec reported net income of $207 million and diluted EPS of $0.70 in the second quarter of 2008. On a non-GAAP basis, Biogen Idec reported net income of $269 million in the second quarter of 2008. Non-GAAP diluted EPS were $0.91 for the second quarter of 2008.
As of June 30, 2008 Biogen Idec had cash, cash equivalents, loaned securities and marketable securities of $1.583 billion.
A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
Revenue Performance
Revenues from AVONEX, one of Biogen Idec’s therapies for patients with relapsing forms of multiple sclerosis (MS), increased 14% in the second quarter to $527 million. U.S. sales increased 13% to $306 million and international sales increased 15% to $221 million.
Revenues for the second quarter of 2008 included $279 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, Inc. All U.S. sales of RITUXAN are recognized by Genentech, and Biogen Idec records its share of the pretax co-promotion profits. As reported by Genentech, U.S. net sales of RITUXAN were $651 million in the second quarter, as compared to $582 million in the second quarter of 2007.
During the second quarter of 2008, Biogen Idec recognized revenue of $147 million related to TYSABRI comprising:
  $46 million related to product sold through Elan in the U.S. (based on $99 million of in-market sales); and
  $101 million related to product sold by Biogen Idec Internationally.
As of the end of June 2008, more than 31,800 patients were on commercial and clinical TYSABRI therapy worldwide. According to data available as of the end of June 2008:

 


 

Page 3    Biogen Idec Reports Second Quarter 2008 Results
  In the U.S., more than 17,800 patients were on TYSABRI therapy commercially and more than 3,100 physicians have prescribed the therapy;
  Outside of the U.S., nearly 13,400 patients were on TYSABRI therapy commercially;
  In global clinical trials, more than 600 patients were on TYSABRI therapy; and
  There have been no confirmed cases of progressive multifocal leukoencephalopathy (PML) since re-launch in the US and the first international approval in July 2006.
Cumulatively, in the combined clinical trial and post-marketing settings:
  More than 43,300 patients have been treated with TYSABRI; and
  Of those patients, nearly 13,900 have received at least one year of TYSABRI therapy and approximately 6,600 patients have been on therapy for 18 months or longer.
Revenues from other products were $10 million and $9 million in the second quarter of 2008 and 2007, respectively. Current quarter revenues consist primarily of FUMADERMÒ (fumaric acid esters).
Table 4 provides individual product revenues.
Royalties were $28 million and $23 million in the second quarter of 2008 and 2007, respectively.
Share Repurchase Program
Biogen Idec repurchased 4,971,804 shares in the second quarter of 2008 under the 20 million share repurchase program authorized by Biogen Idec’s Board of Directors in October 2006.
Financial Guidance
Following its strong performance, Biogen Idec raised its 2008 financial guidance:
    Total revenue growth in the mid 20% range over 2007 as TYSABRI market penetration and favorable foreign exchange continue.
 
    Operating margins similar to previous guidance, and total GAAP and non-GAAP R&D and SG&A expenses to be in the range of $2 billion.
 
    Non-GAAP tax rate expected to be 28%-30%. GAAP Tax rate expected to be 31%-33%. The difference between the GAAP and non-GAAP tax rate is a result of the full year effects of the reconciling items detailed in Table 3 within this press release.
 
    Non-GAAP diluted EPS at or above $3.50, representing growth consistent with the Company’s stated goal of achieving 20% non-GAAP EPS compounded annual growth through 2010. GAAP diluted EPS at or above $2.51. Both Non-GAAP and GAAP diluted EPS estimates exclude the impact of any future acquisitions or transactions.
 
    Capital expenditures of $270 to $290 million.
The reconciling items between the GAAP diluted EPS and non-GAAP diluted EPS for full year 2008 are itemized in Table 3 within this press release.

 


 

Page 4    Biogen Idec Reports Second Quarter 2008 Results
Recent Highlights
    On May 29, 2008, Biogen Idec named Hans Peter Hasler Chief Operating Officer (COO) of the company. Mr. Hasler, age 52, has served as Executive Vice President, Global Neurology and Head of International. In his new role, Mr. Hasler will oversee all commercial operations as well as the company’s business development function.
 
    On June 19, 2008, the Board of Directors announced that Biogen Idec stockholders elected all of its four nominees — Cecil B. Pickett, Ph.D., the Honorable Lynn Schenk, Phillip A. Sharp, Ph.D., and Stelios Papadopoulos, Ph.D. — to the Biogen Idec Board of Directors. Based on the final tabulation, announced on July 9, 2008, Dr. Sharp received 98 percent of the votes cast and each of the Board’s three other nominees received nearly 75 percent of the votes cast.
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 22, 2008, and will be accessible through the investor relations section of Biogen Idec’s homepage, http://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 22, 2008.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, 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
This press release contains forward-looking statements, which appear under the heading “Financial Guidance” above and in the comments from James Mullen, our CEO. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from that which we expect, including our continued dependence on our two principal products, AVONEX and RITUXAN, the uncertainty of success in commercializing other products including TYSABRI, the occurrence of adverse safety events with our products, the failure to execute our growth strategy successfully or to compete effectively in our markets, our dependence on collaborations over which we may not always have full control, possible adverse impact of government regulation and changes in the availability of reimbursement for our products, problems

 


 

Page 5    Biogen Idec Reports Second Quarter 2008 Results
with our manufacturing processes and our reliance on third parties, our ability to attract and retain qualified personnel, the risks of doing business internationally, fluctuations in our operating results, our ability to protect our intellectual property rights and the cost of doing so, product liability claims, our significant investments in marketable securities, fluctuations in our effective tax rate, our substantial indebtedness, environmental risks, the actions of activist shareholders and the other risks and uncertainties that are described in Item 1.A. Risk Factors in our annual report on Form 10-K and our quarterly reports on Form 10-Q and in other reports we file with the SEC. These forward-looking statements speak only as of the date of this press release, and 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, 2008
Consolidated Statements of Income
(in thousands, except per share amounts)
(unaudited)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2008     2007     2008     2007  
REVENUES
                               
 
                               
Product
  $ 684,486     $ 518,625     $ 1,349,556     $ 1,003,013  
 
                               
Unconsolidated joint business
    278,822       230,590       526,045       437,754  
 
                               
Royalties
    28,115       22,648       52,096       45,635  
 
                               
Corporate partner
    2,021       1,313       7,933       2,684  
 
                       
 
                               
Total revenues
    993,444       773,176       1,935,630       1,489,086  
 
                       
 
                               
COST AND EXPENSES
                               
 
                               
Cost of sales
    92,401       84,063       193,335       166,013  
 
                               
Research and development
    252,259       218,149       510,491       409,598  
 
                               
Selling, general and administrative
    245,689       203,668       461,518       391,729  
 
                               
Amortization of acquired intangible assets
    72,869       60,961       147,650       120,881  
 
                               
Collaboration profit (loss) sharing
    33,429       (105 )     54,835       (5,672 )
 
                               
In-process research and development
                25,000       18,405  
 
                       
 
                               
Total cost and expenses
    696,647       566,736       1,392,829       1,100,954  
 
                       
 
                               
Income from operations
    296,797       206,440       542,801       388,132  
 
                               
Other income (expense), net
    (5,463 )     31,586       (5,093 )     53,288  
 
                       
 
                               
INCOME BEFORE INCOME TAXES
    291,334       238,026       537,708       441,420  
 
                               
Income taxes
    84,706       51,886       167,983       123,779  
 
                       
 
                               
NET INCOME
  $ 206,628     $ 186,140     $ 369,725     $ 317,641  
 
                       
 
                               
BASIC EARNINGS PER SHARE
  $ 0.71     $ 0.55     $ 1.26     $ 0.93  
 
                       
 
                               
DILUTED EARNINGS PER SHARE
  $ 0.70     $ 0.54     $ 1.24     $ 0.92  
 
                       
 
                               
WEIGHTED-AVERAGE SHARES USED IN CALCULATING:
                               
BASIC EARNINGS PER SHARE
    290,356       340,315       293,268       340,312  
 
                       
 
                               
DILUTED EARNINGS PER SHARE
    293,476       343,389       296,554       343,713  
 
                       


 

TABLE 2
Biogen Idec Inc.
June 30, 2008
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
                 
    June 30,     December 31,  
    2008     2007  
ASSETS
               
 
               
Cash, cash equivalents and marketable securities
  $ 701,008     $ 979,070  
 
               
Cash collateral received for loaned securities
    146,956       208,209  
 
               
Accounts receivable, net
    482,797       392,646  
 
               
Loaned securities
    191,244       204,433  
 
               
Inventory
    255,028       233,987  
 
               
Other current assets
    383,995       350,062  
 
           
 
               
Total current assets
    2,161,028       2,368,407  
 
           
 
               
Marketable securities
    691,044       932,271  
 
               
Property, plant and equipment, net
    1,629,398       1,497,383  
 
               
Intangible assets, net
    2,347,561       2,492,354  
 
               
Goodwill
    1,139,597       1,137,372  
 
               
Investments and other assets
    204,198       201,028  
 
           
 
               
TOTAL ASSETS
  $ 8,172,826     $ 8,628,815  
 
           
 
               
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
 
               
Collateral payable on loaned securities
  $ 146,956     $ 208,209  
 
               
Current portion of notes payable
    11,544       1,511,135  
 
               
Other current liabilities
    726,941       469,831  
 
               
Long-term deferred tax liability
    501,452       521,525  
 
               
Notes payable
    1,038,086       51,843  
 
               
Other long-term liabilities
    224,916       331,977  
 
               
Shareholders’ equity
    5,522,931       5,534,295  
 
           
 
               
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 8,172,826     $ 8,628,815  
 
           


 

TABLE 3
Biogen Idec Inc.
June 30, 2008
Condensed Consolidated Statements of Income — Non-GAAP
(in millions, except per share amounts)
(unaudited)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
EARNINGS PER SHARE   2008     2007     2008     2007  
 
                               
GAAP earnings per share — Diluted
  $ 0.70     $ 0.54     $ 1.24     $ 0.92  
Adjustment to net income (as detailed below)
    0.21       0.16       0.51       0.37  
 
                       
Non-GAAP earnings per share — Diluted
  $ 0.91     $ 0.70     $ 1.75     $ 1.29  
 
                       
 
                               
An itemized reconciliation between net income on a GAAP basis and net income on a non-GAAP basis is as follows:
 
                               
GAAP net income
  $ 206.6     $ 186.1     $ 369.7     $ 317.6  
Adjustments:
                               
COGS: Stock Option Expense
          0.1             0.1  
R&D: Restructuring
          0.4             0.4  
R&D: Stock option expense
    1.4       2.9       4.1       5.9  
R&D: FIN 46 consolidation of Cardiokine
    1.5             2.3        
SG&A: Restructuring
          0.5             0.6  
SG&A: Stock option expense
    3.8       5.3       6.9       11.4  
Amortization of acquired intangible assets
    72.8       61.0       147.6       120.9  
In-process research and development related to the contingent consideration payment in 2008 associated with Conforma acquisition and the acquisition of Syntonix in 2007
                25.0       18.4  
Other income (expense), net: FIN 46 consolidation of Cardiokine
    (1.5 )           (2.3 )      
Income taxes: Income tax effect of reconciling items
    (16.1 )     (16.0 )     (34.5 )     (32.6 )
 
                       
Non-GAAP net income
  $ 268.5     $ 240.3     $ 518.8     $ 442.7  
 
                       
2008 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 Adjustments:
  $ 740.0       295.0     $ 2.51  
R&D: Stock option expense
    8.5  
SG&A: Stock option expense
    17.0                  
In process research and development
    25.0  
Amortization of acquired intangible assets
    317.5                  
Income taxes: Income tax effect of reconciling items
    (76.5 )
 
     
Projected Non-GAAP net income
  $ 1,031.5       295.0     $ 3.50  
     
 
                         
Use of Non-GAAP Financial Measures
Our “non-GAAP net income” and “non-GAAP diluted EPS” financial measures exclude the following items from GAAP net income and diluted EPS:
1. Purchase accounting and merger-related adjustments.
We exclude certain purchase accounting impacts, such as those related to our 2003 merger with Biogen, 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 the 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 and diluted EPS should not be viewed in isolation or as a substitute for reported, or GAAP, net income and diluted EPS.


 

TABLE 4
Biogen Idec Inc.
June 30, 2008
Product Revenues
(in thousands)
(unaudited)
                 
    Three Months Ended  
    June 30,  
    2008     2007  
PRODUCT REVENUES
               
 
               
Avonex®
  $ 527,152     $ 461,618  
 
               
Tysabri®
    147,173       47,539  
 
               
Amevive®
    113       2  
 
               
Zevalin®
    59       4,290  
 
               
Fumaderm®
    9,989       5,176  
 
           
 
               
Total product revenues
  $ 684,486     $ 518,625  
 
           
                 
    Six Months Ended  
    June 30,  
    2008     2007  
PRODUCT REVENUES
               
 
               
Avonex®
  $ 1,063,261     $ 910,427  
 
               
Tysabri®
    261,836       77,299  
 
               
Amevive®
    252       218  
 
               
Zevalin®
    2,504       9,893  
 
               
Fumaderm®
    21,703       5,176  
 
           
 
               
Total product revenues
  $ 1,349,556     $ 1,003,013